Dormizol Adverse Reactions





Phil Pharmawealth
Full Prescribing Info
Adverse Reactions
There have been reports of life-threatening adverse respiratory and cardiovascular events occurring after administration of Midazolam. Deaths have been reported due to respiratory depression, hypotension, or cardiac arrest in patients given intravenous Midazolam for conscious sedation. Pain, tenderness, and thrombophlebitis have occurred following injection of Midazolam. Hiccups have also been reported.
Effects on children: The bolus I.V. administration of Midazolam should be avoided in neonates due to the occurrences of hypotension. For patients already receiving other receiving other drugs which provide sedation in the early postoperative period, the use of Midazolam should be limited to a continuous infusion. The initial dosage of Midazolam used for continuous intravenous sedation may need to be reduced in critically ill children under 3 years of age.
Effects on the elderly: There is an increase in sensitivity of the CNS to Midazolam in elderly patients, who frequently have inefficient function of one or more organ systems, and dosage requirements have been shown to be reduced with age. Patients with chronic renal failure and congestive heart failure eliminate Midazolam more slowly.
Effects on intensive care patients: Intensive care patients receiving Midazolam by I.V. infusion for prolonged sedation, the elimination half-life was found to increase by up to six times. Abrupt discontinuation of the product may be accompanied by withdrawal symptoms. Therefore, a gradual reduction of Midazolam is recommended.
Effects on mental function: Performance of tasks involving visual-spatial ability and sustained attention was poor in patients taking high doses of benzodiazepines for long periods of time but there was no evidence of impairment in global measures of intellectual functioning such as memory, flexibility, and simple reaction time. In women sedated with intravenous Midazolam, sexual fantasies have been reported.
Effects on the nervous system: Prolonged use of Midazolam with fentanyl has been associated with encephalopathy in infants sedated. Myoclinic twitching of all four limbs was also noted in neonates who received a continuous I.V. infusion of Midazolam at a rate of 30 to 60 mcg per kg body weight per hour. Myoclonus ceased a few hours after discontinuing the infusion and never reoccurred during the myoclonus.
Effects on pregnancy: Midazolam crosses the placenta. Therefore the risk benefit must be carefully considered when using Midazolam.
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