Sular 17 mg/1
nisoldipine · TABLET, FILM COATED, EXTENDED RELEASE · Covis Pharma US, Inc
Sular is a tablet, film coated, extended release containing nisoldipine at 17 mg/1, taken oral. Manufactured by Covis Pharma US, Inc.
Key Facts
- Brand Name
- Sular
- Generic Name
- nisoldipine
- NDC Code (Product)
70515-501- Manufacturer
- Covis Pharma US, Inc
- Strength
- 17 mg/1
- Dosage Form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Marketing Status
- Application #
- NDA020356
- Drug Class
- Dihydropyridine Calcium Channel Blocker [EPC]
- Marketing Start
- 02/03/2017
Recall History
Shionogi Inc.
Failed Dissolution Specifications
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE SULAR is indicated for the treatment of hypertension. It may be used alone or in combination with other anti-hypertensive agents.
Dosage & Administration
DOSAGE AND ADMINISTRATION The dosage of SULAR must be adjusted to each patient's needs. Therapy usually should be initiated with 17 mg orally once daily, then increased by 8.5 mg per week or longer intervals, to attain adequate control of blood pressure. Usual maintenance dosage is 17 to 34 mg once daily. Blood pressure response increases over the 8.5 - 34 mg daily dose range but adverse event rates also increase. Doses beyond 34 mg once daily are not recommended. SULAR has 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 8.5 mg daily is recommended in these patient groups. SULAR tablets should be administered orally once daily. SULAR 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. SULAR is an extended release dosage form and tablets should be swallowed whole, not bitten, divided or crushed.
Warnings
WARNINGS Increased angina and/or myocardial infarction in patients with coronary artery disease: Rarely, patients, particularly those with severe obstructive coronary artery disease, have developed increased frequency, duration and/or severity of angina, or acute myocardial infarction on starting calcium channel blocker therapy or at the time of dosage increase. The mechanism of this effect has not been established. In controlled studies of SULAR in patients with angina this was seen about 1.5% of the time in patients given nisoldipine, compared with 0.9% in patients given placebo.
Contraindications
CONTRAINDICATIONS SULAR is contraindicated in patients with known hypersensitivity to dihydropyridine calcium channel blockers.
Drug Interactions
Drug Interactions A 30 to 45% increase in AUC and C max of nisoldipine was observed with concomitant administration of cimetidine 400 mg twice daily. Ranitidine 150 mg twice daily did not interact significantly with nisoldipine (AUC was decreased by 15 - 20%). No pharmacodynamic effects of either histamine H 2 receptor antagonist were observed. CYP3A4 inhibitors and inducers : SULAR is substrate of CYP3A4 and coadministration of SULAR with any known inducer or inhibitor of CYP3A4 should be avoided in general. Coadministration of phenytoin with a dose bioequivalent to 34 mg SULAR tablets in epileptic patients lowered the nisoldipine plasma concentrations to undetectable levels. Coadministration of SULAR with phenytoin should be avoided and alternative antihypertensive therapy should be considered. Pharmacokinetic interactions between nisoldipine and beta-blockers (atenolol, propranolol) were variable and not significant. Propranolol attenuated the heart rate increase following administration of immediate release nisoldipine. The blood pressure effect of SULAR tended to be greater in patients on atenolol than in patients on no other antihypertensive therapy. Quinidine at 648 mg bid d…
Adverse Reactions
ADVERSE EXPERIENCES More than 6000 patients world-wide have received nisoldipine in clinical trials for the treatment of hypertension, either as the immediate release or the SULAR extended release formulation. Of about 1,500 patients who received SULAR in hypertension studies, about 55% were exposed for at least 2 months and about one third were exposed for over 6 months, the great majority at doses equivalent to 17 mg and above. SULAR is generally well-tolerated. In the U.S. clinical trials of SULAR in hypertension, 10.9% of the 921 SULAR patients discontinued treatment due to adverse events compared with 2.9% of 280 placebo patients. The frequency of discontinuations due to adverse experiences was related to dose, with a 5.4% and 10.9% discontinuation rate at the lowest and highest daily dose, respectively. The most frequently occurring adverse experiences with SULAR are those related to its vasodilator properties; these are generally mild and only occasionally lead to patient withdrawal from treatment. The table below, from U.S. placebo-controlled parallel dose response trials of SULAR using doses across the clinical dosage range in patients with hypertension, lists all of the a…
Frequently Asked Questions
What is Sular used for?
Sular contains nisoldipine. It is a tablet, film coated, extended release taken oral. Consult your doctor for specific uses.
Is Sular a controlled substance?
Sular is not classified as a controlled substance by the DEA.
What is the generic name for Sular?
The generic name for Sular is nisoldipine. There are 3 other brand versions of nisoldipine.
What is the NDC code for Sular 17 mg/1?
The NDC (National Drug Code) for Sular 17 mg/1 is 70515-501, listed by Covis Pharma US, Inc.