Mezacar (carbamazepin) oral suspension 100 mg/5 ml. 100 ml. vial

$14.00

Epilepsy: complex or simple partial seizures (with or without loss of consciousness) with or without secondary generalization; generalized tonic-clonic seizures; mixed forms of seizures.

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Description

Mezacar composition
active substance: carbamazepine;
5 ml of suspension contain carbamazepine 100 mg;
excipients: xanthan gum; hypromellose; potassium sorbate; citric acid, monohydrate; propylene glycol; sorbitol solution that does not crystallize (E 420); saccharose; yellow west FCF (E 110); flavoring “Orange”; flavoring “Vanillin”; purified water.

Dosage form
The suspension is oral.

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:

  • 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.

Children
Oral suspension can be taken from birth.

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

Method of application and dosage
The drug Mezacar can be taken during or after a meal, or in between meals with a small amount of fluid.
Mezacar, oral suspension, administered orally. Shake before use.
Usually the dose is divided into 2-3 doses.
Because the maximum concentration of carbamazepine while taking the suspension is higher than the same dose in tablet form, it is recommended to start the suspension at low doses and gradually increase them (to avoid CNS side effects such as dizziness and drowsiness).
When replacing the tablet form with the suspension, the same dose should be used, but it should be divided into smaller single doses and the number of doses should be increased accordingly.
HLA-B * 1502 screening is recommended for certain ethnic groups (Chinese, Thai) before treatment, as the presence of this allele is a prognostic marker of the possible risk of severe carbamazepine-related Stevens-Johnson syndrome.
Epilepsy
The dose of carbamazepine should be selected individually for each patient in order to achieve adequate control of seizures. Determining the concentration of carbamazepine in blood plasma can help in choosing the optimal dose. In the treatment of epilepsy, carbamazepine dosing usually requires achieving a total plasma concentration of carbamazepine from 4 to 12 mg  / ml (17 to 50 μmol / l).

  • Adults
    For all carbamazepine dosage forms, a gradual dose escalation regimen is recommended, which should be adjusted to meet the needs of each individual patient.
    For adults, the initial dose is 100-200 1-2 times a day. Then slowly increase the dose to achieve the optimal effect; it is usually achieved at a dose of 800-1200 mg per day, divided into 2 or more doses. Some patients may need to increase the dose to 1600-2000 mg / day.
  • Elderly patients
    Due to the increased interaction with other medicinal products, the dosage of carbamazepine should be selected with caution in elderly patients.
  • Children
    For all carbamazepine dosage forms, a gradual dose escalation regimen is recommended, which should be adjusted to meet the needs of each individual patient.
    Usually the daily dose is 10-20 mg / kg body weight, which should be divided into several doses.

The following daily doses are recommended for different ages

  • Up to 1 year – 100-200 mg – 5-10 ml;
  • From 1 to 5 years – 200-400 mg – 10-20 ml;
  • From 5 to 10 years – 400-600 mg – 20-30 ml;
  • From 10 to 15 years – 600-1000 mg – 30-50 ml;
  • Over 15 years – 800-1200 mg – 40-60 ml.

The following maximum daily doses are recommended for different ages

  • Up to 6 years – 35 mg / kg / day;
  • From 6 to 15 years – 1000 mg / day;
  • From 15 years – 1200 mg / day.

Overdose
Symptoms. Symptoms and complaints of overdose usually reflect damage to the central nervous, cardiovascular and respiratory systems.
Treatment. There is no specific antidote. Initially, treatment should be based on the patient’s clinical condition; hospitalization is shown. Plasma concentrations of carbamazepine are determined to confirm poisoning by this drug and to assess the degree of overdose.
Evacuation of gastric contents, gastric lavage, use of activated charcoal is carried out. Late evacuation of gastric contents may lead to delayed absorption and recurrence of symptoms of intoxication during recovery. Symptomatic supportive treatment is used in the intensive care unit, monitoring of heart function, careful correction of electrolyte disorders.

Side effects:

  • From the blood and lymphatic system: leukopenia; thrombocytopenia, eosinophilia, leukocytosis, lymphadenopathy, folic acid deficiency, agranulocytosis, aplastic anemia, pancytopenia, erythrocyte aplasia, anemia, megaloblastic anemia, acute intermittent porphyria, porphyria, porphyria, porphyria.
  • From the immune system: delayed-type multi-organ hypersensitivity with fever, skin rash, vasculitis, lymphadenopathy; pseudolymphoma, arthralgia, leukopenia, eosinophilia, hepatosplenomegaly and altered liver function and bile duct disappearance syndrome (destruction and disappearance of intrahepatic bile ducts), occurring in various combinations.
  • There may be disturbances from other organs (eg liver, lungs, kidneys, pancreas, myocardium, colon), aseptic meningitis with myoclonus and peripheral eosinophilia, anaphylactic reactions, drug rash with eosinophilia, DR, annemia and systemic symptoms. .
  • From the endocrine system: edema, fluid retention, weight gain, hyponatremia and decreased plasma osmolarity due to an effect similar to the action of antidiuretic hormone, which in isolated cases leads to hyperhydration, accompanied by lethargy, vomiting, headache, confusion and confusion. ; increase in the level of blood prolactin, accompanied or not accompanied by such manifestations as galactorrhea, gynecomastia; changes in thyroid function: decreased levels of L-thyroxine (FT4, T4, T3) and increased levels of thyroid-stimulating hormone, which is usually not accompanied by clinical manifestations.
  • Metabolism and nutrition: folate deficiency, loss of appetite, acute porphyria (acute intermittent porphyria and mixed porphyria), mild porphyria (late skin porphyria).
  • Mental disorders: hallucinations (visual or auditory), depression, loss of appetite, anxiety, aggression, agitation, confusion, activation of psychosis.
  • From the nervous system: dizziness, ataxia, drowsiness, sedation, memory impairment, headache, diplopia, impaired accommodation of vision (eg blurred vision); abnormal involuntary movements (eg tremor, dystonia, asterixis, tic), nystagmus; orofacial dyskinesia, eye movement disorders, speech disorders (eg dysarthria or slurred speech), choreoathetosis, peripheral neuropathy, paresthesias, paresis; taste disturbances, malignant neuroleptic syndrome, aseptic meningitis with myoclonus and peripheral eosinophilia, dysgeusia.
  • On the part of the visual organs: accommodation disorders (such as blurred vision), clouding of the lens, conjunctivitis, increased intraocular pressure.
  • From the organs of hearing and labyrinth: hearing disorders, such as ringing in the ears, increased auditory sensitivity, decreased auditory sensitivity, impaired perception of pitch.

Expiration date
2 years.

Storage conditions
Store Mezacar at a temperature not exceeding 25 ° C.
Keep out of reach of children.
After the first opening of the vial, the drug should be stored for no more than 4 weeks.