AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE capsule

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

AMLODIPINE BESYLATE (UNII: 864V2Q084H) (AMLODIPINE - UNII:1J444QC288), BENAZEPRIL HYDROCHLORIDE (UNII: N1SN99T69T) (BENAZEPRILAT - UNII:JRM708L703)

Beszerezhető a:

REMEDYREPACK INC.

Az alkalmazás módja:

ORAL

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

Amlodipine and benazepril hydrochloride capsules are indicated for the treatment of hypertension in patients not adequately controlled on monotherapy with either agent. - Do not coadminister aliskiren with angiotensin receptor blockers (ARBs), ACE inhibitors, including amlodipine and benazepril hydrochloride capsules in patients with diabetes. - Amlodipine 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, to amlodipine, or to any of the excipients of amlodipine and benazepril hydrochloride capsules. - Amlodipine and benazepril hydrochloride capsules are contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril). Do not administer amlodipine and benazepril hydrochloride capsules within 36 hours of switching to or from a neprilysin inhibitor, e.g., sacubitril/valsartan (see Warnings and Precautions 5.1) Teratogenic Effects Pregnancy Category D Use of drugs that act on the RAS 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 and benazepril hydrochloride as soon as possible. These adverse outcomes are usually associated with use of these drugs in the second and third trimester of pregnancy. Most epidemiologic studies examining fetal abnormalities after exposure to antihypertensive use in the first trimester have not distinguished drugs affecting the RAS from other antihypertensive agents. Appropriate management of maternal hypertension during pregnancy is important to optimize outcomes for both mother and fetus. In the unusual case that there is no appropriate alternative to therapy with drugs affecting the RAS for a particular patient, apprise the mother of the potential risk to the fetus. Perform serial ultrasound examinations to assess the intra-amniotic environment. If oligohydramnios is observed, discontinue amlodipine and benazepril hydrochloride, unless it is considered lifesaving for the mother. Fetal testing may be appropriate, based on the week of pregnancy. Patients and physicians should be aware, however, that oligohydramnios may not appear until after the fetus has sustained irreversible injury. Closely observe infants with histories of in utero exposure to amlodipine and benazepril hydrochloride for hypotension, oliguria, and hyperkalemia [see Use in Specific Populations (8.4) ]. The effect of amlodipine and benazepril hydrochloride on labor and delivery has not been studied. Minimal amounts of unchanged benazepril and of benazeprilat are excreted into the breast milk of lactating women treated with benazepril, so that a newborn child ingesting nothing but breast milk would receive less than 0.1% of the maternal doses of benazepril and benazeprilat. It is not known whether amlodipine is excreted in human milk. Nursing or drug should be discontinued. Neonates with a History of in utero Exposure to amlodipine and benazepril hydrochloride If oliguria or hypotension occurs, direct attention toward support of blood pressure and renal perfusion. Exchange transfusions or dialysis may be required as a means of reversing hypotension and/or substituting for disordered renal function. Benazepril, which crosses the placenta, can theoretically be removed from the neonatal circulation by these means; there are occasional reports of benefit from these maneuvers, but experience is limited. In geriatric patients, exposure to amlodipine is increased, thus consider lower initial doses of amlodipine and benazepril hydrochloride [see Clinical Pharmacology (12.3)] . Of the total number of patients who received amlodipine and benazepril hydrochloride in U.S. clinical studies of amlodipine and benazepril hydrochloride, over 19% were 65 years or older while about 2% were 75 years or older. Overall differences in effectiveness or safety were not observed between these patients and younger patients. Clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Exposure to amlodipine is increased in patients with hepatic insufficiency, thus consider using lower doses of amlodipine and benazepril hydrochloride [see Clinical Pharmacology (12.3)] . In patients with severe renal impairment systemic exposure to benazepril is increased. The recommended dose of benazepril in this subgroup is 5 mg which is not an available strength with amlodipine and benazepril hydrochloride. Amlodipine and benazepril hydrochloride is not recommended in patients with severe renal impairment. No dose adjustment of amlodipine and benazepril hydrochloride is needed in patients with mild or moderate impairment of renal function [see Dosage and Administration (2.2),  Warnings and Precautions (5.7) and Clinical Pharmacology (12.3)] .

Termék összefoglaló:

Amlodipine and benazepril hydrochloride is available as capsules containing amlodipine besylate equivalent to 2.5 mg, 5 mg, or 10 mg of amlodipine, with 10 mg, 20 mg, or 40 mg of benazepril hydrochloride providing for the following available combinations:  2.5 mg/10 mg, 5 mg/10 mg, 5 mg/20 mg, 5 mg/40 mg, 10 mg/20 mg, and 10 mg/40 mg. They are available as follows: Amlodipine and Benazepril Hydrochloride Capsules USP, 2.5 mg/10 mg are white to pale yellow colored powder filled in empty hard gelatin capsule shells, size “0” of white cap and white body imprinted with ‘I’ on white cap and ‘96’ on white body with black edible ink.             Bottles of 100                            NDC 65862-582-01             Bottles of 500                            NDC 65862-582-05 Amlodipine and Benazepril Hydrochloride Capsules USP, 5 mg/10 mg are white to pale yellow colored powder filled in empty hard gelatin capsule shells, size “0” of light brown cap and light brown body imprinted with ‘I’ on light brown cap and ‘97’ on light brown body with black edible ink.             Bottles of 100                            NDC 65862-583-01             Bottles of 500                            NDC 65862-583-05 Amlodipine and Benazepril Hydrochloride Capsules USP, 5 mg/20 mg are white to pale yellow colored powder filled in empty hard gelatin capsule shells, size “0” of pink cap and pink body imprinted with ‘I’ on pink cap and ‘98’ on pink body with black edible ink.             Bottles of 100                            NDC 65862-584-01             Bottles of 500                            NDC 65862-584-05 Amlodipine and Benazepril Hydrochloride Capsules USP, 5 mg/40 mg are white to pale yellow colored powder filled in empty hard gelatin capsule shells, size “0” of light blue cap and light blue body imprinted with ‘J’ on light blue cap and ‘01’ on light blue body with black edible ink.             Bottles of 100                            NDC 65862-585-01             Bottles of 500                            NDC 65862-585-05 Amlodipine and Benazepril Hydrochloride Capsules USP, 10 mg/20 mg are white to pale yellow colored powder filled in empty hard gelatin capsule shells, size “0” of purple cap and purple body imprinted with ‘J’ on purple cap and ‘02’ on purple body with black edible ink.             Bottles of 100                            NDC 65862-586-01             Bottles of 500                            NDC 65862-586-05 Amlodipine and Benazepril Hydrochloride Capsules USP, 10 mg/40 mg are white to pale yellow colored powder filled in empty hard gelatin capsule shells, size “0” of dark blue cap and dark blue body imprinted with ‘J’ on dark blue cap and ‘03’ on dark blue body with black edible ink.             Bottles of 100                           NDC 65862-587-01             Bottles of 500                           NDC 65862-587-05 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from moisture. Dispense in tight container (USP).

Engedélyezési státusz:

Abbreviated New Drug Application

Termékjellemzők

AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE- AMLODIPINE AND BENAZEPRIL
HYDROCHLORIDE CAPSULE
REMEDYREPACK INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
AMLODIPINE AND
BENAZEPRIL HYDROCHLORIDE CAPSULES SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING
INFORMATION FOR AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE CAPSULES.
AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 1995
WARNING: FETAL TOXICITY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
_ _
WHEN PREGNANCY IS DETECTED, DISCONTINUE AMLODIPINE AND BENAZEPRIL
HYDROCHLORIDE AS
SOON AS POSSIBLE ( 5.5). DRUGS THAT ACT DIRECTLY ON THE
RENIN-ANGIOTENSIN SYSTEM (RAS)
CAN CAUSE INJURY AND DEATH TO THE DEVELOPING FETUS ( 5.5).
INDICATIONS AND USAGE
Amlodipine and benazepril hydrochloride capsules are a combination
capsule of amlodipine, a
dihydropyridine calcium channel blocker (DHP CCB) and benazepril, an
angiotensin-converting enzyme
(ACE) inhibitor. Amlodipine and benazepril hydrochloride capsules are
indicated for the treatment of
hypertension in patients not adequately controlled on monotherapy with
either agent. (1)
DOSAGE AND ADMINISTRATION
Usual starting dose is 2.5 mg/10 mg. ( 2.1)
May be used as add-on therapy for patients not adequately controlled
with either a dihydropyridine
calcium channel blocker or an ACE inhibitor. ( 2.2)
Patients who experience edema with amlodipine may be switched to
amlodipine and benazepril
hydrochloride capsules containing a lower dose of amlodipine. ( 2.1)
DOSAGE FORMS AND STRENGTHS
Capsules (amlodipine and benazepril): 2.5 mg/10 mg, 5 mg/10 mg, 5
mg/20 mg, 5 mg/40 mg, 10 mg/20
mg, and 10 mg/40 mg. (3)
CONTRAINDICATIONS
Do not coadminister aliskiren with ACE inhibitors, including
amlodipine and benazepril hydrochloride
capsules, in patients with diabetes. (4)
Amlodipine and benazepril hydrochloride capsules are contraindicated
in patients with a history of
angioedema or patients who are hypersensitive to benazepril or