Clinical Information
Gen. Code and Des.
21743 felodipine ORAL TAB ER 24H 2.5 MG
GCN and Des.
2620 felodipine ORAL TAB ER 24H 2.5 MG
Strength
2.5MG ER
Dose Form
TABLET, EXTENDED RELEASE 24 HR
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family
AHFS Class
24280800 DIHYDROPYRIDINES
24081208 DIHYDROPYRIDINES (ANTIHYPERTENSIVE)
24280000 CALCIUM-CHANNEL BLOCKING AGENTS
24129200 VASODILATING AGENTS, MISCELLANEOUS
24089200 HYPOTENSIVE AGENTS, MISCELLANEOUS
Active Ingredients
3602 felodipine 72509763
Inactive Ingredients
2432 lactose 64044515
FELODIPINE- felodipine tablet, film coated, extended release
PD-Rx Pharmaceuticals, Inc.
Rx only
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
Felodipine is a light yellow to yellow 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 extended-release tablets provide extended release of felodipine. They are available as tablets containing 2.5 mg, 5 mg or 10 mg of felodipine, USP for oral administration. In addition to the active ingredient felodipine, the tablets contain the following inactive ingredients: felodipine extended-release 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 extended-release 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 extended-release 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.
CLINICAL PHARMACOLOGY
Mechanism of Action
Felodipine is a member of the dihydropyridine class of calcium channel antagonists (calcium channel blockers). It reversibly competes with nitrendipine and/or other calcium channel blockers for dihydropyridine binding site.
INDICATIONS AND USAGE
Felodipine extended-release tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including felodipine.
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.
