Nitro-Bid

Nitro-Bid may cause the following side effects:

• headache
• lightheadedness
• dizziness
• weakness
• low blood pressure 
• fainting
• flushing
• redness or irritation of the skin that was covered by the ointment

Tell your doctor if you are concerned about any side effects you experience. These are not all the possible side effects of Nitro-Bid. For a complete list, ask your doctor or pharmacist.

• Store Nitrobid at 20°-25°C (68°-77°F).
• Close tightly, immediately after each use.

In the U.S.

• Nitro-Bid
• NITRONAL

Available Dosage Forms:

• Solution
• Kit
• Injectable

Therapeutic Class: Coronary Vasodilator

Chemical Class: Nitrate

It is very important that your doctor check your progress closely while you are receiving this medicine to make sure it is working properly.

Do not take riociguat (Adempas®), sildenafil (Viagra®), tadalafil (Cialis®), or vardenafil (Levitra®) while you are using this medicine. Using these medicines together may cause blurred vision, dizziness, lightheadedness, or fainting. If you are taking these medicines and you experience an angina attack, you must go to the hospital right away.

Dizziness, lightheadedness, or faintness may occur, especially when you get up quickly from a lying or sitting position. Getting up slowly may help.

This medicine may cause headaches. These headaches are a sign that the medicine is working. If you have severe pain, talk with your doctor.

Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain medical tests.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about Nitro-Bid, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Nitro-Bid. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using Nitro-Bid.

Review Date: October 4, 2017

Nitroglycerin is 1,2,3-propanetriol trinitrate, an organic nitrate whose structural formula is:

and whose molecular weight is 227.09. The organic nitrates are vasodilators, active on both arteries and veins.

Nitro-Bid® for topical use contains lactose and 2% nitroglycerin in a base of lanolin, white petrolatum and purified water. Each inch (2.5 cm), as squeezed from the tube, contains approximately 15 mg of nitroglycerin.

Nitroglycerin ointment is indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of transdermal nitroglycerin is not sufficiently rapid for this product to be useful in aborting an acute anginal episode.

Amplification of the vasodilatory effects of nitroglycerin by sildenafil can result in severe hypotension. The time course and dose dependence of this interaction have not been studied. Appropriate supportive care has not been studied, but it seems reasonable to treat this as a nitrate overdose, with elevation of the extremities and with central volume expansion.

The benefits of transdermal nitroglycerin in patients with acute myocardial infarction or congestive heart failure have not been established. If one elects to use nitroglycerin in these conditions, careful clinical or hemodynamic monitoring must be used to avoid the hazards of hypotension and tachycardia.

General: Severe hypotension, particularly with upright posture, may occur with even small doses of nitroglycerin. This drug should therefore be used with caution in patients who may be volume depleted or who, for whatever reason, are already hypotensive. Hypotension induced by nitroglycerin may be accompanied by paradoxical bradycardia and increased angina pectoris.

Nitrate therapy may aggravate the angina caused by hypertrophic cardiomyopathy.

As tolerance to other forms of nitroglycerin develops, the effect of sublingual nitroglycerin on exercise tolerance, although still observable, is somewhat blunted. In industrial workers who have had long-term exposure to unknown (presumably high) doses of organic nitrates, tolerance clearly occurs. Chest pains, acute myocardial infarction, and even sudden death have occurred during temporary withdrawal of nitrates from these workers, demonstrating the existence of true physical dependence.

Some clinical trials in angina patients have provided nitroglycerin for about 12 continuous hours of every 24-hour day. During the nitrate-free intervals in some of these trials, anginal attacks have been more easily provoked than before treatment, and patients have demonstrated hemodynamic rebound and decreased exercise tolerance. The importance of these observations to the routine, clinical use of transdermal nitroglycerin is not known.

Information for Patients: Daily headaches sometimes accompany treatment with nitroglycerin. In patients who get these headaches, the headaches are a marker of the activity of the drug. Patients should resist the temptation to avoid headaches by altering the schedule of their treatment with nitroglycerin, since loss of headache is likely to be associated with simultaneous loss of antianginal efficacy.

Treatment with nitroglycerin may be associated with lightheadedness on standing, especially just after rising from a recumbent or seated position. This effect may be more frequent in patients who have also consumed alcohol. Patient instruction leaflet is included.

Drug Interactions: The vasodilating effects of nitroglycerin may be additive with those of other vasodilators. Alcohol, in particular, has been found to exhibit additive effects of this variety.

Marked symptomatic orthostatic hypotension has been reported when calcium channel blockers and organic nitrates were used in combination. Dose adjustments of either class of agents may be necessary.

Carcinogenesis, Mutagenesis, and Impairment of Fertility: Studies to evaluate the carcinogenic or mutagenic potential of nitroglycerin have not been performed. Nitroglycerin's effect upon reproductive capacity is similarly unknown.

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 whether it can affect reproductive capacity. Nitroglycerin should be given to a pregnant woman only if clearly needed.

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

Pediatric Use: Safety and effectiveness in pediatric patients have not been established.

NOTE: Nitro-Bid® can stain clothing. Care should be taken to completely cover the dose measuring applicator with a plastic kitchen wrap.

Dosage Instructions: Dosage instructions should be obtained from your physician. One appropriate dosing schedule for Nitro-Bid® would begin with two daily 1/2 inch (7.5 mg) doses, one applied on rising in the morning and one applied six hours later. The dose could be doubled, and even doubled again, in patients tolerating this dose but failing to respond to it. The foilpac is intended as a unit dose package only and is equivalent to approximately 1 inch as squeezed from the tube. Use entire contents of foilpac to obtain full dose and discard immediately after use.

INFORMATION FOR PATIENTS:Your daily regimen of Nitro-Bid® administration should include a nitrate-free period. Studies have shown 10-12 hours is sufficient. The most common side effect which is encountered is headache. Faintness, flushing and dizziness may occur, especially when suddenly arising from the recumbent (lying horizontal) position. If these latter symptoms do occur, it may warrant discontinuation of therapy, and your physician should be notified. For changes in dosage and frequency of application consult your physician.

TUBE: KEEP TUBE TIGHTLY CLOSED.

foilpac®: DISCARD IMMEDIATELY AFTER USE.

Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature].

SAVAGE LABORATORIES®
A division of Fougera Pharmaceuticals Inc.
Melville, New York 11747
R09/11