Fosfen

• Control of generalized convulsive status epilepticus
• Prevention and treatment of seizures occurring during neurosurgery or head injury
• Short-term substitution for oral Phenytoin

Fosphenytoin Sodium injection is a pro-drug intended for parenteral administration and its active metabolite is Phenytoin. Fosphenytoin Sodium injection is supplied in ampoule as a ready-mixed solution in Water for Injection and Tromethamine, buffer adjusted to pH 8.6 to 9.0 with either Hydrochloric Acid or Sodium Hydroxide.

Adult Dose (Parenteral):

• Status Epilepticus: IV infusion (100-150 mg/min), initial 15 mg/kg, then IM or IV infusion (50-100 mg/min), 4-5 mg/kg/day (1-2 divided doses).
• Neurosurgery or head injury seizure prophylaxis/treatment: IM or IV infusion (50-100 mg/min), initial 10-15 mg/kg, then 4-5 mg/kg/day.
• Temporary substitution for oral Phenytoin: IM or IV infusion (50-100 mg/min), same dose and frequency as oral Phenytoin.

Children (5+ years):

• Status Epilepticus: IV infusion (2-3 mg/kg/min), initial 15 mg/kg, then IV infusion (1-2 mg/kg/min), 4-5 mg/kg/day (1-4 divided doses).

Elderly, Hepatic & Renal Impairment: Dose reduction or slower infusion may be needed.

* Use as directed by the registered physician

Common Side Effects:

• Vomiting
• Sleepiness
• Dizziness
• Itching
• Impaired coordination
• Nystagmus (involuntary eye movement)
• Paresthesia
• Headache
• Ataxia

Serious Side Effects: Cardiovascular collapse, CNS depression, hypotension, bradycardia, heart block, asystole, ventricular fibrillation.

Use in Pregnancy: Unsafe during pregnancy. Prenatal exposure to Phenytoin may increase the risks for congenital malformations and other adverse developmental outcomes.

Precautions:

• Use with caution in patients with hypotension and severe myocardial insufficiency.
• Discontinue if a skin rash appears.
• Discontinue and do not readminister if acute hepatotoxicity occurs.
• Hemopoietic complications (thrombocytopenia, leukopenia, agranulocytosis) may occur - regular blood tests required.
• Do not abruptly discontinue antiepileptic drugs (may cause status epilepticus).
• Monitor blood glucose levels in diabetic patients.

Overdose:

• Symptoms: Nausea, vomiting, lethargy, tachycardia, bradycardia, asystole, cardiac arrest, hypotension, syncope, hypocalcemia, metabolic acidosis.
• Treatment: No specific antidote. Monitor respiratory and circulatory systems and provide supportive measures. Hemodialysis may be considered.

Storage: Store at 2°C to 8°C (in a refrigerator). Do not keep in deep freeze. Do not store at room temperature for more than 48 hours.