Amlodipine Besylate and Benazepril Hydrochloride

AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE- amlodipine besylate and benazepril hydrochloride capsule
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WARNING: FETAL TOXICITY

When pregnancy is detected, discontinue Amlodipine Besylate and Benazepril Hydrochloride Capsules as soon as possible (5.4). Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus (5.4)

1 INDICATIONS AND USAGE

1.1 Hypertension

Amlodipine Besylate and Benazepril Hydrochloride Capsules are indicated for the treatment of hypertension in patients not adequately controlled on monotherapy with either agent.

2 DOSAGE AND ADMINISTRATION

Amlodipine is an effective treatment of hypertension in once-daily doses of 2.5-10 mg while benazepril is effective in doses of 10-80 mg. In clinical trials of amlodipine/benazepril combination therapy using amlodipine doses of 2.5-10 mg and benazepril doses of 10-40 mg, the antihypertensive effects increased with increasing dose of amlodipine in all patient groups, and the effects increased with increasing dose of benazepril in nonblack groups.

The antihypertensive effect of Amlodipine Besylate and Benazepril Hydrochloride Capsules is largely attained within 2 weeks.

It is usually appropriate to begin therapy with Amlodipine Besylate and Benazepril Hydrochloride Capsules only after a patient has either (a) failed to achieve the desired antihypertensive effect with one or the other monotherapy, or (b) demonstrated inability to achieve adequate antihypertensive effect with amlodipine therapy without developing edema.

Renal Impairment: Regimens of therapy with Amlodipine Besylate and Benazepril Hydrochloride Capsules need not take account of renal function as long as the patient’s creatinine clearance is >30 mL/min/1.73m2 (serum creatinine roughly ≤3 mg/dL or 265 µmol/L). Amlodipine Besylate and Benazepril Hydrochloride Capsules are not recommended in patients with more severe renal impairment.

Hepatic Impairment and Elderly Patients : The recommended initial dose of amlodipine, as monotherapy or as a component of combination therapy, is 2.5 mg.

2.2 Add-on Therapy

A patient whose blood pressure is not adequately controlled with amlodipine (or another dihydropyridine) alone or with benazepril (or another ACE inhibitor) alone may be switched to combination therapy with Amlodipine Besylate and Benazepril Hydrochloride Capsules.

In patients whose blood pressure is adequately controlled with amlodipine but who experience unacceptable edema, combination therapy may achieve similar (or better) blood pressure control with less edema.

2.3 Replacement Therapy

Amlodipine Besylate and Benazepril Hydrochloride Capsules may be substituted for the titrated components.

3 DOSAGE FORMS AND STRENGTHS

Amlodipine Besylate and Benazepril Hydrochloride Capsules are available as follows:

2.5/10 mg, 5/10 mg, 5/20 mg, 5/40 mg, 10/20 mg, and 10/40 mg.

4 CONTRAINDICATIONS

Amlodipine Besylate and Benazepril Hydrochloride Capsules are contraindicated in patients with a history of angioedema, with or without previous ACE inhibitor treatment, or patients who are hypersensitive to benazepril, to any other ACE inhibitor, or to amlodipine.

5 WARNINGS AND PRECAUTIONS

5.1 Anaphylact o i d and Possibly Related Reactions

Presumably because angiotensin-converting enzyme inhibitors affect the metabolism of eicosanoids and polypeptides, including endogenous bradykinin, patients receiving ACE inhibitors (including Amlodipine Besylate and Benazepril Hydrochloride Capsules) may be subject to a variety of adverse reactions, some of them serious. These reactions usually occur after one of the first few doses of the ACE inhibitor, but they sometimes do not appear until after months of therapy. Black patients receiving ACE inhibitors have a higher incidence of angioedema compared to nonblacks.

Head and Neck Angioedema: Angioedema of the face, extremities, lips, tongue, glottis, and larynx has been reported in patients treated with ACE inhibitors. In U.S. clinical trials, symptoms consistent with angioedema were seen in none of the subjects who received placebo and in about 0.5% of the subjects who received benazepril. Angioedema associated with laryngeal edema can be fatal. If laryngeal stridor or angioedema of the face, tongue, or glottis occurs, discontinue treatment with Amlodipine Besylate and Benazepril Hydrochloride Capsules and treat immediately. When involvement of the tongue, glottis, or larynx appears likely to cause airway obstruction, appropriate therapy, e.g., administer subcutaneous epinephrine injection 1:1000 (0.3-0.5 mL ), promptly [see Adverse Reactions (6) ].

Intestinal Angioedema: Intestinal angioedema has been reported in patients treated with ACE inhibitors. These patients presented with abdominal pain (with or without nausea or vomiting); in some cases there was no prior history of facial angioedema and C-1 esterase levels were normal. The angioedema was diagnosed by procedures including abdominal CT scan or ultrasound, or at surgery, and symptoms resolved after stopping the ACE inhibitor. Intestinal angioedema should be included in the differential diagnosis of patients on ACE inhibitors presenting with abdominal pain.

Anaphylactoid Reactions During Desensitization: Two patients undergoing desensitizing treatment with hymenoptera venom while receiving ACE inhibitors sustained life-threatening anaphylactoid reactions. In the same patients, these reactions were avoided when ACE inhibitors were temporarily withheld, but they reappeared upon inadvertent rechallenge.

Anaphylactoid Reactions During Membrane Exposure: Anaphylactoid reactions have been reported in patients dialyzed with high-flux membranes and treated concomitantly with an ACE inhibitor. Anaphylactoid reactions have also been reported in patients undergoing low-density lipoprotein apheresis with dextran sulfate absorption.

5.2 Increased Angina and/or Myocardial Infarction

Rarely, patients, particularly those with severe obstructive coronary artery disease, have developed documented increased frequency, duration or severity of angina or acute myocardial infarction on starting calcium channel blocker therapy or at the time of dosage increase. The mechanism of this effect has not been elucidated.

5. 3 Hypotension

Amlodipine Besylate and Benazepril Hydrochloride Capsules can cause symptomatic hypotension. Symptomatic hypotension is most likely to occur in patients who have been volume or salt depleted as a result of prolonged diuretic therapy, dietary salt restriction, dialysis, diarrhea, or vomiting.

In patients with congestive heart failure, with or without associated renal insufficiency, ACE inhibitor therapy may cause excessive hypotension, which may be associated with oliguria, azotemia, and (rarely) with acute renal failure and death. In such patients, start amlodipine besylate and benazepril hydrochloride therapy under close medical supervision; follow closely for the first 2 weeks of treatment and whenever the dose of the benazepril component is increased or a diuretic is added or its dose increased.

Symptomatic hypotension is also possible in patients with severe aortic stenosis.

If hypotension occurs, place the patient in a supine position, and if necessary, treat with intravenous infusion of physiologic saline. Amlodipine Besylate and Benazepril Hydrochloride Capsules treatment usually can be continued following restoration of blood pressure and volume.

5.4 Fetal Toxicity

Pregnancy Category D

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. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. When pregnancy is detected, discontinue Amlodipine Besylate and Benazepril Hydrochloride Capsules as soon as possible [see Use in Specific Populations (8.1)].

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