Drug Catalog - Product Detail
NIFEDIPINE ER TB 60MG 300
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 62175-0261-55 | KREMERS URBAN | 300 | 60MG | TABLET |
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Description
DESCRIPTION Nifedipine is a drug belonging to a class of pharmacological agents known as the calcium channel blockers. Nifedipine is 3, 5-pyridinedicarboxylic acid, 1, 4-dihydro-2, 6-dimethyl-4-(2-nitrophenyl)-, dimethyl ester, C 17 H 18 N 2 O 6, and has the structural formula: Nifedipine is a yellow crystalline substance, practically insoluble in water but soluble in ethanol. It has a molecular weight of 346.33. Nifedipine Extended-release Tablet is formulated as a once-a-day extended-release tablet for oral administration designed to deliver 30, 60, or 90 mg of nifedipine. Inert ingredients in the formulations are: black iron oxide; cellulose acetate; colloidal silicon dioxide; hypromellose; lactose monohydrate; magnesium stearate; microcrystalline cellulose; polyethylene glycol; polyethylene oxide; polysorbate; povidone; propylene glycol; red ferric oxide; sodium chloride; titanium dioxide; triacetin. Nifedipine Extended-release Tablet is similar in appearance to a conventional tablet. It consists, however, of a semipermeable membrane surrounding an osmotically active drug core. As water from the gastrointestinal tract enters the tablet, pressure increases in the core of the tablet, releasing drug through the precision laser-drilled tablet orifice in the one side of the tablet. Nifedipine Extended-release Tablet is designed to provide nifedipine at an approximately constant rate over 24 hours. This controlled rate of drug delivery into the gastrointestinal lumen is independent of pH or gastrointestinal motility. Nifedipine Extended-release Tablet depends for its action on the existence of an osmotic gradient between the contents of the tablet core and fluid in the GI tract. Drug delivery is essentially constant as long as the osmotic gradient remains constant, and then gradually falls to zero. Upon swallowing, the biologically inert components of the tablet remain intact during GI transit and are eliminated in the feces as an insoluble shell. USP Drug Release Test 5. MM1
How Supplied
HOW SUPPLIED Nifedipine Extended-release Tablets 30 mg are round, biconvex, pink coated tablets imprinted with "KU 260" in black ink. They are supplied as follows: Bottles of 90 Tablets NDC 62175-260-46 Bottles of 100 Tablets NDC 62175-260-37 Bottles of 300 Tablets NDC 62175-260-55 Bottles of 1000 Tablets NDC 62175-260-43 Nifedipine Extended-release Tablets 60 mg are round, biconvex, pink coated tablets imprinted with "KU 261" in black ink. They are supplied as follows: Bottles of 90 Tablets NDC 62175-261-46 Bottles of 100 Tablets NDC 62175-261-37 Bottles of 300 Tablets NDC 62175-261-55 Bottles of 1000 Tablets NDC 62175-261-43 Nifedipine Extended-release Tablets 90 mg are round, biconvex, pink coated tablets imprinted with "KU 262 in black ink. They are supplied as follows: Bottles of 30 Tablets NDC 62175-262-32 Bottles of 90 Tablets NDC 62175-262-46 Bottles of 100 Tablets NDC 62175-262-37 Bottles of 300 Tablets NDC 62175-262-55 Bottles of 500 Tablets NDC 62175-262-41 Store at 20°-25°C (68°-77°F) (See USP Controlled Room Temperature). Protect from moisture, humidity, and light. For Medical Information Contact: Medical Affairs Department Phone: (800) 477-7877 Distributed by: Kremers, Urban Pharmaceuticals, Inc. Princeton, NJ 08540, USA for: Wilmington, NC 28405, USA L4759N Rev.6E 10/2011 MM2
Indications & Usage
INDICATIONS & USAGE Nifedipine Extended-release Tablet is indicated for the management of vasospastic angina confirmed by any of the following criteria: 1) classical pattern of angina at rest accompanied by ST segment elevation, 2) angina or coronary artery spasm provoked by ergonovine, or 3) angiographically demonstrated coronary artery spasm. In those patients who have had angiography, the presence of significant fixed obstructive disease is not incompatible with the diagnosis of vasospastic angina, provided that the above criteria are satisfied. Nifedipine Extended-release Tablet may also be used where the clinical presentation suggests a possible vasospastic component but where vasospasm has not been confirmed, e.g., where pain has a variable threshold on exertion or in unstable angina where electrocardiographic findings are compatible with intermittent vasospasm, or when angina is refractory to nitrates and/or adequate doses of beta-blockers. Nifedipine Extended-release Tablet is indicated for the management of chronic stable angina (effort-associated angina) without evidence of vasospasm in patients who remain symptomatic despite adequate doses of beta-blockers and/or organic nitrates or who cannot tolerate those agents. In chronic stable angina (effort-associated angina) nifedipine has been effective in controlled trials of up to eight weeks duration in reducing angina frequency and increasing exercise tolerance, but confirmation of sustained effectiveness and evaluation of long-term safety in these patients is incomplete. Controlled studies in small numbers of patients suggest concomitant use of nifedipine and beta-blocking agents may be beneficial in patients with chronic stable angina, but available information is not sufficient to predict with confidence the effects of concurrent treatment, especially in patients with compromised left ventricular function or cardiac conduction abnormalities. When introducing such concomitant therapy, care must be taken to monitor blood pressure closely since severe hypotension can occur from the combined effects of the drugs. (See WARNINGS .) Nifedipine Extended-release Tablet is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents.
Dosage and Administration
DOSAGE & ADMINISTRATION Dosage must be adjusted according to each patient's needs. Therapy for either hypertension or angina should be initiated with 30 or 60 mg once daily. Nifedipine Extended-release Tablets should be swallowed whole and should not be bitten or divided. In general, titration should proceed over a 7-14 day period so that the physician can fully assess the response to each dose level and monitor blood pressure before proceeding to higher doses. Since steady-state plasma levels are achieved on the second day of dosing, titration may proceed more rapidly, if symptoms so warrant, provided the patient is assessed frequently. Titration to doses above 120 mg are not recommended. Angina patients controlled on nifedipine capsules alone or in combination with other antianginal medications may be safely switched to Nifedipine Extended-release Tablets at the nearest equivalent total daily dose (e.g., 30 mg t.i.d. of nifedipine capsules may be changed to 90 mg once daily of Nifedipine Extended-release Tablets). Subsequent titration to higher or lower doses may be necessary and should be initiated as clinically warranted. Experience with doses greater than 90 mg in patients with angina is limited. Therefore, doses greater than 90 mg should be used with caution and only when clinically warranted. No "rebound effect" has been observed upon discontinuation of Nifedipine Extended-release Tablets. However, if discontinuation of nifedipine is necessary, sound clinical practice suggests that the dosage should be decreased gradually with close physician supervision. Care should be taken when dispensing Nifedipine Extended-release Tablets to assure that the extended release dosage form has been prescribed. Sublingual nitroglycerin may be taken as required for the control of acute manifestations of angina, particularly during nifedipine titration. See PRECAUTIONS, Drug Interactions , for information on coadministration of nifedipine with beta-blockers or long-acting nitrates.