Tegrital® Soft

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Tegrital® Soft is an anticonvulsant and mood stabilizer in the form of chewable tablets. It is used for control and prevention of epilepsy-associated seizures, manic-depressive disorder, alcohol withdrawal symptoms, and paroxysmal pain caused by certain forms of neuralgia. Formulated for adults and children over 5 years of age.

Active Ingredient:
Carbamazepine

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Tegrital® Soft, 100mg pills

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General Info

Description

Tegrital® Soft is manufactured by Novartis. The active ingredient of this medication is Carbamazepine, anticonvulsant structurally similar to tricyclic antidepressants.

Indications:

- management of epilepsy characterized by generalized tonic-clonic and partial seizures (do not confuse with absence or myoclonic seizures);

- paroxysmal (suddenly occurring) pain associated with trigeminal neuralgia, peripheral diabetic neuropathy, glossopharyngeal neuralgia, tabetic lightning pain, superior laryngeal neuralgia, stump pain, phantom limb pain, and post herpetic neuralgia;

- management of alcohol withdrawal symptoms;

- treatment and prophylaxis of mania and manic-depressive disorder (also known as bipolar disorder). Suitable for patients unresponsive to lithium.

Tegrital® Soft is also used to decrease the urinary volume in patients with diabetes insipidus (do not confuse with diabetes mellitus or sugar diabetes) because of its antidiuretic effect.

MOA (mechanism of action):

Carbamazepine has anticonvulsant, anticholinergic, antidiuretic, antiarrhythmic, muscle relaxant, antidepressant, sedative, and neuromuscular-blocking properties. It stabilizes the electrical activity in the brain and nerves, thereby preventing the seizures. Namely, Carbamazepine stops the built up of electrical signals in the brain and nerves, as well as releases neurotransmitters (nerve-exiting agents). In patients suffering from paroxysmal pain, Carbamazepine is thought to blocking the pain signals so they cannot get into the brain. The mood stabilizing effect of Carbamazepine most likely occurs due to its capability of reducing the glutamate activity in the brain.

Dosage

Tegrital® Soft tablets should be chewed thoroughly before swallowing and taken with food.

The exact dosage, as well as the course duration, must be determined by a doctor for each individual patient.

Tegrital® Soft tablets are only for oral use.

Patients of Han Chinese or Thai origin should be blood tested before starting the Tegrital® Soft treatment course.

Do not give Tegrital® Soft to patients under 5 years of age.

Do not change your usual dosage suddenly or without your doctor’s approval.

Women taking oral contraceptives containing oestrogen and/or progesterone should use alternative forms of contraception during the Tegrital® Soft treatment course.

Epilepsy:

The usual starting dose for adults and elderly varies from 100 to 200 mg once or twice daily. The average adult dose varies from 800 to 1200 mg daily in divided intakes.

The average daily dose for children between 5 and 10 years of age varies from 400 to 600 mg daily in divided intakes.

The average daily dose for children between 10 and 17 years of age varies from 600 to 1000 mg in divided intakes.

Paroxysmal pain:

The usual starting dose for adults varies from 200 to 400 mg once or twice daily. The average adult dose varies from 600 to 800 mg daily in divided intakes.

The usual starting dose for elderly patients is 100 mg twice daily. The average geriatric dose varies from 600 to 800 mg daily in divided intakes.

The average daily dose for children between 5 and 10 years of age varies from 400 to 600 mg daily in divided intakes.

The average daily dose for children between 10 and 17 years of age varies from 600 to 1000 mg in divided intakes.

The daily dose should be slowly reduced by your doctor once the remission is achieved.

The maximum recommended dose is 1200 mg a day.

Manic-depressive disorder:

The usual starting dose is 400 mg daily in divided intakes.

The average recommended dose varies from 400 to 600 mg daily in divided intakes. Depending on patient’s response the dose should be slowly increased until the symptoms are controlled.

The maximum recommended dose is 1600 mg daily.

Missing a dose

If you miss a dose you should take it as soon as you remember about your missing. If it is the time for the next dose you should continue your regular dosing schedule. Do not take a double dose.

Overdose

If an overdose occurs and you are not feeling well, stop taking the medication immediately. You should seek emergency medical attention or contact your healthcare provider immediately.

Storage

Store at room temperature between 10 and 25 degrees C and away from excess moisture and heat. Throw away any unused medicine after the expiration date. Keep out of the reach of children.

Safety Information

Side effects

The most common side effects associated with the use of Tegrital® Soft are:

  • low white cell count (leucopenia) causing more infections than usual
  • severe peeling of the skin
  • difficulty breathing
  • wheezing and coughing
  • sllergic reactions
  • fever
  • skin rash
  • abnormalities in blood and liver function tests
  • joint, muscle or chest pain
  • systemic lupus erythematosus
  • yellowing of your skin or the whites of your eyes
  • dizziness or tiredness
  • difficulty controlling movements
  • nausea
  • fluid retention
  • weight gain
  • headache
  • confusion
  • blurred vision
  • dry mouth
  • headache

Side effects occurrence does not only depend on the medication you are taking, but also on your overall health and other factors.

Contraindications

Do not take Tegrital® Soft if you are allergic to Carbamazepine.

Do not take Tegrital® Soft if you are allergic to any of the other ingredients comprised in Tegrital® Soft.

Do not take Tegrital® Soft if you have a heart disorder, problems with your bone marrow, porphyria, liver or kidney disease, low sodium blood level, alcoholism, difficulty to retain your urine, mental illness, mixed or absence seizures, blood disorders including leucopenia.

Do not take Tegrital® Soft if you have ever interrupted courses of treatment with Carbamazepine.

The use of Tegrital® Soft may affect the therapeutic effect of oral contraceptive drugs containing oestrogen and/or progesterone.

Do not consume alcohol, grapefruits and grapefruit juice while taking Tegrital® Soft.

Do not combine Tegrital® Soft with the use of other antiepileptics (lamotrigine, phenytoin, fosphenytoin, primidone, sodium valproate, phenobarbitone, ethosuximide, oxcarbazepine, tiagabine, topiramate, vigabatrin, levetiracetam, progabide), anticoagulants (warfarin, acenocoumarol), stomach ulcers medications (cimetidine, omeprazole), antipsychotics (lithium, haloperidol, thioridazine, olanzapine, risperidone, clozapine, quetiapine), schizophrenia drugs (paliperidone, aripiprazole), sedatives (lobazam, clonazepam, alprazolam, valnoctamide), antidepressants (imipramine, fluoxetine, amitriptyline, clomipramine, nortriptyline, mianserin, sertraline, paroxteine, fluvoxamine, citalopram, trazodone), St John’s wort preparation, sickness treatments (metoclopramide, aprepitant), antibiotics (doxycycline, isoniazid, erythromycin, clarithromycin, ciprofloxacin), tuberculosis medications (isoniazid, rifampicin), antifungals (itraconazole, fluconazole, ketoconazole, voriconazole, albendazole), corticosteroids (prednisolone, dexamethasone), immunosuppressants (ciclosporin, tacrolimus, sirolimus), painkillers (paracetamol, dextropropoxyphene, methadone, tramadol, buprenorphine), heart medications (felodipine, isradipine, digoxin, verapamil, diltiazem), diuretics (furosemide, hydrochlorothiazide), glaucoma drugs (acetazolamide), muscle relaxants (pancuronium), retinoids (isotretinoin), asthma drugs (theophylline, aminophylline), endometriosis medications (danazol, gestrinone), Hormone Replacement Therapy (tibolone), impotence drugs (tadalafil), cancer treatments (imatinib, lapatinib, toremifene, cisplatin, doxorubicin, temsirolimus, cyclophosphamide), malaria medications (mefloquine), HIV drugs also known as protease inhibitors (indinavir, ritonavir, saquinavir), hypothyroidism drugs (levothyroxine), anti-smoking agents (bupropion), antihistamines (loratadine), and Vitamin B supplements.

Do not give Tegrital® Soft to children under 5 years of age.

It is recommended not to use Tegrital® Soft in pregnant and breastfeeding women.

Do not drive or operate machinery as Tegrital® Soft causes dizziness.

F.A.Q.

Q: What is Tegrital® Soft used for?

A: Tegrital® Soft is an anticonvulsant and mood stabilizer in the form of chewable tablets. It is used for control and prevention of epilepsy-associated seizures, manic-depressive disorder, alcohol withdrawal symptoms, and paroxysmal pain caused by certain forms of neuralgia.

Q: Is Tegrital® Soft save?

A: Tegrital® Soft is safe for patients over 5 years of age as long as used for prescribed conditions and at prescribed doses.

Q: Can pregnant women use Tegrital® Soft?

A: It is recommended not to use Tegrital® Soft in pregnant and breastfeeding women.

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14-21 business days
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