Nitroglycerin Tablets, USP

Nitroglycerin forms free radical nitric oxide (NO) which activates guanylate cyclase, resulting in an increase of guanosine 3'5' monophosphate (cyclic GMP) in smooth muscle and other tissues. This eventually leads to dephosphorylation of the light chain of myosin, which regulates the contractile state in smooth muscle, resulting in vasodilation.

Nitroglycerin is rapidly absorbed following sublingual administration. Its onset of action is approximately one to three minutes. Significant pharmacologic effects are present for 30 to 60 minutes following administration by the above route.

Nitroglycerin is rapidly metabolized to dinitrates and mononitrates, with a short half-life, estimated at 1 to 4 minutes. A liver reductase enzyme is of primary importance in the metabolism of nitroglycerin to glycerol nitrate metabolites and organic nitrate. Two active major metabolites 1,2- and 1,3-dinitroglycerols are less potent vasodilators and have longer half-lives than the parent compound. Dinitrates are metabolized to mononitrates and ultimately glycerol. The monohydrate is not considered biologically active with respect to cardiovascular effects.

At plasma concentrations of between 50 and 500 ng/mL, the binding of nitroglycerin to plasma proteins is approximately 60%, while that of 1,2dinitroglycerin and 1,3-dinitroglycerin is 60% and 30%, respectively. The activity and half-life of 1,2-dinitroglycerin and 1,3-dinitroglycerin are not well characterized. The mononitrate is not active.

Only the smallest dose required for effective relief of the acute anginal attack should be used. Excessive use may lead to the development of tolerance. Nitroglycerin USP tablets are intended for sublingual or buccal administration and should not be swallowed. Severe hypotension, particularly with upright posture, may occur even with small doses of nitroglycerin. The drug should be used cautiously in patients with volume depletion or low systolic blood pressure.

Paradoxical bradycardia and increased angina pectoris may accompany nitroglycerin-induced hypotension.

Nitrate therapy may aggravate angina caused by hypertrophic cardiomyopathy.

Tolerance to the vascular and antianginal effects of nitroglycerin and cross-tolerance to other nitrates and nitrites may occur.

The drug should be discontinued if blurring of vision or drying of the mouth occurs. Excessive dosage of nitroglycerin may produce severe headaches.

If possible, patients should sit down when taking Nitroglycerin tablets USP. This eliminates the possibility of falling due to lightheadedness or dizziness.

Nitroglycerin may produce a burning or tingling sensation when administered sublingually; however, the ability to produce a burning or tingling sensation should not be considered a reliable method for determining the potency of the tablets.

Nitroglycerin should be kept in the original glass container, tightly capped. The cotton should be discarded once the bottle is opened.

Administration of Nitroglycerin tablets USP is contraindicated in patients who are using Viagra^® (sildenafil citrate). Viagra^® has been shown to potentiate the hypotensive effects of organic nitrates (see CONTRAINDICATIONS).

No long-term studies in animals were performed to evaluate the carcinogenic potential of nitroglycerin.

Pregnancy Category C

Animal reproduction studies have not been conducted with nitroglycerin. It is also not known whether nitroglycerin can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Nitroglycerin should be given to apregnant woman only if clearly needed.

It is not known whether nitroglycerin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when intravenous nitroglycerin is administered to a nursing woman.

The safety and effectiveness of nitroglycerin in pediatric patients have not been established.

Angina is a medical condition that causes you to feel temporary pain in your chest. The pain may range from adull ache to a severe, crushing sensation. Attacks can occur several times a day or every few weeks, months, or years.

Angina occurs when your heart muscle needs more oxygen than it can get. This can happen at almost any time, especially during or following physical exertion, stress, or exposure to cold air.

Angina is serious, and, if left untreated, it can lead to additional medical problems such as heart attack. Your angina therapy could save your life. Please read this booklet and make sure to follow your doctor's directions for your angina therapy. Be sure to carry your Nitroglycerin Tablets with you at all times because you never know when you will need them.

In addition to having patients modify their activities, one of the most commonly prescribed medications for angina is nitroglycerin. Nitroglycerin Tablets USP and the nitroglycerin patches are nitrates, a form of nitroglycerin. Nitroglycerin Tablets can be used immediately prior to activities that may bring on an angina attack and to treat an angina attack that has already started.

Nitroglycerin Tablets USP are a form of nitroglycerin used to relieve or prevent episodes of acute angina. The drug is taken sublingually, meaning it is placed under the tongue to dissolve. Nitroglycerin Tablets can relieve angina by dilating the arteries of the heart so that more oxygen-carrying blood can reach the heart muscle.

You may use up to three Nitroglycerin Tablets USP in a 15 minute period. If you continue to feel pain after 15 minutes, call your doctor or seek medical attention immediately. Stay calm and be aware that this unrelieved pain does not necessarily mean you are having a heart attack.

Always follow your doctors directions for use. In general, the following schedule should be followed:

ONSET:

At the first sign of an attack, sit down and then place one Nitroglycerin Tablet under your tongue. You should take Nitroglycerin Tablets while sitting because your blood pressure may drop and cause lightheadedness and dizziness.

5 MIN:

If after waiting 5 minutes, your pain is still present, take a second Nitroglycerin Tablet.

10 MIN:

Again, if after waiting another 5 minutes, the pain is still present, you should take a third Nitroglycerin Tablet.

15 MIN:

If the pain continues 5 minutes or longer after your third Nitroglycerin Tablet, call your doctor or seek medical attention immediately to find out what to do next.

Nitroglycerin Tablets may also be used immediately before activities that you feel might cause an angina attack, such as exercise or sexual intercourse. Since you are the best judge of what may set off an attack, be sure to have a bottle of Nitroglycerin Tablets on hand for those times in those places where you would most expect an attack. Take one Nitroglycerin Tablet 5 to 10 minutes before you begin these activities, or follow your doctor's recommendations.

No. It is very important that each Nitroglycerin Tablet be placed under the tongue until it has fully dissolved. Nitroglycerin Tablets should not be chewed, crushed or swallowed.

No, do not eat, drink any beverages (including alcohol), smoke, or use chewing tobacco while a tablet is dissolving and/or when you are experiencing acute chest pain.

Some patients may feel a slight stinging sensation while the tablet is dissolving under the tongue. You also might experience warmth and flushing of the face or lightheadedness and dizziness. Sometimes, patients experience mild to severe headaches with their first few Nitroglycerin Tablets. These side effects usually are not signs of other problems, but you should let your doctor know if you have any concerns.

Instead of one bottle of 100 tablets, each bottle of Nitroglycerin Tablets USP in the 4-by-25 pack contains 25 tablets. Therefore, you can place the bottles in locations where you might have an angina attack, such as your bedroom, workroom, kitchen, or office. Also, you should always keep a bottle in a jacket or coat pocket (not a shirt or trouser pocket) or purse. By keeping Nitroglycerin Tablets in multiple locations, you will be sure to have your Nitroglycerin Tablets nearby when you need it.

When purchasing just one 100-tablet bottle, patients cannot keep the drug in different locations without removing tablets from the original container. This is a problem since only the original containers protect Nitroglycerin Tablets from air, heat, moisture, and light. Exposure to these elements can reduce the strength of Nitroglycerin Tablets. Use of the 4-by-25 pack is a convenient way to properly store Nitroglycerin Tablets.

The cotton has been left out of these bottles to make it as easy as possible for you to get a tablet when you need one.

Keep bottles where you are likely to have an angina attack, and remember to always keep one bottle with you - for example, in a pocketbook, tote bag, or overcoat. Keep the bottle loose and away from your body to protect the medication from body heat. Nitroglycerin Tablets bottles should not be kept in trouser or shirt pockets. To protect against loss of potency, Nitroglycerin Tablets should be stored in the original bottle and the bottle kept tightly closed. Nitroglycerin Tablets should not be placed in a pillbox or any other container. Do not place other medication in the Nitroglycerin Tablets bottle. Do not refrigerate Nitroglycerin Tablets; room temperature is best. As with all medications, keep Nitroglycerin Tablets out of the reach of children.

If the medication has been exposed to ahigh temperature or if the date on the bottle has expired, it should be discarded. Your pharmacist can help determine if your Nitroglycerin Tablets should be replaced.

Manufactured By:

Konec, Inc,
Tucson, AZ 65713

Manufactured For:

Glenmark Logo

Glenmark Generics Inc., USA
Mahwah, NJ 07430

Questions? 1 (888) 721-7115
www.glenmarkgenerics.com

Repackaged by:

Rebel Distributors Corp

Thousand Oaks, CA 91320