DILANTIN
he precise mechanism by which phenytoin exerts its therapeutic effect has not been established but is thought to involve the voltage-dependent blockade of membrane sodium channels resulting in a reduction in sustained high-frequency neuronal discharges.
DILANTIN is 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.
The recommended starting dose for adult patients who have received no previous treatment is one 100-mg DILANTIN (extended phenytoin sodium capsule, USP) by mouth three times daily. Adjust the dosage to suit individual requirements up to a maximum of two capsules three times a day. For most adults, the satisfactory maintenance dosage will be one capsule three to four times a day.
The following serious adverse reactions are described elsewhere in the labeling:
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- Withdrawal Precipitated Seizure, Status Epilepticus [see WARNINGS AND PRECAUTIONS (5.1)]
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- Suicidal Behavior and Ideation [see WARNINGS AND PRECAUTIONS (5.2)]
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- Serious Dermatologic Reactions [see WARNINGS AND PRECAUTIONS (5.3)]
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- Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity [see WARNINGS AND PRECAUTIONS (5.4)]
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- Hypersensitivity [see WARNINGS AND PRECAUTIONS (5.5)]
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- Cardiac Effects [see WARNINGS AND PRECAUTIONS (5.6)]
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- Angioedema [see WARNINGS AND PRECAUTIONS (5.7)]
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- Hepatic Injury [see WARNINGS AND PRECAUTIONS (5.8)]
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- Hematopoietic Complications [see WARNINGS AND PRECAUTIONS (5.9)]
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- Effects on Vitamin D and Bone [see WARNINGS AND PRECAUTIONS (5.10)]
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- Exacerbation of Porphyria [see WARNINGS AND PRECAUTIONS (5.12)]
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- Teratogenicity and Other Harm to the Newborn [see WARNINGS AND PRECAUTIONS (5.13)]
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- Hyperglycemia [see WARNINGS AND PRECAUTIONS (5.14)]
DILANTIN is contraindicated in patients with:
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- A history of hypersensitivity to phenytoin, its inactive ingredients, or other hydantoins [see WARNINGS AND PRECAUTIONS (5.5)]. Reactions have included angioedema.
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- A history of prior acute hepatotoxicity attributable to phenytoin [see WARNINGS AND PRECAUTIONS (5.8)].
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- 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.
- Withdrawal Precipitated Seizure, Status Epilepticus
- Suicidal Behavior and Ideation
- Serious Dermatologic Reactions
- Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity
- Hypersensitivity
- Cardiac Effects
- Angioedema
- Hepatic Injury
- Hematopoietic Complications
- Effects on Vitamin D and Bone
- Exacerbation of Porphyria
- Teratogenicity and Other Harm to the Newborn
- Hyperglycemia
DILANTIN (phenytoin) is related to the barbiturates in chemical structure, but has a five-membered ring. Each 30 mg DILANTIN- (extended phenytoin sodium capsule, USP) for oral administration contains 30 mg phenytoin sodium, USP. Also contains lactose monohydrate, NF; confectioner's sugar, NF; talc, USP; and magnesium stearate, NF. The capsule shell cap and body components contain titanium dioxide (cap and body); gelatin (cap and body); D&C yellow No. 10 (cap); FD&C red No. 3 (cap). Product in vivoperformance is characterized by a slow and extended rate of absorption with peak blood concentrations expected in 4 to 12 hours as contrasted to Prompt Phenytoin Sodium Capsules, USP with a rapid rate of absorption with peak blood concentration expected in 1½ to 3 hours.