Drug Catalog - Product Detail
NITROGLYCERIN SL TAB 0.6 MG 100 CT
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 68462-0640-01 | GLENMARK PHARMACEUTICALS | 100 | 0.6MG | TABLET |
PACKAGE FILES
Generic Name
NITROGLYCERIN
Substance Name
NITROGLYCERIN
Product Type
HUMAN PRESCRIPTION DRUG
Route
SUBLINGUAL
Application Number
ANDA206391
Description
11 DESCRIPTION Nitroglycerin Sublingual Tablets, USP are stabilized sublingual compressed nitroglycerin tablet that contains 0.3 mg, 0.4 mg, or 0.6 mg nitroglycerin; as well as calcium stearate, croscarmellose sodium, silica dimethyl silylate and lactose monohydrate. Nitroglycerin, an organic nitrate, is a vasodilating agent. The chemical name for nitroglycerin is 1, 2, 3 propanetriol trinitrate and the chemical structure is: Molecular weight: 227.09 Z:\Regulatory Affairs\_Compliance\Drug Listings\Electronic\Gateway Submissions\Nitroglycerin SL Tablets\Version 7\structure.jpg
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Nitroglycerin Sublingual Tablets, USP are supplied as white to off white, round, flat-faced tablets in 3 strengths (0.3 mg, 0.4 mg, and 0.6 mg) in bottles containing 100 tablets each. The 0.4 mg strength is also supplied in Patient Convenience Packages of 4 bottles of 25 tablets each. 0.3 mg: Debossed with “1” on one side and “C” on the other NDC 68462-638-01—Bottle of 100 tablets 0.4 mg: Debossed with “2” on one side and “C” on the other NDC 68462-639-45—Convenience Package NDC 68462-639-01—Bottle of 100 tablets 0.6 mg: Debossed with “3” on one side and “C” on the other NDC 68462-640-01—Bottle of 100 tablets Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Nitroglycerin should be kept in the original glass container and must be tightly capped after each use to prevent loss of tablet potency.
Indications & Usage
1 INDICATIONS AND USAGE Nitroglycerin sublingual tablets are indicated for the acute relief of an attack or acute prophylaxis of angina pectoris due to coronary artery disease. Nitroglycerin sublingual tablets are nitrate vasodilator indicated for relief of an attack or prophylaxis of angina pectoris due to coronary artery disease. ( 1 )
Dosage and Administration
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 every 5 minutes until relief is obtained. No more than three tablets are recommended within a 15-minute period. If the pain persists after a total of 3 tablets in a 15-minute period, or if the pain is different than is typically experienced, seek prompt medical attention. Nitroglycerin sublingual tablets may be used prophylactically 5 to 10 minutes prior to engaging in activities that might precipitate an acute attack. For patients with xerostomia, a small sip of water prior to placing the tablet under the tongue may help maintain mucosal hydration and aid dissolution of the tablet. Administer nitroglycerin sublingual tablets at rest, preferably in the sitting position. At the onset of an attack, administer one tablet under the tongue or buccal pouch. One additional tablet may be administered every 5 minutes as needed. No more than 3 total tablets are recommended within a 15 minute period. ( 2 ) If chest pain persists after three tablets, seek prompt medical attention. ( 2 ) May be used prophylactically 5 to 10 minutes prior to engaging in activities that might precipitate an acute attack. ( 2 )