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CO-TRIMOXAZOLE 16 MG/80 MG PER ML FOR INFUSION

Active substance(s): SULFAMETHOXAZOLE / TRIMETHOPRIM / SULFAMETHOXAZOLE / TRIMETHOPRIM / SULFAMETHOXAZOLE / TRIMETHOPRIM

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The following information is intended for healthcare
professionals only

Co-Trimoxazole

16 mg/80 mg per ml for Infusion
Trimethoprim-sulfamethoxazole
DOSAGE AND ADMINISTRATION INFORMATION ONLY
Please refer to the Summary of Product Characteristics for complete
prescribing information.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml of Co-Trimoxazole 16 mg/80 mg per ml for Infusion contains
80 mg Trimethoprim and 400 mg Sulfamethoxazole.
Excipients:
This product contains 1.7 mmoles of sodium, 13.2 vol % ethanol (alcohol)
per 5 ml and sodium metabisulphite.
For the full list of excipients, see section Pharmaceutical Particulars.
PHARMACEUTICAL FORM
Solution for Infusion
A clear liquid.
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
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.
Age

Dosage

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 require 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):
Creatinine Clearance (ml/min)

Recommended Dosage

More than 30

STANDARD DOSAGE.

15-30

Half the STANDARD DOSAGE.

less than 15

Not recommended.

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 equal 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.
Method of Administration:
Co-Trimoxazole 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
special precautions for disposal and other handling.
OVERDOSE
Symptoms and signs
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.
Treatment
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.
Acidification of the urine will increase the elimination of trimethoprim.
Inducing diuresis plus alkalinisation of urine will enhance the elimination
of sulfamethoxazole. Alkalinisation will reduce the rate of elimination of
trimethoprim. Calcium folinate (5 to 10 mg/day) will reverse any folate
deficiency effect of trimethoprim on the bone marrow should this occur.
General supportive measures are recommended.
PHARMACEUTICAL PARTICULARS
List of excipients
Propylene Glycol (E1520) Ph Eur
Tromethamine USP
Sodium Hydroxide (E524) 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
Special precautions for disposal and other handling
Co-Trimoxazole for infusion must be diluted before administration.
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) added to 125 ml infusion solution.
Two ampoules (10 ml) added to 250 ml infusion solution.
Three ampoules (15 ml) added 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/v and 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 Intravenous Infusion BP (6% w/v) in glucose (5% w/v) or
normal saline;
Dextran 40 Intravenous Infusion BP (10% w/v) in glucose (5% w/v) or
normal saline;
Ringer’s Solution for Injection BPC 1959.
The pH of the solution is in the range 9.5 to 11.0.
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 requirements
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.
MARKETING AUTHORISATION HOLDER
Aspen Pharma Trading Limited
3016 Lake Drive,
Citywest Business Campus,
Dublin 24,
Ireland
DATE OF REVISION OF THE TEXT
Leaflet date: December 2016.

Warnings and precautions

Package leaflet: Information for the patient

Co-Trimoxazole

16 mg/80 mg per ml for Infusion
co-trimoxazole
Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.
- 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 only. Do not pass it on
to others. It may harm them, even if their signs of illness are the
same as yours.
- If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet. See
section 4.
What is in this leaflet
1. What Co-Trimoxazole is and what it is used for
2. What you need to know before you are given Co-Trimoxazole
3. How Co-Trimoxazole is given
4. Possible side effects
5. How to store Co-Trimoxazole
6. Contents of the pack and other 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 a combination of two different antibiotics called
sulfamethoxazole and trimethoprim, which is used to treat infections
caused by certain bacteria. This medicine combination is also named as
co-trimoxazole. 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 PJP) caused by a bacteria called
Pneumocystis jiroveci (previously known as Pneumocystis carinii or PCP).
• infections caused by a bacteria called Toxoplasma (toxoplasmosis).
Co-Trimoxazole can be used to treat:
• urinary bladder or urinary tract infections (water infections).
• an infection called nocardiosis which 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. What you need to know before you are given Co-Trimoxazole
You will not be given 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: Contents of the pack and other information).
• If you are allergic to sulphonamide medicines. Examples include
sulphonylureas (such as gliclazide and glibenclamide) or thiazide
diuretics (such as bendroflumethiazide–a water tablet).
• If you have severe liver or kidney problems.
• If you have ever had a problem with your blood causing bruises or
bleeding (thrombocytopenia).
• If you have been told that you have a rare blood problem called
porphyria, which can affect your skin or nervous system.
If it is for your child, Co-Trimoxazole should not be given if they are less
than 6 weeks old or were premature. Unless it is for the treatment or
prevention of PJP. In this case, Co-Trimoxazole should not be given if they
are less than 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.

Talk to your doctor or pharmacist before being given Co-Trimoxazole:
• 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.
• If you develop a rash or these skin symptoms, seek immediate advice
from a doctor and tell him that you are taking this medicine.
• If you have been told that you are at risk for a rare blood disorder
called porphyria.
• If 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.
• If you have a disease called glucose-6-phosphate dehydrogenase
deficiency, which can cause jaundice or spontaneous destruction of red
blood cells.
• If you have a problem with your metabolism called phenylketonuria
and are not on a special diet to help your condition.
• If you are elderly.
• If you are underweight or malnourished.
• If you have been told by your doctor that you have a lot of potassium
in your blood.
• If you have a kidney disease.
• If you have severe allergy or bronchial asthma.
• If you have a severe blood disorder, such as a low number of red
blood cells (anaemia), a low number of white blood cells (leucopenia)
or a low number of platelets, which may cause bleeding and bruising
(thrombocytopenia).
Other medicines and Co-Trimoxazole
Tell your doctor or pharmacist if you are taking, have recently taken or
might take any other 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 of 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 organ transplant surgeries.
• Blood thinners such as warfarin.
• Phenytoin, used to treat epilepsy (fits).
• Medicines used to treat diabetes, such as glibenclamide, glipizide or
tolbutamide (sulphonylureas) and repaglinide.
• 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 certain cancers or certain
diseases affecting your immune system.
• Rifampicin, an antibiotic.

• Folinic acid.
• Contraceptive medicines.
Pregnancy and breast-feeding
If you are pregnant or 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.
See following section for more information about ethanol content in the
formulation.
Driving and using machines
Effects on the ability to drive and operate machinery in patients taking
this medicine have not been studied.
Co-Trimoxazole 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. How Co-Trimoxazole is given
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 more Co-Trimoxazole than you should
If you think you have been given more Co-Trimoxazole, talk to your doctor
or nurse straight away.
If you have been given too much Co-Trimoxazole 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)
• A fungal infection called thrush or candidiasis which can affect your
mouth or vagina
• Headache
• Feeling sick (nausea)
• Diarrhoea
• Skin rashes
Uncommon (less than 1 in 100)
• Being sick (vomiting)
Very Rare (less than 1 in 10,000 people)
• Fever (high temperature) or frequent infections
• Sudden wheeziness or difficulty breathing
• Potentially life-threatening skin rashes (Stevens-Johnson syndrome,
toxic epidermal necrolysis) have been reported (see Warnings and
precautions)
• Mouth ulcers, cold sores and ulcers or soreness of your tongue
• Skin lumps or hives (raised, red or white, itchy patches of skin)
• Blisters on your skin or inside your mouth, nose, vagina or bottom
• Inflammation of the eye which causes pain and redness
• The appearance of a rash or sunburn when you have been outside
(even on a cloudy day)
• Low levels of sodium in your blood
• Changes in blood tests
• Feeling weak, tired or listless, pale skin (anaemia)
• Heart problems
• Jaundice (the skin and the whites of your eyes turn yellow). This can
occur at the same time as unexpected bleeding or bruising
• Pains in your stomach, which can occur with blood in your
faeces (stools)
• Pains in your chest, muscles or joints and muscle weakness
• Arthritis
• Problems with your urine. Difficulty passing urine. Passing more or less
urine than usual. Blood or cloudiness in your urine
• Kidney problems
• Sudden headache or stiffness of your neck, accompanied by fever (high
temperature).
• Problems controlling your movements
• Fits (convulsions or seizures)
• Feeling unsteady or giddy
• Ringing or other unusual sounds in your ears.
• Tingling or numbness in your hands and feet
• Seeing strange or unusual sights (hallucinations)
• Depression
• Muscle pain and/or muscle weakness in HIV patients
• Loss of appetite
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 nurse.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet. You
can also report side effects directly via the Yellow Card Scheme at
www.‌mhra.gov.uk/yellowcard. By reporting side effects, you can help
provide more information on the safety of this medicine.
5. How to store Co-Trimoxazole
• Keep this medicine out of the sight and reach of children.
• Keep away from direct heat or sunlight.
• Do not store above 30°C.
• Do not have this medicine after the expiry date shown on the carton
and label.
• Store in the original package with this leaflet.

6. Contents of the pack and other information
What Co-Trimoxazole contains
- Co-Trimoxazole is made up of two different medicines called
sulfamethoxazole and trimethoprim.
- The other ingredients of Co-Trimoxazole 16 mg/80 mg per ml for
Infusion are: propylene glycol (E1520), tromethamine, sodium
hydroxide (E524), sodium metabisulphite (E223), ethanol, Water for
Injections.
What Co-Trimoxazole looks like and contents of the pack
Co-Trimoxazole is available in 5 ml glass ampoules.
Each 5 ml ampoule contains 400 mg sulfamethoxazole and 80 mg
trimethoprim.
The ampoules are supplied in packs of 10.
Marketing Authorisation 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
Medical Information Enquiries
For any Medical Information enquires about this product, please
contact:
24 Hour Helpline +441748 828 391 (free phone UK only 0800 0087 392)
This leaflet was last revised in December 2016.
Other source of information:
To listen to or request a copy of this leaflet in Braille, large print or
audio please call, free of charge:

Braille RNIB Helpline 0800 198 5000 (UK Only).
Please be ready to give the following information:
Product name: Co-Trimoxazole 16 mg/80 mg per ml for Infusion
Reference number: PL 39699/0044
This is a service provided by the Royal National Institute of Blind People.

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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