Generic equivalent of Phenytoin
1 SKUs available · Available to order · NABP accredited · DSCSA compliant
Phenytoin is the generic equivalent of the brand-name drug Phenytoin. Licensed pharmacies, clinics, doctor's offices, and veterinary practices can source wholesale Phenytoin through Premier Pharma with same-day fulfillment on in-stock SKUs.
1 INDICATIONS AND USAGE Phenytoin chewable tablets are indicated for the treatment of generalized tonic-clonic (grand mal) and complex partial (psychomotor, temporal lobe) seizures and prevention and treatment of seizures occurring during or following neurosurgery. Phenytoin chewable tablets are indicated for the treatment of generalized tonic-clonic (grand mal) and complex partial (psychomotor, temporal lobe) seizures and prevention and treatment of seizures occurring during or following neurosurgery. ( 1 )
12.1 Mechanism of Action The precise mechanism by which phenytoin exerts its therapeutic effect has not been established but is thought to involve the voltage-dependent blockade of membrane sodium channels resulting in a reduction in sustained high-frequency neuronal discharges.
12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action The precise mechanism by which phenytoin exerts its therapeutic effect has not been established but is thought to involve the voltage-dependent blockade of membrane sodium channels resulting in a reduction in sustained high-frequency neuronal discharges. 12.3 Pharmacokinetics Absorption For phenytoin chewable tablets, peak levels occur 1½ to 3 hours after administration. Steady-state therapeutic levels are achieved at least 7 to 10 days (5 to 7 half-lives) after initiation of therapy with recommended doses of 300 mg/day. When serum level determinations are necessary, they should be obtained at least 5 to 7 half-lives after treatment initiatio…
4 CONTRAINDICATIONS Phenytoin chewable tablets are contraindicated in patients with: A history of hypersensitivity to phenytoin, its inactive ingredients, or other hydantoins [see Warnings and Precautions (5.5) ] . Reactions have included angioedema. A history of prior acute hepatotoxicity attributable to phenytoin [see Warnings and Precautions (5.8) ] . Coadministration with delavirdine because of the potential for loss of virologic response and possible resistance to delavirdine or to the class of non-nucleoside reverse transcriptase inhibitors. Hypersensitivity to phenytoin, its ingredients…
6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in the labeling: Withdrawal Precipitated Seizure, Status Epilepticus [see Warnings and Precautions (5.1) ] Suicidal Behavior and Ideation [see Warnings and Precautions (5.2) ] Serious Dermatologic Reactions [see Warnings and Precautions (5.3) ] Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity [see Warnings and Precautions (5.4) ] Hypersensitivity [see Warnings and Precauti…
7 DRUG INTERACTIONS Phenytoin is extensively bound to plasma proteins and is prone to competitive displacement. Phenytoin is primarily metabolized by the hepatic cytochrome P450 enzyme CYP2C9 and to a lesser extent by CYP2C19, and is particularly susceptible to inhibitory drug interactions because it is subject to saturable metabolism. Inhibition of metabolism may produce significant increases in circulating phenytoin concentrations and enhance the risk of drug toxicity. Monitoring of phenytoin…
2 DOSAGE AND ADMINISTRATION NOT FOR ONCE-A-DAY DOSING ( 2.1 ) Adult starting dose in patients who have received no previous treatment is two phenytoin chewable tablets three times a day, with dose adjustments as necessary. For most adults, the satisfactory maintenance dose will be six to eight phenytoin chewable tablets daily; an increase to twelve phenytoin chewable tablets daily may be made, if necessary. ( 2.2 ) Pediatric starting dose is 5 mg/kg/day in two to three equally divided doses, wit…
17 PATIENT COUNSELING INFORMATION Advise patients to read the FDA-approved patient labeling (Medication Guide). Administration Information Advise patients taking phenytoin of the importance of adhering strictly to the prescribed dosage regimen, and of informing the physician of any clinical condition in which it is not possible to take the drug orally as prescribed, e.g., surgery, etc. Withdrawal of Antiepileptic Drugs Advise patients not to discontinue use of phenytoin without consulting with their healthcare provider. Phenytoin should normally be gradually withdrawn to reduce the potential f…
Source: FDA. For professional use only. Not a substitute for prescribing information.
Premier Pharma stocks 1 Phenytoin SKUs — 0 currently in stock — available to licensed pharmacies, clinics, doctor's offices, and veterinary practices. Phenytoin is the generic equivalent of Phenytoin. Create a free account to see live wholesale pricing and place orders with same-day fulfillment for in-stock items.
Premier Pharma carries Phenytoin in 50 mg/1 and TABLET, CHEWABLE.
Phenytoin carries an FDA Orange Book TE code of AB. Therapeutically equivalent — meets FDA bioequivalence requirements; may be substituted for the reference listed drug. Always verify substitution with the current Orange Book before dispensing.
12.1 Mechanism of Action The precise mechanism by which phenytoin exerts its therapeutic effect has not been established but is thought to involve the voltage-dependent blockade of membrane sodium channels resulting in a reduction in sustained high-frequency neuronal discharges.
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