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COSIUM 50 ml Suspension
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Acute and chronic anxiety states, which may produce the following symptoms in particular: Anxiety, tension, restlessness, excitement, irritability, sleep disturbances from emotional causes, psychovegetative and psychosomatic disorders (for example, in the cardiovascular or gastrointestinal area) and emotional instability. In case of psychovegetative and psychosomatic disorders the doctor should investigate the possibility of an organic cause. Before treatment of anxiety states associated with emotional instability, it must first be determined whether the patient suffers from a depressive disorder requiring adjuvant or different treatment. As adjunctive therapy in patients with epilepsy who are not adequately stabilized with their anticonvulsant monotherapy.
Clobazam binds at distinct binding sites associated with the chloride ionopore at the post-synaptic GABA receptor. These GABA receptors are in various locations in the CNS (limbic, reticular formation) and clobazam increases the duration of time for which the chloride ionopore is open. As a result, hyper polarization and stabilization of the membrane occur as the post-synaptic inhibitory effect of GABA is enhanced.
Pharmaceutical presentation dosage, and duration of treatment must be adjusted to the individual clinical response, the indication, and the severity of the condition. Due regard must be paid to the possibility of interference with alertness and reaction time. The fundamental principle is to keep the dose as low as possible.
In patients with impairment of hepatic or renal function, Clobazam must be administered in reduced doses; in long term treatment hepatic and renal functions should be checked regularly, as a precaution. When treatment with Clobazam is to be discontinued after prolonged administration, the dosage should normally be tapered off over a period of time.
Treatment of anxiety states: The initial dose is usually 20 mg Clobazam daily. If necessary, the daily dose may be increased to 30 mg. For elderly patients, a total daily dose of 10-15 mg is often enough. For Children between 3 and 15 years of age, a daily dose of 5-10 mg is frequently sufficient.
Discontinuation of treatment of anxiety states: After improvement of the symptoms, the dose may be reduced. After prolonged treatment, Clobazam should not be withdrawn suddenly. The dose should be reduced gradually under medical supervision, otherwise symptoms such as restlessness, anxiety, and insomnia may occur.
Treatment of epilepsy: As with other benzodiazepines, the possibility of a decrease in anticonvulsant efficacy in the course of treatment must be borne in mind.
Dosage in adults and adolescents over 75 years of age: Small doses (5-15 mg/day as the initial dose), gradually increasing to maximum daily dose of about 80 mg. Furthermore, constant doses (e.g. 20 mg/day) and intermittent therapy (discontinuing Clobazam and subsequently prescribing it again) have proved effective.
Combined treatment with one or more other antiepileptics in children from 3 to 15 years of age: Treatment should normally be started with 5 mg, and a maintenance dose of 0.3-1.0 mg/ kg body weight daily is usually enough.
Discontinuation of treatment or combined treatment of epilepsy: At the end of treatment- also in cases where there has been a poor response to therapy- the dose should be gradually reduced, because otherwise an increased proneness to seizures cannot be excluded.
The tablets should be swallowed whole with some liquid. If the dose is to be distributed over the day, the larger portion should be taken in the evening. Doses of up to 30 mg Clobazam can also be administered as a single evening dose. The duration of treatment is determined by the doctor, After a period not exceeding 4 weeks, the doctor should decide whether continuation of treatment is necessary. Prolonged spells of uninterrupted treatment should be avoided, since they may lead to dependence.
Especially when Clobazam is applied in higher doses, a mutually potentiating effect is to be expected if other central nervous system depressant drugs (such as analgesics, sedatives and hypnotics) or alcohol are consumed at the same time. If Clobazam is administered simultaneously with anticonvulsants in the treatment of epilepsy, the doses must be adjusted under regular medical supervision (EEG monitoring) as there may be interactions with the patient’s basic anticonvulsant medication. Especially in patients receiving concurrent treatment with valproic acid and Clobazam, there may be a slight to moderate rise in plasma valproic acid concentration. If possible, the blood levels of the active ingredients should be determined in such cases. Carbamazepine and phenytoin may cause an increase in the metabolic conversion of clobazam to N desmethly clobazam. The effects of muscle relaxants, analgesics, and nitrous oxide may be enhanced. Concurrent treatment with drugs that inhibit the monooxygenase system, as for example cimetidine, may enhance and prolong the action of clobazam.
Clobazam must not be administered to patient with hypersensitivity to clobazam or any of the excipients, or with any history of drug dependence.
Symptoms of tiredness may sometimes appear, especially at the beginning of treatment and when higher doses are used. Also in rare instances and usually only temporarily-the patient may experience dryness of the mouth, constipation, loss of appetite, nausea, dizziness, or a fine tremor of the fingers. Another possibility is the emergence of paradoxical reactions (e.g. restlessness, irritability, acute agitational states, anxiety, suicidal tendencies, frequent muscle spasms, difficulty in falling asleep and to sleep through). In the event of such reactions, treatment with Clobazam should be discontinued. Slowing of reaction time, ataxia, drowsiness, confusion and headaches may occasionally occur. Cutaneous reactions, such as eruptions or urticaria, have been observed in isolated cases.
Impairment of respiratory function may become manifest in certain diseases of the respiratory passages (airways obstruction, e.g. in bronchial asthma) and in patients with brain damage. After prolonged use of benzodiazepine, impairment of conciousness, sometimes combined with resiratory disorders, has been reported in very rare cases, particularly in elderly patients: it sometimes persists for some length of time. Especially in patients receiving high doses of long-term treatment, there may be reversible abnormalities such as slowing or indistinctness of speech (disorders of articulation), lack of confidence in walking and other motor functions, visual disorders (double vision, nystagmus), weight gain or loss of libido. When used as an adjuvant in the treatment of epilepsy, this preparation may, in rare case, cause restlessness and muscle weakness.
Pregnancy & Lactation
Clobazam should not be used in the first trimester of pregnancy, and in the later stages only if there are compelling indications for its use.
Precautions & Warnings
Special caution is necessary if Clobazam is to be administered to patients with serious pathological muscle weakness (myasthenia gravis), unsteadiness of movement and gait due to diseases of the spinal cord and cerebellum (spinal and cerebellar ataxia), and in case of acute poisoning by alcohol, hypnotics, analgesics, neuroleptic agents, antidepressives or lithium, in patients with serious liver damage (e.g. cholestatic jaundice), and in patients with transient cessation of respiration in sleep (sleep apnoea syndrome).
Monitoring of respiratory function is necessary in patients with severe acute respiratory impairment (respiratory failure). Children between the ages of 6 months and 3 years should not normally be given Clobazam however, in exceptional cases, where there are compelling indications, it can be used for anticonvulsant treatment. Clobazam should not be taken by nursing mother, since it passes into the breast milk. If there are compelling indications for its use, breast-feeding should be stopped.
Store in a cool dry place. Protect from light. Do not use later than the date of expiry. Keep all medicines out of the reach of children. To be dispensed only on the prescription of a registered physician.
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