Anesticap Adverse Reactions

Commonly observed side effects of Propofol are hypotension, transient apnea and respiratory depression. Occasionally, hypotension requires a lowering of the administration rate of ANESTICAP 1% MCT/LCT and/or fluid replacement therapy, if necessary vasoconstrictive drugs. These effects depend on the Propofol dose administered but also on the type of premedication and other concomitant medication. Specifically, the following side effects have been observed: Immune system disorders: Rare: Clinical features of anaphylaxis, which may include Quincke's oedema, bronchospasm, erythema and hypotension.
Psychiatric disorders: Rare: Euphoria and sexual disinhibition during the recovery period.
Nervous system disorders: Common: During induction of anesthesia spontaneous movements and myocloni, minimal excitation.
Rare: Headache, vertigo, shivering and sensations of cold during the recovery period. Epileptiform movements including convulsions and opisthotonus.
Very rare: Delayed epileptiform attacks, the delay period ranging from a few hours to several days. Risk of convulsions in epileptic patients after administration of Propofol.
Rare: Cases of postoperative unconsciousness (see PRECAUTIONS), post operative fever and discoloration of urine following prolonged administration of Propofol.
Cardiac disorders/vascular disorders: Common: During induction of anesthesia, hypotension, bradycardia, tachycardia, hot flushes.
Uncommon: Marked hypotension. This may require a lowering of the administration rate of ANESTICAP 1% MCT/LCT and/or fluid replacement therapy, if necessary vasoconstrictive medicinal products. Account should be taken of the possibility of a severe drop in blood pressure in patients with impaired coronary or cerebral perfusion or those with hypovolaemia.
Bradycardia during general anesthesia with progressive severity (asystole). The intravenous administration of an anticholinergic medicinal product prior to induction or during maintenance of anesthesia should be considered (see PRECAUTIONS).
Rare: Arrhythmia during the recovery period. Thrombosis and phlebitis.
Changes in cardiovascular parameters may be important in patients with impaired myocardial oxygen delivery capacity, cerebral circulatory disturbances and hypovolaemia. The risk of relative vagal overactivity may be increased because ANESTICAP 1% MCT/LCT lacks vagolytic activity. It has been associated with reports of bradycardia, occasionally profound and also asystole. The intravenous administration of an anticholinergic agent before induction or during maintenance of anesthesia should be considered, especially in situation where vagal tone is likely to predominate or when ANESTICAP 1% MCT/LCT is used in conjunction with other agents likely to cause a bradycardia.
Respiratory, thoracic and mediastinal disorders: Common: During induction of anesthesia hyperventilation, transient apnea, coughing, singultus.
Uncommon: Coughing during maintenance of anesthesia.
Rare: Coughing during the recovery period.
Very rare: Pulmonary oedema.
Gastrointestinal disorders: Rare: Nausea or vomiting during the recovery period. Very rare: Pancreatitis has been reported after administration of Propofol.
Skin and subcutaneous tissue disorders: Very rare: Severe tissue responses after accidental paravenous application.
Renal and urinary disorders: Rare: Cases of discoloration of urine following prolonged administration of Propofol.
General disorders and administration site conditions: Very common: Local pain occurring during the initial injection. Prophylaxis or treatment see as follows.
The local pain which may occur during the initial injection of ANESTICAP 1% MCT/LCT can be minimized by the co-administration of lidocain (see INCOMPATIBILITIES UNDER CAUTIONS FOR USAGE) and by injection or infusion into the larger veins of the forearm and antecubital fossa. Upon co-administration of lidocain the following undesirable effects may occur rarely: Giddiness, vomiting, drowsiness, convulsions, bradycardia, cardiac arrhythmia and shock.
Rare: Cases of post-operative fever.
Very rare: There have been reports of isolated cases of severe undesirable effects presenting as a complex of symptoms including: Rhabdomyolysis, metabolic acidosis, hypercalaemia, and cardiac failure, sometimes with fatal outcome. Most of these effects have been observed in patients in intensive care with doses exceeding 4 mg/kg body weight/hour. For more detail, see PRECAUTIONS.