Quốc gia: Hoa Kỳ
Ngôn ngữ: Tiếng Anh
Nguồn: NLM (National Library of Medicine)
AMLODIPINE BESYLATE (UNII: 864V2Q084H) (AMLODIPINE - UNII:1J444QC288), BENAZEPRIL HYDROCHLORIDE (UNII: N1SN99T69T) (BENAZEPRILAT - UNII:JRM708L703)
PD-Rx Pharmaceuticals, Inc.
AMLODIPINE BESYLATE
AMLODIPINE 5 mg
ORAL
PRESCRIPTION DRUG
Amlodipine and benazepril hydrochloride capsules, USP 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 in patients with diabetes. - Amlodipine and benazepril hydrochloride is 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 is 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
Amlodipine and benazepril hydrochloride capsules USP are available as capsules containing amlodipine besylate equivalent to 5 mg of amlodipine, with 20 mg of benazepril hydrochloride providing for the following available combinations: 5 mg/20 mg,. Amlodipine and benazepril hydrochloride capsules USP, 5 mg/20 mg are size '2' capsules with flesh opaque cap and flesh opaque body, imprinted with 'LU' (in black ink) on cap and 'E13' (in black ink) on body, containing white to off-white powder and white to off-white, circular tablet, plain on both sides. NDC 43063-571-90 Bottles of 90 capsules Storage : Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature.] Protect from moisture. Dispense in tight container (USP).
Abbreviated New Drug Application
HYDROCHLORIDE CAPSULE PD-Rx Pharmaceuticals, Inc. ---------- Patient Information AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE CAPSULES USP (am loe′ di peen and ben az′ e pril hye′′ droe klor′ ide) Read this Patient Information leaflet before you start taking amlodipine and benazepril hydrochloride capsules and each time you get a refill. There may be new information. This leaflet does not replace talking with your doctor. If you have any questions, ask your doctor or pharmacist. What is the most important information I should know about amlodipine and benazepril hydrochloride capsules? • Amlodipine and benazepril hydrochloride capsules can cause harm or death to an unborn baby. • Talk to your doctor about other ways to lower your blood pressure if you plan to become pregnant. • If you get pregnant while taking amlodipine and benazepril hydrochloride capsules, tell your doctor right away. What is amlodipine and benazepril hydrochloride capsule? Amlodipine and benazepril hydrochloride capsule contains 2 prescription medicines that work together to lower blood pressure: amlodipine besylate (the active ingredient found in Norvasc ®), a calcium channel blocker, and benazepril hydrochloride (Lotensin ®), an ACE inhibitor. Your doctor will prescribe amlodipine and benazepril hydrochloride capsules only after other medicines haven't worked. High Blood Pressure (hypertension).Blood pressure is the force of blood in your blood vessels. You have high blood pressure when the force is too much. Amlodipine and benazepril hydrochloride capsules can help your blood vessels relax so your blood pressure is lower. Amlodipine and benazepril hydrochloride capsules have not been studied in children. Who should not take amlodipine and benazepril hydrochloride capsules? Don't take amlodipine and benazepril hydrochloride capsules if you are allergic to any of the ingredients. There is a complete list at the end of this leaflet. What should I tell my Doctor before taking amlodipine and benazepril hydrochloride capsules? Tell Đọc toàn bộ tài liệu
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE- AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE PD-RX PHARMACEUTICALS, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE CAPSULES, USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE CAPSULES, USP. AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE CAPSULES, USP 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 CAPSULES 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 capsule, USP 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, USP is indicated for the treatment of hypertension in patients not adequately controlled on monotherapy with either agent ( 1). DOSAGE AND ADMINISTRATION Usual starting dose is 2.5/10 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, USP containing a lower dose of amlodipine. ( 2.1) DOSAGE FORMS AND STRENGTHS Capsules (amlodipine/benazepril mg): 2.5/10, 5/10, 5/20, 5/40, 10/20, 10/40 ( 3) CONTRAINDICATIONS Do not coadminister aliskiren with ACE inhibitors, including amlodipine and benazepril hydrochloride, in patients with diabetes. ( 4) Amlodipine and benazepril hydrochloride is contraindicated in patients with a history of angioedema or patients who are hypersensitive to benazepril or to Đọc toàn bộ tài liệu