BULA BROMAZEPAM PDF

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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 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: miscarriage , malformation , intrauterine growth retardation , functional deficits, 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 , suckling difficulties, apnea , risk of aspiration of feeds, diarrhea and vomiting, and growth retardation. This syndrome can develop between three days to three 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 breastfeeding , 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.

This further results in an inhibition of synaptic transmission across the central nervous system. Clonazepam does, however, affect glutamate decarboxylase activity. It differs from other anticonvulsant drugs it was compared to in a study. This has been conjectured as a mechanism for high-dose effects on seizures in the study. 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. Plasma levels of clonazepam can vary as much as tenfold between different patients. Clonazepam was the second most frequently implicated benzodiazepine in ED visits. Alcohol alone was responsible for over twice as many ED visits as 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 is available as tablets and orally disintegrating tablets wafers an oral solution drops , and as a solution for injection or intravenous infusion.

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