GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Dopamine Hydrochloride Injection USP 40mg/1ml
B. Dopamine Hydrochloride Injection USP 200mg/5ml
C. Dopamine Hydrochloride Injection USP 400mg/10ml

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Dopamine Hydrochloride Injection USP 40mg/1ml
Each ml contains:
Dopamine Hydrochloride USP……………..….40mg
Sodium metabisulfite (as stabilizer)………….9mg
Citric acid anhydrous…………………………………10mg
Sodium citrate dihydrate (as buffer)…...…….5mg
Water for Injection USP……………………………..q.s


B. Dopamine Hydrochloride Injection USP 200mg/5ml
Each ml contains:
Dopamine Hydrochloride USP…………..…….40mg
Sodium metabisulfite (as stabilizer)………….9mg
Citric acid anhydrous…………………………………10mg
Sodium citrate dihydrate (as buffer)…...…….5mg
Water for Injection USP……………………………..q.s

C. Dopamine Hydrochloride Injection USP 400mg/10ml
Each ml contains:
Dopamine Hydrochloride USP……………..….40mg
Sodium metabisulfite (as stabilizer)………….9mg
Citric acid anhydrous…………………………………10mg
Sodium citrate dihydrate (as buffer)…...…….5mg
Water for Injection USP……………………………..q.s

THERAPEUTIC INDICATIONS:

Dopamine hydrochloride is used for the correction of poor perfusion, low cardiac output, impending renal failure and shock associated with myocardial infarction, trauma, endotoxic septicaemia, open heart surgery and heart failure.

DIRECTION OF USE:

For Intravenous use.
USE ASEPTIC TECHNIQUE.
Mix thoroughly after dilution.
See package insert for detailed information.

CAUTION & WARNING:

CAUTION: The injection should not be used It contains visible particulate matter.
Avoid contact with alkalis, oxidizing agents and from iron salts. 
Do not use the injection if it is darker than slightly yellow or discolored in any other way.
Use only is seal is intact and undamaged.
Contains no bacteriostat; use promptly; discard unused portion.
Warning: Not to be sold by retail without the prescription of a Registered Medical Practitioner.

STORAGE & DOSAGE:

Storage: Store at 20°C to 25°C (68°F to 77°F).
Protect from light.
Do not freeze.
Keep all medicines out of reach of children.
Dosage: As directed by the Physician.

Dopamine Hydrochloride Injection USP 40mg/1ml Technical Specification:

Product Name:Dopamine Hydrochloride Injection USP
Brand Name:Generic
Strength:40mg/1ml200mg/5ml,  400mg/10ml
Dosage Form:Liquid Injection (Sterile and Nonpyrogenic)
Packing:40mg/1ml (1ml Single Dose Ampoule/ Vial)
40mg/1ml (5ml Single Dose Ampoule / Vial)
40mg/1ml (10ml Single Dose Ampoule/ Vial)
Route of Administration:For I.V. use only
Pack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents:COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use:Vasoconstrictor, Inotropic Agent
Indication: Dopamine hydrochloride is used for the correction of poor perfusion, low cardiac output, impending renal failure and shock associated with myocardial infarction, trauma, endotoxic septicaemia, open heart surgery and heart failure.
Storage:Store at 20°C to 25°C (68°F to 77°F). Protect from light. Do not freeze.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Dopamine Hydrochloride Injection USP 40mg/1ml

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Dopamine Hydrochloride Injection USP 40mg/1ml
    Each ml contains:
    Dopamine Hydrochloride USP…………………40mg
    Sodium metabisulfite (as stabilizer)………….9mg
    Citric acid anhydrous…………………………………10mg
    Sodium citrate dihydrate (as buffer)………….5mg
    Water for Injection USP……………………………..q.s

THERAPEUTIC INDICATIONS:

Dopamine hydrochloride is used for the correction of poor perfusion, low cardiac output, impending renal failure and shock associated with myocardial infarction, trauma, endotoxic septicaemia, open heart surgery and heart failure.

DIRECTION OF USE:

For Intravenous use.
USE ASEPTIC TECHNIQUE.
Mix thoroughly after dilution.
See package insert for detailed information.

CAUTION & Warning:

CAUTION: The injection should not be used It contains visible particulate matter.
Avoid contact with alkalis, oxidizing agents and from iron salts.
Do not use the injection if it is darker than slightly yellow or discolored in any other way.
Use only is seal is intact and undamaged.
Contains no bacteriostat; use promptly; discard unused portion.

Warning: Not to be sold by retail without the prescription of a Registered Medical Practitioner.

STORAGE & DOSAGE:

Storage: Store at 20°C to 25°C (68°F to 77°F).
Protect from light.
Do not freeze.
Keep all medicines out of reach of children.

Dosage: As directed by the Physician.