Generic Name: Phenytoin Sodium 100mg
Manufacturer/Distributor: Ambee Pharmaceuticals Ltd
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Indications
Parenteral phenytoin is used to treat generalized tonic-clonic seizures, as well as the prevention and treatment of seizures that occur during neurosurgery. Oral phenytoin can be replaced with intravenous phenytoin for short-term use. When oral phenytoin administration is not possible, parenteral phenytoin should be used.
Pharmacology
Phenytoin works as an anticonvulsant by increasing efflux or decreasing influx of sodium ions across cell membranes in the motor cortex during nerve impulse generation, thereby stabilizing neuronal membranes and reducing seizure activity. It works as an antiarrhythmic by prolonging the effective refractory period and inhibiting the automaticity of the ventricular pacemaker.
Dosage & Administration
Oral: Epilepsy:
Adult: Initially, 3-4 mg/kg daily as single dose or in divided doses. Alternatively, 150-300 mg daily increased gradually to 600 mg daily if necessary. Maintenance: 200-500 mg daily.
Child: Initially, 5 mg/kg daily in 2-3 divided doses. Maintenance: 4-8 mg/kg daily in divided doses. Max dose: 300 mg daily.
Intravenous: Tonic-clonic status epilepticus:
Adult: Adjunctive therapy with a benzodiazepine (e.g. diazepam): 10-15 mg/kg by slow inj or intermittent infusion at a max rate of 50 mg/min. Maintenance: 100 mg IV (or orally) given every 6-8 hr.
Child: Neonates: 20 mg/kg as a loading dose, then 2.5-5 mg/kg bid; 1 mth-12 yr: 18 mg/kg as a loading dose, then 2.5-5 mg/kg bid; >12 yr: 18 mg/kg as a loading dose, then up to 100 mg 3-4 times daily.
Should be taken with food. When administering to patients on nasogastric or other enteral feeds, do not administer feeds 2 hr before or after a dose. Be consistent throughout therapy in relation to feed times. Do not switch dosage forms/brands w/o prior consideration.
Interaction
The effects of other sedatives or ethanol may be amplified. Increases the toxicity of paracetamol and lithium. Acetazolamide raises the risk of osteomalacia. Acyclovir, antineoplastics, benzodiazeines, ciprofloxacin, CYP2C9 inducers (e.g. carbamazepine), CYP2C19 inducers (e.g. rifampin), folic acid, and vigabatrin all reduced serum levels/effects.
Contraindications
Patients with a history of hypersensitivity to phenytoin, its inactive ingredients, or other hydantoins should not take phenytoin sodium.
Because of the effect of parenteral phenytoin on ventricular automaticity, sinus bradycardia, sino-atrial block, second and third-degree A-V block, and Adams-Stokes syndrome can occur.
A history of phenytoin-related acute hepatotoxicity in the past.
Side Effects
Hypersensitivity, loss of appetite, headache, dizziness, tremor, transient nervousness, insomnia, GI disturbances (e.g. nausea, vomiting, constipation), gum tenderness and hyperplasia, acne, hirsutism, coarsening of facial features, rashes, and osteomalacia
Pregnancy & Lactation
Although there is evidence of human fetal risk, the benefits of use in pregnant women may outweigh the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).
Precautions & Warnings
DM; hepatic impairment; hypoalbuminemia; porphyria; seizures (may increase the frequency of petit mal seizures); debilitated patients; elderly. Cardiovascular disease, e.g. sinus bradycardia, heart blocks; DM; hepatic impairment; hypoalbuminemia; porphyria; seizures (may increase the frequency of petit mal seizures). In hypotension, heart failure, or MI, use caution when administering IV medications, and keep a close eye on your blood pressure and ECG during treatment. IV administration should be done slowly to avoid hypotension, CNS depression, and cardiac arrhythmias.
Storage Conditions
Keep the temperature below 15-30°C and away from light and moisture. Keep out of children's reach.
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