Remifentanil B. Braun

Remifentanil B. Braun Adverse Reactions

remifentanil

Manufacturer:

B. Braun

Distributor:

DKSH
/
Four Star
Full Prescribing Info
Adverse Reactions
The most common undesirable effects associated with remifentanil are direct extensions of μ-opioid agonist activities. These adverse events resolve within minutes of discontinuing or decreasing the rate of remifentanil administration.
The following frequencies have been used in order to classify the occurrence of undesirable effects: Very common ≥ 1/10; Common ≥ 1/100 to < 1/10; Uncommon ≥ 1/1,000 to < 1/100; Rare ≥ 1/10,000 to < 1/1,000; Very rare < 1/10,000; not known (cannot be estimated from the available data).
Incidence is listed as follows within each body system: Immune system disorders: Rare: hypersensitivity reactions including anaphylaxis have been reported in patients receiving remifentanil in conjunction with one or more anaesthetic agents.
Psychiatric disorders: Not known: drug dependence.
Nervous system disorders: Very common: skeletal muscle rigidity. Rare: sedation (during awakening after general anaesthesia). Not known: convulsions.
Cardiac disorders: Common: bradycardia. Rare: asystole/cardiac arrest with preceding bradycardia in patients treated with remifentanil in combination with other anaesthetics. Not known: atrioventricular block.
Vascular disorders: Very common: hypotension. Common: post-operatively occurring hypertension.
Respiratory, thoracic and mediastinal disorders: Common: acute respiratory depression, apnoea. Uncommon: hypoxia.
Gastrointestinal disorders: Very common: nausea, vomiting. Uncommon: constipation.
Skin and subcutaneous tissue disorders: Common: pruritus.
General disorders and administration site conditions: Common: post-operative shivering. Uncommon: post-operative pain. Not known: drug tolerance.
Discontinuation of treatment: Symptoms following withdrawal of remifentanil including tachycardia, hypertension and agitation have been reported infrequently upon abrupt cessation, particularly after prolonged administration of more than 3 days (see Precautions).
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