LISINOPRIL WITH HYDROCHLOROTHIAZIDE- lisinopril and hydrochlorothiazide tablet

Land: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

LISINOPRIL (UNII: E7199S1YWR) (LISINOPRIL - UNII:E7199S1YWR), HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)

Fáanlegur frá:

H.J. Harkins Company, Inc.

INN (Alþjóðlegt nafn):

LISINOPRIL

Samsetning:

LISINOPRIL 20 mg

Stjórnsýsluleið:

ORAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

Lisinopril and hydrochlorothiazide is 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 is 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 converting enzyme inhibi

Vörulýsing:

Lisinopril and Hydrochlorothiazide Tablets, 10/12.5 mg are Blue with White Mottling, Round, Unscored Tablet; Embossed "WW 62". Lisinopril and Hydrochlorothiazide Tablets, 20/12.5 mg are Yellow with White Mottling, Round, Unscored Tablet; Embossed "WW 63". Lisinopril and Hydrochlorothiazide Tablets, 20/25 mg are Peach-Red with White Mottling, Round, Unscored Tablet; Embossed "WW 64". They are supplied by H.J. Harkins Company, Inc. as follows: Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature]. Protect from excessive light and humidity. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Manufactured By: West-ward Pharmaceutical Corp. Eatontown, NJ 07724 This Product was Repackaged By: H.J. Harkins Company, Inc. 513 Sandydale Drive Nipomo, CA 93444 United States

Leyfisstaða:

Abbreviated New Drug Application

Vara einkenni

LISINOPRIL WITH HYDROCHLOROTHIAZIDE - LISINOPRIL AND
HYDROCHLOROTHIAZIDE TABLET
H.J. HARKINS COMPANY, INC.
----------
LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS
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, 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)L-lysyl]-L-proline dihydrate. Its
empirical formula is C
H N 0 •2H 0 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 empirical formula is C H CIN 0 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.
Lisinopril and hydrochlorothiazide is available for oral use in three
tablet combinations of lisinopril
and hydrochlorothiazide: 10-12.5 mg containing 10 mg lisinopril and
12.5 mg hydrochlorothiazide,
lisinopril and hydrochlorothiazide: 20-12.5 mg containing 20 mg
lisinopril and 12.5 mg
2
21
31
3
5
2
7
8
3
4
2
hydrochlorothiazide and lisinopril and hydrochlorothiazide: 20-25 mg
containing 20 mg lisinopril and
25 mg hydrochlorothiazide.
Inactive ingredients are as follows:
10/12.5 MG: Calcium Phosphate Dibasic, Colloidal Silicon Dioxide, Corn
Starch, FD&C Blue #2,
Lact