HYDROCHLOROTHIAZIDE- hydrochlorothiazide capsule, gelatin coated

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

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

Предлага се от:

Preferred Pharmaceuticals Inc.

INN (Международно Name):

HYDROCHLOROTHIAZIDE

Композиция:

HYDROCHLOROTHIAZIDE 12.5 mg

Начин на приложение:

ORAL

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

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

Каталог на резюме:

Hydrochlorothiazide Capsules, USP are #4 Teal Opaque/White Opaque two piece hard gelatin capsules imprinted with WATSON 347 and 12.5 mg in black ink. Bottles of 7 NDC #68788-9867-1 Bottles of 30 NDC #68788-9867-3 Bottles of 60 NDC #68788-9867-6 Bottles of 90 NDC #68788-9867-9 Bottles of 100 NDC #68788-9867-8 Dispense in a tight, light-resistant container as defined in the USP. Keep out of reach of children. 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 Repackaged By: Preferred Pharmaceuticals Inc.

Статус Оторизация:

New Drug Application Authorized Generic

Данни за продукта

HYDROCHLOROTHIAZIDE- HYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED
PREFERRED PHARMACEUTICALS INC.
----------
HYDROCHLOROTHIAZIDE CAPSULE
HYDROCHLOROTHIAZIDE CAPSULES, USP
REVISED: OCTOBER 2011
RX ONLY
174788-3
DESCRIPTION
Hydrochlorothiazide Capsules, USP, 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.
7
8
3
4
2
PHARMACOKINETICS AND METABOLISM:
Hydrochlorothiazide is well absorbed (65% to 75%) following oral
administration. Absorption of
hydrochlorothiazide is reduced in pa