Diphedan
Generic Name
Phenytoin 30 mg Oral Suspension
Manufacturer
X Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| diphedan 30 mg suspension | ৳ 30.46 | N/A |
Description
Overview of the medicine
Diphedan 30 mg suspension is an antiepileptic drug containing phenytoin, used to control and prevent various types of seizures, particularly tonic-clonic and complex partial seizures. It works by stabilizing electrical activity in the brain.
Uses & Indications
Dosage
Adults
Adults: For initial dose (oral) 100 mg 3 times daily, adjusted to 300-400 mg daily. (Note: 30 mg suspension is primarily for pediatric use, specific adult dosage for suspension is not common).
Elderly
Elderly: Lower initial doses and slower titration may be required due to altered pharmacokinetics and potential for increased sensitivity to side effects. Monitor plasma levels carefully.
Children
Children: Initially 5 mg/kg/day in 2 or 3 divided doses; maintenance 4-8 mg/kg/day, maximum 300 mg/day. A 30 mg dose is a common unit for pediatric titration.
Renal_impairment
Renal impairment: No specific dosage adjustment required, but careful monitoring of phenytoin plasma levels (especially free levels) is recommended, as protein binding may be altered.
How to Take
Administer orally with or after food to minimize gastrointestinal irritation. Shake the suspension well before each use. Use an accurate measuring device to ensure correct dosing.
Mechanism of Action
Phenytoin works by blocking voltage-dependent sodium channels in the neuronal membranes, particularly in the motor cortex, which leads to a reduction in sustained high-frequency repetitive firing of action potentials. This stabilizes the neuronal membrane and prevents the spread of seizure activity.
Pharmacokinetics
Onset
Oral: 3-12 hours for peak effect. Full therapeutic effect may take several days.
Excretion
Mainly excreted in urine as inactive metabolites and glucuronides.
Half life
Highly variable, typically 7-42 hours, dose-dependent, and non-linear kinetics at therapeutic concentrations.
Absorption
Slowly but completely absorbed from the gastrointestinal tract. Absorption can be variable and affected by food.
Metabolism
Extensively metabolized in the liver by cytochrome P450 enzymes (CYP2C9 and CYP2C19) to inactive metabolites.
Side Effects
Contraindications
- Hypersensitivity to phenytoin, other hydantoins, or any component of the formulation.
- Sinus bradycardia, sinoatrial block, second- or third-degree atrioventricular block, or Stokes-Adams syndrome.
Drug Interactions
Corticosteroids
Phenytoin can decrease corticosteroid levels, requiring dosage adjustment.
Oral Contraceptives
Phenytoin can decrease the efficacy of oral contraceptives; advise alternative birth control.
Anticoagulants (e.g., Warfarin)
Phenytoin can alter the effects of warfarin; monitor INR closely.
Other Antiepileptics (e.g., Carbamazepine, Phenobarbital)
May have complex interactions, affecting each other's metabolism and levels.
Storage
Store below 30°C. Protect from light and moisture. Do not freeze. Keep out of reach of children.
Overdose
Symptoms of overdose include nystagmus, ataxia, dysarthria, tremor, hyperreflexia, lethargy, nausea, and vomiting. Severe overdose can lead to coma, hypotension, and respiratory depression. Management is symptomatic and supportive, including gastric lavage or activated charcoal.
Pregnancy & Lactation
Pregnancy Category D. Phenytoin is associated with an increased risk of birth defects (fetal hydantoin syndrome) and should be used during pregnancy only if the benefits outweigh the risks. Not recommended during breastfeeding as it is excreted in breast milk and may cause adverse effects in the infant.
Side Effects
Contraindications
- Hypersensitivity to phenytoin, other hydantoins, or any component of the formulation.
- Sinus bradycardia, sinoatrial block, second- or third-degree atrioventricular block, or Stokes-Adams syndrome.
Drug Interactions
Corticosteroids
Phenytoin can decrease corticosteroid levels, requiring dosage adjustment.
Oral Contraceptives
Phenytoin can decrease the efficacy of oral contraceptives; advise alternative birth control.
Anticoagulants (e.g., Warfarin)
Phenytoin can alter the effects of warfarin; monitor INR closely.
Other Antiepileptics (e.g., Carbamazepine, Phenobarbital)
May have complex interactions, affecting each other's metabolism and levels.
Storage
Store below 30°C. Protect from light and moisture. Do not freeze. Keep out of reach of children.
Overdose
Symptoms of overdose include nystagmus, ataxia, dysarthria, tremor, hyperreflexia, lethargy, nausea, and vomiting. Severe overdose can lead to coma, hypotension, and respiratory depression. Management is symptomatic and supportive, including gastric lavage or activated charcoal.
Pregnancy & Lactation
Pregnancy Category D. Phenytoin is associated with an increased risk of birth defects (fetal hydantoin syndrome) and should be used during pregnancy only if the benefits outweigh the risks. Not recommended during breastfeeding as it is excreted in breast milk and may cause adverse effects in the infant.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 24 to 36 months when unopened. Once opened, use within 1 month. Refer to the specific product labeling for exact details.
Availability
Pharmacies, Hospitals
Approval Status
Approved (Generic)
Patent Status
Generic
WHO Essential Medicine
YesClinical Trials
Phenytoin has been extensively studied since its introduction, with numerous clinical trials evaluating its efficacy, safety, and pharmacokinetics in various seizure disorders and patient populations, including pediatric patients.
Lab Monitoring
- Monitor phenytoin plasma levels (total and free) to ensure therapeutic range and avoid toxicity, particularly due to its narrow therapeutic index.
- Complete Blood Count (CBC) at baseline and periodically due to risk of hematologic abnormalities.
- Liver function tests (LFTs) at baseline and periodically due to risk of hepatotoxicity.
Doctor Notes
- Emphasize the importance of therapeutic drug monitoring (TDM) due to phenytoin's narrow therapeutic index and non-linear kinetics.
- Educate patients/caregivers on proper administration (shake well, use measuring device) and the critical need for regular dosing and avoiding abrupt discontinuation.
- Counsel on potential long-term side effects like gingival hyperplasia and the need for rigorous oral hygiene.
Patient Guidelines
- Take Diphedan regularly as prescribed; do not suddenly stop taking the medicine, as it can worsen seizures.
- Maintain good oral hygiene and visit the dentist regularly to help prevent gingival hyperplasia.
- Report any unusual side effects like rash, fever, or swollen glands to your doctor immediately.
- Shake the suspension well before each use and use the provided measuring device for accuracy.
Missed Dose Advice
If a dose is missed, take it as soon as you remember, unless it is almost time for your next dose. In that case, skip the missed dose and continue with your regular dosing schedule. Do not double the dose to catch up.
Driving Precautions
Diphedan may cause dizziness, drowsiness, or visual disturbances. Patients should be advised not to drive or operate hazardous machinery until they are reasonably certain that Diphedan therapy does not adversely affect their ability to engage in such activities.
Lifestyle Advice
- Avoid alcohol consumption while taking Diphedan, as it can increase side effects and affect drug levels.
- If you are a woman of childbearing potential, discuss effective birth control methods with your doctor, as phenytoin can reduce the effectiveness of hormonal contraceptives.
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