Amlodipine: Indication, Dosage, Side Effect, Precaution

Generic Medicine Info Full Generic Medicine Info

Dosage/Direction for Use Administration Contraindications Special Precautions Adverse Reactions Pregnancy Category (US FDA) Overdosage Drug Interactions Food Interaction Lab Interference Action Storage CIMS Class ATC Classification

This information is not country-specific. Please refer to the India prescribing information.

Generic Medicine Info

Administration

May be taken with or without food.

Contraindications

Severe hypotension, cardiogenic shock, left ventricular outflow tract obstruction (e.g. high-grade aortic stenosis), heart failure after acute MI.

Special Precautions

Patients with aortic stenosis, congestive heart failure, hypertrophic cardiomyopathy, outflow tract obstruction, severe obstructive coronary disease. Hepatic impairment. Elderly and children. Pregnancy and lactation. Patient Counselling This drug may cause dizziness, headache, fatigue or nausea, if affected, do not drive or operate machinery. Monitoring Parameters Monitor BP, heart rate, pulse, frequency and intensity of angina, weight, and peripheral oedema.

Adverse Reactions

Significant: Peripheral oedema, hypotension, angina/MI. Blood and lymphatic system disorders: Leucopenia, thrombocytopenia. Cardiac disorders: Bradycardia, ventricular tachycardia, chest pain, palpitation. Ear and labyrinth disorders: Tinnitus. Eye disorders: Visual disturbance, diplopia, conjunctivitis. Gastrointestinal disorders: Nausea, dyspepsia, diarrhoea, constipation, abdominal pain. General disorders and administration site conditions: Fatigue, asthenia. Investigations: Weight gain, elevated hepatic enzymes. Musculoskeletal and connective tissue disorders: Muscle cramps, arthralgia, back pain. Nervous system disorders: Headache, somnolence, dizziness, extrapyramidal symptoms. Psychiatric disorders: Insomnia, anxiety, depression. Renal and urinary disorders: Micturition disorder, nocturia. Reproductive system and breast disorders: Sexual dysfunction, gynaecomastia. Respiratory, thoracic and mediastinal disorders: Pulmonary oedema, dyspnoea, cough, rhinitis. Skin and subcutaneous tissue disorders: Rash, skin discolouration, pruritus. Vascular disorders: Flushing.

Pregnancy Category (US FDA)

Drug Interactions

Increased systemic plasma concentration with immunosuppressants (e.g. ciclosporin, tacrolimus). Increased serum concentration of simvastatin. Increased exposure with CYP3A4 enzyme inhibitors (e.g. protease inhibitors, azole antifungals, erythromycin, diltiazem). Decreased plasma concentration with CYP3A4 inducers (e.g. rifampicin).

CIMS Class

Anti-Anginal Drugs / Calcium Antagonists

ATC Classification

C08CA01 - amlodipine ; Belongs to the class of dihydropyridine derivative selective calcium-channel blockers with mainly vascular effects. Used in the treatment of cardiovascular diseases.

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