Midasan Special Precautions

When used for sedation should always be titrated slowly in adult or pediatric patients.
Injectable Midazolam should not be administered to adult or pediatric patients in shock or coma, or in acute alcohol intoxication with depression of vital signs.
When Midazolam is given along with central nervous system depressants, such as potent analgesics, the sedative effect may be intensified and the possibility of severe respiratory or cardiovascular depression should be considered.
Patients should be instructed to avoid alcohol before and for at least 8 hours after administration of Midazolam since the individual response cannot be foreseen.
After prolonged i.v. administration of Midazolam, abrupt discontinuation may be accompanied by withdrawal symptoms, therefore a gradual reduction of Midazolam is recommended.
Midazolam should be given with caution for patients with pulmonary insufficiency, impairment of renal or hepatic function, to elderly or debilitated patients and patients with myasthenia gravis.
During bolus sedation for operative procedures extreme cautions should be exercised in patients with acute pulmonary insufficiency or respiratory depression.
Disinhibiting effects have been noted, even after a single dose. This possibility should be borne in mind if treating patients with a history of personality disorders.
Use in Pregnancy & Lactation: See USE IN PREGNANCY & LACTATION section for further information.
Use in Children: Usage in preterm infants and neonatal: Rapid injection should be avoided in the neonatal population. Midazolam administered rapidly as an intravenous injection (less than 2 minutes) has been associated with severe hypotension in neonates, particularly when the patients has also received Fentanyl.
Use in the Elderly: Caution should be exercised when administering Midazolam parenterally to elderly patients or patients with impaired cardiac and respiratory function. After receiving Midazolam parenterally, patients should not be discharged from hospital or consulting room for at least 3 hours and then only if accompanied by an attendant. They should be warned not to drive a vehicle or operate a machine for at least 12 hours.