Medication Guide App

SEPTRIN 16 MG/80 MG PER ML FOR INFUSION

Active substance: TRIMETHOPRIM

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Impaired hepatic function:
No data are available relating to dosage in patients with impaired
hepatic function.
200317

For the Medical Profession

SEPTRIN®

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 liquid.
Posology and Method of Administration
Method of Administration: Septrin 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 Septrin 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 Septrin 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:
6 months to 5 years:
6 to 12 years:

1.25 ml every 12 hours
2.5 ml every 12 hours
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.

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)
More than 30
15-30
Less than 15

Recommended Dosage
STANDARD DOSAGE
Half the STANDARD DOSAGE
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 Septrin 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 Septrin). (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.

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

Shelf life
36 months

Take special care with Septrin

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
Septrin 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 Septrin 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.
Septrin 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, Septrin 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.
Septrin 16 mg/80 mg per ml for Infusion is licenced for sale in the UK
Aspen Pharma Trading Limited
12/13 Exchange Place,
I.F.S.C,
Dublin 1, Ireland
Leaflet date: May 2013
Septrin is a registered trademark of Aspen

Package leaflet: Information for the User

SEPTRIN®

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 Septrin is and what it is used for
2. Before you have Septrin
3. How to have Septrin 16 mg/80 mg per ml for Infusion
4. Possible side effects
5. How to store Septrin
6. Further information
1 What Septrin is and what it is used for
Septrin 16 mg/80 mg per ml for Infusion (called ‘Septrin’ in this
leaflet) is made up of two different medicines called sulfamethoxazole
and trimethoprim. These medicines are sometimes
given the combined name co-trimoxazole. Both belong to a group of
medicines called antibiotics. They are used to treat infections caused
by bacteria. Like all antibiotics, Septrin only works against some types
of bacteria. This means that it is only suitable for treating some types
of infections.
Septrin 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).
Septrin can be used to treat:
• bladder or urinary tract infections (water infections)
• an infection called nocardiosis, it can affect the lungs, skin and
brain.
Septrin 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 Septrin
Do not take Septrin if:
• you are allergic (hypersensitive) to sulfamethoxazole, trimethoprim
or co-trimoxazole or any of the other ingredients of Septrin (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.

Before you take Septrin, 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
Septrin 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 Septrin you must not be restarted on Septrin at any time.
• if you develop a rash or these skin symptoms, stop taking Septrin,
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 Septrin.
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
Septrin can affect the way some medicines work. Also some other
medicines can affect the way Septrin 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 Septrin.
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 Septrin 16
mg/80 mg per ml for Infusion
Septrin 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 Septrin 16 mg/80 mg per ml for Infusion
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.
Septrin 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 Septrin
• take blood to test whether the medicine is working properly.
If you are given too much Septrin
If you think you have been given too much Septrin, talk to your doctor
or nurse straight away.
If you have been given too much Septrin 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 Septrin can cause side effects, although not
everybody gets them. You may experience the following side effects
with this medicine.
Stop taking Septrin 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).
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 Septrin).
• 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.

6 Further information
What Septrin contains
Septrin is made up of two different medicines called sulfamethoxazole
and trimethoprim. These medicines are sometimes given the combined
name co-trimoxazole.
The other ingredients of Septrin 16 mg/80 mg per ml for Infusion are:
propylene glycol (E1520), tromethamine, sodium hydroxide (E524),
sodium metabisulphite (E223), ethanol, Water for Injections.
What Septrin looks like and contents of the pack
Septrin 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.
Marketing authorisation holder and manufacturer
Marketing authorisation holder:
Aspen Pharma Trading Limited
12/13 Exchange Place,
I.F.S.C, Dublin 1, 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)
Other formats:
To listen to or request a copy of this leaflet in Braille, large print or
audio please call, free of charge:

Braille RNIB Helpline 0303 123 9999 (UK Only).
Please be ready to give the following information:
Product name Septrin 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.
Leaflet date: May 2013
Septrin is a registered trademark of Aspen

5 How to store Septrin
• 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.

200317

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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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