CHLOROTHIAZIDE SODIUM injection, powder, lyophilized, for solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CHLOROTHIAZIDE SODIUM (UNII: SN86FG7N2K) (CHLOROTHIAZIDE - UNII:77W477J15H)

Available from:

Mylan Institutional LLC

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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,

Product summary:

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

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

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