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felodipine er 2.5 mg tablet

Out of Stock Manufacturer TORRENT PHARMAC 13668013201
Out of Stock

Uses

Hypertension

Felodipine is used alone or in combination with other classes of antihypertensive agents in the management of hypertension.

Calcium-channel blocking agents (e.g., felodipine) are considered one of several preferred antihypertensive drugs for the initial management of hypertension; other options include angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor antagonists, and thiazide diuretics. While there may be individual differences with respect to specific outcomes, these antihypertensive drug classes all produce comparable effects on overall mortality and cardiovascular, cerebrovascular, and renal outcomes. (See Uses: Hypertension, in Amlodipine 24:28.08.)

Calcium-channel blockers may be particularly useful in the management of hypertension in black patients; these patients tend to have greater blood pressure response to calcium-channel blockers and thiazide diuretics than to other antihypertensive drug classes (e.g., ACE inhibitors, angiotensin II receptor antagonists). Use of a calcium-channel blocker also may be beneficial in patients with certain coexisting conditions such as ischemic heart disease (e.g., angina) and in geriatric patients, including those with isolated systolic hypertension. (See Uses: Hypertension, in Amlodipine 24:28.08.)

In the Antihypertensive and Lipid-lowering Treatment to Prevent Heart Attack Trial (ALLHAT) study, the long-term cardiovascular morbidity and mortality benefit of a long-acting dihydropyridine calcium-channel blocker (amlodipine), a thiazide-like diuretic (chlorthalidone), and an ACE inhibitor (lisinopril) were compared in a broad population of patients with hypertension at risk for coronary heart disease. Although these antihypertensive agents were comparably effective in providing important cardiovascular benefit, apparent differences in certain secondary outcomes were observed. Patients receiving the ACE inhibitor experienced higher risks of stroke, combined cardiovascular disease, GI bleeding, and angioedema, while those receiving the calcium-channel blocker were at higher risk of developing heart failure. The ALLHAT investigators suggested that the favorable cardiovascular outcome may be attributable, at least in part, to the greater antihypertensive effect of the calcium-channel blocker compared with that of the ACE inhibitor, especially in women and black patients.

For additional information on the role of calcium-channel blockers in the management of hypertension, see Uses: Hypertension, in Amlodipine 24:28.08. For further information on overall principles and expert recommendations for treatment of hypertension, see Uses: Hypertension in Adults, in the Thiazides General Statement 40:28.20.

Hypertensive Crises

Because of the slow onset of hypotensive effect with extended-release tablets containing felodipine, these dosage forms are not suitable for use as acute therapy in rapidly reducing blood pressure in patients with severe hypertension in whom reduction of blood pressure is considered urgent (i.e., hypertensive urgencies) nor in hypertensive emergencies.

Dosage and Administration

Administration

Felodipine is administered orally as extended-release tablets. The tablets should be swallowed intact and should not be chewed or crushed. Since peak concentrations of the drug were increased by 60% when felodipine was administered with a high-fat or high-carbohydrate meal and no changes in pharmacokinetics were observed when the drug was administered with a light meal (e.g., orange juice, toast, and cereal), the manufacturer states that felodipine should be taken either without food or with a light meal. However, the bioavailability of felodipine as determined by area under the plasma concentration-time curve (AUC) was not affected when the extended-release tablets containing felodipine were administered with a high-fat or high-carbohydrate meal.

Concomitant administration with doubly concentrated grapefruit juice has been shown to increase oral bioavailability of felodipine twofold compared with concomitant administration with orange juice or water. Concomitant oral administration of 1,4-dihydropyridine-derivative calcium-channel blocking agents (e.g., felodipine) with grapefruit juice usually should be avoided since potentially clinically important increases in hemodynamic effects can result.

In addition, important drug interactions may occur when felodipine is administered concomitantly with some other drugs. Metabolism of felodipine is mediated by the cytochrome P-450 (CYP) isoenzyme 3A4 and the possibility exists that drugs and foods that inhibit this isoenzyme (e.g., ketoconazole, itraconazole, erythromycin, grapefruit juice, cimetidine) may increase plasma felodipine concentrations several-fold, which may result in increased cardiac effects (e.g., decreases in blood pressure and increases in heart rate). Therefore, the manufacturer states that caution should be exercised in the concomitant use of felodipine and these known inhibitors of the CYP enzyme system. The possibility that felodipine may share the drug interaction potential of nifedipine, another 1,4-dihydropyridine derivative, also should be considered and the usual precautions observed.

Dosage

Hypertension

Usual Dosage

For the management of hypertension, the initial adult dosage of felodipine is 2.5-5 mg once daily. Dosage of the drug should be adjusted according to the patient's blood pressure response and tolerance, generally at intervals of not less than 2 weeks. The manufacturer states that the usual maintenance dosage is 2.5-10 mg once daily. While dosages exceeding 10 mg daily were associated with an increased blood pressure response in clinical studies, such dosages were also associated with exaggerated adverse vasodilatory effects (e.g, peripheral edema). However, some experts have recommended a usual dosage range of 2.5-20 mg once daily.

The panel members appointed to the Eighth Joint National Committee on the Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC 8 expert panel) state that evidence-based dosing information (i.e., dosages shown in randomized controlled trials to reduce complications of hypertension) should be used when available to determine target dosages of antihypertensive agents. Target dosages generally can be achieved within 2-4 weeks, but it may take up to several months.

Although safety and efficacy remain to be fully established in children, some experts have recommended pediatric dosages for hypertension based on currently limited clinical experience. If felodipine is used for the management of hypertension in children, a usual initial dosage of 2.5 mg once daily is recommended. Dosage may be increased as necessary to a maximum dosage of 10 mg once daily. For information on overall principles and expert recommendations for treatment of hypertension in pediatric patients, see Uses: Hypertension in Pediatric Patients, in the Thiazides General Statement 40:28.20.

Antihypertensive therapy should be titrated until goal blood pressure is achieved. If an adequate blood pressure response is not achieved with felodipine monotherapy, another antihypertensive agent with demonstrated benefit may be added; if goal blood pressure is still not achieved with the use of 2 antihypertensive agents at optimal dosages, a third drug may be added. In patients who experience intolerable adverse effects with felodipine, dosage reduction should be considered; if adverse effects worsen or fail to resolve, it may be necessary to discontinue the calcium-channel blocker and initiate another class of antihypertensive agent.

Blood Pressure Monitoring and Treatment Goals

Careful monitoring of blood pressure during initial titration or subsequent upward adjustment in dosage of felodipine is recommended.

The goal of hypertension management and prevention is to achieve and maintain optimal control of blood pressure; specific target levels of blood pressure should be individualized based on consideration of multiple factors, including patient age and comorbidities, and the currently available evidence from clinical studies.

For additional information on initiating and adjusting felodipine dosage in the management of hypertension, see Blood Pressure Monitoring and Treatment Goals under Dosage: Hypertension, in Dosage and Administration in the Thiazides General Statement 40:28.20.

Dosage in Hepatic or Renal Impairment and in Geriatric Patients

Dosage of felodipine should be adjusted carefully and blood pressure response should be closely monitored with each dosage adjustment in geriatric patients and in patients with impaired hepatic function; the usual initial dosage is 2.5 mg daily in such patients. In clinical trials, the risk of peripheral edema was increased substantially in geriatric patients receiving dosages exceeding 10 mg daily. Adjustment of felodipine dosage generally is not necessary in patients with renal impairment.

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