Pentamidine Tillomed: Uses, Dosage & Side Effects
Pentamidine isetionate 300 mg powder for solution for injection, infusion or nebuliser solution
Quick Facts About Pentamidine Tillomed
Key Takeaways About Pentamidine Tillomed
- Broad antiprotozoal activity: Pentamidine isetionate kills Pneumocystis jirovecii, Leishmania species, and Trypanosoma brucei gambiense by binding to parasite DNA, inhibiting nucleic acid synthesis, and disrupting energy metabolism
- Three possible routes: Intravenous infusion for treating active disease, intramuscular injection when IV access is not possible, and nebulised inhalation for secondary prophylaxis of Pneumocystis pneumonia
- Critical blood-pressure and glucose monitoring: Pentamidine can cause sudden severe hypotension and unpredictable swings between hypoglycaemia and hyperglycaemia, sometimes resulting in permanent insulin-dependent diabetes
- Significant organ toxicity: Nephrotoxicity, hepatotoxicity, QT prolongation with torsades de pointes, acute pancreatitis, and bone marrow suppression are serious risks that require baseline and routine laboratory and ECG monitoring
- Reserve therapy: Pentamidine is usually a second-line or salvage option when first-line agents such as co-trimoxazole (for PJP), pentavalent antimonials or liposomal amphotericin B (for leishmaniasis), and other trypanocides are unsuitable, unavailable, or have failed
What Is Pentamidine Tillomed and What Is It Used For?
Pentamidine Tillomed is a 300 mg vial of pentamidine isetionate, an aromatic diamidine antiprotozoal medicine used in hospital settings to treat and prevent Pneumocystis jirovecii pneumonia in people with severely weakened immune systems, to treat visceral and cutaneous leishmaniasis, and to treat early-stage African sleeping sickness caused by Trypanosoma brucei gambiense. It is administered by slow intravenous infusion, deep intramuscular injection, or inhalation via a specialised nebuliser.
Pentamidine belongs to the pharmacotherapeutic group of antiprotozoal agents and is classified under the ATC code P01CX01. It was first synthesised in the 1930s during research into trypanocidal compounds and has since become an essential medicine for several life-threatening opportunistic and tropical infections. Chemically, pentamidine is an aromatic diamidine — two amidine groups linked by a pentamethylene (five-carbon) chain and two phenyl rings — which gives the molecule strong affinity for AT-rich regions of DNA and allows it to disrupt multiple biochemical pathways in susceptible parasites and fungi.
The isetionate (isethionate) salt form used in Pentamidine Tillomed is the water-soluble version of the molecule that can be reconstituted for parenteral and inhaled use. One vial contains 300 mg of pentamidine isetionate, which is equivalent to approximately 174 mg of pentamidine base. The product is supplied as a white, sterile, lyophilised powder and is reconstituted with sterile water for injection immediately before administration. Reconstituted solution is chemically and physically stable for a limited period and should be used promptly according to the manufacturer's instructions.
Pentamidine Tillomed is indicated for the following infections:
- Pneumocystis jirovecii pneumonia (PJP, formerly called PCP): a severe opportunistic fungal pneumonia that occurs almost exclusively in people with impaired cell-mediated immunity, most commonly those with advanced HIV infection and a CD4 count below 200 cells/mm³, solid-organ and haematopoietic stem-cell transplant recipients, patients receiving prolonged high-dose corticosteroids, and people on intensive cancer chemotherapy or biologic immunosuppressants. Pentamidine is used both for treatment of active disease when first-line co-trimoxazole is unsuitable, and for secondary prophylaxis via nebulisation
- Visceral leishmaniasis (kala-azar): a chronic systemic infection caused by Leishmania donovani or Leishmania infantum transmitted by sandflies, characterised by prolonged fever, hepatosplenomegaly, pancytopenia and wasting. Pentamidine is a second- or third-line option in regions where first-line liposomal amphotericin B or pentavalent antimonials are unavailable, unsuitable, or have failed
- Cutaneous and mucocutaneous leishmaniasis: skin and mucosal ulcers caused by several Leishmania species, for which pentamidine has been used particularly in New World disease caused by L. guyanensis and L. panamensis
- Early-stage (haemolymphatic) African trypanosomiasis caused by Trypanosoma brucei gambiense: human African sleeping sickness before central nervous system involvement occurs. Pentamidine does not cross the blood-brain barrier effectively and cannot treat late-stage disease, which requires other agents (nifurtimox-eflornithine combination therapy or fexinidazole)
The exact indications and reimbursement status vary between countries. Pentamidine is included on the World Health Organization Model List of Essential Medicines under antiprotozoal agents for both Pneumocystis pneumonia and African trypanosomiasis. In many high-income countries it is stocked only by specialist hospital pharmacies, infectious-disease units, tropical medicine services, and HIV clinics, and is subject to strict prescribing protocols because of its narrow therapeutic index and serious toxicity profile. Treatment decisions should always involve a specialist in infectious diseases, HIV medicine, or tropical medicine.
First-line therapy for Pneumocystis jirovecii pneumonia in most settings is high-dose co-trimoxazole (trimethoprim-sulfamethoxazole), which is usually more effective and better tolerated than pentamidine. Pentamidine is generally reserved for patients who cannot tolerate or have failed co-trimoxazole, or in whom sulfonamide-related adverse reactions are anticipated. Similarly, in leishmaniasis, liposomal amphotericin B has become the preferred first-line agent in most WHO regions.
What Should You Know Before Taking Pentamidine Tillomed?
Before starting Pentamidine Tillomed, your doctor will review your medical history, heart rhythm (ECG), blood pressure, kidney and liver function, blood glucose, electrolytes (including calcium, magnesium and potassium), and complete blood count. Pentamidine should be used with great caution in pregnancy, breastfeeding, kidney or liver disease, diabetes mellitus, cardiac conduction disorders, and in people receiving other nephrotoxic, QT-prolonging, or bone-marrow-suppressing medicines.
Pentamidine has a narrow therapeutic index and causes serious, predictable, dose-related adverse effects in many patients. A thorough pre-treatment assessment is therefore essential. The prescribing team will usually assemble a baseline profile that includes a 12-lead ECG, measurement of blood pressure lying and standing, serum creatinine and urea with an estimate of glomerular filtration rate, liver function tests (ALT, AST, bilirubin, alkaline phosphatase), fasting and random plasma glucose, glycated haemoglobin (HbA1c) where relevant, a full blood count with differential and platelets, serum electrolytes (sodium, potassium, calcium, magnesium and phosphate), and a serum amylase or lipase to screen for subclinical pancreatic disease. These parameters are then repeated at set intervals during treatment and for several weeks after the last dose because pentamidine has a very long tissue half-life.
Contraindications
Pentamidine Tillomed is contraindicated in patients with documented hypersensitivity to pentamidine isetionate or to any of the excipients in the formulation. A history of severe cutaneous adverse reactions such as Stevens-Johnson syndrome or toxic epidermal necrolysis attributed to pentamidine is an absolute contraindication to re-exposure. Relative contraindications — situations in which the balance of benefit and risk must be weighed very carefully — include severe renal or hepatic impairment, uncontrolled diabetes mellitus, recent or active pancreatitis, significant cardiac conduction abnormality or congenital long-QT syndrome, severe bone marrow suppression, and severe electrolyte disturbance (particularly hypokalaemia or hypomagnesaemia).
Warnings and Precautions
Pentamidine can cause sudden, severe, and sometimes fatal hypotension, particularly if infused too rapidly or given by intramuscular injection. Intravenous infusions should be administered over at least 60 minutes with the patient lying down, and blood pressure should be measured before, during, and for several hours after completion of the dose. Care is needed in patients who are already hypotensive, dehydrated, or receiving antihypertensive agents, vasodilators, or opioids.
Pentamidine has complex effects on pancreatic beta cells and can cause uncontrolled insulin release with severe hypoglycaemia at any time during or up to several weeks after treatment. In some patients this is followed by beta-cell toxicity and hyperglycaemia, which may progress to permanent insulin-dependent diabetes mellitus. All patients should be educated about the symptoms of low and high blood sugar, and capillary blood glucose should be checked regularly during treatment. Diabetic patients may need major adjustments to their insulin or oral antidiabetic therapy.
Nephrotoxicity is a common and potentially serious adverse effect. Renal function often deteriorates during treatment, particularly when other nephrotoxic drugs are given concurrently or when the patient is volume-depleted. Dose reduction, extended dosing interval, or switching to an alternative agent may be needed if creatinine rises. Regular monitoring of serum creatinine, urea, electrolytes (including magnesium and calcium), and urine output is essential. Adequate hydration should be maintained throughout treatment.
Hepatotoxicity ranging from asymptomatic elevation of liver enzymes to severe hepatitis has been reported. Liver function tests should be checked at baseline and periodically during treatment. Pentamidine also prolongs the QT interval on the ECG and can precipitate life-threatening ventricular arrhythmias including torsades de pointes, especially when combined with other QT-prolonging drugs, in patients with electrolyte disturbance, or in those with pre-existing structural heart disease. A baseline ECG is mandatory, electrolytes should be kept within normal limits, and concomitant QT-prolonging medicines should be avoided where possible.
Acute pancreatitis is a well-recognised adverse reaction, particularly in HIV-positive patients and those receiving other pancreatotoxic drugs such as didanosine, zalcitabine, valproate, or corticosteroids. Symptoms of pancreatitis (severe upper abdominal pain radiating to the back, nausea, vomiting) require urgent evaluation and usually discontinuation of pentamidine. Bone marrow suppression with leukopenia, neutropenia, thrombocytopenia, and anaemia is also common; the full blood count should be monitored and growth factors or transfusions considered if cytopenias become severe.
Nebulised pentamidine can trigger bronchospasm, especially in patients with asthma, chronic obstructive pulmonary disease, or smokers. Pre-treatment with an inhaled short-acting bronchodilator such as salbutamol is commonly recommended. Because aerosolised pentamidine escapes from the nebuliser circuit, staff and other patients are potentially exposed; treatment should be delivered in a dedicated, well-ventilated room with appropriate filters and personal protective equipment. Patients with tuberculosis or any undiagnosed cough should be screened for active TB before nebulised pentamidine is used, because the induced cough can aerosolise mycobacteria.
Pregnancy and Breastfeeding
Reproductive toxicity data for pentamidine in humans are limited. Animal studies have shown embryotoxicity at high doses. Pentamidine should only be used during pregnancy when the potential benefit justifies the potential risk to the fetus — for example, when treating severe Pneumocystis pneumonia in a pregnant woman who cannot receive first-line co-trimoxazole, or life-threatening leishmaniasis or trypanosomiasis. Nebulised pentamidine results in very low systemic exposure and is considered acceptable for prophylaxis during pregnancy in selected circumstances, although most clinicians prefer oral alternatives.
It is not known whether pentamidine is excreted in human breast milk. Because of the drug's long tissue half-life and potential for serious adverse effects in the nursing infant, breastfeeding is usually discontinued during parenteral therapy and for a period afterwards. Women should discuss infant feeding options with the specialist team before treatment begins.
Use in Children and Older Adults
Pentamidine has been used safely in children for treatment and prophylaxis of Pneumocystis pneumonia and for leishmaniasis, but experience is limited and doses are calculated by body weight. Children should be monitored with the same parameters as adults, with particular attention to blood glucose and renal function. In older adults, renal impairment is common and pre-existing cardiac disease, polypharmacy, and concomitant diuretics (which may cause hypokalaemia) all increase the risk of adverse events. Doses may need to be adjusted for reduced kidney function, and monitoring should be intensified.
Contact medical services immediately if you experience severe dizziness, fainting, chest pain, palpitations, sudden difficulty breathing, signs of low blood sugar (shaking, sweating, confusion), severe abdominal pain radiating to the back, dark urine, yellowing of the skin or eyes, unexplained bruising or bleeding, a widespread rash with blistering or peeling, high fever, or symptoms of infection such as chills or sore throat during or after treatment with pentamidine.
How Does Pentamidine Tillomed Interact with Other Drugs?
Pentamidine Tillomed interacts with several classes of medicines. The most important interactions are with other QT-prolonging drugs (increased risk of dangerous heart rhythms), nephrotoxic drugs (additive kidney injury), medicines that cause pancreatitis (such as didanosine), drugs that lower blood counts, and insulin or oral antidiabetic agents (unpredictable blood-sugar control). Always tell your doctor and pharmacist about every medicine, supplement, or herbal product you are taking before pentamidine is prescribed.
Because pentamidine binds strongly to tissues and is cleared slowly, interactions may persist for weeks after the last dose. A full medication reconciliation, including over-the-counter medicines, herbal remedies, and recreational substances, should be performed before each course of treatment. Whenever possible, drugs with overlapping toxicities are either discontinued, substituted with safer alternatives, or continued under very close monitoring with dose adjustment.
Major Interactions
| Interacting drug / class | Mechanism & clinical effect | Management |
|---|---|---|
| QT-prolonging drugs (amiodarone, sotalol, quinidine, disopyramide) | Additive QT prolongation and risk of torsades de pointes | Avoid combination where possible; if unavoidable, monitor ECG, potassium and magnesium closely |
| Macrolide antibiotics (erythromycin, clarithromycin) | Additive QT prolongation; erythromycin also inhibits CYP3A4 | Use azithromycin or a non-macrolide alternative when possible |
| Fluoroquinolones (moxifloxacin, levofloxacin) | Additive QT prolongation | Select a quinolone with the lowest QT liability and monitor ECG |
| Antipsychotics (haloperidol, quetiapine, ziprasidone) | Additive QT prolongation | Consider dose reduction; ECG monitoring; discuss with prescriber |
| Methadone | Additive QT prolongation; risk increased in opioid-substitution programmes | Baseline and follow-up ECG; keep electrolytes within normal range |
| Aminoglycosides (gentamicin, amikacin, tobramycin) | Additive nephrotoxicity and potentially ototoxicity | Monitor renal function at least every 48 hours; use therapeutic drug monitoring for aminoglycosides |
| Amphotericin B (especially conventional formulation) | Additive nephrotoxicity, severe hypokalaemia, hypomagnesaemia, and hypocalcaemia | Combination should be avoided; if required, prefer liposomal amphotericin B and correct electrolytes aggressively |
| Foscarnet and cidofovir | Severe nephrotoxicity and electrolyte disturbance | Avoid concurrent use; switch to alternative antiviral or antiprotozoal |
| Didanosine | Markedly increased risk of pancreatitis | Combination contraindicated; substitute an alternative antiretroviral |
| Zidovudine, ganciclovir, flucytosine, cytotoxic chemotherapy | Additive bone-marrow suppression | Frequent full blood counts; consider growth factors; dose reduction |
Minor Interactions
| Interacting drug / class | Mechanism & clinical effect | Management |
|---|---|---|
| Insulin and oral antidiabetic drugs | Unpredictable blood-sugar effects — first hypoglycaemia, later potential hyperglycaemia | Frequent capillary glucose measurement; adjust antidiabetic therapy as needed |
| Loop and thiazide diuretics | Hypokalaemia and hypomagnesaemia increase risk of arrhythmia; volume depletion increases nephrotoxicity | Replace electrolytes actively; consider holding diuretics during therapy |
| NSAIDs (ibuprofen, naproxen, diclofenac) | Additive nephrotoxicity | Use paracetamol for analgesia where possible; monitor creatinine |
| Antihypertensives and vasodilators | Additive hypotension, especially during parenteral pentamidine | Withhold short-acting agents on the morning of infusion; monitor blood pressure |
| Corticosteroids | May exacerbate hyperglycaemia, pancreatitis risk, and infection risk | Use lowest effective steroid dose; monitor glucose |
| Valproate | Additive risk of pancreatitis and liver injury | Monitor amylase/lipase and liver enzymes |
What Is the Correct Dosage of Pentamidine Tillomed?
The dose of Pentamidine Tillomed depends on the indication, patient weight, renal function, and the chosen route of administration. For treatment of Pneumocystis jirovecii pneumonia in adults, the usual intravenous dose is 4 mg/kg once daily for 14 to 21 days. For nebulised prophylaxis, 300 mg every four weeks is standard. Doses for leishmaniasis and African trypanosomiasis are individualised according to the parasite, stage, and patient factors.
Pentamidine is always prescribed by a specialist team and prepared by hospital pharmacy according to national and institutional protocols. The 300 mg vial is typically reconstituted with 3 to 5 ml of sterile water for injection to produce a concentrated solution that is further diluted into 50 to 250 ml of glucose 5% or sodium chloride 0.9% for intravenous infusion. For nebulised use, the powder is dissolved in sterile water without preservatives and delivered through a specified nebuliser system that generates the correct particle size to reach the alveoli. The manufacturer's product information should always be consulted for current preparation and compatibility details.
Adults
Pneumocystis jirovecii pneumonia — treatment
4 mg/kg pentamidine isetionate once daily by slow intravenous infusion over at least 60 minutes, for 14 days in non-HIV patients and 14 to 21 days in people with HIV. Intramuscular administration is possible but less well tolerated and associated with sterile abscess formation at the injection site.
Pneumocystis jirovecii pneumonia — secondary prophylaxis
300 mg pentamidine isetionate by inhalation every four weeks using an appropriate nebuliser. Prophylaxis is typically continued until immune reconstitution is achieved (for example, sustained CD4 count above 200 cells/mm³ for at least 3 months in HIV) or the underlying cause of immunosuppression resolves.
Visceral leishmaniasis
2 to 4 mg/kg pentamidine isetionate every other day (or three times per week) by intramuscular injection or slow intravenous infusion, for 5 to 25 doses. Liposomal amphotericin B is preferred where available.
Cutaneous leishmaniasis (New World)
Typically 2 to 3 mg/kg every other day by intramuscular injection for 4 to 7 doses. Local lesion care and follow-up are required.
Early-stage African trypanosomiasis (T. b. gambiense)
4 mg/kg pentamidine isetionate once daily by deep intramuscular injection for 7 to 10 consecutive days. Pentamidine does not treat late (CNS) stage disease.
Children
Pediatric dosing is individualised by infectious-disease and pediatric specialists. For Pneumocystis jirovecii pneumonia treatment, 4 mg/kg intravenously once daily is commonly used for 14 to 21 days. For secondary prophylaxis in children aged 5 years and older able to use a nebuliser, 300 mg every 4 weeks by inhalation is appropriate; younger children generally receive oral co-trimoxazole or atovaquone instead. Leishmaniasis regimens in children mirror adult mg/kg-based dosing.
Elderly
No specific age-based dose reduction is recommended, but older adults frequently have reduced renal function, more cardiovascular disease, and greater polypharmacy. Creatinine clearance should be estimated and the dose reduced, or the dosing interval extended, when glomerular filtration rate is below 50 ml/min/1.73 m². ECG and blood pressure monitoring should be more frequent. Intramuscular injection in frail older patients is associated with haematoma, sterile abscess, and muscle necrosis and should be avoided where possible.
Renal and Hepatic Impairment
Pentamidine is only partly renally eliminated but accumulates in renal impairment. The dosing interval is usually extended (for example, every 24 to 48 hours rather than daily) when creatinine clearance falls below 50 ml/min. In severe renal impairment or acute kidney injury, the daily dose may be reduced by 50% and the interval extended to 48 hours, with close monitoring of creatinine and drug response. Data in hepatic impairment are limited; liver enzymes should be monitored throughout therapy and the drug should be discontinued if hepatotoxicity develops.
Missed Dose
Pentamidine Tillomed is given by healthcare professionals in a hospital or clinic setting, so missed doses are uncommon. If a dose is missed because of illness or unavoidable delay, the specialist prescriber will decide whether to give it as soon as possible or continue with the next scheduled dose. Doses should never be doubled to make up for a missed administration because of the risk of hypotension, arrhythmia, and hypoglycaemia. For nebulised monthly prophylaxis, a missed dose should be administered as soon as it is realised, and the subsequent schedule recalculated from the new date.
Overdose
Overdose with pentamidine may cause profound hypotension, cardiac arrhythmia, acute renal failure, severe hypoglycaemia, hepatitis, and pancreatitis. There is no specific antidote. Management is supportive: intravenous fluids and vasopressors for hypotension, continuous cardiac and blood-pressure monitoring, correction of electrolyte disturbances, dextrose infusion for hypoglycaemia, and intensive care support as needed. Haemodialysis does not significantly remove pentamidine because of its high tissue binding. All suspected overdoses should be reported to a regional poisons centre.
What Are the Side Effects of Pentamidine Tillomed?
Pentamidine Tillomed causes adverse effects in most patients during a full therapeutic course. Common problems include injection-site reactions, nausea, metallic taste, low blood pressure, abnormal liver enzymes, low blood counts, and impaired kidney function. Serious but less frequent reactions include severe hypoglycaemia followed by insulin-dependent diabetes, acute pancreatitis, torsades de pointes, and Stevens-Johnson syndrome. Nebulised pentamidine more commonly causes cough and bronchospasm.
Because pentamidine has such a wide spectrum of toxicity, patients are normally reviewed daily during parenteral treatment and monitored in a monitored bed or an infectious-disease ward equipped for emergency cardiac and endocrine care. The side effects listed below are reported in company product information, published case series, and large cohort studies of HIV-positive patients treated for Pneumocystis pneumonia. Frequencies are standardised to the Council for International Organisations of Medical Sciences (CIOMS) classification.
Very common side effects
- Hypotension (low blood pressure), particularly during or shortly after IV infusion
- Injection-site pain, induration or sterile abscess after intramuscular injection
- Nausea and loss of appetite
- Metallic or unpleasant taste in the mouth
- Increased blood urea and serum creatinine (reduced kidney function)
- Elevated liver enzymes (ALT, AST) and alkaline phosphatase
- Hypoglycaemia (low blood sugar) — may be delayed
- Cough and bronchospasm (nebulised use)
- Unpleasant taste and dry mouth during nebulisation
Common side effects
- Thrombophlebitis at the infusion site
- Leukopenia and neutropenia
- Thrombocytopenia
- Anaemia
- Hyperkalaemia (high potassium)
- Hypocalcaemia, hypomagnesaemia
- Hyperglycaemia and new-onset diabetes mellitus
- Dizziness, syncope (fainting)
- Headache and confusion
- Rash, itching
- Fever
- Increased amylase and lipase without clinical pancreatitis
Uncommon side effects
- Acute pancreatitis
- QT-interval prolongation on ECG
- Ventricular arrhythmias
- Torsades de pointes
- Acute renal failure requiring dialysis
- Hepatitis with jaundice
- Severe bronchospasm and airway obstruction after nebulisation
- Haemoptysis (coughing blood) — nebulised use
- Pneumothorax after aggressive coughing during nebulisation
Rare side effects
- Stevens-Johnson syndrome and toxic epidermal necrolysis
- Erythema multiforme
- Anaphylaxis
- Rhabdomyolysis
- Cardiac arrest and sudden death
- Agranulocytosis
- Nebuliser-induced spread of Pneumocystis to extrapulmonary sites
Frequency not known
- Insulin-dependent diabetes mellitus persisting after treatment
- Chronic renal impairment
- Pulmonary eosinophilia (nebulised use)
- Neuropsychiatric symptoms (depression, anxiety)
- Auditory disturbance and tinnitus
Reporting suspected adverse reactions. Reporting side effects helps identify new safety information. Patients and healthcare professionals should report any suspected adverse reaction to their national pharmacovigilance authority, such as the MHRA Yellow Card scheme (UK), the FDA MedWatch program (US), the EMA EudraVigilance system (EU), or an equivalent body in other countries.
How Should You Store Pentamidine Tillomed?
Pentamidine Tillomed is a hospital-only medicine that is stored and handled by pharmacy and nursing staff. The unopened 300 mg powder vial is stored in its original packaging below 25°C, protected from light. Reconstituted solution must be used promptly. Do not use the medicine after the expiry date printed on the carton, and do not use vials that appear cracked, damaged, or show visible particles after reconstitution.
As with all pharmaceuticals, specific storage, reconstitution, and compatibility conditions should be taken directly from the current manufacturer's product information, which is the definitive source for pharmacists and nurses preparing the medicine. Most lyophilised pentamidine isetionate products are stored at controlled room temperature (below 25°C or as specified on the carton), in the original packaging to protect against light, and kept out of the sight and reach of children. They should not be frozen.
After reconstitution with sterile water for injection, pentamidine solution is chemically and physically stable for only a limited period (typically up to 24 hours at 2–8°C). From a microbiological perspective, unless the reconstitution has been performed under validated aseptic conditions, the solution should ideally be used immediately. Any unused solution remaining at the end of the infusion, or that has exceeded its in-use stability window, must be discarded according to local hospital waste disposal policy. Pentamidine should never be flushed down domestic drains or placed in household waste; it is classified as hazardous pharmaceutical waste because of its toxicity.
For nebulised use, the reconstituted solution is prepared in the clinic or ward immediately before inhalation. Any residual solution after the nebuliser treatment session must be disposed of as pharmaceutical waste. Nebuliser equipment should be decontaminated according to the manufacturer's instructions between patients to prevent cross-contamination and to protect healthcare workers from aerosol exposure.
What Does Pentamidine Tillomed Contain?
Each Pentamidine Tillomed vial contains 300 mg of pentamidine isetionate as the active substance in the form of a white lyophilised powder. Depending on the specific product formulation there may be no additional excipients, or a small amount of stabilisers. The full list of excipients is provided in the current manufacturer's product information.
Active Substance
Each vial contains 300 mg of pentamidine isetionate (equivalent to approximately 174 mg pentamidine base).
Other Ingredients (Excipients)
Pentamidine Tillomed powder for injection is commonly supplied without additional excipients. Specific batches may include small quantities of stabilisers and pH adjusters. If you have a known allergy to any excipient listed in the current package leaflet, inform your prescriber or pharmacist before the medicine is given.
What the Medicine Looks Like and Contents of the Pack
The product is supplied as a white to off-white sterile, lyophilised powder in a clear glass vial closed with a rubber stopper and aluminium overseal. Each carton contains one or several single-dose vials of 300 mg pentamidine isetionate together with the patient information leaflet. Pack size and vial presentation may vary between markets.
Marketing Authorisation Holder and Manufacturer
Tillomed Laboratories is the marketing authorisation holder and manufacturer of Pentamidine Tillomed in the United Kingdom and several European markets. Product names for pentamidine isetionate in other countries include Pentam, Pentacarinat, and NebuPent; these contain the same active ingredient but may have slightly different excipient profiles, pack sizes, and approved routes of administration. Always use the product and instructions provided by your healthcare team.
Frequently Asked Questions About Pentamidine Tillomed
Medical References
- World Health Organization (WHO) (2023). "WHO Model List of Essential Medicines - 23rd List, 2023." WHO Essential Medicines List Pentamidine is listed as an essential antiprotozoal medicine for Pneumocystis pneumonia and for early-stage human African trypanosomiasis caused by T. b. gambiense.
- European Medicines Agency (EMA). "Summary of Product Characteristics for pentamidine isetionate powder for solution for injection." European Medicines Agency European regulatory product information for pentamidine isetionate including indications, dosing, contraindications, warnings, and adverse reactions.
- U.S. Food and Drug Administration (FDA). "Pentam 300 (pentamidine isethionate) prescribing information." FDA Drug Approval Database FDA-approved prescribing information for the intravenous pentamidine isetionate product used in the United States.
- British National Formulary (BNF). "Pentamidine isetionate: indications, dose, cautions, side effects." BNF – NICE UK national formulary guidance on the prescribing of pentamidine for adults and children.
- Kaplan JE, Benson C, Holmes KH, et al. (2009). "Guidelines for prevention and treatment of opportunistic infections in HIV-infected adults and adolescents: recommendations from CDC, the National Institutes of Health, and the HIV Medicine Association of the Infectious Diseases Society of America." MMWR Recommendations and Reports. 58(RR-4):1-207. CDC MMWR Comprehensive guidelines including the role of pentamidine for treatment and prophylaxis of Pneumocystis jirovecii pneumonia in adults with HIV.
- Helweg-Larsen J, Benfield T, Atzori C, Miller RF (2009). "Clinical efficacy of first- and second-line treatments for HIV-associated Pneumocystis jirovecii pneumonia: a tri-centre cohort study." Journal of Antimicrobial Chemotherapy. 64(6):1282-1290. https://doi.org/10.1093/jac/dkp372 Cohort study comparing co-trimoxazole and pentamidine for treatment of Pneumocystis jirovecii pneumonia in HIV-positive adults.
- World Health Organization (WHO) (2010). "Control of the leishmaniases: report of a meeting of the WHO Expert Committee on the Control of Leishmaniases." WHO Technical Report Series 949. WHO TRS 949 Authoritative WHO report on the diagnosis and treatment of visceral and cutaneous leishmaniasis, including the role of pentamidine.
- Büscher P, Cecchi G, Jamonneau V, Priotto G (2017). "Human African trypanosomiasis." The Lancet. 390(10110):2397-2409. https://doi.org/10.1016/S0140-6736(17)31510-6 Comprehensive review of human African trypanosomiasis, including pentamidine for early-stage T. b. gambiense infection.
- Sands M, Kron MA, Brown RB (1985). "Pentamidine: a review." Reviews of Infectious Diseases. 7(5):625-634. https://doi.org/10.1093/clinids/7.5.625 Classic review of the pharmacology, clinical use, and toxicity of pentamidine.
- Maxwell NM, Nevin RL, Stahl S, et al. (2019). "Prolonged neuropsychiatric effects following management of chloroquine intoxication with psychotropic polypharmacy and pentamidine." Case Reports in Psychiatry. 2019:3493916. https://doi.org/10.1155/2019/3493916 Case report discussing pentamidine-associated neuropsychiatric and cardiac effects.
Evidence grading: This article uses the GRADE framework (Grading of Recommendations Assessment, Development and Evaluation) for evidence-based medicine. Evidence level 1A represents the highest quality of evidence, based on systematic reviews of randomized controlled trials.
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