300 mg powder for injection / infusion / nebulizer solution,
pentamine diisethionate solution
What Pentacarinate is and what it is used for
Pentacarinate is a remedy for protozoa (unicellular organisms ) and is used prophylactically and in the treatment of pneumonia caused by Pneumocystis carinii (PCP) and in the treatment of sleeping sickness.
What you need to know before you take Pentacarinate
Do not use Pentacarinate
– if you are allergic (hypersensitive) to pentamidine.
Warnings and cautions
Talk to your doctor or nurse before taking Pentacarinate:
– if you have impaired liver or kidney function
– if you have too high or too low blood pressure
– if you have an abnormally high or low blood sugar level
– if you have low blood pressure
During inhalation therapy, Pentacarinate should be used with caution in people with asthma and when there is a risk of air or gas accumulating in the alveoli (pneumothorax).
Other medicines and Pentacarinate
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Pentacarinate in combination with phentiazines (for mental disorders), tricyclic antidepressants (for depression), terfenadine, astemizole (for allergies ), erythromycin ( antibiotics ), halofantrine (for malaria ) and quinolones ( antibiotics ) may increase the risk of heart rate. Foskarnet (antiviral agent) can lead to decreased calcium levels.
Pregnancy and breastfeeding
If you are pregnant, breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy: It is unclear whether Pentacarinate affects fetal development and the medicine should not be used during pregnancy unless directed to do so by a doctor.
Breast-feeding: It is unknown whether Pentacarinate passes into breast milk and the medicine should not be used during breast-feeding unless prescribed by a doctor.
Driving and using machines
Dizziness has been reported with the use of Pentacarinate. You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
How to take Pentacarinate
Always use Pentacarinate exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure. Dose one is determined by the doctor, who adjusts it individually for you.
Recommended dose for:
Treatment of pneumonia: 4 mg/kg body weight once daily for 14-21 days as an intravenous infusion.
Prevention of pneumonia: 300 mg is inhaled once a month or 150 mg every fortnight.
Treatment of sleeping sickness: 4 mg/kg body weight once daily or every other day up to a total of 7-10 doses as an intravenous infusion.
If you take more Pentacarinat than you should
If you have ingested too much medicine or if, for example, a child has accidentally ingested the medicine, contact a doctor or hospital for risk assessment and advice.
If you forget to take Pentacarinate
Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Injection treatment
Up to 50% of patients experience serious side effects during treatment, such as low blood pressure , low blood sugar and effects on kidney function.
Contact a doctor immediately if you get any of the following symptoms:
- Severe skin damage (skin detachment of the epidermis and superficial mucous membranes). This may be a sign of toxic epidermal necrolysis which is a common side effect (affects more than 1 in 100 people).
- Swelling of the face, tongue or throat; difficulty swallowing; hives and difficulty breathing ( angioedema ). This side effect has been reported (affects an unknown number of users).
- Unexplained muscle pain, muscle cramps or muscle weakness ( rhabdomyolysis ). This side effect has been reported (affects an unknown number of users).
- An extremely severe allergic reaction with skin rash, usually in the form of blisters or sores in the oral cavity and eyes as well as other mucous membranes, such as genitals (Steven-Johnson syndrome). This side effect has been reported (affects an unknown number of users).
Other side effects include:
Very common (affects more than 1 patient in 10):
Increased nitrogen content in the blood. Acute renal failure. Blood in the urine. Local reactions at the injection site such as pain and discomfort. Acne, calluses and muscle necrosis at the injection site.
Common (affects more than 1 patient in 100):
Decreased white blood cell count. Bruising or bleeding in the skin due to decreased platelet count . Anemia. Low blood sugar. High blood sugar content. Increased potassium content in the blood. Decreased calcium and magnesium content in the blood. Dizziness, fainting. Low blood pressure. Hot flashing. Cough. Cramps in the muscles of the trachea, often associated with increased mucus secretion and thus difficulty breathing. Nausea, vomiting, taste change. Abnormal liver function tests. Skin rash, redness, itching. Kidney impact. Feeling of pressure behind the sternum.
Rare (affects less than 1 in 1,000 people):
Allergic reaction with fever, rash, local fluid swelling and drop in blood pressure (anaphylactic shock ). Diabetes mellitus (may debut several months after treatment). Influence on the rhythm of the heart. Inflammation of the pancreas.
Has been reported (occurs in an unknown number of users):
Influence on the rhythm of the heart ( Torsade de Pointes ). Hypersensitivity reactions include anaphylactic reactions ( acute and severe allergic reaction ). Slow heartbeat ( bradycardia ).
Applies to intravenous treatment only:
Tingling and numbness in the arms and legs as well as reduced sensitivity to touch around the mouth have been reported in both children and adults. The symptoms occurred during infusion or shortly after the start of the infusion but ceased after discontinuation or discontinuation of administration.
Side effects that occur with injection therapy can in rare cases occur with inhalation.
Inhalation treatment
2-5% of patients discontinue inhalation due to side effects, usually due to nausea or cough/spasm of the trachea.
Contact a doctor immediately if you get any of the following symptoms:
Swelling of the face, tongue or throat; difficulty swallowing; hives and difficulty breathing ( angioedema ). This side effect has been reported (affects an unknown number of users)
Other side effects include:
Common (affects more than 1 patient in 100):
Nausea, taste change, cough, shortness of breath, convulsions in the trachea, wheezing or hissing sounds from the airways (especially in smokers and asthmatics). Preventive inhalation of certain drugs can counteract these ailments.
Rare (affects less than 1 in 1,000 people):
Allergic reaction with fever, rash, local fluid swelling and drop in blood pressure (anaphylactic shock ). Allergic pneumonia .
Has been reported (occurs in an unknown number of users):
Low blood sugar. Feeling drunk. Low blood pressure. Accumulation of air or gas in the alveoli that can cause chest pain and difficulty breathing. Inflammation of the pancreas ( acute ). Rash. Kidney failure . Fever. Decreased appetite. Fatigue. Hypersensitivity reactions include anaphylactic reactions ( acute and severe allergic reaction ). Slow heartbeat ( bradycardia ).
How to store Pentacarinat
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label. The expiration date is the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Other information
Content declaration
The active substance is pentamidine diisethionate. One vial contains 300 mg of pentamidine diisethionate.
What the medicine looks like and contents of the pack
One pack contains 5 vials.