Carbamazepine-Astrapharm
Release Forms:
The composition 1 tablets:
- active substance: carbamazepine;
- 1 tablet contains carbamazepine 200 mg;
- excipients: microcrystalline cellulose, povidone, magnesium stearate, sodium croscarmellose.
Dosage form. Tablets.
Basic physical and chemical properties: tablets of white or almost white color, round, with a biconvex surface and a line on one side.
10 tablets in a blister, 2 or 5 blisters in a box.
Indications
- Epilepsy:
- complex or simple partial seizures (with or without loss of consciousness) with or without secondary generalization;
- generalized tonic-clonic seizures;
- mixed forms of convulsive seizures.
Carbamazepin-Astrapharm can be used both as monotherapy and as part of combination therapy.
- Acute manic states; maintenance therapy for bipolar affective disorders in order to prevent exacerbations or to reduce the clinical manifestations of exacerbations.
- Alcohol withdrawal syndrome.
- Idiopathic trigeminal neuralgia and trigeminal neuralgia in multiple sclerosis (typical and atypical).
- Idiopathic glossopharyngeal neuralgia.
Contraindications
Hypersensitivity to carbamazepine or to drugs of a similar chemical ratio (such as tricyclic antidepressants), or to any other component of the drug.
Atrioventricular block.
History of bone marrow suppression.
History of hepatic porphyria (eg, acute intermittent porphyria, mixed porphyria, tardive porphyria of the skin).
Concomitant use with monoamine oxidase inhibitors (MAO).
Carbamazepine-Astrapharm should be prescribed only under medical supervision, only after assessing the benefit/risk ratio and subject to careful monitoring of patients with cardiac, hepatic or renal impairments, a history of adverse hematological reactions to other drugs, and patients with interrupted courses of carbamazepine therapy.
It is recommended to conduct a general analysis of urine and determine the level of urea nitrogen in the blood at the beginning and at regular intervals during therapy.
Carbamazepine-Astrapharm exhibits mild anticholinergic activity, therefore, patients with increased intraocular pressure should be warned and consulted regarding possible risk factors.
It should be remembered about the possible activation of latent psychoses, and with regard to elderly patients – about the possible activation of confusion and anxiety.
The drug is usually ineffective for absences (minor epileptic seizures) and myoclonic seizures. Isolated cases suggest that increased seizures are possible in patients with atypical absences.
Hematological effects. The development of agranulocytosis and aplastic anemia is associated with the use of the drug; however, due to the extremely low incidence of these conditions, it is difficult to assess the significant risk when taking the drug Carbamazepine-Astrapharm. The overall risk for patients not receiving therapy is 4.7 persons / 1,000,000 per year for the development of agranulocytosis and 2 persons / 1,000,000 per year for the development of aplastic anemia.
Patients should be informed about early signs of toxicity and symptoms of possible hematological disorders, as well as symptoms of dermatological and hepatic reactions. The patient should be warned that in the event of such reactions as fever, tonsillitis, skin rashes, ulceration in the mouth, easy bruising, punctate hemorrhages or hemorrhagic purpura, consult a doctor immediately.
If the number of leukocytes or platelets decreases significantly during therapy, the patient’s condition should be closely monitored and a continuous complete blood count of the patient should be performed. Treatment with Carbamazepine-Astrapharm should be discontinued if the patient develops severe, progressive leukopenia or is accompanied by clinical manifestations such as fever or sore throat. The use of the drug Carbamazepine-Astrapharm should be discontinued when signs of bone marrow suppression appear.
A temporary or persistent decrease in the number of platelets or white blood cells was determined in connection with the intake of the drug Carbamazepine-Astrapharm. However, in most cases, these phenomena were temporary and did not indicate the development of aplastic anemia or agranulocytosis. Before starting therapy and periodically during its implementation, a blood test should be performed, including determining the number of platelets (and, possibly, the number of reticulocytes and the level of hemoglobin).
Serious dermatological reactions. Serious dermatological reactions, including toxic epidermal necrolysis (TEN), or Lyell’s syndrome, and Stevens-Johnson syndrome (SJS), are very rare when using the drug Carbamazepine-Astrapharm. Patients with severe dermatologic reactions may need to be hospitalized because these conditions can be life-threatening and fatal. Most cases of SJS / TEN development are determined during the first few months of treatment with Carbamazepine-Astrapharm. With the development of signs indicating serious dermatological reactions (for example, SS, Lyell’s syndrome / TEN), taking the drug Carbamazepine-Astrafarm should be stopped immediately and alternative therapy should be prescribed.
Carbamazepine-Astrapharm should be prescribed only under medical supervision, only after assessing the benefit/risk ratio and subject to careful monitoring of patients with cardiac, hepatic or renal impairments, a history of adverse hematological reactions to other drugs, and patients with interrupted courses of carbamazepine therapy.
It is recommended to conduct a general urinalysis and determine the level of urea nitrogen in the blood at the beginning and at regular intervals during therapy.
Carbamazepine-Astrapharm exhibits mild anticholinergic activity, therefore, patients with increased intraocular pressure should be warned and consulted regarding possible risk factors.
It should be remembered about the possible activation of latent psychoses, and with regard to elderly patients – about the possible activation of confusion and anxiety.
The drug is usually ineffective for absences (minor epileptic seizures) and myoclonic seizures. Isolated cases suggest that increased seizures are possible in patients with atypical absences.
Hematological effects. The development of agranulocytosis and aplastic anemia is associated with the use of the drug; however, due to the extremely low incidence of these conditions