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SEPTRIN 80 MG/400 MG PER 5 ML ADULT SUSPENSION

Active substance: TRIMETHOPRIM

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Septrin 80 mg/400 mg per 5 ml Adult Suspension

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml contains 400 mg Sulfamethoxazole and 80 mg Trimethoprim.
Excipients:
This product contains less than 1 mmol of sodium (23 mg) per dose, and
therefore is essentially sodium free.
Also contains 2.5 g sucrose per 5 ml and less than 100 mg of ethanol per 5 ml.
For a full list of excipients, see Section 6.1.

3

PHARMACEUTICAL FORM
Suspension. Off-white in colour.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
Septrin Adult Suspension is indicated for the treatment of the following
infections when owing to sensitive organisms (see section 5.1):
Treatment and prevention of Pneumocystis jiroveci.(P. carinii) pneumonitis
Treatment and prophylaxis of toxoplasmosis
Treatment of nocardiosis
The following infections may be treated with Septrin where there is bacterial
evidence of sensitivity to Septrin and good reason to prefer the combination of
antibiotics in Septrin to a single antibiotic:
Acute uncomplicated urinary tract infections
Acute otitis media
Acute exacerbation of chronic bronchitis
Consideration should be given to official guidance on the appropriate use of
antibacterial agents.

4.2

Posology and method of administration
Method of administration: oral
It may be preferable to take Septrin with some food or drink to minimise the
possibility of gastrointestinal disturbances.
Standard dosage recommendations for acute infections
Adults and children over 12 years:
Adult Suspension:

10ml every 12 hours

This dosage approximates to 6mg trimethoprim and 30mg sulfamethoxazole
per kilogram body weight per 24 hours.
Treatment should be continued until the patient has been symptom free for two
days; the majority will require treatment for at least 5 days. If clinical
improvement is not evident after 7 days’ therapy, the patient should be
reassessed.
As an alternative to Standard Dosage for acute uncomplicated lower urinary
tract infections, short-term therapy of 1 to 3 days’ duration has been shown to
be effective.
Where dosage is expressed as “tablets” this refers to the adult tablet, i.e. 80mg
Trimethoprim BP and 400 mg Sulfamethoxazole BP. If other formulations are
to be used appropriate adjustment should be made.
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

>30

STANDARD DOSAGE

15 to 30

Half the STANDARD DOSAGE

<15

Not recommended

Measurements of plasma concentration of sulfamethoxazole at intervals of 2 to
3 days are recommended in samples obtained 12 hours after administration of
Septrin.
If the concentration of total sulfamethoxazole exceeds
150 microgram/ml then treatment should be interrupted until the value falls
below 120 microgram/ml.
The elderly:

See Special Warnings and Precautions for Use. Unless otherwise specified
standard dosage applies.
Impaired hepatic function:
No data are available relating to dosage in patients with impaired hepatic
function.
Pneumocystis jiroveci (P. carinii) pneumonitis:
Treatment: A higher dosage is recommended using 20 mg trimethoprim and
100 mg sulfamethoxazole per kg of body weight per day in two or more
divided doses for 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 4.8
Undesirable Effects).
Prevention:
Adults: The following dose schedules may be used:
-

160 mg trimethoprim/800mg sulfamethoxazole daily 7 days per week.

-

160 mg trimethoprim/800mg sulfamethoxazole three days per week on
alternate days.

-

320 mg trimethoprim/1600mg sulfamethoxazole per day in two
divided doses three days per week on alternate days

Children: The following dose schedules may be used for the duration of the
period at risk (see Acute Infections subsection of 4.2):
-

Standard dosage taken in two divided doses, seven days per week

-

Standard dosage taken in two divided doses, three times per week on
alternate days

-

Standard dosage taken in two divided doses, three times per week on
consecutive days

-

Standard dosage taken as a single dose, three times per week on
consecutive days

The daily dose given on a treatment day approximates to 150mg
trimethoprim/m2/day and 750mg sulfamethoxazole /m2/day. The total daily
dose should not exceed 320 trimethoprim and 1600 mg sulfamethoxazole.
Nocardiosis: This 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.

4.3

Contraindications
Septrin should not be given to patients with a history of hypersensitivity to
sulphonamides, trimethoprim, co-trimoxazole or any excipients of Septrin.
Contra-indicated in patients showing marked liver parenchymal damage.
Contra-indicated in severe renal insufficiency where repeated measurements
of the plasma concentration cannot be performed.
Septrin should not be given to premature babies nor to full-term infants during
the first 6 weeks of life except for the treatment/prophylaxis of PCP in infants
4 weeks of age or greater.

4.4.

Special warnings and precautions for use
Fatalities, although very rare, have occurred due to severe reactions including
fulminant hepatic necrosis, agranulocytosis, aplastic anaemia, other blood
dyscrasias and hypersensitivity of the respiratory tract.






Life-threatening cutaneous reactions Stevens-Johnson syndrome (SJS)
and toxic epidermal necrolysis (TEN) have been reported with the use
of Septrin.
Patients should be advised of the signs and symptoms and monitored
closely for skin reactions. The highest risk for occurrence of SJS or
TEN is within the first weeks of treatment.
If symptoms or signs of SJS or TEN (e.g. progressive skin rash often
with blisters or mucosal lesions) are present, Septrin treatment should
be discontinued (see 4.8 Undesirable Effects).
The best results in managing SJS and TEN come from early diagnosis
and immediate discontinuation of any suspect drug. Early withdrawal
is associated with a better prognosis.
If the patient has developed SJS or TEN with the use of Septrin,
Septrin must not be re-started in this patient at any time.

Particular care is always advisable when treating elderly patients because, as a
group, they are more susceptible to adverse reactions and more likely to suffer
serious effects as a result particularly when complicating conditions exist, e.g.
impaired kidney and/or liver function and/or concomitant use of other drugs.
An adequate urinary output should be maintained at all times. Evidence of
crystalluria in vivo is rare, although sulphonamide crystals have been noted in
cooled urine from treated patients. In patients suffering from malnutrition the
risk may be increased.
Regular monthly blood counts are advisable when Septrin is given for long
periods, or to folate deficient patients or to the elderly; since there exists a

possibility of asymptomatic changes in haematological laboratory indices due
to lack of available folate. These changes may be reversed by administration
of folinic acid (5 to 10 mg/day) without interfering with the antibacterial
activity.
In glucose-6-phosphate dehydrogenase (G-6-PD) deficient patients
haemolysis may occur.
Septrin should be given with caution to patients with severe allergy or
bronchial asthma.
Septrin should not be used in the treatment of streptococcal pharayngitis due to
Group A Beta-haemolytic streptococci; eradication of these organisms from
the oropharynx is less effective than with penicillin.
Trimethoprim has been noted to impair phenylalanine metabolism but this is
of no significance in phenylketonuric patients on appropriate dietary
restriction.
The administration of Septrin to patients known or suspected to be at risk of
acute porphyria should be avoided. Both trimethoprim and sulphonamides
(although not specifically sulfamethoxazole) have been associated with
clinical exacerbation of porphyria.
Close monitoring of serum potassium and sodium is warranted in patients at
risk of hyperkalaemia and hyponatraemia.
Except under careful supervision Septrin should not be given to patients with
serious haematological disorders (see 4.8 Undesirable Effects). Septrin has
been given to patients receiving cytotoxic therapy with little or no additional
effect on the bone marrow or peripheral blood.
The combination of antibiotics in Septrin should only be used where, in the
judgement of the physician, the benefits of treatment outweigh any possible
risks; consideration should be given to the use of a single effective
antibacterial agent.
Patients with rare hereditary problems of fructose intolerance, glucosegalactose malabsorption or sucrase-isomaltase insufficiency should not take
this medicine. See Section 2 Quantitative and Qualitative Composition.
This medicinal product contains methyl hydroxybenzoate, which may cause
allergic reactions (possibly delayed).
This medicinal product contains small amounts of ethanol (alcohol), less than
100 mg per 5 ml.
This medicinal product contains less than 1 mmol of sodium (23 mg) per dose,
and therefore is essentially sodium free.

4.5

Interaction with other medicinal products and other forms of interaction
Trimethoprim may interfere with the estimation of serum/plasma creatinine
when the alkaline picrate reaction is used. This may result in overestimation
of serum/plasma creatinine of the order of 10%. The creatinine clearance is
reduced: the renal tubular secretion of creatinine is decreased from 23% to 9%
whilst the glomerular filtration remains unchanged.
In some situations, concomitant treatment with zidovudine may increase the
risk of haematological adverse reactions to co-trimoxazole. If concomitant
treatment is necessary, consideration should be given to monitoring of
haematological parameters.
Reversible deterioration in renal function has been observed in patients treated
with co-trimoxazole and cyclosporin following renal transplantation.
Concurrent use of rifampicin and Septrin results in a shortening of the plasma
half-life of trimethoprim after a period of about one week. This is not thought
to be of clinical significance.
When trimethoprim is administered simultaneously with drugs that form
cations at physiological pH, and are also partly excreted by active renal
secretion (e.g. procainamide, amantadine), there is the possibility of
competitive inhibition of this process which may lead to an increase in plasma
concentration of one or both of the drugs.
In elderly patients concurrently receiving diuretics, mainly thiazides, there
appears to be an increased risk of thrombocytopenia with or without purpura.
Occasional reports suggest that patients receiving pyrimethamine at doses in
excess of 25 mg weekly may develop megaloblastic anaemia should cotrimoxazole be prescribed concurrently.
Co-trimoxazole has been shown to potentiate the anticoagulant activity of
warfarin via stereo-selective inhibition of its metabolism. Sulfamethoxazole
may displace warfarin from plasma-albumin protein-binding sites in vitro.
Careful control of the anticoagulant therapy during treatment with Septrin is
advisable.
Co-trimoxazole prolongs the half-life of phenytoin and if co-administered
could result in excessive phenytoin effect. Close monitoring of the patient's
condition and serum phenytoin levels are advisable.
Concomitant use of trimethoprim with digoxin has been shown to increase
plasma digoxin levels in a proportion of elderly patients.
Co-trimoxazole may increase the free plasma levels of methotrexate.
Trimethoprim interferes with assays for serum methotrexate when
dihydrofolate reductase from Lactobacillus casei is used in the assay. No
interference occurs if methotrexate is measured by radioimmuno assay.
Administration of trimethoprim/sulfamethoxazole 160mg/800mg (cotrimoxazole) causes a 40% increase in lamivudine exposure because of the
trimethoprim component. Lamivudine has no effect on the pharmacokinetics
of trimethoprim or sulfamethoxazole.

Interaction with sulphonylurea hypoglycaemic agents is uncommon but
potentiation has been reported.
Caution should be exercised in patients taking any other drugs that can cause
hyperkalaemia.
If Septrin is considered appropriate therapy in patients receiving other antifolate drugs such as methotrexate, a folate supplement should be considered.

4.6

Fertility, pregnancy and lactation
Pregnancy
There are not any adequate data from the use of Septrin in pregnant women. Casecontrol studies have shown that there may be an association between exposure to
folate antagonists and birth defects in humans.
Trimethoprim is a folate antagonist and, in animal studies, both agents have been
shown to cause foetal abnormalities (see 5.3 Preclinical Safety Data).
Septrin should not be used in pregnancy, particularly in the first trimester, unless
clearly necessary. Folate supplementation should be considered if Septrin is used in
pregnancy.
Sulfamethoxazole competes with bilirubin for binding to plasma albumin. As
significantly maternally derived drug levels persist for several days in the newborn,
there may be a risk of precipitating or exacerbating neonatal hyperbilirubinaemia,
with an associated theoretical risk of kernicterus, when Septrin is administered to the
mother near the time of delivery. This theoretical risk is particularly relevant in
infants at increased risk of hyperbilirubinaemia, such as those who are preterm and
those with glucose-6-phosphate dehydrogenase deficiency.
Lactation
The components of Septrin (trimethoprim and sulfamethoxazole) are excreted in
breast milk. Administration of Septrin should be avoided in late pregnancy and in
lactating mothers where the mother or infant has, or is at particular risk of developing,
hyperbilirubinaemia. Additionally, administration of Septrin should be avoided in
infants younger than eight weeks in view of the predisposition of young infants to
hyperbilirubinaemia.

4.7

Effects on ability to drive and use machines
There have been no studies to investigate the effect of Septrin on driving
performance or the ability to operate machinery. Further a detrimental effect
on such activities cannot be predicted from the pharmacology of the drug.
Nevertheless the clinical status of the patient and the adverse events profile of
Septrin should be borne in mind when considering the patients ability to
operate machinery.

4.8

Undesirable Effects

As co-trimoxazole contains trimethoprim and a sulphonamide the type and
frequency of adverse reactions associated with such compounds are expected
to
be
consistent
with
extensive
historical
experience.
Data from large published clinical trials were used to determine the frequency
of very common to rare adverse events. Very rare adverse events were
primarily determined from post-marketing experience data and therefore refer
to reporting rate rather than a "true" frequency. In addition, adverse events
may vary in their incidence depending on the indication
The following convention has been used for the classification of adverse
events in terms of frequency:- Very common ≥1/10, common ≥1/100 and
1/10, uncommon ≥1/1000 and 1/100, rare ≥1/10,000 and 1/1000, very
rare 1/10,000.
Infections and Infestations
Common:

Municipal overgrowth

Blood and lymphatic system disorders
Very rare:

Leucopenia, neutropenia, thrombocytopenia,
agranulocytosis, megaloblastic anaemia, aplastic anaemia,
haemolytic anaemia, methaemoglobinaemia, eosinophilia,
purpura, haemolysis in certain susceptible G-6-PD deficient
patients

Immune system disorders
Very rare:

Serum sickness, anaphylaxis, allergic myocarditis,
angioedema, drug fever, allergic vasculitis resembling
Henoch-Schoenlein purpura, periarteritis nodosa, systemic
lupus erythematosus

Metabolism and nutrition disorders
Very common:

Hyperkalaemia

Very rare:

Hypoglycaemia, hyponatraemia, anorexia

Psychiatric disorders
Very rare:

Depression, hallucinations

Nervous system disorders

Common:

Headache

Very rare:

Aseptic meningitis, convulsions, peripheral neuritis, ataxia,
vertigo, tinnitus, dizziness

Aseptic meningitis was rapidly reversible on withdrawal of the drug, but
recurred in a number of cases on re-exposure to either co-trimoxazole or to
trimethoprim alone.
Respiratory, thoracic and mediastinal disorders
Very rare:

Cough, shortness of breath, pulmonary infiltrates

Cough, shortness of breath and pulmonary infiltrates may be early indicators
of respiratory hypersensitivity which, while very rare, has been fatal.
Gastrointestinal disorders
Common:

Nausea, diarrhoea

Uncommon:

Vomiting

Very rare:

Glossitis, stomatitis, pseudomembranous colitis, pancreatitis

Eye Disorders
Very rare:

Uveitis

Hepatobiliary disorders
Very rare:

Elevation of serum transaminases, elevation of bilirubin
levels, cholestatic jaundice, hepatic necrosis

Cholestatic jaundice and hepatic necrosis may be fatal.
Skin and subcutaneous tissue disorders
Common:

Skin rashes

Very rare:

Photosensitivity, exfoliative dermatitis, fixed
dreruption, erythema multiforme, severe cutaneous
adverse reactions (SCARs): Stevens-Johnson
syndrome (SJS) and toxic epidermal necrolysis (TEN)
have been reported (see section 4.4)

Musculoskeletal and connective tissue disorders
Very rare:

Arthralgia, myalgia

Renal and urinary disorders
Very rare:

Impaired renal function (sometimes reported as renal
failure), interstitial nephritis

Effects associated with Pneumocystis jiroveci (P. carinii) Pneumonitis (PCP)
management
Very rare:

Severe hypersensitivity reactions, rash, fever, neutropenia,
thrombocytopenia, raised liver enzymes, hyperkalaemia,
hyponatraemia, rhabdomyolysis.

At the high dosages used for PCP management severe hypersensitivity
reactions have been reported, necessitating cessation of therapy. If signs of
bone marrow depression occur, the patient should be given calcium folinate
supplementation (5-10 mg/day). Severe hypersensitivity reactions have been
reported in PCP patients on re-exposure to co-trimoxazole, sometimes after a
dosage interval of a few days. Rhabdomyolysis has been reported in HIV
positive patients receiving co-trimoxazole for prophylaxis or treatment of
PCP.
4.9

Overdose
Nausea, vomiting, dizziness and confusion are likely signs/symptoms of
overdosage.
Bone marrow depression has been reported in acute trimethoprim overdosage.
If vomiting has not occurred, induction of vomiting may be desirable. Gastric
lavage may be useful, though absorption from the gastrointestinal tract is
normally very rapid and complete within approximately two hours. This may
not be the case in gross overdosage. Dependant on the status of renal function
administration of fluids is recommended if urine output is low.
Both trimethoprim and active sulfamethoxazole are moderately dialysable by
haemodialysis. Peritoneal dialysis is not effective.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Pharmacotherapeutic group: Combinations of sulfonamides and trimethoprim,
incl. derivatives; ATC code: J01EE01
Mode of Action
Septrin is an antibacterial drug composed of two active principles,
sulfamethoxazole and trimethoprim. Sulfamethoxazole is a competitive
inhibitor of dihydropteroate synthetase enzyme. Sulfamethoxazole

competitively inhibits the utilisation of para-aminobenzoic acid (PABA) in the
synthesis of dihydrofolate by the bacterial cell resulting in bacteriostasis.
Trimethoprim binds to and reversibly inhibits bacterial dihydrofolate reductase
(DHFR) and blocks the production of tetrahydrofolate. Depending on the
conditions the effect may be bactericidal.
Thus trimethoprim and
sulfamethoxazole block two consecutive steps in the biosynthesis of purines
and therefore nucleic acids essential to many bacteria. This action produces
marked potentiation of activity in vitro between the two agents.
Mechanism of resistance
In vitro studies have shown that bacterial resistance can develop more slowly
with both sulfamethoxazole and trimethoprim in combination that with either
sulfamethoxazole or trimethoprim alone.
Resistance to sulfamethoxazole may occur by different mechanisms. Bacterial
mutations cause an increase the concentration of PABA and thereby outcompete with sulfamethoxazole resulting in a reduction of the inhibitory effect
on dihydropteroate synthetase enzyme. Another resistance mechanism is
plasmid-mediated and results from production of an altered dihydropteroate
synthetase enzyme, with reduced affinity for sulfamethoxazole compared to
the wild-type enzyme.
Resistance to trimethoprim occurs through a plasmid-mediated mutation
which results in production of an altered dihydrofolate reductase enzyme
having a reduced affinity for trimethoprim compared to the wild-type enzyme.
Trimethoprim binds to plasmodial DHFR but less tightly than to bacterial
enzyme. Its affinity for mammalian DHFR is some 50,000 times less than for
the corresponding bacterial enzyme.
Many common pathogenic bacteria are susceptible in vitro to trimethoprim
and sulfamethoxazole at concentrations well below those reached in blood,
tissue fluids and urine after the administration of recommended doses. In
common with other antibiotics, however, in vitro activity does not necessarily
imply that clinical efficacy has been demonstrated and it must be noted that
satisfactory susceptibility testing is achieved only with recommended media
free from inhibitory substances, especially thymidine and thymine.
Breakpoints
EUCAST
Enterobacteriaceae: S≤ 2 R> 4
S. maltophilia: S≤ 4 R> 4
Acinetobacter: S≤ 2 R> 4
Staphylococcus: S≤ 2 R> 4
Enterococcus: S≤ 0.032 R> 1
Streptococcus ABCG: S≤ 1 R> 2
Streptococcus pneumoniae: S≤ 1 R> 2
Hemophilus influenza: S≤ 0.5 R> 1
Moraxella catarrhalis: S≤0.5 R >1

Psuedomonas aeruginosa and other non-enterobacteriaceae: S≤ 2* R> 4*
S = susceptible, R = resistant. *These are CLSI breakpoints since no
EUCAST breakpoints are currently available for these organisms.
Trimethoprim: sulfamethoxazole in the ratio 1:19. Breakpoints are expressed
as trimethoprim concentration.
Antibacterial Spectrum
The prevalence of resistance may vary geographically and with time for
selected species and local information on resistance is desirable, particularly
when treating severe infections. As necessary, expert advice should be sought
when the local prevalence of resistance is such that the utility of the agent in at
least some types of infections is questionable. This information gives only an
approximate guidance on probabilities whether microorganisms will be
susceptible to trimethoprim/sulfamethoxazole or not.
Trimethoprim/sulfamethoxazole susceptibility against a number of bacteria are
shown in the table below:
Commonly susceptible species:
Gram-positive aerobes:
Staphylococcus aureus
Staphylococcus saprophyticus
Streptococcus pyogenes
Gram-negative aerobes:
Enterobacter cloacae
Haemophilus influenzae
Klebsiella oxytoca
Moraxella catarrhalis
Salmonella spp.
Stenotrophomonas maltophilia
Yersinia spp.
Species for which acquired resistance may be a problem:
Gram-positive aerobes:
Enterococcus faecalis
Enterococcus faecium
Nocardia spp.
Staphylococcus epidermidis
Streptococcus pneumoniae
Gram-negative aerobes:
Citrobacter spp.

Enterobacter aerogenes
Escherichia coli
Klebsiella pneumoniae
Klebsiella pneumonia
Proteus mirabilis
Proteus vulgaris
Providencia spp.
Serratia marcesans
Inherently resistant organisms:
Gram-negative aerobes:
Pseudomonas aeruginosa
Shigella spp.
Vibrio cholera

5.2

Pharmacokinetic properties
After oral administration trimethoprim and sulfamethoxazole are rapidly and nearly
completely absorbed. The presence of food does not appear to delay absorption.
Peak levels in the blood occur between one and four hours after ingestion and the
level attained is dose related. Effective levels persist in the blood for up to 24 hours
after a therapeutic dose. Steady state levels in adults are reached after dosing for 2-3
days. Neither component has an appreciable effect on the concentrations achieved in
the blood by the other.
Trimethoprim is a weak base with a pKa of 7.4. It is lipophilic. Tissue levels of
trimethoprim are generally higher than corresponding plasma levels, the lungs and
kidneys showing especially high concentrations. Trimethoprim concentrations exceed
those in plasma in the case of bile, prostatic fluid and tissue, saliva, sputum and
vaginal secretions. Levels in the aqueous humor, breast milk, cerebrospinal fluid,
middle ear fluid, synovial fluid and tissue (intestinal) fluid are adequate for
antibacterial activity. Trimethoprim passes into amniotic fluid and foetal tissues
reaching concentrations approximating those of maternal serum.
Approximately 50% of trimethoprim in the plasma is protein bound. The half-life in
man is in the range 8.6 to 17 hours in the presence of normal renal function. It is
increased by a factor of 1.5 to 3.0 when the creatinine clearance is less than
10 ml/minute. There appears to be no significant difference in the elderly compared
with young patients.
The principal route of excretion of trimethoprim is renal and approximately 50% of
the dose is excreted in the urine within 24 hours as unchanged drug. Several

metabolites have been identified in the urine. Urinary concentrations of trimethoprim
vary widely..

Sulfamethoxazole is a weak acid with a pKa of 6.0. The concentration of active
sulfamethoxazole in a variety of body fluids is of the order of 20 to 50% of the
plasma concentration.
Approximately 66% of sulfamethoxazole in the plasma is protein bound. The half-life
in man is approximately 9 to 11 hours in the presence of normal renal function.
There is no change in the half-life of active sulfamethoxazole with a reduction in
renal function but there is prolongation of the half-life of the major, acetylated
metabolite when the creatinine clearance is below 25ml/minute.
The principal route of excretion of sulfamethoxazole is renal; between 15% and 30%
of the dose recovered in the urine is in the active form. In elderly patients there is a
reduced renal clearance of sulfamethoxazole.

5.3

Preclinical safety data
Reproductive toxicology: At doses in excess of recommended human therapeutic
dose, trimethoprim and sulfamethoxazole have been reported to cause cleft palate and
other foetal abnormalities in rats, findings typical of a folate antagonist. Effects with
trimethoprim were preventable by administration of dietary folate. In rabbits, foetal
loss was seen at doses of trimethoprim in excess of human therapeutic doses.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Syrup or sucrose
Glycerol (E422)
Dispersible Cellulose (E460)
Sodium carboxymethylcellulose (E467)
Methyl hydroxybenzoate (E218)
Saccharin sodium (E954)
Ammonium glycyrrhizinate
Anise Oil
Ethanol (96%)

Flavour, vanilla 407
Polysorbate 80 (E433)
Purified Water

6.2

Incompatibilities
See drug interactions.

6.3

Shelf life
4 years

6.4

Special precautions for storage
Store below 25°C
Protect from light

6.5

Nature and contents of container
Amber glass bottles with metal roll on pilfer proof caps or polypropylene child
resistant caps.
Pack size: 100 ml
Septrin 80 mg/400 mg per 5 ml Adult Suspension comes with a double-ended
polypropylene measuring spoon.

6.6

Special precautions for disposal
Trimethoprim interferes with assays for serum methotrexate when
dihydrofolate reductase from Lactobacillus casei is used in the assay. No
interference occurs if methotrexate is measured by radioimmunoassay.
Trimethoprim may interfere with the estimation of serum/plasma creatinine
when the alkaline picrate reaction is used. This may result in overestimation of
serum/plasma creatinine of the order of 10%. Functional inhibition of the renal
tubular secretion of creatinine may produce a spurious fall in the estimated
rate of creatinine clearance.
Septrin 80 mg/400 mg per 5 ml Adult Suspension may be diluted with Syrup
BP.

Although they may show some sedimentation such dilutions remain stable for
at least a month. Shake thoroughly before use.

7.

Marketing Authorisation Holder
Aspen Pharma Trading Limited
3016 Lake Drive
Citywest Business Campus
Dublin 24, Ireland

8

MARKETING AUTHORISATION NUMBER(S)
PL 39699/0038

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
08/11/2006

10

DATE OF REVISION OF THE TEXT
23/09/2014

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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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