Dilantin 100 Mg Tab

DILANTIN 100 MG TAB is a prescription medication manufactured by Mylan Pharmaceuticals Private Limited, primarily used for seizure control.

Name

• Brand Name: DILANTIN 100 MG TAB
• Common Name: Phenytoin sodium (extended phenytoin sodium capsules, USP)

Composition

Each Dilantin 100 mg extended-release oral capsule contains 100 mg of phenytoin sodium. Inactive ingredients include lactose monohydrate, confectioner's sugar, talc, magnesium stearate, titanium dioxide, and gelatin. The capsule cap also contains FD&C red No. 28 and FD&C yellow No. 6.

Uses

DILANTIN 100 MG TAB is indicated for:

• Control of generalized tonic-clonic (grand mal) and complex partial (psychomotor, temporal lobe) seizures.
• Prevention and treatment of seizures occurring during or following neurosurgery.
• May also be used to treat trigeminal neuralgia (facial nerve pain).

Dosage and Administration

Dosage should be individualized, with serum blood level determinations often necessary for optimal adjustment.

• Adults:
  • Initial Dose: Typically, one 100 mg capsule three times daily.
  • Maintenance Dose: Usually one 100 mg capsule three to four times a day.
  • Maximum Dose: Up to two 100 mg capsules three times a day (600 mg daily).
  • Once-a-day dosage: If seizure control is established with three 100 mg capsules daily, a single daily dose of 300 mg (three 100 mg capsules) may be considered.
  • Dosage adjustments are typically made after 7 to 10 days, guided by blood levels.
• Pediatric Dosage:
  • Initially, 5 mg/kg/day in two or three equally divided doses, with subsequent dosage individualized to a maximum of 300 mg daily.
  • Recommended daily maintenance dosage is usually 4 to 8 mg/kg.

Side Effects

• Common Side Effects: Nystagmus (involuntary eye movements), problems with walking and coordination, slurred speech, drowsiness, confusion, dizziness, trouble sleeping, nervousness, tremor, headache, nausea, vomiting, constipation, and rash. Gingival hyperplasia (swollen and tender gums) can also occur.
• Serious Side Effects:
  • Severe skin reactions such as Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), and exfoliative dermatitis, which can be fatal.
  • Heart problems, including slow or uneven heartbeats, chest pain, and dizziness.
  • Liver problems.
  • Bone problems, including decreased vitamin D levels, osteopenia, osteoporosis, and increased risk of fractures.
  • Suicidal thoughts or actions.
  • Allergic reactions.

Precautions

• Do not take DILANTIN if you are allergic to phenytoin or similar drugs like fosphenytoin, ethotoin, or mephenytoin.
• Sudden Discontinuation: Abruptly stopping DILANTIN can worsen seizures and may lead to severe, life-threatening seizures (status epilepticus). Any dosage changes should be made gradually under medical supervision.
• Interactions: Dilantin may affect the effectiveness of oral contraceptives, requiring additional birth control methods.
• Medical Conditions: Discuss your health history with your doctor if you have depression, mood disorders, suicidal thoughts, liver or kidney problems, porphyria, high blood sugar, diabetes, or heart problems.
• Alcohol: Combining DILANTIN with alcohol can increase drowsiness and dizziness.
• Pregnancy: There are risks to taking Dilantin during pregnancy, including congenital anomalies. Discuss with your doctor if you are pregnant or planning pregnancy.
• Breastfeeding: Infant breast-feeding is not recommended as phenytoin can be secreted in human milk.

Storage

Store DILANTIN capsules at room temperature between 20-25ºC (68-77ºF) in tight, light-resistant containers. Protect from moisture. Keep out of reach of children and pets.

DILANTIN 100 MG TAB (phenytoin) is an anticonvulsant medication primarily used to manage and prevent certain types of seizures. Here are some frequently asked questions about DILANTIN:

What is DILANTIN 100 MG TAB used for?

DILANTIN 100 MG TAB is prescribed to control generalized tonic-clonic (grand mal) seizures and complex partial (psychomotor or temporal lobe) seizures. It is also used to prevent and treat seizures that may occur during or after brain surgery. Additionally, it may be used to treat trigeminal neuralgia, a type of facial nerve pain.

How does DILANTIN work?

DILANTIN, which contains the active ingredient phenytoin, works as an antiepileptic drug by stabilizing neuronal membranes in the brain. It reduces the spread of seizure activity, primarily in the motor cortex, by promoting the outflow of sodium from nerve cells. This action helps to stabilize the nerve cell threshold against over-excitement, preventing seizure foci from activating adjacent brain areas.

What is the usual dosage of DILANTIN 100 MG TAB?

For adults, the typical starting dosage of DILANTIN extended-release capsules is 100 mg three times per day. Your doctor may adjust this dosage based on your individual needs and blood levels of the medication. Once seizures are adequately managed, a maintenance dosage of 300 mg (three 100 mg capsules) once daily may be considered. The maximum dosage is generally 200 mg three times per day. For children, the initial dosage is based on body weight, usually 5 mg per kg per day, divided into two or three doses, with a maximum of 300 mg daily. Regular blood tests are necessary to ensure the dosage is optimal.

What are the possible side effects of DILANTIN?

Common mild side effects of DILANTIN can include drowsiness, nausea, confusion, uncontrollable eye movements (nystagmus), slurred speech, dizziness, headache, problems with coordination, trouble sleeping, and nervousness. More serious or long-term side effects can include peripheral neuropathy (nerve damage), decreased vitamin D levels potentially leading to osteopenia or osteoporosis, gingival hyperplasia (swollen and overgrown gums), and changes in facial features or increased body hair. In rare cases, severe allergic reactions (like Stevens-Johnson syndrome or DRESS), liver problems, kidney problems, blood count reductions, heart problems (such as a slow heartbeat), and suicidal thoughts or behavior can occur.

Is DILANTIN safe during pregnancy or breastfeeding?

Pregnancy: DILANTIN is generally categorized as Pregnancy Category D due to potential risks of birth defects, including Fetal Hydantoin Syndrome, if used during pregnancy, particularly in the first trimester. However, uncontrolled seizures also pose significant risks to both the mother and the developing baby. Therefore, the decision to use DILANTIN during pregnancy should be made in close consultation with a healthcare provider, weighing the potential benefits against the risks. Dosage adjustments may be necessary during pregnancy due to changes in how the body processes the medication. Breastfeeding: Phenytoin, the active ingredient in DILANTIN, is secreted into breast milk in low concentrations. The manufacturer generally does not recommend breastfeeding while taking this medication. You should discuss with your doctor whether to take DILANTIN or breastfeed, as it may not be advisable to do both.

Can DILANTIN be taken with other medications?

DILANTIN can interact with a wide range of other medications, including other seizure drugs, antifungals, antibiotics, HIV medications, antidepressants, anticoagulants (blood thinners), and antacids. These interactions can alter the levels of DILANTIN in your body, potentially affecting its effectiveness or increasing the risk of side effects. DILANTIN can also reduce the effectiveness of oral contraceptives. It can interact with certain vitamins (like vitamin D and folic acid) and minerals (like calcium, magnesium, and aluminum). Alcohol consumption can also change DILANTIN blood levels. It is crucial to inform your doctor and pharmacist about all prescription, over-the-counter medications, vitamins, herbs, and supplements you are taking to prevent potential interactions.

What precautions should be taken while taking DILANTIN?

Do not stop taking DILANTIN suddenly without consulting your healthcare provider, as this can lead to severe seizures (status epilepticus). Your doctor will advise on a gradual reduction if discontinuation is necessary. You should also be monitored for signs of depression, suicidal thoughts or behavior, or any unusual changes in mood or behavior. Discuss your full medical history with your doctor, especially if you have liver or kidney problems, diabetes, or a history of allergic reactions to similar drugs. Avoid driving or operating heavy machinery until you understand how DILANTIN affects you, as it can impair thinking and motor skills. Maintaining good oral hygiene is important to help manage potential gum swelling. Regular blood tests will be needed to monitor drug levels.

What should I do if I miss a dose of DILANTIN?

If you miss a dose of DILANTIN, take it as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you frequently miss doses or are unsure what to do, contact your doctor or pharmacist for guidance, as missing doses can increase your risk of seizures.

How should DILANTIN 100 MG TAB be stored?

DILANTIN 100 MG TAB capsules should be stored at room temperature, typically between 68°F to 77°F (20°C to 25°C). Keep the medication in its original, tight, light-resistant container and protect it from moisture. Avoid storing it in damp or warm places like a bathroom. Always keep DILANTIN and all other medicines out of the reach of children.