Tegretol 200 mg 30 tablets

Tegretol 200 mg 30 tablets

Composition:

Each tablet contains:
Carbamazepine 200 mg.
Excipients: colloidal silicon dioxide (aerosil), potato starch, povidone K30, polysorbate 80, talc, magnesium stearate.

Product Description:

Antiepileptic drug, a dibenzazepine derivative.
Also possesses normothymic, antimanic, antidiuretic (in patients with diabetes insipidus), and analgesic effects (in neuralgia).
Mechanism of action: blockade of voltage-dependent Na⁺ channels, stabilization of neuronal membranes, inhibition of repetitive discharges, and reduction of synaptic impulse conduction.
Decreases glutamate release, raises seizure threshold, modulates K⁺ and Ca²⁺ channels. Effective in partial and generalized tonic-clonic seizures, but not effective in absence or myoclonic seizures.

Indications for use:

Epilepsy (partial and generalized tonic-clonic seizures, mixed forms).
Idiopathic trigeminal neuralgia, trigeminal neuralgia in multiple sclerosis.
Idiopathic glossopharyngeal neuralgia.
Alcohol withdrawal syndrome.
Treatment of affective disorders, prevention of episodic affective disturbances (manic-depressive psychosis, schizoaffective disorders).
Polydipsia and polyuria in diabetes insipidus.
Pain syndrome in diabetic polyneuropathy.

Method of Administration and dosage:

Oral, regardless of meals, with a small amount of liquid.
Adults: initial dose 100–200 mg 1–2 times daily, gradually increased to 400 mg 2–3 times daily (maximum 1600–2000 mg/day).
Children from 3 years: initial dose 20–60 mg/day, gradual increase.
Maintenance doses: 10–20 mg/kg/day in divided doses.
4–5 years: 200–400 mg.
6–10 years: 400–600 mg.
11–15 years: 600–1000 mg.

Contraindications:

Hypersensitivity to carbamazepine, tricyclic antidepressants, or excipients.
Acute intermittent porphyria.
Concomitant use of MAO inhibitors and within 2 weeks after discontinuation.
Bone marrow suppression.
Atrioventricular block.
Pregnancy and breastfeeding.

Precautions:

Before treatment: complete blood count (including platelets, reticulocytes), urinalysis, serum iron, electrolytes, and urea.
Monitoring: weekly during the first month, then monthly.
In patients with increased intraocular pressure — regular monitoring.
Treatment should be discontinued in progressive leukopenia or leukopenia with infection symptoms.

Adverse reaction / Side effects:

CNS: dizziness, ataxia, drowsiness, weakness, headache, tremor, nystagmus, dysarthria, paresthesia, muscle weakness.
Psychiatric: hallucinations, depression, anxiety, aggression, agitation, disorientation.
Blood: leukopenia, thrombocytopenia, eosinophilia, agranulocytosis, aplastic anemia.
Gastrointestinal: nausea, vomiting, dry mouth, diarrhea/constipation, abdominal pain, pancreatitis.
Liver: elevated enzymes, hepatitis, liver failure.
Musculoskeletal: arthralgia, myalgia, cramps.
Sensory organs: taste disturbances, conjunctivitis, hearing disorders.
Allergic reactions: urticaria, dermatitis, erythroderma.
Other: acne, sweating, alopecia, purpura.

Pregnancy and lactation:

Contraindicated.

Storage conditions:

Store at temperatures not exceeding 30 °C, in a dry place.

Packaging:

Carton box containing 3 blisters of 10 tablets and package leaflet.

Tegretol 200 mg 30 tablets