Nitrostat (Page 3 of 4)

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Animal carcinogenesis studies with sublingually administered nitroglycerin have not been performed.

Carcinogenicity potential of nitroglycerin was evaluated in rats receiving up to 434 mg/kg/day of dietary nitroglycerin for 2 years. Rats developed dose-related fibrotic and neoplastic changes in liver, including carcinomas, and interstitial cell tumors in testes. At high dose, the incidences of hepatocellular carcinomas in males was 48% and in females was 33%, compared to 0% in untreated controls. Incidences of testicular tumors were 52% vs. 8% in controls. Lifetime dietary administration of up to 1058 mg/kg/day of nitroglycerin was not tumorigenic in mice.

Nitroglycerin was mutagenic in Ames tests performed in 2 different laboratories. Nevertheless, there was no evidence of mutagenicity in an in vivo dominant lethal assay with male rats treated with doses up to about 363 mg/kg/day, PO, or in ex vivo cytogenetic tests in rat and dog cells.

In a 3-generation reproduction study, rats received dietary nitroglycerin at doses up to about 434 mg/kg/day for 6 months prior to mating of the F0 generation, with treatment continuing through successive F1 and F2 generations. The high dose was associated with decreased feed intake and body weight gain in both sexes at all matings. No specific effect on the fertility of the F0 generation was seen. Infertility noted in subsequent generations, however, was attributed to increased interstitial cell tissue and aspermatogenesis in the high-dose males. In this 3-generation study, there was no clear evidence of teratogenicity.

16 HOW SUPPLIED/STORAGE AND HANDLING

NITROSTAT is supplied as white, round, flat-faced tablets in 3 strengths (0.3 mg, 0.4 mg, and 0.6 mg) in bottles containing 100 tablets each, with color-coded labels, and in color-coded Patient Convenience Packages of 4 bottles of 25 tablets each.

0.3 mg:

Coded “N” on one side and “3” on the other.

NDC 0071-0417-24—Bottle of 100 tablets

0.4 mg:

Coded “N” on one side and “4” on the other.

NDC 0071-0418-13—Convenience Package

NDC 0071-0418-24—Bottle of 100 tablets

0.6 mg:

Coded “N” on one side and “6” on the other.

NDC 0071-0419-24—Bottle of 100 tablets

Store at Controlled Room Temperature 20°–25°C (68°–77°F) [see USP]. Nitroglycerin should be kept in the original glass container and must be tightly capped after each use to prevent loss of tablet potency.

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information).

This product’s label may have been updated. For full prescribing information, please visit www.pfizer.com.

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LAB-0180-9.0

Nitrostat® (Nitroglycerin Sublingual Tablets, USP)

Read this information carefully before you start NITROSTAT® (NYE-troe-stat) and each time you refill your prescription. There may be new information. This information does not replace talking with your doctor. If you have any questions about NITROSTAT , ask your doctor. Your doctor will know if NITROSTAT is right for you.

What is NITROSTAT?

NITROSTAT is a type of medicine known as an organic nitrate and is a vasodilating agent. It is used to treat a type of chest pain called angina.

What is Angina?

Angina is a pain or discomfort that keeps coming back when part of your heart does not get enough blood. Angina feels like a pressing or squeezing pain, usually in your chest under the breastbone. Sometimes you can feel it in your shoulders, arms, neck, jaws, or back. NITROSTAT can relieve this pain.

Who should not use NITROSTAT?

Do not use NITROSTAT if you are allergic to organic nitrates (like the active ingredient in NITROSTAT).

You should not take NITROSTAT if you have the following conditions:

very recent heart attack
severe anemia
increased pressure in the head

Do not take NITROSTAT with drugs for erectile dysfunction, like VIAGRA® (sildenafil citrate), CIALIS® (tadalafil), or LEVITRA® (vardenafil hydrochloride), as this may lead to extreme lowering of your blood pressure.

Do not take NITROSTAT if you take medicines called guanylate cyclase stimulators which include riociguat, a medicine that treats pulmonary arterial hypertension and chronic-thromboembolic pulmonary hypertension.

What should I tell my doctor before taking NITROSTAT?

Before using NITROSTAT , tell your doctor if:

You are taking any medicines that are used to treat angina, heart failure, or an irregular heartbeat.
You are taking any medicines that reduce blood pressure.
You are taking any diuretics (water pills).
You are taking medicines that can cause dry mouth such as tricyclic antidepressants (e.g. amitriptyline, desipramine, doxepin), anticholinergic drugs, or any antimuscarinic drugs (e.g. atropine).
You are taking ergotamine or similar drugs for migraine headaches.
You are taking aspirin.
You are taking any medicines for erectile dysfunction.
You are pregnant or plan to become pregnant.
You are breastfeeding.

How should I take NITROSTAT?

Do not chew, crush, or swallow NITROSTAT tablets.
You should sit down when taking NITROSTAT tablets and use caution when you stand up. This eliminates the possibility of falling due to lightheadedness or dizziness.
One tablet should be dissolved under the tongue or in the oral cavity at the first sign of chest pain.
The dose may be repeated approximately every 5 minutes, until the chest pain is relieved.
If the pain persists after a total of 3 tablets in a 15-minute period, or is different than you typically experience, call your doctor or seek emergency help.
NITROSTAT may be used 5 to 10 minutes prior to activities that might cause chest pain.
You may feel a burning or tingling sensation in your mouth when you take NITROSTAT.

What should I avoid while taking NITROSTAT?

Do not breastfeed. It is not known if NITROSTAT will pass through your milk.
Do not consume alcohol while taking NITROSTAT , as this can lower your blood pressure.
Do not start any new prescription or non-prescription medicines or supplements, unless you check with your doctor first.

What are the possible side effects of NITROSTAT?

NITROSTAT may cause the following side effects:

headache
vertigo (a major symptom of balance disorder)
dizziness
weakness
heart palpitations (unusual awareness of the heartbeat)
low blood pressure upon rising from a seated position
nausea and vomiting
sweating
paleness
fainting
flushing (warm or red condition of your skin)
other skin reactions that may be severe

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

How do I store NITROSTAT?

NITROSTAT should be kept in the original glass container and tightly capped after each use to prevent loss of tablet potency.

Store NITROSTAT tablets at room temperature (between 68° and 77°F).

General advice about NITROSTAT

Sometimes doctors will prescribe a medicine for a condition that is not included in the patient information leaflets. Only use NITROSTAT the way your doctor told you to. Do not give NITROSTAT to other people, even if they have the same symptoms you have. It may harm them.

You can ask your pharmacist or doctor for information about NITROSTAT , or you can visit the Pfizer website at www.pfizer.com or call 1-800-438-1985.

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LAB-0422-3.0
Revised January 2018

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