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Sular
Overview
What is Sular?
SULAR (nisoldipine) is an extended release tablet dosage form of the dihydropyridine calcium channel blocker nisoldipine. Nisoldipine is 3,5-pyridinedicarboxylic acid, 1,4-dihydro-2,6-dimethyl-4-(2-nitrophenyl)-, methyl 2-methylpropyl ester, CHNO, and has the structural formula:
Nisoldipine is a yellow crystalline substance, practically insoluble in water but soluble in ethanol. It has a molecular weight of 388.4. SULAR tablets comprise three layers: a top barrier layer, a middle layer containing nisoldipine, and a bottom barrier layer. The erodible barrier layers and the hydrogel middle layer provide for the controlled release of the drug. SULAR tablets contain either 8.5, 17, or 34 mg of nisoldipine for once-a-day oral administration.
Inactive ingredients in the formulation include: Hypromellose, hypromellose phthalate, lactose, glyceryl behenate, povidone, magnesium stearate, silicon dioxide, methacrylic acid copolymer, and sodium lauryl sulfate. Inactive ingredients in the film coating include: polydextrose, titanium dioxide, hypromellose, polyethylene glycol, iron oxide, and carnauba wax. Additionally, the 17 mg formulation contains FD&C Yellow #5.
What does Sular look like?
What are the available doses of Sular?
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What should I talk to my health care provider before I take Sular?
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How should I use Sular?
SULAR is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents.
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.
What interacts with Sular?
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What are the warnings of Sular?
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What are the precautions of Sular?
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What are the side effects of Sular?
Sorry No records found
What should I look out for while using Sular?
SULAR is contraindicated in patients with known hypersensitivity to dihydropyridine calcium channel blockers.
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.
What might happen if I take too much Sular?
There is no experience with nisoldipine overdosage. Generally, overdosage with other dihydropyridines leading to pronounced hypotension calls for active cardiovascular support including monitoring of cardiovascular and respiratory function, elevation of extremities, judicious use of calcium infusion, pressor agents and fluids. Clearance of nisoldipine would be expected to be slowed in patients with impaired liver function. Since nisoldipine is highly protein bound, dialysis is not likely to be of any benefit; however, plasmapheresis may be beneficial.
How should I store and handle Sular?
Storage temperature should not exceed 30°C (86°F). Keep out of reach of children.Storage temperature should not exceed 30°C (86°F). Keep out of reach of children.SULAR extended release tablets are supplied as 8.5 mg and 17 mg round film coated tablets and 34 mg elliptic film coated tablets. The different strengths can be identified as follows:SULAR Tablets are supplied in bottles of 100:Protect from light and moisture. Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]. Dispense in tight, light-resistant containers. Rx onlySular is a trademark of Covis Pharma ©2017 Covis Pharma. Manufactured for: Covis PharmaZug, 6300 SwitzerlandMade in GermanyRev 07/17SULAR extended release tablets are supplied as 8.5 mg and 17 mg round film coated tablets and 34 mg elliptic film coated tablets. The different strengths can be identified as follows:SULAR Tablets are supplied in bottles of 100:Protect from light and moisture. Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]. Dispense in tight, light-resistant containers. Rx onlySular is a trademark of Covis Pharma ©2017 Covis Pharma. Manufactured for: Covis PharmaZug, 6300 SwitzerlandMade in GermanyRev 07/17SULAR extended release tablets are supplied as 8.5 mg and 17 mg round film coated tablets and 34 mg elliptic film coated tablets. The different strengths can be identified as follows:SULAR Tablets are supplied in bottles of 100:Protect from light and moisture. Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]. Dispense in tight, light-resistant containers. Rx onlySular is a trademark of Covis Pharma ©2017 Covis Pharma. Manufactured for: Covis PharmaZug, 6300 SwitzerlandMade in GermanyRev 07/17SULAR extended release tablets are supplied as 8.5 mg and 17 mg round film coated tablets and 34 mg elliptic film coated tablets. The different strengths can be identified as follows:SULAR Tablets are supplied in bottles of 100:Protect from light and moisture. Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]. Dispense in tight, light-resistant containers. Rx onlySular is a trademark of Covis Pharma ©2017 Covis Pharma. Manufactured for: Covis PharmaZug, 6300 SwitzerlandMade in GermanyRev 07/17SULAR extended release tablets are supplied as 8.5 mg and 17 mg round film coated tablets and 34 mg elliptic film coated tablets. The different strengths can be identified as follows:SULAR Tablets are supplied in bottles of 100:Protect from light and moisture. Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]. Dispense in tight, light-resistant containers. Rx onlySular is a trademark of Covis Pharma ©2017 Covis Pharma. Manufactured for: Covis PharmaZug, 6300 SwitzerlandMade in GermanyRev 07/17SULAR extended release tablets are supplied as 8.5 mg and 17 mg round film coated tablets and 34 mg elliptic film coated tablets. The different strengths can be identified as follows:SULAR Tablets are supplied in bottles of 100:Protect from light and moisture. Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]. Dispense in tight, light-resistant containers. Rx onlySular is a trademark of Covis Pharma ©2017 Covis Pharma. Manufactured for: Covis PharmaZug, 6300 SwitzerlandMade in GermanyRev 07/17SULAR extended release tablets are supplied as 8.5 mg and 17 mg round film coated tablets and 34 mg elliptic film coated tablets. The different strengths can be identified as follows:SULAR Tablets are supplied in bottles of 100:Protect from light and moisture. Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]. Dispense in tight, light-resistant containers. Rx onlySular is a trademark of Covis Pharma ©2017 Covis Pharma. Manufactured for: Covis PharmaZug, 6300 SwitzerlandMade in GermanyRev 07/17SULAR extended release tablets are supplied as 8.5 mg and 17 mg round film coated tablets and 34 mg elliptic film coated tablets. The different strengths can be identified as follows:SULAR Tablets are supplied in bottles of 100:Protect from light and moisture. Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]. Dispense in tight, light-resistant containers. Rx onlySular is a trademark of Covis Pharma ©2017 Covis Pharma. Manufactured for: Covis PharmaZug, 6300 SwitzerlandMade in GermanyRev 07/17
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Nisoldipine is a member of the dihydropyridine class of calcium channel antagonists (calcium ion antagonists or slow channel blockers) that inhibit the transmembrane influx of calcium into vascular smooth muscle and cardiac muscle. It reversibly competes with other dihydropyridines for binding to the calcium channel. Because the contractile process of vascular smooth muscle is dependent upon the movement of extracellular calcium into the muscle through specific ion channels, inhibition of the calcium channel results in dilation of the arterioles. studies show that the effects of nisoldipine on contractile processes are selective, with greater potency on vascular smooth muscle than on cardiac muscle. Although, like other dihydropyridine calcium channel blockers, nisoldipine has negative inotropic effects , studies conducted in intact anesthetized animals have shown that the vasodilating effect occurs at doses lower than those that affect cardiac contractility.
The effect of nisoldipine on blood pressure is principally a consequence of a dose-related decrease of peripheral vascular resistance. While nisoldipine, like other dihydropyridines, exhibits a mild diuretic effect, most of the antihypertensive activity is attributed to its effect on peripheral vascular resistance.
Non-Clinical Toxicology
SULAR is contraindicated in patients with known hypersensitivity to dihydropyridine calcium channel blockers.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.
A 30 to 45% increase in AUC and C 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 receptor antagonist were observed.
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 decreased the bioavailability (AUC) of nisoldipine by 26%, but not the peak concentration. Immediate release nisoldipine increased plasma quinidine concentrations by about 20%. This interaction was not accompanied by ECG changes and its clinical significance is not known. No significant interactions were found between nisoldipine and warfarin or digoxin.
Hypotension
Because nisoldipine, like other vasodilators, decreases peripheral vascular resistance, careful monitoring of blood pressure during the initial administration and titration of SULAR is recommended. Close observation is especially important for patients already taking medications that are known to lower blood pressure. Although in most patients the hypotensive effect of SULAR is modest and well tolerated, occasional patients have had excessive and poorly tolerated hypotension. These responses have usually occurred during initial titration or at the time of subsequent upward dosage adjustment.
Congestive Heart Failure
Although acute hemodynamic studies of nisoldipine in patients with NYHA Class II-IV heart failure have not demonstrated negative inotropic effects, safety of SULAR in patients with heart failure has not been established. Caution therefore should be exercised when using SULAR in patients with heart failure or compromised ventricular function, particularly in combination with a beta-blocker.
Patients with Hepatic Impairment
Because nisoldipine is extensively metabolized by the liver and, in patients with cirrhosis, it reaches blood concentrations about 5 times those in normals, SULAR should be administered cautiously in patients with severe hepatic dysfunction .
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 adverse events, regardless of the causal relationship to SULAR, for which the overall incidence on SULAR was both >1% and greater with SULAR than with placebo.
The common adverse events occurred at about the same rate in men as in women, and at a similar rate in patients over age 65 as in those under that age, except that headache was much less common in older patients. Except for peripheral edema and vasodilation, which were more common in whites, adverse event rates were similar in blacks and whites.
The following adverse events occurred in ≤1% of all patients treated for hypertension in U.S. and foreign clinical trials, or with unspecified incidence in other studies. Although a causal relationship of SULAR to these events cannot be established, they are listed to alert the physician to a possible relationship with SULAR treatment.
Body As A Whole
Cardiovascular
Digestive
Endocrine
Hemic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Nervous
Respiratory
Skin and Appendages
Special Senses
Urogenital
The following postmarketing event has been reported very rarely in patients receiving SULAR: systemic hypersensitivity reaction which may include one or more of the following; angioedema, shortness of breath, tachycardia, chest tightness, hypotension, and rash. A definite causal relationship with SULAR has not been established. An unusual event observed with immediate release nisoldipine but not observed with SULAR was one case of photosensitivity. Gynecomastia has been associated with the use of calcium channel blockers.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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