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)

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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

tamsulosin

Generic Name: tamsulosin (tam soo LOE sin) Brand Names: Flomax

What is tamsulosin?

Tamsulosin is in a group of drugs called alpha-adrenergic (AL-fa ad-ren-ER-jik) blockers. Tamsulosin relaxes the muscles in the prostate and bladder neck, making it easier to urinate.

Tamsulosin is used to improve urination in men with benign prostatic hyperplasia (enlarged prostate).

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

What is the most important information I should know about tamsulosin? You should not use this medication if you are allergic to tamsulosin. Do not take tamsulosin with other similar medicines such as alfuzosin (Uroxatral), doxazosin (Cardura), prazosin (Minipress), silodosin (Rapaflo), or terazosin (Hytrin). Tamsulosin may cause dizziness or fainting, especially when you first start taking it or when you start taking it again. Be careful if you drive or do anything that requires you to be alert. Avoid standing for long periods of time or becoming overheated during exercise and in hot weather. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. If you stop taking tamsulosin for any reason, call your doctor before you start taking it again. You may need a dose adjustment.

Tamsulosin can affect your pupils during cataract surgery. Tell your eye surgeon ahead of time that you are using this medication. Do not stop using tamsulosin before surgery unless your surgeon tells you to.

There are many other drugs that can interact with tamsulosin. Tell your doctor about all medications you use. What should I discuss with my healthcare provider before taking tamsulosin? You should not use this medication if you are allergic to tamsulosin. Do not take tamsulosin with other similar medicines such as alfuzosin (Uroxatral), doxazosin (Cardura), prazosin (Minipress), silodosin (Rapaflo), or terazosin (Hytrin).

If you have a history of prostate cancer, you may need a dose adjustment or special tests to safely take this tamsulosin.

Tamsulosin can affect your pupils during cataract surgery. Tell your eye surgeon ahead of time that you are using this medication. Do not stop using tamsulosin before surgery unless your surgeon tells you to.

Although this medication is not for use in women, tamsulosin is not expected to harm an unborn baby. If you are a woman using this medication, tell your doctor if you are pregnant or breast-feeding. Tamsulosin is not for use in children. How should I take tamsulosin?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Your doctor may occasionally change your dose to make sure you get the best results.

Tamsulosin is usually taken once a day, approximately 30 minutes after a meal. Try to take this medication at the same time each day. Do not crush, chew, or open a tamsulosin capsule. Swallow it whole. Tamsulosin lowers blood pressure and may cause dizziness or fainting, especially when you first start taking it, or when you start taking it again. Call your doctor if you have severe dizziness or feel like you might pass out.

You may feel very dizzy when you first wake up. Be careful when standing or sitting up from a lying position.

If you stop taking tamsulosin for any reason, call your doctor before you start taking it again. You may need a dose adjustment.

Your blood pressure and prostate will need to be checked often. Visit your doctor regularly.

Some things can cause your blood pressure to get too low. This includes vomiting, diarrhea, heavy sweating, heart disease, dialysis, a low-salt diet, or taking diuretics (water pills). Tell your doctor if you have a prolonged illness that causes diarrhea or vomiting.

Store at room temperature away from moisture and heat.

See also: Tamsulosin dosage (in more detail)

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.

If you miss your doses for several days in a row, contact your doctor before restarting the medication. You may need a lower dose.

What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include extreme dizziness or fainting.

What should I avoid while taking tamsulosin? Tamsulosin may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

To prevent dizziness, avoid standing for long periods of time or becoming overheated during exercise and in hot weather.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall. Drinking alcohol can increase certain side effects of tamsulosin. Tamsulosin 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.

Stop using tamsulosin and call your doctor at once if you have any of these serious side effects:

feeling like you might pass out;

chest pain;

fever, chills, body aches, or flu symptoms; or

penis erection that is painful or lasts 4 hours or longer.

Less serious side effects may include:

mild dizziness;

weakness, drowsiness;

headache;

nausea, diarrhea;

back pain;

blurred vision;

dental problems;

sleep problems (insomnia);

abnormal ejaculation, decreased sex drive; or

runny nose, sore throat, cough.

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

Tamsulosin Dosing Information

Usual Adult Dose for Benign Prostatic Hyperplasia:

0.4 mg orally once daily one-half hour following the same meal each day

What other drugs will affect tamsulosin?

Tell your doctor about all other medications you use, especially:

cimetidine (Tagamet);

conivaptan (Vaprisol);

cyclosporine (Gengraf, Neoral, Sandimmune);

imatinib (Gleevec);

isoniazid (for treating tuberculosis);

methimazole (Tapazole);

pioglitazone (Actos);

ropinirole (Requip);

ticlopidine (Ticlid);

warfarin (Coumadin);

an antibiotic such as clarithromycin (Biaxin), dalfopristin/quinupristin (Synercid), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin), metronidazole (Flagyl, Protostat), telithromycin (Ketek), or terbinafine (Lamisil);

an antidepressant such as citalopram (Celexa), clomipramine (Anafranil), desipramine (Norpramin), duloxetine (Cymbalta), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), imipramine (Tofranil), nefazodone, paroxetine (Paxil), sertraline (Zoloft), or tranylcypromine (Parnate);

antifungal medication such as clotrimazole (Mycelex Troche), itraconazole (Sporanox), ketoconazole (Extina, Ketozole, Nizoral, Xolegal), or voriconazole (Vfend);

anti-malaria medication such as chloroquine (Arelan) or pyrimethamine (Daraprim), or quinine (Qualaquin);

erectile dysfunction medicine such as sildenafil (Viagra), tadalafil (Cialis), or vardenafil (Levitra);

heart or blood pressure medication such as diltiazem (Cartia, Cardizem), felodipine (Plendil), nicardipine (Cardene), nifedipine (Nifedical, Procardia), verapamil (Calan, Covera, Isoptin, Verelan), and others;

a heart rhythm medication such as amiodarone (Cordarone, Pacerone) or quinidine (Quin-G);

HIV/AIDS medicine such as atazanavir (Reyataz), delavirdine (Rescriptor), fosamprenavir (Lexiva), indinavir (Crixivan), nelfinavir (Viracept), saquinavir (Invirase), or ritonavir (Norvir); or

medicine to treat psychiatric disorders, such as aripiprazole (Abilify), chlorpromazine (Thorazine), clozapine (Clozaril, FazaClo), fluphenazine (Permitil, Prolixin), haloperidol (Haldol), perphenazine (Trilafon), or thioridazine (Mellaril).

This list is not complete and there are many other drugs that can interact with tamsulosin. 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. Keep a list of all your medicines and show it to any healthcare provider who treats you. More tamsulosin resources Tamsulosin Side Effects (in more detail)Tamsulosin DosageTamsulosin Use in Pregnancy & BreastfeedingDrug ImagesTamsulosin Drug InteractionsTamsulosin Support Group65 Reviews for Tamsulosin - Add your own review/rating tamsulosin Advanced Consumer (Micromedex) - Includes Dosage Information Tamsulosin MedFacts Consumer Leaflet (Wolters Kluwer) Tamsulosin Prescribing Information (FDA) Flomax Prescribing Information (FDA) Flomax Monograph (AHFS DI) Flomax Consumer Overview Compare tamsulosin with other medications Benign Prostatic HyperplasiaOveractive BladderUrinary Tract Stones Where can I get more information? Your pharmacist can provide more information about tamsulosin.

See also: tamsulosin side effects (in more detail)

travoprost ophthalmic

Generic Name: travoprost ophthalmic (TRA voe prost off THAL mik) Brand Names: Travatan, Travatan Z

What is travoprost ophthalmic?

Travoprost ophthalmic (for the eye) reduces pressure in the eye by increasing the amount of fluid that drains from the eye.

Travoprost ophthalmic is used to treat certain types of glaucoma and other causes of high pressure inside the eye.

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

What is the most important information I should know about travoprost ophthalmic?

Travoprost ophthalmic may cause a gradual change in the color of your eyes or eyelids and lashes, as well as increased growth or thickness of your eyelashes. These color changes, usually an increase in brown pigment, occur slowly and you may not notice them for months or years. Color changes may be permanent even after your treatment ends, and may occur only in the eye being treated. This could result in a cosmetic difference in eye or eyelash color from one eye to the other.

Do not allow the dropper 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.

After using this medication, wait at least 5 minutes before using any other eye drops that your doctor has prescribed.

What should I discuss with my health care provider before using travoprost ophthalmic? Do not use this medication if you are allergic to travoprost.

Before using travoprost, tell your doctor if you are allergic to any drugs, or if you have swelling or infection of your eye.

Travoprost ophthalmic may cause a gradual change in the color of your eyes or eyelids and lashes, as well as increased growth or thickness of your eyelashes. These color changes, usually an increase in brown pigment, occur slowly and you may not notice them for months or years. Color changes may be permanent even after your treatment ends, and may occur only in the eye being treated. This could result in a cosmetic difference in eye or eyelash color from one eye to the other.

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

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

Wash your hands before using the eye drops.

To apply the eye drops:

Tilt your head back slightly and pull down on the 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. Squeeze out a drop and close your eye. Gently press your finger to the inside corner of the eye (near the nose) for about 1 minute to keep the liquid from draining into your tear duct.

If you use more than one drop in the same eye, wait about 5 minutes before putting in the next drop. Also wait at least 5 minutes before using any other eye drops that your doctor has prescribed.

Do not allow the dropper 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. At any time during your use of travoprost ophthalmic, tell your doctor at once if you have an eye injury, if you develop an eye infection, or if you plan to have eye surgery. Do not use the eye drops if the liquid changes colors or has particles in it. 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 medication as soon as you remember. If it is almost time for the next dose, skip the missed dose and use the medicine at the next regularly scheduled time. 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 travoprost ophthalmic used in the eyes is not expected to produce life-threatening symptoms.

What should I avoid while using travoprost ophthalmic? Avoid using too much of this medication, which can actually make it less effective in lowering the pressure inside the eye.

Avoid using any eyedrop medicine that has not been prescribed by your doctor.

Travoprost 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. Stop using travoprost ophthalmic and call your doctor at once if you have any of these serious side effects:

redness, swelling, itching, or pain in or around your eye;

oozing or discharge from your eye;

increased sensitivity to light;

vision changes; or

chest pain.

Less serious side effects may include:

mild eye discomfort;

headache;

feeling like something is in your eye;

blurred vision;

dry or watery eyes; or

stinging or burning of the eyes after using the drops.

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.

Travoprost ophthalmic Dosing Information

Usual Adult Dose for Intraocular Hypertension:

Instill 1 drop in the affected eye(s) once daily in the evening.

Usual Adult Dose for Glaucoma (Open Angle):

Instill 1 drop in the affected eye(s) once daily in the evening.

Usual Pediatric Dose for Intraocular Hypertension:

16 years and older:Instill 1 drop in the affected eye(s) once daily in the evening.

Usual Pediatric Dose for Glaucoma (Open Angle):

16 years and older:

Talacen
Pronunciation: a-SEET-a-MIN-oh-fen/pen-TAZ-oh-seenGeneric Name: Acetaminophen/PentazocineBrand Name: Generic only. No brands available.

Thioguanine Tabloid

Generic Name: ThioguanineClass: Antineoplastic AgentsVA Class: AN300

Tambocor 50mg Tablets
1. Name Of The Medicinal Product

Tambocor™ 50mg Tablets

2. Qualitative And Quantitative Composition

Each tablet contains flecainide acetate 50mg

3. Pharmaceutical Form

Tablet

4. Clinical Particulars

Tambocor is a potent sodium channel blocking agent for the treatment of the conditions listed below:

The effect on the JT interval is insignificant at therapeutic levels.

4.1 Therapeutic Indications

Tambocor tablets are indicated for:

a) AV nodal reciprocating tachycardia; arrhythmias associated with Wolff-Parkinson-White Syndrome and similar conditions with accessory pathways.

b) Paroxysmal atrial fibrillation in patients with disabling symptoms when treatment need has been established and in the absence of left ventricular dysfunction (see 4.4, Special warnings and special precautions for use). Arrhythmias of recent onset will respond more readily.

c) Symptomatic sustained ventricular tachycardia.

d) Premature ventricular contractions and/or non-sustained ventricular tachycardia which are causing disabling symptoms, where these are resistant to other therapy or when other treatment has not been tolerated.

Tambocor tablets can be used for the maintenance of normal rhythm following conversion by other means.

Tambocor tablets are for oral administration.

4.2 Posology And Method Of Administration

Adults: Supraventricular arrhythmias: The recommended starting dosage is 50mg twice daily and most patients will be controlled at this dose. If required the dose may be increased to a maximum of 300mg daily.

Ventricular arrhythmias: The recommended starting dosage is 100mg twice daily. The maximum daily dose is 400mg and this is normally reserved for patients of large build or where rapid control of the arrhythmia is required.

After 3-5 days it is recommended that the dosage be progressively adjusted to the lowest level which maintains control of the arrhythmia. It may be possible to reduce dosage during long-term treatment.

Children: Tambocor is not recommended in children under 12, as there is insufficient evidence of its use in this age group.

Elderly Patients: The rate of flecainide elimination from plasma may be reduced in elderly people. This should be taken into consideration when making dose adjustments.

Plasma levels: Based on PVC suppression, it appears that plasma levels of 200-1000 ng/ml may be needed to obtain the maximum therapeutic effect. Plasma levels above 700-1000 ng/ml are associated with increased likelihood of adverse experiences.

Dosage in impaired renal function: In patients with significant renal impairment (creatinine clearance of 35ml/min/1.73 sq.m. or less) the maximum initial dosage should be 100mg daily (or 50mg twice daily).

When used in such patients, frequent plasma level monitoring is strongly recommended.

It is recommended that intravenous treatment with Tambocor should be administered in hospitals.

Treatment with oral Tambocor should be under direct hospital or specialist supervision for patients with:

a) AV nodal reciprocating tachycardia; arrhythmias associated with Wolff-Parkinson-White Syndrome and similar conditions with accessory pathways

b) Paroxysmal atrial fibrillation in patients with disabling symptoms.

Treatment for patients with other indications should continue to be initiated in hospital.

4.3 Contraindications

Tambocor is contra-indicated in cardiac failure and in patients with a history of myocardial infarction who have either asymptomatic ventricular ectopics or asymptomatic non-sustained ventricular tachycardia.

It is also contra-indicated in patients with long standing atrial fibrillation in whom there has been no attempt to convert to sinus rhythm, and in patients with haemodynamically significant valvular heart disease.

Unless pacing rescue is available, Tambocor should not be given to patients with sinus node dysfunction, atrial conduction defects, second degree or greater atrio-ventricular block, bundle branch block or distal block.

4.4 Special Warnings And Precautions For Use

Electrolyte disturbances should be corrected before using Tambocor.

Since flecainide elimination from the plasma can be markedly slower in patients with significant hepatic impairment, flecainide should not be used in such patients unless the potential benefits clearly outweigh the risks. Plasma level monitoring is strongly recommended in these circumstances.

Tambocor is known to increase endocardial pacing thresholds - ie to decrease endocardial pacing sensitivity. This effect is reversible and is more marked on the acute pacing threshold than on the chronic. Tambocor should thus be used with caution in all patients with permanent pacemakers or temporary pacing electrodes, and should not be administered to patients with existing poor thresholds or non-programmable pacemakers unless suitable pacing rescue is available.

Generally, a doubling of either pulse width or voltage is sufficient to regain capture, but it may be difficult to obtain ventricular thresholds less than 1 Volt at initial implantation in the presence of Tambocor.

The minor negative inotropic effect of flecainide may assume importance in patients predisposed to cardiac failure. Difficulty has been experienced in defibrillating some patients. Most of the cases reported had pre-existing heart disease with cardiac enlargement, a history of myocardial infarction, arterio-sclerotic heart disease and cardiac failure.

Tambocor should be avoided in patients with structural organic heart disease or abnormal left ventricular function.

Tambocor should be used with caution in patients with acute onset of atrial fibrillation following cardiac surgery.

In a large scale, placebo-controlled clinical trial in post-myocardial infarction patients with asymptomatic ventricular arrhythmia, oral flecainide was associated with a 2.2 fold higher incidence of mortality or non-fatal cardiac arrest as compared with its matching placebo. In that same study, an even higher incidence of mortality was observed in flecainide-treated patients with more than one myocardial infarction. Comparable placebo-controlled clinical trials have not been done to determine if flecainide is associated with higher risk of mortality in other patient groups.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Flecainide is a class I anti-arrhythmic and interactions are possible with other anti-arrhythmic drugs where additive effects may occur or where drugs interfere with the metabolism of flecainide. The following known categories of drugs may intereact with flecainide:

Cardiac glycosides; Flecainide can cause the plasma digoxin level to rise by about 15%, which is unlikely to be of clinical significance for patients with plasma levels in the therapeutic range. It is recommended that the digoxin plasma level in digitalised patients should be measured not less than six hours after any digoxin dose, before or after administration of flecainide.

Class II anti-arrhythmics; the possibility of additive negative inotropic effects of beta-blockers, and other cardiac depressants such as verapamil, with flecainide should be recognised.

Class III anti-arrhythmics; when flecainide is given in the presence of amiodarone, the usual flecainide dosage should be reduced by 50% and the patient monitored closely for adverse effects. Plasma level monitoring is strongly recommended in these circumstances

Class IV anti-arrhythmics; use of flecainide with other sodium channel blockers is not recommended.

Anti-depressants; fluoxetine increases plasma flecainide concentration; increased risk of arrhythmias with tricyclics; manufacturer of reboxetine advises caution.

Anti-epileptics; limited data in patients receiving known enzyme inducers (phenytoin, phenobarbital, carbamazepine) indicate only a 30% increase in the rate of flecainide elimination.

Anti-psychotics: clozapine– increased risk of arrhythmias

Anti-histamines; increased risk of ventricular arrhythmias with mizolastine and terfenadine (avoid concomitant use)

Anti-malarials: quinine increases plasma concentration of flecainide.

Antivirals: plasma concentration increased by ritonavir, lopinavar and indinavir (increased risk of ventricular arrhythmias (avoid concomitant use)

Diuretics: Class effect due to hypokalaemia giving rise to cardiac toxicity.

Ulcer healing drugs: cimetidine inhibits metabolism of flecainide. In healthy subjects receiving cimetidine (1g daily) for one week, plasma flecainide levels increased by about 30% and the half-life increased by about 10%.

Anti-smoking aids: Co-administration of bupropion with drugs that are metabolized by CYP2D6 isoenzyme including flecainide, should be approached with caution and should be initiated at the lower end of the dose range of the concomitant medication. If bupropion is added to the treatment regimen of a patient already receiving flecainide, the need to decrease the dose of the original medication should be considered.

Treatment with Tambocor is compatible with use of oral anti-coagulants.

4.6 Pregnancy And Lactation

There is no evidence as to drug safety in human pregnancy. In New Zealand White rabbits high doses of flecainide caused some foetal abnormalities, but these effects were not seen in Dutch Belted rabbits or rats. The relevance of these findings to humans has not been established. Data have shown that flecainide crosses the placenta to the foetus in patients taking flecainide during pregnancy.

Flecainide is excreted in human milk and appears in concentrations which reflect those in maternal blood. The risk of adverse effects to the nursing infant is very small.

4.7 Effects On Ability To Drive And Use Machines

No effect.

4.8 Undesirable Effects

Body as a Whole: Asthenia, fatigue, fever,oedema.

Cardiovascular: Pro-arrhythmic effects occur but are most likely in patients with structural heart disease and/or significant left ventricular impairment.

In patients with atrial flutter the use of Tambocor has been associated with

1:1 AV conduction following initial atrial slowing with resultant ventricular acceleration. This has been seen most commonly following the use of the injection for acute conversion. This effect is usually short lived and abates quickly following cessation of therapy.

The following adverse effects have also been reported.

AV block-second-degree and third degree, bradycardia, cardiac failure/congestive cardiac failure, chest pain, hypotension, myocardial infarction, palpitation, sinus pause or arrest and tachycardia (AT or VT).

Skin and Appendages: A range of allergic skin reactions have been reported including rashes, alopecia and rare but serious reports of urticaria. There have also been isolated cases of photosensitivity and rash.

Immune System: A small number of cases of increases in anti-nuclear antibodies have been reported, with and without systemic inflammatory involvement.

Haematological: Reductions in red blood cells, white blood cells and platelets have been occasionally reported. These changes are usually mild.

Psychiatric: Rarely, hallucinations, depression, confusion, amnesia, anxiety and insomnia have been reported.

Gastrointestinal: Occasionally nausea and vomiting. The following have also been reported: abdominal pain, anorexia, constipation, diarrhoea, dyspepsia and flatulence (bloating)

Liver and Bilary System: A number of cases of elevated liver enzymes and jaundice have been reported in association with Tambocor treatment. So far this has always been reversible on stopping treatment. Hepatic dysfunction has also been reported.

Neurological: Most commonly giddiness, dizziness and lightheadedness which are usually transient. Rare instances of dyskinesia have been reported, which have improved on withdrawal of flecainide therapy. Rare instances of convulsions, and during long term therapy a few cases of peripheral neuropathy, paraesthesia and ataxia have been reported.There also have been reports of flushing, headache, hypoaesthesia, increased sweating, somnolence, syncope, tinnitus, tremor and vertigo.

Ophthalmological: Visual disturbances, such as double vision and blurring of vision may occur but these are usually transient and disappear upon continuing or reducing the dosage.

Extremely rare cases of corneal deposits have also been reported.

Respiratory: Dyspnoea and rare cases of pneumonitis have been reported.

4.9 Overdose

Overdosage with flecainide is a potentially life threatening medical emergency. No specific antidote is known. There is no known way of rapidly removing flecainide from the system, but forced acid diuresis may theoretically be helpful. Neither dialysis nor haemoperfusion is helpful and injections of anticholinergics are not recommended.

Treatment may include therapy with an inotropic agent, intravenous calcium, giving circulatory assistance (eg balloon pumping), mechanically assisting respiration, or temporarily inserting a transvenous pacemaker if there are severe conduction disturbances or the patient's left ventricular function is otherwise compromised.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Tambocor is a Class 1 anti-arrhythmic (local anaesthetic) agent.

Tambocor slows conduction through the heart, having its greatest effect on His Bundle conduction. It also acts selectively to increase anterograde and particularly retrograde accessory pathway refractoriness. Its actions may be reflected in the ECG by prolongation of the PR interval and widening of the QRS complex. The effect on the JT interval is insignificant.

5.2 Pharmacokinetic Properties

Oral administration of flecainide results in extensive absorption, with bioavailability approaching 90 to 95%. Flecainide does not appear to undergo significant hepatic first-pass metabolism. In patients, 200 to 600 mg flecainide daily produced plasma concentrations within the therapeutic range of 200-1000 µg/L. Protein binding of flecainide is within the range 32 to 58%.

Recovery of unchanged flecainide in urine of healthy subjects was approximately 42% of a 200mg oral dose, whilst the two major metabolites (Meta-O-Dealkylated and Dealkylated Lactam Metabolites) accounted for a further 14% each. The elimination half-life was 12 to 27 hours.

5.3 Preclinical Safety Data

Not applicable

6. Pharmaceutical Particulars 6.1 List Of Excipients

Pregelatinised Starch, USNF

Croscarmellose Sodium, USNF

Microcrystalline Cellulose, Ph Eur

Hydrogenated Vegetable Oil, USNF

Magnesium Stearate, Ph Eur

6.2 Incompatibilities

None known

6.3 Shelf Life

5 years

6.4 Special Precautions For Storage

Do not store above 30°C. Keep container in the outer carton.

6.5 Nature And Contents Of Container

UPVC/PVDC blister packs containing 60 tablets

6.6 Special Precautions For Disposal And Other Handling

Not applicable

7. Marketing Authorisation Holder

Meda Pharmaceuticals Ltd

Skyway House

Parsonage Road

Takeley

Bishop's Stortford

CM22 6PU

United Kingdom

8. Marketing Authorisation Number(S)

PL 15142/0078

9. Date Of First Authorisation/Renewal Of The Authorisation

22 May 1997/ 16 March 2001

10. Date Of Revision Of The Text

13th July 2010

terbutaline inhalation

Generic Name: terbutaline inhalation (ter BYOO ta leen) Brand Names: Brethaire

What is terbutaline inhalation?

Terbutaline is a bronchodilator. It works by relaxing muscles in the airways to improve breathing.

Terbutaline inhalation is used to treat conditions such as asthma, bronchitis, and emphysema.

Terbutaline inhalation may also be used for conditions other than those listed in this medication guide.

What is the most important information I should know about terbutaline inhalation?

It is very important that you use the terbutaline inhaler properly, so that the medicine gets into your lungs. You doctor may want you to use a spacer with the inhaler. Talk to your doctor about proper inhaler use.

Seek medical attention if you notice that you require more than your usual or more than the maximum amount of any asthma medication in a 24-hour period. An increased need for medication could be an early sign of a serious asthma attack.

What should I discuss with my healthcare provider before using terbutaline inhalation?

Before using terbutaline inhalation, tell your doctor if you have

heart disease or high blood pressure;

epilepsy or another seizure disorder;

diabetes;

an overactive thyroid (hyperthyroidism); or

liver or kidney disease.

You may require a dosage adjustment or special monitoring during treatment with terbutaline inhalation if you have any of the conditions listed above.

Terbutaline is in the FDA pregnancy category B. This means that it is not expected to be harmful to an unborn baby. Do not use terbutaline inhalation without first talking to your doctor if you are pregnant or could become pregnant during treatment. It is not known whether terbutaline passes into breast milk. Do not use terbutaline inhalation without first talking to your doctor if you are breast-feeding a baby. Terbutaline inhalation is not approved for use by children younger than 12 years of age. How should I use terbutaline inhalation?

Use terbutaline inhalation exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Shake the inhaler several times and uncap the mouthpiece. Breathe out fully. For best results, hold the inhaler 1 to 2 inches in front of your open mouth or attach a spacer to the inhaler and place the spacer in your mouth, above your tongue and past your teeth. Take a deep, slow breath as you push down on the canister. Hold your breath for 10 seconds, then exhale slowly. If you place the inhaler directly into your mouth, you may not receive the correct amount of medicine because it will be propelled onto the back of your tongue and/or throat. If you do use the inhaler directly in your mouth, be sure that it is above your tongue and past your teeth.

If you take more than one dose at a time, wait for at least 1 full minute, then repeat the procedure.

If you also use a steroid inhaler, use the terbutaline inhaler first to open up your airways, then use the steroid inhaler as directed.

It is very important that you use the terbutaline inhaler properly, so that the medicine gets into your lungs. Your doctor may want you to use a spacer with the inhaler. Talk to your doctor about proper inhaler use.

It is important to use terbutaline inhalation regularly to get the most benefit.

Seek medical attention if you notice that you require more than your usual or more than the maximum amount of any asthma medication in a 24-hour period. An increased need for medication could be an early sign of a serious asthma attack.

Your doctor may want you to have lung function test or other medical evaluations during treatment with terbutaline inhalation to monitor progress and side effects.

Keep the inhaler clean and dry. Keep the mouthpiece capped to avoid getting dirt inside it. The inhaler can be cleaned by removing the canister and immersing the mouthpiece in warm water or alcohol. Allow the parts to dry, then reassemble the inhaler.

Carry the inhaler with you at all times in case of emergencies. Get a refill before you run out of medicine and before going on vacation.

What happens if I miss a dose?

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

What happens if I overdose? Seek emergency medical attention if an overdose is suspected.

Symptoms of a terbutaline overdose include angina or chest pain, irregular heartbeats or a fluttering heart, seizures, tremor, weakness, headache, nausea, and vomiting.

What should I avoid while using terbutaline inhalation?

Avoid situations that may trigger an asthma attack such as exercising in cold, dry air; smoking; breathing in dust; and exposure to allergens such as pet fur.

Terbutaline inhalation side effects Stop using terbutaline inhalation and seek emergency medical attention if you experience any of the following serious side effects:

an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives); or

chest pain or irregular heartbeats.

Other, less serious side effects may be more likely to occur. Continue to use terbutaline inhalation and talk to your doctor if you experience

headache, dizziness, lightheadedness, or insomnia;

tremor or nervousness;

sweating;

nausea, vomiting, or diarrhea; or

dry mouth.

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.

Terbutaline inhalation Dosing Information

Usual Adult Dose for Asthma -- Maintenance:

Tablets: 5 mg orally 3 times a day at 6 hour intervals during waking hours. May decrease to 2.5 mg/dose if side effects are pronounced. Do not exceed 15 mg in 24 hours.Inhalation aerosol: 2 inhalations separated by 60 seconds every 4 to 6 hours. Do not repeat more often than every 4 to 6 hours.

Usual Adult Dose for Premature Labor:

Tablets: 2.5 to 7.5 mg orally every 6 hours. Therapy should be continued until 36 to 37 weeks gestation.

Tolmetin Sodium

Class: Other Nonsteroidal Anti-inflammatory AgentsVA Class: MS120Chemical Name: Sodium 1-methyl-5-(4-methylbenzoyl)-1H-pyrrole-2-acetate dihydrate

Trimethobenzamide/Benzocaine Suppositories
Pronunciation: trye-METH-oh-BENZ-a-mide/BEN-zoe-kaneGeneric Name: Trimethobenzamide/BenzocaineBrand Name: Examples include Tebamide and Tigan

Tretin-X Gel
Pronunciation: TRET-i-noinGeneric Name: TretinoinBrand Name: Tretin-X

Trihexyphenidyl Hydrochloride

Class: Anticholinergic AgentsVA Class: AU350CAS Number: 52-49-3

Tofranil

Generic Name: imipramine (im IP ra meen) Brand Names: Tofranil, Tofranil-PM

What is Tofranil (imipramine)?

Imipramine is in a group of drugs called tricyclic antidepressants. Imipramine affects chemicals in the brain that may become unbalanced.

Imipramine is used to treat symptoms of depression.

Imipramine may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Tofranil (imipramine)? Do not use imipramine if you have recently had a heart attack, or if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days.

You may have thoughts about suicide when you first start taking an antidepressant, especially if you are younger than 24 years old. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.

Video: Treatment for Depression

Treatments for depression are getting better everyday and there are things you can start doing right away.

Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself. What should I discuss with my healthcare provider before taking Tofranil (imipramine)? Do not use this medication if you are allergic to imipramine, or if you have recently had a heart attack. Do not use imipramine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take imipramine before the MAO inhibitor has cleared from your body.

Before taking imipramine, tell your doctor if you are allergic to any drugs, or if you have:

heart disease;

a history of heart attack, stroke, or seizures;

bipolar disorder (manic-depression);

kidney or liver disease;

overactive thyroid;

diabetes (imipramine may raise or lower blood sugar);

adrenal gland tumor (pheochromocytoma);

glaucoma; or

problems with urination.

If you have any of these conditions, you may not be able to use imipramine, or you may need a dosage adjustment or special tests during treatment.

You may have thoughts about suicide when you first start taking an antidepressant, especially if you are younger than 24 years old. Tell your doctor if you have worsening symptoms of depression or suicidal thoughts during the first several weeks of treatment, or whenever your dose is changed.

Your family or other caregivers should also be alert to changes in your mood or symptoms. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.

This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Imipramine can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Do not give this medication to anyone younger than 18 years old without the advice of a doctor. How should I take Tofranil (imipramine)?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Your doctor may occasionally change your dose to make sure you get the best results from this medication. Follow the directions on your prescription label.

If you need to have any type of surgery, tell the surgeon ahead of time that you are taking imipramine. You may need to stop using the medicine for a short time.

Do not stop using imipramine without first talking to your doctor. You may need to use less and less before you stop the medication completely. Stopping this medication suddenly could cause you to have unpleasant side effects. It may take up to 3 weeks of using this medicine before your symptoms improve. For best results, keep using the medication as directed. Talk with your doctor if your symptoms do not improve after 3 weeks of treatment. Store imipramine at room temperature away from moisture and heat. What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. 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 imipramine can be fatal.

Symptoms of an imipramine overdose may include uneven heartbeats, extreme drowsiness, agitation, vomiting, blurred vision, sweating, muscle stiffness, swelling, shortness of breath, blue lips or fingernails, feeling light-headed, fainting, seizure (convulsions), or coma.

What should I avoid while taking Tofranil (imipramine)? Avoid drinking alcohol. It can cause dangerous side effects when taken together with imipramine.

Avoid using other medicines that make you sleepy (such as cold medicine, pain medication, muscle relaxers, medicine for seizures, or other antidepressants). They can add to sleepiness caused by imipramine.

Grapefruit and grapefruit juice may interact with imipramine. Discuss the use of grapefruit products with your doctor before increasing or decreasing the amount of grapefruit products in your diet.

Imipramine can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds). Imipramine can make your skin more sensitive to sunlight and sunburn may result. Use a sunscreen (minimum SPF 15) and wear protective clothing if you must be out in the sun. Tofranil (imipramine) 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 any new or worsening symptoms such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have any of these serious side effects:

fast, pounding, or uneven heart rate;

chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;

sudden numbness or weakness, especially on one side of the body;

sudden headache, confusion, problems with vision, speech, or balance;

feeling short of breath, even with mild exertion;

swelling, rapid weight gain;

confusion, hallucinations, or seizure (convulsions);

easy bruising or bleeding, unusual weakness;

restless muscle movements in your eyes, tongue, jaw, or neck;

urinating more or less than usual;

extreme thirst with headache, nausea, vomiting, and weakness;

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

Less serious side effects may be more likely to occur, such as:

nausea, vomiting, stomach pain, loss of appetite;

constipation or diarrhea;

dry mouth, unpleasant taste;

weight changes;

weakness, lack of coordination;

feeling dizzy, drowsy, or tired;

nightmares;

blurred vision, headache, ringing in your ears;

breast swelling (in men or women); or

decreased sex drive, impotence, or difficulty having an orgasm.

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.

What other drugs will affect Tofranil (imipramine)?

Before taking imipramine, tell your doctor if you have used an "SSRI" antidepressant in the past 5 weeks, such as citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), paroxetine (Paxil), or sertraline (Zoloft).

Before taking imipramine, tell your doctor if you are currently using any of the following drugs:

cimetidine (Tagamet);

clonidine (Catapres);

guanethidine (Ismelin);

methylphenidate (Concerta, Ritalin, Daytrana); or

heart rhythm medications such as flecainide (Tambocor), propafenone (Rhythmol), or quinidine (Cardioquin, Quinidex, Quinaglute).

If you are using any of these drugs, you may not be able to use imipramine, or you may need dosage adjustments or special tests during treatment.

There are many other medicines that can interact with imipramine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

More Tofranil resources Tofranil Side Effects (in more detail)Tofranil Use in Pregnancy & BreastfeedingDrug ImagesTofranil Drug InteractionsTofranil Support Group9 Reviews for Tofranil - Add your own review/rating Tofranil MedFacts Consumer Leaflet (Wolters Kluwer) Tofranil Advanced Consumer (Micromedex) - Includes Dosage Information Tofranil Prescribing Information (FDA) Imipramine Professional Patient Advice (Wolters Kluwer) Imipramine Prescribing Information (FDA) Imipramine Hydrochloride Monograph (AHFS DI) Tofranil-PM Prescribing Information (FDA) Tofranil-PM MedFacts Consumer Leaflet (Wolters Kluwer) Compare Tofranil with other medications ADHDDepressionInterstitial CystitisNight TerrorsPainPanic DisorderPrimary Nocturnal Enuresis Where can I get more information? Your pharmacist has information about imipramine written for health professionals that you may read.

See also: Tofranil side effects (in more detail)

Tritace Tablet Titration Pack
1. Name Of The Medicinal Product

Tritace Tablet Titration Pack 2.5 mg, 5 mg, 10 mg tablets

2. Qualitative And Quantitative Composition

Tablets

Each 2.5 mg tablet contains ramipril 2.5 mg

Each 5 mg tablet contains ramipril 5 mg

Each 10 mg tablet contain ramipril 10 mg

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Tablets 2.5 mg

Yellowish to yellow oblong tablets with score-line.

Upper stamp: 2.5 & logo (

Lower stamp: HMR & 2.5

The tablet can be divided into equal halves.

Tablets 5 mg

Pale red oblong tablets with score-line.

Upper stamp: 5 & logo (

Lower stamp: HMP & 5

The tablet can be divided into equal halves

Tablets 10 mg

White to almost white oblong tablets with score-line.

Upper stamp: HMO/HMO

The tablet can be divided into equal halves.

4. Clinical Particulars 4.1 Therapeutic Indications

- Treatment of hypertension.

- Cardiovascular prevention: reduction of cardiovascular morbidity and mortality in patients with:

• manifest atherothrombotic cardiovascular disease (history of coronary heart disease or stroke, or peripheral vascular disease) or

• diabetes with at least one cardiovascular risk factor (see section 5.1).

- Treatment of renal disease:

• Incipient glomerular diabetic nephropathy as defined by the presence of microalbuminuria,

• Manifest glomerular diabetic nephropathy as defined by macroproteinuria in patients with at least one cardiovascular risk factor (see section 5.1),

• Manifest glomerular non diabetic nephropathy as defined by macroproteinuria

- Treatment of symptomatic heart failure.

- Secondary prevention after acute myocardial infarction: reduction of mortality from the acute phase of myocardial infarction in patients with clinical signs of heart failure when started > 48 hours following acute myocardial infarction.

4.2 Posology And Method Of Administration

Oral use.

It is recommended that TRITACE is taken each day at the same time of the day.

TRITACE can be taken before, with or after meals, because food intake does not modify its bioavailability (see section 5.2).

TRITACE has to be swallowed with liquid. It must not be chewed or crushed.

Adults

Diuretic-Treated patients

Hypotension may occur following initiation of therapy with TRITACE; this is more likely in patients who are being treated concurrently with diuretics. Caution is therefore recommended since these patients may be volume and/or salt depleted. If possible, the diuretic should be discontinued 2 to 3 days before beginning therapy with TRITACE (see section 4.4).

In hypertensive patients in whom the diuretic is not discontinued, therapy with TRITACE should be initiated with a 1.25 mg dose. Renal function and serum potassium should be monitored. The subsequent dosage of TRITACE should be adjusted according to blood pressure target.

Hypertension

The dose should be individualised according to the patient profile (see section 4.4) and blood pressure control.

TRITACE may be used in monotherapy or in combination with other classes of antihypertensive medicinal products.

Starting dose

TRITACE should be started gradually with an initial recommended dose of 2.5 mg daily.

Patients with a strongly activated renin-angiotensin-aldosterone system may experience an excessive drop in blood pressure following the initial dose. A starting dose of 1.25 mg is recommended in such patients and the initiation of treatment should take place under medical supervision (see section 4.4).

Titration and maintenance dose

The dose can be doubled at interval of two to four weeks to progressively achieve target blood pressure; the maximum permitted dose of TRITACE is 10 mg daily. Usually the dose is administered once daily.

Cardiovascular prevention

Starting dose

The recommended initial dose is 2.5 mg of TRITACE once daily.

Titration and maintenance dose

Depending on the patient's tolerability to the active substance, the dose should be gradually increased. It is recommended to double the dose after one or two weeks of treatment and - after another two to three weeks - to increase it up to the target maintenance dose of 10 mg TRITACE once daily.

See also posology on diuretic treated patients above.

Treatment of renal disease

In patients with diabetes and microalbuminuria:

Starting dose:

The recommended initial dose is 1.25 mg of TRITACE once daily.

Titration and maintenance dose

Depending on the patient's tolerability to the active substance, the dose is subsequently increased. Doubling the once daily dose to 2.5 mg after two weeks and then to 5 mg after a further two weeks is recommended.

In patients with diabetes and at least one cardiovascular risk

Starting dose:

The recommended initial dose is 2.5 mg of TRITACE once daily.

Titration and maintenance dose

Depending on the patient's tolerability to the active substance, the dose is subsequently increased. Doubling the daily dose to 5 mg TRITACE after one or two weeks and then to 10 mg TRITACE after a further two or three weeks is recommended. The target daily dose is 10 mg.

In patients with non- diabetic nephropathy as defined by macroproteinuria

Starting dose:

The recommended initial dose is 1.25 mg of TRITACE once daily.

Titration and maintenance dose

Depending on the patient's tolerability to the active substance, the dose is subsequently increased. Doubling the once daily dose to 2.5 mg after two weeks and then to 5 mg after a further two weeks is recommended.

Symptomatic heart failure

Starting dose

In patients stabilized on diuretic therapy, the recommended initial dose is 1.25 mg daily.

Titration and maintenance dose

TRITACE should be titrated by doubling the dose every one to two weeks up to a maximum daily dose of 10 mg. Two administrations per day are preferable.

Secondary prevention after acute myocardial infarction and with heart failure

Starting dose

After 48 hours, following myocardial infarction in a clinically and haemodynamically stable patient, the starting dose is 2.5 mg twice daily for three days. If the initial 2.5 mg dose is not tolerated a dose of 1.25 mg twice a day should be given for two days before increasing to 2.5 mg and 5 mg twice a day. If the dose cannot be increased to 2.5 mg twice a day the treatment should be withdrawn.

See also posology on diuretic treated patients above.

Titration and maintenance dose

The daily dose is subsequently increased by doubling the dose at intervals of one to three days up to the target maintenance dose of 5 mg twice daily.

The maintenance dose is divided in 2 administrations per day where possible.

If the dose cannot be increased to 2.5 mg twice a day treatment should be withdrawn. Sufficient experience is still lacking in the treatment of patients with severe (NYHA IV) heart failure immediately after myocardial infarction. Should the decision be taken to treat these patients, it is recommended that therapy be started at 1.25 mg once daily and that particular caution be exercised in any dose increase.

Special populations

Patients with renal impairment

Daily dose in patients with renal impairment should be based on creatinine clearance (see section 5.2):

- if creatinine clearance is

- if creatinine clearance is between 30-60 ml/min, it is not necessary to adjust the initial dose (2.5 mg/day); the maximal daily dose is 5 mg;

- if creatinine clearance is between 10-30 ml/min, the initial dose is 1.25 mg/day and the maximal daily dose is 5 mg;

- in haemodialysed hypertensive patients: ramipril is slightly dialysable; the initial dose is 1.25 mg/day and the maximal daily dose is 5 mg; the medicinal product should be administered few hours after haemodialysis is performed.

Patients with hepatic impairment (see section 5.2)

In patients with hepatic impairment, treatment with TRITACE must be initiated only under close medical supervision and the maximum daily dose is 2.5 mg TRITACE.

Elderly

Initial doses should be lower and subsequent dose titration should be more gradual because of greater chance of undesirable effects especially in very old and frail patients. A reduced initial dose of 1.25 mg ramipril should be considered.

Paediatric population

The safety and efficacy of ramipril in children has not yet been established. Currently available data for TRITACE are described in sections 4.8, 5.1, 5.2 and 5.3 but no specific recommendation on posology can be made.

4.3 Contraindications

- Hypersensitivity to the active substance, to any of the excipients or any other ACE (Angiotensin Converting Enzyme) inhibitors (see section 6.1)

- History of angioedema (hereditary, idiopathic or due to previous angioedema with ACE inhibitors or AIIRAs)

- Extracorporeal treatments leading to contact of blood with negatively charged surfaces (see section 4.5)

- Significant bilateral renal artery stenosis or renal artery stenosis in a single functioning kidney

- Second and third trimesters of pregnancy (see sections 4.4 and 4.6)

- Ramipril must not be used in patients with hypotensive or haemodynamically unstable states.

4.4 Special Warnings And Precautions For Use

Special populations

Pregnancy: ACE inhibitors should not be initiated during pregnancy. Unless continued ACE inhibitor therapy is considered essential, patients planning pregnancy should be changed to alternative anti-hypertensive treatments which have an established safety profile for use in pregnancy. When pregnancy is diagnosed, treatment with ACE inhibitors should be stopped immediately, and, if appropriate, alternative therapy should be started (see sections 4.3 and 4.6).

- Patients at particular risk of hypotension

- Patients with strongly activated renin-angiotensin-aldosterone system

Patients with strongly activated renin-angiotensin-aldosterone system are at risk of an acute pronounced fall in blood pressure and deterioration of renal function due to ACE inhibition, especially when an ACE inhibitor or a concomitant diuretic is given for the first time or at first dose increase.

Significant activation of renin-angiotensin-aldosterone system is to be anticipated and medical supervision including blood pressure monitoring is necessary, for example in:

- patients with severe hypertension

- patients with decompensated congestive heart failure

- patients with haemodynamically relevant left ventricular inflow or outflow impediment (e.g. stenosis of the aortic or mitral valve)

- patients with unilateral renal artery stenosis with a second functional kidney

- patients in whom fluid or salt depletion exists or may develop (including patients with diuretics)

- patients with liver cirrhosis and/or ascites

- patients undergoing major surgery or during anaesthesia with agents that produce hypotension.

Generally, it is recommended to correct dehydration, hypovolaemia or salt depletion before initiating treatment (in patients with heart failure, however, such corrective action must be carefully weighed out against the risk of volume overload).

- Transient or persistent heart failure post MI

- Patients at risk of cardiac or cerebral ischemia in case of acute hypotension

The initial phase of treatment requires special medical supervision.

- Elderly patients

See section 4.2.

Surgery

It is recommended that treatment with angiotensin converting enzyme inhibitors such as ramipril should be discontinued where possible one day before surgery.

Monitoring of renal function

Renal function should be assessed before and during treatment and dosage adjusted especially in the initial weeks of treatment. Particularly careful monitoring is required in patients with renal impairment (see section 4.2). There is a risk of impairment of renal function, particularly in patients with congestive heart failure or after a renal transplant.

Angioedema

Angioedema has been reported in patients treated with ACE inhibitors including ramipril (see section 4.8).

In case of angioedema, TRITACE must be discontinued.

Emergency therapy should be instituted promptly. Patient should be kept under observation for at least 12 to 24 hours and discharged after complete resolution of the symptoms.

Intestinal angioedema has been reported in patients treated with ACE inhibitors including TRITACE (see section 4.8). These patients presented with abdominal pain (with or without nausea or vomiting).

Anaphylactic reactions during desensitization

The likelihood and severity of anaphylactic and anaphylactoid reactions to insect venom and other allergens are increased under ACE inhibition. A temporary discontinuation of TRITACE should be considered prior to desensitization.

Hyperkalaemia

Hyperkalaemia has been observed in some patients treated with ACE inhibitors including TRITACE. Patients at risk for development of hyperkalaemia include those with renal insufficiency, age (> 70 years), uncontrolled diabetes mellitus, or those using potassium salts, potassium retaining diuretics and other plasma potassium increasing active substances, or conditions such as dehydration, acute cardiac decompensation, metabolic acidosis. If concomitant use of the above mentioned agents is deemed appropriate, regular monitoring of serum potassium is recommended (see section 4.5).

Neutropenia/agranulocytosis

Neutropenia/agranulocytosis, as well as thrombocytopenia and anaemia, have been rarely seen and bone marrow depression has also been reported. It is recommended to monitor the white blood cell count to permit detection of a possible leucopoenia. More frequent monitoring is advised in the initial phase of treatment and in patients with impaired renal function, those with concomitant collagen disease (e.g. lupus erythematosus or scleroderma), and all those treated with other medicinal products that can cause changes in the blood picture (see sections 4.5 and 4.8).

Ethnic differences

ACE inhibitors cause higher rate of angioedema in black patients than in non black patients. As with other ACE inhibitors, ramipril may be less effective in lowering blood pressure in black people than in non black patients, possibly because of a higher prevalence of hypertension with low renin level in the black hypertensive population.

Cough

Cough has been reported with the use of ACE inhibitors. Characteristically, the cough is nonproductive, persistent and resolves after discontinuation of therapy. ACE inhibitor-induced cough should be considered as part of the differential diagnosis of cough.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Contra-indicated combinations

Extracorporeal treatments leading to contact of blood with negatively charged surfaces such as dialysis or haemofiltration with certain high-flux membranes (e.g. polyacrylonitril membranes) and low density lipoprotein apheresis with dextran sulphate due to increased risk of severe anaphylactoid reactions (see section 4.3). If such treatment is required, consideration should be given to using a different type of dialysis membrane or a different class of antihypertensive agent.

Precautions for use

Potassium salts, heparin, potassium-retaining diuretics and other plasma potassium increasing active substances (including Angiotensin II antagonists, trimethoprim, tacrolimus, ciclosporin): Hyperkalaemia may occur, therefore close monitoring of serum potassium is required.

Antihypertensive agents (e.g. diuretics) and other substances that may decrease blood pressure (e.g. nitrates, tricyclic antidepressants, anaesthetics, acute alcohol intake, baclofen, alfuzosin, doxazosin, prazosin, tamsulosin, terazosin): Potentiation of the risk of hypotension is to be anticipated (see section 4.2 for diuretics)

Vasopressor sympathomimetics and other substances (e.g. isoproterenol, dobutamine, dopamine, epinephrine) that may reduce the antihypertensive effect of TRITACE: Blood pressure monitoring is recommended.

Allopurinol, immunosuppressants, corticosteroids, procainamide, cytostatics and other substances that may change the blood cell count: Increased likelihood of haematological reactions (see section 4.4).

Lithium salts: Excretion of lithium may be reduced by ACE inhibitors and therefore lithium toxicity may be increased. Lithium level must be monitored.

Antidiabetic agents including insulin: Hypoglycaemic reactions may occur. Blood glucose monitoring is recommended.

Non-steroidal anti-inflammatory drugs and acetylsalicylic acid: Reduction of the antihypertensive effect of TRITACE is to be anticipated. Furthermore, concomitant treatment of ACE inhibitors and NSAIDs may lead to an increased risk of worsening of renal function and to an increase in kalaemia.

4.6 Pregnancy And Lactation

Pregnancy

The use of ACE inhibitors is not recommended during the first trimester of pregnancy (see section 4.4). The use of ACE inhibitors is contraindicated during the second and third trimesters of pregnancy (see sections 4.3 and 4.4).

Epidemiological evidence regarding the risk of teratogenicity following exposure to ACE inhibitors during the first trimester of pregnancy has not been conclusive; however a small increase in risk cannot be excluded. Unless continued ACE inhibitor therapy is considered essential, patients planning pregnancy should be changed to alternative anti-hypertensive treatments which have an established safety profile for use in pregnancy. When pregnancy is diagnosed, treatment with ACE inhibitors should be stopped immediately, and, if appropriate, alternative therapy should be started.

Exposure to ACE inhibitor therapy during the second and third trimesters is known to induce human foetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia) (see section 5.3). Should exposure to ACE inhibitors have occurred from the second trimester of pregnancy, ultrasound check of renal function and skull is recommended. Infants whose mothers have taken ACE inhibitors should be closely observed for hypotension (see sections 4.3 and 4.4).

Lactation

Because insufficient information is available regarding the use of ramipril during breastfeeding (see section 5.2), Tritace is not recommended and alternative treatments with better established safety profiles during breast-feeding are preferable, especially while nursing a newborn or preterm infant.

4.7 Effects On Ability To Drive And Use Machines

Some adverse effects (e.g. symptoms of a reduction in blood pressure such as dizziness) may impair the patient's ability to concentrate and react and, therefore, constitute a risk in situations where these abilities are of particular importance (e.g. operating a vehicle or machinery).

This can happen especially at the start of treatment, or when changing over from other preparations. After the first dose or subsequent increases in dose it is not advisable to drive or operate machinery for several hours.

4.8 Undesirable Effects

The safety profile of ramipril includes persistent dry cough and reactions due to hypotension. Serious adverse reactions include angioedema, hyperkalaemia, renal or hepatic impairment, pancreatitis, severe skin reactions and neutropenia/agranulocytosis.

Adverse reactions frequency is defined using the following convention:

Very common (

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

 

Common

Uncommon

Rare

Very rare

Not known

Cardiac disorders

 

Myocardial ischaemia including angina pectoris or myocardial infarction, tachycardia, arrhythmia, palpitations, oedema peripheral

     

Blood and lymphatic system disorders

 

Eosinophilia

White blood cell count decreased (including neutropenia or agranulocytosis), red blood cell count decreased, haemoglobin decreased, platelet count decreased

 

Bone marrow failure, pancytopenia, haemolytic anaemia

Nervous system disorders

Headache, dizziness

Vertigo, paraesthesia, ageusia, dysgeusia,

Tremor, balance disorder

 

Cerebral ischaemia including ischaemic stroke and transient ischaemic attack, psychomotor skills impaired, burning sensation, parosmia

Eye disorders

 

Visual disturbance including blurred vision

Conjunctivitis

   

Ear and labyrinth disorders

   

Hearing impaired, tinnitus

   

Respiratory, thoracic and mediastinal disorders

Non-productive tickling cough, bronchitis, sinusitis, dyspnoea

Bronchospasm including asthma aggravated, nasal congestion

     

Gastrointestinal disorders

Gastrointestinal inflammation, digestive disturbances, abdominal discomfort, dyspepsia, diarrhoea, nausea, vomiting

Pancreatitis (cases of fatal outcome have been very exceptionally reported with ACE inhibitors), pancreatic enzymes increased, small bowel angioedema, abdominal pain upper including gastritis, constipation, dry mouth

Glossitis

 

Aphtous stomatitis

Renal and urinary disorders

 

Renal impairment including renal failure acute, urine output increased, worsening of a pre-existing proteinuria, blood urea increased, blood creatinine increased

     

Skin and subcutaneous tissue disorders

Rash in particular maculo-papular

Angioedema; very exceptionally, the airway obstruction resulting from angioedema may have a fatal outcome; pruritus, hyperhidrosis

Exfoliative dermatitis, urticaria, onycholysis,

Photosensitivity reaction

Toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, pemphigus, psoriasis aggravated, dermatitis psoriasiform, pemphigoid or lichenoid exanthema or enanthema, alopecia

Musculoskeletal and connective tissue disorders

Muscle spasms, myalgia

Arthralgia

     

Metabolism and nutrition disorders

Blood potassium increased

Anorexia, decreased appetite,

   

Blood sodium decreased

Vascular disorders

Hypotension, orthostatic blood pressure decreased, syncope

Flushing

Vascular stenosis, hypoperfusion, vasculitis

 

Raynaud's phenomenon

General disorders and administration site conditions

Chest pain, fatigue

Pyrexia

Asthenia

   

Immune system disorders

       

Anaphylactic or anaphylactoid reactions, antinuclear antibody increased

Hepatobiliary disorders

 

Hepatic enzymes and/or bilirubin conjugated increased,

Jaundice cholestatic, hepatocellular damage

 

Acute hepatic failure, cholestatic or cytolytic hepatitis (fatal outcome has been very exceptional).

Reproductive system and breast disorders

 

Transient erectile impotence, libido decreased

   

Gynaecomastia

Psychiatric disorders

 

Depressed mood, anxiety, nervousness, restlessness, sleep disorder including somnolence

Confusional state

 

Disturbance in attention

Paediatric Population

The safety of ramipril was monitored in 325 children and adolescents, aged 2-16 years old during 2 clinical trials. Whilst the nature and severity of the adverse events are similar to that of the adults, the frequency of the following is higher in the children:

Tachycardia, nasal congestion and rhinitis, “common” (i.e.

Conjunctivitis “common” (i.e.

Tremor and urticaria “uncommon” (i.e.

The overall safety profile for ramipril in paediatric patients dose not differ significantly from the safety profile in adults.

4.9 Overdose

Symptoms associated with overdosage of ACE inhibitors may include excessive peripheral vasodilatation (with marked hypotension, shock), bradycardia, electrolyte disturbances, and renal failure. The patient should be closely monitored and the treatment should be symptomatic and supportive. Suggested measures include primary detoxification (gastric lavage, administration of adsorbents) and measures to restore haemodynamic stability, including, administration of alpha 1 adrenergic agonists or angiotensin II (angiotensinamide) administration. Ramiprilat, the active metabolite of ramipril is poorly removed from the general circulation by haemodialysis.

5. Pharmacological Properties 5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: ACE Inhibitors, plain, ATC code C09AA05.

Mechanism of action

Ramiprilat, the active metabolite of the prodrug ramipril, inhibits the enzyme dipeptidylcarboxypeptidase I (synonyms: angiotensin-converting enzyme; kininase II). In plasma and tissue this enzyme catalyses the conversion of angiotensin I to the active vasoconstrictor substance angiotensin II, as well as the breakdown of the active vasodilator bradykinin. Reduced angiotensin II formation and inhibition of bradykinin breakdown lead to vasodilatation.

Since angiotensin II also stimulates the release of aldosterone, ramiprilat causes a reduction in aldosterone secretion. The average response to ACE inhibitor monotherapy was lower in black (Afro-Caribbean) hypertensive patients (usually a low-renin hypertensive population) than in non-black patients.

Pharmacodynamic effects

Antihypertensive properties:

Administration of ramipril causes a marked reduction in peripheral arterial resistance. Generally, there are no major changes in renal plasma flow and glomerular filtration rate. Administration of ramipril to patients with hypertension leads to a reduction in supine and standing blood pressure without a compensatory rise in heart rate.

In most patients the onset of the antihypertensive effect of a single dose becomes apparent 1 to 2 hours after oral administration. The peak effect of a single dose is usually reached 3 to 6 hours after oral administration. The antihypertensive effect of a single dose usually lasts for 24 hours.

The maximum antihypertensive effect of continued treatment with ramipril is generally apparent after 3 to 4 weeks. It has been shown that the antihypertensive effect is sustained under long term therapy lasting 2 years.

Abrupt discontinuation of ramipril does not produce a rapid and excessive rebound increase in blood pressure.

Heart failure:

In addition to conventional therapy with diuretics and optional cardiac glycosides, ramipril has been shown to be effective in patients with functional classes II-IV of the New-York Heart Association. The drug had beneficial effects on cardiac haemodynamics (decreased left and right ventricular filling pressures, reduced total peripheral vascular resistance, increased cardiac output and improved cardiac index). It also reduced neuroendocrine activation.

Clinical efficacy and safety

Cardiovascular prevention/Nephroprotection;

A preventive placebo-controlled study (the HOPE-study), was carried out in which ramipril was added to standard therapy in more than 9,200 patients. Patients with increased risk of cardiovascular disease following either atherothrombotic cardiovascular disease (history of coronary heart disease, stroke or peripheral vascular disease) or diabetes mellitus with at least one additional risk factor (documented microalbuminuria, hypertension, elevated total cholesterol level, low high-density lipoprotein cholesterol level or cigarette smoking) were included in the study.

The study showed that ramipril statistically significantly decreases the incidence of myocardial infarction, death from cardiovascular causes and stroke, alone and combined (primary combined events).

The HOPE Study: Main Results;

 

Ramipril

Placebo

relative risk

(95% confidence interval)

p-value

 

%

%

   

All patients

n=4,645

N=4,652

 

 

Primary combined events

14.0

17.8

0.78 (0.70-0.86)

<0.001

Myocardial infarction

9.9

12.3

0.80 (0.70-0.90)

<0.001

Death from cardiovascular causes

6.1

8.1

0.74 (0.64-0.87)

<0.001

Stroke

3.4

4.9

0.68 (0.56-0.84)

<0.001

         

Secondary endpoints

 

 

 

 

Death from any cause

10.4

12.2

0.84 (0.75-0.95)

0.005

Need for Revascularisation

16.0

18.3

0.85 (0.77-0.94)

0.002

Hospitalisation for unstable angina

12.1

12.3

0.98 (0.87-1.10)

NS

Hospitalisation for heart failure

3.2

3.5

0.88 (0.70-1.10)

0.25

Complications related to diabetes

6.4

7.6

0.84 (0.72-0.98)

0.03

The MICRO-HOPE study, a predefined substudy from HOPE, investigated the effect of the addition of ramipril 10 mg to the current medical regimen versus placebo in 3,577 patients at least

The primary analysis showed that 117 (6.5 %) participants on ramipril and 149 (8.4 %) on placebo developed overt nephropathy, which corresponds to a RRR 24 %; 95 % CI [3-40], p = 0.027.

The REIN study, a multicenter randomized, double-blind parallel group, placebo-controlled study aimed at a

Tresaderm
Dosage Form: FOR ANIMAL USE ONLYTresaderm®

Tobrex Ophthalmic Ointment
Generic Name: tobramycin Dosage Form: ophthalmic ointmentTobrex® (tobramycin ophthalmic ointment) 0.3% DESCRIPTION

TOBREX® (tobramycin ophthalmic ointment) 0.3% is a sterile topical ophthalmic antibiotic formulation prepared specifically for topical therapy of external ophthalmic infections.

Each gram of TOBREX® (tobramycin ophthalmic ointment) 0.3% contains: Active: tobramycin 0.3% (3 mg). Preservative: chlorobutanol 0.5%. Inactives: mineral oil, white petrolatum.

Tobramycin is a water-soluble aminoglycoside antibiotic active against a wide variety of gram-negative and gram-positive ophthalmic pathogens.

The chemical structure of tobramycin is :

Molecular formula:

C18H37N5O9

Molecular weight:

467.52

Chemical name:

0-{3-amino-3-deoxy-?-D-gluco-pyranosyl-(1?4) }-0-{2,6-diamino-2,3,6-trideoxy-?-D-ribohexo-pyranosyl-(1?6) }-2-deoxystreptamine.

CLINICAL PHARMACOLOGY

In Vitro Data : In vitro studies have demonstrated tobramycin is active against susceptible strains of the following microorganisms: Staphylococci, including S. aureus and S. epidermidis (coagulase-positive and coagulase-negative), including penicillin-resistant strains.

Streptococci, including some of the Group A-beta-hemolytic species, some nonhemolytic species, and some Streptococcus pneumoniae.

Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae, Enterobacter aerogenes, Proteus mirabilis, Morganella morganii, most Proteus vulgaris strains, Haemophilus influenzae and H. aegyptius, Moraxella lacunata, Acinetobacter calcoaceticus and some Neisseria species. Bacterial susceptibility studies demonstrate that in some cases, microorganisms resistant to gentamicin retain susceptibility to tobramycin.

INDICATIONS AND USAGE

TOBREX® (tobramycin ophthalmic ointment) 0.3 % is a topical antibiotic indicated in the treatment of external infections of the eye and its adnexa caused by susceptible bacteria. Appropriate monitoring of bacterial response to topical antibiotic therapy should accompany the use of TOBREX® (tobramycin ophthalmic ointment) 0.3%. Clinical studies have shown tobramycin to be safe and effective for use in children.

CONTRAINDICATIONS

TOBREX® (tobramycin ophthalmic ointment) 0.3 % is contraindicated in patients with known hypersensitivity to any of its components.

WARNINGS

NOT FOR INJECTION INTO THE EYE. Sensitivity to topically applied aminoglycosides may occur in some patients. If a sensitivity reaction to TOBREX® (tobramycin ophthalmic ointment) 0.3% occurs, discontinue use.

PRECAUTIONS

General. As with other antibiotic preparations, prolonged use may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, appropriate therapy should be initiated. Ophthalmic ointments may retard corneal wound healing.

Cross-sensitivity to other aminoglycoside antibiotics may occur; if hypersensitivity develops with this product, discontinue use and institute appropriate therapy.

Patients should be advised not to wear contact lenses if they have signs and symptoms of ocular infections.

Information For Patients

Do not touch tube tip to any surface, as this may contaminate the ointment.

Do not use the product if the imprinted carton seals have been damaged, or removed.

Pregnancy Category B

Reproduction studies in three types of animals at doses up to thirty-three times the normal human systemic dose have revealed no evidence of impaired fertility or harm to the fetus due to tobramycin. There are, however, no adequate and well-controlled studies in pregnant women. Because animal studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Nursing Mothers

Because of the potential for adverse reactions in nursing infants from TOBREX® (tobramycin ophthalmic ointment) 0.3%, a decision should be made whether to discontinue nursing the infant or discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

Safety and effectiveness in pediatric patients below the age of 2 months has not been established.

Geriatric Use

No overall clinical differences in safety or effectiveness have been observed between the elderly and other adult patients.

ADVERSE REACTIONS

The most frequent adverse reactions to TOBREX® (tobramycin ophthalmic ointment) 0.3% are hypersensitivity and localized ocular toxicity, including lid itching and swelling, and conjunctival erythema. These reactions occur in less than three of 100 patients treated with TOBREX® (tobramycin ophthalmic ointment) 0.3%. Similar reactions may occur with the topical use of other aminoglycoside antibiotics. Other adverse reactions have not been reported from TOBREX® (tobramycin ophthalmic ointment) 0.3% therapy; however, if topical ocular tobramycin is administered concomitantly with systemic aminoglycoside antibiotics, care should be taken to monitor the total serum concentration. In clinical trials, TOBREX® (tobramycin ophthalmic ointment) 0.3 % produced significantly fewer adverse reactions (3.7%) than did GARAMYCIN® Ophthalmic Ointment (10.6%).

OVERDOSAGE

Clinically apparent signs and symptoms of an overdose of TOBREX® (tobramycin ophthalmic ointment) 0.3% (punctate keratitis, erythema, increased lacrimation, edema and lid itching) may be similar to adverse reaction effects seen in some patients.

DOSAGE AND ADMINISTRATION

In mild to moderate disease, apply a half-inch ribbon into the affected eye(s) two or three times per day. In severe infections, instill a half-inch ribbon into the affected eye(s) every three to four hours until improvement, following which treatment should be reduced prior to discontinuation.

How to Apply TOBREX® (tobramycin ophthalmic ointment) 0.3%:

1. Tilt your head back.

2. Place a finger on your cheek just under your eye and gently pull down until a ''V'' pocket is formed between your eyeball and your lower lid.

3. Place a small amount (about 1/2 inch) of TOBREX® (tobramycin ophthalmic ointment) 0.3% in the ''V'' pocket. Do not let the tip of the tube touch your eye.

4. Look downward before closing your eye.

HOW SUPPLIED

3.5 g STERILE ointment supplied in an aluminum tube with a white polyethylene tip and white polyethylene cap (NDC 0065-0644-35), containing tobramycin 0.3% (3 mg/g).

Storage: Store at 2°- 25°C (36°- 77°F).

Rx Only

© 2002, 2008 Alcon, Inc.

Revised: July 2008

Manufactured for:

ALCON LABORATORIES, INC.

Fort Worth, Texas 76134 USA

Manufactured by:

S.A. ALCON-COUVREUR N.V.

Puurs, Belgium

44280-1

PRINCIPAL DISPLAY PANEL

NDC 0065-0644-35  Alcon®

Tobrex®

(tobramycin ophthalmic

ointment) 0.3%

Sterile 3.5 g Net Wt.

  

  

Tempo Chewable Tablets
Pronunciation: a-LOO-min-uhm/KAL-see-uhm/mag-NEE-zee-uhm/si-METH-i-koneGeneric Name: Aluminum/Calcium/Magnesium/SimethiconeBrand Name: Tempo

Tositumomab

Class: Antineoplastic AgentsVA Class: AN600CAS Number: 192391-48-3

Tums Plus Chewable Tablets
Pronunciation: KAL-see-uhm/si-METH-i-koneGeneric Name: Calcium/SimethiconeBrand Name: Examples include Titralac Plus and Tums Plus

typhoid vaccine (live), oral

Generic Name: typhoid vaccine (live), oral (TYE foid vax EEN) Brand Names: Vivotif Berna

What is typhoid vaccine?

Typhoid (also called "typhoid fever") is a serious disease caused by Salmonella typhi bacteria. Typhoid can be fatal if left untreated.

Typhoid can cause high fever, muscle aches, severe headache, weakness, confusion or agitation, loss of appetite, stomach pain, diarrhea or constipation, and rose-colored spots on the skin.

Untreated typhoid infection may lead to kidney failure, or intestinal bleeding caused by perforation (forming of a hole), which can be fatal. If the infection spreads to the gallbladder, the infected person may become a chronic carrier of the bacteria that causes typhoid. A carrier may have no symptoms but is capable of spreading the infection to others.

Typhoid is spread through contact with the stool (bowel movements) of a person infected with the bacteria. This usually occurs by eating food or drinking water that has become contaminated with feces from an infected person. Once in the digestive tract, typhoid infection can spread to the blood and other parts of the body.

Typhoid fever is most common in non-industrialized parts of the world, especially Asia, Africa, and Central or South America. People who travel to those regions are at risk of coming into contact with the disease.

The typhoid vaccine is used to help prevent this disease in adults and children who are at least 6 years old. Although not part of a routine immunization schedule in the U.S., typhoid vaccine is recommended for people who travel to areas where the disease is common.

This vaccine works by exposing you to a small amount of the bacteria, which causes your body to develop immunity to the disease.

Typhoid vaccine will not treat an active infection that has already developed in the body, and will not prevent any disease caused by bacteria other than Salmonella typhi.

Like any vaccine, the typhoid vaccine may not provide protection from disease in every person.

What is the most important information I should know about typhoid vaccine? You should not receive this vaccine if you have ever had an allergic reaction to typhoid vaccine in the past, or if you have fever with any type of infection or illness, or a weak immune system caused by disease or by using certain medicines such as chemotherapy. Typhoid vaccine should not be used in a person who is a typhoid carrier.

Before you receive this vaccine, tell the doctor if you have any illness with vomiting or diarrhea, if you are taking an antibiotic or sulfa drug (Azulfidine, Bactrim, Cotrim, Gantrisin, Septra, SMX-TMP, Sulfazine), or if you plan to start taking an anti-malaria medication within 10 days after receiving typhoid vaccine.

You can still receive a vaccine if you have a minor cold. In the case of a more severe illness with a fever or any type of infection, the doctor may ask you to wait until you get better before you can receive the vaccine.

The typhoid oral vaccine is given in a series of 4 capsules that are taken 1 per day on alternating days (days 1, 3, 5, and 7). On this alternating-day schedule, you will take 1 capsule every 48 hours for 7 days. You must take each capsule according to the recommended schedule for this vaccine to be effective.

You should complete all doses at least 1 week before your scheduled travel or possible exposure to typhoid.

You must keep typhoid vaccine capsules cold when not in use. Once you receive the capsules from your doctor or pharmacy, take them directly home and place them in the refrigerator. Keep each capsule in the foil blister pack in the refrigerator until you are ready to take it. Do not allow the capsules to freeze.

Like any vaccine, the typhoid vaccine may not provide protection from disease in every person.

In addition to receiving typhoid vaccine, take precautions while traveling such as avoiding raw fruits or vegetables that cannot be peeled, drinks that contain ice, flavored ices that may have been made with contaminated water, unbottled or unboiled water, or any food or beverage purchased from a street vendor.

What should I discuss with my healthcare provider before receiving typhoid vaccine? Typhoid vaccine should not be used in a person who is a typhoid carrier. You should not receive this vaccine if you have ever had an allergic reaction to typhoid vaccine in the past, or if you have:

fever with any type of infection or illness;

a weak immune system caused by disease such as HIV/AIDS or cancer; or

a weak immune system caused by using certain medicines such as chemotherapy.

You may not be able to receive this vaccine if you have:

stomach flu or any illness with vomiting or diarrhea;

if you are taking an antibiotic, especially a sulfa drug such as sulfasalazine (Azulfidine, Sulfazine), sulfamethoxazole (Bactrim, Cotrim, Septra, SMX-TMP), or sulfisoxazole (Gantrisin); or

if you plan to start taking an anti-malaria medication within 10 days after receiving a typhoid oral vaccine.

You can still receive a vaccine if you have a minor cold. In the case of a more severe illness with a fever or any type of infection, the doctor may ask you to wait until you get better before you can receive the vaccine.

Vaccines may be harmful to an unborn baby and generally should not be given to a pregnant woman. However, not vaccinating the mother could be more harmful to the baby if the mother becomes infected with a disease that this vaccine could prevent. Your doctor will decide whether you should receive this vaccine, especially if you have a high risk of infection with typhoid. It is not known whether typhoid vaccine passes into breast milk, or if it could harm a nursing baby. Do not receive this vaccine without telling your doctor if you are breast-feeding a baby. How is typhoid vaccine given?

Typhoid vaccine is recommended for adults and children in the following situations:

people who travel to countries where typhoid fever is common;

people who will have long-term exposure to food or water that may be contaminated with typhoid;

people who live with someone who is a typhoid carrier; and

laboratory workers who may come into contact with Salmonella typhi in a work setting.

The typhoid oral vaccine is given in a series of 4 capsules that are taken 1 per day on alternating days (days 1, 3, 5, and 7). On this alternating-day schedule, you will take 1 capsule every 48 hours for 7 days. You must take each capsule according to the recommended schedule for this vaccine to be effective.

You should complete all doses at least 1 week before your scheduled travel or possible exposure to typhoid.

You must keep typhoid vaccine capsules cold when not in use. Once you receive the capsules from your doctor or pharmacy, take them directly home and place them in the refrigerator. Keep each capsule in the foil blister pack in the refrigerator until you are ready to take it. Do not allow the capsules to freeze. Take the capsule on an empty stomach, at least 1 hour before a meal.

Swallow the capsule as quickly as possible after placing it in your mouth. Take with a full glass of cold or lukewarm water or other beverage. Do not use warm or hot drinks such as coffee, tea, or warm milk. The liquid you use to help swallow the typhoid vaccine capsule should not be warmer than your body temperature (98.6 degrees F).

Do not crush, chew, or break a typhoid vaccine capsule. Swallow the pill whole. The enteric-coated pill has a special coating to release the vaccine slowly into your body. Breaking the pill could damage this coating.

The complete series of 4 vaccine capsules should provide protection against typhoid for up to 5 years. Another series of 4 capsules is then recommended every 5 years during possible exposure to typhoid. Your individual booster schedule may be different from these guidelines. Follow your doctor's instructions or the schedule recommended by the Centers for Disease Control and Prevention (CDC).

Be sure you receive all recommended doses of this vaccine. If you do not receive the full series of capsules every 5 years during continued exposure, you may not be fully protected against the disease.

Wash your hands often to help prevent typhoid when you are in an area where contamination is possible. What happens if I miss a dose?

Contact your doctor if you forget to take a capsule on the scheduled day. You may need to start over to make sure you are fully protected against the disease.

Be sure to receive another series of 4 capsules every 5 years during continued exposure to typhoid.

What happens if I overdose?

An overdose of this vaccine is unlikely to occur when taken as directed.

What should I avoid before or after getting typhoid vaccine?

In addition to receiving typhoid vaccine, take precautions while traveling to further prevent coming into contact with bacteria that cause typhoid fever:

Avoid eating leafy vegetables such as spinach or lettuce, which are harder to wash properly.

Avoid eating raw fruits or vegetables that cannot be peeled, or that have been peeled by another person.

Avoid drinks that contain ice, or frozen treats and flavored ices that may have been made with contaminated water.

Avoid eating foods you have not cooked or prepared yourself. Use clean surfaces and utensils when preparing food.

Drink only bottled water (carbonated is best) or water that has been boiled for at least 1 minute.

Avoid any food or beverage purchased from a street vendor.

Typhoid vaccine side effects You should not receive a booster dose if you had a life-threatening allergic reaction after taking a typhoid vaccine capsule.

Becoming infected with typhoid is much more dangerous to your health than receiving the vaccine to protect against it. Like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely low.

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.

Less serious side effects include:

low fever;

headache;

nausea, vomiting, diarrhea, stomach pain; or

mild skin rash.

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

Typhoid vaccine (live), oral Dosing Information

Usual Adult Dose for Typhoid Prophylaxis:

One capsule orally 1 hour before a meal with a cold or lukewarm drink [temperature not to exceed body temperature, e.g., 37 ?°C (98.6 ?°F)] on alternate days, e.g., days 1, 3, 5 and 7.Immunization with all 4 doses should be completed at least 1 week prior to potential exposure to Salmonella typhi.

Usual Pediatric Dose for Typhoid Prophylaxis:

>= 6 years: One capsule orally 1 hour before a meal with a cold or lukewarm drink [temperature not to exceed body temperature, e.g., 37 ?°C (98.6 ?°F)] on alternate days, e.g., days 1, 3, 5 and 7.

TF Defense
Generic Name: silybum marianum seed, crotalus horridus horridus venom, artemisia cina flower, aconitum napellus and ferrum phosphoricum granule Dosage Form: FOR ANIMAL USE ONLYTF Defense

Boosts red blood cells and the immune system

Indications: Homeopathic remedy to boost red blood cells and immune function.

Dosage: Initial dose: Administer every hour for up to 10 doses. Thereafter 3 times daily for approximately 7-10 days. Cats and dogs under 20 lbs: Large pinch of granules sprinkled into the mouth. Dogs 20-50 lbs: 2 pinches sprinkled into the mouth. Dogs over 50 lbs:1/4 cap of granules sprinkled into the mouth.

Caution: Recommended for use under veterinary supervision. Consult your vet if symptoms persist or worsen. Keep this and all medicines from the reach of children.

Ingredients: Each dose contains equal parts of Carduus mar (3X) (HPUS), Crotalus hor (200C) (HPUS), Cina (6C) (HPUS), Aconitum nap (6C) (HPUS), Ferrum phos (6C) (HPUS)

Sucrose (inactive ingredient).

Contains no gluten, artificial flavors, colors or preservatives.

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