nifedipine (Rx)Brand and Other Names:Procardia, Procardia XL, more...Adalat CC, Nifedical XL, Adalat, Afeditab CR, Nifediac CC

 
 
 

Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

capsule

  • 10mg
  • 20mg

tablet, extended release

  • 30mg
  • 60mg
  • 90mg
more...

Angina

10 mg (conventional) PO q8hr or 30-60 mg (extended release) PO once daily initially; may be increased every 7-14 days PRN

Maintenance: 10-20 mg (conventional) PO q8hr up to 20-30 mg PO q6-8hr; not to exceed 180 mg/day (conventional) or 120 mg/day (extended release)

Hypertension

30-60 mg (extended release) PO once daily; may be increased every 7-14 days PRN; not to exceed 90 mg/day (Adalat CC) or 120 mg/day (Procardia XL)

Pulmonary Hypertension

30 mg (extended-release) PO q12hr; may be increased to 120-240 mg/day (monitor)

Raynaud Phenomenon (Off-label)

30-120 mg (extended release) PO once daily

Anal Fissures (Off-label)

0.2% topical gel/ointment (extemporaneously compounded) q12hr for 3-6 weeks

20 mg sublingual

Dosing Modifications

Peritoneal dialysis (PD) or hemodialysis (HD): Supplemental dose not necessary

Cirrhosis: Consider dose adjustment

Administration

Take on empty stomach

Dosage Forms & Strengths

capsule

  • 10mg
  • 20mg

tablet, extended release

  • 30mg
  • 60mg
  • 90mg
more...

Not FDA approved for children

Potential toxic dose in children <6 years: 2 mg/kg

Hypertension (Off-label)

0.25-0.5 mg/kg/day (extended release) PO in 1 or 2 daily doses initially; not to exceed 3 mg/kg/day (120 mg/day) 

Avoid conventional (ie, immediate-release) product; potential for hypotension and risk of precipitating myocardial ischemia

Angina

10 mg (conventional) PO q8hr or 30-60 mg (extended release) PO once daily initially; may be increased every 7-14 days PRN

Maintenance: 10-20 mg (conventional) PO q8hr up to 20-30 mg PO q6-8hr; not to exceed 180 mg/day (conventional) or 120 mg/day (extended release)

Hypertension

30-60 mg (extended release) PO once daily; may be increased every 7-14 days PRN; not to exceed 90 mg/day (Adalat CC) or 120 mg/day (Procardia XL)

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Interactions

Interaction Checker

nifedipine and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            Adverse effects differ between short-acting (conventional) and extended-release formulations, with the conventional preparations having more serious adverse drug reactions in some cases

            >10%

            Peripheral edema (10-30%)

            Dizziness (23-27%)

            Flushing (23-27%)

            Headache (10-23%)

            Heartburn (11%)

            Nausea (11%)

            1-10%

            Muscle cramps (8%)

            Mood change (7%)

            Nervousness (7%)

            Cough (6%)

            Dyspnea (6%)

            Palpitations (6%)

            Wheezing (6%)

            Hypotension, transient (5%)

            Urticaria (2%)

            Pruritus (2%)

            Constipation (<2%)

            Chest pain (<2%)

            Frequency Not Defined

            Gingival hyperplasia

            Agranulocytosis

            Erectile dysfunction

            Postmarketing Reports

            Exfoliative or bullous skin adverse events (eg, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis)

            Photosensitivity reactions

            Acute generalized exanthematous pustulosis

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            Warnings

            Contraindications

            Hypersensitivity to nifedipine or other calcium-channel blockers

            Cardiogenic shock

            Concomitant administration with strong CYP3A4 inducers (eg, rifampin, rifabutin, phenobarbital, phenytoin, carbamazepine, St John's wort) significantly reduces nifedipine efficacy

            Immediate release preparation (sublingually or orally) for urgent or emergent hypertension

            Cautions

            Use with caution in (≤4 weeks) myocardial infarction (MI), congestive heart failure (CHF), advanced aortic stenosis, peripheral edema, symptomatic hypotension, unstable angina, concurrent use of beta blockers, hepatic or renal impairment, persistent progressive dermatologic reactions, exacerbation of angina (during initiation of treatment, after a dose increase, or after withdrawal of beta blocker)

            Short-acting nifedipine may be less safe than other calcium-channel blockers in management of angina, hypertension, or acute MI

            Use cautiously in combination with quinidine

            Conventional (short-acting) form not indicated for hypertension

            Use extended-release form with caution in severe GI stenosis; rare reports of GI obstructive symptoms in patients with known strictures or without history of GI obstruction in association with ingestion of long-acting nifedipine; bezoars can occur in very rare cases and may necessitate surgical intervention

            Extended-release form contains lactose; thus, patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicine

            Cirrhosis: Clearance reduced and systemic exposure increased

            CYP3A inhibitors (eg, ketoconazole, fluconazole, itraconazole clarithromycin, erythromycin, grapefruit, nefazodone, saquinavir, indinavir, nelfinavir, ritonavir) may inhibit nifedipine metabolism and result in increased exposure when coadministered

            Strong CYP3A inducers (eg, rifampin, rifabutin, phenobarbital, phenytoin, carbamazepine, and St John’s wort) may enhance nifedipine metabolism and result in decreased exposure when coadministered

            Avoid use in heart failure due to lack of benefit, and/or worse outcomes with calcium channel blockers in general

            Use with caution in patients with hypertrophic cardiomyopathy and outflow tract obstruction; reduction in afterload may worsen symptoms associated with this condition

            Avoid use of immediate release formulation in the elderly; may cause hypotension and risk precipitating myocardial ischemia

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            Pregnancy & Lactation

            Pregnancy category: C

            Lactation: Drug is distributed into breast milk; manufacturer suggests discontinuing drug or refraining from nursing (however, American Academy of Pediatrics states that drug is safe for nursing)

            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.

            more...
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            Pharmacology

            Mechanism of Action

            Calcium-channel blocker; inhibits transmembrane influx of extracellular calcium ions across myocardial and vascular smooth muscle cell membranes without changing serum calcium concentrations; this results in inhibition of cardiac and vascular smooth muscle contraction, thereby dilating main coronary and systemic arteries

            Vasodilation with decreased peripheral resistance and increased heart rate

            Absorption

            Bioavailability: Conventional, 40-77%; extended release, 65-89%

            Onset: Conventional, 20 min; extended release, 30 min

            Duration: Conventional, 8 hr; extended release, 24 hr

            Peak plasma time: Conventional, 30-120 min; extended release, 6 hr (Procardia XL) or 2.5-5 hr (Adalat CC)

            Distribution

            Protein bound: 92-98%

            Vd: 1.42-2.2 L/kg

            Metabolism

            Metabolized in liver by CYP3A4

            Metabolites: Nitropyridine analogue (inactive)

            Elimination

            Half-life: Conventional, 2-5 hr; 7 hr in cirrhosis

            Dialyzable: No dose adjustments necessary in HD or PD

            Excretion: Urine (60-80%), feces (20-40%)

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            Images

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            Formulary

            FormularyPatient Discounts

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            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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