Amlodipine

Brand names: Amlodipine Besylate and Benazepril Hydrochloride, Amlodipine and Benazepril Hydrochloride, Amlodipine besylate and Atorvastatin calcium, Amlodipine, Valsartan, and Hydrochlorothiazide, Azor, Caduet, Tekamlo, amlodipine besylate and atorvastatin calcium, Sdamlo, Katerzia, NORLIQVA

Warnings

Key warnings include symptomatic hypotension risk, particularly in severe aortic stenosis patients. "Worsening angina and acute myocardial infarction can develop after starting or increasing the dose," especially in severe obstructive coronary artery disease cases. Hepatic impairment requires slower titration due to extended elimination half-life (56 hours).

Contraindications

4 CONTRAINDICATIONS NORLIQVA is contraindicated in patients with sensitivity to amlodipine. Sensitivity to amlodipine ( 4 )

Overdose

10 OVERDOSAGE Overdosage might be expected to cause excessive peripheral vasodilation with marked hypotension and possibly a reflex tachycardia. Single oral doses of amlodipine maleate equivalent to 40 mg amlodipine/kg and 100 mg amlodipine/kg in mice and rats, respectively, caused deaths. Single oral amlodipine maleate doses equivalent to 4 or more mg amlodipine/kg or higher in dogs (11 or more times the maximum recommended human dose on a mg/m 2 basis) caused a marked peripheral vasodilation and hypotension. If massive overdose should occur, initiate active cardiac and respiratory monitoring. Frequent blood pressure measurements are essential. Should hypotension occur, provide cardiovascular support including elevation of the extremities and the judicious administration of fluids. If hypotension remains unresponsive to these conservative measures, consider administration of vasopressors (such as phenylephrine) with attention to circulating volume and urine output. As amlodipine is highly protein bound, hemodialysis is not likely to be of benefit.

Drug interactions

7 DRUG INTERACTIONS Do not exceed doses greater than 20 mg daily of simvastatin. ( 7.2 ) 7.1 Impact of Other Drugs on Amlodipine CYP3A Inhibitors Co-administration with CYP3A inhibitors (moderate and strong) results in increased systemic exposure to amlodipine and may require dose reduction. Monitor for symptoms of hypotension and edema when amlodipine is co-administered with CYP3A inhibitors to determine the need for dose adjustment [see Clinical Pharmacology (12.3) ] . CYP3A Inducers No information is available on the quantitative effects of CYP3A inducers on amlodipine. Blood pressure should be closely monitored when amlodipine is co-administered with CYP3A inducers. 7.2 Impact of Amlodipine on Other Drugs Simvastatin Co-administration of simvastatin with amlodipine increases the systemic exposure of simvastatin. Limit the dose of simvastatin in patients on amlodipine to 20 mg daily [see Clinical Pharmacology (12.3) ] . Immunosuppressants Amlodipine may increase the systemic exposure of cyclosporine or tacrolimus when co-administered. Frequent monitoring of trough blood levels of cyclosporine and tacrolimus is recommended and adjust the dose when appropriate [see Clinical Pharmacology (12.3) ] .

Uses

Amlodipine besylate treats hypertension and coronary artery disease conditions. For high blood pressure, it "lower[s] blood pressure" to reduce cardiovascular event risk. For heart disease, it addresses chronic stable angina, vasospastic angina, and documented CAD in patients without heart failure or ejection fraction below 40%. The medication may be used alone or combined with other agents.

Dosage forms & strengths

Capsule Tablet, Film Coated SOLUTION SUSPENSION

ALISKIREN HEMIFUMARATE 150 mg AMLODIPINE BESYLATE 5 mg AMLODIPINE BESYLATE 10 mg ATORVASTATIN CALCIUM TRIHYDRATE 20 mg ATORVASTATIN CALCIUM TRIHYDRATE 80 mg BENAZEPRIL HYDROCHLORIDE 20 mg BENAZEPRIL HYDROCHLORIDE 40 mg AMLODIPINE BESYLATE 2.5 mg ATORVASTATIN CALCIUM TRIHYDRATE 10 mg BENAZEPRIL HYDROCHLORIDE 10 mg OLMESARTAN MEDOXOMIL 40 mg VALSARTAN 160 mg HYDROCHLOROTHIAZIDE 25 mg amlodipine besylate 2.5 mg Atorvastatin Calcium Trihydrate 10 mg AMLODIPINE BESYLATE 5 mg/5mg AMLODIPINE BENZOATE 1 mg/mL AMLODIPINE BESYLATE 2.5 mg/2.5mg AMLODIPINE 1 mg/mL AMLODIPINE BESYLATE 10 mg/10mg

2 DOSAGE AND ADMINISTRATION Adult recommended starting dose: 5 mg orally once daily with a maximum of 10 mg orally once daily. ( 2.1 ) Small, fragile, or elderly patients, or patients with hepatic insufficiency may be started on 2.5 mg orally once daily. ( 2.1 ) Pediatric starting dose: 2.5 mg to 5 mg orally once daily. ( 2.2 ) 2.1 Adults The usual initial antihypertensive oral dose of NORLIQVA is 5 mg orally once daily, and the maximum dose is 10 mg orally once daily. Small, fragile, or elderly patients, or patients with hepatic insufficiency may be started on 2.5 mg orally once daily and this dose may be used when adding NORLIQVA to other antihypertensive therapy [see Clinical Pharmacology (12.3) ] . Adjust dosage according to blood pressure goals. In general, wait 7 to 14 days between titration steps. Titrate more rapidly, however, if clinically warranted, provided the patient is assessed frequently. Angina : The recommended dose for chronic stable or vasospastic angina is 5 mg to 10 mg orally once daily, with the lower dose suggested in the elderly and in patients with hepatic insufficiency. Most patients will require 10 mg orally once daily for adequate effect. Coronary artery disease : The recommended dose range for patients with coronary artery disease is 5 mg to 10 mg orally once daily. In clinical studies, the majority of patients required 10 mg orally once daily [see Clinical Studies (14.4) ] . 2.2 Children The effective antihypertensive oral dose in pediatric patients ages 6 years of age and older is 2.5 mg to 5 mg orally once daily. Doses in excess of 5 mg daily have not been studied in pediatric patients [see Clinical Pharmacology (12.4) , Clinical Studies (14.1) ] .