Before taking clonazepam , tell your doctor or pharmacist if you are allergic to it; or to other benzodiazepines such as diazepam , lorazepam ; or if you have any other allergies. The addition to the regimen of another suitable drug may be necessary or, in some cases, it may be advisable to discontinue clonazepam therapy. Do not drive whilst taking this medicine until you know how this medicine affects you. A 3 mg cut of any benzodiazepine is a very large cut at one time! Clonazepam is not recommended for patients with chronic schizophrenia. BULA DE CLONAZEPAM - ANSIEDADE E CONVULSOES
The elderly metabolize benzodiazepines more slowly than younger individuals and are also more sensitive to the effects of benzodiazepines, even at similar blood plasma levels. Doses for the elderly are recommended to be about half of that given to younger adults and are to be administered for no longer than two weeks. Long-acting benzodiazepines such as clonazepam are not generally recommended for the elderly due the risk of drug accumulation.
The elderly are especially susceptible to increased risk of harm from motor impairments and drug accumulation side effects. Benzodiazepines also require special precaution if used by individuals that may be pregnant, alcohol- or drug-dependent, or may have comorbid psychiatric disorders. Clonazepam is not recommended for use in those under Use in very young children may be especially hazardous. Of anticonvulsant drugs, behavioural disturbances occur most frequently with clonazepam and phenobarbital.
Doses higher than 0. Clonazepam may aggravate hepatic porphyria. Clonazepam is not recommended for patients with chronic schizophrenia. A double-blinded, placebo-controlled study found clonazepam increases violent behavior in individuals with chronic schizophrenia. Clonazepam has similar effectiveness to other benzodiazepines at often a lower dose. Clonazepam decreases the levels of carbamazepine ,   and, likewise, clonazepam's level is reduced by carbamazepine.
Azole antifungals, such as ketoconazole , may inhibit the metabolism of clonazepam. Combined use of clonazepam with certain antidepressants , antiepileptics , such as phenobarbital , phenytoin and carbamazepine , sedative antihistamines , opiates , antipsychotics , nonbenzodiazepine hypnotics like zolpidem and alcohol may result in enhanced sedative effects. There is some medical evidence of various malformations, e. The data are also inconclusive on whether benzodiazepines such as clonazepam cause developmental deficits or decreases in IQ in the developing fetus when taken by the mother during pregnancy.
Clonazepam, when used late in pregnancy, may result in the development of a severe benzodiazepine withdrawal syndrome in the neonate. Withdrawal symptoms from benzodiazepines in the neonate may include hypotonia , apnoeic spells, cyanosis and impaired metabolic responses to cold stress. The safety profile of clonazepam during pregnancy is less clear than that of other benzodiazepines, and if benzodiazepines are indicated during pregnancy, chlordiazepoxide and diazepam may be a safer choice.
The use of clonazepam during pregnancy should only occur if the clinical benefits are believed to outweigh the clinical risks to the fetus. Caution is also required if clonazepam is used during breastfeeding. Possible adverse effects of use of benzodiazepines such as clonazepam during pregnancy include: Neonatal withdrawal syndrome associated with benzodiazepines include hypertonia , hyperreflexia , restlessness , irritability , abnormal sleep patterns, inconsolable crying, tremors or jerking of the extremities, bradycardia , cyanosis , suckling difficulties, apnea , risk of aspiration of feeds, diarrhea and vomiting, and growth retardation.
This syndrome can develop between 3 days to 3 weeks after birth and can have a duration of up to several months. The pathway by which clonazepam is metabolized is usually impaired in newborns. If clonazepam is used during pregnancy or breast feeding , it is recommended that serum levels of clonazepam are monitored and that signs of central nervous system depression and apnea are also checked for.
In many cases, non-pharmacological treatments, such as relaxation therapy, psychotherapy and avoidance of caffeine , can be an effective and safer alternative to the use of benzodiazepines for anxiety in pregnant women. Clonazepam acts by binding to the benzodiazepine site of the GABA receptors, which enhances the electric effect of GABA binding on neurons, resulting in an increased influx of chloride ions into the neurons. This further results in an inhibition of synaptic transmission across the central nervous system.
Benzodiazepines do not have any effect on the levels of GABA in the brain. Clonazepam does, however, affect glutamate decarboxylase activity. It differs from other anticonvulsant drugs it was compared to in a study. Benzodiazepines, including clonazepam, bind to mouse glial cell membranes with high affinity.
This has been conjectured as a mechanism for high-dose effects on seizures in the study. Clonazepam is a chlorinated derivative of nitrazepam  and therefore a chloro-nitro benzodiazepine. Clonazepam is lipid-soluble, rapidly crosses the blood—brain barrier , and penetrates the placenta. It is extensively metabolised into pharmacologically inactive metabolites. Clonazepam is metabolized extensively via nitroreduction by cytochrome P enzymes, including CYP3A4.
Erythromycin , clarithromycin , ritonavir , itraconazole , ketoconazole , nefazodone , cimetidine , and grapefruit juice are inhibitors of CYP3A4 and can affect the metabolism of benzodiazepines. In some individuals, however, peak blood concentrations were reached at 4—8 hours. Clonazepam passes rapidly into the central nervous system, with levels in the brain corresponding with levels of unbound clonazepam in the blood serum.
Plasma levels of clonazepam can vary as much as tenfold between different patients. Clonazepam is largely bound to plasma proteins. It is effective for 6—8 hours in children, and 6—12 in adults. A US government study of emergency department ED visits found that sedative-hypnotics were the most frequently implicated pharmaceutical drug in ED visits, with benzodiazepines accounting for the majority of these.
Clonazepam was the second most frequently implicated benzodiazepine in ED visits. Alcohol alone was responsible for over twice as many ED visits than clonazepam in the same study. The study examined the number of times the non-medical use of certain drugs was implicated in an ED visit. The criteria for non-medical use in this study were purposefully broad, and include, for example, drug abuse , accidental or intentional overdose , or adverse reactions resulting from legitimate use of the medication.
Clonazepam was approved in the United States as a generic drug in and is now manufactured and marketed by several companies. Clonazepam is available as tablets and orally disintegrating tablets wafers an oral solution drops , and as a solution for injection or intravenous infusion. From Wikipedia, the free encyclopedia. Not to be confused with clozapine , clonazolam , or clorazolam.
D Evidence of risk. Class B1 Psychoactive drugs CA: Archived from the original on Retrieved Aug 15, Therapeutic uses of botulinum toxin. A Review of the Literature". The primary care companion for CNS disorders. A Historical Dictionary of Psychiatry. International Drug Price Indicator Guide. Retrieved 15 August Advances in the neurochemistry and neuropharmacology of Tourette Syndrome. In several countries, prescription and use is now severely limited due to abusive recreational use of clonazepam.
A review of a new anticonvulsant drug". Journal of Clinical Psychopharmacology. Opinion of Brazilian experts]". Archived PDF from the original on The Annals of pharmacotherapy. The Cochrane Database of Systematic Reviews. What Can Go Wrong? American Psychiatric Publishing, Inc. Beware the sleeping pill hangover". Jeffrey; Nemeroff, Charles B. Principles of psychopharmacology for mental health professionals. Eur J Clin Pharmacol. The combination of clonazepam 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 induce the metabolism of clonazepam causing higher clearance and lower 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.
The selective serotonin reuptake inhibitors sertraline and fluoxetine do not affect the pharmacokinetics of clonazepam when administered concomitantly. Known inhibitors of hepatic enzymes, e. Preclinical studies in animals have shown reproductive toxicity and from preclinical studies it cannot be excluded that clonazepam possesses the possibility of producing congenital malformations see section 5. 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. Clonazepam should only be administered to pregnant women if the potential benefits outweigh the risk to the foetus. During pregnancy, Clonazepam 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 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. Therefore clonazepam should not be used in pregnancy unless clearly necessary. Although clonazepam 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 clonazepam, 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. This medicine can impair cognitive function and can affect a patient's ability to drive safely. When prescribing this medicine, patients should be told:. Allergic reactions and very few cases of anaphylaxis and angioedema 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 and 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: 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 clonazepam therapy.
In rare cases loss of libido may occur. Clonazepam generally has a beneficial effect on behaviour disturbances in epileptic patients. Somnolence, slowed reaction, muscular hypotonia, dizziness, ataxia, light-headedness, co-ordination disturbances, fatigue and muscle weakness. These undesirable effects occur relatively frequently and are usually transient and generally disappear spontaneously in the course of the treatment or on reductions of the dosage. They can be partially prevented by increasing the dose slowly at the start of treatment.
Particularly in long-term or high-dose treatment, reversible disorders such as a slowing or slurring of speech dysarthria , reduced co-ordination of movements and gait ataxia and nystagmus may occur. Anterograde amnesia may occur using benzodiazepines at therapeutic dosages, the risks 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.
Rarely respiratory depression may occur with intravenous clonazepam, particularly if pre-existing airways obstruction or brain damage or if other depressant drugs have been administered. As a rule, this effect can be avoided by careful adjustment of the dose in individual requirements. In infants and small children, and particularly those with a degree of mental impairment, clonazepam may give rise to salivary or bronchial hypersecretion with drooling.
Supervision of the airway may be required. The following effects have been reported in rare cases: The following effects may occur in rare cases: 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 the treatment.
In rare cases erectile dysfunction, decrease in sexual drive loss of libido and impotence may occur. 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. 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. In rare case decreased platelet count may occur. Isolated cases of blood dyscrasias and abnormal liver function tests have been reported.
Although Clonazepam has been given uneventfully to patients with porphyria, rarely it may induce convulsions in these patients. Reporting suspected adverse reactions after authorisation of the medicinal product is important. As with other benzodiazepine drugs, overdosage should not present undue problems of management or threat to life.
Patients have recovered from overdoses in excess of 60mg without special treatment. Severe somnolence with muscle hypotonia will be present. The symptoms of overdosage or intoxication vary greatly from person to person depending on age, bodyweight and individual response. Benzodiazepines commonly cause drowsiness, ataxia, dysarthria and nystagmus.
Overdose of clonazepam is seldom life-threatening if the drug is taken alone, but may lead to coma, areflexia, apnoea, hypotension and cardiorespiratory depression. Coma, if it occurs, usually lasts only a few hours but in elderly people it may be more protracted and cyclical. Benzodiazepine respiratory depressant effects are more serious in patients with severe chronic obstructive airways disease. Benzodiazepines potentiate the effects of other central nervous system depressants, including alcohol.
Supportive measures as indicated by the patient's clinical state. In particular, patients may require symptomatic treatment for cardiorespiratory effects or central nervous system effects. Further absorption should be prevented using an appropriate method e. If activated charcoal is used airway protection is imperative for drowsy patients. In case of mixed ingestion gastric lavage may be considered, however not as a routine measure.
Flumazenil, a benzodiazepine antagonist is available but should rarely be required. If CNS depression is severe consider the use of flumazenil. This should only be administered under closely monitored conditions. It has a short half-life about an hour , therefore patients administered flumazenil will require monitoring after the effects have worn off.
Flumazenil is to be used with extreme caution in the presence of drugs that reduce seizure threshold e. Refer to the prescribing information for flumazenil, for further information on the correct use of this drug. The benefit of gastric decontamination is uncertain. Consider activated charcoal 50g for an adult, g for a child in adults or children who have taken more than 0. The use of flumazenil is not recommended in epileptic patients who have been receiving benzodiazepine treatment for a prolonged period.
Although flumazenil exerts a slight intrinsic anticonvulsant effect, its abrupt suppression of the protective effect of a benzodiazepine agonist can give rise to convulsions in epileptic patients. Clonazepam exhibits pharmacological properties which are common to benzodiazepines and include anticonvulsive, sedative, muscle relaxing and anxiolytic effects.
Animal data and electroencephalographic investigations in man have shown that clonazepam rapidly suppresses many types of paroxysmal activity including the spike and wave discharge in absence seizures petit mal , slow spike wave, generalised spike wave, spikes with temporal or other locations as well as irregular spikes and waves. Generalised EEG abnormalities are more readily suppressed by clonazepam than are focal EEG abnormalities such as focal spikes.
Clonazepam has beneficial effects in generalised and focal epilepsies. Clonazepam is quickly and completely absorbed after oral administration. Peak plasma concentrations are reached in most cases within 1 - 4 hours after an oral dose. Routine monitoring of plasma concentrations of clonazepam is of unproven value since this does not appear to correlate well with either therapeutic response or side-effects.
Clonazepam must be assumed to cross the placental barrier and has been detected in maternal milk. The biotransformation of clonazepam involves oxidative hydroxylation and reduction of the 7-nitro group by the liver with formation of 7-amino or 7-acetylamino compounds, with trace amounts of 3-hydroxy derivatives of all three compounds, and their glucuronide and sulphate conjugates. The nitro compounds are pharmacologically active, whereas the amino compounds are not.
No 2-year carcinogenicity studies have been conducted with clonazepam. Genotoxicity tests using bacterial systems with in vitro or host mediated metabolic activation did not indicate a genotoxic liability for clonazepam. In the absence of compatibility studies this medicinal product must not be mixed with other medicinal products. Care should be taken during administration due to the oily nature of the product. It is recommended to administer the dose prior to delivering feed through the NG or PEG tube and to follow the instruction below:.
Healthcare professionals should be aware that if the instructions above cannot be followed e. Extra flushing with water or feed may combat this. In these situations the patient should be monitored closely. Any unused product or waste material should be disposed of in accordance with local requirements. Link to this document from your website: This site complies with the HONcode standard for trustworthy health information: Summary of Product Characteristics last updated on medicines.
Table of Contents 1. Go to top of the page 1. Go to top of the page 2. Go to top of the page 3. Go to top of the page 4. Elderly The elderly are particularly sensitive to the effects of centrally depressant drugs and may experience confusion. Paediatric Population Due to the presence of ethanol in the formulation, this product is not indicated for paediatric use. Method of administration A 2. In cases of loss or bereavement, psychological adjustment may be inhibited by benzodiazepines.
Dependence Use of benzodiazepines may lead to the development of physical and psychological dependence upon these products see section 4. This product contains the following excipients: Harmful for those suffering from alcoholism.