HYDROCHLOROTHIAZIDE- hydrochlorothiazide capsule, gelatin coated

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:

REMEDYREPACK INC.

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 capsules are indicated in the management of hypertension either as the sole therapeutic agent, or in combination with other antihypertensives. Unlike potassium sparing combination diuretic products, Hydrochlorothiazide capsules may be used in those patients in whom the development of hyperkalemia cannot be risked, including patients taking ACE inhibitors. The routine use of diuretics in an otherwise healthy woman 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 developed toxemia. Edema during pregnancy may arise from pathological causes or from the physiologic and mechanical consequences of pregnancy. Diuretics are indicated in pregnancy when edema is due to pathologic causes, just as they are in the absence of pregnancy. Dependent edema in pregnancy resulting from restriction of venous return by the expanded uterus is properly tre

Tóm tắt sản phẩm:

Hydrochlorothiazide capsules USP, 12.5 are #4 Blue Opaque / White Opaque hard gelatin capsules imprinted with TL382 in black ink and are available in the following package sizes: Storage: Keep container tightly closed. Protect from light, moisture, freezing, -20°C (-4°F) and store at 20°-25°C (68° - 77°F) [See USP Controlled Room temperature]. Keep this and all medication out of the reach of children. Manufactured by: Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD 21801, USA 01/12

Tình trạng ủy quyền:

Abbreviated New Drug Application

Đặc tính sản phẩm

HYDROCHLOROTHIAZIDE- HYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED
REMEDYREPACK INC.
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HYDROCHLOROTHIAZIDE CAPSULES USP, 12.5 MG
RX ONLY
DESCRIPTION
Hydrochlorothiazide capsules 12.5 mg is the 3,4-dihydro derivative of
chlorothiazide. Its chemical
name is 6-Chloro-3,4-dihydro-2 H -1 ,2,4-benzothiadiazine-7-
sulfonamide 1,1-dioxide. Its empirical
formula is C
H
ClN
O
S
;its molecular weight is 297.74; and its structural formula is
It is a white, or practically white, crystalline powder which is
slightly soluble in water, but freely
soluble in sodium hydroxide solution.
Hydrochlorothiazide is supplied as 12.5 mg capsules for oral use. Each
capsule contains the following
inactive ingredients: colloidal silicon dioxide, D&C Yellow #10, FD&C
Blue #1, FD&C Blue #2,
FD&C Red #40, gelatin, iron oxide black, lactose monohydrate,
magnesium stearate, pregelatinized
starch, propylene glycol, shellac, and titanium dioxide.
CLINICAL PHARMACOLOGY
Hydrochlorothiazide blocks the reabsorption of sodium and chloride
ions, and it thereby increases the
quantity of sodium traversing the distal tubule and the volume of
water excreted. A portion of the
additional sodium presented to the distal tubule is exchanged there
for potassium and hydrogen ions.
With continued use of hydrochlorothiazide and depletion of sodium,
compensatory mechanisms tend to
increase this exchange and may produce excessive loss of potassium,
hydrogen and chloride ions.
Hydrochlorothiazide also decreases the excretion of calcium and uric
acid, may increase the excretion
of iodide and may reduce glomerular filtration rate. Metabolic
toxicities associated with excessive
electrolyte changes caused by hydrochlorothiazide have been shown to
be dose-related.
PHARMACOKINETICS AND METABOLISM:
Hydrochlorothiazide is well absorbed (65% to 75%) following oral
administration. Absorption of
hydrochlorothiazide is reduced in patients with congestive heart
failure.
Peak plasma concentrations are observed within 1 to 5 hours of dosing,
and range from 70 to 490 ng/mL
follow