LISINOPRIL WITH HYDROCHLOROTHIAZIDE- lisinopril and hydrochlorothiazide tablet

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

LISINOPRIL (UNII: E7199S1YWR) (LISINOPRIL ANHYDROUS - UNII:7Q3P4BS2FD), HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)

Disponible des:

Aphena Pharma Solutions - Tennessee, LLC

Designació comuna internacional (DCI):

LISINOPRIL

Composición:

LISINOPRIL 20 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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 Tablets, 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 the use of Lisinopril and Hydrochlorothiazide Tablets, it should be noted that ACE inhibitors have been associated with a higher rate of angioedema in black than in non-black patients.(See WARNINGS ,Lisinopril . ) Lisinopril and Hydrochlorothiazide Tablets are contraindicated in patients who are hypersensitive to this product and in patients with a history of angioedema related to previous treatment with an angiotensin-converting enzyme in

Resumen del producto:

Repackaged by Aphena Pharma Solutions - TN. See Repackaging Information for available configurations. Lisinopril and Hydrochlorothiazide Tablets, 10-12.5 mg are Blue with White Mottling, Round, Unscored Tablet, Debossed “WW 62” and are available in: Lisinopril and Hydrochlorothiazide Tablets, 20-12.5 mg are Yellow with White Mottling, Round, Unscored Tablet, Debossed 'WW 63' and are available in: Lisinopril and Hydrochlorothiazide Tablets, 20-25 mg are Peach-Red with White Mottling, Round, Unscored Tablet, Debossed 'WW 64' and are available in: 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 Revised April 2012

Estat d'Autorització:

Abbreviated New Drug Application

Fitxa tècnica

LISINOPRIL WITH HYDROCHLOROTHIAZIDE- LISINOPRIL AND
HYDROCHLOROTHIAZIDE TABLET
APHENA PHARMA SOLUTIONS - TENNESSEE, LLC
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LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS
Rev. 04/12
RX ONLY WARNING: FETAL TOXICITY
WHEN PREGNANCY IS DETECTED, DISCONTINUE LISINOPRIL AND
HYDROCHLOROTHIAZIDE TABLETS 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
Lisinopril and Hydrochlorothiazide Tablets combine 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 1-[_N_
-[(S)-1-Carboxy-3-phenylpropyl]-L-lysyl]-L-proline
dihydrate. Its empirical 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 empirical formula is C H ClN O S and its structural formula is:
Hydrochlorothiazide is a white, or practically white, crystalline
powder with a molecular weight of
297.74, which is slightly soluble in water, but freely soluble in
sodium hydroxide solution.
Lisinopril and Hydrochlorothiazide Tablets are available for oral use
in three tablet combinations of
2
21
31
3
5
2
7
8
3
4
2
Lisinopril and Hydrochlorothiazide Tablets: 10-12.5 mg containing 10
mg lisinopril and 12.5 mg
hydrochlorothiazide; Lisinopril and Hydrochlorothiazide Tablets:
20-12.5 mg containing 20 mg
lisinopril and 12.5 mg hydrochlorothiazide; and Lisinopril and
Hydrochlorothiazide Tablets: 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,
Lactos