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Pronunciation:

(am LOE di peen & ben AY ze pril)

U.S. Brand Names:

Lotrel®

Synonyms:

Benazepril and Amlodipine

Generic Available:

Use:

Treatment of hypertension

Pregnancy Risk Factor:

C/D (2nd and 3rd trimesters)

Pregnancy Implications:

See individual agents.

Lactation:

Amlodipine: Excretion in breast milk unknown

Benazepril: Enters breast milk

Contraindications:

Hypersensitivity to amlodipine, benazepril, other ACE inhibitors, or any component of the formulation; pregnancy (2nd and 3rd trimesters)

Warnings/Precautions:

Used as a replacement for separate dosing of components or combination when response to single agent is suboptimal; the fixed combination is not indicated for initial treatment of hypertension; see individual monographs for additional warnings/precautions

Adverse Reactions:

See individual agents.

Drug Interactions:

Amlodipine: Substrate of CYP3A4 (major); Inhibits CYP1A2 (moderate), 2A6 (weak), 2B6 (weak), 2C8/9 (weak), 2D6 (weak), 3A4 (weak)

Also see individual agents.

Mechanism of Action:

The mechanism through which benazepril lowers blood pressure is believed to be primarily suppression of the renin-angiotensin-aldosterone system, benazepril has an antihypertensive effect even in patients with low-renin hypertension; amlodipine is a dihydropyridine calcium antagonist that inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle; amlodipine is a peripheral arterial vasodilator that acts directly on vascular smooth muscle to cause a reduction in peripheral vascular resistance and reduction in blood pressure

Pharmacodynamics/Kinetics:

See individual agents.

Dosage:

Oral:

Adults: Dose is individualized, given once daily

Elderly: Initial dose: 2.5 mg based on amlodipine component

Dosage adjustment in renal impairment: Clcr 30 mL/minute: Use of combination product is not recommended.

Dosage adjustment in hepatic impairment: Initial dose: 2.5 mg based on amlodipine component

Patient Education:

See individual agents. Pregnancy/breast-feeding precautions: Inform prescriber if you are or intend to become pregnant. Consult prescriber if breast-feeding.

Dental Health: Effects on Dental Treatment:

Fewer reports of gingival hyperplasia with amlodipine than with other CCBs (usually resolves upon discontinuation); consultation with physician is suggested.

Dental Health: Vasoconstrictor/Local Anesthetic Precautions:

No information available to require special precautions

Mental Health: Effects on Mental Status:

May cause drowsiness; rarely may produce insomnia and nervousness

Mental Health: Effects on Psychiatric Treatment:

May decrease lithium clearance resulting in an increase in serum lithium levels and potential lithium toxicity; monitor serum lithium levels

Dosage Forms:

Capsule:

Amlodipine 2.5 mg and benazepril hydrochloride 10 mg

Amlodipine 5 mg and benazepril hydrochloride 10 mg

Amlodipine 5 mg and benazepril hydrochloride 20 mg

Amlodipine 10 mg and benazepril hydrochloride 20 mg

References

Wynn RL, "An Update on Calcium Channel Blocker-Induced Gingival Hyperplasia,"Gen Dent, 1995, 43(3):218-22.

Wynn RL, "Calcium Channel Blockers and Gingival Hyperplasia,"Gen Dent, 1991, 39(4):240-3.

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