Pentamidine is used to treat leishmaniasis, a tropical infectious disease caused by the Leishmania parasite. This small organism can be transmitted to humans in certain tropical regions through insect bites or by sand flies. There are different types of Leishmania parasites, each causing different symptoms. Some cause only skin damage, such as ulcers that are difficult or impossible to heal. Other variants of this parasitic infection also damage mucous membranes or internal organs. The different variants are treated in different ways, depending on the symptoms and the specific variant of the parasite.
For some forms of leishmaniasis, treatment with pentamidine is necessary. Pentamidine (Pentacarinat®) is primarily used for the Leishmania species Leishmania b. guyanensis . This type is common in Suriname and French Guiana, and is therefore often seen in the Netherlands as a tropical imported disease among tourists who have visited the interior of Suriname. Pentamidine kills the Leishmania parasite. Although the drug can have significant side effects, it is considered the best treatment for this form of leishmaniasis. These side effects are well-known and temporary. By precisely calculating the dosage based on your body weight and by having regular check-ups (blood pressure, pulse, ECG, blood tests) before and during treatment, the drug can be used safely.
Before treatment, it is important that you tell your doctor if you have ever been treated with pentamidine or similar drugs and whether you have experienced any side effects. You should also report any other illnesses you currently have, especially heart disease, cardiac arrhythmias, liver disease, or kidney disease. You should also tell your doctor all medications you are taking, including over-the-counter medications.
Pentamidine can be administered by intramuscular injection or intravenously. For intramuscular injection, it is administered in two divided doses; for intravenous administration, it is administered slowly (over 60 minutes). The treatment takes place in the hospital and consists of four sessions, administered Monday - Wednesday - Friday - Monday. Treatment is provided as an outpatient procedure or as a short hospital stay. You will be monitored and observed before, during, and after the administration. If you choose outpatient procedure, you can go home two hours after the administration, provided everything is in order. If any side effects occur, the treatment will be stopped or temporarily interrupted.
An ECG (heart tracing) is performed several times before and during treatment. If any abnormalities are detected on the ECG, treatment will be stopped. Blood pressure and pulse are also monitored regularly during treatment. Blood tests are also performed before and during treatment to detect any damage to internal organs such as the kidneys, liver, and pancreas at an early stage. If any abnormal blood values are found, treatment will be stopped or temporarily interrupted.
PACKAGE LEAFLET TEXT OF PENTAMIDINE (PENTACARINAT®)
Pentacarinat® 300, powder for solution for injection
Composition:
The active substance is pentamidine isethionate. One vial of Pentacarinat contains 300 mg pentamidine isethionate. This corresponds to 0.575 mg pentamidine base.
Other ingredients (excipients): Pentacarinat does not contain any excipients
Marketing Authorisation Holder:
Aventis Pharma BV
Bijenvlucht 30
3871 JJ Hoevelaken
Telephone: 033 - 25 33 911
Pentacarinat is registered in the register under RVG 13417
1. What is Pentacarinat and what is it used for?
Pentacarinat is available as a powder for solution for injection. Pentacarinat is packed in glass vials with a rubber stopper and aluminium seal. One pack contains 5 vials. Each vial contains 300 mg of pentamidine isethionate.
Pentacarinat belongs to the group of antiprotozoa. These medicines are used to combat infectious diseases caused by protozoa (single-celled animals, such as Pneumocystis carinii and certain forms of leishmaniasis). Pentacarinat is used to treat pneumonia caused by Pneumocystis carinii in AIDS patients who cannot use co-trimoxazole or in whom co-trimoxazole is ineffective.
2. What you need to know before you use Pentacarinat
Do not use Pentacarinat:
- if you have been shown to be sensitive to any of the ingredients of this medicine.
Take special care with Pentacarinat:
- if you have low blood pressure (hypotension) or high blood pressure (hypertension). Your doctor will monitor your blood pressure during and immediately after taking Pentacarinat.
- if you have too little (hypoglycemia) or too much sugar (hyperglycemia) in your blood.
You can recognize low blood sugar levels by feeling hungry, sweating, dizziness, and palpitations. Your blood sugar level should be checked regularly.
- if you have inflammation of the pancreas. You can recognize this by severe pain in the upper abdomen radiating to the back, and nausea and vomiting (pancreatitis).
- if you suffer from heart rhythm disturbances (arrhythmias). Your doctor will regularly check your heart with an electrocardiogram (ECG).
- if you have severe kidney or liver problems. If your kidneys are not functioning properly, your dosage must be adjusted.
- if you have a blood count disorder (leukopenia, thrombocytopenia, anemia).
- if your heart beats too fast.
Consult your doctor if any of the above warnings apply to you, or have applied in the past.
Pregnancy:
Administration during pregnancy is not recommended unless your doctor considers it necessary. Ask your doctor or pharmacist for advice before taking any medicine. Also consult a doctor if you are taking Pentacarinat and wish to become pregnant.
Breastfeeding:
The use of Pentacarinat during breastfeeding is not recommended. If your doctor considers it necessary to treat you with this medicine, you are advised to stop breastfeeding. Pentacarinat could be harmful to your baby. Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines:
No data are available on this. Pentacarinat can occasionally cause side effects, such as dizziness. In that case, it is not advisable to drive or operate machinery.
Using Pentacarinat in combination with other medicines:
Please note: the following information may also apply to the use of medicines recently or in the near future.
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Pentacarinat may interact with the following medicines. Your doctor can tell you if you are taking any of these:
- medicines to lower your blood levels
- medicines that are toxic to your kidneys
- medicines that affect your heart and blood vessels, kidney, liver or pancreas function
- medicines that affect your blood count
- if you are taking medicines to combat viruses (such as didanosine or zidovudine)
3. How is Pentacarinat used?
- The dosage varies per patient and will be determined by your doctor
- Pentacarinat is usually administered slowly as an infusion, but can also be injected into a muscle. You should lie down during the administration.
- In patients with normal kidney function, the usual dose for Pneumocystis carinii is 4 mg/kg body weight per day for 14 days. If the effect is insufficient, treatment can be continued for a further week. For Leishmaniasis guyanensis, the dosage is also 4 mg/kg, but a total of 4 doses is sufficient, in a schedule Mon - Wed - Fri - Mon. These can be given via an IV or injected into the muscle.
- in patients with reduced kidney function, the dose should be
adjusted (creatine clearance <10 ml/min). Your doctor will reduce the dosage.
- In patients with impaired liver function but normal kidney function, your doctor will determine whether Pentacarinat can be administered.
If you notice that the effect of Pentacarinat is too strong or too weak, consult your doctor.
What to do if you take too much Pentacarinat:
The injection will be administered to you by a doctor or nurse, so the risk of an overdose is extremely small. If this does happen, the doctor or nurse will take action.
4. Possible side effects
Like all medicines, Pentacarinat can cause side effects, although not everyone gets them.
The most serious side effects that have been reported during treatment with Pentacarinat are low blood pressure (hypotension), low blood sugar (hypoglycemia) accompanied by feelings of hunger, sweating, dizziness and palpitations, acute inflammation of the pancreas (pancreatitis) and heart rhythm disturbances (arrhythmias).
It is customary to report whether side effects occur frequently, rarely (>1:10,000 to <1:1000), or very rarely. The frequency of most side effects of Pentacarinat is unknown because there is insufficient data to estimate this.
Blood and lymphatic system:
- decreased white blood cell count (leukopenia), accompanied by increased susceptibility to infections
- decreased platelet count (thrombocytopenia), accompanied by bruising and a tendency to bleed
- anemia
Nutritional and metabolic disorders:
- low blood sugar (hypoglycemia), accompanied by hunger, sweating, dizziness, and palpitations.
- increased blood sugar (diabetes). If this level remains too high for a prolonged period, unconsciousness (diabetic coma) may occur.
- low potassium levels in the blood (hypokalemia), which in severe form can be recognized by muscle cramps or muscle weakness and fatigue.
- low sodium levels in the blood (hyponatremia).
- too little magnesium in the blood (hypomagnesemia).
- too much potassium in the blood (hyperkalemia), sometimes manifesting as muscle cramps, diarrhea, nausea, dizziness, headache.
- too high sugar levels in the blood (hyperglycemia) .
Psychiatric disorders:
- acute psychiatric disorder (toxic delirium), characterized by, among other things, decreased attention, incoherent speech, disturbance in consciousness, anxiety, chaotic thinking, and memory disorders.
Nervous system disorders:
- dizziness.
- fainting (syncope).
Heart disorders:
- heart rhythm disturbances (arrhythmias), including a faster heart rate (ventricular tachycardia).
Vascular disorders:
- rarely: vein inflammation due to the infusion (phlebitis).
- low blood pressure (hypotension).
- rarely: shock (significant drop in blood pressure, pallor, restlessness, weak, rapid pulse, clammy skin, decreased consciousness) due to sudden severe vasodilation as a result of severe hypersensitivity to certain substances (anaphylactic shock).
Gastrointestinal disorders:
- acute inflammation of the pancreas (pancreatitis).
- rarely: severe damage to the pancreas can lead to diabetes.
- decreased taste (dysgeusia) and altered taste (metallic aftertaste).
- nausea and vomiting.
- inflammation of the liver manifesting as abnormalities in blood tests (increased liver enzyme levels) and sometimes by jaundice.
Skin disorders:
- allergic reaction, patchy rash over the body
- hot flushes (flushing)
- attack of intensely itchy bumps (hives, urticaria)
- rarely: Stevens-Johnson syndrome, a serious hypersensitivity reaction with fever and a rash with blisters on the body, oral cavity, lips, and eyes, and sometimes with joint pain.
Muscles:
- breakdown of muscle tissue (rhabdomyolysis) accompanied by muscle cramps, fever, and reddish-brown discoloration of the urine.
- death of muscle tissue (muscle necrosis).
Kidneys and urinary tract:
- acute decreased kidney function (renal impairment).
- increased blood nitrogen levels (azotemia).
- blood in the urine (hematuria).
Local reactions:
- with infusion: pain, reddening of the injection site, vein inflammation
- with intramuscular administration: mild pain and abnormalities at the injection site such as redness and swelling and/or hardening of the skin (induration).
- accumulation of pus (formation of an abscess).
5. How to store Pentacarinat?
Do not store above 30°C.
After preparing the solution, store at 2-8°C (in a refrigerator).
Expiry date
Do not use Pentacarinat after the expiry date which is stated on the carton and on the bottle after the words "do not use after" or "exp".
If you experience any side effects during use or have any other questions, please contact your doctor.
|
