128 Code Ref. No. xxxxxx

aspen

For the Medical Profession

Co-Trimoxazole

16 mg/80 mg per ml for Infusion co-trimoxazole

DOSAGE AND ADMINISTRATION INFORMATION ONLY

Please refer to the Summary of Product Characteristics for complete prescribing information.

Qualitative and Quantitative Composition

Solution for Infusion. Each 5 ml contains:

Trimethoprim 80 mg Sulfamethoxazole 400 mg Excipients:

This product contains 1.7 mmoles of sodium and 13.2 vol% ethanol (alcohol) per 5 ml.

For a full list of excipients, see Pharmaceutical Particulars.

Pharmaceutical Form

Solution for Infusion A clear liguid.

Posology and Method of Administration

Method of Administration: Co-Trimoxazole 16 mg/80 mg per ml for Infusion is for administration only by the intravenous route and must be diluted before administration.

It is intended that Co-Trimoxazole for Infusion should be used only during such a period as the patient is unable to accept oral therapy, where initiation of treatment is particularly urgent or for convenience if the patient is already receiving intravenous fluids. Although Co-Trimoxazole for Infusion is useful in critically ill patients, there may be no therapeutic advantage over the oral preparation.

For instructions on dilution of the product before administration, see Instructions for Use and Handling (and Disposal).

Standard dosage recommendations for acute infections

Adults and children over 12 years

2 ampoules (10 ml) every 12 hours.

Children aged 12 years and under

The recommended dosage is approximately 6 mg trimethoprim and 30 mg sulfamethoxazole per kg bodyweight per 24 hours, given in two equally divided doses. As a guide the following schedules may be used diluted as described above.

6 weeks to 5 months:    1.25 ml every 12 hours

6 months to 5 years:    2.5 ml every 12 hours

6 to 12 years:    5.0 ml every 12 hours

For severe infections in all age groups, dosage may be increased by 50%. Treatment should be continued until the patient has been symptom free for two days; the majority will reguire treatment for at least 5 days.

The elderly

See SPC section 4.4 Special warnings and precautions for use.

Impaired hepatic function

No data are available relating to dosage in patients with impaired hepatic function.

Special Dosage Recommendations

(Standard dosage applies unless otherwise specified)

Impaired renal function

Adults and children over 12 years (no information is available for children under 12 years of age):

Measurements of plasma concentrations of sulfamethoxazole at intervals of 2 to 3 days are recommended in samples obtained 12 hours after administration of Co-Trimoxazole 16 mg/80 mg per ml for Infusion. If the concentration of total sulfamethoxazole exceeds 150 micrograms/ml then treatment should be interrupted until the value falls below 120 micrograms/ml.

Pneumocystis jiroveci (P. carinii) pneumonitis Treatment

20 mg trimethoprim and 100 mg sulfamethoxazole per kg of bodyweight per day in two or more divided doses. Therapy should be changed to the oral route as soon as possible and continued for a total treatment period of two weeks. The aim is to obtain peak plasma or serum levels of trimethoprim of greater than or egual to 5 microgram/ml (verified in patients receiving 1-hour infusions of intravenous Co-Trimoxazole). (see SPC section 4.8 Undesirable Effects)

Prevention

Standard dosage for the duration of the period at risk.

Nocardiosis: There is no consensus on the most appropriate dosage.

Adult doses of 6 to 8 tablets daily for up to 3 months have been used (one tablet contains 400 mg sulfamethoxazole and 80 mg trimethoprim).

Toxoplasmosis: There is no consensus on the most appropriate dosage for the treatment or prophylaxis of this condition. The decision should be based on clinical experience. For prophylaxis, however, the dosages suggested for prevention of Pneumocystis jiroveci pneumonitis may be appropriate.

Overdose

The maximum tolerated dose in humans is unknown. Nausea, vomiting, dizziness and confusion are likely symptoms of overdosage. Bone marrow depression has been reported in acute trimethoprim overdosage. In cases of known, suspected or accidental overdosage, stop therapy. Dependent on the status of renal function, administration of fluids is recommended if urine output is low. Both trimethoprim and active sulfamethoxazole are dialysable by renal dialysis. Peritoneal dialysis is not effective.

Pharmaceutical Particulars

List of excipients

Propylene Glycol (E1520) Ph. Eur.

Tromethamine USP Sodium Hydroxide BP Sodium Metabisulphite (E223) BP Ethanol BP

Water for Injections Ph. Eur.

Incompatibilities

None known.

Shelf life

36 months

Special Precautions for Storage

Store below 30°C. Protect from light.

Nature and Contents of Container

Neutral glass ampoules (5 ml nominal fill volume)

Pack size: 10 x 5 ml ampoules

Instructions for Use and Handling (and Disposal)

Dilution should be carried out immediately before use. After adding Co-Trimoxazole 16 mg/80 mg per ml for Infusion to the infusion solution, shake thoroughly to ensure complete mixing. If visible turbidity or crystallisation appears at any time before or during an infusion, the mixture should be discarded.

It is recommended that Co-Trimoxazole 16 mg/80 mg per ml for Infusion is diluted according to the following schedules:

One ampoule (5 ml) to 125 ml infusion solution.

Two ampoules (10 ml) to 250 ml infusion solution.

Three ampoules (15 ml) to 500 ml infusion solution.

Co-Trimoxazole 16 mg/80 mg per ml for Infusion is known to be compatible, when diluted as recommended above, with the following fluids:

Glucose Intravenous Infusion BP(5%w/vand 10%w/v).

Sodium Chloride Intravenous Infusion BP (0.9% w/v).

Sodium Chloride (0.18% w/v) and Glucose (4% w/v) Intravenous Infusion BP.

Dextran 70 Injection BP (6% w/v) in glucose (5% w/v) or normal saline. Dextran 40 Injection BP (10% w/v) in glucose (5% w/v) or normal saline. Ringer's Solution for Injection BPC 1959.

No other substance should be mixed with the infusion.

The duration of the infusion should be approximately one to one and a half hours, but this should be balanced against the fluid reguirements of the patient. When fluid restriction is necessary, Co-Trimoxazole 16 mg/80 mg per ml for Infusion may be administered at a higher concentration, 5 ml diluted with 75 ml of glucose 5% w/v in water.

The resultant solution, whilst being clear to the naked eye, may on occasion exceed the BP limits set for particulate matter in large volume parenterals. The solution should be infused over a period not exceeding one hour. Discard any unused solution.

Co-Trimoxazole 16 mg/80 mg per ml for Infusion is licenced for sale in the UK

Aspen Pharma Trading Limited 3016 Lake Drive,

Citywest Business Campus,

Dublin 24,

Ireland

This leaflet was last revised in September 2015.

aspen

aspen

leaflet: Information for the User

Co-Trimoxazole

16 mg/80 mg per ml for Infusion co-trimoxazole

Read all of this leaflet carefully before you start taking this medicine

•    Keep this leaflet. You may need to read it again.

•    If you have any further questions, ask your doctor or pharmacist.

•    This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

•    If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

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

2.    Before you have Co-Trimoxazole

3.    How to have Co-Trimoxazole

4.    Possible side effects

5.    How to store Co-Trimoxazole

6.    Further information

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

Co-Trimoxazole 16 mg/80 mg per ml for Infusion (called 'Co-Trimoxazole' in this leaflet) is made up of two different medicines called sulfamethoxazole and trimethoprim. Both belong to a group of medicines called antibiotics. They are used to treat infections caused by bacteria. Like all antibiotics, Co-Trimoxazole only works against some types of bacteria. This means that it is only suitable for treating some types of infections.

Co-Trimoxazole can be used to treat or prevent:

•    lung infections (pneumonia or PCP) caused by a bacteria called Pneumocystis jiroveci(previously known as Pneumocystis carinii)

•    infections caused by a bacteria called Toxoplasma (toxoplasmosis).

Co-Trimoxazole can be used to treat:

•    bladder or urinary tract infections (water infections)

•    an infection called nocardiosis, it can affect the lungs, skin and brain.

Co-Trimoxazole 16 mg/80 mg per ml for infusion will usually only be given to you if you are unable to take medicines by mouth.

2. Before you have Co-Trimoxazole

Do not take Co-Trimoxazole if:

•    you are allergic (hypersensitive) to sulfamethoxazole, trimethoprim or co-trimoxazole or any of the other ingredients of Co-Trimoxazole (see section 6: Further information)

•    you are allergic to sulphonamide medicines. Examples include sulphonylureas (such as gliclazide and glibenclamide) or thiazide diuretics (such as bendroflumethiazide - a water tablet)

•    you have liver or kidney problems

•    you have ever had a problem with your blood

•    it is for your child and they are less than 6 weeks old or were premature. Unless it is for the treatment or prevention of PCP. In this case, babies should be at least 4 weeks old.

If you are not sure if any of the above apply to you, talk to your doctor or

pharmacist before taking Co-Trimoxazole.

Take special care with Co-Trimoxazole

Before you take Co-Trimoxazole, tell your doctor or pharmacist if:

•    you have severe allergies or asthma

•    potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported with the use of Co-Trimoxazole appearing initially as reddish target-like spots or circular patches often with central blisters on the trunk Additional signs

to look for include ulcers in the mouth, throat, nose, genitals and conjunctivitis (red and swollen eyes). These potentially life-threatening skin rashes are often accompanied by flu-like symptoms. The rash may progress to widespread blistering or peeling of the skin. The highest risk for occurrence of serious skin reactions is within the first weeks of treatment. If you have developed Stevens-Johnson syndrome or toxic epidermal necrolysis with the use of Co-Trimoxazole you must not be re-started on Co-Trimoxazole at any time.

•    you develop a rash or these skin symptoms, stop taking Co-Trimoxazole, seek urgent advice from a doctor and tell him that you are taking this medicine.

•    you have been told that you have a rare blood problem called porphyria, which can affect your skin or nervous system

•    you don't have enough folic acid (a vitamin) in your body - which can make your skin pale and make you feel tired, weak and breathless. This is known as anaemia.

•    you have ever had jaundice which can cause yellowing of your skin or the whites of your eyes

•    you have a problem with your metabolism called phenylketonuria and are not on a special diet to help your condition

•    you are elderly

•    you are underweight or malnourished

•    you have been told by your doctor that you have a lot of potassium in your blood

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Co-Trimoxazole.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This includes herbal medicines. This is because Co-Trimoxazole can affect the way some medicines work. Also some other medicines can affect the way Co-Trimoxazole works.

In particular tell your doctor or pharmacist if you are taking any of the following medicines:

•    Diuretics (water tablets), which help increase the amount of urine you produce

•    Pyrimethamine, used to treat and prevent malaria, and to treat diarrhoea

•    Ciclosporin, used after transplant operations or for your immune system

•    Medicines used to thin the blood such as warfarin

•    Phenytoin, used to treat epilepsy (fits)

•    Medicines for diabetes, such as glibenclamide, glipizide or tolbutamide (sulphonylureas)

•    Medicines to treat problems with the way your heart beats such as digoxin or procainamide

•    Amantadine, used to treat Parkinson's disease, multiple sclerosis, flu or shingles

•    Medicines to treat HIV (Human Immunodeficiency Virus), called zidovudine or lamivudine

•    Medicines that can increase the amount of potassium in your blood, such as diuretics (water tablets, which help increase the amount of urine you produce), steroids (like prednisolone) and digoxin

•    Methotrexate, a medicine used to treat cancer or for your immune system.

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Co-Trimoxazole.

Pregnancy and breast-feeding

Talk to your doctor before taking this medicine if you are pregnant, planning to get pregnant, or breast-feeding.

Important information about the ingredients of Co-Trimoxazole 16 mg/80 mg per ml for Infusion

Co-Trimoxazole 16 mg/80 mg per ml for Infusion contains

•    Sodium metabisulphite. This can cause allergic type reactions including 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.

•    13.2 vol% ethanol (alcohol). There can be up to 521 mg per dose. This is equivalent to 2.64 ml of beer, or 1.1 ml of wine. It may be harmful

if you are alcoholic. The ethanol content should also be taken in to account if you are pregnant or breast-feeding, a child or if you have liver problems or epilepsy.

•    1.7 mmoles (or 38.87 mg) of sodium. To be taken into consideration by patients on a sodium controlled diet.

3. Howto have Co-Trimoxazole

You will never be expected to give yourself this medicine. It will always be given to you by a person who is trained to do so. Co-Trimoxazole 16 mg/80 mg per ml for Infusion will be given to you as a continuous infusion into your vein. This is where the drug is slowly given to you over a period of time. Before the medicine is given to you it will be diluted. The dose you will be given and the frequency of the dose will depend on:

•    the type of infection you have

•    your weight

•    your age.

If you have kidney problems your doctor may:

•    prescribe a lower dose of Co-Trimoxazole

•    take blood to test whether the medicine is working properly.

If you are given too much Co-Trimoxazole

If you think you have been given too much Co-Trimoxazole, talk to your doctor or nurse straight away.

If you have been given too much Co-Trimoxazole 16 mg/80 mg per ml for Infusion you may:

•    feel or be sick

•    feel dizzy or confused.

4. Possible side effects

Like all medicines Co-Trimoxazole can cause side effects, although not everybody gets them. You may experience the following side effects with this medicine. Stop taking Co-Trimoxazole and tell your doctor immediately if you have an allergic reaction. Chances of an allergic reaction is very rare (fewer than 1 in 10,000 people are affected), signs of an allergic reaction include:

Allergic reactions

•    Difficulty in breathing

•    Fainting

•    Swelling of face

•    Swelling of mouth, tongue or throat which may be red and painful and/or cause difficulty in swallowing

•    Chest pain

•    Red patches on the skin

Very Common (more than 1 in 10 people)

•    High levels of potassium in your blood, which can cause abnormal heart beats (palpitations)

Common (less than 1 in 10 people)

•    An infection called thrush or candidiasis which can affect your mouth or vagina. It is caused by a fungus

•    Headache

•    Feeling sick (nausea)

•    Diarrhoea

•    Skin rashes

Uncommon (less than 1 in 100)

•    Being sick (vomiting)