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Frisium

Generic Name: Clobazam
Product Name: Frisium

Indication of Frisium:

AnxietySleep disturbance associated with anxietyEpilepsy

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Action of Frisium:

Benzodiazepines potentiate the inhibitory effects of gamma aminobutyric acid (GABA throughout the CNS, resulting in anxiolytic, sedative hypnotic, muscle relaxant and antiepileptic effects

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Dose advice of Frisium:

Using benzodiazepines:There is no convincing evidence for the use of benzodiazepines to treat depressionBenzodiazepines are sometimes abused for their euphoric and sedative effects, both alone and with other drugs; reserve for short term use only (e.g. 2-4 weeks). They should be part of a broader treatment plan, not a sole treatmentLong term use of benzodiazepines may result in tolerance and dependence: signs of dependence include drug-seeking behaviour, craving and disturbed work and personal functionSuddenly stopping treatment in dependent people may produce withdrawal symptoms, including anxiety, dysphoria, irritability, insomnia, nightmares, sweating, memory impairment, hallucinations, hypertension, tachycardia, psychosis, tremors and seizuresWithdrawal symptoms may not occur until several days after stopping, and can last for several weeks after prolonged use; prevent or alleviate by gradual dose reductionPatients should be advised that they may feel drowsy while taking benzodiazepines- they should avoid driving or operating heavy equipment until they know how they react.Patients should be advised to avoid alcohol and other medications that cause sedation, whilst taking benzodiazepines until they know how they react.Patients should be advised that tolerance and dependence may occur after more than 2-4 weeks regular use of benzodiazepines, and that withdrawal effects may then occur when the medication is stoppedContraindications:Respiratory depressionSevere hepatic impairment, particularly when hepatic encephalopathy is presentMyasthenia gravisSpecific considerations:Respiratory disease, sleep apnoea- compromised respiratory drive may result in hypoventilation and hypoxaemiaMuscle weakness- risk of exacerbationRenal impairment: Increased sensitivity to CNS effects; use a lower initial dose in severe impairmentHepatic impairment:Can precipitate coma; low doses of a short acting preparation are preferableElderly:Use low doses of a short or medium acting preparation; increased risk of over-sedation, ataxia, confusion, falls, respiratory depression and short term memory impairmentChildren:Avoid except in short term specific conditions, (eg night terrors, sleep walking). Greater sensitivity to CNS effects.Pregnancy:Avoid if possible, particularly large doses and regular use (risk of growth retardation and neonatal withdrawal syndrome) Administration of high doses before or during labour may cause floppy infant syndrome (hypotonia, lethargy, poor suckling). If used during pregnancy, short acting drugs are preferable to long acting; plan to stop gradually before deliveryADEC category CLactation:Avoid repeated doses; may cause lethargy and weight loss in the infantDrug interactions:CNS depressants (alcohol, anaesthetics, barbiturates, opioid analgesics, abtidepressants, antihistamines, antipsychotics)- additive CNS depression, enhanced sedative effect and respiratory depression; monitor and reduce benzodiazepine dose if necessaryAzole antifungals (itraconazole, ketoconazole); macrolides (erythromycin, clarithromycin); indinavir, ritonavir, fluoxetine, fluvoxamine, nefazodone, diltiazem, verapamil- inhibit metabolism of some benzodiazepines by CYP3A4. Enhanced sedative effect and respiratory depression may result. Monitor and reduce benzodiazepine dose if necessary. Benzodiazepines involved include alprazolam, midazolam and triazolam.Ripamicin- increased benzodiazepine metabolism; decreased effect of benzodiazepine; increase benzodiazepine dose if neededComparative information:Very short acting (half life < 6 hours)- midazolam, triazolamShort acting (half life 6-12 hours)- alprazolam, oxazepam, temazepamLong acting (half life12-24 hours)- clobazam, clonazepam, diazepam, flunitrazepam, nitrazepamRapid onset(onset of action within 1 hour of oral administration)- alprazolam, diazepam, flunitrazepam, oxazepam, temazepam, triazolamShorter acting agents, particularly those with rapid onset of action are more likely to lead to acute withdrawal symptoms. Diazepam’s rapid onset of action and long half life mean it is associated with less withdrawal.When using benzodiazepines as prophylaxis against withdrawal from alcohol barbiturates or other benzodiazepines, long acting agents such as diazepam or clonazepam are preferred.

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Schedule of Frisium:

S4

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Common side effects of Frisium:

DrowsinessOver-sedationLight-headednessMemory lossAtaxiaSlurred speech

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Uncommon side effects of Frisium:

HeadacheVertigoHypotensionDisorientationConfusionParadoxical excitationEuphoriaAggression and hostilityAnxietyDecreased libido Anterograde amnesiaPain and thrombophlebitis with IV injectionRespiratory arrest with IV use

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Article Dates:

calendar icon Created: 22/7/2003

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