Mexazolam

Enhancement of the central depressive effect may occur in cases of concomitant use of mexazolam with antipsychotic (neuroleptics), hypnotics, anxiolytics/sedatives, antidepressant agents, narcotic analgesics, anti-epileptic products, anesthetises, and antihistamine sedatives.

In the case of narcotic analgesics enhancement of the euphoria may also occur leading to an increase in psychic dependence.

Benzodiazepines should be used with extreme caution in patients with a history of drug abuse and alcoholism.

The sedative effect may be enhanced when mexazolam is used in combination with alcohol; this affects the ability to drive or use machines.

A lower dosage is recommended for patients with chronic respiratory insufficiency due to the risk of respiratory depression.

Although pre-clinical trials on animals did not suggest any harm of mexazolam during pregnancy, its safety in humans was not established during pregnancy. Benzodiazepines may cause congenital abnormalities when administered in the first trimester of pregnancy. If for compelling reasons mexazolam is administered during the late phase of pregnancy or during labour at high doses, effects on the neonate such as hypothermia, hypotonia and moderate respiratory depression can be expected.

Infants born to mothers who took benzodiazepines chronically during pregnancy may have developed physical dependence and may be at some risk for developing withdrawal symptoms in the postnatal period.

Every woman of childbearing potential should contact the physician if she intends to become or suspects that she is pregnant.

Since mexazolam may be found in the breast milk, it should not be given to breast feeding mothers.

Sedation, amnesia, impaired concentration and impaired muscular function resulting from the administration of mexazolam may adversely affect the ability to drive or use machines.

If insufficient sleep duration occurs the likelihood of impaired alertness may be increased.

The most frequent side effects of benzodiazepines are likely to be an extension of the pharmacological actions and include drowsiness during the day, numbed emotions, reduced alertness, confusion, fatigue, headache, light-headedness, muscle weakness, ataxia or double vision.

1. Rarely (<0,1%) the following adverse events were reported with mexazolam: swollen tongue, hypotension, light-headedness, nausea, vomiting, anorexia, gastric discomfort, gastric pain, abdominal pain, diarrhoea, hypersensitivity reactions (e.g. skin reactions), decreased libido, decrease of alkaline phosphatase, anaemia and leukopenia. Commonly (0.1-5%) were reported drowsiness, vertigo, dizziness, headache, ataxia, dry mouth, weakness, increases of aspartate aminotransferase, alanine aminotransferase and gamma – glutamyl transpeptidase.

Side effects occur predominantly at the start of therapy and usually disappear upon continued administration.

Amnesia: Anterograde amnesia may occur using therapeutic doses of benzodiazepines, the risk increasing when higher doses are used. Amnestic effects may be associated with inappropriate behaviour.

Depression: Pre-existing depression may recur when benzodiazepines are used.

Psychiatric and paradoxical reactions.

Reactions like restlessness, agitation, irritability, aggressiveness, delusions, rage, nightmares, psychoses, inappropriate behaviour and other related adverse behavioural effects are known to occur and become particularly severe with benzodiazepines. They are more likely to occur in children and the elderly.

Dependence: Even at therapeutic doses, mexazolam may lead to the development of physical dependence – discontinuance of the therapy may result in withdrawal or rebound phenomena. Psychic dependence may also occur. Abuse of benzodiazepines has been reported.