Mezacar SR tablets with prolonged release 400 mg. №50

Description

Mezacar SR  composition
active substance: carbamazepine;
1 tablet contains carbamazepine 400 mg;
Excipients: microcrystalline cellulose, hypromellose, sodium lauryl sulfate, povidone (PVP K 30), colloidal anhydrous silica, magnesium stearate.

Dosage form
Prolonged-release tablets.

Pharmacological properties
It is an antiepileptic medication. It has an anti-manic, normotimic (normalizing mood) effect. The active substance activates the inhibitory GABAergic system in the brain. It also blocks the voltage-dependent Na-channels of the membranes of nerve cells, which leads to the stabilization of their function, reduces the activity of neurotransmitter acids (aspartate, glutamate), interacts with brain adenosine receptors. Increases the seizure threshold, corrects epileptic personality changes.

Indications
Applied Mezacar SR:

• with epilepsy;
• with complex and simple partial convulsive seizures (with / without loss of consciousness, with / without signs of secondary generalization);
• with mixed forms of convulsive seizures;
• with generalized tonic-clonic seizures;
• in acute manic conditions;
• with alcohol withdrawal syndrome;
• with bipolar affective disorders;
• with idiopathic trigeminal neuralgia, trigeminal neuralgia in multiple sclerosis;
• with idiopathic neuralgia of the glossopharyngeal nerve.

Contraindications:

• with intolerance to the components;
• in case of allergic reactions to tricyclic antidepressants in the past;
• with AV block;
• with inhibition of bone marrow function;
• with hepatic porphyria (acute intermittent, mixed, late porphyria of the skin), incl. in past;
• when treated with MAO inhibitors.

Application during pregnancy and lactation
Mezacar SR is contraindicated during these periods.

Method of administration and dosage
Mezacar SR is administered orally (by mouth), regardless of food.
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 may 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 divided doses).

Overdose
Symptoms: disorientation, drowsiness, decreased level of consciousness, agitation, blurred vision, hallucinations, coma, slurred speech, ataxia, dysarthria, nystagmus, dyskinesia, hyper / hyporeflexia, psychomotor disorders, convulsions, myoclonus, mydriasis, hypothermia, pulmonary depression , tachycardia, arterial hyper / hypotension, fainting, cardiac conduction disturbances, cardiac arrest, retention of food in the stomach, metabolic acidosis, rhabdomyolysis, urinary retention, oliguria / anuria, hyperhydration, fluid retention, hyponatremia, hyperglycemia, increased muscle CPK fraction.
Treatment: hospitalization, gastric lavage, use of sorbents, determination of the concentration of carbamazepine in the blood, supportive treatment, monitoring of heart function, correction of electrolyte disorders.

Side effects:

• Blood test changes: reticulocytosis, thrombocytopenia, leukopenia, eosinophilia, leukocytosis, lymphadenopathy, agranulocytosis, folic acid deficiency, aplastic anemia, erythrocytic aplasia, pancytopenia, anemia, porphyria, megaloblastic anemia, hemolytic anemia.
• Immune disorders: delayed-type 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, aggressiveness, confusion, activation of psychosis.
• Neurological disorders: dizziness, cephalalgia, ataxia, drowsiness, diplopia, blurred vision, involuntary movements (tremor, dystonia, fluttering tremor, tic), orofacial dyskinesia, nystagmus, eye movement disorders, dysarthria, slurred speech, peripheral neuropathy, chorerestoesthesia, chorerestoesthesia paresis, muscle weakness, impaired taste, aseptic meningitis.
• Visual disorders: disturbance of accommodation, glaucoma, clouding of the lens, conjunctivitis.
• Hearing disorders: hearing impairment, ringing in the ears, increased / decreased hearing sensitivity.
• Cardiovascular disorders: intracardiac conduction disorders, arterial hypotension / hypertension, bradycardia, arrhythmia, syncope, congestive heart failure, circulatory collapse, exacerbation of coronary artery disease, thromboembolism, thrombophlebitis.
• Respiratory disorders: shortness of breath, pneumonitis, pneumonia.
• Digestive disorders: nausea, dry mouth, diarrhea / constipation, stomatitis, abdominal pain, glossitis, pancreatitis, increased levels of gamma glutamyltransferase, alkaline phosphatase, transaminases, hepatitis, biliary tract disappearance syndrome, granulomatous hepatitis, jaundice, liver failure.
• Skin changes: allergic dermatitis, erythroderma, urticaria, exfoliative dermatitis, systemic lupus erythematosus, Stevens-Johnson syndrome, epidermal necrolysis, pruritus, photosensitivity, erythema nodosum or multiforme, purpura, acne, skin pigmentation disorders, increased hair loss, increased sweating …
• Musculoskeletal disorders: muscle weakness, arthralgia, muscle spasms.
• Genitourinary disorders: tubulointerstitial nephritis, kidney failure, renal dysfunction (hematuria, albuminuria, oliguria, azotemia), urinary retention, frequent urination, impotence, spermatogenesis disorders, erectile dysfunction.
• General disorders: weakness.

Storage conditions and periods
Store Mezacar SR at 15–25 ° С for no more than two years.