Phenytoindrug info
phenytoin sodium 300 MG Extended Release Oral Capsule [Phenytek]
What it is used for
PHENYTEK ® capsules (extended phenytoin sodium capsules) are indicated for the treatment of tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures and prevention and treatment of seizures occurring during or following neurosurgery. PHENYTEK ® CAPSULES are indicated for the treatment of tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures and prevention and treatment of seizures occurring during or following neurosurgery.
Text above is quoted in full from the FDA-approved drug label published by openFDA, effective October 15, 2024. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.
Description
Phenytoin sodium is related to the barbiturates in chemical structure, but has a five-membered ring. The chemical name is 5,5-Diphenylhydantoin sodium salt, having the following structural formula: Each 200 mg or 300 mg PHENYTEK ® capsule (extended phenytoin sodium capsule, USP) for oral administration contains 200 mg or 300 mg phenytoin sodium, USP. Also contains colloidal silicon dioxide, FD&C Blue No. 1, gelatin, hydroxyethyl cellulose, magnesium oxide, magnesium stearate, microcrystalline cellulose, povidone, sodium lauryl sulfate and titanium dioxide. In addition, the imprinting ink contains black iron oxide, D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, propylene glycol and shellac glaze. Product in vivo performance is characterized by a slow and extended rate of absorption with peak blood concentrations expected in 4 to 12 hours as contrasted to prompt phenytoin sodium capsules with a rapid rate of absorption with peak blood concentration expected in 1½ to 3 hours. Meets USP Dissolution Test 3. Phenytoin Structural Formula
Text above is quoted in full from the FDA-approved drug label published by openFDA, effective October 15, 2024. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.
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