nisoldipine (Rx)

Brand and Other Names:Sular
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Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

tablet, extended-release (generic)

  • 8.5mg
  • 17mg
  • 20mg
  • 25.5mg
  • 30mg
  • 34mg
  • 40mg

tablet, extended-release (Sular, new hydrogel ER formulation)

  • 8.5mg
  • 17mg
  • 34mg
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Hypertension

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

Hepatic Impairment

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

Administration

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

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Interactions

Interaction Checker

and nisoldipine

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Headache (22%)

            Peripheral edema (22%)

            1-10%

            Dizziness (5%)

            Palpitation (3%)

            Vasodilation (4%)

            Increased severity of angina (1.5%)

            Nausea (2%)

            Pharyngitis (5%)

            Sinusitis (3%)

            < 1%

            Gingival hyperplasia

            Colitis

            Anemia

            Alopecia

            Anorexia

            Anxiety

            Ischemia

            Diabetes mellitus

            Dyspepsia

            Dysphagia

            Postmarketing Reports

            Urogenital: Dysuria, hematuria, impotence, nocturia, urinary frequency, increased BUN and serum creatinine, vaginal hemorrhage, vaginitis

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            Warnings

            Contraindications

            Hypersensitivity to nisoldipine or other calcium channel blockers

            Cautions

            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

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            Pregnancy & Lactation

            Pregnancy Category: C

            Lactation: not known if excreted in breast milk, use caution

            Pregnancy Categories

            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.

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            Pharmacology

            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

            Absorption

            Bioavailability: 4-8%

            Peak Plasma Time: 6-12 hr

            Duration: 24 hr

            Distribution

            Protein Bound: 99%

            Vd: 4-5 L/kg

            Metabolism

            Mainly metabolized in liver by CYP3A4

            Metabolites: Hydroxylated isobutyl ester derivative (active, 10% potency of parent drug)

            Elimination

            Clearance: 1400-2200 L/hr

            Excretion: Urine (60-80%); feces (6-12%)

            Dialyzable: HD: No

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            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

            Adding plans allows you to:

            • View the formulary and any restrictions for each plan.
            • Manage and view all your plans together – even plans in different states.
            • Compare formulary status to other drugs in the same class.
            • Access your plan list on any device – mobile or desktop.

            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.

            Tier Description
            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.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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