Consumer medicine information

Pentamidine-EMC

Pentamidine isetionate

BRAND INFORMATION

Brand name

Pentamidine-EMC

Active ingredient

Pentamidine isetionate

Schedule

What is in this leaflet

This leaflet answers some common questions about PENTAMIDINE-EMC

It does not contain all the available information.

It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor or pharmacist has weighed the risks of you being given PENTAMIDINE-EMC against the benefits they expect it will have for you.

If you have any concerns about being given this medicine, ask your doctor or pharmacist.

Keep this leaflet in a safe place. You may need to read it again.

What PENTAMIDINE-EMC is used for

PENTAMIDINE-EMC is used to treat an infection called Pneumocystis carinii pneumonia (PCP). This kind of pneumonia occurs commonly in patients whose immune system is not working normally, such as cancer patients, transplant patients, or patients with acquired immune deficiency syndrome (AIDS). PENTAMIDINE-EMC can also be used to treat other types of protozoal infections, such as Leishmaniasis and Trypanosomiasis.

Your doctor may have prescribed PENTAMIDINE-EMC for another reason.

Ask your doctor if you have any questions about why this medicine has been prescribed for you.

There is no evidence that PENTAMIDINE-EMC is addictive.

This medicine is available only with a doctor’s prescription.

Before you are given PENTAMIDINE-EMC

When you must not be given it

You must not be given PENTAMIDINE-EMC if you have an allergy to pentamidine.

Symptoms of an allergic reaction to pentamidine may include:

shortness of breath, wheezing or difficulty breathing
swelling of the face, lips, tongue or other parts of the body
rash, itching or hives on the skin.

You should not be given PENTAMIDINE-EMC if you are pregnant or intend to become pregnant. Pentamidine is not recommended for use during pregnancy. If there is a need to consider pentamidine during your pregnancy, your doctor will discuss with you the benefits and risks of being given it.

You should not be given PENTAMIDINE-EMC if you are breastfeeding or plan to breast-feed. Pentamidine is not recommended while you are breast-feeding, as it is not known whether pentamidine passes into breast milk. If there is a need to consider pentamidine while you are breastfeeding, your doctor will discuss with you the benefits and risks of being given it.

If you are not sure whether you should be given PENTAMIDINE-EMC, talk to your doctor or pharmacist.

Before you are given it

Tell your doctor or pharmacist if you have allergies to:

any other medicines
any other substances, such as foods, preservatives or dyes.

Tell your doctor or pharmacist if you have or have had any medical conditions, especially the following:

malnutrition
high or low blood sugar levels
liver problems
kidney problems
heart problems
blood pressure problems (high or low blood pressure)
low numbers of red blood cells, white blood cells, or platelets.

If you have not told your doctor or pharmacist about any of the above, tell them before you are given PENTAMIDINE-EMC.

Taking other medicines

Tell your doctor or pharmacist if you are taking/using any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines and pentamidine may interfere with each other. These include:

Amphotericin B, a drug used to treat serious fungal infections
aminoglycoside antibiotics, such as gentamicin
cisplatin, a drug used to treat certain types of cancer
vancomycin, a type of antibiotic
foscarnet, an antiviral drug used to treat cytomegalovirus (CMV) infections in AIDS patients.

These medicines may be affected by pentamidine, or may affect how well it works. You may need different amounts of your medicine, or you may need to take/use different medicines. Your doctor or pharmacist will advise you.

Your doctor and pharmacist may have more information on medicines to be careful with or avoid while being given pentamidine.

How PENTAMIDINE-EMC is given

How much is given

Your doctor will decide what dose of pentamidine you will receive. This depends on your condition and other factors, such as your weight.

How it is given

PENTAMIDINE-EMC is given as a slow injection into a vein (intravenously) over a period of at least 60 minutes. Pentamidine Isetionate for Injection must only be given by a doctor or nurse.

Some patients develop sudden, severe low blood pressure after a dose of pentamidine. Therefore, you should be lying down while you are being given pentamidine. Your blood pressure will be closely monitored.

How long it is given

To treat Pneumocystis carinii pneumonia (PCP), PENTAMIDINE-EMC is usually given once daily for 14 days.

To treat Leishmaniasis, PENTAMIDINE-EMC may be given once, twice or three times a week.

To treat Trypanosomiasis, PENTAMIDINE-EMC may be given either daily or on alternate days for a total of 7 to 10 doses.

If you are given too much (Overdose)

As PENTAMIDINE-EMC is given to you under the supervision of your doctor, it is very unlikely that you will receive too much. However, if you experience any severe side effects after being given this medicine, tell your doctor immediately, telephone the Poisons Information Centre (telephone 13 11 26) for advice, or go to the Accident and Emergency department at your nearest hospital. You may need urgent medical attention.

Symptoms of a pentamidine overdose may include the side effects listed below in the ‘Side Effects’ section, but are usually of a more severe nature.

While you are being given PENTAMIDINE-EMC

Things you must do

Tell any other doctors, dentists, and pharmacists who are treating you that you are being given pentamidine.

If you are about to be started on any new medicine, tell your doctor, dentist or pharmacist that you are being given pentamidine.

If you plan to have surgery that needs a general anaesthetic, tell your doctor or dentist that you are being given pentamidine.

If you become pregnant while being given pentamidine, tell your doctor immediately.

Keep all of your doctor’s appointments so that your progress can be checked. Your doctor may do some tests (such as blood and platelet counts, blood glucose tests or liver function tests) from time to time to make sure the medicine is working and to prevent unwanted side effects.

Things to be careful of

Be careful driving or operating machinery until you know how PENTAMIDINE-EMC affects you. Pentamidine may cause dizziness and light-headedness in some people.

Make sure you know how you react to pentamidine before you drive a car, operate machinery, or do anything else that could be dangerous if you are dizzy or light-headed. If this occurs do not drive.

If you drink alcohol, dizziness or light-headedness may be worse.

Side effects

Tell your doctor or nurse as soon as possible if you do not feel well while you are being given PENTAMIDINE-EMC. This medicine helps most people with protozoal infections, but it may have unwanted side effects in a few people. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

If you are over 65 years of age you may have an increased chance of getting side effects.

Ask your doctor, pharmacist or nurse to answer any questions you may have.

Tell your doctor or nurse if you notice any of the following and they worry you:

nausea and vomiting
taste disturbances, metallic taste
flushing.

These are the more common side effects of PENTAMIDINE-EMC These side effects are usually mild.

Tell your doctor or nurse immediately if you notice any of the following:

pain or redness at the injection site
skin rash, redness, itching.

These may be serious side effects. You may need urgent medical attention.

If any of the following happen, tell your doctor or nurse immediately or, if you are not in a hospital, go to the Accident and Emergency department at your nearest hospital:

signs of an infection such as sore throat or fever
unusual bleeding or bruising
signs of high blood sugar, which may include increased urination, unusual thirst, tiredness
peeling of the skin
signs of low blood sugar, which may include trembling or shaking, light-headedness, irritability
dizziness or fainting, which may be signs of low blood pressure
slow, fast or irregular heart rate
pain in upper abdomen
breathlessness, difficulty in breathing.
Fever, chills, headache and muscle pain (signs of Herxheimer reaction)

These are very serious side effects. You may need urgent medical attention or hospitalisation.

Other side effects not listed above may occur in some patients.

Tell your doctor or nurse if you notice anything that is making you feel unwell.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

Storage

PENTAMIDINE-EMC will generally be stored in the pharmacy or on the ward. The injection is kept in a cool dry place, protected from light, where the temperature stays below 25°C.

Product description

What it looks like

PENTAMIDINE-EMC r is a white or almost white powder. It must be dissolved and further diluted before it is given.

Ingredients

Active ingredient:

Pentamidine Isetionate

There are no other ingredients.

PENTAMIDINE-EMC does not contain lactose, sucrose, gluten, tartrazine or any other azo dyes.

Sponsor

Emcure Pharmaceuticals Pty Ltd.

Distributed by:

Luminarie Pty Ltd
Baulkham Hills NSW 2153
[email protected]

PENTAMIDINE-EMC is available in the following strength:

300 mg /vial
AUST R: 338274

Published by MIMS December 2023

BRAND INFORMATION

Brand name

Pentamidine-EMC

Active ingredient

Pentamidine isetionate

Schedule

Notes

Distributed by Luminarie Pty Ltd

1 Name of Medicine

Pentamidine isetionate.

2 Qualitative and Quantitative Composition

Pentamidine-EMC pentamidine isetionate powder for injection is a white or almost white, odourless or almost odourless hygroscopic powder. Each 4 mg of pentamidine isetionate is equivalent to 2.3 mg pentamidine base.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Vials containing 300 mg pentamidine isetionate as a lyophilized powder/cake.

4 Clinical Particulars

4.1 Therapeutic Indications

Pentamidine isetionate is indicated for intravenous administration in the treatment of the following conditions:
as an alternative first line treatment for Pneumocystis carinii infection in AIDS patients;
as second line treatment for Pneumocystis carinii infection in non-AIDS patients;
as second line treatment of Leishmaniasis (visceral and cutaneous), except Leishmania aethiopica where it may be used as first line therapy;
as second line treatment for Trypanosomiasis (except for the Trypanosomiasis rhodesiense strain due to lack of efficacy).

4.2 Dose and Method of Administration

Dosage.

The following dosage regimens are recommended.
P. carinii pneumonia. 4 mg/kg bodyweight pentamidine isetionate once daily for 14 days, preferably by slow intravenous infusion.
Leishmaniasis. On the basis of current knowledge the following dosage are suggested however the optimal treatment regimen has yet to be established.

Visceral (Kala-azar).

3 to 4 mg/kg bodyweight pentamidine isetionate on alternate days (3 times a week) to a maximum of 10 injections.

Cutaneous.

3 to 4 mg/kg bodyweight pentamidine isetionate once or twice weekly, until the condition resolves.
Trypanosomiasis. (Haemolymphete stage only.)
4 mg/kg bodyweight pentamidine isetionate daily or on alternate days to a total of 7 to 10 injections.

Dosage adjustment.

Renal impairment.

Creatinine clearance < 35 mL/min.

There is little information on the kinetics or the adverse effects profile of pentamidine in patients with impaired renal function.
Hepatic impairment. No information available.

Method of administration.

Pentamidine-EMC should be given as a slow intravenous infusion with a patient in a supine position in order to reduce the incidence of sudden severe hypotension. Direct bolus intravenous injection or rapid administration must not be used.

Reconstitution.

The contents of a 300 mg vial should be dissolved in 3 mL to 5 mL of Water for Injections. The reconstitution time is 2 minutes. The required dose of pentamidine isetionate should then be diluted further in 50 to 250 mL of glucose intravenous infusion 5% or sodium chloride intravenous infusion 0.9%. The reconstituted solutions should be visually examined before use. Any solutions which are hazy, discoloured or contain visible particulate matter should not be used. Diluted solutions containing pentamidine isetionate should be infused over a period of at least 60 minutes under close medical supervision, whilst the patient is kept lying down.

Compatibilities.

Reconstituted solutions at concentrations of 100 mg/mL and 60 mg/mL are chemically stable for 48 hours when stored at 2 to 8°C and room temperature under fluorescent light. Pentamidine-EMC when reconstituted with water for injections and diluted to 1.0 mg/mL and 2.5 mg/mL in sodium chloride intravenous infusion 0.9% and glucose intravenous infusion 5% retained its potency for at least 48 hours when stored under fluorescent light at 21 ± 2°C. To reduce microbiological hazard, use as soon as practicable after dilution. If storage is necessary, hold at 2°-8°C for not more than 24 hours.

4.3 Contraindications

Patients with a known hypersensitivity to pentamidine.
Pentamidine should not be administered to patients who are pregnant or breastfeeding unless considered essential by the physician.

4.4 Special Warnings and Precautions for Use

Serious warnings and precautions.

Severe, sometimes fatal, hypotension, hypoglycaemia, acute pancreatitis, renal impairment and cardiac arrhythmias have been reported. Other life threatening reactions requiring immediate corrective measures and withdrawal of treatment have included leucopenia (less than 1,000 per cubic millimetre), thrombocytopenia (less than 20,000 per cubic mm), acute renal failure, hypocalcaemia, and ventricular tachycardia. A possible case of Stevens-Johnson syndrome has been reported.
Fatalities have been documented following pentamidine administration. The ratio of therapeutic to toxic dose of pentamidine is very low and adverse effects, some of which may be life threatening, occur frequently during its use. Pentamidine isetionate powder for injection should be used only in a hospital setting with facilities to monitor blood glucose, blood count, renal function and hepatic function. Electrocardiograms should be carried out at regular intervals (see Section 4.4 Special Warnings and Precautions for Use, Monitoring and laboratory tests).
Extravasation reactions may result in ulceration, tissue necrosis and long-term sequelae (see Section 4.8 Adverse Effects (Undesirable Effects)).
Pentamidine isetionate is not approved for inhaled use. Bronchospasm has been reported to occur following the use of inhaled product (see Section 4.8 Adverse Effects (Undesirable Effects)). 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 should be used with caution in patients with the following:
1. Malnutrition.
2. Hyperglycaemia or hypoglycaemia.
3. Hepatic dysfunction.
4. Renal dysfunction.
5. Hypertension or hypotension.
6. Anaemia, leucopenia or thrombocytopenia.

General.

Pentamidine isetionate powder for injection should only be administered under close medical supervision, and the patient should be very carefully monitored for the development of serious adverse reactions (see Section 4.8 Adverse Effects (Undesirable Effects)).
The administration of pentamidine isetionate powder for Injection should be limited to patients in whom Pneumocystis jirovecii infection has been confirmed.
Some patients may become nauseated or develop fever after taking each dose of pentamidine isetionate for Injection. In such cases, the prophylactic use of an antiemetic and/or paracetamol may be considered.

Cardiovascular.

Patients may develop sudden, severe hypotension after receiving a single intramuscular or intravenous dose of pentamidine isetionate. Therefore, patients receiving pentamidine isetionate for Injection should be in a supine position and the blood pressure monitored closely during administration of the drug and several times thereafter until the blood pressure is stable. Equipment for emergency resuscitation should be readily available. Pentamidine isetionate for Injection should be infused over a period of at least 60 minutes to minimise the risk of hypotension.
Severe hypotension with accompanying bradycardia has been observed in a patient after the sixth dose of pentamidine isetionate. This hypotension did not respond to intravenous colloids, graded compression stockings or corticosteroids but resolved within four days of stopping treatment.
Ventricular tachycardia and ECG abnormalities (including QT interval prolongation and torsade de pointes) may develop in patients receiving pentamidine isetionate. ECG's may be required at regular intervals if signs of cardiotoxicity develop.

Endocrine and metabolism.

Pentamidine isetionate can produce hypoglycaemia, which may be severe, life-threatening and/or prolonged. It generally occurs after 5 to 7 days of therapy but can even occur up to several days after the drug is discontinued. The duration appears quite variable, persisting for one day to several weeks. Pentamidine isetionate-induced hypoglycemia has been associated with pancreatic islet cell necrosis and inappropriately high plasma insulin concentrations. Hyperglycemia and diabetes mellitus, with or without preceding hypoglycemia, have also occurred, sometimes several months after termination of therapy with pentamidine isetionate.
Hypoglycaemia induced by pentamidine isetionate may be controlled by intravenous administration of dextrose or (oral) diazoxide, but it is not known if such therapy can prevent the subsequent development of diabetes mellitus.

Gastrointestinal.

Cases of nausea and vomiting have been observed with pentamidine isetionate treatment.

Haematologic.

Leucopenia and thrombocytopenia, which can be severe (e.g. leucocyte count less than 1,000 per cubic millimetre, platelet count less than 20,000 per cubic millimetre), occur occasionally in patients receiving pentamidine isetionate. Cases of anaemia have been observed. In a few cases, pentamidine isetionate therapy has been associated with neutropenia.

Hepatic/biliary/pancreatic.

Abnormal liver function tests may occur. Liver function should be routinely monitored in patients receiving pentamidine isetionate powder for Injection (see Section 4.4 Special Warnings and Precautions for Use, Monitoring and laboratory tests). Cases of acute pancreatitis have been observed with pentamidine isetionate treatment.

Immune.

Hypersensitivity reactions at the injection site, such as skin rash and erythema, may occur (see Section 4.4 Special Warnings and Precautions for Use, Skin; Section 4.8 Adverse Effects (Undesirable Effects)).

Skin.

Intramuscular injections are often associated with pain, tenderness, erythema, and induration at the site of injection. Sterile abscesses have been observed. Therefore, intramuscular administration should be reserved for patients with adequate muscle mass and limited to the rare situations where intravenous infusion is not feasible.

Vascular.

Phlebitis can occur after intravenous injection.

Monitoring and laboratory tests.

In order to monitor for possible toxicity, the following tests should be performed before, during and after treatment.
1. Blood urea nitrogen and serum creatinine daily during therapy.
2. Complete blood and platelet counts daily during therapy.
3. Fasting blood glucose measurements should be taken before, daily during therapy, and at regular intervals after completion of therapy. Hyperglycaemia and diabetes mellitus, with or without preceding hypoglycaemia, have occurred up to several months after cessation of therapy.
4. Liver function tests (LFTs) including serum bilirubin, alkaline phosphatase, aspartate aminotransferase (AST/SGOT), and alanine aminotransferase (ALT/SGPT). If baseline measurements are normal and remain so during therapy, test weekly thereafter. When there is baseline elevation in LFTs or LFTs increase during therapy, continue monitoring weekly unless the patient is on other hepatotoxic agents, when monitoring every 3 to 5 days is appropriate.
5. Serum calcium, test weekly.
6. Urine analysis and serum electrolytes daily during therapy.
7. Electrocardiograms at regular intervals.

Use in renal impairment.

Severe renal impairment resulting in death may also occur in the presence of various clinical complications (e.g. bacterial sepsis), concurrent administration of other nephrotoxic antibiotic agents or previous evidence of renal disease.

Use in the elderly.

There is no information on the safe use of pentamidine in the elderly.

Paediatric use.

The safety and efficacy of pentamidine isetionate for Injection has not been established in the paediatric population, and pharmacokinetic data are extremely limited.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Since nephrotoxic effects may be additive, the concurrent or sequential use of pentamidine isetionate with drugs having a nephrotoxic potential (e.g. aminoglycosides, amphotericin B, cisplatin, methoxyflurane or vancomycin) should be undertaken with caution. Pentamidine isetionate powder for injection should be administered with caution to patients who are receiving drugs with hepatotoxic potential or medication that can impair the haematopoietic system.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
(Category B3)
Category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed.
Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.
Pentamidine has been found to cross the placenta in rats given high doses late in pregnancy. Studies in rabbits have also shown pentamidine to be mildly embryotoxic, with an increase in postimplantation losses and delayed foetal ossification at doses of 1, 3 and 8 mg/kg of body weight.
It is not known whether pentamidine isetionate crosses the placenta or causes foetal harm when administered to pregnant women; therefore, pentamidine is contraindicated during pregnancy and should only be used when considered essential.
Since it is not known whether pentamidine isetionate is distributed into milk, the medicine is contraindicated during lactation and should only be administered to nursing mothers when considered essential.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.8 Adverse Effects (Undesirable Effects)

Fatalities due to severe hypotension, hypoglycemia, acute pancreatitis, renal impairment and cardiac arrhythmias have been reported in patients treated with pentamidine isetionate.

Life threatening reactions.

1. severe hypotension.
2. severe hypoglycaemia.
3. acute pancreatitis.
4. cardiac arrhythmias and cardiac arrest (including QT prolongation and torsades de pointes).
5. syncope.
6. ventricular tachycardia.
7. leucopenia (less than 1,000 cells per cubic millimetre).
8. thrombocytopenia (less than 20,000 cells per cubic millimetre).
9. acute renal failure.
10. hypocalcaemia.
11. Stevens-Johnson syndrome (single possible case).
12. toxic delirium.
13. Herxheimer reaction.
The above mentioned adverse effects can be severe, sometimes fatal, and require immediate corrective measures and withdrawal of treatment.

Other reactions.

1. azotaemia, glycosuria, increased creatinine levels, albuminuria.
2. abnormal liver function tests.
3. anaemia, leucopenia and thrombocytopenia.
4. hyperkalaemia, hyponatraemia, hypocalcaemia.
5. nausea and vomiting.
6. diabetes mellitus.
7. hyperglycaemia or hypoglycaemia.
8. dizziness, hypotension, syncope.
9. facial flushing, venous thrombosis.
10. rash.
11. taste disturbances.
12. local reactions at the injection site including abscess, pain, thrombophlebitis.
13. tachycardia, bradycardia.
14. hallucinations.
15. abscess and/or necrosis, rash, itching, alopecia, erythema multiforme.
16. depressed serum folate.
17. 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.

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. Healthcare professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-problems.

4.9 Overdose

There is no information available concerning the treatment of overdosage. There is no specific antidote. In general, overdosage would be expected to produce effects that are an extension of common adverse effects or of the serious metabolic sequelae observed. Treatment should be symptomatic and supportive. Neither peritoneal dialysis nor haemodialysis appear to remove the drug rapidly enough to cause a precipitous decline in the plasma concentration of pentamidine isetionate.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Pentamidine isetionate exhibits antiprotozoal activity against Pneumocystis carinii, Leishmania and some species of Trypanosoma.
The exact mechanism of antiprotozoal action of pentamidine has not been fully elucidated. Several mechanisms of action may be involved, and the role of the mechanism(s) may vary among the different types of protozoa (e.g. trypanosome, sporozoons). Most information on the antiprotozoal activity of pentamidine has been derived from studies involving trypanosomes. In vitro studies indicate that the drug interferes with nuclear metabolism.

Microbiology.

Pentamidine isetionate exhibits antiprotozoal activity against Pneumocystis carinii, Leishmania and some species of Trypanosoma.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Limited information is available concerning the pharmacokinetics of pentamidine isetionate.

Absorption.

Following a single 4 mg/kg IV dose of pentamidine isetionate (given as a 2 hour infusion), peak plasma pentamidine concentrations averaged 612 nanogram/mL after completion of the IV infusion.

Distribution.

Distribution of pentamidine into human body tissues and fluids has not been well characterised, but the drug appears to be rapidly and extensively distributed and/or bound to tissues. Pentamidine has a distribution half life of 5 to 15 minutes after intravenous administration. Following parenteral administration, highest concentrations have been found in the liver, followed by the kidneys, adrenals, spleen, lungs and pancreas. Pentamidine penetrates the CNS only very poorly after prolonged therapy.
In vitro, pentamidine is reportedly 69% bound to serum proteins.
It is not known whether pentamidine isetionate crosses the placenta or is distributed into breast milk.

Excretion.

Little is known about the elimination in humans. Plasma concentrations of pentamidine have been found to decline in a biphasic manner following a single IV infusion in patients with normal renal function. The mean elimination half life was found to be 18 minutes in the initial phase and 6.4 hours in the terminal phase. Pentamidine appears to be eliminated very slowly from tissues in which the drug principally accumulates (e.g. liver, lungs). The half life of pentamidine may be prolonged in patients with impaired renal function, however no correlation between renal function and plasma clearance of pentamidine has been found. It is not known if the drug is excreted in faeces.
Only a small amount (approximately 6%) of the administered dose is excreted unchanged in the urine over a 15 day period.
Following a single 4 mg/kg IV dose of pentamidine isetionate in patients with AIDS or pneumocystis pneumonia who had normal renal function, about 2.5 to 5% of the dose was excreted in urine as unchanged drug over 24 hours, mainly within the first 8 hours after administration. Similar amounts (about 1 to 4% of the dose) were also excreted in urine as unchanged drug in 24 hours in patients with mild to moderate renal impairment.
Limited data suggest that pentamidine is not appreciably removed by haemodialysis or peritoneal dialysis.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

None.

6.2 Incompatibilities

After reconstitution with water for injections, Pentamidine-EMC pentamidine isetionate powder for injection should not be mixed with any injection solution other than glucose intravenous infusion 5% or sodium chloride intravenous infusion 0.9%.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 25°C.
Product is for single use in one patient only. Discard any residue.

6.5 Nature and Contents of Container

20 mL clear glass (Type I) vial stoppered with 20 mm dark grey rubber stopper and sealed with 20 mm flip off seal.
Strength: 300 mg/vial.
Pack size: 1's.
AUST R: 338274.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.

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