HYDROCHLOROTHIAZIDE capsule, gelatin coated

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

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

Prieinama:

NCS HealthCare of KY, Inc dba Vangard Labs

INN (Tarptautinis Pavadinimas):

HYDROCHLOROTHIAZIDE

Sudėtis:

HYDROCHLOROTHIAZIDE 12.5 mg

Vartojimo būdas:

ORAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

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 tr

Produkto santrauka:

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 blistercards of 30, 31, 15, 14 capsules and unit dose boxes of 30 capsules. 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 For all medical inquiries contact: WATSON Medical Communications Parsippany, NJ 07054 USA 800-272-5525 Manufactured By: Watson Pharma Private Limited Verna, Salcette Goa 403 722 INDIA Distributed By: Watson Pharma, Inc. Parsippany, NJ 07054 USA Revised: October 2011 174788-3

Autorizacija statusas:

New Drug Application Authorized Generic

Prekės savybės

HYDROCHLOROTHIAZIDE- HYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED
NCS HEALTHCARE OF KY, INC DBA VANGARD LABS
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HYDROCHLOROTHIAZIDE CAPSULES
DESCRIPTION
Hydrochlorothiazide Capsules, USP, 12.5 mg is the 3,4-dihydro
derivative of chlorothiazide. Its
chemical name is
6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide
1,1-dioxide. Its
empirical formula is C7H8ClN3O4S2; 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 are obser