LISINOPRIL AND HYDROCHLOROTHIAZIDE tablet

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Tersedia dari:

Physicians Total Care, Inc.

INN (Nama Internasional):

LISINOPRIL

Komposisi:

LISINOPRIL 20 mg

Rute administrasi :

ORAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

Lisinopril-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-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-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, Angioedema) . Lisinopril-hydrochlorothiazide tablets 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 angiot

Ringkasan produk:

Lisinopril-hydrochlorothiazide tablets 10-12.5 mg are blue, round, flat face, beveled edge tablets debossed with “RX536” on one side and plain on the other side. Each tablet contains 10 mg of lisinopril and 12.5 mg of hydrochlorothiazide. They are supplied as follows: Bottles of 30 (NDC 54868-4977-1) Bottles of 90 (NDC 54868-4977-2) Bottles of 100 (NDC 54868-4977-0) They are supplied as follows: Bottles of 30 (NDC 54868-4637-0) Bottles of 60 (NDC 54868-4637-2) Bottles of 90 (NDC 54868-4637-3) Bottles of 100 (NDC 54868-4637-1) Bottles of 180 (NDC 54868-4637-4) Lisinopril-hydrochlorothiazide tablets 20-25 mg are light peach, round, flat face, beveled edge tablets debossed with “RX538” on one side and plain on the other side. Each tablet contains 20 mg of lisinopril and 25 mg of hydrochlorothiazide. They are supplied as follows: Bottles of 30 (NDC 54868-4785-0) Bottles of 60 (NDC 54868-4785-1) Bottles of 90 (NDC 54868-4785-3) Bottles of 100 (NDC 54868-4785-2) Storage Store at 20 - 25° C (68 - 77° F). (See USP Controlled Room Temperature). Protect from excessive light and humidity. Dispense in a well closed container, if product package is subdivided.

Status otorisasi:

Abbreviated New Drug Application

Karakteristik produk

LISINOPRIL AND HYDROCHLOROTHIAZIDE - LISINOPRIL AND
HYDROCHLOROTHIAZIDE TABLET
PHYSICIANS TOTAL CARE, INC.
----------
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-
Hydrochlorothiazide Tablets should be discontinued as soon as
possible. See WARNINGS,
_Pregnancy, Lisinopril, Fetal/Neonatal Morbidity and Mortality_.
DESCRIPTION
Lisinopril-hydrochlorothiazide tablets 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
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-2H-1,2,4-benzothiadiazine-7-sulfonamide
1,1-dioxide.
Its molecular formula is C H ClN O S and its structural formula is:
CLINICAL PHARMACOLOGY
2
21
31
3
5
2
7
8
3
4
2
Lisinopril-Hydrochlorothiazide
As a result of its diuretic effects, hydrochlorothiazide increases
plasma renin activity, increases
aldosterone secretion, and decreases serum potassium. Administration
of lisinopril blocks the renin-
angiotensin aldosterone axis and tends to reverse the potassium loss
associated with the diuretic.
In clinical studies, the extent of blood pressure reduction seen with
the combination of lisinopril and
hydrochlorothiazide was approximately additive. The
lisinopril-hydrochlorothiazide tablets 10-12.5 mg
combination worked equally well in black and white patients. The
lisinopril-hydrochlorothiazide tablets
20-12.5 and lisinopril-hydrochlorothiazide tablet 20-25 mg
combinations appeared somewhat less
effective in black patien