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Tegrital 400 Mg Tablet (10 Tab)

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10 TABLETProduct code 248813

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Product information

Manufacturer
Novartis India Limited
Category
Allopathy
Composition
Not provided
Packaging
10 TABLET
Box / case pack
1 / —
Description

TEGRITAL 400 MG TABLET

Tegrital 400 MG Tablet, manufactured by Novartis India Limited, is an anticonvulsant medication primarily used to manage various neurological conditions.

Name

  • Common Name: Carbamazepine
  • Brand Name: Tegrital 400 MG Tablet (also known as Tegretol in some regions)

Composition

Each tablet contains 400 mg of Carbamazepine as the active ingredient.

Uses

Tegrital 400 MG Tablet is prescribed for:

  • Epilepsy: Effective in treating certain types of seizures, including partial seizures with complex symptomatology, generalized tonic-clonic (grand mal) seizures, and mixed seizure patterns. It works by decreasing abnormal electrical activity in the brain.
  • Trigeminal Neuralgia: Used to relieve the severe nerve pain associated with trigeminal neuralgia, a condition affecting facial nerves.
  • Glossopharyngeal Neuralgia: May also be beneficial for nerve pain in glossopharyngeal neuralgia.
  • Bipolar Disorder/Mania: In some cases, it is used for acute mania and maintenance treatment of bipolar affective disorders to prevent or attenuate recurrence.
  • Painful Diabetic Neuropathy: Can be prescribed to alleviate nerve pain related to diabetes.

Dosage and Administration

Tegrital 400 MG Tablet should be taken orally, typically with food, as directed by a healthcare professional. Dosage is individualized and usually involves a low initial dose with gradual increases until an optimal response is achieved. Abrupt discontinuation of the medicine should be avoided as it may lead to increased seizure frequency.

Side Effects

Common side effects include:

  • Dizziness, drowsiness, and unsteadiness
  • Nausea and vomiting
  • Dry mouth
  • Changes in liver enzymes or low white blood cell count

Serious side effects, though rare, can include:

  • Severe dermatologic reactions (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis)
  • Aplastic anemia and agranulocytosis (serious blood problems)
  • Suicidal thoughts or behavioral changes
  • Hypersensitivity reactions

Precautions

  • Allergies: Do not take if allergic to carbamazepine or other related tricyclic compounds.
  • Blood Problems: Should be used with caution in patients with a history of bone marrow suppression or blood disorders. Regular blood tests may be required.
  • Liver/Kidney/Heart Problems: Inform your doctor if you have pre-existing conditions affecting the heart, liver, or kidneys.
  • Drug Interactions: May interact with MAO inhibitors (avoid concurrent use and for 14 days after discontinuation), certain antidepressants, hormonal birth control, and grapefruit products.
  • Pregnancy and Breastfeeding: Carbamazepine can cause fetal harm. Discuss risks and benefits with your doctor. It passes into breast milk, so consult your doctor before breastfeeding.
  • Driving: May cause dizziness or drowsiness, impairing ability to drive or operate machinery.
  • Genetic Risk: Patients of Asian ancestry (especially Han Chinese or Thai) may have an increased risk of severe skin reactions, and blood tests may be recommended.

Storage

Store at room temperature away from moisture, heat, and light. Keep the tablets dry and out of the reach and sight of children.

Frequently asked questions

TEGRITAL 400 MG TABLET contains carbamazepine, an anticonvulsant medication. It is used to manage certain neurological conditions by stabilizing nerve activity in the brain.

What is Tegrital 400 mg Tablet used for?

Tegrital 400 mg Tablet (carbamazepine) is primarily used to treat certain types of seizures in people with epilepsy, including partial seizures with complex symptoms, generalized tonic-clonic seizures, and mixed seizure patterns. It is also prescribed for the pain associated with true trigeminal neuralgia, a condition causing severe facial nerve pain. Additionally, it can be used to help control manic and mixed episodes in patients with bipolar I disorder.

How does Tegrital 400 mg Tablet work?

Tegrital (carbamazepine) works as an anticonvulsant by stabilizing the electrical activity in the brain and nerves. Its main mechanism involves binding to voltage-dependent sodium channels in nerve cells, which prevents excessive and repetitive firing of electrical impulses. This action reduces the release of excitatory neurotransmitters like glutamate. For bipolar disorder, it is also thought to influence dopamine turnover and GABA transmission, contributing to its mood-stabilizing effects.

What is the usual dosage for Tegrital 400 mg Tablet?

The dosage of Tegrital 400 mg Tablet varies depending on the condition being treated and is individualized by a doctor. For adults with epilepsy, an initial dosage might be 200 mg twice daily (400 mg/day), gradually increasing at weekly intervals. The usual maintenance dose for epilepsy in adults is often between 800 mg to 1200 mg daily, but can go up to 1600 mg daily in some cases. For trigeminal neuralgia, treatment typically starts with 100-200 mg once or twice daily, increasing until pain relief is achieved, usually between 400 mg and 800 mg daily, with a maximum recommended dose of 1200 mg per day. For bipolar disorder, an initial dose of 200 mg twice daily may be prescribed, with the usual range being 400 mg to 600 mg daily, not exceeding 1600 mg per day. It's important to take the tablets with meals to minimize stomach upset.

What are the possible side effects of Tegrital 400 mg Tablet?

Common side effects of Tegrital can include dizziness, drowsiness, nausea, vomiting, problems with walking or coordination, dry mouth, constipation, and blurred or double vision.

More serious, though rare, side effects that require immediate medical attention include severe skin reactions (like Stevens-Johnson syndrome and toxic epidermal necrolysis), which can be life-threatening. The risk of these skin reactions is higher in individuals of Asian ancestry, especially those with the HLA-B*1502 genetic factor, and a blood test may be recommended before starting treatment. Other serious side effects can involve blood problems (such as aplastic anemia or a low white blood cell count), liver injury, suicidal thoughts or behaviors, allergic reactions (including anaphylaxis and angioedema), and low blood sodium levels.

Is Tegrital 400 mg Tablet safe during pregnancy or breastfeeding?

Tegrital (carbamazepine) can cause harm to an unborn baby and is classified as a Pregnancy Category D drug. It has been associated with an increased risk of certain birth defects, particularly affecting the head, face, and fingernails. If pregnancy occurs while taking Tegrital, it's crucial to consult a doctor immediately, as the benefits of preventing seizures may sometimes outweigh the risks to the baby. Women of childbearing potential should use effective forms of birth control during treatment and for at least 28 days after stopping the medication, as Tegrital can reduce the effectiveness of hormonal contraceptives.

Tegrital passes into breast milk. Breastfeeding is generally not recommended while using Tegrital. If breastfeeding, you should inform your doctor immediately if the baby develops any unusual symptoms like excessive sleepiness, a skin rash, or yellowing of the skin or eyes.

Can Tegrital 400 mg Tablet be taken with other medications?

Tegrital has many significant drug interactions that can affect its own levels and the levels of other medications.

It should not be taken with monoamine oxidase (MAO) inhibitors, and at least 14 days should pass after stopping an MAO inhibitor before starting Tegrital.

Tegrital can decrease the effectiveness of many drugs, including oral contraceptives (potentially leading to unplanned pregnancy), warfarin (a blood thinner), immunosuppressants, certain antipsychotics, antidepressants, and corticosteroids.

Conversely, some medications can increase the levels of carbamazepine in the blood, potentially leading to increased side effects. These include macrolide antibiotics (e.g., erythromycin, clarithromycin), antifungals (e.g., fluconazole, ketoconazole), certain antidepressants (e.g., fluoxetine, fluvoxamine), cimetidine, diltiazem, verapamil, omeprazole, and isoniazid. Grapefruit and grapefruit juice can also increase carbamazepine levels and should be avoided.

Other antiepileptic drugs like phenytoin, phenobarbital, and primidone, as well as the herbal remedy St. John's Wort, can decrease Tegrital levels, potentially making it less effective. Short-term use of paracetamol and ibuprofen is generally considered safe with Tegrital. Always inform your doctor and pharmacist about all prescription, over-the-counter, and herbal products you are taking.

What precautions should be taken while on Tegrital 400 mg Tablet?

Regular medical check-ups, including blood and urine tests, are important to monitor your body's response to Tegrital and check for potential side effects such as blood problems, liver injury, and low sodium levels. You should avoid consuming grapefruit or grapefruit juice while taking this medication. Tegrital can cause dizziness, drowsiness, blurred vision, or problems with coordination, so avoid driving or operating heavy machinery until you know how the medicine affects you. The medication can also increase your sensitivity to sunlight; therefore, wear protective clothing and use sunscreen (SPF 30 or higher) when outdoors. Do not stop taking Tegrital suddenly, as this can lead to an increase in seizure frequency or worsening of your condition. Any discontinuation or dosage adjustment should be done gradually under a doctor's supervision.

What happens if a dose is missed?

If you miss a dose of Tegrital 400 mg Tablet and your next dose is not due for more than 2 or 3 hours, take the missed dose as soon as you remember. Otherwise, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.

How should Tegrital 400 mg Tablet be stored?

Tegrital 400 mg Tablet should be stored at room temperature, away from moisture, heat, and direct light. Keep the medicine out of reach of children.