| Product Name: | Diazepam Injection IP |
| Brand Name: | Generic |
| Strength: | 10mg/2ml, 50mg/10ml |
| 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
- Diazepam Injection IP 50mg/10ml
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. - Diazepam Injection IP 50mg/10ml
Each 2 ml contains:
Diazepam IP…………………………….50 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: