DBL Pentamidine Isethionate

DBL Pentamidine Isethionate Adverse Reactions





Zuellig Pharma
Full Prescribing Info
Adverse Reactions
Fatalities due to severe hypotension, hypoglycemia, acute pancreatitis, renal impairment and cardiac arrhythmias have been reported in patients treated with pentamidine isethionate.
Life threatening reactions: Blood and lymphatic system disorders: Leucopenia (less than 1,000 cells per cubic millimetre), thrombocytopenia (less than 20,000 cells per cubic millimetre).
Immune system disorders: Herxheimer reaction.
Metabolism and nutrition disorders: Severe hypoglycaemia, hypocalcaemia.
Psychiatric disorders: Toxic delirium.
Nervous system disorders: Syncope.
Cardiac disorders: Cardiac arrhythmias and cardiac arrest (including QT interval prolongation and torsade de pointes), ventricular tachycardia.
Vascular disorders: severe hypotension.
Gastrointestinal disorders: acute pancreatitis.
Skin and subcutaneous tissue disorders: Stevens-Johnson syndrome (single possible case).
Renal and urinary disorders: Acute renal failure.
The previously mentioned adverse effects can be severe, sometimes fatal, and require immediate corrective measures and withdrawal of treatment.
Other reactions: Other adverse reactions reported are listed in this section per MedDRA system organ class.
Blood and lymphatic system disorders: Anaemia, thrombocytopenia, leucopenia.
Metabolism and nutrition disorders: Hypocalcaemia, hypoglycaemia, hyperglycaemia, hyperkalaemia, hyponatraemia, diabetes mellitus.
Psychiatric disorders: Hallucinations.
Nervous system disorders: Taste disturbances, dizziness, syncope.
Cardiac disorders: Tachycardia, bradycardia.
Vascular disorders: Hypotension, facial flushing, venous thrombosis.
Respiratory, thoracic and mediastinal disorders: Breathlessness.
Local reactions ranging in severity from cough, breathlessness, wheezing, bronchospasms (with inhaled use), particularly in patients with a history of smoking or asthma, which can usually be controlled by prior use of bronchodilator.
Gastrointestinal disorders: Nausea, vomiting.
Hepatobiliary disorders: Abnormal liver function (hepatic dysfunction).
Skin and subcutaneous tissue disorders: Abscess and/or necrosis, rash, itching, alopecia, erythema multiforme.
Renal and urinary disorders: Azotaemia, albuminuria, glycosuria, increased creatinine levels.
General disorders and administration site conditions: Local reactions at the injection site including abscess, pain, thrombophlebitis.
Investigations: Depressed serum folate.
Reporting suspected adverse effects: Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product.
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