Amocal-BZ 5 mg+10 mg (Capsule)

Indications

• Treatment of hypertension
• Not indicated for initial therapy of hypertension

Pharmacology

• Inhibits angiotensin-converting enzyme (ACE)
• Inhibits calcium ion influx into vascular smooth muscle and cardiac muscle
• Peripheral arterial vasodilator
• Reduction in peripheral vascular resistance
• Reduction in blood pressure
• Peak plasma concentrations reached in 0.5-2 hours (Benazepril)
• Peak plasma concentrations reached 6-12 hours after administration (Amlodipine)
• Rate and extent of absorption not significantly different from individual tablet formulations
• Antihypertensive effect within 1 hour
• Peak reductions achieved 2-8 hours after dosing
• Effect of a single dose persists for 24 hours

Dosage & Administration

• Amlodipine effective in once-daily doses of 2.5-10 mg
• Benazepril effective in doses of 10-80 mg
• Dose titration guided by clinical effect
• Steady-state levels reached after approximately 2 and 7 days of dosing
• Recommended initial dose of Amlodipine for small, elderly, or hepatically impaired patients is 2.5 mg

Interactions

• May interact with diuretics, potassium supplements, potassium-sparing diuretics, oral anticoagulants, beta-adrenergic-blocking agents, calcium-blocking agents, cimetidine, digoxin, hydralazine, naproxen, thiazide diuretics, long-acting nitrates, sublingual nitroglycerin, warfarin, nonsteroidal anti-inflammatory drugs, antibiotics, oral hypoglycemic drugs

Contraindications

• Hypersensitivity to Benazepril, ACE inhibitor, or Amlodipine

Side Effects

• Mild and transient side effects
• No relationship between side effects and age, sex, race, or duration of therapy
• Discontinuation required in approximately 4% of patients
• Most common reasons for discontinuation: cough and edema
• Incidence of edema statistically greater with Amlodipine monotherapy
• Dose-dependent incidence of certain side effects with Amlodipine monotherapy

Pregnancy & Lactation

• Pregnancy Categories C (first trimester) and D (second and third trimesters)
• Discontinue when pregnancy detected
• Minimal amounts excreted into breast milk
• Recommendation to discontinue nursing while administered

Precautions & Warnings

• Caution in patients with severe renal disease
• Risk of hyperkalemia
• Caution in patients with impaired hepatic function
• Consideration of ACE inhibitor-induced cough in differential diagnosis of cough
• Caution during surgery or anesthesia
• No evidence of carcinogenicity, mutagenicity, or impairment of fertility

Use in Special Populations

• No identified differences in responses between elderly and younger patients
• Safety and effectiveness not established in pediatric patients

Overdose Effects

• No reported human overdoses
• No reports of death in human overdoses of Benazepril and other ACE inhibitors

Therapeutic Class

• Combined antihypertensive preparations

Storage Conditions

• Keep below 25°C temperature
• Away from light & moisture
• Keep out of the reach of children

Related Brands

• Amlozep 5 mg+10 mg (Capsule) - beacon-pharmaceuticals-plc
• Benadip 5 mg+10 mg (Capsule) - incepta-pharmaceuticals-ltd