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CLONAZEPAM THAME is a brand name for Clonazepam. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Clonazepam is indicated, primarily as an adjunct or in refractory cases, in most forms of epilepsy especially absence seizures including atypical absence seizures; Lennox- Gastaut syndrome; myoclonic and atonic seizures. For infantile spasms (including West-Syndrome) and tonic-clonic seizures it is only indicated as…
Verbatim from this product's MHRA label. Tap a section to expand.
5mg/5ml oral solution facilitates the administration of lower daily doses in the initial stages of treatment. The 2mg/5ml solution should be used for maintenance and maximum dosage regimens. Adults Initial dosage should not exceed 1mg/day.
The maintenance dosage for adults normally falls within the range 4 to 8 mg. Elderly The elderly are particularly sensitive to the effects of centrally depressant drugs and may experience confusion. The lowest possible dose should be used in the elderly.
5mg/day and particular care should be taken during uptitration. 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 20mg daily.
The maintenance dose should be attained after 2 to 4 weeks of treatment. Infants and Children Due to the presence of ethanol in the formulation, this product is not indicated for paediatric use. 3). Patients with mild to moderate hepatic impairment should be given the lowest possible dose.
Method of administration 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 clonazepam 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. 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 antiepileptic drug is a common practice in the treatment of epilepsy and may be undertaken with clonazepam. The dosage of each drug may be required to be adjusted to obtain the optimum effect.
Before adding clonazepam to an existing anticonvulsant regimen, it should be considered that the use of multiple anticonvulsants may result in an increase of undesired effects. For oral use only.
The following have been observed:
Immune System Disorders Allergic reactions and very rare cases of anaphylaxis have been reported to occur with benzodiazepines. Angioedema may occur in rare cases Endocrine Disorders Isolated cases of reversible development of premature secondary sex characteristics in children (incomplete precocious puberty) have been reported.
Psychiatric Disorders Emotional and mood disturbances, restlessness, confusional state, disorientation have been observed. Depression may occur in patients treated with clonazepam, but it may be also associated with the underlying disease.
The following paradoxical reactions have been observed: excitability, irritability, aggressiveness, agitation, nervousness, hostility, anxiety, delusion, anger, sleep disturbances, nightmares, abnormal dreams, hallucinations, psychoses, hyperactivity, inappropriate behaviour and other adverse behavioural effects and activation of new types of seizures are known to occur.
If these occur, the drug should be discontinued. Paradoxical reactions are more likely to occur in children and in the elderly. The addition to the regimen of another suitable drug may be necessary or, in some cases, it may be advisable to discontinue clonazepam therapy.
In rare cases changes in libido may occur. Nervous System Disorders Impaired concentration, 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.
Some loss of effect may occur during the course of clonazepam long-term treatment. Prolonged use of benzodiazepines may result in dependence development with withdrawal symptoms on cessation of use. Clonazepam 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. In cases of loss or bereavement, psychological adjustment may be inhibited by benzodiazepines. Hepatic impairment Benzodiazepines may have a contributory role in precipitating episodes of hepatic encephalopathy in severe hepatic impairment.
3). Central Nervous System (CNS), psychosis and depression Clonazepam should be used with particular caution in patients with ataxia. Benzodiazepines are not recommended for the primary treatment of psychotic illness. Patients with a history of depression and/or suicide attempts should be kept under close supervision.
Suicidal ideation and behaviour have been reported in patients treated with anti- epileptic agents in several indications. 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. Concomitant use of alcohol/CNS depressants The concomitant use of Clonazepam with alcohol or/and CNS depressants should be avoided.
9). Clonazepam should be used with particular caution in the event of acute intoxication with alcohol or drugs. 8). Should this occur, the use of the drug should be discontinued. Paradoxical reactions are more likely to occur in children and in the elderly.
1. Patients with known acute pulmonary insufficiency, severe respiratory insufficiency, medical history of sleep apnoea syndrome myasthenia gravis and severe hepatic impairment as benzodiazepines may precipitate hepatic encephalopathy.
Clonazepam must not be used in patients in a coma, or in patients known to be abusing pharmaceuticals, drugs or alcohol.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Anterograde amnesia may occur using benzodiazepines at therapeutic dosages, the risk increasing at higher dosages. Amnestic effects may be associated with inappropriate behaviour. With certain forms of epilepsy, an increase in the frequency of seizures during long-term treatment is possible.
Eye Disorders Particularly in long-term or high-dose treatment, reversible disorders of vision (diplopia) may occur. Common : nystagmus. Cardiac Disorders Cardiac failure including cardiac arrest has been reported. v. administration of clonazepam.
This effect 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.
In infants and young children, particularly those with a degree of mental impairment, Clonazepam may cause increased production of saliva or of bronchial secretion. Particular attention should therefore be paid to maintaining patency of the airways.
Gastrointestinal Disorders The following effects have been reported in rare cases: nausea, gastrointestinal and epigastric symptoms. Skin and Subcutaneous Tissue Disorders The following effects may occur in rare cases: urticaria, pruritus, rash, transient hair loss , pigmentation changes and angioedema.
Musculoskeletal and Connective Tissue Disorders Muscle weakness, this undesirable effect occurs relatively frequently and is usually transient and generally disappears spontaneously in the course of the treatment or on reduction of the dosage.
It can be partially prevented by increasing the dose slowly at the start of treatment. Renal and Urinary Disorders In rare cases urinary incontinence may occur. Reproductive System and Breast Disorders In rare cases erectile dysfunction may occur.
General Disorders and Administration Site Conditions Fatigue (tiredness, lassitude), this undesirable effect occurs relatively frequently and is usually transient and generally disappears spontaneously in the course of the treatment or on reduction of the dosage.
It can be partially prevented by increasing the dose slowly at the start of treatment. Paradoxical reactions including irritability have been observed (see also psychiatric disorders). Injury, Poisoning and Procedural Complications There have been reports of falls and fractures in benzodiazepine users.
The risk is increased in those taking concomitant sedatives (including alcoholic beverages) and in the elderly. Investigations In rare cases decreased platelet count may occur. As with other benzodiazepines, isolated cases of blood dyscrasias and abnormal liver function tests have been reported.
4). Although Clonazepam has been given uneventfully to patients with porphyria, rarely it may induce convulsions in these patients. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Amnesia 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. 8) during long-term treatment is possible.
3). g. chronic obstructive pulmonary disease). 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.
5). As with all other antiepileptic drugs, treatment with clonazepam 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 clonazepam therapy. Porphyria Clonazepam is considered to be probably nonporphyrinogenic, although there is some conflicting evidence.
Therefore in patients with porphyria, clonazepam should be used with care. Paediatric population In infants and small children Clonazepam may cause increased production of saliva and bronchial secretion. Therefore special attention must be paid to maintaining patency of the airways.
Elderly Benzodiazepine pharmacologic effects appear to be greater in elderly patients than in younger patients even at similar plasma benzodiazepine concentrations, possibly because of age-related changes in drug–receptor interactions, post-receptor mechanisms and organ function.
8). 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). The risk of dependence increases with dose and duration of treatment; it is also greater in patients with a medical history of alcoholism and/or drug abuse.
Abuse has been reported in poly-drug abusers. Clonazepam should be used with extreme caution in patients with a history of alcohol or drug abuse. 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 […]