Dopamine Hydrochloride and 5% Dextrose Injection USP 400mg/500ml (800mcg/1ml)

GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Dopamine Hydrochloride and 5% Dextrose Injection USP 200mg/250ml (800mcg/1ml)
B. Dopamine Hydrochloride and 5% Dextrose Injection USP 400mg/250ml (1600mcg/1ml)
C. Dopamine Hydrochloride and 5% Dextrose Injection USP 800mg/250ml (3200mcg/1ml)
D. Dopamine Hydrochloride and 5% Dextrose Injection USP 400mg/500ml (800mcg/1ml)
E. Dopamine Hydrochloride and 5% Dextrose Injection USP 800mg/500ml (1600mcg/1ml)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Dopamine Hydrochloride and 5% Dextrose Injection USP 200mg/250ml (800mcg/1ml)
Each 100ml contains:
Dopamine Hydrochloride USP……………….…..80mg
Dextrose Hydrous USP…………...…5gm
Sodium Bisulfite (as stabilizer)…. 50mg
Water for Injection USP…………….q.s

B. Dopamine Hydrochloride and 5% Dextrose Injection USP 400mg/250ml (1600mcg/1ml)
Each 100ml contains:
Dopamine Hydrochloride USP……………………......160mg
Dextrose Hydrous USP……………….…..5gm
Sodium Metaisulfite (as stabilizer)….50mg
Water for Injection USP………………….q.s

C. Dopamine Hydrochloride and 5% Dextrose Injection USP 800mg/250ml (3200mcg/1ml)
Each 100ml contains:
Dopamine Hydrochloride USP……………….….320mg
Dextrose Hydrous USP…………...…5gm
Sodium Bisulfite (as stabilizer)….50mg
Water for Injection USP …………..q.s

D. Dopamine Hydrochloride and 5% Dextrose Injection USP 400mg/500ml (800mcg/1ml)
Each 100ml contains:
Dopamine Hydrochloride USP…………………..80mg
Dextrose Hydrous USP………..……5gm
Sodium Bisulfite (as stabilizer)…. 50mg
Water for Injection USP ……………q.s

E. Dopamine Hydrochloride and 5% Dextrose Injection USP 800mg/500ml (1600mcg/1ml)
Each 100ml contains:
Dopamine Hydrochloride USP……………………160mg
Dextrose Hydrous USP………………5gm
Sodium Bisulfite (as stabilizer)…. 50mg
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.
See package insert for full prescribing information.

CAUTION & WARNING:

CAUTION:
The content should not be used It contains visible particulate matter.
Do not add any supplementary medication.
FOODS, DRUGS, DEVICES AND COSMETICS ACT prohibits dispensing without prescription.
Discard unused portion.
Discard unit if overwrap is damaged or if solution is darker than slightly yellow or discolored in any other way.
Use unit prompltyl when overwrap is opened.
After removing the overwrap, check for minute leaks by squeezing container firmly. If leaks are found, discard solution as sterility may be impaired.
Warning: Not to be sold by retail without the prescription of a Registered Medical Practitioner.
Contains sodium metabisulfite that may cause hypersentivity reactions.

STORAGE & DOSAGE:

Storage: Store in a moisture and oxygen barrier overwrap at room temperature 25°C (77°F) until ready to use.
Protect from freezing.
Avoid excessive heat.
Keep all medicines out of reach of children.
Dosage: As directed by the Physician.

Dopamine Hydrochloride and 5% Dextrose Injection USP 400mg/500ml Technical Specification:

Product Name:Dopamine Hydrochloride and 5% Dextrose Injection USP
Brand Name:Generic
Strength:200mg/250ml (800mcg/1ml), 400mg/250ml (1600mcg/1ml), 800mg/250ml (3200mcg/1ml), 400mg/500ml (800mcg/1ml), 800mg/500ml (1600mcg/1ml)
Dosage Form:Liquid Injection (Sterile)
Packing:250ml,  500ml Single Dose Container
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 and 5% Dextrose Injection, USP is indicated for the correction of hemodynamic imbalances present in the shock syndrome due to myocardial infarction, trauma, endotoxic septicemia, open-heart surgery, renal failure and chronic cardiac decompensation as in congestive failure.
Storage:Store in a moisture and oxygen barrier overwrap at room temperature 25°C (77°F) until ready to use. Protect from freezing.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Dopamine Hydrochloride and 5% Dextrose Injection USP 400mg/500ml (800mcg/1ml)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Dopamine Hydrochloride and 5% Dextrose Injection USP 400mg/500ml (800mcg/1ml)
    Each 100ml contains:
    Dopamine Hydrochloride USP……………….…..80mg
    Dextrose Hydrous USP………………5gm
    Sodium Bisulfite (as stabilizer)…. 50mg
    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.
See package insert for full prescribing information.

CAUTION & WARNING:

CAUTION:

  • The content should not be used It contains visible particulate matter.
  • Do not add any supplementary medication.
  • FOODS, DRUGS, DEVICES AND COSMETICS ACT prohibits dispensing without prescription.
  • Discard unused portion.
  • Discard unit if overwrap is damaged or if solution is darker than slightly yellow or discolored in any other way.
  • Use unit prompltyl when overwrap is opened.
  • After removing the overwrap, check for minute leaks by squeezing container firmly. If leaks are found, discard solution as sterility may be impaired.

Warning: Not to be sold by retail without the prescription of a Registered Medical Practitioner.
Contains sodium metabisulfite that may cause hypersentivity reactions.

STORAGE & DOSAGE:

Storage: Store in a moisture and oxygen barrier overwrap at room temperature 25°C (77°F) until ready to use.
Protect from freezing.
Avoid excessive heat.
Keep all medicines out of reach of children.

Dosage: As directed by the Physician.