GENERIC NAME OF THE MEDICINAL PRODUCT:

A) Chlorothiazide Sodium Dry Powder for Injection (Lyophilized) 500 mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Chlorothiazide Sodium Dry Powder for Injection (Lyophilized) 500 mg
Sterile, lyophilized.
Each vial contains:
Chlorothiazide sodium
equivalent to 500 mg chlorothiazide
250 mg mannitol. Sodium hydroxide added to adjust pH.
Reconstitution: Reconstitute with a minimum of 18 mL
of Sterile Water for Injection (an isotonic solution is obtained if 18 mL is added).

THERAPEUTIC INDICATIONS:

Chlorothiazide sodium for injection is indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy.

CAUTION & SCHEDULE:

CAUTION: For the preparation of intravenous solutions.
SCHEDULE “H” Prescription Drug -Warning: Not to be sold by retail without the prescription of a Registered Medical Prescriber.

STORAGE & DOSAGE:

Storage: STORE LYOPHILIZED POWDER BETWEEN: 2° and 25°C (36° and 77°F). The container closure is not made with natural rubber latex.
Dosage: Single Dose Vial.
For single dose only.
Use reconstituted solution immediately.
Discard unused portion.
As directed by the Physician.
Usual adult dosage: See package insert.

Chlorothiazide Sodium Dry Powder for Injection (Lyophilized) 500 mg Technical Specification:

Product Name:
Chlorothiazide Sodium Dry Powder for Injection (Lyophilized)
Brand Name:Generics
Strength:500mg
Dosage Form:Dry Powder for Injection (Lyophilized)
Route of Administration:For the preparation of intravenous solutions.
Packing:500 mg per vial
Pack Insert/Leaflet:PIL (Patient Information Leaflet)
Regulatory Documents:COA, MOA, Stability Studies, GMP
Therapeutic use:Diuretics
Indication: Chlorothiazide sodium for injection is indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy.
Storage:STORE LYOPHILIZED POWDER BETWEEN: 2° and 25°C (36° and 77°F).The container closure is not made with natural rubber latex.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Chlorothiazide Sodium Dry Powder for Injection (Lyophilized) 500 mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Chlorothiazide Sodium Dry Powder for Injection (Lyophilized) 500 mg
    Sterile, lyophilized.
    Each vial contains:
    Chlorothiazide sodium
    equivalent to 500 mg chlorothiazide
    250 mg mannitol. Sodium hydroxide added to adjust pH.
    Reconstitution: Reconstitute with a minimum of 18 ml
    of Sterile Water for Injection (an isotonic solution is obtained if 18 ml is added).

THERAPEUTIC INDICATIONS:

Chlorothiazide sodium for injection is indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy.

CAUTION & SCHEDULE:

CAUTION:
For the preparation of intravenous solutions.
SCHEDULE “H” Prescription Drug -Warning: Not to be sold by retail without the prescription of a Registered Medical Prescriber.

STORAGE & DOSAGE:

Storage:STORE LYOPHILIZED POWDER BETWEEN:
2° and 25°C (36° and 77°F).
The container closure is not made with natural rubber latex.
Dosage:Single Dose Vial.
For single dose only.
Use reconstituted solution immediately.
Discard unused portion.
As directed by the Physician.
Usual adult dosage:See package insert.