Eusaprim 16 mg/ml + 80 mg/ml concentrate for solution for infusion trimethoprim + sulfamethoxazole
1. What Eusaprim Is And What Eusaprim Used For
Eusaprim 16 mg/ml + 80 mg/ml concentrate for solution for infusion (called “Eusaprim” in this leaflet) is a combination of two different antibiotics called sulfamethoxazole and trimethoprim. It is used to treat infections caused by bacteria. This drug combination is also called co-trimoxazole. Like all antibiotics, Eusaprim only works against certain types of bacteria. This means that it is only suitable for treating certain types of infection.
Eusaprim can be used to treat or prevent the following:
- Lung infections ( pneumonia or Pneumocystis jirovecii – pneumonia ) caused by a bacterium called Pneumocystis jirovecii
- Infection is caused by a bacterium called Toxoplasma (toxoplasmosis).
Eusaprim can be used to treat:
- Bladder or urinary tract infections
- An infection called nocardiosis that can affect the lungs, skin, and brain.
- Eusaprim infusion is usually only given to you if you cannot take medicines by mouth.
- Eusaprim concentrate for solution for infusion is intended for children from 6 weeks of age and adults (> 18 years).
The account should be taken of official guidelines regarding the appropriate use of antibacterial agents.
2. What You Need To Know Before Using Eusaprim
It would help if you were not given Eusaprim:
- If you are allergic (hypersensitive) to sulfamethoxazole, trimethoprim, cotrimoxazole, or any of the other ingredients of Eusaprim (see section 6: Contents of the pack and other information)
- If you are allergic to sulfonamide medicines. Such drugs may be sulphonylureas (eg glyclazide and glibenclamide) or thiazide diuretics (eg bendroflumethiazide – a diuretic tablet)
- If you have severe renal impairment
- If you have severe hepatic impairment
- If you have ever had problems with your blood that have caused bruising and bleeding ( thrombocytopenia )
- If you have ever been told that you have a rare blood problem called porphyria, which can affect your skin or nervous system.
- Eusaprim should not be given to infants during the first 6 weeks of life.
- If you are unsure if any of the above applies to you, talk to your doctor or pharmacist before taking Eusaprim.
Warnings And Cautions
Talk to your doctor, pharmacist, or nurse before receiving Eusaprim:
- You must seek medical attention immediately if you develop a rash during treatment. Rash that may be life-threatening ( Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug-induced rash with eosinophilia and systemic symptoms) have been reported using sulfamethoxazole and trimethoprim. See section 4 for more information on symptoms.
- At the beginning of treatment, generalized blushing with blisters and fever should raise suspicion of a serious reaction called acute generalized exanthematous pustulosis (AGEP) (see section 4).
- If you have severe allergies or severe asthma
- If you have kidney disease
- If you have been told that you are at risk for a rare blood disorder called porphyria that can affect your skin or nervous system
- If you do not have enough folic acid (a vitamin ) in your body, it can make your skin pale and make you feel tired, weak, and short of breath. This is called anaemia.
- If you have a condition called glucose -6-phosphate dehydrogenase deficiency, which may cause jaundice or spontaneous red blood cell breakdown
- If you have a metabolic problem called phenylketonuria and are not on a special diet to improve your condition
- If you are older
- If your doctor has told you that you have a lot of potassium in your blood
- If you are underweight or malnourished
- If you have a severe blood disorder, such as low red blood cell count (anaemia), low white blood cell count ( leukopenia ), or low platelet count, which may cause bleeding and bruising ( thrombocytopenia ).
Other Medicines And Eusaprim
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. The reason is that Eusaprim may affect how some other medicines work, and some other medicines may affect how Eusaprim works.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines:
- Diuretics ( diuretic tablets) that can increase the amount of urine you produce
- Pyrimethamine used to treat and prevent malaria and to treat diarrhoea
- Ciclosporin used after organ transplants
- Blood-thinning drugs such as warfarin
- Phenytoin is used to treat epilepsy (seizures)
- Drugs for the treatment of diabetes, e.g.
- Glibenclamide
- Glipizide
- Tolbutamide (sulphonylureas)
- Repaglinide
- Drugs to treat heart problems, e.g. digoxin or procainamide
- Amantadine is used to treat Parkinson’s disease, multiple sclerosis, influenza, or shingles
- Medicines to treat HIV (human immunodeficiency virus), called zidovudine or lamivudine
- Drugs that can increase the amount of potassium in the blood, e.g. diuretics ( diuretic tablets such as spironolactone, which helps increase the amount of urine you produce) or ACE inhibitors (can be used to treat high blood pressure or certain heart problems)
- Azathioprine, which can be used in patients after organ transplantation or for the treatment of disorders of the immune system or inflammatory bowel diseases
- Methotrexate is a medicine used to treat certain cancers or certain diseases that affect the immune system
- Rifampicin which is an antibiotic
- Folic acid.
Pregnancy And Breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Eusaprim should not be used during pregnancy, especially during the first 3 months, unless necessary. If breastfeeding, you should avoid Eusaprim as your baby would be at increased risk of jaundice.
See the next section for more information on the medicine’s ethanol content.
Driving And Using Machines
Some patients have experienced dizziness or fainting when using Eusaprim. Do not drive or use machines if you experience these side effects.
Eusaprim contains
- Sodium metabisulfite. This can lead to allergic reactions, e.g. rash, swelling of the eyelids, face, or lips, or difficulty breathing. These reactions are rare, but the risk of being affected may be greater if you suffer from allergies or asthma.
- 13.2% by volume of ethanol (alcohol). It can be up to 521 mg per dose, equivalent to 13.2 ml of beer or 5.5 ml of wine. This can be harmful if you are an alcoholic. You should also consider the ethanol content if you are pregnant or breastfeeding, have a baby, or have liver problems or epilepsy.
- 1.7 mmol (or 38.87 mg) sodium. This should be considered for patients prescribed a low-salt diet.
How To Use Eusaprim
- You are never expected to give yourself this medicine. It is always given by trained staff.
- Eusaprim is given as a continuous infusion into a vein. This happens slowly over a while.
- Before you receive the medicine, it will be diluted.
What you receive and how often you receive a dose depends on the following:
- What type of infection do you have
- Severity of infection
- Your weight
- Your age
Dosage
- Norm Aldo Recommendations for acute infections
Adults (> 18 years)
| Age | Dose |
| Adults (> 18 years) | 2 ampoules (5 ml) morning and evening. The maximum dose is 3 ampoules (5 ml) of Eusaprim morning and evening. |
The usual dose for children is approximately 6 mg trimethoprim and 30 mg sulfamethoxazole per kg body weight per day, divided into two equal doses. The schedule for children corresponds to the child’s age and body weight according to the table below:
Children 12-18 years how
| Age | Dose |
| Children 12-18 years | 2 ampoules (5 ml) morning and evening. The maximum dose is 3 ampoules (5 ml) of Eusaprim morning and evening. |
Children from 6 weeks up to 12 years of age
| Age | Dose |
| Children from 6 weeks up to 6 months | 1.25 ml morning and evening |
| Children from 6 months up to 6 years | 2.5 ml morning and evening |
| Children 6-12 years | 5 ml morning and evening |
The infusion lasts about 1–1.5 hours, balanced against your fluid needs.
If you have kidney problems, your doctor may
- Prescribe a lower dose of Eusaprim
- Take blood samples to check if the medicine is working properly.
If you have been taking Eusaprim for a long time, your doctor may
- Take blood samples to test if the medicine works properly
- Prescribe folic acid (a vitamin ) that you should take at the same time as Eusaprim.
If You Take More Eusaprim Then, You Should
If you have been given too much Eusaprim, contact your doctor or nurse immediately.
If you think you have been given too much Eusaprim, you can:
- Feel nauseous or vomit
- Feel dizzy or confused
4. Possible Eusaprim Side Effects
This medicine can cause side effects like all medicines, although not everybody gets them.
You may experience the following side effects with this medicine.
Contact a doctor immediately if you have an allergic reaction. The risk of an allergic reaction is very low (less than 1 in 10,000 people are affected). Signs of an allergic reaction include:
- Allergic reactions
- Difficulty breathing
- Fainting
- Swelling of the face
- Swelling of the mouth, tongue, or throat may become red and painful and lead to difficulty swallowing.
- Chest pain
- Red spots on the skin
You must seek medical attention immediately if you develop a rash during treatment. Rash that may be life-threatening ( Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug-induced rash with eosinophilia and systemic symptoms) has been reported with sulfamethoxazole and trimethoprim. It can start as reddish-purple, target-like spots or round spots with blisters in the middle, often symmetrically distributed on the body. These skin reactions, which can be life-threatening, often occur along with flu-like symptoms. The rash can develop into widespread blistering or flaking of the skin. Additional signs of being aware of are sores in the mouth, throat, nose, or genitals or conjunctivitis(red and swollen eyes). If you get a rash or signs of these skin reactions, stop taking Eusaprim immediately, seek emergency medical advice and tell your doctor that you are taking this medicine.
Get Stevens-Johnson syndrome, toxic epidermal necrolysis, or drug-induced rash with eosinophilia and systemic symptoms after using sulfamethoxazole and trimethoprim, which are found in Eusaprim. You can never use drugs containing sulfamethoxazole or trimethoprim again.
The greatest risk of serious skin reactions is within the first few weeks of treatment.
Other side effects include:
Very common Eusaprim side effects (more than 1 in 10 people)
- High potassium levels in the blood can lead to abnormal heartbeats ( palpitations ).
Regular (less than 1 in 10 people)
- A fungal infection called cod or candida can affect the mouth or vagina
- Headache
- Nausea
- Diarrhoea
- Rash
Uncommon (less than 1 in 100 people)
- Vomiting
Very rare (less than 1 in 10,000 people)
- High fever or recurrent infections
- Wheezing or difficulty breathing
- A potentially life-threatening rash ( Stevens-Johnson syndrome, toxic epidermal necrolysis ) has been reported (see Warnings and Precautions)
- Very rare cases of generalized redness of the whole body ( acute generalized exanthematous pustulosis (AGEP)) (see section 2)
- Sores in the mouth, cold sores and sores or soreness on the tongue
- Lumps of skin or hives (raised, red or white, itchy spots on the skin)
- Blisters on the skin or in the mouth, nose, vagina, or tail
- Inflammation of the eye leads to pain and redness
- Rash or sun damage when you have been out (even on cloudy days)
- Low levels of sodium in the blood
- Changed blood levels
- Feeling weak, tired or listless, pale skin (anaemia)
- Heart problems
- Jaundice (skin or whites of the eyes turn yellow). This can occur at the same time as unexpected bleeding or a bruise.
- Abdominal pain, which may occur with blood in the stool
- Pain in the chest, muscles or joints and muscle weakness
- Arthritis
- Urinary problems. Difficulty urinating. You urinate more or less than usual. Blood in the urine or cloudy urine
- Kidney problems
- Sudden headache or stiffness in the neck, accompanied by fever
- Problems controlling movements
- Seizures (convulsions or seizures)
- Instability or dizziness
- Ringing or unusual sounds in the ears
- Tingling or numbness in the hands or feet
- You get strange or unusual visions (hallucinations)
- Depression
- Muscle pain or muscle weakness in HIV patients
- Loss of appetite
Has been reported (occurs in an unknown number of users)
- Psychotic states (mental states that can cause you to lose touch with reality)
- Drug-induced rash with eosinophilia and systemic symptoms (a type of allergic reaction that can cause fever, rash, and abnormal results on blood tests and liver function tests [may be a sign of multiple organ failure])
- Plum-colored raised and painful sores on limbs and sometimes on the face and neck, along with fever (Sweet’s syndrome).
5. How To Store Eusaprim
- Keep this medicine out of sight and reach of children
- Protect from heat and direct sunlight.
- Use before the expiry date, which is stated on the carton and label.
- Store in the original package together with the package leaflet.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer required. These measures will help to protect the environment.
6. Contents Of The Packaging And Other Information
Content Declaration
- The active substances are sulfamethoxazole and trimethoprim. This combination of drugs is sometimes called cotrimoxazole. 5 ml Eusaprim contains 400 mg sulfamethoxazole and 80 mg trimethoprim.
- The other ingredients are:
- Propylene glycol (E1520)
- Tromethamine
- Sodium hydroxide (E524)
- Sodium metabisulfite (E223)
- Ethanol
- Water for injection
What The Medicine Looks Like And The Contents Of The Pack
- Eusaprim 16 mg / ml + 80 mg / ml concentrate for solution for infusion in a 5 ml glass ampoule .
- Each 5 ml ampoule contains 400 mg of sulfamethoxazole and 80 mg of trimethoprim.
- The ampoules are delivered in packs of 10 pcs.
Marketing Authorization Holder And Manufacturer
Marketing Authorisation Holder:
Aspen Pharma Trading Limited
3016 Lake Drive,
Citywest Business Campus,
Dublin 24, Ireland
Manufacturer:
Aspen Bad Oldesloe GmbH, Industriestrasse 32-36,
D-23843 Bad Oldesloe
Germany