Trade Names:Adalat CC- Tablets, extended-release 30 mg- Tablets, extended-release 60 mg- Tablets, extended-release 90 mg
Trade Names:Afeditab CR- Tablets, extended-release 30 mg- Tablets, extended-release 60 mg
Trade Names:Nifediac CC- Tablets, extended-release 30 mg- Tablets, extended-release 60 mg- Tablets, extended-release 90 mg
Trade Names:Nifedical XL- Tablets, extended-release 30 mg- Tablets, extended-release 60 mg
Trade Names:Procardia- Capsules 10 mg
Trade Names:Procardia XL- Tablets, extended-release 30 mg- Tablets, extended-release 60 mg- Tablets, extended-release 90 mgAdalat XL (Canada)Apo-Nifed (Canada)Apo-Nifed PA (Canada)
Inhibits movement of calcium ions across cell membrane in systemic and coronary vascular smooth muscle and myocardium. Decreases peripheral vascular resistance. Reduces myocardial oxygen demand; relaxes and prevents coronary artery spasm.
Nifedipine is rapidly and fully absorbed (100%). T max is about 30 min (immediate-release) and 2.5 to 5 h (extended-release). Bioavailability is 84% to 89% (extended-release) and 45% to 75% (immediate-release).
Nifedipine protein binding is 92% to 98%.
Nifedipine is metabolized extensively in the liver to inactive metabolites.
Nifedipine is eliminated in urine (0.1% unchanged) and in small amounts in feces. The t ½ is about 7 h (extended-release) and 2 h (immediate-release). 60% to 80% excreted in urine and the remainder in feces in metabolized form.
Longer t ½ , higher bioavailability, and reduced protein binding may occur in patients with liver cirrhosis.Elderly
Mean C max is 36% higher and plasma concentration is 70% greater in elderly patients.
Chronic stable angina (except Adalat CC , Afeditab CR , Nifediac CC ); vasospastic angina (except Adalat CC , Afeditab CR , Nifediac CC ); hypertension (except Procardia ).
PO Start with 10 mg 3 times daily and titrate dose over 7- to 14-day period (usual dose range, 10 to 20 mg 3 times daily). Some patients (eg, coronary artery spasm) respond only to higher doses and/or more frequent administration (eg, 20 to 30 mg 3 to 4 times daily; max, 180 mg/day). In hospitalized patient, under close observation, dose may be increased in 10 mg increments over 4- to 6-h periods as required to control pain and arrhythmias caused by ischemia. A single dose rarely exceeds 30 mg.Extended-release tabletsAdults Procardia XL and Nifedical XL
PO 30 or 60 mg once daily, titrated over 7- to 14-day period (max, 120 mg/day). Administer on an empty stomach. Swallow whole. Do not crush, chew, cut, or break extended-release tablets.Adalat CC , Afeditab CR , and Nifediac CC (hypertension)
PO Start with 30 mg once daily and titrate dose over 7- to 14-day period (max, 90 mg/day). Administer on an empty stomach. Swallow whole. Do not crush, chew, cut, or break extended-release tablets.
Store immediate-release capsules at controlled room temperature (59° to 77°F). Protect from light and moisture. Store extended-release tablets below 86°F). Protect from light, moisture, and freezing.
Coadministration may lead to loss of glucose control.Anticoagulants (eg, warfarin)
May increase PT during coadministration.Antiviral agents, azole antifungal agents, cisapride, diltiazem, erythromycin, nefazodone, quinupristin/dalfopristin, valproic acid, verapamil
May elevate nifedipine levels, increasing the risk of side effects.Barbiturates, carbamazepine, nafcillin, rifampin, St. John's wort
May reduce nifedipine levels, decreasing the therapeutic effect.Cimetidine
May increase bioavailability of nifedipine.Digitalis
Reports are conflicting; however, digoxin levels may be increased.Fentanyl, parenteral magnesium
Hypotension may occur.Grapefruit juice
Nifedipine plasma levels may be elevated, increasing the pharmacologic and adverse reactions. Avoid coadministration.Melatonin
May interfere with the antihypertensive effects of nifedipine.Micafungin
Nifedipine plasma levels may be elevated by micafungin, increasing the pharmacologic and adverse reactions.Phenytoin
Phenytoin plasma levels may be increased.Quinidine
May decrease quinidine plasma levels during coadministration.Tacrolimus
Tacrolimus trough concentrations may be elevated, increasing the risk of toxicity.Other hypertensive agents
May have additive effects.
None well documented.
Peripheral edema (10%); palpitation (7%); transient hypotension (5%); asthenia, fatigue, insomnia (less than 3%).
Dizziness, lightheadedness, giddiness (27%); headache (23%); weakness (12%); nervousness, mood changes (7%); paresthesia, vertigo (3% or less); fatigue, asthenia, insomnia (less than 3%); shakiness, jitteriness, sleep disturbances, difficulty in balance, somnolence (2% or less).
Rash, pruritis (3% or less); urticaria, sweating, dermatitis (2% or less); exfoliative or bullous skin reactions including erythema multiforme, Steven-Johnson syndrome, toxic epidermal necrolysis (postmarketing).
Nasal congestion, sore throat (6%); blurred vision, epistaxis, rhinitis (3% or less).
Nausea, heartburn (11%); diarrhea, constipation, flatulence (3% or less); abdominal pain, dry mouth, dyspepsia (less than 3%); cramps (2% or less).
Impotence, polyuria, urinary frequency (3% or less); sexual difficulties (2% or less).
Muscle cramps, tremor (8%); arthralgia, leg cramps (3% or less); inflammation, joint stiffness (2% or less).
Dyspnea, cough, wheezing (6%); shortness of breath (2% or less).
Flushing/heat sensation (25%); pain (less than 3%); chills, fever (2% or less).
Frequently assess patient for response to treatment. Ensure that therapy is periodically reviewed to determine if it needs to be continued without change or if a dose change (eg, increase, decrease, discontinuation) is indicated. Frequently monitor BP during initial administration and following any dose escalation.
Category C .
Excreted in breast milk.
Safety and efficacy not established.
May experience greater hypotensive effects.
Absorption of nifedipine from extended-released form could be modified by renal disease. Use with caution.
Use drug with caution in patients with impaired hepatic function, reduced hepatic blood flow, or hepatic cirrhosis.
In rare instances, nifedipine has been associated with significant elevations in liver enzymes, symptoms consistent with acute hepatic injury, cholestasis with or without jaundice and allergic hepatitis.
Nifedipine decreases platelet aggregation and can increase bleeding time in some patients.
Patients withdrawn from beta-blockers while taking nifedipine may experience increased angina.
Use drug with caution in patients with CHF. New onset CHF and worsening of preexisting CHF have been reported, usually in patients also receiving a beta-blocker.
Decrease dose gradually. Abrupt withdrawal may cause increased frequency and duration of angina.
Nifedipine has been associated with edema in some cases and should be distinguished from fluid retention secondary to heart failure.
Excessive and poorly tolerated hypotension has occurred. This appears to occur during initial titration or during upward dosage adjustment and may be more common in patients with concurrent beta-blocker use.
Severe hypotension occurred in patients receiving immediate-release nifedipine together with a beta-blocker and who underwent coronary artery bypass surgery using high-dose fentanyl anesthesia. If possible, withdraw nifedipine 36 h before surgery when using high-dose fentanyl.
Use extended-release nifedipine with caution in patient with severe GI narrowing. Obstructive symptoms have been rarely reported in patients with known strictures in association with ingestion of extended-release nifedipine.
Occasional patients may have increased frequency, duration, or severity of angina at start of therapy or when dose is increased. Sublingual nitroglycerin may be used to control acute angina episodes.
Two 30 mg Afeditab and Nifediac CC tablets may be interchanged with one 60 mg Afeditab or Nifediac CC tablets. Three 30 mg tablets are not considered interchangeable with a single 90 mg tablet.
Immediate-release nifedipine should not be used within the first 2 weeks following MI, and should be avoided in the setting of acute coronary syndrome.
Hypotension, nausea, dizziness, second- or third-degree AV block, marked and prolonged hypotension and bradycardia, functional rhythms, loss of consciousness, metabolic acidosis, hypoxia, cardiogenic shock with pulmonary edema, palpitations, flushing, nervousness, vomiting, generalized edema, ECG abnormalities.
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