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NITROSTAT®(nitroglycerin)

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Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.

NITROSTAT® Quick Finder

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the...
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1 INDICATIONS AND USAGE

NITROSTAT is indicated for the acute relief of an attack or acute prophylaxis of angina pectoris due to coronary artery disease.

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2 DOSAGE AND ADMINISTRATION

Administer one tablet under the tongue or in the buccal pouch at the first sign of an acute anginal attack. Allow tablet to dissolve without swallowing. One additional tablet may be administered...

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3 DOSAGE FORMS AND STRENGTHS

NITROSTAT is supplied as white, round, flat-faced tablets in three strengths:

 
0.3 mg (Coded with "N" on one side and "3" on the other)
 
0.4 mg (Coded with "N...
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4 CONTRAINDICATIONS

4.1 PDE-5-Inhibitors and sGC-Stimulators

Do not use NITROSTAT in patients who are taking PDE-5 Inhibitors, such as avanafil, sildenafil, tadalafil...

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5 WARNINGS AND PRECAUTIONS

5.1 Tolerance

Excessive use may lead to the development of tolerance. Only the smallest dose required for effective relief of the acute...

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7 DRUG INTERACTIONS

7.1 PDE-5-Inhibitors and sGC-Stimulators

NITROSTAT is contraindicated in patients who are using a selective inhibitor of cyclic guanosine...

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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

Limited published data...

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10 OVERDOSAGE

10.1 Signs and Symptoms, Methemoglobinemia

Nitrate overdosage may result in: severe hypotension, persistent throbbing headache, vertigo, palpitation,...

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11 DESCRIPTION

NITROSTAT is a stabilized sublingual compressed nitroglycerin tablet that contains 0.3 mg, 0.4 mg , or 0.6 mg nitroglycerin; as well as lactose monohydrate, NF; glyceryl monostearate, NF; pregelatinized starch...

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12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Nitroglycerin forms free radical nitric oxide (NO) which activates guanylate cyclase, resulting in an increase of...

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13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Animal carcinogenesis studies with sublingually administered nitroglycerin have...

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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...

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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....

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