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drug-medicine : co-trimoxazole

 

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Medicine: co-trimoxazole

PATIENT INFORMATION LEAFLET

This leaflet contains important information about your medicine; read it carefully.

Keep this leaflet; you may want to read it again.

If you have any questions or are not sure about anything, ask your doctor or pharmacist.

Co-Trimoxazole Sterile Concentrate

  • The active substances are trimethoprim and sulphamethoxazole.
  • The other ingredients are diethanolamine, propylene glycol, ethanol, sodium metabisulphite (E223), sodium hydroxide and Water for Injections.

1. What Co-Trimoxazole Sterile Concentrate is and what it is used for

Co-Trimoxazole is an antibiotic medicine (used to fight infections caused by bacteria) in the form of a concentrate for solution for infusion (a concentrated solution which is diluted to make a solution which can be given as a slow injection via a drip).

Each millilitre (ml) of solution contains 16 milligrams (mg) of trimethoprim and 80mg of sulphamethoxazole. It is presented in glass containers called ampoules. The 5ml ampoule contains 80mg of trimethoprim and 400mg of sulphamethoxazole, the 10ml ampoule contains 160mg of trimethoprim and 800mg of sulphamethoxazole and the 20ml ampoule contains 320mg of trimethoprim and 1600mg of sulphamethoxazole. It is available in packs containing 5 x 5ml, 5 x 10ml or 1 x 20ml ampoules.

Co-Trimoxazole is used in the:

  • treatment and prevention of lung infections caused by the bacteria Pneumocystis carinii (PCP)
  • treatment and prevention of toxoplasmosis and treatment of nocardia (diseases of the blood)
  • treatment of infections of the bladder or kidney (urinary tract infection)
  • treatment of bronchitis (inflammation of the airways)
  • treatment of ear infections in children

2. Before Co-Trimoxazole Sterile Concentrate is used

Co-Trimoxazole Sterile Concentrate should not be used:

  • if you have shown signs of hypersensitivity (severe allergy) to this or a similar medicine on previous occasions
  • if you have a certain type of anaemia due to folate deficiency.
  • if you have a form of liver disease
  • if you have suffer from certain blood disorders
  • if you have severe kidney disease
  • if you are pregnant or breastfeeding
  • in infants under 6 weeks of age (it can however be used to treat or prevent PCP in infants over 4 weeks of age).

Special care will be taken:

  • if you are an elderly person
  • if you have mild to moderate kidney disease or liver disease
  • if you suffer from severe allergies or asthma
  • if you suffer from porphyria (a build up of a substance called porphyria in the blood)
  • if you suffer from G6PD deficiency (a disease that causes abnormal destruction of your red blood cells)
  • if you have problems in passing urine
  • if you are taking certain other medicines such as:
    • methotrexate (anti-cancer medicine)
    • rifampicin (antibiotic medicine)
    • medicines used to thin your blood e.g. warfarin
    • phenytoin, primidone or barbiturates (medicines used to treat epilepsy)
    • pyrimethamine (medicine used to treat malaria)
    • urinary acidifiers
    • some water tablets e.g. acetazolamide
    • cyclosporin (a medicine that reduces the activity of the body’s immune system)
    • procainamide or digoxin (used to treat heart conditions)
    • amantadine (medicine used to treat Parkinson’s disease)
    • some tablets used for treating diabetes
    • some anti-inflammatory agents (e.g. phenylbutazone, oxyphenylbutazone and indomethacin)
    • some drugs used to treat thyroid disorders
    • Para-aminobenzoic acid (PABA) and some related drugs (such as aminobenzoic acid or aminobenzoates) are sometimes used to treat fibrosis type diseases such as scleroderma (hardening of the skin)
    • Some local anaesthetic agents
  • Regular blood tests may be taken by your doctor if you are on long – term therapy with co-trimoxazole, if you have low folic acid levels in your blood (e.g. elderly patients, chronic alcoholics, patients with rheumatoid arthritis), if you have a malabsorption disease or malnutrition or are treated with some anti-epilepsy drugs. This is because co-trimoxazole may alter the metabolism of folate.

 

Please tell your doctor if you are taking, or have recently taken, any other medicines, including ones that are not prescribed for you.

Do not drive or use machines:

  • if you experience any effect which may impair your ability to drive or use machines

Important information about three of the ingredients of Co-Trimoxazole Sterile Concentrate

This medicine contains sodium metabisulphite (E223), which can cause an allergic type reaction (skin rash, swelling of eyelids, face or lips, or difficulty in breathing). This is rare but you may be more at risk if you suffer from allergies or asthma.

This medicine contains propylene glycol which may cause alcohol like symptoms.

This medicinal product also contains 99.5 volume % ethanol (alcohol), i.e., up to 1200 mg per dose, equivalent to 30 ml beer, 12 ml wine per dose. Harmful for those suffering from alcoholism. To be taken into account in pregnant or breast-feeding women, children and high-risk groups such as patients with liver disease or epilepsy.

3. How Co-Trimoxazole Sterile Concentrate is used

The dose of medicine given to you will depend on your medical condition and how well your kidneys are working.

The standard dose in adults is 10ml twice a day but this may be adjusted depending on your individual circumstance (e.g. severe infection or kidney problems). It may be increased for severe infections. In children the dose will be given according to the body weight of the child. Treatment will normally only be for a few days or until you can take medicines by mouth (tablets or suspension).

This medicine will be diluted before it is given to you. It will be given slowly, usually via a drip into a vein.

As this medicine will be given to you whilst you are in hospital it is unlikely that you will be given too little or too much, however, tell your doctor or pharmacist if you have any concerns.

4. Possible Side Effects

Like all medicines, Co-Trimoxazole can have side effects.

If any of the following happen, tell your doctor immediately:

  • you find it difficult to breathe
  • chest pain
  • severe allergic reaction – you may experience a sudden itchy rash (hives), swelling of the hands, feet, ankles, face, lips, mouth or throat (which may cause difficulty in swallowing or breathing), and you may feel you are going to faint.

These are very serious side-effects. You may need urgent medical attention. All of these very serious side-effects are rare.

If you experience any of the following tell your doctor as soon as possible:

  • feeling or being sick
  • sore or swollen tongue or mouth ulcers
  • stomach pain, abdominal cramps and/or diarrhoea
  • fever
  • loss of appetite
  • yellowing of the skin (jaundice)
  • rashes, redness and scaling of the skin which may be itchy
  • blisters on the lips, eyes, mouth, nose, vagina or back passage
  • sensitivity of the skin to sunlight
  • sudden headache or stiffness in the neck, accompanied by fever (high temperature)
  • convulsions (sudden contraction of the muscles in your body)
  • tingling or numbness in the hands or feet
  • feeling unsteady or giddy
  • a feeling of either yourself or your surroundings constantly moving
  • ringing or other unusual sounds in the ears
  • headache or dizziness
  • depression
  • hallucinations (seeing things that are not there)
  • cough or shortness of breath
  • pain in the joints or muscles and rashes particularly on the face, fever, kidney, lung and heart problems (a disease known as systemic lupus erythematosus [SLE] )
  • pain and inflammation at the site of injection or other blood vessels
  • chest pain
  • changes in the amount of urine you pass, blood or cloudiness in your urine or difficulty passing urine

Other side effects that may occur are:

  • alteration in blood cells or blood chemistry
  • changes in liver enzymes or kidney function

Your doctor will monitor you for these side effects.

If you are suffering from Pneumocystis Carinii lung infection (PCP), the side effects may be more severe.

If you notice any side effects not mentioned in this leaflet, please tell your doctor or pharmacist.

5. Storing Co-Trimoxazole Sterile Concentrate

Keep out of the reach of children.

The ampoules should not be stored above 30°C. They should not be kept in the fridge.

The ampoules should be kept in the outer carton to protect from light.

This medicine should not be used after the expiry date printed on the ampoule label and carton.

 

 

Medicamentweb.com, the website for Patient Information Leaflets, is dedicated to share information about pharmaceutical products with the general public, and is particularly interested in making PILs available online. Of course, this information cannot replace the advice of your GP, doctor or pharmacist. If you should be worried in any way about your health, we urge you to see a doctor.

 

 

 

 

 

 

 

 

 

 

 

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