Zylam Special Precautions

Midazolam should be administered only in a setting with monitoring and cardiopulmonary resuscitation equipment available, suitable for the corresponding age and size, as IV administration of midazolam may depress the myocardial contractility and cause apnea. Severe cardiorespiratory adverse events have been reported. These have included respiratory depression, apnoea, respiratory arrest and/or cardiac arrest. Such life-threatening incidents are more likely to occur when the injection is given too rapidly or when a high dosage is administered.
Paediatric patients less than 6 months of age are particularly vulnerable to airway obstruction and hypoventilation, therefore titration with small increments to clinical effect and careful respiratory rate and oxygen saturation monitoring are essential.
When midazolam is used for premedication, adequate observation of the patient after administration is mandatory as interindividual sensitivity varies and symptoms of overdose may occur.
Special caution should be exercised when administering midazolam to high- risk patients: adults over 60 years of age, chronically ill or debilitated patients, patients with chronic respiratory insufficiency, patients with chronic renal failure, impaired hepatic function or impaired cardiac function, paediatric patients especially those with cardiovascular instability.
These high-risk patients require lower dosages and should be continuously monitored for early signs of alterations of vital functions.
Benzodiazepines should be used with caution patients with a history of alcohol or drug abuse.
As with any substance with CNS depressant and/or muscle-relaxant properties, particular care should be taken when administering midazolam to a patient with myasthenia gravis.
Tolerance: Some loss of efficacy has been reported when midazolam was used as long- term sedation in intensive care units (ICU).
Dependence: When midazolam is used in long-term sedation in ICU, it should be borne in mind that physical dependence on midazolam may develop. The risk of dependence increases with dose and duration of treatment; it is also greater in patients with a medical history of alcohol and/or drug abuse.
Withdrawal symptoms: During prolonged treatment with midazolam in ICU, physical dependence may develop. Therefore, abrupt termination of the treatment will be accompanied by withdrawal symptoms. The following symptoms may occur: headache, muscle pain, anxiety, tension, restlessness, confusion, irritability, rebound insomnia, mood changes, hallucinations and seizures. Since the risk of withdrawal symptoms is greater after abrupt discontinuation of treatment, it is recommended to decrease doses gradually.
Amnesia: Anterograde amnesia may occur at therapeutic doses (frequently this effect is very desirable in situations such as before and during surgical and diagnostic procedures), the duration of which is directly related to the administered dose. Prolonged amnesia can present problems in outpatients, who are scheduled for discharge following intervention. After receiving midazolam parenterally, patients should be discharged from hospital or consulting room only if accompanied by an attendant.
Paradoxical reactions: Paradoxical reactions such as agitation, involuntary movements (including tonic/clonic convulsions and muscle tremor), hyperactivity, hostility, rage reaction, aggressiveness, paroxysmal excitement and assault, have been reported to occur with midazolam. These reactions may occur with high doses and/or when the injection is given rapidly. The highest incidence to such reactions has been reported among children and the elderly. In the event of these reactions, discontinuation of the drug should be considered.
Altered elimination of midazolam: Midazolam elimination may be altered in patients receiving compounds that inhibit or induce CYP3A4 and the dose of midazolam may need to be adjusted accordingly. Midazolam elimination may also be delayed in patients with liver dysfunction, low cardiac output and in neonates.
Premature infants and neonates: Due to an increased risk of apnoea, extreme caution is advised when sedating neonates and premature infants. Careful monitoring of respiratory rate and oxygen saturation is required. Rapid injection should be avoided in the neonatal population.
Adverse haemodynamic events have been reported in paediatric patients with cardiovascular instability; rapid intravenous administration should be avoided in this population.