Amlodipine

NORLIQVA is a calcium channel blocker for the treatment of: Hypertension ( 1.1 ) NORLIQVA is indicated for the treatment of hypertension in adults and children 6 years of age and older, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. Coronary Artery Disease ( 1.2 ) Chronic Stable Angina Vasospastic Angina (Prinzmetal's or Variant Angina) Angiographically Documented Coronary Artery Disease in patients without heart failure or an ejection fraction

• Adult recommended starting dose: 5 mg orally once daily with a maximum of 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
• Pediatric starting dose: 2.5 mg to 5 mg orally once daily
• 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 ]
• 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 ]
• 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. …

Oral Solution: 1 mg/mL clear, pale straw-colored solution with a mixed berry flavor. Oral solution: 1 mg/mL ( 3 )

• Amlodipine (2.5 to 5 mg daily) is effective in lowering blood pressure in patients 6 years of age and older [see Clinical Studies ]
• Effect of amlodipine on blood pressure in patients less than 6 years of age is not known
• Hepatic Impairment Patients with hepatic impairment have reduced clearance of amlodipine with a resulting increase of AUC
• A lower initial dose may be required [see Dosage and Administration ]

Clinical studies of amlodipine did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. …

• NORLIQVA is contraindicated in patients with sensitivity to amlodipine
• Sensitivity to amlodipine

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. …

Symptomatic hypotension is possible, particularly in patients with severe aortic stenosis. However, acute hypotension is unlikely. ( 5.1 ) Worsening angina and acute myocardial infarction can develop after starting or increasing the dose of NORLIQVA, particularly in patients with severe obstructive coronary artery disease. ( 5.2 ) Titrate slowly in patients with severe hepatic impairment. ( 5.3 ) 5.1 Hypotension Symptomatic hypotension is possible, particularly in patients with severe aortic stenosis. Because of the gradual onset of action, acute hypotension is unlikely. …

Most common adverse reactions to amlodipine were edema, dizziness, flushing and palpitation which occurred in a dose related manner. Other adverse reactions not clearly dose-related but reported with an incidence >1.0% are fatigue and nausea. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact CMP Pharma, Inc. at 1-844-321-1443 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. …

8.1 Pregnancy Risk Summary: The limited available data based on post-marketing reports with amlodipine use in pregnant women are not sufficient to inform a drug-associated risk for major birth defects and miscarriage. There are risks to the mother and fetus associated with poorly controlled hypertension in pregnancy [see Clinical Considerations] In animal reproduction studies, there was no evidence of adverse developmental effects when pregnant r …

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. …

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.