Praxilene
1. Name Of The Medicinal Product

Praxilene 100mg Capsules

2. Qualitative And Quantitative Composition

100mg naftidrofuryl oxalate equivalent to 81.0 mg naftidrofuryl and 19.0 mg oxalate.

3. Pharmaceutical Form

Capsule

4. Clinical Particulars 4.1 Therapeutic Indications

Peripheral vascular disorders - intermittent claudication, night cramps, rest pain, incipient gangrene, trophic ulcers, Raynaud's Syndrome, diabetic arteriopathy and acrocyanosis.

Cerebral vascular disorders - cerebral insufficiency and cerebral atherosclerosis, particularly where these manifest themselves as mental deterioration and confusion in the elderly.

4.2 Posology And Method Of Administration

Peripheral vascular disorders - one or two capsules three times daily for a minimum of three months, or at the discretion of the physician.

Cerebral vascular disorders - one 100mg capsule three times daily for a minimum of three months, or at the discretion of the physician.

There is no recommended use for children.

Administration:

For oral administration. The capsules should be swallowed whole during meals with a sufficient amount of water (minimum) of one glass.

4.3 Contraindications

Hypersensitivity to the drug. Patients with a history of hyperoxaluria or recurrent calcium-containing stones.

4.4 Special Warnings And Precautions For Use

A sufficient amount of liquid should be taken during treatment to maintain an adequate level of diuresis.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

Pregnancy: There is no, or inadequate, evidence of the safety of naftidrofuryl oxalate in human pregnancy, but it has been in wide use for many years without apparent ill consequence, animal studies having shown no hazard. If drug therapy is needed in pregnancy, this drug can be used if there is no safer alternative.

Lactation: No information is available.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

Naftidrofuryl oxalate is normally well tolerated in the dosage recommended. Occasionally nausea, epigastric pain and rashes have been noted.

Rarely, hepatitis has been reported. Very rarely, calcium oxalate kidney stones have been reported.

4.9 Overdose

Signs and symptoms: Depression of cardiac conduction and convulsions may occur.

Treatment: The stomach should be emptied by gastric lavage and emesis. Activated charcoal may be employed if necessary. Cardiovascular function and respiration should be monitored and, in severe cases, electrical pacemaking or the use of isoprenaline should be considered. Convulsions may be managed by diazepam.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Naftidrofuryl oxalate has been shown to exert a direct effect on intracellular metabolism. Thus it has been shown in man and animals that it produces an increase of ATP levels and a decrease of lactic acid levels in ischaemic conditions, evidence for an enhancement of cellular oxidative capacity. Furthermore, naftidrofuryl oxalate is a powerful spasmolytic agent.

5.2 Pharmacokinetic Properties

Naftidrofuryl oxalate is well absorbed when given orally. Peak plasma levels occur about 30 minutes after dosing and the half life is about an hour, although inter subject variation is relatively high. Accumulation does not occur at a dose level of 200mg three times daily.

The drug becomes extensively bound to plasma proteins and is excreted principally via the urine, all in the form of metabolites.

5.3 Preclinical Safety Data

No toxic effects were seen in animal studies which provide additional information to that obtained in man. In repeated dose studies the no effect level was 25mg/kg/day or greater. There was no evidence of effects on reproduction below doses which caused maternal toxicity.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Talc

Magnesium Stearate

Purified Water*

Denatured Ethanol*

Capsule Shells:

Erythrosine (E127)

Titanium Dioxide (E171)

Gelatine

Printing ink:

Black iron oxide (E172)

*Not present in final product

6.2 Incompatibilities

None known.

6.3 Shelf Life

36 months.

6.4 Special Precautions For Storage

Store below 20°C in a dry place away from light.

6.5 Nature And Contents Of Container

Pack size 10 (medical sample), 21 and 84 capsules:-

Cardboard carton containing blister strips comprising heat-sealable PVC (250?m) and aluminium foil (30?m).

Pack size 100 and 500:

Polyethylene securitainers with tamper evident closures.

6.6 Special Precautions For Disposal And Other Handling

None.

7. Marketing Authorisation Holder

Merck Serono Ltd

Bedfont Cross

Stanwell Road

Feltham

Middlesex

TW14 8NX, UK

8. Marketing Authorisation Number(S)

PL 11648/0064

9. Date Of First Authorisation/Renewal Of The Authorisation

24 March 2009

10. Date Of Revision Of The Text

24 March 2009

Minims Phenylephrine Hydrochloride 2.5% w / v
1. Name Of The Medicinal Product

Minims Phenylephrine Hydrochloride 2.5%

2. Qualitative And Quantitative Composition

Clear, colourless, sterile eye drops containing Phenylephrine Hydrochloride Ph.Eur. 2.5% w/v.

3. Pharmaceutical Form

Sterile, single-use eye drop

4. Clinical Particulars 4.1 Therapeutic Indications

Phenylephrine is a directly acting sympathomimetic agent used topically in the eye as a mydriatic. It may be indicated to dilate the pupil for diagnostic or therapeutic procedures.

4.2 Posology And Method Of Administration

Adults

Apply one drop topically to each eye. If necessary, this dose may be repeated once only, at least one hour after the first drop.

The use of a drop of topical anaesthetic a few minutes before instillation of phenylephrine is recommended to prevent stinging.

Children and the Elderly

Apply one drop topically to the eye. It is not usually necessary to exceed this dose.

4.3 Contraindications

Patients with cardiac disease, hypertension, aneurysms, thyrotoxicosis, long-standing insulin dependent diabetes mellitus and tachycardia.

Patients on monoamine oxidase inhibitors, tricyclic antidepressants and anti-hypertensive agents (including beta-blockers).

Patients with closed angle glaucoma (unless previously treated with iridectomy) and patients with a narrow angle prone to glaucoma precipitated by mydriatics.

Hypersensitivity to phenylephrine or any component of the preparation.

4.4 Special Warnings And Precautions For Use

Use with caution in the presence of diabetes, cerebral arteriosclerosis or long-standing bronchial asthma.

To reduce the risk of precipitating an attack of narrow angle glaucoma evaluate the anterior chamber angle before use.

Ocular hyperaemia can increase the absorption of phenylephrine given topically.

Corneal clouding may occur if phenylephrine 10% is instilled when the corneal epithelium has been denuded or damaged.

Systemic absorption may be minimised by compressing the lacrimal sac at the medial canthus for one minute during and after the instillation of the drops. (This blocks the passage of the drops via the naso-lacrimal duct to the wide absorptive area of the nasal and pharyngeal mucosa. It is especially advisable in children.)

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Anti-hypertensive Agents

Topical phenylephrine should not be used as it may reverse the action of many anti-hypertensive agents with possibly fatal consequences.

Monoamine Oxidase Inhibitors

There is an increased risk of adrenergic reactions when used simultaneously with, or up to three weeks after, the administration of MAOIs.

Tricyclic Antidepressants

The pressor response to adrenergic agents and the risk of cardiac arrythmia may be potentiated in patients receiving tricyclic antidepressants (or within several days of their discontinuation).

Halothane

Because of the increased risk of ventricular fibrillation, phenylephrine should be used with caution during general anaesthesia with anaesthetic agents which sensitise the myocardium to sympathomimetics.

Cardiac Glycosides or Quinidine

There is an increased risk of arrythmias.

4.6 Pregnancy And Lactation

Safety for use during pregnancy and lactation has not been established. This product should only be used during pregnancy if it is considered by the physician to be essential.

4.7 Effects On Ability To Drive And Use Machines

May cause stinging and temporarily blurred vision. Warn patients not to drive or operate hazardous machinery until vision is clear.

4.8 Undesirable Effects

Local

Eye pain and stinging on instillation (use of a drop of topical anaesthetic a few minutes before the instillation of phenylephrine is recommended), temporarily blurred vision and photophobia, conjunctival sensitisation and allergy may occur.

Systemic

Palpitations, tachycardia, extrasystoles, cardiac arrythmias and hypertension.

Serious cardiovascular reactions including coronary artery spasm, ventricular arrythmias and myocardial infarctions have occurred following topical use of 10% phenylephrine. These sometimes fatal reactions have usually occurred in patients with pre-existing cardiovascular disease.

4.9 Overdose

Because a severe toxic reaction to phenylephrine is of rapid onset and short duration, treatment is primarily supportive. Prompt injection of a rapidly acting alpha-adrenergic blocking agent such as phentolamine (dose 2 to 5mg iv) has been recommended.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Phenylephrine is a direct acting sympathomimetic agent. It causes mydriasis via the stimulation of alpha receptors. There is almost no cycloplegic effect.

Maximal mydriasis occurs in 60 - 90 minutes with recovery after 5 - 7 hours.

The mydriatic effects of phenylephrine can be reversed with thymoxamine.

5.2 Pharmacokinetic Properties

Phenylephrine is a weak base at physiological pH. The extent of ocular penetration is determined by the condition of the cornea. A healthy cornea presents a physical barrier, in addition to which, some metabolic activity may occur. Where the corneal epithelium is damaged, the effect of the barrier and the extent of metabolism are reduced, leading to greater absorption.

5.3 Preclinical Safety Data

The use of phenylephrine in ophthalmology has been well established for many years. No unexpected adverse safety issues were identified during the development of the Minims format.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Sodium metabisulphite

Disodium edetate

Purified water

6.2 Incompatibilities

None stated.

6.3 Shelf Life

15 months.

6.4 Special Precautions For Storage

Store below 25°C. Do not freeze. Store in the original container in order to protect from light.

6.5 Nature And Contents Of Container

A sealed conical shaped polypropylene container fitted with a twist and pull off cap. Each Minims unit is overwrapped in an individual polypropylene/paper pouch. Each container holds approximately 0.5ml of solution.

6.6 Special Precautions For Disposal And Other Handling

Each Minims unit should be discarded after a single use.

7. Marketing Authorisation Holder

Chauvin Pharmaceuticals Ltd

106 London Road

Kingston-upon-Thames

Surrey

KT2 6TN

8. Marketing Authorisation Number(S)

PL 0033/0117

9. Date Of First Authorisation/Renewal Of The Authorisation

21/05/1986

10. Date Of Revision Of The Text

September 2006

Vagifem
Pronunciation: ES-tra-DYE-olGeneric Name: EstradiolBrand Name: Vagifem

Acular LS

Generic Name: ketorolac ophthalmic (KEE toe ROLE ak) Brand Names: Acular, Acular LS, Acular PF, Acuvail

What is Acular LS (ketorolac ophthalmic)?

Ketorolac is in a group of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs). Ketorolac works by reducing hormones that cause inflammation and pain in the body.

Ketorolac ophthalmic (for the eye) is used to relieve eye itching caused by seasonal allergies.

Ketorolac ophthalmic is also used to reduce swelling, pain, and burning or stinging after cataract surgery or corneal refractive surgery.

Ketorolac ophthalmic may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Acular LS (ketorolac ophthalmic)? You should not use this medication if you are allergic to ketorolac or other NSAIDs (nonsteroidal anti-inflammatory drugs).

Before using ketorolac ophthalmic, tell your doctor if you are allergic to any medications, or if you have a bleeding or blood-clotting disorder, diabetes, arthritis, glaucoma, dry eye syndrome, or if you have had other recent eye surgeries.

Tell your doctor about all other medications you use, especially a blood thinner such as warfarin (Coumadin).

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. Using the medication for longer than prescribed may increase the risk of serious side effects on your eyes.

While you are using this medication, do not wear any contact lens that has not been approved by your doctor. Do not use any other eye medications unless your doctor has prescribed them. What should I discuss with my healthcare provider before I use Acular LS (ketorolac ophthalmic)? You should not use this medication if you are allergic to ketorolac or other NSAIDs.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely use this medication:

a bleeding or blood-clotting disorder;

diabetes;

arthritis;

glaucoma;

dry eye syndrome; or

if you have had other recent eye surgeries.

FDA pregnancy category C. It is not known whether ketorolac ophthalmic is harmful to an unborn baby. Before taking this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether ketorolac ophthalmic passes into breast milk or if it could harm a nursing baby. Do not use ketorolac ophthalmic without telling your doctor if you are breast-feeding a baby. How should I use Acular LS (ketorolac ophthalmic)?

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.

Ketorolac ophthalmic is usually given 24 hours before cataract surgery, and continued for up to 14 days after surgery. Using the medication for longer than prescribed may increase the risk of serious side effects on your eyes.

Wash your hands before using the eye drops.

To apply the eye drops:

Tilt your head back slightly and pull down your lower eyelid to create a small pocket. Hold the dropper above the eye with the dropper tip down. Look up and away from the dropper as you squeeze out a drop, then close your eye.

Gently press your finger to the inside corner of the eye (near your nose) for about 1 minute to keep the liquid from draining into your tear duct.

Use the eye drops only in the eye you are having surgery on.

Do not allow the dropper tip to touch any surface, including the eyes or hands. If the dropper becomes contaminated it could cause an infection in your eye, which can lead to vision loss or serious damage to the eye.

Do not use the eye drops if the liquid has changed colors or has particles in it. Call your doctor for a new prescription.

Store the drops at room temperature away from heat and moisture. Keep the bottle tightly closed when not in use. What happens if I miss a dose?

Use the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose? Seek emergency medical attention if you think you have used too much of this medicine.

An overdose of ketorolac is not likely to cause life-threatening symptoms.

What should I avoid while using Acular LS (ketorolac ophthalmic)? While using this medication, do not wear any contact lens that has not been approved by your doctor.

Do not use any other eye medications unless your doctor has prescribed them.

Acular LS (ketorolac ophthalmic) 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 burning, stinging, or itching of your eyes;

eye pain, redness, or watering;

vision changes, increased sensitivity to light;

white patches on your eyes; or

crusting or drainage from your eyes.

Less serious side effects may include:

mild burning, stinging, or itching of your eyes;

swollen or puffy eyelids; or

headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Acular LS (ketorolac ophthalmic)?

Tell your doctor about all other medications you use, especially a blood thinner such as warfarin (Coumadin).

This list is not complete and there may be other drugs that can interact with ketorolac ophthalmic. 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 Acular LS resources Acular LS Side Effects (in more detail)Acular LS Use in Pregnancy & BreastfeedingAcular LS Drug InteractionsAcular LS Support Group1 Review for Acular LS - Add your own review/rating Acular LS Prescribing Information (FDA) Acular LS Drops MedFacts Consumer Leaflet (Wolters Kluwer) Acular LS Advanced Consumer (Micromedex) - Includes Dosage Information Acular Drops MedFacts Consumer Leaflet (Wolters Kluwer) Acular Prescribing Information (FDA) Acular eent Monograph (AHFS DI) Acular PF Prescribing Information (FDA) Acular PF Drops MedFacts Consumer Leaflet (Wolters Kluwer) Acuvail Prescribing Information (FDA) Acuvail Drops MedFacts Consumer Leaflet (Wolters Kluwer) Acuvail Consumer Overview Compare Acular LS with other medications Corneal Refractive SurgeryPostoperative Ocular InflammationSeasonal Allergic Conjunctivitis Where can I get more information? Your doctor or pharmacist can provide more information about ketorolac ophthalmic.

See also: Acular LS side effects (in more detail)

Mineral Ice Gel
Generic Name: menthol gel Dosage Form: FOR ANIMAL USE ONLY Active Ingredient:   Menthol 2%

GENERAL PRECAUTIONS

cytomegalovirus immune globulin (CMV IG) injectable

Generic Name: cytomegalovirus immune globulin (CMV IG) (injectable) (sye toe MEH gah loe vye rus ih MUNE GLAW byoo lin) Brand Names: Cytogam

What is CMV IG?

Cytomegalovirus immune globulin (CMV IG) is a sterilized solution obtained from pooled human blood. It contains the immunoglobulins (or antibodies) to protect against infection from cytomegalovirus. Antibodies are substances in the blood that fight infections.

CMV IG is used to help prevent infection by cytomegalovirus in people who receive an organ transplant.

CMV IG may also be used for purposes other than those listed here.

What is the most important information I should know about CMV IG?

CMV IG is made from human plasma (part of the blood) and may contain infectious agents (e.g., viruses) that can cause disease. Although CMV IG is screened, tested, and treated to reduce the possibility that it carries an infectious agent, it can still potentially transmit disease. Discuss with your doctor the risks and benefits of using CMV IG.

Treatment with immune globulin products such as CMV IG has been associated with the development of kidney problems, sometimes resulting in kidney failure and/or death. Notify your doctor immediately if you develop decreased urination, sudden weight gain, fluid retention or swelling, or shortness of breath. These may be signs of kidney problems. Rare cases of aseptic meningitis syndrome (AMS) have been associated with the use of immune globulin products such as CMV IG. Notify your doctor immediately if you experience severe headache, neck stiffness, drowsiness, fever, eye sensitivity to light, painful eye movements, and nausea or vomiting. These may be signs of AMS. Stopping treatment with the immune globulin has resulted in resolution of AMS without any lasting problems. What should I discuss with my healthcare provider before taking CMV IG? Do not use CMV IG without first talking to your doctor if you have

kidney disease;

diabetes;

IgA deficiency; or

a previous allergic reaction to another immune globulin product.

You may not be able to use CMV IG, or you may require a dosage adjustment or special monitoring during treatment.

CMV IG is in the FDA pregnancy category C. This means that it is not known whether it will be harmful to an unborn baby. Do not use CMV IG without first talking to your doctor if you are pregnant or could become pregnant during treatment. It is not known whether CMV IG passes into breast milk. Do not use CMV IG without first talking to your doctor if you are breast-feeding a baby. Individuals over the age of 65 years may have an increased risk of kidney problems with the use of CMV IG. Your doctor may prescribe a lower dose of the medication or special monitoring during treatment. How should I take CMV IG?

CMV IG will be administered by intravenous (into a vein) injection by a healthcare provider in a hospital or clinic setting.

Your doctor may want you to have blood tests or other forms of monitoring during treatment with CMV IG to monitor progress and side effects.

Your healthcare provider will store CMV IG as directed by the manufacturer. If you are storing CMV IG at home, your healthcare provider will provide storage instructions.

See also: Cytomegalovirus immune globulin (CMV IG) dosage (in more detail)

What happens if I miss a dose?

Contact your healthcare provider if a dose of CMV IG is missed.

What happens if I overdose? Seek emergency medical attention or contact your healthcare provider if an overdose of CMV IG is suspected.

No information is available regarding an overdose of CMV IG.

What should I avoid while taking CMV IG? Do not receive vaccines that use live strains of the virus (e.g., measles, mumps, and rubella or MMR) during and for approximately three months following treatment with CMV IG. These vaccines may not work properly when CMV IG has been recently administered. CMV IG side effects

CMV IG is made from human plasma (part of the blood) and may contain infectious agents (e.g., viruses) that can cause disease. Although CMV IG is screened, tested, and treated to reduce the possibility that it carries an infectious agent, it can still potentially transmit disease. Discuss with your doctor the risks and benefits of using CMV IG.

Treatment with immune globulin products such as CMV IG has been associated with the development of kidney problems, sometimes resulting in kidney failure and/or death. Notify your doctor immediately if you develop decreased urination, sudden weight gain, fluid retention or swelling, or shortness of breath. These may be signs of kidney problems. Rare cases of aseptic meningitis syndrome (AMS) have been associated with the use of immune globulin products such as CMV IG. Notify your doctor immediately if you experience severe headache, neck stiffness, drowsiness, fever, eye sensitivity to light, painful eye movements, and nausea or vomiting. These may be signs of AMS. Stopping treatment with the immune globulin has resulted in resolution of AMS without any lasting problems. Notify your doctor immediately if you experience a rare but serious allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives) to CMV IG.

Other less serious side effects may also occur. Upon injection of the medication, some patients experience the following side effects:

flushing or sweating;

wheezing;

muscle cramps;

joint pain;

nausea or vomiting; or

fever or chills.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

Cytomegalovirus immune globulin (CMV IG) Dosing Information

Usual Adult Dose for CMV Prophylaxis:

Kidney transplant:Within 72 hours of transplant: 150 mg/kg

Acromegaly Medications

Definition of Acromegaly: Acromegaly is a chronic metabolic disorder caused by the presence of too much growth hormone. It results in gradual enlargement of body tissues including the bones of the face, jaw, hands, feet, and skull.

Drugs associated with Acromegaly

The following drugs and medications are in some way related to, or used in the treatment of Acromegaly. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

Learn more about Acromegaly

Medical Encyclopedia:

Acromegaly Drug List:SandostatinSomatuline-DepotSomavert

Acetaminophen/Chlorpheniramine/Phenylephrine Controlled-Release Tablets
Pronunciation: ah-seet-ah-MIN-oh-fen/klor-fen-EER-a-meen/fen-ill-EF-rinGeneric Name: Acetaminophen/Chlorpheniramine/PhenylephrineBrand Name: Protid

Vinate AZ

Generic Name: prenatal multivitamins (PRE nay tal VYE ta mins) Brand Names: Advance Care Plus, Bright Beginnings, Cavan Folate, Cavan One, Cavan-Heme OB, Cenogen Ultra, CitraNatal Rx, Co Natal FA, Complete Natal DHA, Complete-RF, CompleteNate, Concept OB, Docosavit, Dualvit OB, Duet, Edge OB, Elite OB 400, Femecal OB, Folbecal, Folcaps Care One, Folivan-OB, Foltabs, Gesticare, Icar Prenatal, Icare Prenatal Rx, Inatal Advance, Infanate DHA, Kolnatal DHA, Lactocal-F, Marnatal-F, Maternity, Maxinate, Mission Prenatal, Multi-Nate 30, Multinatal Plus, Nata 29 Prenatal, Natachew, Natafort, Natelle, Neevo, Nestabs, Nexa Select with DHA, Novanatal, NovaStart, O-Cal Prenatal, OB Complete, OB Natal One, Ob-20, Obtrex DHA, OptiNate, Paire OB Plus DHA, PNV Select, PNV-Total, PR Natal 400, Pre-H-Cal, Precare, PreferaOB, Premesis Rx, PrenaCare, PrenaFirst, PrenaPlus, Prenatabs OBN, Prenatabs Rx, Prenatal 1 Plus 1, Prenatal Elite, Prenatal Multivitamins, Prenatal Plus, Prenatal S, Prenatal-U, Prenate Advanced Formula, Prenate DHA, Prenate Elite, Prenavite FC, PreNexa, PreQue 10, Previte Rx, PrimaCare, Pruet DHA, RE OB Plus DHA, Renate, RightStep, Rovin-NV, Se-Care, Se-Natal One, Se-Plete DHA, Se-Tan DHA, Select-OB, Seton ET, Strongstart, Stuart Prenatal with Beta Carotene, Tandem OB, Taron-BC, Tri Rx, TriAdvance, TriCare, Trimesis Rx, Trinate, Triveen-PRx RNF, UltimateCare Advance, Ultra-Natal, Vemavite PRX 2, VeNatal FA, Verotin-BY, Verotin-GR, Vinacal OR, Vinatal Forte, Vinate Advanced (New Formula), Vinate AZ, Vinate Care, Vinate Good Start, Vinate II (New Formula), Vinate III, Vinate One, Vitafol-OB, VitaNatal OB plus DHA, Vitaphil, Vitaphil Aide, Vitaphil Plus DHA, Vitaspire, Viva DHA, Vol-Nate, Vol-Plus, Vol-Tab Rx, Vynatal F.A., Zatean-CH, Zatean-PN

What are Vinate AZ (prenatal multivitamins)?

There are many brands and forms of prenatal vitamin available and not all brands are listed on this leaflet.

Prenatal vitamins are a combination of many different vitamins that are normally found in foods and other natural sources.

Prenatal vitamins are used to provide the additional vitamins needed during pregnancy. Minerals may also be contained in prenatal multivitamins.

Prenatal vitamins may also be used for purposes not listed in this medication guide.

What is the most important information I should know about prenatal vitamins?

There are many brands and forms of prenatal vitamin available and not all brands are listed on this leaflet.

Never take more than the recommended dose of a multivitamin. Avoid taking any other multivitamin product within 2 hours before or after you take your prenatal vitamins. Taking similar vitamin products together at the same time can result in a vitamin overdose or serious side effects.

Many multivitamin products also contain minerals such as calcium, iron, magnesium, potassium, and zinc. Minerals (especially taken in large doses) can cause side effects such as tooth staining, increased urination, stomach bleeding, uneven heart rate, confusion, and muscle weakness or limp feeling. Read the label of any multivitamin product you take to make sure you are aware of what it contains.

Seek emergency medical attention if you think you have used too much of this medicine. An overdose of vitamins A, D, E, or K can cause serious or life-threatening side effects and can also harm your unborn baby. Certain minerals contained in a prenatal multivitamin may also cause serious overdose symptoms or harm to the baby if you take too much.

Overdose symptoms may include stomach pain, vomiting, diarrhea, constipation, loss of appetite, hair loss, peeling skin, tingly feeling in or around your mouth, changes in menstrual periods, weight loss, severe headache, muscle or joint pain, severe back pain, blood in your urine, pale skin, and easy bruising or bleeding.

Do not take this medication with milk, other dairy products, calcium supplements, or antacids that contain calcium. Calcium may make it harder for your body to absorb certain ingredients of the multivitamin. What should I discuss with my healthcare provider before taking prenatal vitamins? Many vitamins can cause serious or life-threatening side effects if taken in large doses. Do not take more of this medication than directed on the label or prescribed by your doctor.

Before taking prenatal vitamins, tell your doctor about all of your medical conditions.

You may need to continue taking prenatal vitamins if you breast-feed your baby. Ask your doctor about taking this medication while breast-feeding. How should I take prenatal vitamins?

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Never take more than the recommended dose of prenatal vitamins.

Many multivitamin products also contain minerals such as calcium, iron, magnesium, potassium, and zinc. Minerals (especially taken in large doses) can cause side effects such as tooth staining, increased urination, stomach bleeding, uneven heart rate, confusion, and muscle weakness or limp feeling. Read the label of any multivitamin product you take to make sure you are aware of what it contains.

Take your prenatal vitamin with a full glass of water.

Swallow the regular tablet or capsule whole. Do not break, chew, crush, or open it.

The chewable tablet must be chewed or allowed to dissolve in your mouth before swallowing. You may also allow the chewable tablet to dissolve in drinking water, fruit juice, or infant formula (but not milk or other dairy products). Drink this mixture right away.

Use prenatal vitamins regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Store at room temperature away from moisture and heat. Keep prenatal vitamins in their original container. Storing vitamins in a glass container can ruin the medication. What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose? Seek emergency medical attention if you think you have used too much of this medicine. An overdose of vitamins A, D, E, or K can cause serious or life-threatening side effects and can also harm your unborn baby. Certain minerals contained in a prenatal multivitamin may also cause serious overdose symptoms or harm to the baby if you take too much.

Overdose symptoms may include stomach pain, vomiting, diarrhea, constipation, loss of appetite, hair loss, peeling skin, tingly feeling in or around your mouth, changes in menstrual periods, weight loss, severe headache, muscle or joint pain, severe back pain, blood in your urine, pale skin, and easy bruising or bleeding.

What should I avoid while taking prenatal vitamins? Avoid taking any other multivitamin product within 2 hours before or after you take your prenatal vitamins. Taking similar vitamin products together at the same time can result in a vitamin overdose or serious side effects.

Avoid the regular use of salt substitutes in your diet if your multivitamin contains potassium. If you are on a low-salt diet, ask your doctor before taking a vitamin or mineral supplement.

Do not take this medication with milk, other dairy products, calcium supplements, or antacids that contain calcium. Calcium may make it harder for your body to absorb certain ingredients of the prenatal vitamin. Prenatal vitamins 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.

When taken as directed, prenatal vitamins are not expected to cause serious side effects. Less serious side effects may include:

upset stomach;

headache; or

unusual or unpleasant taste in your mouth.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect prenatal vitamins?

Vitamin and mineral supplements can interact with certain medications, or affect how medications work in your body. Before taking a prenatal vitamin, tell your doctor if you also use:

diuretics (water pills);

heart or blood pressure medications;

tretinoin (Vesanoid);

isotretinoin (Accutane, Amnesteen, Clavaris, Sotret);

trimethoprim and sulfamethoxazole (Cotrim, Bactrim, Gantanol, Gantrisin, Septra, TMP/SMX); or

an NSAID (non-steroidal anti-inflammatory drug) such as ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn, Naprelan, Treximet), celecoxib (Celebrex), diclofenac (Cataflam, Voltaren), indomethacin (Indocin), meloxicam (Mobic), and others.

This list is not complete and other drugs may interact with prenatal vitamins. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Vinate AZ resources Vinate AZ Side Effects (in more detail)Vinate AZ Use in Pregnancy & BreastfeedingVinate AZ Drug InteractionsVinate AZ Support Group0 Reviews for Vinate AZ - Add your own review/rating Vinate AZ Prescribing Information (FDA) Cal-Nate MedFacts Consumer Leaflet (Wolters Kluwer) CareNatal DHA MedFacts Consumer Leaflet (Wolters Kluwer) CitraNatal 90 DHA MedFacts Consumer Leaflet (Wolters Kluwer) CitraNatal Assure Prescribing Information (FDA) CitraNatal Harmony Prescribing Information (FDA) Concept DHA Prescribing Information (FDA) Docosavit Prescribing Information (FDA) Duet DHA with Ferrazone MedFacts Consumer Leaflet (Wolters Kluwer) Folbecal MedFacts Consumer Leaflet (Wolters Kluwer) Folcal DHA Prescribing Information (FDA) Folcaps Care One Prescribing Information (FDA) Gesticare DHA Prescribing Information (FDA) Gesticare DHA MedFacts Consumer Leaflet (Wolters Kluwer) Inatal Advance Prescribing Information (FDA) Inatal Ultra Prescribing Information (FDA) Multi-Nate DHA Prescribing Information (FDA) Multi-Nate DHA Extra Prescribing Information (FDA) MultiNatal Plus MedFacts Consumer Leaflet (Wolters Kluwer) Natelle One Prescribing Information (FDA) Neevo Caplets MedFacts Consumer Leaflet (Wolters Kluwer) Neevo DHA MedFacts Consumer Leaflet (Wolters Kluwer) OB Complete 400 MedFacts Consumer Leaflet (Wolters Kluwer) Paire OB Plus DHA Prescribing Information (FDA) PreNexa MedFacts Consumer Leaflet (Wolters Kluwer) PreNexa Prescribing Information (FDA) PreferaOB Prescribing Information (FDA) Prenatal Plus Prescribing Information (FDA) Prenatal Plus Iron Prescribing Information (FDA) Prenate Elite Prescribing Information (FDA) Prenate Elite MedFacts Consumer Leaflet (Wolters Kluwer) Prenate Elite tablets Prenate Essential Prescribing Information (FDA) PrimaCare Advantage MedFacts Consumer Leaflet (Wolters Kluwer) PrimaCare ONE capsules PrimaCare One MedFacts Consumer Leaflet (Wolters Kluwer) Renate DHA Prescribing Information (FDA) Se-Natal 19 Chewable Tablets MedFacts Consumer Leaflet (Wolters Kluwer) Se-Natal 19 Prescribing Information (FDA) Tandem DHA Prescribing Information (FDA) Tandem OB Prescribing Information (FDA) TriAdvance Prescribing Information (FDA) Triveen-One MedFacts Consumer Leaflet (Wolters Kluwer) Triveen-PRx RNF Prescribing Information (FDA) UltimateCare ONE NF Prescribing Information (FDA) Ultra NatalCare MedFacts Consumer Leaflet (Wolters Kluwer) Vitafol-One MedFacts Consumer Leaflet (Wolters Kluwer) Zatean-CH Prescribing Information (FDA) Compare Vinate AZ with other medications Vitamin/Mineral Supplementation during Pregnancy/Lactation Where can I get more information? Your pharmacist can provide more information about prenatal vitamins.

See also: Vinate AZ side effects (in more detail)

Alteplase
Pronunciation: AL-teh-PLACEGeneric Name: AlteplaseBrand Name: Cathflo Activase

Tersi Foam Topical

Generic Name: selenium sulfide (Topical route)

se-LEE-nee-um SUL-fide

Commonly used brand name(s)

In the U.S.

Dandrex Selenos Selseb Selsun Blue Medicated Treatment Tersi Foam

In Canada

Versel

Available Dosage Forms:

Lotion Cream Shampoo Foam Suspension

Therapeutic Class: Antiseborrheic

Uses For Tersi Foam

Selenium sulfide 1% and 2.5% strengths are used on the scalp to help control the symptoms of dandruff and seborrheic dermatitis.

Selenium sulfide 2.5% strength is used also on the body to treat tinea versicolor (a type of fungus infection of the skin).

In the United States, the 2.5% strength is available only with your doctor's prescription.

Before Using Tersi Foam

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 this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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

There is no specific information comparing use of selenium sulfide in infants and children with use in other age groups; however, this medicine is not expected to cause different side effects or problems in children than it does in adults.

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 use of selenium sulfide in the elderly with use in other age groups, this medicine is not expected to cause different side effects or problems in older people than it does in younger adults.

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 this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

Blistered, raw, or oozing areas on your scalp or body—Use of this medicine on these areas may increase the chance of absorption through the skin Proper Use of selenium sulfide

This section provides information on the proper use of a number of products that contain selenium sulfide. It may not be specific to Tersi Foam. Please read with care.

If you are using the 2.5% strength of selenium sulfide: Use this medicine only as directed. Do not use it more often than recommended on the label, unless otherwise directed by your doctor.

If you are using the 1% strength of selenium sulfide : For best results, use this medicine at least 2 times a week or as directed by your doctor.

To use selenium sulfide for dandruff or seborrheic dermatitis of the scalp:

Before using this medicine, wet the hair and scalp with lukewarm water. Apply enough medicine (1 or 2 teaspoonfuls) to the scalp to work up a lather. Allow the lather to remain on the scalp for 2 to 3 minutes, then rinse. Apply the medicine again and rinse well. If this medicine is used on light or blond, gray, or chemically treated (bleached, tinted, permanent-waved) hair, rinse your hair well for at least 5 minutes after using the medicine to lessen the chance of hair discoloration. After treatment, wash your hands well.

To use selenium sulfide for tinea versicolor of the body:

Apply the medicine to the affected areas of your body, except for your face and genitals (sex organs). Work up a lather using a small amount of water. Allow the medicine to remain on your skin for 10 minutes. Rinse your body well to remove all the medicine.

Do not use this medicine if blistered, raw, or oozing areas are present on your scalp or the area of your body that is to be treated , unless otherwise directed by your doctor.

Keep this medicine away from the eyes. If you should accidentally get some in your eyes, flush them thoroughly with water.

Dosing

The dose of this medicine 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 this medicine. 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 lotion dosage form: For dandruff or seborrheic dermatitis: Adults and children—If you are using the 1% lotion, use on the scalp two times a week. If you are using the 2.5% lotion, use on the scalp two times a week for two weeks, then use one time a week or less often. Infants—Use and dose must be determined by your doctor. For tinea versicolor: Adults and children—Use the 2.5% lotion on the body one time a day for seven days. Infants—Use and dose must be determined by your doctor. Missed Dose

If you miss a dose of this medicine, 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.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Tersi Foam

If your condition does not get better after regular use of this medicine, or if it gets worse, check with your doctor.

Tersi Foam 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:

Less common or rare Skin irritation

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 Unusual dryness or oiliness of hair or scalp Less common Increase in normal hair loss

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.

See also: Tersi Topical side effects (in more detail)

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.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Tersi Foam Topical resources Tersi Foam Topical Side Effects (in more detail)Tersi Foam Topical Use in Pregnancy & BreastfeedingTersi Foam Topical Support Group0 Reviews for Tersi Topical - Add your own review/rating Compare Tersi Foam Topical with other medications Seborrheic DermatitisTinea Versicolor

Begrivac 2010 / 2011 suspension for injection in pre-filled syringe
1. Name Of The Medicinal Product

Begrivac® 2010/2011 / suspension for injection in pre-filled syringe

Influenza vaccine (split virion, inactivated)

2. Qualitative And Quantitative Composition

Influenza virus (inactivated, split) of the following strains*:

A/California/07/2009 (H1N1) - derived strain used NYMC X-181

15 micrograms HA**

A/Perth/16/2009 (H3N2) - like strain used NYMC X-187

derived from A/Victoria/210/2009

15 micrograms HA**

B/Brisbane/60/2008 - derived strain used NYMC BX-35

15 micrograms HA**

----------------------------------------------------------------------------------------------------------------------

per 0.5 ml dose

* propagated in fertilised hen's eggs from healthy chicken flocks .

** haemagglutinin

This vaccine complies with the WHO recommendation (northern hemisphere) and EU decision for the 2010/2011 season.

For a full list of excipients see section 6.1.

3. Pharmaceutical Form

Suspension for injection in pre-filled syringe.

Slightly opalescent.

4. Clinical Particulars 4.1 Therapeutic Indications

Prophylaxis of influenza, especially in those who run an increased risk of associated complications.

The use of Begrivac 2010/2011 should be based on official recommendations.

4.2 Posology And Method Of Administration

Adults and children from 36 months: 0.5 ml.

Children from 6 months to 35 months: Clinical data are limited. Dosages of 0.25 ml or 0.5 ml have been used.

For children, who have not previously been vaccinated, a second dose should be given after an interval of at least 4 weeks.

Immunisation should be carried out by intramuscular or deep subcutaneous injection.

For instructions for preparation, see section 6.6.

4.3 Contraindications

Hypersensitivity to the active substances, to any of the excipients and to residues, e.g. eggs, chicken proteins, such as ovalbumin.

The vaccine may contain residues of polymyxin B, formaldehyde, diethylether or polysorbate 80.

Immunisation shall be postponed in patients with febrile illness or acute infection.

4.4 Special Warnings And Precautions For Use

As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of an anaphylactic event following the administration of the vaccine.

Begrivac 2010/2011 should under no circumstances be administered intravascularly.

Antibody response in patients with endogenous or iatrogenic immunosuppression may be insufficient.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Begrivac 2010/2011 may be given at the same time as other vaccines. Immunisation should be carried out on separate limbs. It should be noted that the adverse reactions may be intensified.

The immunological response may be diminished if the patient is undergoing immuno-suppressant treatment.

Following influenza vaccination, false positive results in serology tests using the ELISA method to detect antibodies against HIV1, Hepatitis C and especially HTLV1 have been observed. The Western Blot technique disproves the false-positive ELISA test results. The transient false positive reactions could be due to the IgM response by the vaccine.

4.6 Pregnancy And Lactation

The limited data from vaccinations in pregnant women do not indicate that adverse fetal and maternal outcomes were attributable to the vaccine. The use of this vaccine may be considered from the second trimester of pregnancy. For pregnant women with medical conditions that increase their risk of complications from influenza, administration of the vaccine is recommended, irrespective of their stage of pregnancy.

Begrivac 2010/2011 may be used during lactation.

4.7 Effects On Ability To Drive And Use Machines

The vaccine is unlikely to produce an effect on the ability to drive and use machines.

4.8 Undesirable Effects

Adverse reactions observed from clinical trials

The safety of trivalent inactivated influenza vaccines is assessed in open label, uncontrolled clinical trials performed as annual update requirement, including at least 50 adults aged 18 – 60 years of age and at least 50 elderly aged 61 years or older. Safety evaluation is performed during the first 3 days following vaccination.

The following undesirable effects have been observed during clinical trials with the following frequencies:

Very common (>1/10); common (

Nervous system disorders

Common:

Headache*

Skin and subcutaneous tissue disorders

Common:

Sweating*

Musculoskeletal and connective tissue disorders

Common:

Myalgia, arthralgia*

General disorders and administration site conditions

Common:

Fever, malaise, shivering, fatigue. Local reactions: redness, swelling, pain, ecchymosis, induration.*

* These reactions usually disappear within 1-2 days without treatment.

Adverse reactions reported from post-marketing surveillance

Adverse reactions reported from post-marketing surveillance are, next to the reactions which have also been observed during the clinical trials, the following:

Blood and lymphatic system disorders:

Transient thrombocytopenia, transient lymphadenopathy

Immune system disorders:

Allergic reactions, in rare cases leading to shock, angioedema

Nervous system disorders:

Neuralgia, paraesthesia, febrile convulsions, neurological disorders, such as encephalomyelitis, neuritis and Guillain Barr? syndrome

Vacsular disorders:

Vasculitis associated in very rare cases with transient renal involvement.

Skin and subcutaneous tissue disorders:

Generalised skin reactions including pruritus, urticaria or non-specific rash.

4.9 Overdose

Overdosage is unlikely to have any untoward effect.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Influenza vaccine

ATC-Code: J07BB02

Seroprotection is generally obtained within 2 to 3 weeks. The duration of postvaccinal immunity to homologous strains or to strains closely related to the vaccine strains varies but is usually 6-12 months.

5.2 Pharmacokinetic Properties

Not applicable

5.3 Preclinical Safety Data

Not applicable

6. Pharmaceutical Particulars 6.1 List Of Excipients

Buffer solution (pH = 7.2) containing: sodium chloride, potassium chloride, magnesium chloride hexahydrate, disodium phosphate dihydrate, potassium dihydrogen phosphate and water for injections.

6.2 Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

6.3 Shelf Life

1 year

6.4 Special Precautions For Storage

Store in a refrigerator (2 °C – 8 °C). Do not freeze. Keep the syringe in the outer carton in order to protect from light.

6.5 Nature And Contents Of Container

0.5 ml suspension in pre-filled syringe (Type I glass) with plunger stopper (bromobutyl rubber) with or without needle – in pack sizes of 1, 10 or 20 (2 ? 10)

Not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

The vaccine should be allowed to reach room temperature before use.

Shake before use.

For children, when a dose of 0.25 ml is indicated, the following procedure is recommended:

Syringe without mark for the 0.25 ml dose:

The pre-filled syringe should be held in the upright position and half of the volume should be eliminated. The remaining volume should be injected.

Syringe with a mark for the 0.25 ml dose:

Discard half the contained volume up to the mark (little black line indicated on the syringe barrel below the label), before injection.

Any unused product or waste material should be disposed of in accordance with local requirements.

7. Marketing Authorisation Holder

Novartis Vaccines and Diagnostics GmbH

P.O. Box 1630

D-35006 Marburg

8. Marketing Authorisation Number(S)

national:

MRP: DE/H/125/01

9. Date Of First Authorisation/Renewal Of The Authorisation

Date of first authorization (national): 8. August 1996

Renewal of the authorization: 20. February 2008

10. Date Of Revision Of The Text

May 2010

vasopressin Injection

vay-soe-PRES-in

Commonly used brand name(s)

In the U.S.

Pitressin

Available Dosage Forms:

Solution

Therapeutic Class: Endocrine-Metabolic Agent

Pharmacologic Class: Vasopressin (class)

Uses For vasopressin

Vasopressin is a hormone that is produced by your body. It is necessary to maintain good health. If you do not have enough vasopressin, your body will lose too much water.

Vasopressin is used to control the frequent urination, increased thirst, and loss of water associated with diabetes insipidus (water diabetes).

vasopressin is available only with your doctor's prescription.

Before Using vasopressin

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 vasopressin, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to vasopressin 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

Children may be especially sensitive to the effects of vasopressin. This may increase the chance of side effects during treatment.

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 or if they cause different side effects or problems in older people. Although there is no specific information comparing the use of vasopressin in the elderly with use in other age groups, the elderly may be more sensitive to its effects.

Pregnancy Pregnancy Category Explanation All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women. 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. When you are receiving vasopressin, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using vasopressin with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Bepridil Cisapride Levomethadyl Mesoridazine Pimozide Terfenadine Thioridazine Ziprasidone

Using vasopressin with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Acecainide Ajmaline Amiodarone Amisulpride Amitriptyline Amoxapine Aprindine Arsenic Trioxide Astemizole Azimilide Bretylium Chloral Hydrate Chloroquine Chlorpromazine Clarithromycin Clomipramine Desipramine Dibenzepin Disopyramide Dofetilide Dothiepin Doxepin Droperidol Encainide Enflurane Erythromycin Flecainide Fluconazole Fluoxetine Foscarnet Gemifloxacin Halofantrine Haloperidol Halothane Hydroquinidine Ibutilide Imipramine Isoflurane Isradipine Lidoflazine Lorcainide Mefloquine Nortriptyline Octreotide Pentamidine Pirmenol Prajmaline Probucol Procainamide Prochlorperazine Propafenone Protriptyline Quetiapine Quinidine Risperidone Sematilide Sertindole Sotalol Spiramycin Sulfamethoxazole Sultopride Tedisamil Telithromycin Trifluoperazine Trimethoprim Trimipramine Venlafaxine Zolmitriptan Zotepine 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 vasopressin. Make sure you tell your doctor if you have any other medical problems, especially:

Asthma or Epilepsy or Heart disease or Kidney disease or Migraine headaches—If fluid retention (keeping more body water) caused by vasopressin occurs too fast, these conditions may be worsened. Heart or blood vessel disease—Vasopressin can cause chest pain or a heart attack; it can also increase blood pressure. Proper Use of vasopressin

Use vasopressin 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.

Dosing

The dose of vasopressin 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 vasopressin. 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 injection dosage form: For controlling water loss when urinating too often (diabetes insipidus): Adults and teenagers—5 to 10 Units injected into a muscle or under the skin two or three times a day as needed. Children—2.5 to 10 Units injected into a muscle or under the skin three or four times a day. Missed Dose

If you miss a dose of vasopressin, 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.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

vasopressin 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 immediately if any of the following side effects occur:

Rare Chest pain coma confusion convulsions (seizures) drowsiness fever headache that continues problems with urination redness of skin skin rash, hives, or itching swelling of face, feet, hands, or mouth weight gain wheezing or trouble with breathing

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:

Less common Abdominal or stomach cramps belching diarrhea dizziness or lightheadedness increased sweating increased urge for a bowel movement nausea or vomiting pale skin passage of gas "pounding'' in head trembling white-colored area around the mouth

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.

See also: vasopressin Injection side effects (in more detail)

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.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More vasopressin Injection resources Vasopressin Injection Side Effects (in more detail)Vasopressin Injection Use in Pregnancy & BreastfeedingVasopressin Injection Drug InteractionsVasopressin Injection Support Group0 Reviews for Vasopressin Injection - Add your own review/rating Compare vasopressin Injection with other medications Abdominal Distension Prior to Abdominal X-rayAsystoleDiabetes InsipidusEsophageal Varices with BleedingGastrointestinal HemorrhagePostoperative Gas PainsVentricular FibrillationVentricular Tachycardia

Mountain Sickness / Altitude Sickness Medications

Definition of Mountain Sickness / Altitude Sickness: Acute mountain sickness is an illness that can affect mountain climbers, hikers, skiers, or travelers who ascend too rapidly to high altitude (typically above 8,000 feet or 2,400 meters). This is especially for persons who normally reside at or near sea level.

Drugs associated with Mountain Sickness / Altitude Sickness

The following drugs and medications are in some way related to, or used in the treatment of Mountain Sickness / Altitude Sickness. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

Drug List:De-Sone-La-InjectionDexacen-4-InjectionDexamethasone-IntensolDexasone-La-InjectionDiamoxSolurex-InjectionZema-Pak-10-Day

Alocril
nedocromil sodium Dosage Form: ophthalmic solutionAlocril® (nedocromil sodium ophthalmic solution) 2%

sterile

Alocril Description

Alocril® (nedocromil sodium ophthalmic solution) 2% is a clear, yellow, sterile solution for topical ophthalmic use.

Nedocromil sodium is represented by the following structural formula:

Chemical name:

4H-Pyrano[3,2-g]quinoline-2,8-dicarboxylic acid, 9-ethyl-6,9-dihydro-4,6-dioxo-10-propyl-, disodium salt.

Each mL contains: Active: Nedocromil sodium 20 mg/mL (2%); Preservative: Benzalkonium chloride 0.01%; Inactives: Edetate disodium 0.05%, purified water, and sodium chloride 0.5%. It has a pH range of 4.0 to 5.5 and an osmolality range of 270 to 330 mOsm/kg.

Alocril - Clinical Pharmacology

Nedocromil sodium is a mast cell stabilizer. Nedocromil sodium inhibits the release of mediators from cells involved in hypersensitivity reactions. Decreased chemotaxis and decreased activation of eosinophils have also been demonstrated.

In vitro studies with adult human bronchoalveolar cells showed that nedocromil sodium inhibits histamine release from a population of mast cells having been defined as belonging to the mucosal sub type and inhibits beta-glucuronidase release from macrophages.

Pharmacokinetics and Bioavailability

Nedocromil sodium exhibits low systemic absorption. When administered as a 2% ophthalmic solution in adult human volunteers, less than 4% of the total dose was systemically absorbed following multiple dosing. Absorption is mainly through the nasolacrimal duct rather than through the conjunctiva. It is not metabolized and is eliminated primarily unchanged in urine (70%) and feces (30%).

Indications and Usage for Alocril

Alocril® ophthalmic solution is indicated for the treatment of itching associated with allergic conjunctivitis.

Contraindications

Alocril® ophthalmic solution is contraindicated in those patients who have shown hypersensitivity to nedocromil sodium or to any of the other ingredients.

Precautions Information for Patients

Patients should be advised to follow the patient instructions listed on the Information for Patients sheet.

Users of contact lenses should refrain from wearing lenses while exhibiting the signs and symptoms of allergic conjunctivitis.

Patients should be instructed to avoid allowing the tip of the dispensing container to contact the eye, surrounding structures, fingers, or any other surface in order to avoid contamination of the solution by common bacteria known to cause ocular infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions.

Carcinogenesis, Mutagenesis, and Impairment of Fertility

A two-year inhalation carcinogenicity study of nedocromil sodium at a dose of 24 mg/kg/day (approximately 400 times the maximum recommended human daily ocular dose on a mg/kg basis) in Wistar rats showed no carcinogenic potential.

Nedocromil sodium showed no mutagenic potential in the Ames Salmonella/microsome plate assay, mitotic gene conversion in Saccharomyces cerevisiae, mouse lymphoma forward mutation and mouse micronucleus assays.

Reproduction and fertility studies in mice and rats showed no effects on male and female fertility at a subcutaneous dose of 100 mg/kg/day (more than 1600 times the maximum recommended human daily ocular dose).

Pregnancy Teratogenic Effects: Pregnancy Category B

Reproduction studies performed in mice, rats and rabbits using a subcutaneous dose of 100 mg/kg/day (more than 1600 times the maximum human daily ocular dose on a mg/kg basis) revealed no evidence of teratogenicity or harm to the fetus due to nedocromil sodium. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, Alocril® ophthalmic solution should be used during pregnancy only if clearly needed.

Nursing Mothers

After intravenous administration to lactating rats, nedocromil was excreted in milk. 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 Alocril® ophthalmic solution is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in children below the age of 3 years have not been established.

Geriatric Use

No overall differences in safety or effectiveness have been observed between elderly and younger patients.

Adverse Reactions

The most frequently reported adverse experience was headache (~40%).

Ocular burning, irritation and stinging, unpleasant taste, and nasal congestion have been reported to occur in 10- 30% of patients. Other events occurring between 1 – 10% included asthma, conjunctivitis, eye redness, photophobia, and rhinitis.

Some of these events were similar to the underlying ocular disease being studied.

Alocril Dosage and Administration

The recommended dosage is one or two drops in each eye twice a day. Alocril® ophthalmic solution should be used at regular intervals.

Treatment should be continued throughout the period of exposure (i.e., until the pollen season is over or until exposure to the offending allergen is terminated), even when symptoms are absent.

How is Alocril Supplied

Alocril® (nedocromil sodium ophthalmic solution) 2% is supplied sterile in opaque white LDPE plastic bottles with dropper tips and white high impact polystyrene (HIPS) caps as follows:

5 mL in 10 mL bottle NDC 0023-8842-05

Storage: Store at 2? – 25?C (36? – 77?F).

Rx Only

Revised June 2008

© 2008 Allergan, Inc.

Penicillin V Potassium
Pronunciation: PEN-i-SIL-in V poe-TAS-ee-umGeneric Name: Penicillin V PotassiumBrand Name: Examples include Penicillin-VK and Veetids

Fanatrex
gabapentin Dosage Form: oral suspension - kitFanatrex Fanatrex Description

NDC 43093-105-01

Ipvent

Ipvent may be available in the countries listed below.

Ingredient matches for Ipvent Ipratropium

Ipratropium Bromide is reported as an ingredient of Ipvent in the following countries:

South Africa

International Drug Name Search

Zenalb20, a Human Albumin 20% Solution
1. Name Of The Medicinal Product

Zenalb®20, a 200 g/L of human albumin solution for infusion (20% Solution).

2. Qualitative And Quantitative Composition

Zenalb®20 contains 200 g/L and is a solution containing 200 g/L (20%) of total protein of which at least 95% is human albumin.

A vial of 100 mL contains 20 g of human albumin

Zenalb®20 has a mildly hyperoncotic effect.

For excipients see section 6.1.

3. Pharmaceutical Form

Solution for infusion.

A clear, slightly viscous liquid, it is almost colourless, yellow, amber or green.

4. Clinical Particulars 4.1 Therapeutic Indications

Restoration and maintenance of circulating blood volume where volume deficiency has been demonstrated, and use of a colloid is appropriate.

The choice of albumin rather than artificial colloid will depend on the clinical situation of the individual patient, based on official recommendations.

4.2 Posology And Method Of Administration

The concentration of the albumin preparation, dosage and the infusion-rate should be adjusted to the patient's individual requirements.

The choice of albumin rather than artificial colloid will depend on the clinical situation of the patient, based on official recommendations.

Posology

The dose required depends on the size of the patient, the severity of trauma or illness and on continuing fluid and protein losses. Measures of adequacy of circulating volume, and not plasma albumin levels, should be used to determine the dose required.

If human albumin is to be administered, haemodynamic performance should be monitored regularly; this may include:

- arterial blood pressure and pulse rate

- central venous pressure

- pulmonary artery wedge pressure

- urine output

- electrolyte

- haematocrit/haemoglobin

Method of administration

Human albumin can be directly administered by the intravenous route, or it can also be diluted in an isotonic solution (e.g. 5% glucose or 0.9% sodium chloride).

The infusion rate should be adjusted according to the individual circumstances and the indication.

4.3 Contraindications

Hypersensitivity to albumin preparations or to any of the excipients.

4.4 Special Warnings And Precautions For Use

Suspicion of allergic or anaphylactic-type reactions requires immediate discontinuation of the injection. In the case of shock, the standard medical standards treatment for shock should be implemented.

Albumin should be used with caution in conditions where hypervolaemia and its consequences or haemodilution could represent a special risk for the patient. Examples of such conditions are:

- Decompensated cardiac insufficiency

- Hypertension

- Oesophageal varices

- Pulmonary oedema

- Haemorrhagic diathesis

- Severe anaemia

- Renal and post-renal anuria

The colloid-osmotic effect of human albumin 200 g/L is approximately four times that of blood plasma. Therefore, when concentrated albumin is administered, care must be taken to ensure adequate hydration of the patient. Patients should be monitored carefully to guard against circulatory overload and hyperhydration.

200 g/L human albumin solutions are relatively low in electrolytes compared to 40-50 g/L human albumin solutions. When albumin is given, the electrolyte status of the patient should be monitored (see section 4.2) and appropriate steps taken to restore or maintain the electrolyte balance.

Albumin solutions must not be diluted with water for injections as this may cause haemolysis in recipients.

If comparatively large volumes are to be replaced, controls of coagulation and haematocrit are necessary. Care must be taken to ensure adequate substitution of other blood constituents (coagulation factors, electrolytes, platelets and erythrocytes).

Hypervolaemia may occur if the dosage and rate of infusion are not adjusted to the patient's circulatory situation. At the first clinical signs of cardiovascular overload (headache, dyspnoea, jugular vein congestion), or increased blood pressure, raised venous pressure and pulmonary oedema, the infusion is to be stopped immediately.

Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pools for specific markers of infection and the inclusion of effective manufacturing steps for the inactivation/removal of viruses. Despite this, when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infective agents cannot be totally excluded. This also applies to unknown or emerging viruses and other pathogens.

There are no reports of virus transmissions with albumin manufactured to European Pharmacopoeia specifications by established processes.

Appropriate vaccination (hepatitis A and B) should be considered for patients in regular/repeated receipt of plasma-derived human albumin solutions.

It is strongly recommended that every time that Zenalb®20 is administered to a patient, the name and batch number of the product are recorded in order to maintain a link between the patient and the batch of product.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

No specific interactions of human albumin with other medicinal products are known.

4.6 Pregnancy And Lactation

The safety of Zenalb®20 for use in human pregnancy has not been established in controlled clinical trials. However, clinical experience with albumin suggests that no harmful effects on the course of pregnancy, or on the foetus or the neonate are to be expected.

No animal reproduction studies have been conducted with Zenalb®20.

Experimental animal studies are insufficient to assess the safety with respect to reproduction, development of the embryo or foetus, the course of gestation and peri and postnatal development. However, human albumin is a normal constituent of human blood.

4.7 Effects On Ability To Drive And Use Machines

No effects on the ability to drive and use machines have been observed.

4.8 Undesirable Effects

Mild reactions such as flush, urticaria, fever and nausea occur rarely. These reactions normally disappear rapidly when the infusion rate is slowed down or the infusion is stopped. Very rarely, severe reactions such as shock may occur. In these cases, the infusion should be stopped and appropriate treatment should be initiated.

Post-marketing experience:

Additional side effects reported spontaneously include rigors, hypertension, hypotension, feeling cold, tachycardia, tremor, bronchospasm, dyspnoea, chest tightness, stridor and dizziness.

For safety with respect to transmissible agents, see 4.4.

4.9 Overdose

Hypervolaemia may occur if the dosage and rate of infusion are too high. At the first clinical signs of cardiovascular overload (headache, dyspnoea, jugular vein congestion), or increased blood pressure, raised central venous pressure and pulmonary oedema, the infusion should be stopped immediately and the patient's haemodynamic parameters carefully monitored.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: plasma substitutes and plasma protein fractions, ATC code: B05AA01

Human albumin accounts quantitatively for more than half of the total protein in the plasma and represents about 10% of the protein synthesis activity of the liver.

Physicochemical data: Zenalb®20, human albumin 200 g/L has a corresponding hyperoncotic effect.

The most important physiological functions result from its contribution to oncotic pressure of the blood and transport function. Albumin stabilises circulating blood volume and is a carrier for hormones, enzymes, medicinal products and toxins.

5.2 Pharmacokinetic Properties

Under normal conditions the total exchangeable albumin pool is 4-5 g/kg bodyweight, of which 40-45% is present intravascularly and 55-60% in the extravascular space. Increased capillary permeability will alter albumin kinetics and abnormal distribution may occur in conditions such as severe burns or septic shock.

Under normal conditions the half-life of albumin is about 19 days. The balance between synthesis and breakdown is normally achieved by feedback regulation. Elimination is predominantly intracellular and due to lysosome proteases.

In healthy people, less than 10% of infused albumin leaves the intravascular compartment during the first 2 hours following infusion. There is considerable individual variation in the effect on plasma volume. In some patients the plasma volume can remain increased for some hours. However, in critically ill patients, albumin can leak out of the vascular space in substantial amounts at an unpredictable rate.

5.3 Preclinical Safety Data

Human albumin is a normal constituent of plasma and acts like physiological albumin.

In animals, single dose toxicity testing is of little relevance and does not permit the estimation of toxic or lethal doses or of a dose-effect relationship. Repeated dose toxicity testing is impracticable due to the development of antibodies to heterologous protein in animal models.

To date, human albumin has not been reported to be associated with embryo-foetal toxicity, oncogenic or mutagenic potential.

No signs of acute toxicity have been described in animal models.

6. Pharmaceutical Particulars 6.1 List Of Excipients

Sodium 50-120 mmol/L

Potassium

Chloride

Citrate

Sodium n-octanoate

Zenalb® 20 contains not more than 200 µg/L of aluminium

6.2 Incompatibilities

Human albumin should not be mixed with other medicinal products (except those mentioned in 6.6), whole blood and packed red cells.

6.3 Shelf Life

50 mL and 100 mL size

Unopened

36 months

Opened

3 hours

6.4 Special Precautions For Storage

Zenalb®20 should be stored between 2°C and 25°C. DO NOT FREEZE.

The expiry date of the product is stated on the label.

Store in the original container. Keep container in the outer carton in order to protect from light.

6.5 Nature And Contents Of Container

The solution is contained in glass bottles stoppered with a rubber bung. The bung is over-sealed with a tamper evident cap.

6.6 Special Precautions For Disposal And Other Handling

The solution can be directly administered by the intravenous route or it can be diluted in an isotonic solution (e.g. 5% glucose or 0.9% sodium chloride). Albumin solutions must not be diluted with water for injections as this may cause haemolysis in recipients.

If large volumes are administered, the product should be warmed to room temperature before use.

Do not use solutions which are cloudy or have deposits. This may indicate that the protein is unstable or that the solution has become contaminated.

Once the infusion container has been opened, the contents should be used immediately. Any unused product should be disposed of in accordance with local requirements.

7. Marketing Authorisation Holder

This product is manufactured and marketed by

Bio Products Laboratory

Dagger Lane

Elstree

Hertfordshire

WD6 3BX

United Kingdom.

8. Marketing Authorisation Number(S)

PL 08801/0007

9. Date Of First Authorisation/Renewal Of The Authorisation

27th April 1993 / June 2000

10. Date Of Revision Of The Text

September 2008

Version Code: ABS8

POM

 

 

Pronap-100

Generic Name: propoxyphene and acetaminophen (Oral route)

a-seet-a-MIN-oh-fen, proe-POX-i-feen NAP-si-late

Oral route(Tablet)

Accidental and intentional overdose with propoxyphene products either alone or in combination with other CNS depressants, including alcohol, has occurred, and may be fatal within the first hour. Many of the fatalities have occurred in patients with previous histories of emotional disturbances or suicidal ideation/attempts and/or concomitant administration of sedatives, tranquilizers, muscle relaxants, antidepressants, or other CNS-depressant drugs. Do not prescribe propoxyphene for patients who are suicidal or have a history of suicidal ideation. The metabolism of propoxyphene may be altered by strong CYP3A4 inhibitors leading to enhanced propoxyphene plasma levels; monitor patients closely and adjust dosages if necessary in patients receiving any CYP3A4 inhibitor concomitantly .

Commonly used brand name(s)

In the U.S.

Balacet 325 Darvocet A500 Darvocet-N 100 Darvocet-N 50 Pronap-100 Propoxacet-N Propoxacet-N 100

Available Dosage Forms:

Tablet

Therapeutic Class: Opioid/Acetaminophen Combination

Chemical Class: Propoxyphene

Uses For Pronap-100

Propoxyphene and acetaminophen combination is used to relieve mild to moderate pain. Propoxyphene belongs to the group of medicines called narcotic analgesics (pain medicines). It acts on the central nervous system (CNS) to relieve pain.

Acetaminophen is used to relieve pain and reduce fever in patients. It does not become habit-forming when taken for a long time. But acetaminophen may cause other unwanted effects when taken in large doses, including liver damage.

When propoxyphene is used for a long time, it may become habit-forming, causing mental or physical dependence. However, people who have continuing pain should not let the fear of dependence keep them from using narcotics to relieve their pain. Mental dependence (addiction) is not likely to occur when narcotics are used for this purpose. Physical dependence may lead to withdrawal side effects if treatment is stopped suddenly. However, severe withdrawal side effects can usually be prevented by gradually reducing the dose over a period of time before treatment is stopped completely.

Products containing propoxyphene were withdrawn from the U.S. market starting November 19, 2010.

This medicine was available only with your doctor's prescription.

Before Using Pronap-100

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 this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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

Appropriate studies have not been performed on the relationship of age to the effects of propoxyphene and acetaminophen combination in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of propoxyphene and acetaminophen combination in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving propoxyphene and acetaminophen combination.

Pregnancy Pregnancy Category Explanation All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women. 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. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Naltrexone Rasagiline Selegiline

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Adinazolam Alfentanil Alprazolam Amobarbital Anileridine Aprobarbital Bromazepam Brotizolam Buprenorphine Butabarbital Butalbital Butorphanol Carbamazepine Carisoprodol Chloral Hydrate Chlordiazepoxide Chlorzoxazone Clobazam Clonazepam Clorazepate Codeine Dantrolene Dezocine Diazepam Estazolam Ethchlorvynol Fentanyl Flunitrazepam Flurazepam Fospropofol Halazepam Hydrocodone Hydromorphone Ketazolam Levorphanol Lorazepam Lormetazepam Medazepam Meperidine Mephenesin Mephobarbital Meprobamate Metaxalone Methocarbamol Methohexital Midazolam Morphine Morphine Sulfate Liposome Nalbuphine Nitrazepam Nordazepam Opium Oxazepam Oxycodone Oxymorphone Pentazocine Pentobarbital Phenobarbital Prazepam Propoxyphene Quazepam Remifentanil Secobarbital Sodium Oxybate Sufentanil Tapentadol Temazepam Thiopental Triazolam

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Acenocoumarol Carbamazepine Doxepin Isoniazid Metoprolol Phenytoin Propranolol Warfarin Zidovudine 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. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

Ethanol

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

Cabbage Other Medical Problems

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

Alcohol abuse, or history of or Brain tumor, history of or Chronic obstructive pulmonary disease (COPD) or Cor pulmonale (serious heart condition) or Drug dependence, especially with narcotics, or history of or Gallbladder disease or gallstones or Head injuries, history of or Hypovolemia (low blood volume)—Use with caution. May increase risk for more serious side effects. Asthma, severe or Breathing problems, severe (e.g., hypoxia) or Paralytic ileus (intestine stops working and may be blocked) or Respiratory depression (very slow breathing) or Suicidal ideation (thoughts of hurting or killing oneself), history of—Should not be used in patients with these conditions. Hypotension (low blood pressure) or Pancreatitis (inflammation of the pancreas)—Use with caution. May make these conditions worse. Kidney disease or Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body. Proper Use of propoxyphene and acetaminophen

This section provides information on the proper use of a number of products that contain propoxyphene and acetaminophen. It may not be specific to Pronap-100. Please read with care.

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. This is especially important for elderly patients, who may be more sensitive to the effects of pain medicines. If too much of this medicine is taken for a long time, it may become habit-forming (causing mental or physical dependence). Liver damage can occur if large amounts of acetaminophen are taken for a long time.

This combination medicine contains acetaminophen (Tylenol®). Carefully check the labels of all other medicines you are using, because they may also contain acetaminophen. It is not safe to use more than 4 grams (4,000 milligrams) of acetaminophen in one day (24 hours).

This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Dosing

The dose of this medicine 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 this medicine. 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 oral dosage form (tablets): For mild to moderate pain: Adults—One or two tablets every 4 hours as needed. Your doctor may adjust your dose if needed. However, the dose is usually not more than 6 to 12 tablets per day. Children—Use and dose must be determined by your doctor. Missed Dose

If you miss a dose of this medicine, 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.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Throw any unused medicine by mixing it with used coffee grounds or kitty litter and place it in a sealable bag, empty can, or container.

Precautions While Using Pronap-100

It is very important that your doctor check your progress while you are taking this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it.

Talk to your doctor first before you stop taking this medicine and changing to another pain medicine.

This medicine can cause changes in heart rhythms, such as conditions called PR, QRS, and QT prolongation. It may change the way your heart beats and cause fainting, dizziness, lightheadedness, or serious side effects in some patients. Contact your doctor right away if you have any symptoms of heart rhythm problems, such as fast, pounding, or irregular heartbeats.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that can make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for allergies or colds; sedatives, tranquilizers, or sleeping medicine; other prescription pain medicine or narcotics; medicine for seizures or barbiturates; muscle relaxants; or anesthetics, including some dental anesthetics. Also, there may be a greater risk of liver damage if you drink three or more alcoholic beverages while you are taking acetaminophen. Do not drink alcoholic beverages, and check with your doctor before taking any of the medicines listed above while you are using this medicine.

This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.

Dizziness, lightheadedness, or fainting may occur when you get up suddenly from a lying or sitting position. Getting up slowly may help lessen this problem. Also, lying down for a while may relieve the dizziness or lightheadedness.

This medicine may make you dizzy, drowsy, or lightheaded. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert.

Using narcotics for a long time can cause severe constipation. To prevent this, your doctor may direct you to take laxatives, drink a lot of fluids, or increase the amount of fiber in your diet. Be sure to follow the directions carefully, because continuing constipation can lead to more serious problems.

If you have been using this medicine regularly for several weeks or longer, do not change your dose or suddenly stop using it without checking with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping it completely. This may help prevent worsening of your condition and reduce the possibility of withdrawal symptoms, such as abdominal or stomach cramps, anxiety, fever, nausea, runny nose, sweating, tremors, or trouble with sleeping.

Using this medicine while you are pregnant may cause serious unwanted effects in your newborn baby. Tell your doctor right away if you think you are pregnant or if you plan to become pregnant while using this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Pronap-100 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 immediately if any of the following side effects occur:

Rare Abdominal or stomach pain chills clay-colored stools dark urine dizziness fever headache itching loss of appetite nausea rash unpleasant breath odor unusual tiredness or weakness vomiting of blood yellow eyes or skin Incidence not known Bloating bloody or black, tarry stools bloody or cloudy urine change in consciousness chest pain or discomfort confusion cough decreased urine output difficult or troubled breathing dilated neck veins drowsiness extreme fatigue fainting fast, slow, pounding, or irregular heartbeat or pulse fever with or without chills general feeling of discomfort or illness hives hoarseness irregular, fast, slow, or shallow breathing itching joint pain, stiffness, or swelling light-colored stools loss of consciousness low blood pressure or pulse muscle aches and pains muscle tremors pain or discomfort in the arms, jaw, back, or neck pains in the stomach, side, or abdomen, possibly radiating to the back pale or blue lips, fingernails, or skin rapid, deep breathing redness of the skin restlessness right upper stomach pain and fullness runny nose severe stomach pain shakiness and unsteady walk shivering shortness of breath sore throat stomach cramps sudden decrease in the amount of urine sweating swelling of the eyelids, face, fingers, lips, hands, lower legs, or feet thoughts of suicide tightness in the chest trouble sleeping troubled breathing or swallowing unconsciousness unsteadiness, trembling, or other problems with muscle control or coordination very slow breathing very slow heartbeat vomiting of blood or material that looks like coffee grounds weight gain wheezing

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose Agitation bluish color of the fingernails, lips, skin, palms, or nail beds convulsion coughing that sometimes produces a pink frothy sputum decreased awareness or responsiveness depression difficult, fast, or noisy breathing, sometimes with wheezing dilated pupils hostility increased sweating irritability lethargy muscle tremors muscle twitching pale skin pounding or rapid pulse rapid weight gain rapid, deep breathing severe sleepiness sleepiness or unusual drowsiness slow to respond slurred speech weight loss

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 Relaxed and calm feeling Incidence not known Abnormal behavior blurred or loss of vision constipation diarrhea disturbed color perception double vision false or unusual sense of well-being halos around lights indigestion muscular pain, tenderness, wasting, or weakness night blindness nightmares or unusually vivid dreams overbright appearance of lights seeing, hearing, or feeling things that are not there swelling of the eye tunnel vision

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.

See also: Pronap-100 side effects (in more detail)

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More Pronap-100 resources Pronap-100 Side Effects (in more detail)Pronap-100 Use in Pregnancy & BreastfeedingDrug ImagesPronap-100 Drug InteractionsPronap-100 Support Group77 Reviews for Pronap-100 - Add your own review/rating Compare Pronap-100 with other medications OsteoarthritisPain

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