LISINOPRIL AND HYDROCHLOROTHIAZIDE- lisinopril and hydrochlorothiazide tablet

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

AvKARE, Inc.

INN (International Nazwa):

LISINOPRIL

Skład:

LISINOPRIL 10 mg

Droga podania:

ORAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

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 use of lisinopril and hydrochlorothiazide tablets, 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 ,  Head and Neck 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 treat

Podsumowanie produktu:

Lisinopril and hydrochlorothiazide tablets, 10 mg/12.5 mg are light pink, round, biconvex tablets, debossed " E " over "71" on one side and plain on the other and are available in: bottles of 90 (42291-390-90) bottles of 100 (42291-390-01) bottles of 1000 (42291-390-10) Lisinopril and hydrochlorothiazide tablets, 20 mg/12.5 mg are white, round, biconvex tablets, debossed " E " over "152" on one side and plain on the other and are available in: bottles of 90 (42291-391-90) bottles of 100 (42291-391-01) bottles of 1000 (42291-391-10) Lisinopril and hydrochlorothiazide tablets, 20 mg/25 mg are light pink, round, biconvex tablets, debossed " E " over "173" on one side and plain on the other and are available in: bottles of 90 (42291-392-90) bottles of 100 (42291-392-01) bottles of 1000 (42291-392-10) Storage Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from excessive light and humidity. Dispense contents in a tight, light-resistant container as defined in the USP with a child-resistant closure, as required. Manufactured for: AvKARE, Inc. Pulaski, TN 38478 Mfg. Rev. 07/07 AV 10/13 (P)

Status autoryzacji:

Abbreviated New Drug Application

Charakterystyka produktu

LISINOPRIL AND HYDROCHLOROTHIAZIDE- LISINOPRIL AND HYDROCHLOROTHIAZIDE
TABLET
AVKARE, INC.
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LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS
BOXED WARNING
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
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-2H-1,2,4-benzothiadiazine-7-sulfonamide
1,1-dioxide.
Its empirical formula is C
H
CIN
O
S
and its structural formula is: [Enter image caption here]
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 tablets are available for oral use
in three tablet combinations of
lisinopril with hydrochlorothiazide: lisinopril and
hydrochlorothiazide tablets, 10 mg/12.5 mg, 20
mg/12.5 mg, and 20 mg/25 mg.
Inactive ingredients are: calcium phosphate, colloidal silicon
dioxide, crospovidone, magnesium
stearate, mannitol, and starch. Lisinopril and hydrochlorothiazide
tablets, 10 mg/12.5 mg, and 20 mg/25
mg also contain iron oxides.
2
21
31
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8
3
4
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CLINICAL PHARMACOLOGY
LISINOPRIL AND HYDROCHLOROTHIAZIDE
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