Mastocytosis Medications

There are currently no drugs listed for "Mastocytosis".

Definition of Mastocytosis: A disease that produces skin lesions, intense itching, and hive formation at the site of the lesion upon rubbing.

Drug List:

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cromolyn sodium inhalation

Generic Name: cromolyn sodium (inhalation) (KROE moe lin SOE dee um)
Brand Names: Intal, Intal Inhaler

What is cromolyn sodium inhalation?

Cromolyn sodium is an anti-inflammatory medication. It works by preventing the release of substances in the body that cause inflammation.

Cromolyn sodium inhalation is used to prevent asthma attacks in people with bronchial asthma. Cromolyn sodium is also used to prevent bronchospasm (wheezing, chest tightness, trouble breathing) caused by exercise, pollutants in the air, or exposure to certain chemicals.

Cromolyn sodium inhalation may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about cromolyn sodium inhalation? You should not use this medication if you are allergic to cromolyn sodium.

Before using cromolyn sodium inhalation, tell your doctor if you have heart disease or a heart rhythm disorder, coronary artery disease, kidney disease, or liver disease.

Do not use cromolyn sodium inhalation to treat an asthma attack that has already begun. It will not work fast enough. Use only a fast-acting inhalation medicine to treat an asthma attack. Your dosage needs may change if you have surgery, are ill, are under stress, or have recently had an asthma attack. Do not change your doses or stop using cromolyn sodium inhalation without first talking to your doctor. Stopping suddenly or not using enough medicine can make your condition worse.

Talk with your doctor if any of your asthma medications do not seem to work as well in treating or preventing asthma attacks.

What should I discuss with my healthcare provider before using cromolyn sodium inhalation? You should not use this medication if you are allergic to cromolyn sodium.

If you have certain conditions, you may need a dose adjustment or special tests to safely use this medication. Before using cromolyn sodium inhalation, tell your doctor if you have:

heart disease or a heart rhythm disorder;

coronary artery disease;

kidney disease; or liver disease. FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether cromolyn sodium passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. How should I use cromolyn sodium inhalation?

Use this medication exactly as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended. Follow the directions on your prescription label.

Do not use cromolyn sodium inhalation to treat an asthma attack that has already begun. It will not work fast enough. Use only a fast-acting inhalation medicine to treat an asthma attack.

Cromolyn sodium inhalation is given using a nebulizer or with a metered-dose inhaler. You will inhale the medication through a face mask or mouth piece. Do not swallow this medicine.

To prevent bronchial asthma attacks, cromolyn sodium inhalation is usually given 4 times daily. If you are using cromolyn sodium inhalation to prevent asthma caused by exercise, air pollutants, or exposure to chemicals, use the medicine 10 to 15 minutes (but not more than 1 hour) before exercising or exposure. Follow your doctor's instructions about your individual dosing schedule.

The instructions below are for standard use of the inhaler and nebulizer devices. Your doctor may want you to use your device differently. Be sure you understand all instructions that are specific to your use of this medication.

To use cromolyn sodium with a metered-dose inhaler:

Uncap the mouthpiece of the inhaler and shake the inhaler gently.

Breathe out fully. Put the mouthpiece into your mouth and close your lips. Do not block the mouthpiece with your tongue. Tilt your head back and breathe in slowly while pushing down on the top of the canister. Take the inhaler out of your mouth and hold your breath for several seconds, then breathe out slowly.

Clean your inhaler twice a week by removing the canister and rinsing the mouthpiece under warm running water. Allow the parts to dry before putting the inhaler back together. Never place the medicine canister in water.

To use cromolyn sodium inhalation solution with a nebulizer:

Break open the ampule and empty the medicine into the chamber of the nebulizer. Attach the mouthpiece or face mask to the drug chamber. Then, attach the drug chamber to the compressor.

Sit upright in a comfortable position. Place the mouthpiece into your mouth or put the face mask on, covering your nose and mouth. Turn on the compressor.

Breathe in slowly and evenly until you have inhaled all of the medicine. The treatment is complete when no more mist is formed by the nebulizer and the drug chamber is empty.

Clean the nebulizer after each use. Follow the cleaning directions that came with your nebulizer.

It may take up to 4 weeks of using cromolyn sodium before you get the full effect. For best results, keep using the medication as directed. Call your doctor if your symptoms do not improve after 4 weeks of treatment, or if they get worse.

Your dosage needs may change if you have surgery, are ill, are under stress, or have recently had an asthma attack. Do not change your doses or stop using cromolyn sodium inhalation without first talking to your doctor. Stopping suddenly or not using enough medicine can make your condition worse.

Asthma is usually treated with a combination of different drugs. To best treat your condition, use all of your medications as directed by your doctor. Be sure to read the medication guide or patient instructions provided with each of your medications. Talk with your doctor if any of your asthma medications do not seem to work as well in treating or preventing asthma attacks.

If you also use a steroid medication, do not stop using the steroid suddenly or you may have unpleasant withdrawal symptoms. Talk with your doctor about using less and less of the steroid before stopping completely.

To be sure this medication is helping your condition, your blood may need to be tested on a regular basis. Do not miss any scheduled appointments.

Store this medication at room temperature away from moisture and heat. Keep the inhaler canister away from open flame or high heat, such as in a car on a hot day. The canister may explode if it gets too hot. Do not puncture an inhaler canister.

Keep track of the number of sprays you have used and throw away the canister after 112 sprays if you use the 8.1-gram inhaler, or 200 sprays if you use the 14.2-gram inhaler, even if it feels like there is still medicine in the canister.

What happens if I miss a dose?

Use the missed dose as soon as you remember. However, if it is almost time for your next regularly scheduled dose, skip the missed dose and use the next one as directed. Do not use a double dose of this medication.

What happens if I overdose? Seek emergency medical attention if you think you have used too much of this medicine. An overdose of cromolyn sodium inhalation is not likely to cause life-threatening symptoms. What should I avoid while taking cromolyn sodium inhalation? Avoid spraying the inhaler into your face or getting the medication in your eyes.

Do not mix cromolyn sodium inhalation with other medicines in a nebulizer.

Cromolyn sodium inhalation side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:

severe wheezing or chest tightness just after inhaling the medication;

skin rash, bruising, severe tingling, numbness, pain, muscle weakness; or

fever, swollen glands, rash or itching, joint pain, and a general ill feeling.

Less serious side effects may include:

dry or irritated throat, temporary or occasional cough;

sneezing, stuffy or itchy nose, watery eyes;

burning or bleeding of your nose;

nausea, heartburn, stomach pain;

urinating more or less than usual;

dizziness, drowsiness, headache; or

unusual or unpleasant taste in your mouth.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Cromolyn sodium Dosing Information

Usual Adult Dose for Asthma -- Maintenance:

Nebulization solution: 20 mg 4 times a day at regular intervals.
Metered dose inhaler: 2 puffs 4 times a day at regular intervals.

Usual Adult Dose for Inflammatory Bowel Disease:

200 mg orally 4 times a day. If satisfactory control of symptoms is not achieved within 2 to 3 weeks the dosage may be increased to 400 mg 4 times a day.

Usual Adult Dose for Systemic Mastocytosis:

200 mg orally 4 times a day. May double dose (to 400 mg 4 times/day) if effect is not satisfactory within 2 to 3 weeks.

Usual Pediatric Dose for Asthma -- Maintenance:

Nebulization solution:
> 2 years: 20 mg 4 times a day at regular intervals.
Metered dose inhaler:
> 5 years: 2 puffs 4 times a day at regular intervals.

Usual Pediatric Dose for Inflammatory Bowel Disease:

2 to 12 years: 100 mg orally 4 times a day, one-half hour before meals and bedtime. If satisfactory control of symptoms is not achieved within 2 to 3 weeks the dosage may be increased but should not exceed 40 mg/kg/day.
> 12 years: 200 mg orally 4 times a day. May double dose (to 400 mg 4 times/day) if effect is not satisfactory within 2 to 3 weeks.
Use of this product in pediatric patients

Usual Pediatric Dose for Systemic Mastocytosis:

2 to 12 years: 100 mg orally 4 times a day. Do not exceed 40 mg/kg/day.
>12 years: 200 mg orally 4 times a day. May double dose (to 400 mg 4 times/day) if effect is not satisfactory within 2 to 3 weeks.

What other drugs will affect cromolyn sodium inhalation?

There may be other drugs that can interact with cromolyn sodium inhalation. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

More cromolyn sodium resources Cromolyn sodium Use in Pregnancy & Breastfeeding Cromolyn sodium Drug Interactions Cromolyn sodium Support Group 6 Reviews for Cromolyn sodium - Add your own review/rating Compare cromolyn sodium with other medications Asthma, Maintenance Inflammatory Bowel Disease Systemic Mastocytosis Where can I get more information? Your pharmacist can provide more information about cromolyn sodium inhalation.

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Cromolyn Sodium

Cromolyn Sodium, USP
Oral Concentrate

Rx Only

Iss. 10/10

CROMp-10-01

For Oral Use Only – Not for Inhalation or Injection.

DESCRIPTION:

Each 5 mL ampule of Cromolyn Sodium, USP contains 100 mg Cromolyn Sodium, USP, in purified water. Cromolyn Sodium is a hygroscopic, white powder having little odor. It may leave a slightly bitter aftertaste. Cromolyn Sodium, USP Oral Concentrate is clear, colorless, and sterile. It is intended for oral use.

Chemically, Cromolyn Sodium is disodium 5,5’-[(2-hydroxytrimethylene)dioxy]bis[4-oxo-4H-1-benzopyran-2-carboxylate]. The empirical formula is C23H14Na2O11; the molecular weight is 512.34. Its chemical structure is:

Pharmacologic Category: Mast cell stabilizer

Therapeutic Category: Antiallergic

CLINICAL PHARMACOLOGY:

In vitro and in vivo animal studies have shown that Cromolyn Sodium inhibits the release of mediators from sensitized mast cells. Cromolyn Sodium acts by inhibiting the release of histamine and leukotrienes (SRS-A) from the mast cell.

Cromolyn Sodium has no intrinsic vasoconstrictor, antihistamine, or glucocorticoid activity.

Cromolyn Sodium is poorly absorbed from the gastrointestinal tract. No more than 1% of an administered dose is absorbed by humans after oral administration, the remainder being excreted in the feces. Very little absorption of Cromolyn Sodium was seen after oral administration of 500 mg by mouth to each of 12 volunteers. From 0.28 to 0.50% of the administered dose was recovered in the first 24 hours of urinary excretion in 3 subjects. The mean urinary excretion of an administered dose over 24 hours in the remaining 9 subjects was 0.45%.

CLINICAL STUDIES:

Four randomized, controlled clinical trials were conducted with Cromolyn Sodium, USP in patients with either cutaneous or systemic mastocytosis; two of which utilized a placebo-controlled crossover design, one utilized an active-controlled (chlorpheniramine plus cimetidine) crossover design, and one utilized a placebo-controlled parallel group design. Due to the rare nature of this disease, only 36 patients qualified for study entry, of whom 32 were considered evaluable. Consequently, formal statistical analyses were not performed. Clinically significant improvement in gastrointestinal symptoms (diarrhea, abdominal pain) were seen in the majority of patients with some improvement also seen for cutaneous manifestations (urticaria, pruritus, flushing) and cognitive function. The benefit seen with Cromolyn Sodium, USP 200 mg QID was similar to chlorpheniramine (4 mg QID) plus cimetidine (300 mg QID) for both cutaneous and systemic symptoms of mastocytosis.

Clinical improvement occurred within 2-6 weeks of treatment initiation and persisted for 2-3 weeks after treatment withdrawal. Cromolyn Sodium, USP did not affect urinary histamine levels or peripheral eosinophilia, although neither of these variables appeared to correlate with disease severity. Positive clinical benefits were also reported for 37 of 51 patients who received Cromolyn Sodium, USP in United States and foreign humanitarian programs.

INDICATIONS AND USAGE:

Cromolyn Sodium, USP is indicated in the management of patients with mastocytosis. Use of this product has been associated with improvement in diarrhea, flushing, headaches, vomiting, urticaria, abdominal pain, nausea, and itching in some patients.

CONTRAINDICATIONS:

Cromolyn Sodium, USP is contraindicated in those patients who have shown hypersensitivity to Cromolyn Sodium.

WARNINGS:

The recommended dosage should be decreased in patients with decreased renal or hepatic function. Severe anaphylactic reactions may occur rarely in association with Cromolyn Sodium administration.

PRECAUTIONS:

In view of the biliary and renal routes of excretion of Cromolyn Sodium, USP, consideration should be given to decreasing the dosage of the drug in patients with impaired renal or hepatic function.

Carcinogenesis, Mutagenesis, and Impairment of Fertility:

In carcinogenicity studies in mice, hamsters, and rats, Cromolyn Sodium had no neoplastic effects at intraperitoneal doses up to 150 mg/kg three days per week for 12 months in mice, at intraperitoneal doses up to 53 mg/kg three days per week for 15 weeks followed by 17.5 mg/kg three days per week for 37 weeks in hamsters, and at subcutaneous doses up to 75 mg/kg six days per week for 18 months in rats. These doses in mice, hamsters, and rats are less than the maximum recommended daily oral dose in adults and children on a mg/m2 basis.

Cromolyn Sodium showed no mutagenic potential in Ames Salmonella/microsome plate assays, mitotic gene conversion in Saccharomyces cerevisiae and in an in vitro cytogenetic study in human peripheral lymphocytes.

In rats, Cromolyn Sodium showed no evidence of impaired fertility at subcutaneous doses up to 175 mg/kg in males (approximately equal to the maximum recommended daily oral dose in adults on a mg/m2 basis) and 100 mg/kg in females (less than the maximum recommended daily oral dose in adults on a mg/m2 basis).

Pregnancy: Pregnancy Category B.

In reproductive studies in pregnant mice, rats, and rabbits, Cromolyn Sodium produced no evidence of fetal malformations at subcutaneous doses up to 540 mg/kg in mice (approximately equal to the maximum recommended daily oral dose in adults on a mg/m2 basis) and 164 mg/kg in rats (less than the maximum recommended daily oral dose in adults on a mg/m2 basis) or at intravenous doses up to 485 mg/kg in rabbits (approximately 4 times the maximum recommended daily oral dose in adults on a mg/m2 basis). There are, however, no adequate and well controlled studies in pregnant women.

Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Drug Interaction During Pregnancy:

In pregnant mice, Cromolyn Sodium alone did not cause significant increases in resorptions or major malformations at subcutaneous doses up to 540 mg/kg (approximately equal to the maximum recommended daily oral dose in adults on a mg/m2 basis). Isoproterenol alone increased both resorptions and major malformations (primarily cleft palate) at a subcutaneous dose of 2.7 mg/kg (approximately 7 times the maximum recommended daily inhalation dose in adults on a mg/m2 basis). The incidence of major malformations increased further when Cromolyn Sodium at a subcutaneous dose of 540 mg/kg was added to isoproterenol at a subcutaneous dose of 2.7 mg/kg. No such interaction was observed in rats or rabbits.

Nursing Mothers:

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Cromolyn Sodium, USP is administered to a nursing woman.

Pediatric Use:

In adult rats no adverse effects of Cromolyn Sodium were observed at oral doses up to 6144 mg/kg (approximately 25 times the maximum recommended daily oral dose in adults on a mg/m2 basis). In neonatal rats, Cromolyn Sodium increased mortality at oral doses of 1000 mg/kg or greater (approximately 9 times the maximum recommended daily oral dose in infants on a mg/m2 basis) but not at doses of 300 mg/kg or less (approximately 3 times the maximum recommended daily oral dose in infants on a mg/m2 basis). Plasma and kidney concentrations of cromolyn after oral administration to neonatal rats were up to 20 times greater than those in older rats. In term infants up to six months of age, available clinical data suggest that the dose should not exceed 20 mg/kg/day. The use of this product in pediatric patients less than two years of age should be reserved for patients with severe disease in which the potential benefits clearly outweigh the risks.

Geriatric Use:

Clinical studies of Cromolyn Sodium, USP did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

ADVERSE REACTIONS:

Most of the adverse events reported in mastocytosis patients have been transient and could represent symptoms of the disease. The most frequently reported adverse events in mastocytosis patients who have received Cromolyn Sodium, USP during clinical studies were headache and diarrhea, each of which occurred in 4 of the 87 patients. Pruritus, nausea, and myalgia were each reported in 3 patients and abdominal pain, rash, and irritability in 2 patients each. One report of malaise was also recorded.

Other Adverse Events:

Additional adverse events have been reported during studies in other clinical conditions and from worldwide postmarketing experience. In most cases the available information is incomplete and attribution to the drug cannot be determined. The majority of these reports involve the gastrointestinal system and include: diarrhea, nausea, abdominal pain, constipation, dyspepsia, flatulence, glossitis, stomatitis, vomiting, dysphagia, esophagospasm.

Other less commonly reported events (the majority representing only a single report) include the following:

Skin: pruritus, rash, urticaria/angioedema, erythema/ burning, photosensitivity Musculoskeletal: arthralgia, myalgia, stiffness/weakness of legs Neurologic: headache, dizziness, hypoesthesia, paresthesia, migraine, convulsions, flushing Psychiatric: psychosis, anxiety, depression, hallucinations, behavior change, insomnia, nervousness Heart Rate: tachycardia, premature ventricular contractions (PVCs), palpitations Respiratory: pharyngitis, dyspnea Miscellaneous: fatigue, edema, unpleasant taste, chest pain, postprandial lightheadedness and lethargy, dysuria, urinary frequency, purpura, hepatic function test abnormal, polycythemia, neutropenia, pancytopenia, tinnitus, lupus erythematosus (LE) syndrome DOSAGE AND ADMINISTRATION:

NOT FOR INHALATION OR INJECTION. SEE DIRECTIONS FOR USE.

The usual starting dose is as follows:

Adults and Adolescents (13 Years and Older):

Two ampules four times daily, taken one-half hour before meals and at bedtime.

Children 2-12 Years:

One ampule four times daily, taken one-half hour before meals and at bedtime.

Pediatric Patients Under 2 Years:

Not recommended.

If satisfactory control of symptoms is not achieved within two to three weeks, the dosage may be increased but should not exceed 40 mg/kg/day.

Patients should be advised that the effect of Cromolyn Sodium, USP therapy is dependent upon its administration at regular intervals, as directed.

Maintenance Dose:

Once a therapeutic response has been achieved, the dose may be reduced to the minimum required to maintain the patient with a lower degree of symptomatology. To prevent relapses, the dosage should be maintained.

Administration:

Cromolyn Sodium, USP should be administered as a solution at least 1/2 hour before meals and at bedtime after preparation according to the following directions:

    1. Break open ampule(s) and squeeze liquid contents of ampule(s) into a glass of water.
    2. Stir solution.
    3. Drink all of the liquid.

HOW SUPPLIED:

Cromolyn Sodium, USP Oral Concentrate is an unpreserved, colorless solution supplied in a low density polyethylene plastic unit dose ampule with 8 ampules per foil pouch. Each 5 mL ampule contains 100 mg Cromolyn Sodium, USP, in purified water.

       NDC 66993-470-96     96 ampules x 5 mL

Cromolyn Sodium, USP Oral Concentrate should be stored between 15°-30°C (59°-86°F) and protected from light. Do not use if it contains a precipitate or becomes discolored. Keep out of the reach of children.

Store ampules in foil pouch until ready for use.

Distributed by:

Prasco Laboratories
Mason, OH 45040 USA

Manufactured by:
Catalent Pharma Solutions
Woodstock, IL 60098 USA

Iss. 10/10

CROMp-10-01

PHARMACIST – DETACH HERE AND GIVE INSTRUCTIONS TO PATIENT

PATIENT INSTRUCTIONS

Cromolyn Sodium, USP

Oral Concentrate

For Oral Use Only – Not for Inhalation or Injection.

How to Use Cromolyn Sodium, USP:

As with all prescription drugs, follow the directions for dosage that your physician recommends.

The effect of Cromolyn Sodium, USP therapy is dependent upon its administration at REGULAR intervals, for as long as recommended by your physician.

Usual Starting Dose:
Adults and Adolescents (13 Years and Older):
Two ampules four times daily, taken one-half hour before meals and at bedtime.

Children 2-12 Years:
One ampule four times daily, taken one-half hour before meals and at bedtime.

Note:

Your physician may decide to increase OR decrease your dosage to achieve optimum results with Cromolyn Sodium, USP. However, do not change your dose or stop taking Cromolyn Sodium, USP without first consulting your physician.

Care & Storage:

Cromolyn Sodium, USP Oral Concentrate should be stored between 15°-30°C (59°-86°F) and protected from light. Do not use if it contains a precipitate (particles or cloudiness) or becomes discolored. Keep out of the reach of children.

Store ampules in foil pouch until ready for use.

Recycling Information: Cromolyn Sodium, USP Oral Concentrate ampules are made with a low density polyethylene plastic (recycling material code:

Directions for Use:

    1. Open foil pouch by tearing at serrated edge as shown.

    2. Remove ampule(s) from the strip.

    3. Open the ampule by twisting off the tabbed top section.

    4. Squeeze liquid contents into a glass of water. Stir solution. Drink all of the liquid. Discard the empty ampule.

Distributed by:

Prasco Laboratories
Mason, OH 45040 USA

Manufactured by:
Catalent Pharma Solutions
Woodstock, IL 60098 USA

Iss. 10/10

CROMp-10-01

PRINICIPAL DISPLAY PANEL - Carton Side and Front Panel

Carton Side and Front Panel

NDC 66993-470-96

PRASCO

Cromolyn Sodium, USP

Oral Concentrate

FOR ORAL USE ONLY -

NOT FOR INHALATION OR INJECTION.

100 mg/5 mL

96 Plastic Ampules

Rx Only

PRINCIPAL DISPLAY PANEL - Carton Side, Back and Top Panel

Carton Side, Back and Top Panel

NDC 66993-470-96

PRASCO

Cromolyn Sodium, USP

Oral Concentrate

Distributed by:

Prasco Laboratories, Mason, OH 45040 USA

Manufactured by:
Catalent Pharma Solutions, Woodstock, IL 60098 USA

DESCRIPTION: Each 5 mL ampule contains 100 mg Cromolyn Sodium, USP, in purified water.

NOTE: See package circular for full prescribing information including contraindications, warnings, and precautions.

Cromolyn Sodium, USP Oral Concentrate should be stored between 15°-30°C (59°-86°F) and protected from light. Do not use if it contains a precipitate or becomes discolored. Keep out of the reach of children.

Store ampules in foil pouch until ready to use.

NDC 66993-470-96

PRASCO

Cromolyn Sodium, USP

Oral Concentrate

FOR ORAL USE ONLY -

NOT FOR INHALATION OR INJECTION.

Rx Only

100 mg/5 mL

96 Plastic Ampules

Cromolyn Sodium 
Cromolyn Sodium  solution, concentrate Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 66993-470 Route of Administration ORAL DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Cromolyn Sodium (CROMOLYN) Cromolyn Sodium 20 mg  in 1 mL Inactive Ingredients Ingredient Name Strength WATER   Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 66993-470-96 12 POUCH In 1 CARTON contains a POUCH 1 8 AMPULE In 1 POUCH This package is contained within the CARTON (66993-470-96) and contains a AMPULE 1 5 mL In 1 AMPULE This package is contained within a POUCH and a CARTON (66993-470-96)
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA AUTHORIZED GENERIC NDA020479 12/12/2011
Labeler - Prasco Laboratories (065969375) Revised: 12/2011Prasco Laboratories

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Prevacid Delayed-Release Capsules

Pronunciation: lan-SOE-pra-zole
Generic Name: Lansoprazole
Brand Name: Prevacid
Prevacid Delayed-Release Capsules are used for:

Preventing or treating certain types of ulcers. It is also used to treat symptoms of gastroesophageal reflux disease (GERD) (eg, heartburn) and irritation of the esophagus. It is also used to treat conditions that cause your body to make too much stomach acid (eg, Zollinger-Ellison syndrome). It may also be used for other conditions as determined by your doctor.

Prevacid Delayed-Release Capsules are a proton pump inhibitor. It works by decreasing the amount of acid produced in the stomach.

Do NOT use Prevacid Delayed-Release Capsules if: you are allergic to any ingredient in Prevacid Delayed-Release Capsules you are taking an HIV protease inhibitor (eg, atazanavir)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Prevacid Delayed-Release Capsules:

Some medical conditions may interact with Prevacid Delayed-Release Capsules. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement if you have allergies to medicines, foods, or other substances if you have low blood potassium or magnesium levels, liver problems, or stomach or bowel cancer if you have osteoporosis (weak bones), a family history of osteoporosis, or other risk factors of osteoporosis (eg, smoking, poor nutrition)

Some MEDICINES MAY INTERACT with Prevacid Delayed-Release Capsules. Tell your health care provider if you are taking any other medicines, especially any of the following:

Diuretics (eg, furosemide, hydrochlorothiazide) because the risk of low blood magnesium levels may be increased Clarithromycin or voriconazole because they may increase the risk of Prevacid Delayed-Release Capsules's side effects Anticoagulants (eg, warfarin), digoxin, or tacrolimus because the risk of their side effects may be increased by Prevacid Delayed-Release Capsules Azole antifungals (eg, ketoconazole), clopidogrel, HIV protease inhibitors (eg, atazanavir), iron, or theophylline because their effectiveness may be decreased by Prevacid Delayed-Release Capsules

This may not be a complete list of all interactions that may occur. Ask your health care provider if Prevacid Delayed-Release Capsules may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Prevacid Delayed-Release Capsules:

Use Prevacid Delayed-Release Capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take Prevacid Delayed-Release Capsules by mouth on an empty stomach before eating. Swallow Prevacid Delayed-Release Capsules whole. Do not break, crush, or chew before swallowing. If you cannot swallow the capsule whole, you may open it and sprinkle the contents over 1 tablespoon (15 mL) of applesauce, Ensure pudding, cottage cheese, yogurt, or strained pears. Swallow the mixture right away. Do not crush or chew the medicine before swallowing. Do not store the mixture for future use. You may also open the capsule and sprinkle the contents into 2 oz (60 mL) apple juice, orange juice, or tomato juice. Mix briefly, then swallow at once. Do not chew or crush the granules. Do not store the mixture for use at a later time. After you take your dose, rinse the glass with at least 4 oz (120 mL) of juice and swallow to be sure you have received all of the medicine. Do NOT mix Prevacid Delayed-Release Capsules with other foods or liquids. You may take antacids while you are using Prevacid Delayed-Release Capsules if you are directed to do so by your doctor. If you are also taking an imidazole antifungal (eg, ketoconazole), take it at least 2 hours before taking Prevacid Delayed-Release Capsules. If you also take sucralfate, take Prevacid Delayed-Release Capsules at least 30 minutes before taking sucralfate. Continue to take Prevacid Delayed-Release Capsules even if you feel well. Do not miss any doses. If you miss a dose of Prevacid Delayed-Release Capsules, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Prevacid Delayed-Release Capsules.

Important safety information: Prevacid Delayed-Release Capsules may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Prevacid Delayed-Release Capsules with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it. Contact your doctor if you have any symptoms of a bleeding ulcer, such as black, tarry stools or vomit that looks like coffee grounds; or if you experience throat pain, chest pain, severe stomach pain, or trouble swallowing. Prevacid Delayed-Release Capsules may increase the risk of hip, wrist, and spine fractures in patients with weak bones (osteoporosis). The risk may be greater if you use Prevacid Delayed-Release Capsules in high doses, for long periods of time, or if you are over 50 years old. Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor. Contact your doctor if you have any questions about this information. Low blood magnesium levels have been reported rarely in patients taking PPIs for at least 3 months. In most cases, this effect was seen after a year of treatment. If you will be taking Prevacid Delayed-Release Capsules for a long time, or if you take certain other medicines (eg, digoxin, diuretics), your doctor may perform lab tests to check for low blood magnesium levels. Seek medical attention right away if you experience symptoms of low blood magnesium levels (eg, dizziness; fast or irregular heartbeat; involuntary muscle movements; jitteriness or tremors; muscle aches, cramps, pain, spasms, or weakness; seizures). Check with your doctor to see whether you should take a calcium and vitamin D supplement while you use Prevacid Delayed-Release Capsules. Prevacid Delayed-Release Capsules may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Prevacid Delayed-Release Capsules. Prevacid Delayed-Release Capsules should be used with caution in Asian patients; the risk of side effects may be increased in these patients. Use Prevacid Delayed-Release Capsules with caution in the ELDERLY; they may be more sensitive to its effects, especially hip, wrist, and spine fractures. Prevacid Delayed-Release Capsules should be used with extreme caution in CHILDREN younger than 1 year old; safety and effectiveness in these children have not been confirmed. PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Prevacid Delayed-Release Capsules while you are pregnant. It is not known if Prevacid Delayed-Release Capsules are found in breast milk. Do not breast-feed while taking Prevacid Delayed-Release Capsules. Possible side effects of Prevacid Delayed-Release Capsules:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; diarrhea; headache; nausea; stomach pain.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); bone pain; chest pain; fast or irregular heartbeat; fever, chills, or sore throat; red, swollen, blistered, or peeling skin; seizures; unusual bruising or bleeding; unusual tiredness; vision changes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Prevacid side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Prevacid Delayed-Release Capsules:

Store Prevacid Delayed-Release Capsules at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Prevacid Delayed-Release Capsules out of the reach of children and away from pets.

General information: If you have any questions about Prevacid Delayed-Release Capsules, please talk with your doctor, pharmacist, or other health care provider. Prevacid Delayed-Release Capsules are to be used only by the patient for whom it is prescribed. Do not share it with other people. If your symptoms do not improve or if they become worse, check with your doctor. Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Prevacid Delayed-Release Capsules. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Prevacid resources Prevacid Side Effects (in more detail) Prevacid Dosage Prevacid Use in Pregnancy & Breastfeeding Drug Images Prevacid Drug Interactions Prevacid Support Group 26 Reviews for Prevacid - Add your own review/rating Compare Prevacid with other medications Aspiration Pneumonia Barrett's Esophagus Duodenal Ulcer Duodenal Ulcer Prophylaxis Erosive Esophagitis GERD Helicobacter Pylori Infection Multiple Endocrine Adenomas NSAID-Induced Gastric Ulcer NSAID-Induced Ulcer Prophylaxis Stomach Ulcer Systemic Mastocytosis Zollinger-Ellison Syndrome

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Cimetidine Injection

Generic Name: cimetidine hydrochloride
Dosage Form: injection, solution
Cimetidine Injection, USP

Single-dose Fliptop Vial

Multiple-dose Fliptop Vial

Single-dose LifeShield® Fliptop Vial

Rx only

Cimetidine Injection Description

Cimetidine is a histamine H2-receptor antagonist. Chemically it is N?-cyano-N-methyl-N?-[2-[[(5-methyl-1H-imidazol-4-yl)methyl]thio]-ethyl]-guanidine.

The molecular formula for cimetidine hydrochloride is C10H16N6S • HCl and the molecular weight is 288.80. The structural formula of cimetidine hydrochloride is:

Cimetidine Hydrochloride

Cimetidine contains an imidazole ring, and is chemically related to histamine.

Cimetidine hydrochloride has a bitter taste and characteristic odor.

Cimetidine hydrochloride is freely soluble in water, soluble in alcohol, very slightly soluble in chloroform and practically insoluble in ether.

Single-dose Vials for Intramuscular or Intravenous Administration:

Cimetidine Injection, USP is a sterile aqueous solution. Each mL contains cimetidine hydrochloride equivalent to 150 mg cimetidine. May contain sodium hydroxide and/or hydrochloric acid for pH adjustment. pH is 5.4 (3.8 to 6.0).

Multiple-dose Vials for Intramuscular or Intravenous Administration:

Cimetidine Injection, USP is a sterile aqueous solution. Each mL contains cimetidine hydrochloride equivalent to 150 mg cimetidine; benzyl alcohol added as a bacteriostatic preservative, 9 mg. May contain sodium hydroxide and/or hydrochloric acid for pH adjustment. pH is 5.4 (3.8 to 6.0).

Cimetidine Injection - Clinical Pharmacology

Cimetidine competitively inhibits the action of histamine at the histamine H2 receptors of the parietal cells and thus is a histamine H2-receptor antagonist.

Cimetidine is not an anticholinergic agent. Studies have shown that cimetidine inhibits both daytime and nocturnal basal gastric acid secretion. Cimetidine also inhibits gastric acid secretion stimulated by food, histamine, pentagastrin, caffeine and insulin.

Antisecretory Activity

1) Acid Secretion: Nocturnal: Cimetidine 800 mg orally at bedtime reduces mean hourly H+ activity by greater than 85% over an eight-hour period in duodenal ulcer patients, with no effect on daytime acid secretion. Cimetidine 1600 mg orally h.s. produces 100% inhibition of mean hourly H+ activity over an eight-hour period in duodenal ulcer patients, but also reduces H+ activity by 35% for an additional five hours into the following morning. Cimetidine 400 mg b.i.d. and 300 mg q.i.d. decrease nocturnal acid secretion in a dose-related manner, i.e., 47% to 83% over a six- to eight-hour period and 54% over a nine-hour period, respectively.

Food Stimulated: During the first hour after a standard experimental meal, oral cimetidine 300 mg inhibited gastric acid secretion in duodenal ulcer patients by at least 50%. During the subsequent two hours cimetidine inhibited gastric acid secretion by at least 75%.

The effect of a 300 mg breakfast dose of cimetidine continued for at least four hours and there was partial suppression of the rise in gastric acid secretion following the luncheon meal in duodenal ulcer patients. This suppression of gastric acid output was enhanced and could be maintained by another 300 mg dose of cimetidine given with lunch.

In another study, cimetidine 300 mg given with the meal increased gastric pH as compared with placebo.

Mean Gastric pH

Cimetidine

Placebo

1 hour

3.5

2.6

2 hours

3.1

1.6

3 hours

3.8

1.9

4 hours

6.1

2.2

24 Hour Mean H+ Activity: Cimetidine 800 mg h.s., 400 mg b.i.d. and 300 mg q.i.d. all provide a similar, moderate (less than 60%) level of 24 hour acid suppression. However, the 800 mg h.s. regimen exerts its entire effect on nocturnal acid, and does not affect daytime gastric physiology.

Chemically Stimulated: Oral cimetidine significantly inhibited gastric acid secretion stimulated by betazole (an isomer of histamine), pentagastrin, caffeine and insulin as follows:

Stimulant

Stimulant Dose

Cimetidine

% Inhibition

Betazole

1.5 mg/kg (sc)

300 mg (po)

 85% at 2? hours

Pentagastrin

6 mcg/kg/hr (iv)

100 mg/hr (iv)

 60% at 1 hour

Caffeine

5 mg/kg/hr (iv)

300 mg (po)

100% at 1 hour

Insulin

0.03 units/kg/hr (iv)

100 mg/hr (iv)

 82% at 1 hour

When food and betazole were used to stimulate secretion, inhibition of hydrogen ion concentration usually ranged from 45 to 75% and the inhibition of volume ranged from 30 to 65%.

Parenteral administration also significantly inhibits gastric acid secretion. In a crossover study involving patients with active or healed duodenal or gastric ulcers, either continuous I.V. infusion of cimetidine 37.5 mg/hour (900 mg/day) or intermittent injection of cimetidine 300 mg q6h (1200 mg/day) maintained gastric pH above 4.0 for more than 50% of the time under steady-state conditions.

2) Pepsin: Oral cimetidine 300 mg reduced total pepsin output as a result of the decrease in volume of gastric juice.

3) Intrinsic Factor: Intrinsic factor secretion was studied with betazole as a stimulant. Oral cimetidine 300 mg inhibited the rise in intrinsic factor concentration produced by betazole, but some intrinsic factor was secreted at all times.

Other

Lower Esophageal Sphincter Pressure and Gastric Emptying

Cimetidine has no effect on lower esophageal sphincter (LES) pressure or the rate of gastric emptying.

Pharmacokinetics

The half-life of cimetidine is approximately 2 hours. Both oral and parenteral (I.V. or I.M.) administration provide comparable periods of therapeutically effective blood levels; blood concentrations remain above that required to provide 80% inhibition of basal gastric acid secretion for 4 to 5 hours following a dose of 300 mg.

Steady-state blood concentrations of cimetidine with continuous infusion of cimetidine hydrochloride are determined by the infusion rate and clearance of the drug in the individual patient. In a study of peptic ulcer patients with normal renal function, an infusion rate of 37.5 mg/hour produced average steady-state plasma cimetidine concentrations of about 0.9 mcg/mL. Blood levels with other infusion rates will vary in direct proportion to the infusion rate.

The principal route of excretion of cimetidine is the urine. Following parenteral administration, most of the drug is excreted as the parent compound; following oral administration, the drug is more extensively metabolized, the sulfoxide being the major metabolite. Following a single oral dose, 48% of the drug is recovered from the urine after 24 hours as the parent compound. Following I.V. or I.M. administration, approximately 75% of the drug is recovered from the urine after 24 hours as the parent compound.

Clinical Trials

Duodenal Ulcer

Cimetidine has been shown to be effective in the treatment of active duodenal ulcer and, at reduced dosage, in maintenance therapy following healing of active ulcers.

Active Duodenal Ulcer: Cimetidine accelerates the rate of duodenal ulcer healing. Healing rates reported in U.S. and foreign controlled trials with oral cimetidine are summarized below, beginning with the regimen providing the lowest nocturnal dose.

Duodenal Ulcer Healing Rates with Various Oral Cimetidine Dosage Regimens*

Regimen

300 mg

q.i.d.

400 mg

b.i.d.

800 mg

h.s.

1600 mg

h.s.

week 4

68%

73%

80%

86%

week 6

80%

80%

89%

—

week 8

—

92%

94%

—

*Averages from controlled clinical trials.

A U.S., double-blind, placebo-controlled, dose-ranging study demonstrated that all once-daily at bedtime (h.s.) cimetidine regimens were superior to placebo in ulcer healing and that cimetidine 800 mg h.s. healed 75% of patients at four weeks. The healing rate with 800 mg h.s. was significantly superior to 400 mg h.s. (66%) and not significantly different from 1600 mg h.s. (81%).

In the U.S. dose-ranging trial, over 80% of patients receiving cimetidine 800 mg h.s. experienced nocturnal pain relief after one day. Relief from daytime pain was reported in approximately 70% of patients after two days. As with ulcer healing, the 800 mg h.s. dose was superior to 400 mg h.s. and not different from 1600 mg h.s.

In foreign, double-blind studies with cimetidine 800 mg h.s., 79 to 85% of patients were healed at four weeks.

While short-term treatment with cimetidine can result in complete healing of the duodenal ulcer, acute therapy will not prevent ulcer recurrence after cimetidine has been discontinued. Some follow-up studies have reported that the rate of recurrence once therapy was discontinued was slightly higher for patients healed on cimetidine than for patients healed on other forms of therapy; however, the cimetidine-treated patients generally had more severe disease.

Maintenance Therapy in Duodenal Ulcer: Treatment with a reduced dose of cimetidine has been proven effective as maintenance therapy following healing of active duodenal ulcers.

In numerous placebo-controlled studies conducted worldwide, the percent of patients with observed ulcers at the end of one year’s therapy with cimetidine 400 mg h.s. was significantly lower (10% to 45%) than in patients receiving placebo (44% to 70%). Thus, from 55% to 90% of patients were maintained free of observed ulcers at the end of one year with cimetidine 400 mg h.s.

Factors such as smoking, duration and severity of disease, gender, and genetic traits may contribute to variations in actual percentages.

Trials of other anti-ulcer therapy, whether placebo-controlled, positive-controlled or open, have demonstrated a range of results similar to that seen with cimetidine.

Active Benign Gastric Ulcer

Cimetidine has been shown to be effective in the short-term treatment of active benign gastric ulcer.

In a multicenter, double-blind U.S. study, patients with endoscopically confirmed benign gastric ulcer were treated with cimetidine 300 mg four times a day or with placebo for six weeks. Patients were limited to those with ulcers ranging from 0.5 to 2.5 cm in size. Endoscopically confirmed healing at six weeks was seen in significantly* more cimetidine treated patients than in patients receiving placebo, as shown below:

Cimetidine

Placebo

week 2

14/63 (22%)

 7/63 (11%)

total at week 6

 43/65 (66%)*

30/67 (45%)

*p < 0.05

In a similar multicenter U.S. study of the 800 mg h.s. oral regimen, the endoscopically confirmed healing rates were:

Cimetidine

Placebo

total at week 6

63/83 (76%)*

44/80 (55%)

*p = 0.005

Similarly, in worldwide double-blind clinical studies, endoscopically evaluated benign gastric ulcer healing rates were consistently higher with cimetidine than with placebo.

Prevention of Upper Gastrointestinal Bleeding in Critically Ill Patients

A double-blind, placebo-controlled randomized study of continuous infusion cimetidine was performed in 131 critically ill patients (mean APACHE II score = 15.99) to compare the incidence of upper gastrointestinal bleeding, manifested as hematemesis or bright red blood which did not clear after adjustment of the nasogastric tube and a 5 to 10 minute lavage, persistent Gastroccult (R) positive coffee grounds for 8 consecutive hours which did not clear with 100 cc lavage and/or which were accompanied by a drop in hematocrit of 5 percentage points, or melena, with an endoscopically documented upper gastrointestinal source of bleed. 14% (9/65) of patients treated with cimetidine continuous infusion developed bleeding compared to 33% (22/66) of the placebo group. Coffee grounds was the manifestation of bleeding that accounted for the difference between groups. Another randomized, double-blind placebo-controlled study confirmed these results for an end point of upper gastrointestinal bleeding with a confirmed upper gastrointestinal source noted on endoscopy, and by post hoc analyses of bleeding episodes between groups.

Pathological Hypersecretory Conditions (such as Zollinger-Ellison Syndrome)

Cimetidine significantly inhibited gastric acid secretion and reduced occurrence of diarrhea, anorexia and pain in patients with pathological hypersecretion associated with Zollinger-Ellison Syndrome, systemic mastocytosis and multiple endocrine adenomas. Use of cimetidine was also followed by healing of intractable ulcers.

Indications and Usage for Cimetidine Injection

Cimetidine Injection, USP is indicated in:

(1) Short-term treatment of active duodenal ulcer. Most patients heal within 4 weeks and there is rarely reason to use cimetidine at full dosage for longer than 6 to 8 weeks (see DOSAGE AND ADMINISTRATION — Duodenal Ulcer). Concomitant antacids should be given as needed for relief of pain. However, simultaneous administration of oral cimetidine and antacids is not recommended, since antacids have been reported to interfere with the absorption of oral cimetidine.

(2) Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of active ulcer. Patients have been maintained on continued treatment with cimetidine 400 mg h.s. for periods of up to five years.

(3) Short-term treatment of active benign gastric ulcer. There is no information concerning usefulness of treatment periods of longer than 8 weeks.

(4) Prevention of upper gastrointestinal bleeding in critically ill patients.

(5) The treatment of pathological hypersecretory conditions (i.e., Zollinger-Ellison Syndrome, systemic mastocytosis, multiple endocrine adenomas).

Contraindications

Cimetidine is contraindicated for patients known to have hypersensitivity to the product.

Precautions

General: Rare instances of cardiac arrhythmias and hypotension have been reported following the rapid administration of cimetidine hydrochloride injection by intravenous bolus.

Symptomatic response to cimetidine therapy does not preclude the presence of a gastric malignancy. There have been rare reports of transient healing of gastric ulcers despite subsequently documented malignancy.

Reversible confusional states (see ADVERSE REACTIONS) have been observed on occasion, predominantly, but not exclusively, in severely ill patients. Advancing age (50 or more years) and pre-existing liver and/or renal disease appear to be contributing factors. In some patients these confusional states have been mild and have not required discontinuation of cimetidine therapy. In cases where discontinuation was judged necessary, the condition usually cleared within 3 to 4 days of drug withdrawal.

Drug Interactions: Cimetidine, apparently through an effect on certain microsomal enzyme systems, has been reported to reduce the hepatic metabolism of warfarin-type anticoagulants, phenytoin, propranolol, nifedipine, chlordiazepoxide, diazepam, certain tricyclic antidepressants, lidocaine, theophylline and metronidazole, thereby delaying elimination and increasing blood levels of these drugs.

Clinically significant effects have been reported with the warfarin anticoagulants; therefore, close monitoring of prothrombin time is recommended, and adjustment of the anticoagulant dose may be necessary when cimetidine is administered concomitantly. Interaction with phenytoin, lidocaine and theophylline has also been reported to produce adverse clinical effects.

However, a crossover study in healthy subjects receiving either cimetidine 300 mg q.i.d. or 800 mg h.s. concomitantly with a 300 mg b.i.d. dosage of theophylline extended-release tablets demonstrated less alteration in steady-state theophylline peak serum levels with the 800 mg h.s. regimen, particularly in subjects aged 54 years and older. Data beyond ten days are not available. (Note: All patients receiving theophylline should be monitored appropriately, regardless of concomitant drug therapy.)

Dosage of the drugs mentioned above and other similarly metabolized drugs, particularly those of low therapeutic ratio or in patients with renal and/or hepatic impairment, may require adjustment when starting or stopping concomitantly administered cimetidine to maintain optimum therapeutic blood levels.

Alteration of pH may affect absorption of certain drugs (e.g., ketoconazole). If these products are needed, they should be given at least 2 hours before cimetidine administration.

Additional clinical experience may reveal other drugs affected by the concomitant administration of cimetidine.

Carcinogenesis, Mutagenesis, Impairment of Fertility: In a 24-month toxicity study conducted in rats, at dose levels of 150, 378 and 950 mg/kg/day (approximately 8 to 48 times the recommended human dose), there was a small increase in the incidence of benign Leydig cell tumors in each dose group; when the combined drug-treated groups and control groups were compared, this increase reached statistical significance. In a subsequent 24 month study, there were no differences between the rats receiving 150 mg/kg/day and the untreated controls. However, a statistically significant increase in benign Leydig cell tumor incidence was seen in the rats that received 378 and 950 mg/kg/day. These tumors were common in control groups as well as treated groups and the difference became apparent only in aged rats.

Cimetidine has demonstrated a weak antiandrogenic effect. In animal studies this was manifested as reduced prostate and seminal vesicle weights. However, there was no impairment of mating performance or fertility, nor any harm to the fetus in these animals at doses 8 to 48 times the full therapeutic dose of cimetidine, as compared with controls. The cases of gynecomastia seen in patients treated for one month or longer may be related to this effect.

In human studies, cimetidine has been shown to have no effect on spermatogenesis, sperm count, motility, morphology or in vitro fertilizing capacity.

Pregnancy: Teratogenic Effects. Pregnancy Category B: Reproduction studies have been performed in rats, rabbits and mice at doses up to 40 times the normal human dose and have revealed no evidence of impaired fertility or harm to the fetus due to cimetidine. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproductive studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Nursing Mothers: Cimetidine is secreted in human milk and, as a general rule, nursing should not be undertaken while a patient is on a drug.

Pediatric Use: Clinical experience in pediatric patients is limited. Therefore, cimetidine therapy cannot be recommended for pediatric patients under 16, unless, in the judgment of the physician, anticipated benefits outweigh the potential risks. In very limited experience, doses of 20 to 40 mg/kg per day have been used.

Immunocompromised Patients: In immunocompromised patients, decreased gastric acidity, including that produced by acid-suppressing agents such as cimetidine, may increase the possibility of a hyperinfection of strongyloidiasis.

Adverse Reactions

Adverse effects reported in patients taking cimetidine are described below by body system. Incidence figures of 1 in 100 and greater are generally derived from controlled clinical studies.

Gastrointestinal: Diarrhea (usually mild) has been reported in approximately 1 in 100 patients.

CNS: Headaches, ranging from mild to severe, have been reported in 3.5% of 924 patients taking 1600 mg/day, 2.1% of 2,225 patients taking 800 mg/day and 2.3% of 1,897 patients taking placebo. Dizziness and somnolence (usually mild) have been reported in approximately 1 in 100 patients on either 1600 mg/day or 800 mg/day.

Reversible confusional states, e.g., mental confusion, agitation, psychosis, depression, anxiety, hallucinations, disorientation, have been reported predominantly, but not exclusively, in severely ill patients. They have usually developed within 2 to 3 days of initiation of cimetidine therapy and have cleared within 3 to 4 days of discontinuation of the drug.

Endocrine: Gynecomastia has been reported in patients treated for one month or longer. In patients being treated for pathological hypersecretory states, this occurred in about 4% of cases while in all others the incidence was 0.3% to 1% in various studies. No evidence of induced endocrine dysfunction was found, and the condition remained unchanged or returned toward normal with continuing cimetidine treatment.

Reversible impotence has been reported in patients with pathological hypersecretory disorders, e.g., Zollinger-Ellison Syndrome, receiving cimetidine, particularly in high doses, for at least 12 months (range 12 to 79 months, mean 38 months). However, in large-scale surveillance studies at regular dosage, the incidence has not exceeded that commonly reported in the general population.

Hematologic: Decreased white blood cell counts in cimetidine-treated patients (approximately 1 per 100,000 patients), including agranulocytosis (approximately 3 per million patients), have been reported, including a few reports of recurrence on rechallenge. Most of these reports were in patients who had serious concomitant illnesses and received drugs and/or treatment known to produce neutropenia. Thrombocytopenia (approximately 3 per million patients) and, very rarely, cases of pancytopenia or aplastic anemia have also been reported. As with some other H2-receptor antagonists, there have been extremely rare reports of immune hemolytic anemia.

Hepatobiliary: Dose-related increases in serum transaminase have been reported. In most cases they did not progress with continued therapy and returned to normal at the end of therapy. There have been rare reports of cholestatic or mixed cholestatic hepatocellular effects. These were usually reversible. Because of the predominance of cholestatic features, severe parenchymal injury is considered highly unlikely. However, as in the occasional liver injury with other H2-receptor antagonists, in exceedingly rare circumstances fatal outcomes have been reported.

There has been reported a single case of biopsy-proven periportal hepatic fibrosis in a patient receiving cimetidine.

Rare cases of pancreatitis, which cleared on withdrawal of the drug, have been reported.

Hypersensitivity: Rare cases of fever and allergic reactions including anaphylaxis and hypersensitivity vasculitis, which cleared on withdrawal of the drug, have been reported.

Renal: Small, possibly dose-related increases in plasma creatinine, presumably due to competition for renal tubular secretion, are not uncommon and do not signify deteriorating renal function. Rare cases of interstitial nephritis and urinary retention, which cleared on withdrawal of the drug, have been reported.

Cardiovascular: Rare cases of bradycardia, tachycardia and A-V heart block have been reported with H2-receptor antagonists.

Musculoskeletal: There have been rare reports of reversible arthralgia and myalgia; exacerbation of joint symptoms in patients with pre-existing arthritis has also been reported. Such symptoms have usually been alleviated by a reduction in cimetidine dosage. Rare cases of polymyositis have been reported, but no causal relationship has been established.

Integumental: Mild rash and, very rarely, cases of severe generalized skin reactions including Stevens-Johnson syndrome, epidermal necrolysis, erythema multiforme, exfoliative dermatitis and generalized exfoliative erythroderma have been reported with H2-receptor antagonists. Reversible alopecia has been reported very rarely.

Immune Function: There have been extremely rare reports of strongyloidiasis hyperinfection in immunocompromised patients.

Overdosage

Studies in animals indicate that toxic doses are associated with respiratory failure and tachycardia which may be controlled by assisted respiration and the administration of a beta blocker.

Reported acute ingestions orally of up to 20 grams have been associated with transient adverse effects similar to those encountered in normal clinical experience. The usual measures to remove unabsorbed material from the gastrointestinal tract, clinical monitoring and supportive therapy, should be employed.

There have been reports of severe CNS symptoms, including unresponsiveness, following ingestion of between 20 and 40 grams of cimetidine, and extremely rare reports following concomitant use of multiple CNS- active medications and ingestion of cimetidine at doses less than 20 grams. An elderly, terminally ill dehydrated patient with organic brain syndrome receiving concomitant antipsychotic agents and cimetidine 4800 mg intravenously over a 24 hour period experienced mental deterioration with reversal on cimetidine discontinuation.

There have been two deaths in adults who were reported to have ingested over 40 grams orally on a single occasion.

Cimetidine Injection Dosage and Administration

Parenteral Administration

In hospitalized patients with pathological hypersecretory conditions or intractable ulcers, or in patients who are unable to take oral medication, cimetidine may be administered parenterally.

The doses and regimen for parenteral administration in patients with GERD have not been established.

Recommendations for Parenteral Administration:

Intramuscular Injection: 300 mg every 6 to 8 hours (no dilution necessary). Transient pain at the site of injection has been reported.

Intravenous Injection: 300 mg every 6 to 8 hours. In some patients it may be necessary to increase dosage. When this is necessary, the increases should be made by more frequent administration of a 300 mg dose, but should not exceed 2400 mg per day. Dilute Cimetidine Injection, USP, 300 mg, in Sodium Chloride Injection (0.9%) or another compatible I.V. solution (see Stability of Cimetidine Injection, USP) to a total volume of 20 mL and inject over a period of not less than 5 minutes (see PRECAUTIONS).

Intermittent Intravenous Infusion: 300 mg every 6 to 8 hours, infused over 15 to 20 minutes. In some patients it may be necessary to increase dosage. When this is necessary, the increases should be made by more frequent administration of a 300 mg dose, but should not exceed 2400 mg per day.

Dilute Cimetidine Injection, USP, 300 mg, in at least 50 mL of 5% Dextrose Injection, or another compatible I.V. solution (see Stability of Cimetidine Injection, USP).

Continuous Intravenous Infusion: 37.5 mg/hour (900 mg/day). For patients requiring a more rapid elevation of gastric pH, continuous infusion may be preceded by a 150 mg loading dose administered by I.V. infusion as described above. Dilute 900 mg Cimetidine Injection, USP in a compatible I.V. fluid (see Stability of Cimetidine Injection, USP) for constant rate infusion over a 24-hour period. Note: Cimetidine Injection, USP may be diluted in 100 to 1000 mL; however, a volumetric pump is recommended if the volume for 24-hour infusion is less than 250 mL. In one study in patients with pathological hypersecretory states, the mean infused dose of cimetidine was 160 mg/hour with a range of 40 to 600 mg/hour.

These doses maintained the intragastric acid secretory rate at 10 mEq/hour or less. The infusion rate should be adjusted to individual patient requirements.

Stability of Cimetidine Injection, USP

When added to or diluted with most commonly used intravenous solutions, e.g., Sodium Chloride Injection (0.9%), Dextrose Injection (5% or 10%), Lactated Ringer’s Injection, 5% Sodium Bicarbonate Injection, Cimetidine Injection, USP should not be used after more than 48 hours of storage at room temperature.

NOTE: The products accompanying this insert are for I.M./I.V. use only. Much of the following relates to the use of oral cimetidine and is for informational purposes only. See Parenteral Administration (above) for specific dosing recommendations.

Duodenal Ulcer

Active Duodenal Ulcer

Clinical studies have indicated that suppression of nocturnal acid is the most important factor in duodenal ulcer healing (see CLINICAL PHARMACOLOGY — Acid Secretion). This is supported by recent clinical trials (see Clinical Trials—Active Duodenal Ulcer). Therefore, there is no apparent rationale, except for familiarity with use, for treating with anything other than a once-daily at bedtime oral dosage regimen (h.s.).

In a U.S. oral dose-ranging study of 400 mg h.s., 800 mg h.s. and 1600 mg h.s., a continuous dose response relationship for ulcer healing was demonstrated.

However, 800 mg h.s. is the dose of choice for most patients, as it provides a high healing rate (the difference between 800 mg h.s. and 1600 mg h.s. being small), maximal pain relief, a decreased potential for drug interactions (see PRECAUTIONS — Drug Interactions) and maximal patient convenience. Patients unhealed at four weeks, or those with persistent symptoms, have been shown to benefit from two to four weeks of continued therapy.

It has been shown that patients who both have an endoscopically demonstrated ulcer larger than 1 cm and are also heavy smokers (i.e., smoke one pack of cigarettes or more per day) are more difficult to heal. There is some evidence which suggests that more rapid healing can be achieved in this subpopulation with cimetidine 1600 mg at bedtime. While early pain relief with either 800 mg h.s. or 1600 mg h.s. is equivalent in all patients, 1600 mg h.s. provides an appropriate alternative when it is important to ensure healing within four weeks for this subpopulation. Alternatively, approximately 94% of all patients will also heal in eight weeks with cimetidine 800 mg h.s.

Other cimetidine oral regimens in the U.S. which have been shown to be effective are: 300 mg four times daily, with meals and at bedtime, the original regimen with which U.S. physicians have the most experience, and 400 mg twice daily, in the morning and at bedtime (see Clinical Trials —Active Duodenal Ulcer).

Concomitant antacids should be given as needed for relief of pain. However, simultaneous administration of oral cimetidine and antacids is not recommended, since antacids have been reported to interfere with the absorption of oral cimetidine.

While healing with cimetidine often occurs during the first week or two, treatment should be continued for 4 to 6 weeks unless healing has been demonstrated by endoscopic examination.

Maintenance Therapy for Duodenal Ulcer

In those patients requiring maintenance therapy, the recommended adult oral dose is 400 mg at bedtime.

Active Benign Gastric Ulcer

The recommended adult oral dosage for short-term treatment of active benign gastric ulcer is 800 mg h.s., or 300 mg four times a day with meals and at bedtime. Controlled clinical studies were limited to six weeks of treatment (see Clinical Trials). 800 mg h.s. is the preferred regimen for most patients based upon convenience and reduced potential for drug interactions. Symptomatic response to cimetidine does not preclude the presence of a gastric malignancy. It is important to follow gastric ulcer patients to assure rapid progress to complete healing.

Prevention of Upper Gastrointestinal Bleeding

The recommended adult dosing regimen is continuous I.V. infusion of 50 mg/hour. Patients with creatinine clearance less than 30 cc/min. should receive half the recommended dose. Treatment beyond 7 days has not been studied.

Pathological Hypersecretory Conditions (such as Zollinger-Ellison Syndrome)

Recommended adult dosage: 300 mg four times a day with meals and at bedtime. In some patients it may be necessary to administer higher doses more frequently. Doses should be adjusted to individual patient needs, but should not usually exceed 2400 mg per day and should continue as long as clinically indicated.

Dosage Adjustment for Patients with Impaired Renal Function

Patients with severely impaired renal function have been treated with cimetidine. However, such usage has been very limited. On the basis of this experience the recommended dosage is 300 mg every 12 hours orally or by intravenous injection. Should the patient’s condition require, the frequency of dosing may be increased to every 8 hours or even further with caution. In severe renal failure, accumulation may occur and the lowest frequency of dosing compatible with an adequate patient response should be used. When liver impairment is also present, further reductions in dosage may be necessary. Hemodialysis reduces the level of circulating cimetidine. Ideally, the dosage schedule should be adjusted so that the timing of a scheduled dose coincides with the end of hemodialysis.

Patients with creatinine clearance less than 30 cc/min. who are being treated for prevention of upper gastrointestinal bleeding should receive half the recommended dose.

Do not administer product unless solution is clear and container is undamaged. Discard unused portion. All parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

How is Cimetidine Injection Supplied

Cimetidine Injection, USP 300 mg/2 mL cimetidine is supplied as follows:

List No.

Container

Size

7444

Single-dose Fliptop Vial

2 mL

7444

Single-dose

LifeShield® Fliptop Vial*

2 mL

7445

Multiple-dose Fliptop Vial

8 mL

*For use with the LifeShield® blunt cannula.

Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Do not refrigerate.

Revised: August, 2006

 

©Hospira 2006        EN - 1270        Printed in USA

Hospira, Inc., Lake Forest, IL 60045 USA

RL-0581
CIMETIDINE 
cimetidine hydrochloride  injection, solution Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0409-7444 Route of Administration INTRAMUSCULAR, INTRAVENOUS DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CIMETIDINE HYDROCHLORIDE (CIMETIDINE) CIMETIDINE 150 mg  in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM HYDROXIDE   HYDROCHLORIC ACID   Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 0409-7444-01 10 VIAL In 1 CARTON contains a VIAL, SINGLE-DOSE 1 2 mL In 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (0409-7444-01)
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA074344 07/08/2011
CIMETIDINE 
cimetidine hydrochloride  injection, solution Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0409-7445 Route of Administration INTRAMUSCULAR, INTRAVENOUS DEA Schedule      Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CIMETIDINE HYDROCHLORIDE (CIMETIDINE) CIMETIDINE 150 mg  in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM HYDROXIDE   HYDROCHLORIC ACID   BENZYL ALCOHOL 9 mg  in 1 mL Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains          Packaging # NDC Package Description Multilevel Packaging 1 0409-7445-01 10 VIAL In 1 CARTON contains a VIAL, MULTI-DOSE 1 8 mL In 1 VIAL, MULTI-DOSE This package is contained within the CARTON (0409-7445-01)
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA074345 07/08/2011
Labeler - Hospira, Inc. (141588017) Revised: 07/2011Hospira, Inc. More Cimetidine Injection resou

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cromolyn Inhalation, oral/nebulization

KROE-mo-lin

Commonly used brand name(s)

In the U.S.

Intal Intal Inhaler

Available Dosage Forms:

Solution Capsule Aerosol Liquid Aerosol Powder

Therapeutic Class: Antiasthma

Pharmacologic Class: Mast Cell Stabilizer

Uses For cromolyn

Cromolyn is used to prevent the symptoms of asthma. When it is used regularly, cromolyn lessens the number and severity of asthma attacks by reducing inflammation in the lungs. Cromolyn is also used just before exposure to conditions or substances (for example, exercise, allergens, such as pollen, aspirin, chemicals, cold air, or air pollutants) that cause bronchospasm (wheezing or difficulty in breathing). Cromolyn will not help an asthma or bronchospasm attack that has already started.

Cromolyn may be used alone or with other asthma medicines, such as bronchodilators (medicines that open up narrowed breathing passages) or corticosteroids (cortisone-like medicines).

Cromolyn inhalation works by acting on certain inflammatory cells in the lungs to prevent them from releasing substances that cause asthma symptoms or bronchospasm.

cromolyn is available only with your doctor's prescription.

It is very important that you read and understand the following information. If any of it causes you special concern, check with your doctor. Also, if you have any questions or if you want more information about cromolyn or your medical problem, ask your doctor, nurse, or pharmacist.

Before Using cromolyn

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For cromolyn, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to cromolyn or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Although there is no specific information comparing the use of cromolyn in children with use in other age groups, cromolyn is not expected to cause different side effects or problems in children than it does in adults. The inhalation solution form of cromolyn should not be used in children younger than 2 years of age, and the inhalation aerosol should not be used in children younger than 5 years of age.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing the use of cromolyn inhalation in the elderly with use in other age groups, cromolyn is not expected to cause different side effects or problems in older people than it does in younger adults.

Pregnancy Pregnancy Category Explanation All Trimesters B Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus. Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of cromolyn. Make sure you tell your doctor if you have any other medical problems, especially:

Heart disease or Irregular heartbeat—The propellants used to deliver the medicine in the aerosol inhaler may worsen these conditions Proper Use of cromolyn

Cromolyn oral inhalation is used to help prevent symptoms of asthma or bronchospasm (wheezing or difficulty in breathing). Cromolyn will not relieve an asthma or a bronchospasm attack that has already started. It is important to use cromolyn at regular times as directed by your doctor.

Use cromolyn inhalation only as directed. Do not use more of it and do not use it more often than your doctor ordered. To do so may increase the chance of side effects.

Cromolyn inhalation usually comes with patient directions. Read them carefully before using cromolyn. If you do not understand the directions that come with the inhaler or if you are not sure how to use the inhaler, ask your health care professional to show you how to use it. Also, ask your health care professional to check regularly how you use the inhaler to make sure you are using it properly.

For patients using cromolyn inhalation aerosol:

The cromolyn aerosol canister provides about 112 or 200 inhalations, depending on the size of the canister your doctor ordered. You should try to keep a record of the number of inhalations you use so you will know when the canister is almost empty. This canister, unlike some other aerosol canisters, cannot be floated in water to test its fullness. When you use the inhaler for the first time, or if you have not used it in a while, the inhaler may not deliver the right amount of medicine with the first puff. Therefore, before using the inhaler, test or prime it. To test or prime the inhaler: Insert the medicine container (canister) firmly into the clean mouthpiece according to the manufacturer's directions. Check to make sure the canister is placed properly into the mouthpiece. Take the cap off the mouthpiece and shake the inhaler three or four times. Hold the inhaler well away from you at arm's length and press the top of the canister, spraying the medicine one time into the air. The inhaler will now be ready to provide the right amount of medicine when you use it. To use the inhaler: Using your thumb and one or two fingers, hold the inhaler upright, with the mouthpiece end down and pointing toward you. Take the cap off the mouthpiece. Check the mouthpiece to make sure it is clear. Do not use the inhaler with any other mouthpieces. Gently shake the inhaler three or four times. Hold the mouthpiece away from your mouth and breathe out slowly and completely to the end of a normal breath. Use the inhalation method recommended by your doctor. Open-mouth method: Place the mouthpiece about 1 to 2 inches (2 fingerwidths) in front of your widely opened mouth. Make sure the inhaler is aimed into your mouth so the spray does not hit the roof of your mouth or your tongue. Avoid spraying in eyes. Closed-mouth method: Place the mouthpiece in your mouth between your teeth and over your tongue with your lips closed tightly around it. Make sure your tongue or teeth are not blocking the opening. Tilt your head back a little. Start to breathe in slowly through your mouth. At the same time, press the top of the canister once to get one puff of medicine. Continue to breathe in slowly for 3 to 4 seconds until you have taken a full deep breath. It is important to press down on the canister and breathe in slowly at the same time so the medicine gets into your lungs. This step may be difficult at first. If you are using the closed-mouth method and you see a fine mist coming from your mouth or nose, the inhaler is not being used correctly. Hold your breath as long as you can up to 10 seconds (count slowly to ten). This gives the medicine time to settle into your airways and lungs. Take the mouthpiece away from your mouth and breathe out slowly. If your doctor has told you to inhale more than 1 puff of medicine at each dose, wait about 1 minute between puffs. Then, gently shake the inhaler again, and take the second puff following exactly the same steps you used for the first puff. Breathe in only one puff at a time. When you are finished using the inhaler, wipe off the mouthpiece and replace the cap. Keep track of the number of sprays you have used from the inhaler, and discard the inhaler after the labeled maximum number of sprays has been used.

Your doctor may want you to use a spacer device with the inhaler. A spacer makes the inhaler easier to use. It allows more of the medicine to reach your lungs, rather than staying in your mouth and throat.

To use a spacer device with the inhaler: Attach the spacer to the inhaler according to the manufacturer's directions. There are different types of spacers available, but the method of breathing remains the same with most spacers. Gently shake the inhaler and spacer well. Hold the mouthpiece of the spacer away from your mouth and breathe out slowly and completely. Place the mouthpiece of the spacer into your mouth between your teeth and over your tongue with your lips closed around it. Press down on the canister top once to release one puff of medicine into the spacer. Then, within 1 or 2 seconds, begin to breathe in slowly and deeply through your mouth for 5 to 10 seconds. Count the seconds while inhaling. Hold your breath as long as you can up to 10 seconds (count slowly to 10). Breathe out slowly. Wait a minute between puffs. Then, gently shake the inhaler and spacer again and take the second puff, following exactly the same steps you used for the first puff. Do not spray more than one puff at a time into the spacer. When you are finished using the inhaler, remove the spacer device from the inhaler and replace the cap.

Clean the inhaler, mouthpiece, and spacer at least once a week.

To clean the inhaler: Remove the canister from the inhaler and set the canister aside. Do not get the canister wet. Wash the mouthpiece, cap, and the spacer in warm soapy water. Rinse well with warm, running water. Shake off the excess water and let the inhaler parts air dry completely before putting the inhaler back together.

For patients using cromolyn capsules for inhalation :

Do not swallow the capsules. The medicine will not work if you swallow it. cromolyn is used with a special inhaler, either the Spinhaler or the Halermatic. If you do not understand the directions that come with the inhaler or if you are not sure how to use the inhaler, ask your health care professional to show you how to use it. Also, ask your health care professional to check regularly how you use the inhaler to make sure you are using it properly. If you are using cromolyn capsules for inhalation with the Spinhaler: To load the Spinhaler: Make sure your hands are clean and dry. Insert the capsule into the inhaler just before using cromolyn. Hold the inhaler upright with the mouthpiece pointing down. Unscrew the body of the inhaler from the mouthpiece. Keep the mouthpiece pointing down and the propeller on the spindle. Remove the foil from the capsule and insert the colored end of the cromolyn capsule firmly into the cup of the propeller. Avoid too much handling of the capsule, because moisture from your hands may make the capsule soft. Make sure the propeller moves freely. Screw the body of the inhaler back into the mouthpiece and make certain that it is fastened well. While keeping the inhaler upright with the mouthpiece pointing down, slide the grey outer sleeve down firmly until it stops. This will puncture the capsule. Then slide the sleeve up as far as it will go. This step may be repeated a second time to make sure the capsule is punctured. To use the Spinhaler: Check to make sure the mouthpiece is properly attached to the body of the inhaler. Hold the inhaler away from your mouth and breathe out slowly to the end of a normal breath. Place the mouthpiece in your mouth, close your lips around it, and tilt your head back. Do not block the mouthpiece with your teeth or tongue. Take a deep and rapid breath. You should hear and feel the vibrations of the rotating propeller as you breathe in. Take the inhaler from your mouth and hold your breath for a few seconds or as long as possible. Hold the inhaler away from your mouth and breathe out slowly and completely to the end of a normal breath. Do not breathe out through the inhaler because this may prevent the inhaler from working properly. Keep taking inhalations of cromolyn until all the powder from the capsule is inhaled. A light dusting of powder remaining in the capsule is normal and is not a sign that the inhaler is not working properly. Throw away the empty capsule. Then return the inhaler to the container and replace the lid on the container. To clean the Spinhaler: At least once a week, brush off any powder left sticking to the propeller. Take the inhaler apart and wash the parts of the inhaler with clean, warm water. Wash the inside of the propeller shaft by moving the propeller on and off the steel spindle under water. Shake out the excess water. Allow all parts of the inhaler to dry completely before putting it back together. The Spinhaler should be replaced after 6 months. If you are using cromolyn capsules for inhalation with the Halermatic: To load the Halermatic: Make sure your hands are clean and dry. Insert the capsule cartridge into the inhaler just before using cromolyn. Remove the mouthpiece cover. Then pull off the mouthpiece. Push a cromolyn capsule cartridge firmly down to the bottom of the slot. Slide the mouthpiece back on the body of the inhaler. Push down slowly as far as the mouthpiece will go. This punctures the capsule cartridge and lifts it into the rotation chamber. Do not repeat this step because the capsule cartridge needs to be punctured only once. To use the Halermatic: Hold the inhaler away from your mouth and breathe out slowly to the end of a normal breath. Place the mouthpiece in your mouth, close your lips around it, and tilt your head back. Do not block the flow of medicine into the lungs with your teeth or tongue. Breathe in quickly and steadily through the mouthpiece. Hold your breath for a few seconds to keep the medicine in the lungs as long as possible. Then take the inhaler away from your mouth. Hold the inhaler well away from your mouth and breathe out to the end of a normal breath. Do not breathe out through the inhaler because this may prevent the inhaler from working properly. Keep taking inhalations of cromolyn until all the powder from the capsule is inhaled. A light dusting of powder remaining in the capsule is normal and is not a sign that the inhaler is not working properly. Throw away the empty capsule cartridge. To clean the Halermatic: Brush away powder deposits each day with a brush. When powder deposits build up, wipe them away with a slightly damp cloth. The mouthpiece may be washed separately if necessary. However, do not wet the blue-based body of the inhaler. Be sure the mouthpiece grid is dry before putting the inhaler back together. The Halermatic should be replaced every 6 months.

For patients using cromolyn inhalation solution:

Cromolyn inhalation solution comes in a small glass container called an ampul. The ampul must be broken gently to empty the contents. If you do not understand the manufacturer's directions, ask your health care professional to show you what to do. Do not use the solution in the ampul if it is cloudy or contains particles. To break and empty the ampul: The glass ampul is weak at each end so the ends can be broken easily by hand. Hold the ampul away from the nebulizer and your face when you break it. Hold the ampul at an angle and carefully break off the lower end. No solution will come out. Turn the ampul over so the open end faces up. Place a forefinger carefully over the open end. Keep your finger firmly in place and break off the lower end of the ampul. To empty the ampul, hold it over the bowl of the nebulizer unit and remove your finger to let the solution flow out. Throw away any solution left in the nebulizer after you have taken your treatment. Use cromolyn only in a power-operated nebulizer that has an adequate flow rate and is equipped with a face mask or mouthpiece. Your doctor will advise you on which nebulizer to use. Make sure you understand exactly how to use it. Hand-squeezed bulb nebulizers cannot be used with cromolyn. If you have any questions about this, check with your doctor.

For patients using cromolyn oral inhalation regularly (for example, every day):

In order for cromolyn to work properly, it must be inhaled every day in regularly spaced doses as ordered by your doctor. Up to 4 weeks may pass before you feel the full effects of the medicine. Dosing

The dose of cromolyn will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of cromolyn. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For inhalation aerosol dosage form: For prevention of asthma symptoms: Adults and children 5 years of age or older—2 inhalations (puffs) taken four times a day with doses spaced four to six hours apart. Children up to 5 years of age—Cromolyn inhalation aerosol should not be used in children younger than 5 years of age. For prevention of bronchospasm caused by exercise or a condition or substance: Adults and children 5 years of age or older—2 inhalations (puffs) taken at least ten to fifteen (but not more than sixty) minutes before exercise or exposure to any condition or substance that may cause an attack. Children up to 5 years of age—Cromolyn inhalation aerosol should not be used in children younger than 5 years of age. For capsule for inhalation dosage form: For prevention of asthma symptoms: Adults and children 2 years of age or older—20 mg (contents of 1 capsule) used in an inhaler, taken four times a day with doses spaced four to six hours apart. Children up to 2 years of age—The capsule for inhalation should not be used in children younger than 2 years of age. For prevention of bronchospasm caused by exercise or a condition or substance: Adults and children 2 years of age or older—20 mg (contents of 1 capsule) used in an inhaler, taken at least ten to fifteen (but not more than sixty) minutes before exercise or exposure to any condition or substance that may cause an attack. Children up to 2 years of age—The capsule for inhalation should not be used in children younger than 2 years of age. For inhalation solution dosage form: For prevention of asthma symptoms: Adults and children 2 years of age or older—20 mg (contents of 1 ampul) used in a nebulizer. cromolyn should be used four times a day with doses spaced four to six hours apart. Use a new ampul of solution for each dose. Children up to 2 years of age—Cromolyn inhalation solution should not be used in children younger than 2 years of age. For prevention of bronchospasm caused by exercise or a condition or substance: Adults and children 2 years of age or older—20 mg (contents of 1 ampul) used in a nebulizer. cromolyn should be used at least ten to fifteen (but not more than sixty) minutes before exercise or exposure to any condition or substance that may cause an attack. Use a new ampul of solution for each dose. Children up to 2 years of age—Cromolyn inhalation solution should not be used in children younger than 2 years of age. Missed Dose

If you miss a dose of cromolyn, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Store the canister at room temperature, away from heat and direct light. Do not freeze. Do not keep cromolyn inside a car where it could be exposed to extreme heat or cold. Do not poke holes in the canister or throw it into a fire, even if the canister is empty.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using cromolyn

If your symptoms do not improve within 4 weeks or if your condition becomes worse after you begin using cromolyn, check with your doctor.

If you are also taking a corticosteroid or a bronchodilator for your asthma along with cromolyn, do not stop taking the corticosteroid or bronchodilator even if your asthma seems better, unless you are told to do so by your doctor.

Dryness of the mouth or throat or throat irritation may occur after you use cromolyn. Gargling and rinsing your mouth or taking a drink of water after each dose may help prevent these effects.

cromolyn Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

Rare Difficulty in swallowing hives increased wheezing or difficulty in breathing itching of skin low blood pressure shortness of breath swelling of face, lips, or eyelids tightness in chest

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common Coughing nausea throat irritation or dryness

If you are using the cromolyn inhalation aerosol, you may notice an unpleasant taste. This may be expected and will go away when you stop using the medicine.

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

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More cromolyn Inhalation, oral/nebulization resources Cromolyn Inhalation, oral/nebulization Use in Pregnancy & Breastfeeding Cromolyn Inhalation, oral/nebulization Drug Interactions Cromolyn Inhalation, oral/nebulization Support Group 6 Reviews for Cromolyn Inhalation,/nebulization - Add your own review/rating Compare cromolyn Inhalation, oral/nebulization with other medications Asthma, Maintenance Inflammatory Bowel Disease Systemic Mastocytosis

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Cimetidine Hydrochloride

Class: Histamine H2-Antagonists
VA Class: GA301
CAS Number: 51481-61-9
Brands: Tagamet

Introduction

Histamine H2 receptor antagonist.b

Uses for Cimetidine Hydrochloride Duodenal Ulcer

Short-term treatment of active duodenal ulcer (endoscopically or radiographically confirmed).a b

Maintainence of healing and reduction in recurrence of duodenal ulcer.a b

Pathologic GI Hypersecretory Conditions

Long-term treatment of Zollinger-Ellison syndrome, multiple endocrine adenomas, systemic mastocytosis.a b

Gastric Ulcer

Short-term treatment of active benign gastric ulcer.a b

Gastroesophageal Reflux (GERD)

Short-term treatment of erosive esophagitis (endoscopically diagnosed) in patients with GERD.118

Treatment of symptomatic GERD†.105 106 123 288

Self-medication as initial therapy to achieve acid suppression, control symptoms, and prevent complications of less severe symptomatic GERD†.288

Upper GI Bleeding

Prevention of upper GI bleeding resulting from stress-related mucosal damage (erosive esophagitis, stress ulcers) in critically ill patients.118 142 143 144 145 146 147 152 153 154 155 156 157 161 162 163 164 165 166 170 171 172 173 174 175 176 177 179 188 191

Treatment of upper GI bleeding† secondary to hepatic failure, esophagitis, duodenal or gastric ulcers when hemorrhage is not caused by major blood vessel erosion.b

Heartburn (pyrosis), Acid Indigestion (hyperchlorhydria), or Sour Stomach

Short-term self-medication for relief of heartburn symptoms in adults and adolescents?12 years of age.c

Short-term self-medication for prevention of heartburn symptoms associated with acid indigestion (hyperchlorhydria) and sour stomach brought on by ingestion of certain foods and beverages in adults and children ?12 years of age.c

Allergic Conditions and Urticarias†124 125 126 127 128 129 130 131 132 133 134 135 136 137 Cimetidine Hydrochloride Dosage and Administration Administration

Administer orally, IV, or IM.118

Administer by IM or slow IV injection, or by intermittent or continuous IV infusion in hospitalized patients with pathological GI hypersecretory conditions or intractable duodenal ulcer, or when oral therapy is not feasible.118

Oral Administration

Administer with or without food; administration with food may delay and slightly decrease absorption, but achieves maximum antisecretory effect when stomach is no longer protected by food buffering effect. Administer oral tablets with water.b

Antacids may be given as necessary for pain relief, but not at the same time.a b

For duodenal ulcer treatment, administration once daily at bedtime is the regimen of choice because of a high healing rate, maximal pain relief, decreased drug interaction potential, and maximal compliance.117 118 119

For gastric ulcer treatment, administration once daily at bedtime is the regimen of choice because of convenience and decreased drug interaction potential.118

For gastroesophageal reflux, once-daily dosing is not considered appropriate.288

IM Administration

May be administered undiluted.a b

Intermittent Direct IV Injection Dilution

Dilute 300 mg to 20 mL with 0.9% sodium chloride injection or other compatible IV solution before direct IV injection (see Compatibility under Stability).118

Rate of Administration

Inject over ?5 minutes.118

Intermittent IV infusion Reconstitution

Reconstitute ADD-Vantage vials according to manufacturer’s directions.118

Dilution

Dilute 300 mg in at least 50 mL of 0.9% sodium chloride injection or 5% dextrose injection or other compatible IV solution (see Compatibility under Stability).118

No additional dilution required for commercially available infusion solution (300 mg cimetidine in 50 mL of 0.9% sodium chloride injection).a

Rate of Administration

Over 15–20 minutes.118

Continuous IV Infusion Dilution

Dilute 900 mg in 100–1000 mL of a compatible IV solution (see Compatibility under Stability).a b

Rate of Administration

Over 24 hours.a b

Adjust rate to individual patient requirements.a b

Volume <250 mL: use controlled-infusion device (e.g., pump).a b

Dosage

Dosage of cimetidine hydrochloride expressed in terms of cimetidine.118

Pediatric Patients

20–40 mg/kg daily in divided doses has been used in a limited number of children when potential benefits are thought to outweigh the possible risks.118

Heartburn, Acid Indigestion, or Sour Stomach Heartburn Relief (Self-medication) Oral

Adolescents ?12 years of age: 200 mg once or twice daily, or as directed by a clinician.268

Prevention of Heartburn (Self-medication) Oral

Adolescents ?12 years of age: 200 mg once or twice daily or as directed by a clinician; administer immediately (or up to 30 minutes) before ingestion of causative food or beverage.c

Adults General Parenteral Dosage

Parenteral dosage regimens for GERD have not been established.a

General parenteral dosage (in hospitalized patients with pathologic hypersecretory conditions or intractable ulcer, or for short-term use when oral therapy is not feasible):a

IM

300 mg every 6–8 hours.118

Intermittent Direct IV Injection

300 mg every 6–8 hours.118

300 mg more frequently if increased daily dosage is necessary (i.e., single doses not >300 mg), up to 2400 mg daily.118

Intermittent IV Infusion

300 mg every 6–8 hours.118

300 mg more frequently if increased daily dosage is necessary (i.e., single doses not >300 mg), up to 2400 mg daily.118

Continuous IV infusion

900 mg over 24 hours (37.5 mg/hour).a b See Pathologic GI Hypersecretory Conditions under Dosage: Adults.

For more rapid increase in gastric pH, a loading dose of 150 mg may be given as an intermittent infusion before continuous infusion.a b

Duodenal Ulcer Treatment of Active Duodenal Ulcer Oral

Dosage of choice: 800 mg once daily at bedtime.117 118 119

Patients with ulcer >1 cm in diameter who are heavy smokers (i.e., ?1 pack daily) when rapid healing (e.g., within 4 weeks) is considered important:118 1.6 g daily at bedtime.117 118 119

Administer for 4–6 weeks unless healing is confirmed earlier.117 118 If not healed or symptoms continue after 4 weeks, additional 2–4 weeks of full dosage therapy may be beneficial.118 More than 6–8 weeks at full dosage is rarely needed.118

Healing of active duodenal ulcers may occur in 2 weeks in some, and occurs within 4 weeks in most patients.117 118 119 120 121 122

Other regimens (no apparent rationale for these other than familiarity of use) that have been used:117 118 300 mg 4 times daily with meals and at bedtime; 200 mg 3 times daily and 400 mg at bedtime; 400 mg twice daily in the morning and at bedtime.b

Maintenance of Healing of Duodenal Ulcer Oral

400 mg daily at bedtime.118 Efficacy not increased by higher dosages or more frequent administration.b

Pathologic GI Hypersecretory Conditions Zollinger-Ellison Syndrome Oral

300 mg 4 times daily with meals and at bedtime.118

Higher doses administered more frequently may be necessary;a b adjust dosage according to response and tolerance but in general, do not exceed 2400 mg daily.a

Continue as long as necessary.118

Continuous IV Infusion

Mean infused dose of 160 mg/hour (range: 40-600 mg/hour) in one study.a

Gastric Ulcer Oral

Preferred regimen: 800 mg once daily at bedtime.118

Alternative regimen: 300 mg 4 times daily, with meals and at bedtime.118

Monitor to ensure rapid progress to complete healing.a b

Studies limited to 6 weeks, efficacy for >8 weeks not established.118

GERD

Once daily (at bedtime) not considered appropriate therapy.288

Treatment of Symptomatic GERD† Oral

300 mg 4 times daily has been used.105 106 123

Treatment of Erosive Esophagitis Oral

800 mg twice daily or 400 mg 4 times daily (e.g., before meals and at bedtime) for up to 12 weeks.118

Upper GI Bleeding Prevention of Upper GI Bleeding Continuous IV Infusion

50 mg/hour; loading dose not required.118

Safety and efficacy of therapy beyond 7 days has not been established.118

Alternative dosage: Some clinicians recommend 300-mg IV loading dose over 5–20 minutes, then continuous IV infusion at 37.5–50 mg/hour; titrate with 25-mg/hour increments up to 100 mg/hour based on gastric pH (e.g., to maintain a pH of at least 3.5–4).118 143 144 173 174 176 188

Intermittent IV doses may be less effective in preventing upper GI bleeding than continuous IV infusion.155 172 173 174 175 176 177 178 188 189 191

Treatment of Upper GI Bleeding† Oral

1–2 g daily in 4 divided doses has been used.b

IV

1–2 g daily in 4 divided doses has been used.b

Heartburn, Acid Indigestion, or Sour Stomach Heartburn (Self-medication) Oral

200 mg once or twice daily, or as directed by clinician.268

Maximum 400 mg in 24 hours, but not continuously for >2 weeks except under clinician supervision.c

Prevention of Heartburn (Self-medication) Oral

200 mg once or twice daily or as directed by a clinician; administer immediately (or up to 30 minutes) before ingestion of causative food or beverage.c

Maximum 400 mg in 24 hours, but not continuously for >2 weeks except under clinician supervision.c

Prescribing Limits Pediatric Patients Heartburn, Acid Indigestion, or Sour Stomach Heartburn (Self-Medication) Oral

Adolescents ?12 years of age: Maximum 400 mg in 24 hours, but not continuously for >2 weeks except under clinician supervision.c

Prevention of Heartburn (Self-medication) Oral

Adolescents ?12 years of age: Maximum 400 mg in 24 hours, but not continuously for >2 weeks except under clinician supervision.c

Adults General Parenteral Dosage

General parenteral dosage (hospitalized patients with pathologic hypersecretory conditions or intractable duodenal ulcer, or short-term use when oral therapy is not feasible):

Direct IV injection

Maximum 2.4 g daily.a

Maximum 300 mg per dose.a

Maximum concentration 300 mg/20 mL.a

Maximum injection rate: 20 mL over not less than 5 minutes (4 mL per minute).a

Intermittent IV Infusion

Maximum 2.4 g daily.a

Maximum 300 mg per dose.a

Maximum concentration 300 mg/50 mL.a

Maximum infusion rate: 15–20 minutes.a

GERD Short-term Treatment of Erosive Esophagitis Oral

Safety and efficacy beyond 12 weeks of administration have not been established.a

Heartburn, Acid Indigestion, or Sour Stomach Heartburn Relief (Self-medication) Oral

Maximum 400 mg in 24 hours, but not continuously for >2 weeks except under clinician supervision.c

Prevention of Heartburn (Self-medication) Oral

Maximum 400 mg in 24 hours, but not continuously for >2 weeks except under clinician supervision.c

Duodenal Ulcer Intermittent Direct IV Injecton

Maximum 2.4 g daily.a

Intermittent IV Infusion

Maximum 2.4 g daily.a

Gastric Ulcer Short-term treatment of Active Benign Gastric Ulcer Oral

Safety and efficacy beyond 8 weeks have not been established.118

Intermittent Direct IV Injection

Maximum 2.4 g daily.a

Intermittent IV Infusion

Maximum 2.4 g daily.a

Pathologic GI Hypersecretory Conditions (e.g., Zollinger-Ellison Syndrome) Oral

Maximum usually 2.4 g daily.118

Intermittent Direct IV Injection

Maximum 2.4 g daily.a

Intermittent IV Infusion

Maximum 2.4 g daily.a

Upper GI Bleeding Prevention of Upper GI Bleeding Continuous IV Infusion

Safety and efficacy beyond 7 days have not been established.a

Special Populations Renal Impairment Severe (Clcr< 30 mL/minute) Oral

300 mg every 12 hours.118

Accumulation may occur; use lowest frequency of dosing compatible with adequate response.118

Increase frequency to every 8 hours or more frequently (with caution) if required.118

Presence of hepatic impairment may require further dosage reduction.118

Direct IV Injection

300 mg every 12 hours.118

Accumulation may occur; use lowest frequency compatible with adequate response.118

Increase frequency to every 8 hours or more frequently (with caution) if required118

Presence of hepatic impairment may require further dosage reduction.118

Continuous IV Infusion

Prevention of Upper GI Bleeding: One-half recommended dosage (i.e., 25 mg/hour).118

Hemodialysis

Decreases blood levels; administer at the end of hemodialysis and every 12 hours during interdialysis.b

Hepatic Impairment

May require further dosage reduction in the presence of severe renal impairment.118

Cautions for Cimetidine Hydrochloride Contraindications

Known hypersensitivity to cimetidine or any ingredient in the formulation.118

Warnings/Precautions General Precautions Cardiovascular Effects

Rapid IV administration associated rarely with hypotension, cardiac arrhythmias; avoid.a b

Gastric Malignancy

Response to cimetidine does not preclude presence of gastric malignancy.118

CNS Effects

Reversible confusional states reported, especially in geriatric (i.e., ?50 years) and severely ill (e.g., hepatic or renal disease, organic brain syndrome) patients.118 b Usually occurs within 2–3 days after initiating cimetidine and resolves within 3–4 days after discontinuance.118 b

Respiratory Effects

Administration of H2-receptor antagonists has been associated with an increased risk for developing certain infections (e.g., community-acquired pneumonia).302 303

Specific Populations Pregnancy

Category B.a

Pregnant women should consult a clinician before using for self-medication.268

Lactation

Distributed into milk.118 Generally, do not nurse during therapy with cimetidine.118

Nursing women should consult a clinician before using for self-medication.268

Pediatric Use

Safety and efficacy not established in children <16 years of age; do not use unless potential benefits outweigh risks.118

Safety and efficacy for self-medication not established in children <12 years of age; do not use unless directed by a clinician.c

Renal Impairment

Dosage adjustments necessary in patients with severe renal impairment.118 (See Renal Impairment under Dosage and Administration.)

Hepatic Impairment

Further dosage adjustments may be necessary in presence of severe renal impairment.118 (See Hepatic Impairment under Dosage and Administration.)

Immunocompromised Patients

Increased possibility of Strongyloides stercoralis hyperinfection with decreased gastric acidity.118 269 270

Common Adverse Effects

Headache,118 144 dizziness, somnolence, diarrhea.118

With ?1 month of therapy: gynecomastia.118 b

With IM therapy: transient pain at injection site.118

Interactions for Cimetidine Hydrochloride

Inhibits hepatic microsomal enzyme systems, decreases hepatic metabolism of some drugs.118 If necessary, adjust dosage of hepatically metabolized drugs when cimetidine therapy is initiated or discontinued.b

Specific Drugs

Drug

Interaction

Comments

Alcohol

Possible increased blood alcohol concentrations,256 257 258 259 260 261 263 264 265 psychomotor impairment256 257 258 259 260 261 267

Potential for psychomotor impairment controversial, 256 257 258 259 260 261 267 but use caution during performance of hazardous tasks requiring mental alertness, physical coordination257 258 261

Antacidsb

Decreased cimetidine absorptionb

Administer 1 hour before or after cimetidine in the fasting state, or 1 hour after cimetidine is taken with food.a b

Benzodiazepines118

Potential for delayed elimination, increased blood concentrations of certain benzodiazepines (e.g., diazepam, chlordiazepoxide, triazolam)118

Adjust dosage if needed b

Calcium-channel blockers (e.g., nifedipine)a

Potential for delayed elimination, increased blood concentrations of nifedipine118

Adjust dosage if needed b

Ketoconazole118

Absorption of ketoconazole may be affected by altered gastric pH118

Administer ?2 hours before cimetidine118

Lidocaine118

Potential for delayed elimination, increased blood concentrations of lidocaine118

Adverse effects reported, adjust dosage if needed b

Metronidazole118

Potential for delayed elimination, increased blood concentrations of metronidazole118

Adjust dosage if neededb

Myelosuppressive drugs (e.g., alkylating agents [e.g., carmustine], antimetabolites) and/or therapies (radiation)b

May potentiate myelosuppressionb

 

Phenytoin118

Potential for delayed elimination, increased blood concentrations of phenytoin118

Adverse effects reported, adjust dosage if needed b

Propranolol118

Potential for delayed elimination, increased blood concentrations of propranolol118

Adjust dosage if needed b

Theophylline118

Potential for delayed elimination, increased blood concentrations of theophylline118

Adverse effects reported, adjust dosage if needed b

Triamterene108

Potential for delayed elimination, increased blood concentrations of triamterene118

Consider potential of clinically important interaction108

Tricyclic Antidepressants118

Potential for delayed elimination, increased blood concentrations of certain tricyclic antidepressants118

Adjust dosage if neededb

Warfarin118

Potential for delayed elimination, increased blood concentrations of warfarin118

Monitor PT, adjust dosage if neededb

Cimetidine Hydrochloride Pharmacokinetics Absorption Bioavailability

Oral: 60–70%.b

Onset

?70% decrease in basal acid secretion within 45 minutes after single 300- or 400-mg IV dose in healthy males.100

Duration

Dosage Regimen

Effect On Acid Secretion

Comments

Oral: 800 mg at bedtime in duodenal ulcer patients118

Mean hourly nocturnal secretion decreased by 85% over 8 hours.118

No effect on daytime acid secretion118

Oral: 1600 mg at bedtime in duodenal ulcer patients 118

Mean hourly nocturnal secretion decreased by 100% over 8 hours, 35% decrease for additional 5 hours.118

Moderate (<60%) 24-hour suppression118

Oral: 400 mg twice daily in duodenal ulcer pateints118

Nocturnal secretion decreased by 47–83% over 6–8 hours 118

Moderate (<60%) 24-hour suppression118

Oral: 300 mg 4 times daily in duodenal ulcer patients118

Nocturnal secretion decreased by 54% over 9 hours118

Moderate (<60%) 24-hour suppression118

Oral: Single 300-mg dose within 1 hour after meal in duodenal ulcer patientsa

Food-stimulated secretion decreased by 50% for 1 hour, then 75% for 2 hours.a

 

Oral: 300-mg dose at breakfast in duodenal ulcer patientsa

Continued suppression for 4 hours, with partial suppression after luncha

Effect enhanced and maintained by additional 300-mg dose with luncha

Oral: 300-mg dose with foodb

Mean gastric pH 3.5–4 at 1 hour, 5.5–6.1 at 4 hoursb

 

Oral: Single dose 300 mg with fooda

Mean gastric pH: 3.5, 3.1, 3.8, 6.1 at hour 1, 2, 3, 4, respectivelya

Placebo mean gastric pH: 2.6, 1.6, 1.9, 2.2 at hour 1, 2, 3, 4, respectivelya

Oral: 300–400 mg in fasting state in duodenal ulcer patientsb

Anacidity for up to 8 hoursb

 

Oral: 300 mg in duodenal ulcer patientsb

Basal gastric acid output decreased by 90% for 4 hoursb

Meal-stimulated acid secretion by 66% for 3 hoursb

IV continuous infusion: mean dosage of 160 mg/hour (range:40-600 mg/hour) in pathologic hypersecretory conditionsb

Maintained secretion at ?10 mEq/hourb

 

IV continuous infusion (37.5 mg/hour or 900 mg daily) in patients with active or healed duodenal or gastric ulcerb

Maintained gastric pH at >4 for >50% of the time at steady-state.b

 

Intermittent injection: (300 mg every 6 hours or 1200 mg daily) in patients with active or healed duodenal or gastric ulcerb

Maintained gastric pH at >4 for >50% of the time at steady-state.b

 

IV: Single 300- or 400-mg dose in healthy males

?70% decrease in basal acid secretion maintained for 4–4.5 hours100

 

Food

Delays, slightly decreases absorption.b However, administration with meals achieves maximum blood concentrations and antisecretory effect when stomach is no longer protected by food buffering effect.b

Distribution Extent

Widely distributed throughout the body.b

Distributed into human milk.b

Crosses the placenta in animals.b

Plasma Protein Binding

15–20%.b

Elimination Metabolism

Metabolized to sulfoxide (major metabolite) and 5-hydroxymethyl derivatives in liver.a b More extensively metabolized after oral than parenteral administration.a

Elimination Route

Excreted principally in urine.a b Single oral dose: 48% (unchanged) excreted in urine over 24 hours.a IV or IM: about 75% (unchanged) excreted in urine within 24 hours.a Single IV dose of radiolabeled cimetidine: 80–90% (50–73% unchanged, remainder as metabolites) excreted in urine over 24 hours.b About 10% excreted in feces.b

Half-life

2 hours.a

After IV administration in children 4.1–15 years of age: Apparent biphasic decline of plasma cimetidine and cimetidine sulfoxide concentrations with half-lives of 1.4 and 2.6 hours, respectively.102

Special Populations

2.9 hours in patients with Clcr 20–50 mL/minute.b 3.7 hours in patients with Clcr <20 mL/minute.b 5 hours in anephric patients.b

Stability Storage Oral Liquid and Tablets

Tight, light-resistant containers at 15–30°C.b

Parenteral Injection

15–30°C.b Protect from light.b Do not refrigerate.b Stable in most IV solutions for at least 3 days at room temperature in concentrations of 1.2–5 mg/mL,b but use within 48 hours when diluted as directed.118 b

Injection for IV infusion only

15–30°C.b Protect from excessive heat; brief exposure up to 40°C does not adversely affect stability.b Stable through the labeled expiration date when stored as recommended.118

Compatibility

For information on systemic interactions resulting from concomitant use, see Interactions.

Parenteral Solution CompatibilityHID

Compatible

Amino acids 3.5, 5.5, or 8.5% with electrolytes

Amino acids 5.5 or 8.5%

Dextrose 5% with Ascor-B-Sol

Dextrose 5% and Electrolyte #48

Dextrose 5% and Electrolyte #75

Dextrose 5% in Ringer’s injection, lactated

Dextrose 5% in sodium chloride 0.2, 0.45, or 0.9%

Dextrose 10% in sodium chloride 0.9%

Dextrose 5% in water

Dextrose 10% in water

Dextrose 5% in water with vitamins

Fructose 5% and Electrolyte #48

Fructose 5% and Electrolyte #75

Invert sugar 5% in water

Invert sugar 10% in water

Ionosol B in dextrose 5% in water

Ionosol MB in dextrose 5% in water

Ionosol T in dextrose 5% in water

Mannitol 10% in water

Normosol M, 900 cal

Normosol M in dextrose 5% in water

Normosol M and Surbex T in dextrose 5% in water

Normosol R

Normosol R, pH 7.4

Normosol R in dextrose 5% in water

Plasma-Lyte 56 in dextrose 5% in water

Plasma-Lyte M in dextrose 5% in water

Ringer’s injection

Ringer’s injection, lactated

Sodium bicarbonate 5%

Sodium chloride 0.9%

Drug Compatibility Admixture CompatibilityHID

Compatible

Acetazolamide sodium

Amikacin sulfate

Aminophylline

Atracurium besylate

Cefoxitin sodium

Chlorothiazide sodium

Ciprofloxacin

Clindamycin phosphate

Colistimethate sodium

Dexamethasone sodium phosphate

Digoxin

Epinephrine HCl

Erythromycin lactobionate

Ethacrynate sodium

Flumazenil

Furosemide

Gentamicin sulfate

Insulin, regular

Isoproterenol HCl

Lidocaine HCl

Lincomycin HCl

Meropenem

Metaraminol bitartrate

Methylprednisolone sodium succinate

Midazolam HCl

Norepinephrine bitartrate

Penicillin G potassium

Phytonadione

Polymyxin B sulfate

Potassium chloride

Protamine sulfate

Quinidine gluconate

Sodium nitroprusside

Tacrolimus

Vancomycin HCl

Verapamil HCl

Vitamin B complex

Vitamin B complex with C

Incompatible

Amphotericin B

Variable

Ampicillin sodium

Cefazolin sodium

Metoclopramide HCl

Y-Site CompatibilityHID

Compatible

Acyclovir sodium

Amifostine

Aminophylline

Anakinra

Anidulafungin

Atracurium besylate

Aztreonam

Bivalirudin

Cisplatin

Cladribine

Clarithromycin

Cyclophosphamide

Cytarabine

Dexmedetomidine HCl

Diltiazem HCl

Docetaxel

Doxorubicin HCl

Doxorubicin HCl liposome injection

Enalaprilat

Esmolol HCl

Etoposide phosphate

Fenoldopam mesylate

Filgrastim

Fluconazole

Fludarabine phosphate

Foscarnet sodium

Gallium nitrate

Gemcitabine HCl

Granisetron HCl

Haloperidol lactate

Heparin sodium

Hetastarch in lactated electrolyte injection (Hextend)

Hetastarch in sodium chloride 0.9%

Idarubicin HCl

Inamrinone lactate

Labetalol HCl

Levofloxacin

Linezolid

Melphalan HCl

Meropenem

Methotrexate sodium

Midazolam HCl

Milrinone lactate

Nicardipine HCl

Ondansetron HCl

Oxaliplatin

Paclitaxel

Pancuronium bromide

Pemetrexed disodium

Piperacillin sodium–tazobactam sodium

Propofol

Remifentanil HCl

Sargramostim

Tacrolimus

Teniposide

Theophylline

Thiotepa

Topotecan HCl

Vecuronium bromide

Vinorelbine tartrate

Zidovudine

Incompatible

Allopurinol sodium

Amphotericin B cholesteryl sulfate complex

Amsacrine

Cefepime HCl

Indomethacin sodium trihydrate

Lansoprazole

Warfarin sodium

ActionsActions

Inhibits basal and stimulated gastric acid secretion.b

Competitively inhibits histamine at parietal cell H2 receptors.b

Weak antiandrogenic effect.b

Advice to Patients

Importance of patients informing clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs.289

Importance of taking antacids on an empty stomach 1 hour before or 1 hour after oral administration of cimetidine, or 1 hour after the drug is taken with food,b but not at same time as oral cimetidine.a b

Importance of women informing clinician if they are or plan to become pregnant or plan to breast-feed.289

Before self-medication, importance of consulting clinician if taking warfarin, theophylline, or phenytoin.268

Importance of following dosage instructions when cimetidine is administered for self-medication, unless otherwise directed by a clinician.c

Importance of promptly informing clinician of persistent abdominal pain or difficulty swallowing.268

Importance of informing patients of other important precautionary information. (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Cimetidine

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Solution

300 mg/mL*

Cimetidine Hydrochloride Oral Solution

Actavis, Duramed, Endo, Hi-Tech, Morton Grove, Pharmaceutical Associates, Teva

Tagamet (with parabens, povidone, and propylene glycol)

GlaxoSmithKline

Tablets, film-coated

200 mg*

Tagamet HB 200

GlaxoSmithKline

Tagamet HB (with povidone)

GlaxoSmithKline

300 mg*

Tagamet (with povidone and propylene glycol)

GlaxoSmithKline

400 mg*

Tagamet Tiltab (with povidone and propylene glycol)

GlaxoSmithKline

800 mg*

Tagamet Tiltab (with povidone and propylene glycol; scored)

GlaxoSmithKline

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Cimetidine Hydrochloride

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Solution

300 mg (of cimetidine) per 5 mL*

Tagamet HCl (with alcohol 2.8% parabens and propylene glycol)

GlaxoSmithKline

Parenteral

Injection

150 mg (of cimetidine) per mL

Cimetidine Hydrochloride Injection

Read More:

Cimetidine Hydrochloride

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