Phenytoin Infatabs 50 mg/1

Phenytoin · TABLET, CHEWABLE · NCS HealthCare of KY, LLC dba Vangard Labs

No Recall History

Plain English

Phenytoin Infatabs is a tablet, chewable containing phenytoin at 50 mg/1, taken oral. Manufactured by NCS HealthCare of KY, LLC dba Vangard Labs.

Key Facts

Brand Name: Phenytoin Infatabs
Generic Name: Phenytoin
NDC Code (Product): 0615-8424
Manufacturer: NCS HealthCare of KY, LLC dba Vangard Labs
Strength: 50 mg/1
Dosage Form: TABLET, CHEWABLE
Route: ORAL
Marketing Status
Application #: ANDA084427
Drug Class: Anti-epileptic Agent [EPC]
Marketing Start: 11/23/2021

Recall History

No Recall History

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE Phenytoin Infatabs 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 Infatabs 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 )

Dosage & Administration

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 Infatabs three times a day, with dose adjustments as necessary. For most adults, the satisfactory maintenance dose will be six to eight Infatabs daily; an increase to twelve Infatabs daily may be made, if necessary. ( 2.2 ) 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. ( 2.3 ) 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 concentration is 1 to 2 mcg/mL). ( 2.4 ) 2.1 Important Administration Instructions NOT FOR ONCE-A-DAY DOSING. Phenytoin Infatabs can be either chewed thoroughly before being swallowed or swallowed whole. 2.2 Adult Dosage The recommended starting dosage for adult patients who have received no previous treatment is two 50 mg Infatabs by mouth three times daily. Adjust the dosage to suit individual requirements up to a maximum of twelve Infatabs daily. For most adult…

Contraindications

4 CONTRAINDICATIONS Phenytoin 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 were identified in clinical studies or postmarketing reports. Because these reactions are reported voluntarily from a populati…

Frequently Asked Questions

What is Phenytoin Infatabs used for?

Phenytoin Infatabs contains Phenytoin. It is a tablet, chewable taken oral. Consult your doctor for specific uses.

Is Phenytoin Infatabs a controlled substance?

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

What is the generic name for Phenytoin Infatabs?

The generic name for Phenytoin Infatabs is Phenytoin. There are 12 other brand versions of Phenytoin.

What is the NDC code for Phenytoin Infatabs 50 mg/1?

The NDC (National Drug Code) for Phenytoin Infatabs 50 mg/1 is 0615-8424, listed by NCS HealthCare of KY, LLC dba Vangard Labs.

Product NDC

0615-8424

Package NDC

0615-8424-39

Other Phenytoin Brands

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

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