lisinopril and hydrochlorothiazide- lisinopril and hydrochlorothiazide tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

lisinopril (UNII: E7199S1YWR) (lisinopril - UNII:E7199S1YWR), hydrochlorothiazide (UNII: 0J48LPH2TH) (hydrochlorothiazide - UNII:0J48LPH2TH)

Available from:

Actavis Elizabeth, LLC

INN (International Name):

lisinopril and hydrochlorothiazide

Pharmaceutical form:

TABLET

Composition:

10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Lisinopril and hydrochlorothiazide tablets are indicated for the treatment of hypertension. These fixed-dose combinations are not indicated for initial therapy (see DOSAGE AND ADMINISTRATION). In using lisinopril and hydrochlorothiazide, consideration should be given to the fact that an angiotensin converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease, and that available data are insufficient to show that lisinopril does not have a similar risk. (See WARNINGS.) In considering use of lisinopril and hydrochlorothiazide, it should be noted that black patients receiving ACE inhibitors have been reported to have a higher incidence of angioedema compared to non-blacks. (See WARNINGS, Angioedema.) Lisinopril and hydrochlorothiazide tablets are contraindicated in patients who are hypersensitive to any component of this product and in patients with a history of angioedema related to previous treatment with an angiotensin converti

Product summary:

Lisinopril and Hydrochlorothiazide Tablets are available as follows: 10 mg/12.5 mg — Each white to off-white, round tablet imprinted with and 706 on one side and plain on the other side contains 10 mg of lisinopril and 12.5 mg of hydrochlorothiazide. Tablets are supplied in bottles of 30 (NDC 0228-2706-03) and 100 (NDC 0228-2706-11) with a child-resistant closure and bottles of 500 (NDC 0228-2706-50) and 1000 (NDC 0228-2706-96) without a child-resistant closure. 20 mg/12.5 mg — Each yellow, round tablet imprinted with and 707 on one side and plain on the other side contains 20 mg of lisinopril and 12.5 mg of hydrochlorothiazide. Tablets are supplied in bottles of 30 (NDC 0228-2707-03) and 100 (NDC 0228-2707-11) with a child-resistant closure and bottles of 500 (NDC 0228-2707-50) and 1000 (NDC 0228-2707-96) without a child-resistant closure. 20 mg/25 mg — Each pink mottled, round tablet imprinted with and 708 on one side and plain on the other side contains 20 mg of lisinopril and 25 mg of hydrochlorothiazide. Tablets are supplied in bottles of 30 (NDC 0228-2708-03) and 100 (NDC 0228-2708-11) with a child-resistant closure and bottles of 500 (NDC 0228-2708-50) and 1000 (NDC 0228-2708-96) without a child-resistant closure. Store at controlled room temperature, 15-30°C (59-86°F)[see USP]. Protect from excessive light and humidity. Dispense in a tight, light-resistant container as defined in the USP. Manufactured by: PUREPAC PHARMACEUTICAL CO. Elizabeth, NJ 07207 USA 40-8951 Revised — July 2004

Summary of Product characteristics

LISINOPRIL AND HYDROCHLOROTHIAZIDE- LISINOPRIL AND HYDROCHLOROTHIAZIDE
TABLET
ACTAVIS ELIZABETH, LLC
----------
LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS
40-8951
REVISED — JULY 2004
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, lisinopril and
hydrochlorothiazide should be discontinued as soon as possible. See
WARNINGS, Pregnancy,
Lisinopril, Fetal/Neonatal Morbidity and Mortality.
DESCRIPTION
Lisinopril and hydrochlorothiazide combines an angiotensin converting
enzyme inhibitor, lisinopril, and
a diuretic, hydrochlorothiazide.
Lisinopril, a synthetic peptide derivative, is an oral long-acting
angiotensin converting enzyme inhibitor.
It is chemically described as (_S_)-1-[_N_
-(1-carboxy-3-phenylpropyl)-
-lysyl]-
-proline dihydrate. Its
molecular formula is C
H N O •2H O and its structural formula is:
Lisinopril is a white to off-white, crystalline powder, with a
molecular weight of 441.52. It is soluble
in water, sparingly soluble in methanol, and practically insoluble in
ethanol. Hydrochlorothiazide is 6-
chloro-3,4-dihydro-2_H_-1,2,4-benzothiadiazine-7-sulfonamide
1,1-dioxide. Its molecular formula is
C H CIN O S and its structural formula is:
Hydrochlorothiazide is a white, or practically white, crystalline
powder with a molecular weight of
297.73, which is slightly soluble in water, but freely soluble in
sodium hydroxide solution.
Each lisinopril and hydrochlorothiazide 10 mg/12.5 mg tablet for oral
administration, contains:
Lisinopril . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
mg
Hydrochlorothiazide . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . 12.5 mg
_2_
L
L
21
31
3
5
2
7
8
3
4
2
Each lisinopril and hydrochlorothiazide 20 mg/12.5 mg tablet for oral
administration, contains:
Lisinopril . . . . . . . . . . . . . . . . . . . . .