nifedipine (Rx)

Brand and Other Names:Procardia, Procardia XL, more...Adalat CC, Nifedical XL, Adalat, Afeditab CR, Nifediac CC
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Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

capsule

  • 10mg
  • 20mg

tablet, extended release

  • 30mg
  • 60mg
  • 90mg

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

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

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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.

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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

            BRAND FORM. UNIT PRICE PILL IMAGE
            nifedipine oral
            -
            10 mg capsule
            nifedipine oral
            -
            90 mg tablet
            nifedipine oral
            -
            60 mg tablet
            nifedipine oral
            -
            30 mg tablet
            nifedipine oral
            -
            30 mg tablet
            nifedipine oral
            -
            90 mg tablet
            nifedipine oral
            -
            90 mg tablet
            nifedipine oral
            -
            30 mg tablet
            nifedipine oral
            -
            60 mg tablet
            nifedipine oral
            -
            90 mg tablet
            nifedipine oral
            -
            60 mg tablet
            nifedipine oral
            -
            20 mg capsule
            nifedipine oral
            -
            10 mg capsule
            nifedipine oral
            -
            10 mg capsule
            nifedipine oral
            -
            60 mg tablet
            nifedipine oral
            -
            90 mg tablet
            nifedipine oral
            -
            30 mg tablet
            nifedipine oral
            -
            60 mg tablet
            nifedipine oral
            -
            20 mg capsule
            nifedipine oral
            -
            60 mg tablet
            nifedipine oral
            -
            10 mg capsule
            nifedipine oral
            -
            30 mg tablet
            nifedipine oral
            -
            90 mg tablet
            nifedipine oral
            -
            20 mg capsule
            nifedipine oral
            -
            60 mg tablet
            nifedipine oral
            -
            10 mg capsule
            nifedipine oral
            -
            30 mg tablet
            nifedipine oral
            -
            60 mg tablet
            nifedipine oral
            -
            90 mg tablet
            nifedipine oral
            -
            30 mg tablet
            nifedipine oral
            -
            60 mg tablet
            nifedipine oral
            -
            30 mg tablet
            Procardia XL oral
            -
            60 mg tablet
            Procardia XL oral
            -
            30 mg tablet
            Procardia XL oral
            -
            90 mg tablet

            Copyright © 2010 First DataBank, Inc.

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            Patient Handout

            Patient Education
            nifedipine oral

            NIFEDIPINE SUSTAINED-ACTION - ORAL

            (nye-FED-i-peen)

            COMMON BRAND NAME(S): Adalat CC

            USES: This medication is used alone or in combination with other drugs to treat high blood pressure (hypertension). Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems. Nifedipine belongs to a class of medications known as calcium channel blockers. It works by relaxing blood vessels so blood can flow more easily.

            HOW TO USE: Take this medication by mouth on an empty stomach, usually once daily or as directed by your doctor. Swallow the tablets whole. Do not crush or chew the tablets. Doing so can release all of the drug at once, increasing the risk of side effects.Your doctor may gradually increase your dose. Follow your doctor's instructions carefully. Dosage is based on your medical condition and response to treatment.Avoid eating grapefruit or drinking grapefruit juice while being treated with this medication unless your doctor instructs you otherwise. Grapefruit juice can increase the amount of certain medications in your bloodstream. Consult your doctor or pharmacist for more details.Use this medication regularly in order to get the most benefit from it. Remember to use it at the same time each day. Keep taking this medication even if you feel well. Most people with high blood pressure do not feel sick.Do not suddenly stop taking this medication without consulting your doctor. Your condition may become worse when the drug is suddenly stopped. Your dose may need to be gradually decreased.Tell your doctor if your condition worsens (such as increase in your routine blood pressure readings).

            SIDE EFFECTS: Headache, dizziness, nausea, flushing, constipation, leg/muscle cramps, or sexual problems may occur. To reduce dizziness and lightheadedness, get up slowly when rising from a sitting or lying position. If any of these effects last or get worse, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: swelling of the ankles/feet, shortness of breath, unusual weakness/tiredness, fast/slow/irregular heartbeat, fainting, mental/mood changes, swollen/tender gums, vision changes.Although this medication is effective in preventing chest pain (angina), some people who already have severe heart disease may rarely develop worsening chest pain or a heart attack after starting this medication or increasing the dose. Get medical help right away if you experience: worsening chest pain, symptoms of a heart attack (such as chest/jaw/left arm pain, shortness of breath, unusual sweating).A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

            PRECAUTIONS: Before taking this medication, tell your doctor or pharmacist if you are allergic to it; or to other calcium channel blockers (such as felodipine, amlodipine); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart problems (such as congestive heart failure, aortic stenosis), liver problems, kidney problems, a certain metabolic disorder (porphyria).Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.Nifedipine passes into breast milk. While there have been no reports of harm to nursing infants, consult your doctor before breast-feeding.

            DRUG INTERACTIONS: See also How to Use section.Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug include: alpha blockers (such as doxazosin), calcium or magnesium sulfate received through a vein, digoxin, fentanyl, melatonin.Other medications can affect the removal of nifedipine from your body, which may affect how nifedipine works. Examples include apalutamide, cimetidine, enzalutamide, mitotane, quinupristin/dalfopristin, St. John's wort, rifamycins (such as rifabutin, rifampin), drugs used to treat seizures (such as carbamazepine, phenytoin), among others.Some products have ingredients that could raise your heart rate or blood pressure. Tell your pharmacist what products you are using, and ask how to use them safely (especially cough-and-cold products, diet aids, or NSAIDs such as ibuprofen/naproxen).

            OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe dizziness, fainting, fast/slow/irregular heartbeat.

            NOTES: Do not share this medication with others.Lifestyle changes such as stress reduction programs, exercise, and dietary changes may increase the effectiveness of this medicine. Talk to your doctor or pharmacist about lifestyle changes that might benefit you.Lab and/or medical tests (such as liver/kidney function, EKG) may be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.Have your blood pressure checked regularly while taking this medication. Learn how to monitor your own blood pressure at home, and share the results with your doctor.There are different tablet strengths of this medication available. Some tablet strengths may not be used in place of others. Do not change tablet strengths or use a different number of tablets for your dose without consulting your doctor or pharmacist.

            MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

            STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

            MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

            Information last revised December 2022. Copyright(c) 2022 First Databank, Inc.

            IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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            Formulary

            FormularyPatient Discounts

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

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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.

            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.
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            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
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            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
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.