Χώρα: Ηνωμένες Πολιτείες
Γλώσσα: Αγγλικά
Πηγή: NLM (National Library of Medicine)
HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)
Sun Pharmaceutical Industries, Inc.
HYDROCHLOROTHIAZIDE
HYDROCHLOROTHIAZIDE 12.5 mg
ORAL
PRESCRIPTION DRUG
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 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 pr
Hydrochlorothiazide capsules, 12.5 mg are size #4 Teal Opaque/Teal Opaque colored hard gelatin capsules, imprinted with ‘195’ on both cap and body in black ink. They are available as follows: Bottles of 100 NDC 57664-195-88 Bottles of 500 NDC 57664-195-13 Bottles of 1000 NDC 57664-195-18 Store at 20° to 25°C (68° to 77°F); excursions permitted 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from light, moisture, freezing, -20°C (-4°F). Keep container tightly closed. Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 Revised: 10/2014
Abbreviated New Drug Application
HYDROCHLOROTHIAZIDE - HYDROCHLOROTHIAZIDE CAPSULE SUN PHARMACEUTICAL INDUSTRIES, INC. ---------- HYDROCHLOROTHIAZIDE CAPSULES DESCRIPTION Hydrochlorothiazide, USP 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 molecular formula 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 capsules, USP are for oral administration contains 12.5 mg of hydrochlorothiazide, USP. Each capsule contains the following inactive ingredients: lactose monohydrate, corn starch, pregelatinized starch, colloidal silicon dioxide, magnesium stearate, D&C Red #28, D&C Yellow #10, FD&C Blue #1, FD&C Blue #2, FD&C Red #40, titanium dioxide, gelatin, black iron oxide, propylene glycol and shellac. 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 ra Διαβάστε το πλήρες έγγραφο