Index of drugs

Acute and chronic anxiety, especially manifested by: increased anxiety, tension, internal anxiety, excitement, irritability, sleep disturbances of emotional origin, psycho-vegetative and psychosomatic disorders (eg within the circulatory system or digestive system) - excluding the cause of organic origin. Supportive in epilepsy, when the current anticonvulsant therapy did not give satisfactory results.

1 tabl contains 10 mg of clobazam.

A benzodiazepine derivative with anxiolytic and anticonvulsant activity. After oral administration, they are rapidly absorbed from the gastrointestinal tract at least 87%. The maximum concentration in the blood reaches 0.25-4 h after administration. The drug binds to plasma proteins in 85-91%. T_0,5 in the elimination phase, it is about 20 hours. It is mainly excreted by the liver. The active metabolite is N-desmethylclobezam, which reaches its maximum plasma concentration after 24-72 h, its T_0,5 in the elimination phase is 50 hours.

Hypersensitivity to clobazam or other components of the preparation. Addiction to drugs and alcohol in an interview. Muscle tiredness(myasthenia gravis). acute respiratory disorder. Sleep apnea syndrome. Severe liver dysfunction. And trimester of pregnancy. Breastfeeding period. Benzodiazepines must not be administered to children without careful assessment of the need for these medicines. Do not use the drug in children from 6 months to 6 years of age, except in special cases of convulsions with absolute indications.

Before treating anxiety associated with mood disorders, first determine whether the patient has depressive disorders that require additional or different treatment. The use of the preparation may lead to the development of mental and physical dependence, especially in patients with a tendency to become addicted to alcohol or medication - in the case of long-term use of the drug should be considered benefits in relation to the risk of developing addiction. Caution should be exercised in patients with personality disorders due to the risk of suicidal behavior. Carefully use in patients with chronic or acute respiratory failure, in patients with a history of muscle weakness, ataxia of spinal or cerebellar origin, with impaired renal or liver function. In the elderly, due to the increased susceptibility to side effects such as drowsiness, dizziness, muscle weakness, there is an increased risk of falling, which may result in a serious injury - a dose reduction is recommended. During treatment of epilepsy with benzodiazepines, including clobazam, care should be taken and attention should be paid to the possibility of tolerance during treatment. In patients metabolic with CYP2C19 is slow metabolism, the concentration of the active metabolite N-demethylclobazam is expected to increase compared to the rapidly metabolizing patients. Dosage adjustment of clobazam may be necessary (eg careful adjustment of the low initial dose). The product contains lactose - should not be used in patients with rare hereditary galactose intolerance, Lapp lactase deficiency or malabsorption of glucose-galactose.

The use of the drug in the first trimester of pregnancy is contraindicated. In the second and third trimester, the drug can only be used if absolutely necessary. Long-term use later in pregnancy may lead to physical dependence in the child and may lead to the risk of withdrawal syndrome. The use of high doses before and during labor can cause signs and symptoms of the so-called "flaccid child band". Do not use during breast-feeding.

Clobazam may have a sedative effect, which leads to feelings of tiredness and drowsiness, especially at the beginning of treatment and when using higher doses. The following may occur: slow reaction time, drowsiness, weakening of emotional reactions, confusion, pain and dizziness, muscle weakness, lack of mobility, slight finger tremor.There may also be: slowed or indistinct speech (abnormal articulation), instability gait or other motor activities, decreased libido. The following were noted: visual impairment (double vision, nystagmus), dry mouth, constipation, loss of appetite, nausea, weight gain, falls. Very rare: disturbances of consciousness, sometimes with respiratory disorders - with prolonged use, especially in elderly patients; rash or urticaria, Stevens-Johnson syndrome, toxic epidermal necrolysis. Especially elderly patients and children may experience paradoxical reactions (anxiety, difficulty in falling asleep, sleep disturbances, irritability, acute arousal states, anxiety, aggression, delusions, delusions, anger, nightmares, hallucinations, psychotic reactions, suicidal tendencies, increased muscle cramps) - in such cases, treatment should be discontinued. If the preparation is used for a long time, addiction and tolerance may develop. Subsequent amnesia may occur, which may be accompanied by unusual behavior. Clobazam, especially at high doses, can cause respiratory depression; there is a risk of developing or exacerbating respiratory failure, especially in patients with pre-existing dyspnea caused by airway obstruction (eg in asthma) or in patients with brain damage. When benzodiazepines are used, it may reveal a pre-existing depression. When using the preparation for the treatment of epilepsy, anxiety and weakness of muscle strength may rarely occur.
When a sudden discontinuation of the drug may occur, so-called "reflections" (with symptoms such as: anxiety, fits, sudden changes in mood, anxiety, sleep disturbances, anxiety). In cases where physical dependence has developed, abrupt discontinuation symptoms occur at the abrupt discontinuation of treatment: headache, sleep disturbances, more frequent daydreams, increased anxiety, tension, anxiety, confusion, agitation, loss of sense of reality, depersonalization, hallucinations, symptomatic psychosis (e.g.delirium with withdrawal), numbness and tingling of the extremities, muscle aches, tremors, sweating, nausea, vomiting, acute hearing, hypersensitivity to light, sound, physical contact, fits).

Orally.Anxiety. Adults: the recommended starting dose is 20 mg daily. If necessary, it can be increased to 30 mg a day. It is not recommended to exceed the daily dose of 30 mg. Elderly patients: a low initial dose is required and gradual dose titration with careful observation of the patient. The daily maintenance dose is usually 10-15 mg. After improvement, the dose can be reduced. If the daily dose is divided, most of it should be taken in the evening. The duration of treatment should not exceed 8-12 weeks (including the period of gradual dose reduction). The patient should be re-assessed after a period of not more than 4 weeks, and then at regular intervals. If necessary, the treatment period may be extended, but only after re-evaluation of the patient's clinical status.Epilepsy (in combination with one or more anticonvulsant medicines).AdultsThe recommended starting dose is 5-15 mg / day, if necessary the dose may be gradually increased to a maximum daily dose of 80 mg.Children 6 years and older: it is recommended to start treatment with an initial dose of 5 mg per day. Maintenance dose ranging from 0.3 to 1 mg / kg. it's usually enough. Children may have an increased susceptibility to side effects, which requires a gradual increase in the dose under strict control. Benzodiazepines must not be administered to children without a thorough assessment of the need for these medicines. There are no recommendations on the dosage of clobazam in children under 6 years of age due to the lack of an appropriate form to ensure safe use and appropriate dosage. In elderly patients, patients with impaired renal and hepatic function may experience an increased susceptibility to side effects, which requires the use of low starting doses and gradual dose escalation under strict control. If the daily dose is divided, most of it should be taken in the evening. Doses up to 30 mg can be taken once in the evening. The patient should be re-assessed after a period of not more than 4 weeks, and then at regular intervals.Way of giving. The tablets can be taken whole or crushed and mixed with apple sauce, regardless of meals.