Zeptol (carbamazepine) tablets 200 mg. №100

Description

Zeptol (carbamazepine) tablets 200 mg. №100

Composition 

active substance: carbamazepine;

1 tablet contains carbamazepine 200 mg;

Excipients: microcrystalline cellulose, povidone (K-30), colloidal anhydrous silica, hypromellose, corn starch, talc, magnesium stearate, sodium starch glycolate (type A), sodium lauryl sulfate.

Dosage form

Tablets.

Basic physical and chemical properties: white round flat tablets with a bevel, with a dividing line on one side, on the other – with the inscription “ZEPTOL 200”.

Pharmacotherapeutic group

Antiepileptics.

ATX code N0ZA F01.

Pharmacological properties

As an anticonvulsant, carbamazepine is effective in focal (partial) seizures (simple and complex), accompanied or not accompanied by secondary generalization, in generalized tonic-clonic seizures, as well as in combination with these types of seizures.

The use of carbamazepine as monotherapy in patients with epilepsy (especially children and adolescents) showed a psychotropic effect of the drug, which was partially positive effect on the symptoms of anxiety and depression, as well as reducing irritability and aggression. According to a number of studies, the effect of carbamazepine on cognitive function and psychomotor performance was dose-dependent and was either questionable or negative. Other studies have shown a positive effect of the drug on the indicators of attention, ability to learn and remember.

As a neurotropic drug, carbamazepine is effective in some neurological diseases: for example, it prevents pain attacks in idiopathic and secondary trigeminal neuralgia. In addition, carbamazepine is used to relieve neurogenic pain in various conditions, including spinal tuberculosis, post-traumatic paresthesias and postherpetic neuralgia. In alcohol withdrawal syndrome, carbamazepine increases the threshold of convulsive readiness (which is reduced in this condition) and reduces the severity of clinical manifestations of the syndrome, such as excitability, tremor, gait disturbances. In patients with diabetes mellitus of central origin, carbamazepine reduces diuresis and thirst.

It has been confirmed that carbamazepine is effective as a psychotropic drug in affective disorders, namely: for the treatment of acute manic states, for the maintenance treatment of bipolar affective (manic-depressive) disorders (as monotherapy, and in combination with neuroleptics, antidepressants or antidepressants). in schizoaffective psychoses, manic psychoses, in which it is used in combination with neuroleptics, as well as in acute polymorphic schizophrenia (rapid cycling episodes). The mechanism of action of carbamazepine – the active substance of the drug – is only partially understood.

Carbamazepine stabilizes the membranes of overexcited nerve fibers, inhibits the recurrence of neuronal discharges and reduces the synaptic conduction of excitatory impulses. It was found that the main mechanism of action of the drug is to prevent the re-formation of sodium-dependent action potentials in depolarized neurons by blocking sodium channels. The anticonvulsant effect of the drug is mainly due to reduced glutamate release and stabilization of neuronal membranes, while the antimanic effect may be due to inhibition of dopamine and norepinephrine metabolism.

Indications

Zeptol is used:

• in epilepsy;
• at difficult and simple partial convulsive attacks (with / without loss of consciousness, with / without
• signs of secondary generalization);
• in mixed forms of seizures;
• with generalized tonic-clonic seizures;
• in acute manic states;
• with alcohol withdrawal syndrome;
• in bipolar affective disorders (as maintenance therapy) to reduce the severity of clinical manifestations in exacerbations, as well as to prevent exacerbations;
• at idiopathic neuralgia of a trigeminal nerve, neuralgia of a trigeminal nerve at a multiple sclerosis;
  with idiopathic lingual-pharyngeal nerve neuralgia.

Contraindications

Zeptol is not used:

• in case of intolerance of components;
• in allergic reactions to tricyclic antidepressants in the past;
• in case of AV blockade;
• in the suppression of bone marrow function;
• with hepatic porphyria (acute intermittent, mixed, late porphyria of the skin), including in the past;
• during treatment with MAO inhibitors.

Method of application and dose

Zeptol is administered orally (orally), regardless of food.
The selected daily dose is divided into two or three doses.
The dosage depends on the diagnosis.
Standard doses for adults: 100-200 mg once or twice a day, the dose should be increased slowly until the desired effect is achieved; the daily dose can be 800-2000 mg / day.
Standard doses for children: 100 mg / day, the dose is gradually increased (by 100 mg every week). The usual dose is 10-20 mg / kg / day (in several doses).

Overdose:

• Symptoms: disorientation, drowsiness, decreased consciousness, agitation, blurred vision, hallucinations, coma, slurred speech, ataxia, dysarthria, nystagmus, dyskinesia, hyper / hyporeflexia, psychomotor disorders, convulsions, myomiconies, myoclonus, myoclonus, myoclonus , tachycardia, arterial hyper / hypotension, syncope, cardiac conduction disturbances, cardiac arrest, gastric retention, metabolic acidosis, rhabdomyolysis, urinary retention, oliguria / anuria, hyperhydration, fluid retention, hyponatraemia, hypertension.
• Treatment: hospitalization, gastric lavage, use of sorbents, determination of carbamazepine concentration in the blood, supportive treatment, monitoring of heart function, correction of electrolyte disorders.

Side effects:

• Changes in blood analysis: reticulocytosis, thrombocytopenia, leukopenia, eosinophilia, leukocytosis, lymphadenopathy, agranulocytosis, folic acid deficiency, aplastic anemia, erythrocyte aplasia, pancytopenia, anemia, porphyria, megaga.
• Immune disorders: delayed hypersensitivity, skin rash, vasculitis, lymphadenopathy, hepatosplenomegaly, bile duct disappearance syndrome, aseptic meningitis with myoclonus, peripheral eosinophilia; angioneurotic edema, anaphylactic shock, hypogammaglobulinemia.
• Endocrine disorders: edema, weight gain, decreased plasma osmolarity, hyponatremia, hyperhydration (lethargy, vomiting, headache, confusion), increased prolactin levels (galactorrhea, bone metabolism disorders, gynecomastia).
• Metabolic disorders: decreased appetite, folate deficiency.
• Mental disorders: hallucinations, depression, anxiety, agitation, aggression, confusion, activation of psychosis.
• Neurological disorders: dizziness, cephalgia, ataxia, drowsiness, diplopia, blurred vision, involuntary movements (tremor, dystonia, fluttering tremor, tic), orofacial dyskinesia, nystagmus, eye disorders, dysarthria, slurred speech, peripheral neuroaesthesia, peripheral neuropathy paresis, muscle weakness, taste disturbance, aseptic meningitis.
• Visual disorders: accommodation disorders, glaucoma, clouding of the lens, conjunctivitis.
• Hearing disorders: hearing impairment, tinnitus, increased / decreased auditory sensitivity.
• Cardiovascular disorders: intracardiac conduction disorders, arterial hypotension / hypertension, bradycardia, arrhythmia, syncope, congestive heart failure, circulatory collapse, exacerbation of coronary heart disease, thromboembolism, thrombophlebitis.
• Respiratory disorders: shortness of breath, pneumonitis, pneumonia.
• Digestive disorders: nausea, dry mouth, diarrhea / constipation, stomatitis, abdominal pain, glossitis, pancreatitis, increased gamma-glutamyltransferase, FF, transaminases, hepatitis, biliary tract syndrome, granulomatous hepatitis, jaundice.
• Skin changes: allergic dermatitis, erythroderma, urticaria, exfoliative dermatitis, systemic lupus erythematosus, Stevens-Johnson syndrome, epidermal necrolysis, pruritus, photosensitivity, nodular or erythema multiforme, purpura, acne, acne, skin disorders .
• Musculoskeletal disorders: muscle weakness, arthralgia, muscle spasms.
• Genitourinary disorders: tubulointerstitial nephritis, renal failure, renal dysfunction (hematuria, albuminuria, oliguria, azotemia), urinary retention, increased urination, impotence, spermatogenesis disorders, erectile dysfunction.
• General disorders: weakness.