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Carbamazepine Tablets

Function and Efficacy

This product is an anticonvulsant and antiepileptic drug. The pharmacological effects of carbamazepine are anticonvulsant, antiepileptic, anti-neuropathic pain, anti-manic-depressive, improvement of symptoms of certain mental illnesses, and anti-central diabetes insipidus. The mechanisms of these effects may be: 1. Use-dependent blocking of various Na channels of excitable cell membranes, so it can significantly inhibit the occurrence and spread of abnormal high-frequency discharges. 2. Inhibit T-type calcium channels. 3. Enhance the activity of central noradrenergic nerves. 4. Promote the secretion of antidiuretic hormone (ADH) or increase the sensitivity of effectors to ADH.

Ingredients

Carbamazepine, its chemical name is: 5H-dibenzo[b,f]azepine-5-carboxamide

Name Description Content CAS NO. Manufacturer
CarbamazepineIngredients

Anticonvulsant, anti-epileptic, anti-neuropathic pain, anti-manic-depressive, improve the symptoms of certain mental illnesses, and treat central diabetes insipidus. The mechanism may include use-dependent blocking of various excitable cell membrane Na channels, inhibition of T-type calcium channels, enhancement of central noradrenergic nerve activity, promotion of antidiuretic hormone (ADH) secretion, or increased sensitivity of effectors to ADH.

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298-46-4 43

Appearance

This product is white tablets.

Indication

1. Complex partial seizures (also known as psychomotor seizures or temporal lobe epilepsy), generalized tonic-clonic seizures, mixed seizures of the above two types, or other partial or generalized seizures; ineffective for typical or atypical absence seizures, myoclonic or absence atonic seizures. 2. Attacks of trigeminal neuralgia and glossopharyngeal neuralgia. It is also used as a long-term preventive medication after the relief of trigeminal neuralgia. It can also be used for tabes dorsalis and multiple sclerosis, diabetic peripheral neuropathy, pain in the affected limbs, post-traumatic neuralgia, and post-herpetic neuralgia. 3. Prevention or treatment of manic-depression; it can be used alone or in combination with lithium salts and other antidepressants for manic-depression that is ineffective or intolerant to lithium, antipsychotics, or antidepressants. 4. Central partial diabetes insipidus. It can be used alone or in combination with chlorpropamide or clofibrate.

Usage and Dosage

Common dosage for adults 1. Anticonvulsant, start with 0.1g once, 2-3 times a day; increase 0.1g daily after the second day until the effect is shown; the maintenance dose is adjusted to the minimum effective dose, taken in divided doses; pay attention to individualization, the maximum daily dose does not exceed 1.2g. 2. Analgesic, start with 0.1g once, 2 times a day; increase 0.1-0.2g every other day after the second day until the pain is relieved, the maintenance dose is 0.4-0.8g per day, taken in divided doses; the maximum daily dose does not exceed 1.2g. 3. Diabetes insipidus, 0.3-0.6g per day when used alone, if used in combination with other antidiuretics, 0.2-0.4g per day, taken in 3 times. 4. Anti-mania or antipsychotic, start with 0.2-0.4g per day, gradually increase to the maximum dose of 1.6g per week, taken in 3-4 times. Daily limit, 12-15 years old, no more than 1g; no more than 1.2g for those over 15 years old; a few use up to 1.6g. Usually the adult limit is 1.2g, and no more than 1g per day for children aged 12 to 15 years. A few people need up to 1.6g. For analgesia, no more than 1.2g per day is allowed. The common dosage for children is anticonvulsant. Before the age of 6, start with 5mg/kg per day based on body weight, and increase the dosage every 5 to 7 days to 10mg/kg per day. If necessary, increase to 20mg/kg, and adjust the maintenance dose to maintain a blood concentration of 8~12μg/kg, generally 10~20mg/kg based on body weight, about 0.25~0.3g, not more than 0.4g; children aged 6 to 12 years old take 0.05g~0.1g on the first day, take 2 times, and increase by 0.1g every other week until the effect appears; the maintenance dose is adjusted to the minimum effective dose, generally 0.4~0.8g per day, not more than 1g, taken in 3~4 times

Adverse Reactions

1. The most common adverse reactions are reactions of the central nervous system, manifested as blurred vision, diplopia, and nystagmus. 2. Water retention and hyponatremia (or water intoxication) caused by stimulating the secretion of antidiuretic hormone, with an incidence of about 10-15%. 3. Less common adverse reactions include allergic reactions, Stevens-Johnson syndrome or toxic epidermal necrolysis, rash, urticaria, itching; behavioral disorders in children, severe diarrhea, and lupus erythematosus-like syndrome (urticaria, itching, rash, fever, sore throat, bone or joint pain, fatigue). 4. Rare adverse reactions include glandular disease, arrhythmia or atrioventricular block (especially for the elderly), bone marrow suppression, central nervous system poisoning (language difficulties, mental restlessness, tinnitus, tremor, hallucinations), allergic hepatitis, hypocalcemia, direct impact on bone metabolism leading to osteoporosis, kidney poisoning, peripheral neuritis, acute urinary porphyria, thromboangiitis, allergic pneumonia, acute intermittent porphyria, and hypothyroidism. It is noted that there is a patient with myoclonic epilepsy combined with aseptic meningitis, who suffered recurrence of meningitis after receiving this product. Occasionally, granulocytopenia, reversible thrombocytopenia, aplastic anemia, and toxic hepatitis are seen.

Precautions

Contraindications: Patients with a history of atrioventricular block, severe abnormal serum iron, bone marrow suppression, severe liver dysfunction, etc.

Special Population Medication

Precautions for children: This product can be used for children of all ages, please refer to [Usage and Dosage] for details. Precautions for pregnancy and lactation: This product can pass through the placenta, and it is not clear whether it is teratogenic. It should be used with caution in early pregnancy; this product can be secreted into breast milk, with a blood concentration of about 60%, and it should not be used by lactating women. Precautions for the elderly: Elderly patients are more sensitive to this product, which can often cause cognitive dysfunction, agitation, restlessness, anxiety, mental confusion, atrioventricular block or bradycardia, and can also cause aplastic anemia.

Drug Interactions

1. When used in combination with acetaminophen, especially in a single overdose or long-term large doses, the risk of liver poisoning increases, which may reduce the efficacy of the latter. 2. When used in combination with coumarin anticoagulants, due to the positive induction of liver enzymes by this product, the blood concentration of anticoagulants is reduced, the half-life is shortened, and the anticoagulant effect is weakened. The prothrombin time should be measured and the dosage should be adjusted. 3. When used in combination with carbonic anhydrase inhibitors, the risk of osteoporosis increases. 4. Due to the liver enzyme induction effect of this product, when used in combination with chlorpropamide, clofibrate (clofibrate), desmopressin, lypressin, vasopressin, vasopressin, etc., the antidiuretic effect can be enhanced, and the dosage of each combined drug needs to be reduced. 5. When used in combination with estrogen-containing contraceptives, cyclosporine, digitalis (except possibly digoxin), estrogen, levothyroxine or quinidine, the effects of these drugs will be reduced due to the positive induction of liver metabolic enzymes by carbamazepine. The dosage should be adjusted and oral contraceptives containing only progestin (progesterone) should be used instead. Vaginal bleeding may occur when used in combination with oral contraceptives. 6. When used in combination with doxycycline (doxycycline), the latter's blood concentration may be reduced. If necessary, the dosage needs to be adjusted. 7. Erythromycin, troleomycin and detropropoxyphene can inhibit the metabolism of carbamazepine, causing the latter's blood concentration to increase and toxic reactions to occur. 8. Haloperidol, loxapine, maprotiline, thioxanthenes or tricyclic antidepressants can enhance the metabolism of carbamazepine, causing the latter's blood concentration to increase and toxic reactions to occur. 9. Lithium salts can reduce the antidiuretic effect of carbamazepine. 10. When used in combination with monoamine oxidase (MAO) inhibitors, it can cause high fever or (and) hypertensive crisis, severe convulsions and even death. The two drugs should be used at least 14 days apart. When carbamazepine is used as an anticonvulsant, MAO inhibitors can change the type of epileptic seizures. 11. Carbamazepine can reduce the absorption of nomifensine and accelerate its elimination. 12. Phenobarbital and phenytoin accelerate the metabolism of carbamazepine and can reduce the t1/2 of carbamazepine to 9-10 hours.

Storage

Keep away from light and store in airtight container.

Packaging Specification

0.2 g

Validity Period

60 months.

Manufacturer

ORxes Biopharmaceuticals (Shenyang) Co., Ltd.

  • Founded in:

    2004-08-09
  • Address:

    No. 176, Shenbei Road, Huishan Economic Development Zone, Shenbei New District, Shenyang
  • Tax NO.:

    91210100764362386F
  • Registered Funds:

    115 million yuan
  • Email:

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