Nifedipine


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult : PO HTN Immediate-release: Initial: 5 mg tid. Maintenance: 10-20 mg tid. Extended- release: 10-40 mg bid or 20-90 mg once daily. Angina pectoris Immediate-release: Initial: 5 mg tid. Maintenance: 10-20 mg tid. Extended- release: 10-40 mg bid or 30-90 mg once daily. Raynaud's syndrome As immediate release tab: Initial: 5 mg 8 hourly. May increase, according to response  up to Max of 20 mg 8 hourly. As extended-release tab: In patient with mild to moderate cases: Initial: 20 mg once daily. May increase to 90 mg once daily according to individual requirement.
Dosage Details
Oral
Raynaud's syndrome
Adult: As immediate release tab: Initially, 5 mg 8 hourly. May increase, according to response  up to Max of 20 mg 8 hourly. As extended-release tab: In patient with mild to moderate cases: Initially, 20 mg once daily. May increase to 90 mg once daily according to individual requirement.
Elderly: Dose reduction may be necessary.

Oral
Hypertension
Adult: Immediate-release: Initially, 5 mg tid. Maintenance: 10-20 mg tid. Extended-release: Initially, 10-40 mg bid or 20-90 mg once daily.
Elderly: Dose reduction may be necessary.

Oral
Angina pectoris
Adult: Immediate-release: Initially, 5 mg tid. Maintenance: 10-20 mg tid. Extended-release: 10-40 mg bid or 30-90 mg once daily.
Elderly: Dose reduction may be necessary.
Hepatic Impairment
Dose reduction may be necessary.
Administration
Immediate-Release: May be taken with or without food. Avoid grapefruit juice.
Contraindications
Cardiogenic shock, acute unstable angina, use w/in 1 mth of MI. Treatment of angina attack in chronic stable angina or acute reduction of BP in adults. Concomitant use w/ strong CYP3A4 inducers.
Special Precautions
Patients w/ hypotension, poor cardiac reserve, heart failure, severe aortic stenosis, DM, underlying severe GI narrowing (extended-release tab). Avoid abrupt withdrawal as it may casue rebound angina. Hepatic impairment. Elderly. Pregnancy and lactation.
Adverse Reactions
Dizziness, flushing, headache, hypotension, peripheral oedema, tachycardia, palpitations, nausea, constipation, other GI disturbances, increased micturition frequency, lethargy, eye pain, visual disturbances, syncope, vertigo, migraine, mood disturbances, rashes (including erythema multiforme), liver function abnormalities (including cholestasis), pruritus, gingival hyperplasia, myalgia, gynaecomastia, tremor, impotence, fever. Paradoxical increase in ischaemic chest pain during initiation of treatment. GI obstruction in some tablets covered in indigestible membrane.
Patient Counseling Information
Discontinue if ischaemic pain follows after admin.
MonitoringParameters
Monitor BP, heart rate.
Overdosage
Symptoms: Pronounced hypotension, bradycardia, hyperglycaemia, loss of consciousness leading to coma, heart rhythm disturbances, metabolic acidosis, hypoxia, cardiogenic shock w/ pulmonary oedema. Management: Symptomatic and supportive treatment. Activated charcoal may be given if symptoms occur w/in 1 hr of ingestion. Gastric lavage may be considered in adults. Atropine should be given for symptomatic bradycardia. If w/ significant features of poisoning, IV Ca should be given. Insulin and glucose infusion may improve myocardial contractility and systemic perfusion in severe cases. Lipid infusion may be helpful for unresponsive cardiotoxicity. Unresponsive hypotension may require an adrenoceptor agonist (e.g. norepinephrine, dopamine). Glucagon has also been utilised to correct myocardial depression and hypotension. Plasmapheresis may be beneficial.
Drug Interactions
Enhanced antihypertensive effects w/ other antihypertensives, aldesleukin, and antipsychotics. Concomitant use w/ fentanyl during surgery caused severe hypotension. May modify insulin and glucose responses. Attenuation of tachycardic effect when used w/ benazerpril. Prothrombin time may be increased w/ coumarin anticoagulants. Increased serum levels w/ CYP3A4 inhibitors (e.g. azole antifungals, cimetidine, erythromycin, HIV-protease inhibitors, nefazodone, fluoxetine, quinupristin/dalfopristin).
Potentially Fatal: Decreased bioavailability and efficacy w/ strong CYP3A4 inducers (e.g. rifampicin, phenytoin, carbamazepine).
Food Interaction
Absorption may be affected by food and results may vary depending on the preparation used. Metabolism is inhibited by alcohol. Avoid concomitant use w/ St John's wort as it may reduce the bioavailability and efficacy of nifedipine. Avoid concomitant use w/ grapefruit juice as it may elevate plasma levels of nifedipine.
Lab Interference
May cause falsely elevated spectrophotometric values of urinary vanillylmandelic acid.
Action
Description: Nifedipine prevents Ca ion from entering the slow channels of cardiac and smooth muscles during depolarisation, producing peripheral and coronary vasodilatation. It reduces afterload, peripheral resistance and BP; increases coronary blood flow and causes reflex tachycardia. It has little or no effect on cardiac conduction and rarely has negative inotropic activity.
Onset: Immediate-release: Approx 20 min.
Pharmacokinetics:
Absorption: Rapidly and almost completely absorbed from the GI tract. Absorption may be affected by food, but result vary depending on the preparation used. Bioavailability: 45-56% (liquid-filled cap); 65-89% (extended-release). Time to peak plasma concentration: 30-60 min (liquid-filled cap).
Distribution: Enters breast milk. Plasma protein binding: Approx 92-98%.
Metabolism: Extensively oxidised in the liver via CYP3A4 isoenzyme. Undergoes extensive hepatic first-pass metabolism.
Excretion: Via urine (80-95% as inactive metabolites) and faeces. Elimination half-life: Approx 2 hr (liquid-filled cap).
Storage
Store below 30°C. Protect from light and moisture.
References
Adalat CC (Bayer Healthcare Pharmaceuticals Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/.

Anon. Nifedipine. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 13/12/2013.

Buckingham R (ed). Nifedipine. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 13/12/2013.

McEvoy GK, Snow EK, Miller J et al (eds). Nifedipine. AHFS Drug Information (AHFS DI) [online]. American Society of Health-System Pharmacists (ASHP). https://www.medicinescomplete.com. Accessed 13/12/2013.

Procardia 10 mg Capsules. U.S. FDA. https://www.fda.gov/.

Wickersham RM. Nifedipine. Facts and Comparisons [online]. St. Louis, MO. Wolters Kluwer Clinical Drug Information, Inc. https://www.wolterskluwercdi.com/facts-comparisons-online/. Accessed 13/12/2013.

Disclaimer: This information is independently developed by MIMS based on Nifedipine from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 MIMS. All rights reserved. Powered by MIMS.com
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