Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Aventis Pharma Limited, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK Trading as: Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK
The drug should not be administered to patients with a known hypersensitivity to pentamidine.
Pentamidine isetionate should be used with particular caution in patients with hepatic and/or renal dysfunction, hypertension or hypotension, hyperglycaemia or hypoglycaemia, leucopenia, thrombocytopenia or anaemia.
Fatalities due to severe hypotension, hypoglycaemia, acute pancreatitis and cardiac arrhythmias have been reported in patients treated with pentamidine isetionate, by both the intramusclar and intravenous routes. Baseline blood pressure should be established and patients should receive the drug lying down. Blood pressure should be closely monitored during administration and at regular intervals until treatment is concluded.
Therefore patients receiving pentamidine by inhalation should be closely monitored for the development of severe adverse reactions.
Bronchospasm has been reported to occur following the use of nebuliser (see section 4.8). This has been particularly noted in patients who have a history of smoking or asthma. This can be controlled by prior use of bronchodilators.
Pentamidine isetionate may prolong the QT interval. Cardiac arrhythmias indicative of QT prolongation, such as Torsades de Pointes, have been reported in isolated cases with administration of pentamidine isetionate. Therefore, pentamidine isetionate should be used with care in patients with conditions known to increase the proarrhythmic risk, including patients with long QT syndrome, cardiac disease (e.g. coronary heart disease, heart failure) a history of ventricular arrhythmias, uncorrected hypokalaemia and/or hypomagnesaemia, bradycardia (<50 bpm), or during concomitant administration of pentamidine isetionate with QT prolonging agents (see section 4.5).
Particular caution is necessary if the QTc exceeds 500 msec whilst receiving pentamidine isetionate therapy, continuous cardiac monitoring should be considered in this case.
Should the QTc interval exceed 550 msec then an alternative regimen should be considered
Laboratory monitoring: The following tests should be carried out before, during and after therapy by the parenteral route:
The benefit of aerosolised pentamidine therapy in patients at high risk of a pneumothorax should be weighed against the clinical consequences of such a manifestation.
Caution is advised when pentamidine isetionate is concomitantly used with:
There is no evidence of the safety of pentamidine isetionate in human pregnancy. A miscarriage within the first trimester of pregnancy has been reported following aerosolised prophylactic administration. Pentamidine isetionate should not be administered to pregnant patients unless considered essential.
The use of pentamidine isetionate is contra-indicated in breast feeding mothers unless considered essential by the physician.
There are no data on the effects of pentamidine on fertility in animals or humans.
Pentamidine has no known effect on the ability to drive and use machines. Considering the risk of dizziness, one should be careful.
Adverse reactions frequency is defined using the following convention: 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).
Common: leucopenia, thrombocytopenia, anaemia.
Frequency not known: Hypersensitivity reactions, including anaphylactic reactions and anaphylactic shock, angioedema.
Very common: azotemia
Common: hypoglycaemia, hyperglycaemia, hyperkalaemia, hypocalcaemia, hypomagnesemia.
Common: syncope, dizziness.
Frequency not known: Extremity paraesthesia as well as facial and perioral hypoesthesia have been reported with IV administration of pentamidine, both in children and adults. The cases occurred during or shortly after the IV infusion and resolved after completion or interruption of the infusion.
__Rare: QT interval prolongation, cardiac arrhythmia.
Frequency not known: Torsades de Pointes, bradycardia.
Common: hypotension, flushing.
Common: nausea and vomiting, taste disturbance.
Rare: pancreatitis.
Common: abnormal liver function tests.
Common: rash.
Frequency not known: Stevens-Johnson syndrome.
Very common: acute renal failure, macroscopic haematuria.
Very common: local reactions ranging in severity from discomfort and pain to induration, abscess formation and muscle necrosis.
Frequency not known: rhabdomyolysis has been reported following intramuscular administration.
Frequency not known: Hypersensitivity reactions, including anaphylactic reactions and anaphylactic shock, angioedema.
Frequency not known: hypoglycaemia.
Frequency not known: light-headedness.
Frequency not known: bradycardia.
Frequency not known: hypotension.
Common: local reactions ranging in severity from cough, shortness of breath, wheezing, bronchospasms, particularly in patients with a history of smoking or asthma, which can usually be controlled by prior use of bronchodilators.
Rare: eosinophilic pneumonia.
Frequency not known: pneumothorax in patients presenting a history of Pneumocystis carinii pneumonia.
Common: taste disturbance, nausea.
Frequency not known: acute pancreatitis.
Frequency not known: rash.
Frequency not known: renal insufficiency.
Frequency not known: fever, decrease in appetite, fatigue.
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Pentamidine isetionate solution should not be mixed with any injection solutions other than Water for Injections BP, Glucose Intravenous Infusion BP and 0.9% (normal) Sodium Chloride Injection BP.
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