Amlod Tablet 5mg & 10mg
DESCRIPTION : US-FDA Approved
INDICATION
Hypertension.
Coronary arteriosclerosis. To reduce the risk of hospitalization for angina and the risk of a coronary revascularization procedure.
Stable angina, chronic.
Variant angina
PHARMACOKINETICS :
Absorption : Bioavailability, oral: 64% to 90% absorption ,not affected by food
Effect of food : No significant effect.
Distribution : Protein binding: 93%
Metabolism : Liver: Extensive (about 90%). Weak CYP3A inhibitor.
Excretion : Renal excretion: 10% unchanged. Dialyzable: No (hemodialysis). Total body clearance: Decreased in elderly patients and those with hepatic insufficiency.
Elimination Half Life : 30 to 50 hours. Impaired hepatic function, 56 hours.
DOSAGE/ADMINISTRATION :
Adult dose
Hypertension : Initial, 5 mg orally once daily; titrate according to blood pressure goals, generally waiting 7 to 14 days between titrations steps; MAX 10 mg orally once daily (FDA dosage). Initial, 2.5 mg orally once daily; target dose, 10 mg once daily (guideline dosage).
Coronary arteriosclerosis : 5 to 10 mg orally once daily; most patients required the 10 mg dose in clinical trials.
Stable angina, chronic : 5 to 10 mg orally once daily; most patients will require 10 mg for adequate effect.
Variant angina : 5 to 10 mg orally once daily; most patients will require 10 mg for adequate effect.
Pediatric Dose :
Hypertension – (6 to 17 years) 2.5 to 5 mg orally once daily.
Dose Adjustment :
Renal impairment : No adjustment required.
Hemodialysis : Dosage adjustments do not appear to be required.
Hepatic impairment : with angina: 5 mg orally once daily. With hypertension: Initial or when adding to other antihypertensive therapy, 2.5 mg orally once daily. Hepatic impairment (severe): Titrate slowly.
Geriatrics : With angina: 5 mg orally once daily. With hypertension: Initial or when adding to other antihypertensive therapy, 2.5 mg orally once daily.
Fragile or small patients with hypertension : Initial or when adding to other antihypertensive therapy, 2.5 mg orally once daily.
ADVERSE EFFECTS :
Common : Cardiovascular: Edema (1.8% to 10.8% ). Gastrointestinal: Abdominal pain (1.6% ), Nausea (2.9% ). Neurologic: Somnolence (1.4% ).
Other: Fatigue (4.5% )
PRECAUTIONS :
Cardiovascular: Symptomatic hypotension may occur, especially in patients with severe aortic stenosis.
Cardiovascular: Worsening angina and acute myocardial infarction may occur after starting or increasing the dose, especially in patients with severe obstructive coronary artery disease.
Hepatic: In patients with severe hepatic impairment, titrate dose slowly.
CONTRAINDICATIONS :
Cardiovascular : Symptomatic- hypotension may occur, especially in patients with severe aortic stenosis. Worsening angina and acute myocardial infarction may occur after starting or increasing the dose, especially in patients with severe obstructive coronary artery disease.
Hepatic: : In patients with severe hepatic impairment, titrate dose slowly
PACK SIZES : Amlod 5mg (10 x 10’s) , Amlod 10mg (10 x 10’s)
