Drug Catalog - Product Detail
FELODIPINE ER TB 5MG 100
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 53489-0369-01 | SUN PHARMACEUTICALS | 100 | 5MG | TABLET |
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Description
DESCRIPTION Felodipine is a calcium antagonist (calcium channel blocker). Felodipine is a dihydropyridine derivative that is chemically described as ± ethyl methyl 4-(2,3-dichlorophenyl)-1,4-dihydro-2,6-dimethyl-3,5-pyridinedicarboxylate. Its molecular formula is C 18 H 19 Cl 2 NO 4 and its structural formula is: Felodipine is a slightly yellowish, crystalline powder with a molecular weight of 384.26. It is insoluble in water and is freely soluble in dichloromethane and ethanol. Felodipine is a racemic mixture. Felodipine tablets provide extended release of felodipine. They are available as tablets containing 2.5 mg, 5 mg, or 10 mg of felodipine for oral administration. In addition to the active ingredient felodipine, the tablets contain the following inactive ingredients: felodipine tablets 2.5 mg — carnauba wax, D&C Yellow #10 Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, hydroxypropyl cellulose, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, silicon dioxide, and titanium dioxide. Felodipine tablets 5 mg — carnauba wax, D&C Yellow No. 10 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, hypromellose, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, silicon dioxide, and titanium dioxide. Felodipine tablets 10 mg — carnauba wax, D&C Yellow #10 Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, hydroxypropyl cellulose, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, silicon dioxide, and titanium dioxide. The USP drug release test # is pending. Chemical Structure
How Supplied
HOW SUPPLIED Felodipine extended-release tablets are supplied as follows: Felodipine extended-release tablets, 2.5 mg, are round, light green, film-coated, unscored, debossed MP 771 Bottles of 30 NDC 53489-368-07 Bottles of 90 NDC 53489-368-90 Bottles of 100 NDC 53489-368-01 Bottles of 250 NDC 53489-368-03 Bottles of 500 NDC 53489-368-05 Bottles of 1000 NDC 53489-368-10 Felodipine extended-release tablets, 5 mg, are round, light orange, film-coated, unscored, debossed MP 772 Bottles of 30 NDC 53489-369-07 Bottles of 90 NDC 53489-369-90 Bottles of 100 NDC 53489-369-01 Bottles of 250 NDC 53489-369-03 Bottles of 500 NDC 53489-369-05 Bottles of 1000 NDC 53489-369-10 Felodipine extended-release tablets, 10 mg, are round, brown, film-coated, unscored, debossed MP 773 Bottles of 30 NDC 53489-370-07 Bottles of 90 NDC 53489-370-90 Bottles of 100 NDC 53489-370-01 Bottles of 250 NDC 53489-370-03 Bottles of 500 NDC 53489-370-05 Bottles of 1000 NDC 53489-370-10 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature] PROTECT FROM LIGHT. DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.
Indications & Usage
INDICATIONS AND USAGE Felodipine is indicated for the treatment of hypertension. Felodipine may be used alone or concomitantly with other antihypertensive agents.
Dosage and Administration
DOSAGE AND ADMINISTRATION The recommended starting dose is 5 mg once a day. Depending on the patient's response, the dosage can be decreased to 2.5 mg or increased to 10 mg once a day. These adjustments should occur generally at intervals of not less than 2 weeks. The recommended dosage range is 2.5–10 mg once daily. In clinical trials, doses above 10 mg daily showed an increased blood pressure response but a large increase in the rate of peripheral edema and other vasodilatory adverse events (see ADVERSE REACTIONS ). Modification of the recommended dosage is usually not required in patients with renal impairment. Felodipine should regularly be taken either without food or with a light meal (see CLINICAL PHARMACOLOGY, Pharmacokinetics and Metabolism ). Felodipine should be swallowed whole and not crushed or chewed. Geriatric Use Patients over 65 years of age are likely to develop higher plasma concentrations of felodipine (see CLINICAL PHARMACOLOGY ). In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range (2.5 mg daily). Elderly patients should have their blood pressure closely monitored during any dosage adjustment. Patients with Impaired Liver Function Patients with impaired liver function may have elevated plasma concentrations of felodipine and may respond to lower doses of felodipine extended-release tablets; therefore, patients should have their blood pressure monitored closely during dosage adjustment of felodipine extended-release tablets (see CLINICAL PHARMACOLOGY ).