AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE

Electrolyte / Mineral

Brand names: Amlodipine Besylate and Benazepril Hydrochloride

Oral

Mechanism of Action

12.1 Mechanism of Action Benazepril Benazepril and benazeprilat inhibit angiotensin-converting enzyme (ACE) in human subjects and in animals. ACE is a peptidyl dipeptidase that catalyzes the conversion of angiotensin I to the vasoconstrictor substance angiotensin II. Angiotensin II also stimulates aldosterone secretion by the adrenal cortex. Inhibition of ACE results in decreased plasma angiotensin II, which leads to decreased vasopressor activity and to decreased aldosterone secretion. The latter decrease may result in a small increase of serum potassium. Hypertensive patients treated with benazepril and amlodipine for up to 56 weeks had elevations of serum potassium up to 0.2 mEq/L [see Warnings and Precautions ( 5.8 )] . Removal of angiotensin II negative feedback on renin secretion leads to increased plasma renin activity. In animal studies, benazepril had no inhibitory effect on the vasopressor response to angiotensin II and did not interfere with the hemodynamic effects of the au

Indications

1 INDICATIONS AND USAGE Amlodipine and benazepril hydrochloride capsule

is a combination capsule of amlodipine

a dihydropyridine calcium channel blocker (DHP CCB) and benazepril

an angiotensin converting-enzyme (ACE) inhibitor. Amlodipine and benazepril hydrochloride capsule

Contraindications

• 4 CONTRAINDICATIONS Do not coadminister aliskiren with ACE inhibitors
• including amlodipine and benazepril hydrochloride
• sacubitril). Do not administer amlodipine and benazepril hydrochloride capsules within 36 hours of switching to or from a neprilysin inhibitor
• e.g.
• sacubitril/valsartan. ( 5.1 ) Do not coadminister aliskiren with angiotensin receptor blockers (ARBs)

FDA Warnings

5 WARNINGS AND PRECAUTIONS Anaphylactoid reactions, including angioedema ( 5
Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death
Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death
Angioedema associated with edema of the larynx, tongue, or glottis can compromise the airway and be fatal

Known Side Effects

12 documented side effects by frequency

Fatigue

1-10%

Diarrhea

1-10%

Nausea

1-10%

Shortness of Breath

1-10%

Drug Not Working

1-10%

Dizziness

1-10%

Headache

1-10%

Weakness

1-10%

Falls

1-10%

Vomiting

1-10%

High Blood Pressure

1-10%

General Unwellness

1-10%

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Formulations

Dosage Forms

Tablet

Route

Oral