AMLODIPINE BESYLATE 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:

PD-Rx Pharmaceuticals, Inc.

INN (nemzetközi neve):

AMLODIPINE BESYLATE

Összetétel:

AMLODIPINE 5 mg

Az alkalmazás módja:

ORAL

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

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

Termék összefoglaló:

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).  

Engedélyezési státusz:

Abbreviated New Drug Application

Betegtájékoztató

HYDROCHLORIDE CAPSULE
PD-Rx Pharmaceuticals, Inc.
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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

Termékjellemzők

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