Dosing & Uses
Dosage Forms & Strengths
tablet, extended-release (generic)
tablet, extended-release (Sular, new hydrogel ER formulation)
Hydrogel ER tablets (Sular's new formulation): 17 mg PO qDay initially; may increase slowly by at least 1-week intervals; not to exceed 34 mg PO qDay
Coat-core ER tablets (generic; old Sular formulation): 20 mg PO qDay initially; may increase slowly by at least 1-week intervals; not to exceed 60 mg/day
Hydrogel ER tablets (Sular's new formulation): Initial dose should not exceed 8.5 mg PO qDay; may increase slowly by at least 1-week intervals; not to exceed 34 mg PO qDay
Coat-core ER tablets (generic; old Sular formulation): Initial dose should not exceed 10 mg PO qDay; may increase slowly by at least 1-week intervals; not to exceed 30 mg PO qDay
Take on empty stomach; 1 hr before or 2 hr after meals
Swallow tablet whole; do not crush, divide, or chew
Safety and efficacy not established
Hydrogel ER tablets (Sular's new formulation): 8.5 mg PO qDay initially; may increase slowly by at least 1-week intervals; not to exceed 34 mg PO qDay
Coat-core ER tablets (generic; old Sular formulation): 10 mg PO qDay initially; may increase slowly by at least 1-week or longer intervals to minimum effective dose
Serious - Use Alternative
Significant - Monitor Closely
Peripheral edema (22%)
Increased severity of angina (1.5%)
Hypersensitivity to nisoldipine or other calcium channel blockers
Use caution in CHF, aortic stenosis, hypotension (initially or after dose increases), persistent progressive dermatologic reactions, exacerbation of angina (during initiation of treatment, after dose increased, beta blocker withdrawal), liver impairment
Reflex tachycardia resulting in angina and/or MI in patients with obstructive coronary disease reported
Peripheral edema may occur within 2-3 weeks of initiating therapy
Hypotension with or without syncope is possible (particularly with severe aortic stenosis)
Do not take with high fat meal or grapefruit products
Start at lower dose with liver/kidney dysfunction, elderly
Pregnancy & Lactation
Pregnancy Category: C
Lactation: not known if excreted in breast milk, use caution
A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA:Information not available.
Mechanism of Action
Calcium channel blocker (dihydropyridine): inhibits transmembrane influx of extracellular Ca ions across membranes of myocardial cells and vascular smooth muscle cells, without changing serum calcium concentrations, resulting in inhibition of cardiac and vascular smooth muscle contraction, thereby dilating the main coronary and systemic arteries
Produces vasodilation and decreases peripheral resistance
Peak Plasma Time: 6-12 hr
Duration: 24 hr
Protein Bound: 99%
Vd: 4-5 L/kg
Mainly metabolized in liver by CYP3A4
Metabolites: Hydroxylated isobutyl ester derivative (active, 10% potency of parent drug)
Clearance: 1400-2200 L/hr
Excretion: Urine (60-80%); feces (6-12%)
Dialyzable: HD: No
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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.
|1||This drug is available at the lowest co-pay. Most commonly, these are generic drugs.|
|2||This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.|
|3||This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.|
|NC||NOT COVERED – Drugs that are not covered by the plan.|
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.