GENERIC NAME OF MEDICINAL PRODUCT

(A) Diazepam Injection IP 10mg/2ml

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Diazepam Injection IP 10mg/2ml
Each 2 ml contains:
Diazepam IP…………………………….10 mg
Benzyl Alcohol IP……………………….1.5% v/v
Water for Injection IP……………………..q.s.

THERAPEUTIC INDICATION:

Diazepam Injection belongs to a group of medications called benzodiazepine used to treat anxiety, muscle spasms, and epilepsy/seizures/fits. It can also be used as a sedative during surgery or dental procedure. Besides this, it is also used to manage alcohol withdrawal symptoms like agitation, tremor, or hallucinations.

DIRECTION OF USE:

For I.M. /I. V use only

CAUTION AND SCHEDULE:

CAUTION: Do not use if solution is not clear or has suspended matter.
Discard any unused portion
SCHEDULE H1 PRESCRIPTION DRUG: WARNING: It is dangerous to take this preparation except in accordance with medical advice.
Not to be sold by retail without the prescription of Registered Medical Practitioner.

STORAGE AND DOSAGE:

STORAGE: Store protected from light & excessive heat.
KEEP OUT OF REACH OF CHILDREN.
ACTION: Diazepam Injection calms the limbic system to tranquilize the brain, & augment GABA activity to relax muscles and stop convulsions.

DOSAGE: Premedication: 10 mg IM 1/2 hour before surgery.
Short Surgical Procedures: 10 to 20 mg slow IV until eyelids droop. May be administered together with Diazepam injection.
Endoscopy: 10 mg IV just prior to the procedure or 10 mg IM 1/2 hour before procedure.
Severe anxiety: 5 to 10 mg IV or IM. Repeat in 3 to 4 hours, if necessary.
Induction: 10 to 40 mg slow IV, one ml/min. until eyelids droop.
Labor: 10 to 20 mg IV once to facilitate delivery when cervix is dilated 2-3 finger's breadth.
Convulsive disorders: 10 to 20 mg IV/IM, repeated 3 to 4 hourly, max. 100 mg/day, as per need of the patient.
Alcohol withdrawal:
Status epilepticus:
Tetanus. Eclampsia:

Diazepam Injection IP 10mg/2ml Technical Specification:

Product Name:Diazepam Injection IP
Brand Name:Generic
Strength:10mg/2ml
Dosage Form:Liquid Injection (Sterile)
Packing:2ml Ampoule
Route of Administration:For I.M. /I. V use only
Pack Insert/Leaflet:PIL (Patient Information Leaflet)
Documents:COA, MOA, Product Permission, Stability Studies, GMP
Therapeutic use:Antipsychotic, Anti-anxiety, Anti-epilepsy, CNS
Indication: Diazepam Injection belongs to a group of medications called benzodiazepine used to treat anxiety, muscle spasms, and epilepsy/seizures/fits. It can also be used as a sedative during surgery or dental procedure. Besides this, it is also used to manage alcohol withdrawal symptoms like agitation, tremor, or hallucinations.
Storage:Store protected from light & excessive heat.

GENERIC NAME OF MEDICINAL PRODUCT

  • Diazepam Injection IP 10mg/2ml 

QUALITATIVE AND QUANTITATIVE COMPOSITION:

Diazepam Injection IP 10mg/2ml
Each 2 ml contains:
Diazepam IP…………………………….10 mg
Benzyl Alcohol IP……………………….1.5% v/v
Water for Injection IP……………………..q.s.

THERAPEUTIC INDICATION:

Diazepam Injection belongs to a group of medications called benzodiazepine used to treat anxiety, muscle spasms, and epilepsy/seizures/fits. It can also be used as a sedative during surgery or dental procedure. Besides this, it is also used to manage alcohol withdrawal symptoms like agitation, tremor, or hallucinations.

DIRECTION OF USE:

For I.M. /I. V uses only.

CAUTION AND SCHEDULE:

CAUTION: Do not use it if the solution is not clear or has suspended matter. 

Discard any unused portion 

SCHEDULE H1 PRESCRIPTION DRUG: WARNING: It is dangerous to take this preparation except in accordance with medical advice.
Not to be sold by retail without the prescription of a Registered Medical Practitioner. 

STORAGE AND DOSAGE:

STORAGE: Store protected from light & excessive heat.

KEEP OUT OF REACH OF CHILDREN. 

ACTION: Diazepam Injection calms the limbic system to tranquilize the brain, &augment GABA activity to relax muscles and stop convulsions.
DOSAGE:
Premedication: 10 mg IM 1/2 hour before surgery.
Short Surgical Procedures: 10 to 20 mg slow IV until eyelids droop. May be administered together with a Diazepam injection.
Endoscopy: 10 mg IV just prior to the procedure or 10 mg IM 1/2 hour before the procedure.
Severe anxiety: 5 to 10 mg IV or IM. Repeat in 3 to 4 hours, if necessary.
Induction: 10 to 40 mg slow IV, one ml/min. until eyelids droop.
Labor: 10 to 20 mg IV once to facilitate delivery when the cervix is dilated 2-3 finger’s breadth.
Convulsive disorders: 10 to 20 mg IV/IM, repeated 3 to 4 hourly, max. 100 mg/day, as per the need of the patient. 
Alcohol withdrawal:
Status epilepticus:
Tetanus. Eclampsia: