Pharmaniaga Midazolam Side Effects

The most common undesirable effects after parenteral administration of midazolam are changes in vital functions, particularly a loss of respiratory volume and/or a fall in respiratory rate or apnoea which are observed frequently. The apnoea is usually a short duration, and respiration resumes rapidly and spontaneously.
However, serious cardiorespiratory undesirable effects, including respiratory depression, apnoea, respiratory and/or cardiac arrest, in many cases fatal, have also been observed after intravenous injection. These life-threatening incidents may occur especially in elderly patients or patients with pre-existing respiratory insufficiency, particularly if excessive or too rapidly-injected doses are administered. At the same time, changes in the blood pressure and heart rate are possible. Changes in cardiovascular parameters are slight but can include a decrease in mean arterial pressure, cardiac output, stroke volume and systemic vascular resistance. Such changes may be important in patients with impaired myocardial oxygen delivery capacity and hypovolaemia.
The following reactions have been reported occasionally (>1%): hiccoughs, nausea, vomiting, dry cough, marked sedation, headache, dizziness, as well as local symptoms such as sensitivity, erythema and induration at the injection site. However, the number of cases or pain following injection and thrombophlebitis was lower.
The following undesirable effects have been reported in less than 1% of cases after intravenous administration: Respiratory system: Laryngospasm, bronchospasm, dyspnoea, hyperventilation, laboured respiration, shallow respiration, obstructed airways and rapid breathing.
Cardiovascular system: Bigeminal pulse, premature ventricular contractions, vasovagal episodes, tachycardia, nodal rhythm.
Gastrointestinal tract: Sour taste in mouth, increased salivation, vomiting.
CNS/neuromuscular: Retrograde amnesia, euphoria, confusion, quarrelsome behaviour, nervousness, anxiety, feeling or drunkenness, restlessness, sudden delirium or excitation, hallucinations, prolonged waking from anaesthesia and dreams, sleep disturbances, insomnia, nightmares. athetotic movements, muscle twitching, ataxia, dizziness. dysphoria, unclear speech, dysphonia, paraesthesia.
Other sensory organs: Blurred vision, double vision, nystagmus, miosis, fluttering of the eyelids, impaired vision, convergence disorders, impaired hearing, loss of balance, disorientation.
Skin: Urticaria, swelling or burning of the skin, warm or cold feeling, spotty skin, pruritus, particularly at the injection site.
Miscellaneous: Yawning, lethargy, tremor, asthenia, toothache, fainting, haematoma.
General hypersensitivity reactions: shock-like states, amongst others - have been reported only rarely. There have been isolated reports of cerebral convulsions, particularly in neonates.
Patients must be warned that use of the product can cause amnesia.
Withdrawal symptoms have been reported on abrupt cessation after continuous administration (more than 3 to 5 days) of midazolam for long-term sedation. The following symptoms may occur: headaches, muscle pain, anxiety, tension, restlessness, confusion, irritability, rebound insomnia, mood changes, hallucinations (some of a sexual nature) and convulsions.
The treatment must therefore be discontinued gradually.