HYDROCHLOROTHIAZIDE- hydrochlorothiazide tablet

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)

Sẵn có từ:

Golden State Medical Supply, Inc

INN (Tên quốc tế):

HYDROCHLOROTHIAZIDE

Thành phần:

HYDROCHLOROTHIAZIDE 25 mg

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

Hydrochlorothiazide tablets are indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Hydrochlorothiazide tablets have also been found useful in edema due to various forms of renal dysfunction such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure. Hydrochlorothiazide tablets are indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effectiveness of other antihypertensive drugs in the more severe forms of hypertension. Routine use of diuretics during normal pregnancy is inappropriate and exposes mother and fetus to unnecessary hazard. Diuretics do not prevent development of toxemia of pregnancy and there is no satisfactory evidence that they are useful in the treatment of toxemia. Edema during pregnancy may arise from pathologic causes or from the physiologic and mechanical consequences of pregnancy. Thiazides are indicated in pregnancy when edema is du

Tóm tắt sản phẩm:

Hydrochlorothiazide tablets, USP are available containing 25 mg and 50 mg hydrochlorothiazide, USP. The 25 mg tablets are White to off white, round shaped bevel edge, scored tablets debossed with 111 on one side of the tablet and S to the left of the score and G to the right of the score on the other side. They are available as follows: Bottles of 90 (NDC 60429-214-90) Bottles of 100 (NDC 60429-214-01) The 50 mg tablets are White to off white, round shaped bevel edge, scored tablets debossed with 112 on one side of the tablet and S to the left of the score and G to the right of the score on the other side. They are available as follows: Bottles of 100 (NDC 60429-215-01) Store at 20° to 25°C (68° to 77°F). [See USP for Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Manufactured by: ScieGen Pharmaceuticals, Inc. Hauppauge, NY 11788 Marketed and packaged by: GSMS, Inc. Camarillo, CA 93012 USA Rev: 01/14

Tình trạng ủy quyền:

Abbreviated New Drug Application

Đặc tính sản phẩm

HYDROCHLOROTHIAZIDE- HYDROCHLOROTHIAZIDE TABLET
GOLDEN STATE MEDICAL SUPPLY, INC
----------
HYDROCHLOROTHIAZIDE TABLETS, USP 25 MG AND 50 MG
DESCRIPTION
Hydrochlorothiazide is a diuretic and antihypertensive. It is the
3,4-dihydro derivative of
chlorothiazide. It is chemically designated as 6-chloro-3,4-dihydro-2
H-1,2,4-benzothiadiazine-7-
sulfonamide 1,1-dioxide and has the following structural formula:
C
H
CIN
O
S M.W. 297.74
Hydrochlorothiazide, USP is a white, or practically white, crystalline
powder which is very slightly
soluble in water, freely soluble in sodium hydroxide solution, in
n-butylamine, and in
dimethylformamide; sparingly soluble in methanol; insoluble in ether,
in chloroform and in dilute
mineral acids. Each tablet for oral administration contains 25 mg and
50 mg hydrochlorothiazide, USP.
In addition, each tablet contains the following inactive ingredients:
microcrystalline cellulose, NF,
lactose anhydrous NF, pregelatinized starch NF, sodium lauryl sulfate
NF, silicon dioxide NF and
magnesium stearate, NF.
CLINICAL PHARMACOLOGY
The mechanism of the antihypertensive effect of thiazides is unknown.
Hydrochlorothiazide does not
usually affect normal blood pressure.
Hydrochlorothiazide affects the distal renal tubular mechanism of
electrolyte reabsorption. At maximal
therapeutic dosage all thiazides are approximately equal in their
diuretic efficacy.
Hydrochlorothiazide increases excretion of sodium and chloride in
approximately equivalent amounts.
Natriuresis may be accompanied by some loss of potassium and
bicarbonate.
After oral use diuresis begins within 2 hours, peaks in about 4 hours
and lasts about 6 to 12 hours.
PHARMACOKINETICS AND METABOLISM
Hydrochlorothiazide is not metabolized but is eliminated rapidly by
the kidney. When plasma levels
7
8
3
4
2
have been followed for at least 24 hours, the plasma half-life has
been observed to vary between 5.6
and 14.8 hours. At least 61 percent of the oral dose is eliminated
unchanged within 24 hours.
Hydrochlorothiazide crosses the placental but