Phenytek 300 mg/1

phenytoin sodium · CAPSULE, EXTENDED RELEASE · Mylan Pharmaceuticals Inc.

No Recall History

Plain English

Phenytek is a capsule, extended release containing phenytoin sodium at 300 mg/1, taken oral. Manufactured by Mylan Pharmaceuticals Inc..

Key Facts

Brand Name: Phenytek
Generic Name: phenytoin sodium
NDC Code (Product): 0378-3750
Manufacturer: Mylan Pharmaceuticals Inc.
Strength: 300 mg/1
Dosage Form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Marketing Status
Application #: ANDA040298
Marketing Start: 12/10/2001

Recall History

No Recall History

Side Effects Reported to FDA

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

drug ineffective624 reports

seizure354 reports

convulsion288 reports

drug interaction259 reports

toxicity to various agents237 reports

dizziness143 reports

fall140 reports

off label use126 reports

epilepsy124 reports

pyrexia121 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE 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. ( 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 PHENYTEK ® 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 concentr…

Contraindications

4 CONTRAINDICATIONS PHENYTEK ® capsules 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, 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 PHENYTEK ® capsules were identified in clinical studies or postmarketing reports. Because these reactions are …

Frequently Asked Questions

What is Phenytek used for?

Phenytek contains phenytoin sodium. It is a capsule, extended release taken oral. Consult your doctor for specific uses.

Is Phenytek a controlled substance?

Phenytek is not classified as a controlled substance by the DEA.

What is the generic name for Phenytek?

The generic name for Phenytek is phenytoin sodium. There are 12 other brand versions of phenytoin sodium.

What is the NDC code for Phenytek 300 mg/1?

The NDC (National Drug Code) for Phenytek 300 mg/1 is 0378-3750, listed by Mylan Pharmaceuticals Inc..

Product NDC

0378-3750

Package NDC

0378-3750-01

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)