Dormicum Special Precautions

Tablet: Tolerance: Some loss of efficacy to the hypnotic effects of short-acting benzodiazepines may develop after repeated use for a few weeks.
Dependence: Use of benzodiazepines and benzodiazepine-like agents may lead to the development of physical and psychological dependence upon these products. The risk of dependence increases with dose and duration of treatment; it is also greater in patients with a history of alcohol or drug abuse.
Once physical dependence has developed, abrupt termination of treatment will be accompanied by withdrawal symptoms. These may consist of headaches, muscle pain, extreme anxiety, tension, restlessness, confusion and irritability. In severe cases, the following symptoms may occur: Derealization, depersonalization, hyperacusis, numbness and tingling of the extremities, hypersensitivity to light, noise and physical contact, hallucinations or epileptic seizures.
Rebound Insomnia: A transient syndrome whereby the symptoms that led to treatment with a benzodiazepine or benzodiazepine-like agent recur in an enhanced form, may occur on withdrawal of hypnotic treatment. It may be accompanied by other reactions including mood changes, anxiety and restlessness.
Since the risk of withdrawal phenomena/rebound phenomena is greater after abrupt discontinuation of treatment, it is recommended that the dosage is decreased gradually.
Duration of Treatment: The duration of treatment with benzodiazepine hypnotics should be as short as possible (see Dosage & Administration), but it should not exceed 2 weeks. The tapering off process should be tailored to the individual. Extension beyond this period should not take place without re-evaluation of the situation.
It may be useful to inform the patient when treatment is started that it will be of limited duration and to explain precisely how the dosage will be progressively decreased. Moreover, it is important that the patient should be aware of the possibility of rebound phenomena, thereby minimising anxiety over such symptoms should they occur while the medicinal product is being discontinued.
There are indications that, in the case of benzodiazepines with a short duration of action, withdrawal phenomena can be manifested within the dosage interval, especially when the dosage is high.
Amnesia: Benzodiazepines may induce anterograde amnesia. The condition occurs most frequently within the first few hours after ingesting the product and therefore to reduce the risk, patients should ensure that they are able to have an uninterrupted sleep of 7-8 hrs (see Side Effects).
Psychiatric and Paradoxical Reactions: Reactions ie, restlessness, agitation, irritability, aggressiveness, and more rarely, delusion, rages, nightmares, hallucinations, psychoses, inappropriate behaviour and other adverse behavioural effects are known to occur when using benzodiazepines. Should this occur, use of midazolam should be discontinued.
They are more likely to occur in the elderly.
Benzodiazepines are not recommended for the primary treatment of psychotic illness. These should not be used alone to treat depression or anxiety associated with depression as suicide may occur in such patients.
Benzodiazepines should be used with extreme caution in patients with a history of alcohol or drug abuse.
Hypersensitivity reactions may occur in susceptible individuals.
Ampoule: Special caution should be exercised when administering Dormicum parenterally to patients representing a higher risk group: Adults >60 years, debilitated or chronically ill, patients with obstructive pulmonary disease, with chronic renal failure, impaired hepatic function or with congestive heart failure. These higher-risk patients require lower dosages (see Dosage & Administration) and should be continuously monitored for early signs of alterations of vital functions. As with any substance with CNS depressant and/or muscle-relaxant properties, particular care should be taken when administering Dormicum to a patient with myasthenia gravis, owing to preexisting muscle weakness.
In rare cases, paradoxical reactions eg, agitation,hyperactivity and aggressivity have occurred; involuntary movements (including tonic/clonic convulsions and muscle tremor) have also been observed. Should such symptoms suggestive of a paradoxical reaction occur, the response to Dormicum should be evaluated before proceeding.
Convulsions have been reported in premature infants and neonates.
Dormicum should be used only when resuscitation facilities are available, as IV administration of Dormicum may depress myocardial contractility and cause apnea.
After receiving Dormicum parenterally, patients should not be discharged from hospital or consulting room for at least 3 hrs and then only if accompanied by an attendant.
After prolonged IV administration of Dormicum, abrupt discontinuation of the product may be accompanied by withdrawal symptoms. Therefore, a gradual reduction of Dormicum is recommended.
Effects on the Ability to Drive or Operate Machinery: Tablet: Sedation, amnesia and impaired concentration and muscular function may adversely affect the ability to drive or to use machines. If insufficient sleep duration occurs, the likelihood of impaired alertness may be increased (see Interactions).
Ampoule: Prior to receiving Dormicum, the patient should be warned not to drive a vehicle or operate a machine for at least 12 hrs.
Use in pregnancy: Tablet: If exceptionally it is considered by a physician that administration of the medicinal product during the last 3 months of pregnancy or during labour is essential, effects on the neonate eg, hypothermia, hypotonia, moderate respiratory depression can be expected due to the pharmacological action of Dormicum.
Insufficient data are available on midazolam to assess its safety during pregnancy and lactation. A woman of childbearing potential must be warned to contact a physician regarding discontinuance of the Dormicum if the patient intends to become or suspects that she is pregnant.
Moreover, infants born to mothers who took benzodiazepines chronically during the latter stages of pregnancy may have developed physical dependence and may be at some risk of developing withdrawal symptoms in the postnatal period.
Ampoule: Dormicum should not be given during pregnancy. Special care must be taken when benzodiazepines are used during labour and delivery, as high single doses may produce respiratory depression, hypotonia, hypothermia and poor sucking in the neonate.
Use in lactation: Since benzodiazepines are found in the breast milk, midazolam should not be administered to breastfeeding mothers.
Use in the elderly: Tablet: See Dosage & Administration.