Drugplain

Extended Phenytoin Sodium 100 mg/1

Phenytoin Sodium · CAPSULE · Aurobindo Pharma Limited

4 Recalls on Record
Plain English

Extended phenytoin sodium is an oral capsule medication used to treat and prevent seizures in patients with epilepsy and certain other seizure disorders. This prescription medication works by stabilizing electrical activity in the brain to reduce the frequency and severity of seizures.

Key Facts

Brand Name
Extended Phenytoin Sodium
Generic Name
Phenytoin Sodium
NDC Code (Product)
65862-692
Manufacturer
Aurobindo Pharma Limited
Strength
100 mg/1
Dosage Form
CAPSULE
Route
ORAL
Marketing Status
Application #
ANDA204309
Marketing Start
06/10/2015

Recall History

4 Recalls on Record
Class II05/30/2023

Amneal Pharmaceuticals of New York, LLC

Failed Dissolution Specifications: Out-of-specification results for dissolution (above specification)

TerminatedVoluntary: Firm initiated
Class II10/27/2023

Amneal Pharmaceuticals of New York, LLC

Failed Dissolution Specifications

TerminatedVoluntary: Firm initiated
Class II04/22/2015

Wockhardt Usa Inc.

CGMP Deviations: Firm did not adequately investigate customer complaints.

TerminatedVoluntary: Firm initiated
Class II08/17/2013

Amneal Pharmaceuticals of New York, LLC.

Failed dissolution specifications; 18 month CRT

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective614 reports
seizure349 reports
convulsion274 reports
drug interaction258 reports
toxicity to various agents236 reports
dizziness138 reports
fall135 reports
off label use125 reports
epilepsy123 reports
pyrexia118 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE 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. 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. ( 1 )

Dosage & Administration

2 DOSAGE AND ADMINISTRATION Adult starting dose in patients who have received no previous treatment is one 100 mg extended phenytoin sodium capsule three times a day, with dose adjustments as necessary. For most adults, the satisfactory maintenance dose will be one capsule three to four times a day. An increase, up to two capsules three times a day may be made, if necessary. ( 2.1 ) Adult once-a-day dose: If seizure control is established with divided doses of three 100 mg extended phenytoin sodium capsules daily, once-a-day dosage with 300 mg extended phenytoin sodium capsules may be considered. ( 2.1 ) Adult loading dose: reserved for patients in a clinic or hospital setting who require rapid steady-state serum levels and where intravenous administration is not desired. Refer to full prescribing information. ( 2.1 ) Pediatric starting dose is 5 mg/kg/day in two to three equally divided doses, with dosage adjustments as necessary, up to a maximum of 300 mg daily. Maintenance dosage is 4 to 8 mg/kg/day. ( 2.2 ) Serum blood level determinations may be necessary for optimal dosage adjustments—the clinically effective serum total concentration is 10 to 20 mcg/mL (unbound phenytoin con…

Contraindications

4 CONTRAINDICATIONS Phenytoin sodium is 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, or other hydantoins ( 4 , 5.5 ) A history of prior acute hepatotoxicity attributable to phenytoin ( 4 , 5.8 ) Coadministration with delavirdine ( 4 )

Drug Interactions

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 serum levels is recommended when a drug interaction is suspected. Phenytoin is a potent inducer of hepatic drug-metabolizing enzymes. Multiple drug interactions because of extensive plasma protein binding, saturable metabolism and potent induction of hepatic enzymes. ( 7.1 , 7.2 ) 7.1 Drugs that Affect Phenytoin Concentrations Table 2 includes commonly occurring drug interactions that affect phenytoin concentrations. However, this list is not intended to be inclusive or comprehensive. Individual prescribing information from relevant drugs should be consulted. The addition or withdrawal of these agents in patients on phenytoin therapy may require an adjustment of the phenytoin dose to achieve…

Adverse Reactions

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 Precautions (5.5) ] Cardiac Effects [see Warnings and Precautions (5.6) ] Angioedema [see Warnings and Precautions (5.7) ] Hepatic Injury [see Warnings and Precautions (5.8) ] Hematopoietic Complications [see Warnings and Precautions (5.9) ] Effects on Vitamin D and Bone [see Warnings and Precautions (5.10) ] Exacerbation of Porphyria [see Warnings and Precautions (5.12) ] Teratogenicity and Other Harm to the Newborn [see Warnings and Precautions (5.13) ] Hyperglycemia [see Warnings and Precautions (5.14) ] The following adverse reactions associated with the use of phenytoin sodium were identified in clinical studies or postmarketing reports. Because these reactions are reported voluntarily from a p…

Frequently Asked Questions

What is Extended Phenytoin Sodium used for?

Extended phenytoin sodium is an oral capsule medication used to treat and prevent seizures in patients with epilepsy and certain other seizure disorders. This prescription medication works by stabilizing electrical activity in the brain to reduce the frequency and severity of seizures.

Is Extended Phenytoin Sodium a controlled substance?

Extended Phenytoin Sodium is not classified as a controlled substance by the DEA.

What is the generic name for Extended Phenytoin Sodium?

The generic name for Extended Phenytoin Sodium is Phenytoin Sodium. There are 10 other brand versions of Phenytoin Sodium.

What is the NDC code for Extended Phenytoin Sodium 100 mg/1?

The NDC (National Drug Code) for Extended Phenytoin Sodium 100 mg/1 is 65862-692, listed by Aurobindo Pharma Limited.

Product NDC

65862-692

Package NDC

65862-692-01

Other Extended Phenytoin Sodium Dosages

Other Phenytoin Brands

See all →

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)