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Pentamidine isetionate parenteral


Injectable formulations of pentamidine

Drugs List

  • PENTACARINAT 300mg powder for solution for injection
  • pentamidine 300mg powder for solution for injection
  • Therapeutic Indications


    Pneumocystis jiroveci pneumonia
    Prophylaxis of pneumocystis jiroveci pneumonia in HIV patients

    Prophylaxis of Pneumocystis jiroveci pneumonia (PCP) in patients infected with human immunodeficiency virus (HIV) who have had a previous episode of PCP. Administration is by inhalation route.



    Treatment of Pneumocystis jiroveci pneumonia
    By slow intravenous infusion: 4 mg/kg bodyweight once daily for a minimum of 14 days.
    By inhalation: 600 mg reconstituted for a nebuliser, once daily for 3 weeks.

    Treatment of visceral leishmaniasis
    3 - 4 mg/kg bodyweight on alternate days to a maximum of 10 injections, preferably by intramuscular injection.
    A repeat course may be required.

    Treatment of cutaneous leishmaniasis
    3 - 4 mg/kg bodyweight, once or twice weekly by intramuscular injection until the condition resolves.

    Treatment of trypanosomiasis
    4 mg/kg bodyweight once daily or on alternate days to a total of 7 - 10 injections. The intramuscular or intravenous infusion route may be used.

    Prophylaxis of Pneumocystis jiroveci pneumonia in HIV patients
    Inhalation route only: 300mg every 4 weeks or 150mg every 2 weeks.


    (See Dosage; Adult)


    (See Dosage; Adult)

    Patients with Renal Impairment

    Creatinine clearance of less than 10ml/minute

    Treatment of Pneumocystis jiroveci pneumonia

    Life threatening cases
    4 mg/kg bodyweight once daily for 7 - 10 days, then 4 mg/kg bodyweight on alternate days.
    A course of at least 14 doses must be completed.

    Less severe cases
    4 mg/kg bodyweight on alternate days.
    A course of at least 14 doses must be completed.

    Treatment of leishmaniasis or trypanosomiasis

    No dosage adjustment necessary.


    For intravenous infusion, deep intramuscular injection or inhalation.


    Neonates under 1 month

    Precautions and Warnings

    Predisposition to pneumothorax
    Tobacco smoking
    Bradycardia with pulse rate at rest < 50 beats per minute
    Hepatic impairment
    History of ventricular arrhythmias
    Ischaemic heart disease
    Renal impairment

    Advise patient dizziness may affect ability to drive or operate machinery
    Keep patient supine when receiving injection
    Staff: Not to be handled by pregnant staff
    Monitor blood pressure before starting treatment
    Monitor serum electrolytes before and during treatment
    Perform liver function tests before commencing therapy and during therapy
    If QTc >550msec during therapy, consider alternative regimen
    If QTc>500msec during therapy, continuous cardiac monitoring is required
    Monitor blood and platelet counts daily during therapy
    Monitor blood pressure
    Monitor blood urea nitrogen and serum creatinine daily
    Monitor cardiac function by ECG
    Monitor fasting blood glucose daily, and regularly after therapy completion
    Monitor serum calcium weekly
    Monitor serum magnesium twice weekly
    Perform urine analysis daily during treatment

    Take baseline measurements of liver function tests (LFTs), including bilirubin, alkaline phosphatase, aspartate aminotransferase (AST) and alkaline aminotransferase (ALT). Test weekly if baseline measurements are normal.
    If there is baseline elevation of LFTs or LFTs increase during therapy, continue to monitor weekly unless the patient is receiving concurrent hepatotoxic drugs, when monitoring every 3 - 5 days is appropriate.

    Hyperglycaemia with or without preceding hypoglycaemia have occurred up to several months after cessation of therapy. Monitor fasting blood glucose daily during therapy and at regular intervals after cessation of therapy.

    The use of aerosolised therapy in patients at high risk of a pneumothorax should be weighed against the clinical consequences of such a manifestation.

    Bronchospasm has been reported following nebulised administration. Patients with a history of smoking or asthma seem to be at greater risk. Prior use of bronchodilators can help to control this effect.

    Pregnancy and Lactation


    Pentamidine isetionate should not be used during pregnancy unless considered essential. Safety of use during pregnancy has not been established.

    A miscarriage during the first trimester has been reported while using aerosolised pentamidine for prophylactic use.

    Bystanders, including medical personnel, women of child bearing potential and pregnant women should avoid atmospheric exposure to pentamidine from nebuliser usage.

    Animal studies conducted with rats using human equivalent doses showed embryotoxicity but no teratogenic effects. These doses were embryocidal when administered during embryogenesis. Significant placental transfer was observed in rats administered pentamidine in late pregnancy.

    Schaefer (2007) concludes that pentamidine should only be administered to pregnant women in cases of life threatening infections when other antibiotics have been ineffective. Inadvertent use does not warrant the termination of pregnancy or the employment of invasive prenatal diagnostic procedures.

    The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14-17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( ) or if this is unavailable at the backup site ( ).


    Pentamidine isetionate should not be used during breastfeeding unless considered essential.

    There are no reports available on the use of pentamidine during breastfeeding via any route. The levels of pentamidine in breast milk after administration via nebulisation are probably nil.

    Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
    Specialist advice is available from the UK Drugs in Lactation Advisory Service at

    Side Effects

    Abnormal liver function tests
    Abscess formation (injection site)
    Acute renal failure
    Bronchospasm (on inhalation)
    Decreased appetite
    Eosinophilic pneumonia
    Induration (injection site)
    Macroscopic haematuria
    Necrosis (injection site)
    Pain on injection
    Prolongation of QT interval
    Renal impairment
    Shortness of breath
    Stevens-Johnson syndrome
    Taste disturbances
    Torsades de pointes
    Urinary tract disorders


    It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

    The following number will direct the caller to the relevant local centre (0844) 892 0111

    Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( ) or if this is unavailable at the backup site ( ).

    Further Information

    Last Full Review Date: February 2013

    Reference Sources

    British National Formulary, 64th Edition (2012) Pharmaceutical Press, London.

    BNF for Children (2012-2013) Pharmaceutical Press, London.

    Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

    Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.

    Summary of Product Characteristics: Pentacarinat 300mg. Sanofi-aventis. Revised March 2012.

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