Kraj: Singapur
Język: angielski
Źródło: HSA (Health Sciences Authority)
PHENYTOIN SODIUM
PFIZER PRIVATE LIMITED
N03AB02
250 mg/5 ml
INJECTION
INTRAVENOUS, INTRAMUSCULAR
Prescription Only
Actavis Italy S.p.A.
1996-06-20
Page 1 of 13 DILANTIN ® (PHENYTOIN SODIUM INJECTION, USP) 1. NAME(S) OF THE MEDICINAL PRODUCT Dilantin 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Phenytoin sodium is an anticonvulsant drug, related to the barbiturates in chemical structure, but has a five-membered ring. The chemical name is sodium 5,5-diphenyl-2,4-imidazolidinedione. Each 5 mL of the sterile solution contains 250 mg phenytoin sodium. 3. PHARMACEUTICAL FORM Solution for injection. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Phenytoin is indicated for the control of status epilepticus of the tonic clonic (grand mal) type and prevention and treatment of seizures occurring during or following neurosurgery. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION General Phenytoin capsules and solution for injection are formulated with the sodium salt of phenytoin. The free acid form of phenytoin is used in the phenytoin suspension 30 mg/5 mL (pediatric) and 125 mg/5 mL) and in the phenytoin tablets. Because there is approximately an 8% increase in drug content with the free acid form over that of the sodium salt, dosage adjustments and serum level monitoring may be necessary when switching from a product formulated with the free acid to a product formulated with the sodium salt and vice versa. Phenytoin serum level determinations may be necessary to achieve optimal dosage adjustments. Optimum control without clinical signs of toxicity occurs most often with serum levels between 10 and 20 mcg/mL. Parenteral phenytoin may be administered as a slow intravenous (IV) bolus or it may be administered via an IV infusion. Because of the risk of local toxicity, intravenous phenytoin should be administered directly into a large peripheral or central vein through a large-gauge catheter. Pr Przeczytaj cały dokument