Phenytoin (Dilantin-125)

Trade Name : Dilantin-125

Parke-Davis Div of Pfizer Inc

SUSPENSION

Strength 125 mg/5mL

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-125) which is also known as Dilantin-125 and Manufactured by Parke-Davis Div of Pfizer Inc. It is available in strength of 125 mg/5mL per ml. Read more

Phenytoin (Dilantin-125) 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

Packaging and Delivery

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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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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 is indicated for the treatment of tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures.
  • DILANTIN is indicated for the treatment of tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures. ()
  • No data
  • Adult starting dose in patients who have received no previous treatment is 5mL three times daily, with dose adjustments as necessary, up to 25 mL daily. ()
  • 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-125 is available as a 125 mg phenytoin/5 mL oral suspension of orange color with an orange-vanilla flavor.
  • DILANTIN-125 is available as a 125 mg phenytoin/5 mL oral suspension. ()
  • 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:
  • The 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 5 mL of the oral suspension contains 125 mg of phenytoin, USP; alcohol, USP (maximum content not greater than 0.6 percent); banana flavor; carboxymethylcellulose sodium, USP; citric acid, anhydrous, USP; glycerin, USP; magnesium aluminum silicate, NF; orange oil concentrate; polysorbate 40, NF; purified water, USP; sodium benzoate, NF; sucrose, NF; vanillin, NF; and FD&C yellow No. 6.
  • No data
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  • Advise patients to read the FDA-approved patient labeling (Medication Guide).
  • LAB-0203-31.0
  • No data
  • ALWAYS DISPENSE WITH MEDICATION GUIDE
  • Pfizer
  • NDC 0071-2214-20
  • Dilantin-125
  • 125 mg per 5 mL
  • IMPORTANTu2013SHAKE WELLBEFORE EACH USE
  • NOT FOR PARENTERAL USE
  • 8 fl oz (237 mL)n n
  • ALWAYS DISPENSE WITH MEDICATION GUIDE
  • Pfizer NDC 0071-2214-20
  • Dilantin-125n (phenytoin, USP)Oral Suspension
  • 125 mg per 5 mL
  • IMPORTANTu2013SHAKE WELLBEFORE EACH USE
  • NOT FOR PARENTERAL USE
  • 8 fl oz (237 mL)Rx only

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