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Rivotril 2mg by Roche x 1 Strip

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Product Description

Product Description

Clonazepam

is a benzodiazepine drug having anxiolytic, anticonvulsant, muscle relaxant, and hypnotic properties.It is marketed by Roche under the trade name Klonopin in the United States and Rivotrilin Australia, Brazil, Canada, Mexico and the European Union (and in countries like Serbia, Macedonia, Croatia and Montenegro). Other names such as Ravotril, Rivatril, Clonex, Paxam, or Kriadex are known throughout the rest of the world.[citation needed] Clonazepam has an unusually long elimination half-life of 18–50 hours, making it generally considered to be among the long-acting benzodiazepines.Clonazepam is a chlorinated derivative of nitrazepamand therefore a chloro-nitrobenzodiazepine.

Benzodiazepines such as clonazepam have a fast onset of action and high effectiveness rate and low toxicity in overdose but have drawbacks due to adverse reactions including paradoxical effects, drowsiness, and cognitive impairment. Cognitive impairments can persist for at least six months after withdrawal of clonazepam; it is unclear whether full recovery of memory functions occurs. Other long-term effects of benzodiazepines include tolerance, benzodiazepine dependence, and benzodiazepine withdrawal syndrome, which occurs in a third of people treated with clonazepam for longer than four weeks.

Clonazepam is classified as a high potency benzodiazepine and is sometimes used as a second-line treatment of epilepsy. Clonazepam, like other benzodiazepines, while being a first-line treatment for acute seizures, is not suitable for the long-term treatment of seizures due to the development of tolerance to the anticonvulsant effects. The benzodiazepine clorazepate may be preferred over clonazepam due to a slower onset of tolerance and availability in slow-release formulation to counter fluctuations in blood levels. Clonazepam is also used for the treatment of panic disorder. The pharmacological property of clonazepam as with other benzodiazepines is the enhancement of the neurotransmitter GABA via modulation of the GABAA receptor.

Medical uses

Clonazepam may be prescribed for the following:

  • Epilepsy
  • Anxiety disorders
  • Panic disorder
  • Initial treatment of mania or acute psychosis together with firstline drugs such as lithium, haloperidol or risperidone
  • For the management of the visual effects of
  • Hyperekplexia
  • Many forms of parasomnia are sometimes treated with clonazepam.Restless legs syndrome can be treated using clonazepam as a third line treatment option as the use of clonazepam is still investigational.Bruxism also responds to clonazepam in the short-termRapid eye movement behavior disorder responds well to low doses of clonazepam.
  • The treatment of acute and chronic akathisia induced by neuroleptics also calledantipsychotics.
  • Spasticity related to amyotrophic lateral sclerosis

The effectiveness of clonazepam in the short-term treatment of panic disorder has been demonstrated in controlled clinical trials. Some long-term trials have suggested a benefit of clonazepam for up to three years without the development of tolerance but these trials were not placebo controlled. Clonazepam is also effective in the management of acute mania.

Clonazepam is sometimes used for certain rare childhood epilepsies and for refractory epilepsies; however, long-term prophylactic treatment of epilepsy has considerable limitations, the most notable ones being the loss of antiepileptic effects due to tolerance, which renders the drug ineffective with long term use which is why clonazepam and benzodiazepines as a class are, in general, to be prescribed only for the acute management of epilepsies. However, a subgroup of people with treatment resistant epilepsy may benefit from long-term use of clonazepam; the benzodiazepine clorazepate may be preferred however, due to its slower onset of tolerance.

Clonazepam or diazepam has been found to be effective in the acute control of nonconvulsive status epilepticus. However, the benefits tended to be transient in many of the patients, and the addition of phenytoin for lasting control was required in these patients.

In general, clonazepam has been found to be ineffective in the control of infantile spasms.Clonazepam is less effective and potent as an anticonvulsant in bringing infantile seizures under control compared with nitrazepam in the treatment of West syndrome, which is an age-dependent epilepsy affecting the very young. However, as with other epilepsies treated with benzodiazepines, long-term therapy becomes ineffective with prolonged therapy, and the side effects of hypotonia and drowsiness are troublesome with clonazepam therapy; other antiepileptic agents are, therefore, recommended for long-term therapy, possibly Corticotropin (ACTH) or vigabatrin. Furthermore, clonazepam is not recommended for widespread use in the management of seizures related to West syndrome.

Clonazepam has shown itself to be highly effective as a short-term (3 weeks) adjunct to SSRItreatment in obsessive-compulsive disorder and clinical depression in reducing SSRI side effects with the combination being superior to SSRI treatment alone in a study funded by the manufacturers of clonazepam, Hoffman LaRoche Inc.

Side effects

Very common

  • Drowsiness
  • Interference with cognitive and motor performance
  • Euphoria

Less common

  • Irritability and aggression
  • Psychomotor agitation
  • Lack of motivation
  • Loss of libido
  • Impaired motor function
    • Impaired coordination
    • Impaired balance
    • Dizziness
  • Cognitive impairments
    • Hallucinations
    • Short-term memory loss
    • Anterograde amnesia (common with higher doses)
  • Some users report hangover-like symptoms of being drowsy, having a headache, being sluggish, and being irritable after waking up if the medication is taken before sleep. This is likely the result of the medication's long half-life, which continues to affect the user after waking up.
  • The "hangover effect" some experience not only results from clonazepam's considerably long half-life. Like many other benzodiazepines, when taken as a sleep-aid, clonazepam disrupts or interferes with the brain's delta waves. Delta waves signify the brain's slowest waves (~4 Hz) and occur during Stage 4 sleep, which represents humans' deepest sleep state (our muscles are the most relaxed; breathing slows and becomes shallow), and the stage right before R.E.M. sleep and dreaming (Stage 5). Therefore, upon waking, this disruption of Stage 4 delta wave sleep causes a failure for an adequate brain/body rest or "recharge".

While benzodiazepines induce sleep, they tend to produce a poorer quality sleep than natural sleep. Benzodiazepines such as clonazepam suppress REM sleep.After regular use rebound insomnia can occur when discontinuing clonazepam.

  • Benzodiazepines may cause or worsen depression.

Tolerance

Tolerance to the anticonvulsant effects of clonazepam occurs in both animals and humans. In humans, tolerance to the anticonvulsant effects of clonazepam occurs frequently.Chronic use of benzodiazepines leads to the development of tolerance with a decrease of benzodiazepine binding sites. The degree of tolerance is more pronounced with clonazepam than with chlordiazepoxide.In general, short-term therapy is more effective than long-term therapy with clonazepam for the treatment of epilepsy.Many studies have found that tolerance develops to the anticonvulsant properties of clonazepam with chronic use, which limits its long term effectiveness as an anticonvulsant.

Withdrawal

Abrupt or over-rapid withdrawal from clonazepam may result in the development of the benzodiazepine withdrawal syndrome, causing psychosis characterised by dysphoricmanifestations, irritability, aggressiveness, anxiety, and hallucinations.Sudden withdrawal may also induce the potentially life threatening condition status epilepticus. Antiepileptic drugs, benzodiazepines such as clonazepam in particular, should be reduced slowly and gradually when discontinuing the drug to reduce withdrawal effects.Carbamazepine has been trialed in the treatment of clonazepam withdrawal and has been found to be ineffective in preventing clonazepam withdrawal status epilepticus from occurring.

Special precautions

The elderly metabolise 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 given for no longer than 2 weeks. Long-acting benzodiazepines such as clonazepam are not generally recommended for the elderly due the risk of drug accumulation.

Caution in the elderly: increased risk of impairments, falls and drug accumulation. Benzodiazepines also require special precaution if used in pregnant, alcohol- or drug-dependent individuals and individuals with comorbid psychiatric disorders.Clonazepam is generally not recommended for use in elderly people for insomnia due to its high potency relative to other benzodiazepines.

Caution in children: Clonazepam is not recommended for use in those under 18. Use in very young children may be especially hazardous. Of anticonvulsant drugs behavioural disturbances occur most frequently with clonazepam and phenobarbital.

Caution using high dosages of clonazepam. Doses higher than 0.5 – 1 mg per day are associated with significant sedation.

Clonazepam may aggravate hepatic porphyria.

Caution in chronic schizophrenia. A 1982 double blinded placebo controlled study found clonazepam increases violent behavior in individuals with chronic schizophrenia.

Interactions

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.Clonazepam may affect levels of phenytoin (diphenylhydantoin) by decreasing,or increasing.In turn Phenytoin may lower clonazepam plasma levels, by increasing the speed of clonazepam clearance by approximately 50% and decreasing its half-life by 31%.Clonazepam increases the levels of primidone,and phenobarbital.

Combined use of clonazepam with certain antidepressantsantiepileptics such as phenobarbital, phenytoin and carbamazepine, sedative antihistaminesopiatesantipsychotics and alcohol may result in enhanced sedative effects.

Warnings

Clonazepam, like other benzodiazepines, will impair one's ability to drive or operate machinery. The central nervous system depressing effects of the drug can be intensified by alcohol consumption. Benzodiazepines have been shown to cause both psychological and physical dependence. Patients physically dependent on clonazepam should be slowly titrated off under the supervision of a qualified healthcare professional to reduce the intensity of withdrawal or rebound symptoms.

Pregnancy

There is some medical evidence of various malformations, e.g., cardiac or facial deformations, when used in early pregnancy, however the data is not conclusive. 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 theneonate. 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 for 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 be used if the clinical benefits are believed to outweigh the clinical risks to the fetus. Caution is also required if clonazepam is used during breast feeding. Possible adverse effects of use of benzodiazepines such as clonazepam during pregnancy include; abortion, malformationintrauterine growth retardation, functional deficits,floppy infant syndrome, carcinogenesis and mutagenesis. Neonatal withdrawal syndrome associated with benzodiazepines include hypertonia, hyperreflexia, restlessness, irritability, abnormal sleep patterns, inconsolable crying, tremors or jerking of the extremities, bradycardia, cyanosis, sucklingdifficulties, apnea, risk of aspiration of feeds, diarrhea and vomiting, and growth retardation. This syndrome can develop between 3 days and 3 weeks after birth and can have a duration of up to several months. The pathway by which clonazepam is metabolised is usually impaired in new borns. If clonazepam is used during pregnancy or breast feeding it is recommended that serum levels of clonazepam are monitored and signs of central nervous system depression and apnea are also monitored for. In many cases non-pharmacological treatments such as relaxation therapy, psychotherapy and avoidance of caffeine can be an effective and safer alternative to use of benzodiazepines for anxiety in pregnant women.

Overdose

An individual who has consumed too much clonazepam may display one or more of the following symptoms:

  • Somnolence (difficulty staying awake)
  • Mental confusion
  • Nausea
  • Impaired motor functions
    • Impaired reflexes
    • Impaired coordination
    • Impaired balance
    • Dizziness
  • Respiratory depression
  • Hypotension
  • Coma

Coma can be cyclic, with the individual alternating from a comatose state to a hyperalert state of consciousness, as occurred in a 4-year-old boy who suffered an overdose of clonazepam.The combination of clonazepam and certain barbiturates e.g. amobarbital at prescribed doses has resulted in a synergistic potentiation of the effects of each drug leading to serious respiratory depression.

Overdose symptoms may include extreme drowsiness, confusion, muscle weakness, and fainting

Recreational use

A 2006 US government study of nationwide emergency department (ED) visits conducted bySAMHSA found that sedative-hypnotics in the USA were the most frequently implicated pharmaceutical drug in ED visits. Benzodiazepines accounted for the majority of these. Clonazepam was the second most frequently implicated benzodiazepine in ED visits in the study. The study examined the number of times non-medical use of certain drugs were implicated in ED visits; 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

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