LISINOPRIL AND HYDROCHLOROTHIAZIDE tablet

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

NCS HealthCare of KY, Inc dba Vangard Labs

INN (International namn):

LISINOPRIL

Sammansättning:

LISINOPRIL 10 mg

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

Lisinopril and Hydrochlorothiazide Tablets USP 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 ACE inhibitors have been associated with a higher rate of angioedema in black than in nonblack patients (see WARNINGS, Lisinopril ). Lisinopril and hydrochlorothiazide is 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 inhibitor and in patients with

Produktsammanfattning:

Lisinopril and Hydrochlorothiazide Tablets USP,10/12.5mg are available as blue, round, biconvex, unscored tablets debossed and “5033” on one side and “10/12.5” on the other side containing 10 mg lisinopril USP and 12.5 mg hydrochlorothiazide USP, packaged in blisterpacks of 30 tablets. Lisinopril and Hydrochlorothiazide Tablets USP, 20/12.5mg are available as yellow, round, flat-faced, beveled edge, unscored tablets debossed and “5034” on one side and “20/12.5” on the other side containing 20 mg lisinopril USP and 12.5 mg hydrochlorothiazide USP, packaged in blisterpacks of 30 tablets. Lisinopril and Hydrochlorothiazide Tablets USP, 20/25mg are available as peach, round, flat-faced, beveled edge, unscored tablets debossed and “5032” on one side and “20/25” on the other side containing 20 mg lisinopril USP and 25 mg hydrochlorothiazide USP, packaged in blisterpacks of 30 tablets. Dispense in a tight container as defined in the USP, with a child-resistant closure (as required). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. PROTECT FROM EXCESSIVE LIGHT AND HUMIDITY KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Manufactured In India By: EMCURE PHARMACEUTICALS LTD. Hinjwadi, Pune, India Manufactured For: TEVA PHARMACEUTICALS USA Sellersville, PA 18960 Rev. E 8/2011

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

LISINOPRIL AND HYDROCHLOROTHIAZIDE- LISINOPRIL AND HYDROCHLOROTHIAZIDE
TABLET
NCS HEALTHCARE OF KY, INC DBA VANGARD LABS
----------
LISINOPRIL AND HYDROCHLOROTHIAZIDE
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 USP combines an angiotensin
converting enzyme inhibitor, lisinopril
USP, and a diuretic, hydrochlorothiazide USP.
Lisinopril USP, 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 and has the following structural formula:
C
H N O •2H O M.W. 441.53
Lisinopril USP is a white to off-white, crystalline powder. It is
soluble in water, sparingly soluble in
methanol, and practically insoluble in ethanol.
DESCRIPTION
Hydrochlorothiazide USP is 6-chloro-3,4-dihydro-2_H
_-1,2,4-benzothiadiazine-7-sulfonamide 1,1-
dioxide and has the following structural formula:
2
21
31
3
5
2
C H ClN O S M.W. 297.72
Hydrochlorothiazide USP is a white, or practically white, crystalline
powder which is slightly soluble
in water, but freely soluble in sodium hydroxide solution.
Lisinopril and Hydrochlorothiazide Tablets USP, for oral
administration, are available in three tablet
combinations of lisinopril with hydrochlorothiazide: lisinopril and
hydrochlorothiazide 10/12.5 mg,
containing 10 mg lisinopril USP and 12.5 mg hydrochlorothiazide USP;
lisinopril and
hydrochlorothiazide 20/12.5 mg, containing 20 mg lisinopril USP and
12.5 mg hydrochlorothiazide USP
and lisinopril and hydrochlorothiazide 20/25 mg, containing 20 mg
lisinopril USP and 25 mg
hydrochlorothiazide USP. In addition, each lisinopril and
hydrochlorothiazide tablet USP contains the
follow