QUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDE tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

QUINAPRIL HYDROCHLORIDE (UNII: 33067B3N2M) (QUINAPRILAT - UNII:34SSX5LDE5), HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)

Available from:

Lake Erie Medical DBA Quality Care Products LLC

INN (International Name):

QUINAPRIL HYDROCHLORIDE

Composition:

QUINAPRIL 20 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Quinapril hydrochloride/hydrochlorothiazide tablets are indicated for the treatment of hypertension.  This fixed combination is not indicated for the initial therapy of hypertension (see DOSAGE AND ADMINISTRATION ). In using quinapril hydrochloride/hydrochlorothiazide, consideration should be given to the fact that another angiotensin-converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen-vascular disease. Available data are insufficient to show that quinapril does not have a similar risk (see WARNINGS: Neutropenia/Agranulocytosis ). Angioedema in Black Patients Black patients receiving ACE inhibitor monotherapy have been reported to have a higher incidence of angioedema compared to non-blacks. It should also be noted that in controlled clinical trials, ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks. Quinapril hydrochloride/hydrochlorothiazidetablets are contraindicated

Product summary:

Quinapril Hydrochloride/Hydrochlorothiazide 10 mg/12.5 mg* Tablets are Pink colored, scored, oval shaped, biconvex, film-coated tablets debossed with ‘D’ on scored side and ‘18’ on other side. *Quinapril hydrochloride equivalent to 10 mg of quinapril. Quinapril Hydrochloride/Hydrochlorothiazide 20 mg/12.5 mg* Tablets are Pink colored, scored, round shaped, biconvex, film-coated tablets debossed with ‘D’ on scored side and ‘19’ on other side. NDC: 35356-998-30  Bottles of 30 NDC: 35356-998-60  Bottles of 60 NDC: 35356-998-90  Bottles of 90 *Quinapril hydrochloride equivalent to 20 mg of quinapril. Quinapril Hydrochloride/Hydrochlorothiazide 20 mg/25 mg* Tablets are Pink colored, round shaped, biconvex, film-coated tablets debossed with ‘D’ on one side and ‘20’ on other side. *Quinapril hydrochloride equivalent to 20 mg of quinapril. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from light. Manufactured for: Aurobindo Pharma USA, Inc. 2400 Route 130 North Dayton, NJ 08810 Manufactured by: Aurobindo Pharma Limited Hyderabad–500 072, India Revised: 10/2012

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

QUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDE- QUINAPRIL
HYDROCHLORIDE/HYDROCHLOROTHIAZIDE TABLET, FILM COATED
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
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QUINAPRIL HYDROCHLORIDE/HYDROCHLOROTHIAZIDE TABLETS
WARNING: FETAL TOXICITY
WHEN PREGNANCY IS DETECTED, DISCONTINUE QUINAPRIL
HYDROCHLORIDE/HYDROCHLOROTHIAZIDE
AS SOON AS POSSIBLE.
DRUGS THAT ACT DIRECTLY ON THE RENIN-ANGIOTENSIN SYSTEM CAN CAUSE
INJURY AND DEATH TO THE
DEVELOPING FETUS. SEE WARNINGS: FETAL TOXICITY.
DESCRIPTION
Quinapril hydrochloride/hydrochlorothiazide is a fixed-combination
tablet that combines an
angiotensin-converting enzyme (ACE) inhibitor, quinapril
hydrochloride, and a thiazide diuretic,
hydrochlorothiazide.
Quinapril hydrochloride is chemically described as [3S-[2[R*(R*)],
3R*]]-2-[2-[[1-(ethoxycarbonyl)-3-
phenylpropyl]amino]-1-oxopropyl]-1,2,3,4-tetrahydro-3-isoquinolinecarboxylic
acid,
monohydrochloride. Its molecular formula is C
H N O . HCl and its structural formula is:
Quinapril hydrochloride USP is a white to off-white amorphous powder
that is freely soluble in
aqueous solvents.
Hydrochlorothiazide is chemically described as:
6-Chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-
sulfonamide 1,1-dioxide. Its molecular formula is C H CIN O S and its
structural formula is:
Hydrochlorothiazide USP is a white to off-white, crystalline powder
which is slightly soluble in water
but freely soluble in sodium hydroxide solution.
Quinapril hydrochloride/hydrochlorothiazide is available for oral use
as fixed combination tablets in
25
30
2
5
7
8
3
4
2
three strengths of quinapril with hydrochlorothiazide: 10 mg with 12.5
mg (quinapril
hydrochloride/hydrochlorothiazide 10/12.5), 20 mg with 12.5 mg
(quinapril
hydrochloride/hydrochlorothiazide 20/12.5), and 20 mg with 25 mg
(quinapril
hydrochloride/hydrochlorothiazide20/25). The strength of the quinapril
hydrochloride component is in
terms of quinapril. Inactive ingredients: lactose monohydrate,
magnesium carbonate, crospovidone,
povidone, magnesium stearate, hypromellose, hydroxypro