Country: United States
Language: English
Source: NLM (National Library of Medicine)
HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)
PD-Rx Pharmaceuticals, Inc.
HYDROCHLOROTHIAZIDE
HYDROCHLOROTHIAZIDE 12.5 mg
ORAL
PRESCRIPTION DRUG
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
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. They are supplied in bottles of : NDC 55289-565-07 Bottles of 7 NDC 55289-565-14 Bottles of 14 NDC 55289-565-30 Bottles of 30 NDC 55289-565-60 Bottles of 60 NDC 55289-565-90 Bottles of 90 NDC 55289-565-98 Bottles of 120 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: ACTAVIS Medical Communications Parsippany, NJ 07054 USA 1-888-838-2872
New Drug Application Authorized Generic
HYDROCHLOROTHIAZIDE- HYDROCHLOROTHIAZIDE CAPSULE, GELATIN COATED PD-RX PHARMACEUTICALS, INC. ---------- HYDROCHLOROTHIAZIDE CAPSULE HYDROCHLOROTHIAZIDE CAPSULES, USP RX ONLY 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 7 8 3 4 2 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 fai Read the complete document