Phenytoin (Dilantin Infatabs)

Trade Name : Dilantin Infatabs

Parke-Davis Div of Pfizer Inc

TABLET, CHEWABLE

Strength 50 mg/1

PHENYTOIN Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Phenytoin (Dilantin Infatabs) which is also known as Dilantin Infatabs and Manufactured by Parke-Davis Div of Pfizer Inc. It is available in strength of 50 mg/1 per ml. Read more

Phenytoin (Dilantin Infatabs) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • DILANTIN 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.
  • DILANTIN 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. ()
  • No data
  • NOT FOR ONCE-A-DAY DOSING
  • 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. ()
  • 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. ()
  • Serum blood level determinations may be necessary for optimal dosage adjustmentsu2014the clinically effective serum total concentration is 10 to 20 mcg/mL (unbound phenytoin concentration is 1 to 2 mcg/mL). ()
  • DILANTIN INFATABS are available as 50 mg phenytoin yellow triangular scored chewable tablets.
  • DILANTIN INFATABS are available as 50 mg phenytoin scored chewable tablets. ()
  • DILANTIN is contraindicated in patients with:
  • Hypersensitivity to phenytoin, its ingredients, or other hydantoins (, )
  • A history of prior acute hepatotoxicity attributable to phenytoin (, )
  • Coadministration with delavirdine ()
  • No data
  • Withdrawal Precipitated Seizure:
  • Suicidal Behavior and Ideation:
  • Serious Dermatologic Reactions:
  • Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity:
  • Cardiac Effects:
  • Angioedema:
  • Hepatic Injury:
  • Hematopoietic Complications:
  • The following serious adverse reactions are described elsewhere in the labeling:
  • tThe following adverse reactions associated with the use of DILANTIN were identified in clinical studies or postmarketing reports. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
  • Body as a Whole:n- [see , , )]
  • There have also been reports of coarsening of facial features, systemic lupus erythematosus, periarteritis nodosa, and immunoglobulin abnormalities.
  • Digestive System:
  • Hematologic and Lymphatic System:n- [see ]
  • Laboratory Test Abnormality:n- [see ]
  • Nervous System:n- [see ]
  • A predominantly sensory peripheral polyneuropathy has been observed in patients receiving long-term phenytoin therapy.
  • Skin and Appendages:n- [see ]
  • Special Senses:
  • Urogenital:
  • The most common adverse reactions are nervous system reactions, including nystagmus, ataxia, slurred speech, decreased coordination, somnolence, and mental confusion. ()
  • To report SUSPECTED ADVERSE REACTIONS, contact Pfizer, Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or .
  • Phenytoin is extensively bound to plasma proteins and is prone to competitive displacement. Phenytoin is metabolized by hepatic cytochrome P450 enzymes CYP2C9 and 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. (, )
  • No data
  • Pregnancy:
  • Renal and/or Hepatic Impairment or Hypoalbuminemia:
  • The lethal dose in pediatric patients is not known. The lethal dose in adults is estimated to be 2 to 5 grams. The initial symptoms are nystagmus, ataxia, and dysarthria. Other signs are tremor, hyperreflexia, lethargy, slurred speech, blurred vision, nausea, and vomiting. The patient may become comatose and hypotensive. Bradycardia and cardiac arrest have been reported . Death is caused by respiratory and circulatory depression.
  • There are marked variations among individuals with respect to phenytoin serum levels where toxicity may occur. Nystagmus, on lateral gaze, usually appears at 20 mcg/mL, ataxia at 30 mcg/mL; dysarthria and lethargy appear when the serum concentration is over 40 mcg/mL, but as high a concentration as 50 mcg/mL has been reported without evidence of toxicity. As much as 25 times the therapeutic dose has been taken to result in a serum concentration over 100 mcg/mL with complete recovery. Irreversible cerebellar dysfunction and atrophy have been reported.
  • Treatment:
  • The adequacy of the respiratory and circulatory systems should be carefully observed and appropriate supportive measures employed. Hemodialysis can be considered since phenytoin is not completely bound to plasma proteins. Total exchange transfusion has been used in the treatment of severe intoxication in pediatric patients.
  • In acute overdosage the possibility of other CNS depressants, including alcohol, should be borne in mind.
  • DILANTIN (phenytoin) is related to the barbiturates in chemical structure, but has a five-membered ring. The chemical name is 5,5-diphenyl-2,4 imidazolidinedione, having the following structural formula:
  • Each DILANTIN INFATAB, chewable tablet for oral administration, contains 50 mg phenytoin, USP. Also contains: D&C yellow No. 10, Aluminum Lake; FD&C yellow No. 6, Aluminum Lake; flavor; saccharin sodium, USP; confectioner's sugar, NF; talc, USP; magnesium stearate, NF; and purified water, USP.
  • No data
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  • Advise patients to read the FDA-approved patient labeling (Medication Guide).
  • LAB-0204-31.0
  • No data
  • ALWAYS DISPENSE WITH ACCOMPANYINGMEDICATION GUIDE
  • Pfizer
  • NDC 0071-0007-24
  • INFATABSn n n n
  • Phenytoin ChewableTablets, USP
  • 50 mg
  • 100 Tabletsn n
  • INFATABSu00aen n n Phenytoin ChewableTablet, USP
  • 50 mg
  • Protect From Moisture.
  • DIST BY PARKE-DAVISDIV OF PFIZER INC, NY, NY 10017
  • EXP & LOT AREA
  • ALWAYS DISPENSE WITH ACCOMPANYINGMEDICATION GUIDE
  • Pfizer
  • NDC 0071-0007-40
  • INFATABSn n n n
  • Phenytoin Chewable Tablets, USP
  • 50 mg
  • Chewable/Flavored for Pediatric Patients
  • For in-institution use only
  • 100 Tabletsn n

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