| Product Name: | Phenytoin Sodium Injection USP |
| Brand Name: | Generic |
| Strength: | 50mg/1ml, 100mg/2ml, 250mg/5ml |
| Dosage Form: | Liquid Injection (Sterile) |
| Packing: | 2ml, 5ml Ampoule |
| Route of Administration: | For IM & IV Injection 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: | Anti-Epileptic, Anticonvulsant, CNS, Neuropsychiatric. |
| Indication: | Phenytoin injection is used to control certain types of seizures (convulsions) in the treatment of epilepsy. It is also used to prevent and treat seizures that occur during brain surgery. This medicine is an anticonvulsant that works in the brain tissue to stop seizures. |
| Storage: | Store at 20°C to 25°C (68° to 77°). See USP-controlled room temperature. |
GENERIC NAME OF MEDICINAL PRODUCT:
- Phenytoin Sodium Injection USP 50mg/ml
- Phenytoin Sodium Injection USP 100mg/2ml
- Phenytoin Sodium Injection USP 250mg/5ml
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Phenytoin Sodium Injection USP 50mg/ml
Each ml contains:
Phenytoin Sodium USP……………………50 mg
Propylene Glycol USP…………………….0.4 ml
Ethyl Alcohol USP……………………………0.1 ml
Water for Injections BP………………..q.s. - Phenytoin Sodium Injection USP 100mg/2ml
Each ml contains:
Phenytoin Sodium USP……………………100 mg
Propylene Glycol USP…………………….0.4 ml
Ethyl Alcohol USP……………………………0.1 ml
Water for Injections BP………………..q.s. - Phenytoin Sodium Injection USP 250mg/5ml
Each ml contains:
Phenytoin Sodium USP……………………250 mg
Propylene Glycol USP…………………….0.4 ml
Ethyl Alcohol USP……………………………0.1 ml
Water for Injections BP………………..q.s.
THERAPEUTIC INDICATION:
Phenytoin injection is used to control certain types of seizures (convulsions) in the treatment of epilepsy. It is also used to prevent and treat seizures that occur during brain surgery. This medicine is an anticonvulsant that works in the brain tissue to stop seizures.
DIRECTION OF USE:
For IM & IV Injection only.
The Injection must not be diluted before administration.
CAUTION & WARNING:
Phenytoin Sodium injection should not be diluted but its clear solution should only be used.
Not to exceed 50 mg per minute intramuscularly or intravenously.
A faint yellow coloration may develop; however, this has no effect on the potency of the solution.
Do not use it in case there is any haze, crystals, or deposits in the ampoule.
KEEP OUT OF REACH AND SIGHT OF CHILDREN.
WARNING: It is dangerous to take this preparation except under medical supervision.
STORAGE & DOSAGE:
Storage: Store at 20°C to 25°C (68° to 77°). See USP-controlled room temperature.
Dosage: As directed by the Physician.