Pays: États-Unis
Langue: anglais
Source: NLM (National Library of Medicine)
CHLOROTHIAZIDE SODIUM (UNII: SN86FG7N2K) (CHLOROTHIAZIDE - UNII:77W477J15H)
Mylan Institutional LLC
INTRAVENOUS
PRESCRIPTION DRUG
Chlorothiazide sodium for injection, USP is indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Chlorothiazide sodium for injection, USP has also been found useful in edema due to various forms of renal dysfunction such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure. Routine use of diuretics during normal pregnancy 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 toxemia. Edema during pregnancy may arise from pathologic causes or from the physiologic and mechanical consequences of pregnancy. Thiazides are indicated in pregnancy when edema is due to pathologic causes, just as they are in the absence of pregnancy (see PRECAUTIONS, Pregnancy). Dependent edema in pregnancy, resulting from restriction of venous return by the gravid uterus,
Chlorothiazide Sodium for Injection, USP is a dry, sterile lyophilized white powder usually in cake form, supplied in vials containing chlorothiazide sodium equivalent to 500 mg of chlorothiazide. NDC 67457-263-30 500 mg single-dose vial, packaged individually. Storage : Store lyophilized powder at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] For single-dose only. Use solution immediately after reconstitution (see DOSAGE AND ADMINISTRATION, Directions for Reconstitution). Discard unused portion of the reconstituted solution. Manufactured for: Mylan Institutional LLC Rockford, IL 61103 U.S.A. Manufactured by: Oakwood Laboratories, LLC Solon, OH 44139 U.S.A. Revised: 6/2017 MI:CLTZIJ:R2
Abbreviated New Drug Application
CHLOROTHIAZIDE SODIUM- CHLOROTHIAZIDE SODIUM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION MYLAN INSTITUTIONAL LLC ---------- DESCRIPTION Chlorothiazide sodium for injection, USP is a diuretic and antihypertensive. It is 6-chloro-2_H_-1,2,4- benzothiadiazine-7-sulfonamide 1,1-dioxide monosodium salt and its molecular weight is 317.71. Its molecular formula is C H ClN NaO S and its structural formula is: Chlorothiazide sodium for injection, USP is a sterile lyophilized white powder and is supplied in a vial containing: Chlorothiazide sodium equivalent to chlorothiazide 500 mg Inactive ingredients: Mannitol 250 mg Sodium hydroxide to adjust pH. Chlorothiazide is a diuretic and antihypertensive. It is 6-chloro-2_H_-1,2,4-benzothiadiazine-7- sulfonamide 1,1-dioxide. Its molecular formula is C H ClN O S and its structural formula is: It is a white, or practically white, crystalline powder with a molecular weight of 295.72, which is very slightly soluble in water, but readily soluble in dilute aqueous sodium hydroxide. It is soluble in urine to the extent of about 150 mg per 100 mL at pH 7. CLINICAL PHARMACOLOGY The mechanism of the antihypertensive effect of thiazides is unknown. Chlorothiazide does not usually affect normal blood pressure. Chlorothiazide affects the distal renal tubular mechanism of electrolyte reabsorption. At maximal therapeutic dosage all thiazides are approximately equal in their diuretic efficacy. Chlorothiazide increases excretion of sodium and chloride in approximately equivalent amounts. Natriuresis may be accompanied by some loss of potassium and bicarbonate. After oral use diuresis begins within 2 hours, peaks in about 4 hours and lasts about 6 to 12 hours. 7 5 3 4 2 7 6 3 4 2 Following intravenous use of Chlorothiazide sodium for injection onset of the diuretic action occurs in 15 minutes and the maximal action in 30 minutes. _PHARMACOKINETICS AND METABOLISM_ Chlorothiazide is not metabolized but is eliminated rapidly by the kidney; 96 percent of an intravenous dose is excreted unchanged in Lire le document complet