Drug Catalog - Product Detail
NISOLDIPINE ER OF TB 20MG 100
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 00378-2222-01 | MYLAN | 100 | 20MG | TABLET |
PACKAGE FILES
Generic Name
NISOLDIPINE
Substance Name
NISOLDIPINE
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA079051
Description
DESCRIPTION Nisoldipine is an extended-release tablet dosage form of the dihydropyridine calcium channel blocker nisoldipine. Nisoldipine is (±)-Isobutyl methyl 1,4-dihydro-2,6-dimethyl-4-( o -nitrophenyl)-3,5-pyridinedicarboxylate, C 20 H 24 N 2 O 6 , and has the structural formula: Nisoldipine is a yellow crystalline powder, practically insoluble in water but soluble in acetone, ethanol and methanol. It has a molecular weight of 388.4. Nisoldipine extended-release tablets contain 20 mg, 30 mg or 40 mg of nisoldipine for once-a-day oral administration. Inactive ingredients include: colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, polydextrose, polyethylene glycol and titanium dioxide. The 20 mg tablets also contain FD&C Blue No. 2 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake and triacetin. The 30 mg tablets also contain red iron oxide, triacetin and yellow iron oxide. The 40 mg tablets also contain D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake and FD&C Yellow No. 6 Aluminum Lake. Nisoldipine Structural Formula
How Supplied
HOW SUPPLIED Nisoldipine Extended-Release Tablets are available containing 20 mg, 30 mg or 40 mg of nisoldipine. The 20 mg tablets are beige, film-coated, round, unscored tablets debossed with M on one side of the tablet and N over 22 on the other side. They are available as follows: NDC 0378-2222-01 bottles of 100 tablets The 30 mg tablets are orange, film-coated, round, unscored tablets debossed with M on one side of the tablet and N over 23 on the other side. They are available as follows: NDC 0378-2223-01 bottles of 100 tablets The 40 mg tablets are yellow, film-coated, round, unscored tablets debossed with M on one side of the tablet and N over 24 on the other side. They are available as follows: NDC 0378-2224-01 bottles of 100 tablets Store at 20° to 25°C (68° to 77°F). [See USP for Controlled Room Temperature.] Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Revised: 6/2017 NLDP:R3
Indications & Usage
INDICATIONS AND USAGE Nisoldipine extended-release tablets are indicated for the treatment of hypertension. They may be used alone or in combination with other antihypertensive agents.
Dosage and Administration
DOSAGE AND ADMINISTRATION The dosage of nisoldipine extended-release tablets must be adjusted to each patient’s needs. Therapy usually should be initiated with 20 mg orally once daily, then increased by 10 mg per week or longer intervals, to attain adequate control of blood pressure. Usual maintenance dosage is 20 mg to 40 mg once daily. Blood pressure response increases over the 10 mg to 60 mg daily dose range but adverse event rates also increase. Doses beyond 60 mg once daily are not recommended. Nisoldipine extended-release tablets have been used safely with diuretics, ACE inhibitors, and beta-blocking agents. Patients over age 65, or patients with impaired liver function, are expected to develop higher plasma concentrations of nisoldipine. Their blood pressure should be monitored closely during any dosage adjustment. A starting dose not exceeding 10 mg daily is recommended in these patient groups. Nisoldipine extended-release tablets should be administered orally once daily. Nisoldipine extended-release tablets should be taken on an empty stomach (1 hour before or 2 hours after a meal). Grapefruit products should be avoided before and after dosing. Nisoldipine is an extended release dosage form and tablets should be swallowed whole, not bitten, divided or crushed.