HYDROCHLOROTHIAZIDE capsule, gelatin coated

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

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

Disponible des:

STAT RX USA LLC

Designació comuna internacional (DCI):

HYDROCHLOROTHIAZIDE

Composición:

HYDROCHLOROTHIAZIDE 12.5 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Hydrochlorothiazide is 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 may be used in those patients in whom the development of hyperkalemia cannot be risked, including patients taking ACE inhibitors. Usage in Pregnancy: 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 t

Resumen del producto:

Hydrochlorothiazide Capsules are #4 Teal Opaque/White Opaque two piece hard gelatin capsules imprinted with WATSON 347 and 12.5 mg in black ink. They are supplied in bottles of 100 and 500. Bottles of 100 are supplied with child resistant closures. Store at 20°- 25°C (68°-77°F). [See USP controlled room temperature.] Protect from light, moisture, freezing, -20°C (-4°F). Keep container tightly closed. Rx only Watson Pharma Private Limited Verna, Salcette Goa 403 722 INDIA Distributed By: Watson Pharma, Inc. Corona, CA 92880 USA Revised: March 2009 174788 S0309

Estat d'Autorització:

New Drug Application Authorized Generic

Fitxa tècnica

HYDROCHLOROTHIAZIDE - HYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED
STAT RX USA LLC
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HYDROCHLOROTHIAZIDE CAPSULES
REVISED: MARCH 2009
RX ONLY
174788
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.
_Inactive ingredients: _colloidal silicon dioxide, corn starch,
lactose monohydrate, magnesium stearate.
Gelatin capsules contain D&C Red No. 28, D&C Yellow No. 10, FD&C Blue
No. 1, gelatin, titanium
dioxide. The capsules are printed with edible ink containing black
iron oxide, D&C Yellow No. 10,
FD&C Blue No. 1, FD&C Blue No. 2, FD&C Red No. 40.
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 a