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For a full list of excipients, see section 6. The tablets can be broken into equal halves or quarters to facilitate dosing. Go to top of the page 4. The maintenance dosage for adults normally falls within the range 4 to 8 mg. The elderly are particularly sensitive to the effects of centrally depressant drugs and may experience confusion. It is recommended that the initial dosage of Rivotril should not exceed 0. These are total daily dosages which should be divided into 3 or 4 doses taken at intervals throughout the day.
If necessary, larger doses may be given at the discretion of the physician, up to a maximum of 20 mg daily. The maintenance dose should be attained after 2 to 4 weeks of treatment. To ensure optimum dosage adjustment, children should be given the 0. The maintenance dosage normally falls within the ranges: School children 5 to 12 years Small children 1 to 5 years Infants 0 to 1 year 3 to 6 mg 1 to 3 mg micrograms to 1 mg In some forms of childhood epilepsy, certain patients may cease to be adequately controlled by Rivotril.
Control may be re-established by increasing the dose, or interrupting treatment with Rivotril for 2 or 3 weeks. During the interruption in therapy, careful observation and other drugs may be needed. Treatment should be started with low doses. The dose may be increased progressively until the maintenance dose suited to the individual patient has been found.
The dosage of Rivotril must be adjusted to the needs of each individual and depends on the individual response to therapy. The maintenance dosage must be determined according to clinical response and tolerance. The daily dose should be divided into 3 equal doses. If doses are not equally divided, the largest dose should be given before retiring.
Once the maintenance dose level has been reached, the daily amount may be given in a single dose in the evening. Simultaneous administration of more than one anti-epileptic drug is a common practice in the treatment of epilepsy and may be undertaken with Rivotril. The dosage of each drug may be required to be adjusted to obtain the optimum effect. If status epilepticus occurs in a patient receiving oral Rivotril, intravenous Rivotril may still control the status. Before adding Rivotril to an existing anticonvulsant regimen, it should be considered that the use of multiple anticonvulsants may result in an increase of undesired effects.
Rivotril must not be used in patients in a coma, or in patients known to be abusing pharmaceuticals, drugs or alcohol. A meta-analysis of randomised placebo controlled trials of anti-epileptic drugs has also shown a small increased risk of suicidal ideation and behaviour. The mechanism of this risk is not known and the available data do not exclude the possibility of an increased risk for clonazepam.
Therefore patients should be monitored for signs of suicidal ideation and behaviours and appropriate treatment should be considered. Patients and caregivers of patients should be advised to seek medical advice should signs of suicidal ideation or behaviour emerge. Rivotril should be used with caution in patients with chronic pulmonary insufficiency, or with impairment of renal or hepatic function, and in the elderly or the debilitated.
In these cases dosage should generally be reduced. As with all other anti-epileptic drugs, treatment with Rivotril even if of short duration, must not be abruptly interrupted, but must be withdrawn by gradually reducing the dose in view of the risk of precipitating status epilepticus. In such cases a combination with other antiepileptics is indicated. This precaution must also be taken when withdrawing another drug while the patient is still receiving Rivotril therapy.
Prolonged use of benzodiazepines may result in dependence development with withdrawal symptoms on cessation of use. Rivotril may be used only with particular caution in patients with spinal or cerebellar ataxia, in the event of acute intoxication with alcohol or drugs and in patients with severe liver damage e. Rivotril should be used with extreme caution in patients with a history of alcohol or drug abuse.
In infants and small children Rivotril may cause increased production of saliva and bronchial secretion. Therefore special attention must be paid to maintaining patency of the airways. The dosage of Rivotril must be carefully adjusted to individual requirements in patients with pre-existing disease of the respiratory system e. Effects on the respiratory system may be aggravated by pre-existing airways obstruction or brain damage or if other medications which depress respiration have been given.
As a rule, this effect can be avoided by careful adjustment of the dose to individual requirements. Clonazepam is considered to be probably nonporphyrinogenic, although there is some conflicting evidence. Therefore in patients with porphyria, clonazepam should be used with care. Like all drugs of this type, Rivotril may, depending on dosage, administration and individual susceptibility, modify the patient's reactions e. Even when adequately controlled on Rivotril, it should be remembered that any increase in dosage or alteration in timings of dosage may modify patients' reactions, depending on individual susceptibility.
In cases of loss or bereavement, psychological adjustment may be inhibited by benzodiazepines. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption, should not take this medicine. Use of benzodiazepines may lead to the development of physical and psychic dependence upon these products see 4. In particular long-term or high-dose treatment, may lead to reversible disorders such as dysarthria, reduced coordination of movements and gait disorder ataxia , nystagmus and vision diplopia.
Furthermore, the risk of anterograde amnesia, which may occur using benzodiazepines at therapeutic dosages, increases at higher dosages. Amnestic effects may be associated with inappropriate behaviour. With certain forms of epilepsy, an increase in the frequency of seizures see 4. Once physical dependence has developed, abrupt termination of treatment will be accompanied by withdrawal symptoms. During long-term treatment, withdrawal symptoms may develop after a lengthy period of use, especially with high doses or if the daily dose is reduced rapidly or abruptly discontinued.
The symptoms include tremor, sweating, agitation, sleep disturbances and anxiety, headaches, muscle pain, extreme anxiety, tension, restlessness, confusion, irritability and epileptic seizures which may be associated with the underlying disease. In severe cases the following symptoms may occur: Since the risk of withdrawal symptoms is greater after abrupt discontinuation of treatment, abrupt withdrawal of the drug should therefore be avoided and treatment - even if only of short duration - should be terminated by gradually reducing the daily dose.
The risk of withdrawal symptoms is increased when benzodiazepines are used together with day-time sedatives crossed tolerance. In combination with Rivotril, alcohol may modify the effects of the drug, compromise the success of therapy or give rise to unpredictable side-effects. Enhanced effects on sedation, respiration and haemodynamics may occur when Rivotril is co-administered with any centrally acting depressants e. In combination therapy with centrally-acting medications, the dosage of each drug must be adjusted to achieve the optimum effect.
When Rivotril is used in conjunction with other anti-epileptic drugs, side-effects such as sedation and apathy and toxicity may be more evident, particularly with hydantoins or phenobarbital and combinations including them. In such cases, the dosage of each drug must be adjusted to achieve the optimum desired effect, particularly in the initial stages of treatment. The combination of Rivotril and sodium valproate has, rarely, been associated with the development of absence status epilepticus.
Although some patients tolerate and benefit from this combination of drugs, this potential hazard should be borne in mind when its use is considered. The antiepileptic drugs phenytoin, phenobarbital, carbamazepine and valproate may increase the clearance of clonazepam thereby decreasing the plasma concentrations of the latter during combined treatment. In concurrent treatment with phenytoin or primidone a change, usually a rise, in the serum concentration of these two substances has occasionally been observed.
Clonazepam itself does not induce the enzymes responsible for its own metabolism. The selective serotonin reuptake inhibitors sertraline and fluoxetine do not affect the pharmacokinetics of clonazepam when administered concomitantly. Known inhibitors of hepatic enzymes, e. From epidemiological evaluations there is evidence that anticonvulsant drugs act as teratogens. However, it is difficult to determine from published epidemiological reports which drug or combination of drugs is responsible for defects in the newborn.
The possibility also exists that other factors e. Rivotril should only be administered to pregnant women if the potential benefits outweigh the risk to the foetus. During pregnancy, Rivotril may be administered only if there is a compelling indication. Administration of high doses in the last trimester of pregnancy or during labour can cause irregularities in the heart beat of the unborn child and hypothermia, hypotonia, mild respiratory depression and poor feeding in the neonate. Infants born to mothers who took benzodiazepines chronically during the later stages of pregnancy may have developed a physical dependence and may be at some risk for developing withdrawal symptoms in the post-natal period.
It should be borne in mind that both pregnancy itself and abrupt discontinuation of the medication can cause exacerbation of epilepsy. Although, the active ingredient of Rivotril has been found to pass into the maternal milk in small amounts only, mothers undergoing treatment with this drug should not breastfeed. If there is a compelling indication for Rivotril, breastfeeding should be discontinued.
Even if taken as directed, clonazepam can slow reactions to such an extent that the ability to drive a vehicle or operate machinery is impaired. This effect is aggravated by consumption of alcohol. Driving, operating machinery and other hazardous activities should therefore be avoided altogether or at least during the first few days of treatment. The decision on this question rests with the patient's physician and should be based on the patient's response to treatment and the dosage involved.
Allergic reactions and very rare cases of anaphylaxis have been reported to occur with benzodiazepines. Isolated cases of reversible development of premature secondary sex characteristics in children incomplete precocious puberty have been reported. Impaired concentration, restlessness, confusional state, disorientation have been observed. Depression may occur in patients treated with Rivotril, but it may be also associated with the underlying disease.
The following paradoxical reactions have been observed: If these occur, the benefit of continuing the drug should be weighed against the adverse effect. The addition to the regimen of another suitable drug may be necessary or, in some cases, it may be advisable to discontinue Rivotril therapy. In rare cases loss of libido may occur. Somnolence, slowed reaction, muscular hypotonia, dizziness, ataxia and co-ordination disturbance. These undesirable effects occur relatively frequently and are usually transient and generally disappear spontaneously in the course of the treatment or on reduction of the dosage.
They can be partially prevented by increasing the dose slowly at the start of treatment. Headache was observed in rare cases. Causing of generalised fits was observed very rarely. Particularly in long-term or high-dose treatment, reversible disorders such as dysarthria, reduced coordination of movements and gait disorder ataxia and nystagmus may occur.
Anterograde amnesia may occur using benzodiazepines at therapeutic dosages, the risk increasing at higher dosages. With certain forms of epilepsy, an increase in the frequency of seizures during long-term treatment is possible. Particularly in long-term or high-dose treatment, reversible disorders of vision diplopia may occur.
Cardiac failure including cardiac arrest has been reported. Respiratory, Thoracic and Mediastinal System Disorders. Respiratory depression may occur, particularly on i. This effect may be aggravated by pre-existing airways obstruction or brain damage or if other medications which depress respiration have been given. In infants and young children, particularly those with a degree of mental impairment, Rivotril may cause increased production of saliva or of bronchial secretion.
Particular attention should therefore be paid to maintaining patency of the airways.