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:

Leading Pharma, LLC

INN (Tên quốc tế):

HYDROCHLOROTHIAZIDE

Thành phần:

HYDROCHLOROTHIAZIDE 12.5 mg

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

Hydrochlorothiazide tablets USP are indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Hydrochlorothiazide tablets USP 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 USP 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. Use in pregnancy 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 indicat

Tóm tắt sản phẩm:

Hydrochlorothiazide tablets USP, 12.5 mg are available as peach color, round, flat face, beveled edge tablets, debossed “EP” above and “155” below on one side, and plain on the other side containing 12.5 mg of hydrochlorothiazide USP, packaged in bottles of 100 (NDC 69315-155-01) and 1000 (NDC 69315-155-10) tablets. Hydrochlorothiazide tablets USP, 25 mg are available as peach color, round, flat face, beveled edge bisected tablets, debossed "EP" above bisect and "131" below bisect on one side and plain on the other side containing 25 mg of hydrochlorothioazide USP, packaged in bottles of 100 (NDC 69315-131-01), 1000 (NDC 69315-131-10) and 5000 (NDC 69315-131-50) tablets. Packaged in Bulk Pack for Repackaging [3 kg (around 28571 Tablets)] in Corrugated Box. (NDC 69315-131-99). Hydrochlorothiazide tablets USP, 50 mg are available as peach color, round, flat face, beveled edge, bisected tablets, debossed "EP" above bisect and "130" below bisect on one side and plain on the other side containing 50 mg of hydrochlorothiazide USP, packaged in bottles of 100 (NDC 69315-130-01) and 1000 (NDC 69315-130-10) tablets. Dispense in a well-closed 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]. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Manufactured by: Leading Pharma, LLC Fairfield, NJ 07004 Rev.05 10-22

Tình trạng ủy quyền:

Abbreviated New Drug Application

Đặc tính sản phẩm

HYDROCHLOROTHIAZIDE- HYDROCHLOROTHIAZIDE TABLET
LEADING PHARMA, LLC
----------
HYDROCHLOROTHIAZIDE TABLETS, USP
RX ONLY
DESCRIPTION
Hydrochlorothiazide USP 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:
Hydrochlorothiazide USP is a white, or practically white, crystalline
powder which is
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 12.5 mg, 25 mg
and 50 mg of hydrochlorothiazide USP respectively. In addition, each
tablet contains the
following inactive ingredients: FD&C yellow #6, lactose anhydrous,
magnesium stearate,
microcrystalline cellulose, sodium starch glycolate, and stearic acid.
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
to12 hours.
PHARMACOKINETICS AND METABOLISM
Hydrochlorothiazide is not metabolized but is eliminated rapidly by
the kidney. When
plasma levels 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% of the oral
dose is
eliminated unchanged within 24 hours. Hydrochlorothiazide crosses the
placental but
not the blood-brain barrier and is excreted in breast milk.
INDIC