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

Active substance(s): SULFAMETHOXAZOLE / TRIMETHOPRIM

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128 Code Ref. No. xxxxxx

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.

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.

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.

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)

Pharmaceutical Form
Solution for Infusion
A clear liquid.

Prevention
Standard dosage for the duration of the period at risk.

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.

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).

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.

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

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.

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

Pharmaceutical Particulars

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.

Incompatibilities
None known.

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)

List of excipients
Propylene Glycol (E1520) Ph. Eur.
Tromethamine USP
Sodium Hydroxide BP
Sodium Metabisulphite (E223) BP
Ethanol BP
Water for Injections Ph. Eur.

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

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/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 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 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
Aspen Pharma Trading Limited
3016 Lake Drive,
Citywest Business Campus,
Dublin 24,
Ireland
This leaflet was last revised in September 2015.

Package 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 ‘CoTrimoxazole’ 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 CoTrimoxazole 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 CoTrimoxazole, 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 CoTrimoxazole 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. How to 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.

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Amended on:
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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)

160 mm Measuring Bar

xxxxxx

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.

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

5. How to store Co-Trimoxazole
Keep out of the reach and sight 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. Further information

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)
Other formats
To listen to or request a copy of this leaflet in Braille, large print or audio
please call, free of charge:

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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
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Manufacturing Site:
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This leaflet was last revised in September 2015.

Drawing Version:
02

Drawing Ref. Number:
SEPTRIN_LAYOUT4

Originated by:
Aidan Collins
Originated at:
APTL
Originated on:
28 Jul 2015
Amended on:
21 Sep 2015

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What Co-Trimoxazole contains
Co-Trimoxazole is made up of two different medicines called
sulfamethoxazole and trimethoprim.

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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.

Date Signature

What Co-Trimoxazole looks like and contents of the pack
Co-Trimoxazole 16 mg/80 mg per ml for Infusion 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.

160 mm Measuring Bar

Marketing authorisation holder and manufacturer
Marketing authorisation holder
Aspen Pharma Trading Limited,
3016 Lake Drive,
Citywest Business Campus,
Dublin 24,
Ireland

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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 Take special care
with Co-Trimoxazole).
• 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 (poo)
• Pains in your chest or joints
• 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.
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.

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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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