QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE tablet, film coated QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE- qinapril h

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

QUINAPRIL HYDROCHLORIDE (UNII: 33067B3N2M) (QUINAPRIL - UNII:RJ84Y44811), HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)

Available from:

Physicians Total Care, Inc.

INN (International Name):

QUINAPRIL HYDROCHLORIDE

Composition:

QUINAPRIL HYDROCHLORIDE 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Quinapril hydrochloride and 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 and 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 and hydrochlorothiazide tablets are contra

Product summary:

Quinapril hydrochloride and hydrochlorothiazide tablets are available in three different strengths: 10 mg/12.5 mg tablets: pink colored, capsule shaped, biconvex, film-coated tablets, debossed with "RX" and "161" on either side of the scoreline on one side and a deep breakline on the other side. Each tablet contains 10 mg of quinapril and 12.5 mg of hydrochlorothiazide. NDC-54868-1802-0   Bottles of 30 20 mg/12.5 mg tablets: pink colored, capsule shaped, biconvex, film-coated tablets, debossed with "RX" and "162" on either side of the scoreline on one side and a deep breakline on the other side. Each tablet contains 20 mg of quinapril and 12.5 mg of hydrochlorothiazide. NDC 54868-2847-1  Bottles of 10 NDC 54868-2847-0  Bottles of 30 20 mg/25 mg tablets: pink colored, round biconvex, film-coated tablets, debossed with "RX 163" on one side and plain on the other side. Each tablet contains 20 mg of quinapril and 25 mg of hydrochlorothiazide NDC 54868-5475-0   Bottles of 30 Dispense in tight containers as defined in the USP. Store at 20 - 25° C (68 - 77° F) (See USP Controlled Room Temperature). Manufactured for: Ranbaxy Pharmaceuticals Inc. Jacksonville, FL 32257 USA by: Ohm Laboratories Inc North Brunswick, NJ 08902 January 2006 Repackaging and Relabeling by: Physicians Total Care, Inc. Tulsa, OK      74146

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE - QUINAPRIL
HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED
PHYSICIANS TOTAL CARE, INC.
----------
Rx only
USE IN PREGNANCY
WHEN USED IN PREGNANCY DURING THE SECOND AND THIRD TRIMESTERS, ACE
INHIBITORS CAN CAUSE
INJURY AND EVEN DEATH TO THE DEVELOPING FETUS. When pregnancy is
detected, quinapril
hydrochloride and hydrochlorothiazide should be discontinued as soon
as possible. See
WARNINGS: FETAL/NEONATAL MORBIDITY AND MORTALITY.
DESCRIPTION
Quinapril hydrochloride and hydrochlorothiazide is a fixed-combination
tablet that combines an
angiotensin-converting enzyme (ACE) inhibitor, quinapril
hydrochloride, and a thiazide diuretic,
hydrochlorothiazide.
Quinapril hydrochloride USP is chemically described as [3S-[2[R*(R*)],
3R*]]-2-[2-[[1-
(ethoxycarbonyl)-3-phenylpropyl]amino]-1-oxopropyl]-1,2,3,4-tetrahydro-3-isoquinoline-carboxylic
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 powder with a pink
cast at times that is freely
soluble in aqueous solvents.
Hydrochlorothiazide USP 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 ClN O S and its structural
formula is:
Hydrochlorothiazide USP is a white to off-white, practically odorless,
crystalline powder which is
25
30
2
5
7
8
3
4
2
slightly soluble in water, freely soluble in sodium hydroxide
solution, in n-butylamine, and in
dimethylformamide, sparingly soluble in methanol, insoluble in ether,
in chloroform, and in dilute
mineral acids.
Quinapril hydrochloride and hydrochlorothiazide is available for oral
use as fixed combination tablets
in three strengths of quinapril with hydrochlorothiazide: 10 mg/12.5
mg containing10 mg of quinapril
hydrochloride USP and 12.5 mg of hydrochlorothiazide USP, 20 mg/12.5
mg containing 20 mg of
quinapril hydrochloride USP and 12.5 mg of hydrochlorothiazide USP and
20 mg/25 mg containing 20
mg of q