Total Cost
Free shipping on all orders

Powered by GeniusRx

nisoldipine er 34 mg tablet generic sular

In stock Manufacturer PRASCO LABS 66993047502
$11.55 / Tablet

Select Quantity

Prescription is required

Uses

Hypertension

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

Calcium-channel blocking agents (e.g., nisoldipine) 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.

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.

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.

Interim analysis (mean follow-up: 5 years) of a prospective, randomized, double-blind study (the Appropriate Blood Pressure Control in Diabetes; [ABCD trial]) in hypertensive patients with type 2 (noninsulin-dependent) diabetes mellitus (NIDDM) indicated that use of nisoldipine was associated with a fivefold higher risk of fatal and nonfatal myocardial infarction than enalapril. However, these findings of increased cardiovascular risk should be interpreted with caution, since they were based on analysis of secondary clinical end-points. The ABCD study originally was designed to compare the effects of moderate control of blood pressure (target diastolic pressure of 80-89 mm Hg) with those of intensive control of blood pressure (target diastolic pressure of 75 mm Hg) on the incidence and progression of complications of diabetes (i.e., renal function measured by the 24-hour creatinine clearance). Based on these findings, however, the trial's Data Safety and Monitoring Board recommended that the nisoldipine treatment arm be terminated prematurely (67 months after initiation of the study) and that such patients be switched to enalapril therapy. It is not known whether the higher incidence of myocardial infarction associated with the use of nisoldipine in this study resulted from a deleterious effect of the drug, a beneficial effect of enalapril, or a combination of these effects. It also should be considered that many patients receiving enalapril also were receiving β-blockers, drugs known to have a beneficial effect on myocardial infarction. In addition, findings from the robust ALLHAT study revealed no difference in the primary outcome of combined fatal coronary heart disease or nonfatal myocardial infarction among thiazide diuretics (chlorthalidone), calcium-channel blockers (amlodipine), and ACE inhibitors (lisinopril). (.)

For further information on overall principles and expert recommendations for treatment of hypertension, see For information on overall principles and expert recommendations for treatment of hypertension in pediatric patients, .

Hypertensive Crises

Because of the slow onset of hypotensive effect with extended-release nisoldipine tablets, this dosage form is not suitable for use as acute therapy in rapidly reducing blood pressure in patients with hypertensive crises, including those with severe hypertension in whom reduction of blood pressure is considered urgent (I.e., hypertensive urgencies) or an emergency (hypertensive emergencies).

Dosage and Administration

Administration

Nisoldipine is administered orally. The extended-release tablets should be swallowed intact; they should not be chewed, broken, or crushed.

Nisoldipine extended-release tablets should be administered on an empty stomach (1 hour before or 2 hours after a meal); because high-fat food increases the peak concentration of nisoldipine, concomitant administration of the drug with such food should be avoided. In addition, because grapefruit juice increases peak concentrations and oral bioavailability of the drug, patients should be instructed to avoid grapefruit-containing foods and beverages for at least 1 hour before and after administration of a dose of nisoldipine. The manufacturer also states that concomitant use of nisoldipine and any known inducer (e.g., phenytoin) or inhibitor of the cytochrome P-450 (CYP) 3A4 isoenzyme should be avoided and alternative antihypertensive therapy should be considered for patients receiving such agents. Concomitant use of nisoldipine and phenytoin reportedly has resulted in a reduction of plasma nisoldipine concentrations to undetectable levels. The possibility that nisoldipine may share the drug interaction potential of nifedipine, another 1,4-dihydropyridine derivative, also should be considered and the usual precautions observed.

Patients should be advised that some commercially available preparations may contain the dye tartrazine (FD&C yellow No. 5), which may cause allergic reactions including bronchial asthma in susceptible individuals. Although the incidence of tartrazine sensitivity is low, it frequently occurs in individuals who are sensitive to aspirin.

The manufacturer states that safety and efficacy of nisoldipine in children have not been established.

Dosage

Although the hypotensive effect of nisoldipine usually is modest and well tolerated, excessive and poorly tolerated hypotension occasionally occurs. Because such exaggerated responses usually have been observed during initial titration or subsequent upward adjustment in dosage of the drug, careful monitoring of blood pressure during these periods is recommended. Close observation is particularly important in patients already receiving drugs known to lower blood pressure.

The reformulated extended-release tablets of nisoldipine containing 8.5 or 34 mg of the drug are bioequivalent to the original extended-release formulation (no longer commercially available) containing 10 or 40 mg, respectively, of the drug.

Hypertension

Usual Dosage

For the management of hypertension in adults, the manufacturer states that the usual initial dosage of nisoldipine extended-release tablets is 17 mg once daily. In geriatric patients older than 65 years of age, the initial dosage should not exceed 8.5 mg daily, and blood pressure response should be monitored closely with each dosage adjustment. If blood pressure response is inadequate with the initial dosage, nisoldipine dosage may be increased in increments of 8.5 mg daily at weekly or less frequent intervals up to a maximum of 34 mg once daily. The manufacturer states that the usual maintenance dosage of the drug is 17-34 mg once daily. Experts have recommended a usual dosage range of 10-40 mg once daily as the original extended-release formulation (equivalent to 8.5-34 mg once daily as the reformulated extended-release tablets).

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.

Antihypertensive therapy should be titrated until goal blood pressure is achieved. If an adequate blood pressure response is not achieved with nisoldipine 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 nisoldipine, 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 nisoldipine 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 nisoldipine dosage in the management of hypertension, .

Dosage in Renal and Hepatic Impairment

Because patients with hepatic impairment may have substantially reduced nisoldipine clearance, the manufacturer recommends that the initial dosage not exceed 8.5 mg daily in such adult patients, and blood pressure response should be monitored closely with each dosage adjustment. Patients with cirrhosis generally require and tolerate lower than usual initial and maintenance dosages of the drug. Nisoldipine should be administered cautiously in patients with severe hepatic dysfunction.

Since pharmacokinetics and bioavailability of nisoldipine are not altered substantially in patients with mild-to-moderate renal impairment, the manufacturer states that modification of nisoldipine dosage is not necessary in such patients.

Write Your Own Review

Your meds on autopilot. Forever.