INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo SPECTRIM CAPSULES
SPECTRIM DS TABLETS

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

SPECTRIM CAPSULES
SPECTRIM DS TABLETS

COMPOSITION:
Each capsule contains:
       
Trimethoprim 80 mg, Sulphamethoxazole 400 mg
Each tablet contains:
        Trimethoprim 160 mg, Sulphamethoxazole 800 mg

PHARMACOLOGICAL CLASSIFICATION:
A 20.2.1. Sulphonamides.

PHARMACOLOGICAL ACTION:
It is a broad-spectrum agent, effective against gram-positive and gram-negative organisms. Its action is based on the sequential blockage of two enzymes which act within the bacterial metabolic pathway of the biosynthesis of folic acid. Co-trimoxazole is bactericidal at concentrations at which the components trimethoprim and sulphamethoxazole are usually bacteriostatic. Thus it is often active against organisms resistant to one of the components. Co-trimoxazole is effective against susceptible strains of gram-positive and gram-negative organisms including: Streptococci (including group A and B Haemolytic Streptococci); Staphylococci, Pneumococci, Neisseria, Bordetella, Salmonella, Klebsiella aerobacter, Shigella and Vibrio cholera. It is also effective against Haemophilus influenzae, Escherichia coli and Proteus mirabilis and vulgaris.
Mycobacterium tuberculosis, Treponema pallidum and Pseudomonas aeruginosa are organisms which are usually resistant to Co-trimoxazole.

INDICATIONS:
Upper and lower respiratory tract infections:
Acute and chronic bronchitis, pneumonia, bronchiectasis, tonsillitis, pharyngitis and otitis media.

Renal and-urinary tract infections: Pyelonephritis, pyelitis, acute and chronic cystitis, urethritis.
There is some difference of opinion concerning the therapeutic value of this combination.

Gastro-Intestinal tract infections: Typhoid, paratyphoid; enteritis.

Genital tract infections (male and female): Including gonococcal urethritis.

Skin infections: Such as pyoderma, boils, furuncles, abscesses (as an adjunct to the appropriate surgical treatment).and wound infections

Infections caused by sensitive pathogens at other sites: Such as meningitis, toxoplasmosis, sepsis, wound infections, osteomyelitis.

CONTRA-INDICATIONS:
Co-trimoxazole must not be given to patients who are hypersensitive to sulphonamides or trimethoprim. It is contra-indicated in disorders of liver function, renal insufficiency and disorders of the haemopoietic system. In impaired renal function it should be used under strict medical supervision because of the possibility of sulphonamide retention. If there is any doubt, serum creatinine clearance and, if necessary, the blood level of sulphonamide should be determined. Here the dosage of co-trimoxazole must be adjusted to suit the excretory capacity of the kidneys in each particular patient.
Co-trimoxazole is not recommended during pregnancy. Co-trimoxazole should not be given to infants during the first four months of life or to premature babies because of the danger of producing kernicterus. Co-trimoxazole should not be given to porphyric patients.

DOSAGE AND DIRECTIONS FOR USE:
SPECTRIM CAPSULES:
Adults
:
        2 capsules twice daily, morning and evening, after meals with liquid.
        In acute infections, Spectrim should be given for at least five days or until the patient has been symptom-free for 2 days.

SPECTRIM DS TABLETS:
Adults:
        1 tablet twice daily.
Maximum dosage (for severe infections) excluding the conditions referred to below*:
        1 tablet twice daily.
Children over 12 years: As for adults.
6 - 12 years: Not to be used.

Dosage in gonorrhoea*: In uncomplicated gonorrhoea 2 SPECTRIM DS TABLETS every 12 hours for 2 days or 2 tablets followed 8 hours later by a further dose of 2 tablets.
In treatment of Pneumocystis carinii pneumonitis* dosage is 20 mg trimethoprim/100 mg sulphamethoxazole per kg per day in two divided doses for 2 weeks. Treatment should normally only be carried out when facilities for regular estimation of the sulphamethoxazole components are available.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Co-trimoxazole is usually well tolerated at the recommended dosage levels. However nausea, vomiting, headache, drug fever, pruritus, and skin rashes may occasionally occur, such as Steven's-Johnson syndrome and toxic epidermal necrolysis (Lyell's syndrome).
Photosensitivity may also occur. Haematological reactions include various types of anaemia (including aplastic haemolytic and macrocytic), coagulation disorders, granulocytopenia, agranulocytosis, purpura, Henoch-Schölein purpura and sulphaemoglobinemia. (Reactions usually occur in elderly patients and are reversible on withdrawal of the drug). In patients with renal impairment, a reduced or more widely spaced dosage regimen is indicated to avoid accumulation in the blood. Plasma concentration measurement is advisable in these patients and in patients on long -term therapy.
Other side-effects include acidosis, anorexia, stomatitis, goitre, hypo-thyroidism, arthralgia, drowsiness, fatigue, insomnia, nightmares, confusion, depression, psychosis, vertigo, ataxia, tinnitus, peripheral neuritis and polyarteritis nodosa. Glossitis may also occur. Mild and transient jaundice has been noted and appears to have the histological features of allergic cholestatic hepatitis. Most patients who have developed icterus have a history of prior infectious hepatitis.
Central Nervous System reactions consist of headache, depression and hallucinations, manifestations known to be produced by sulphonamides. Previous or simultaneous administration of diuretics with co-trimoxazole may carry an increased risk of thrombocytopenia; especially in elderly patients with heart failure, death may occur.
Haematuria may occur whenever fluid intake is restricted or the urine is acid. Chemical compounds derived from p-aminobenzoic acid, particularly the procaine group of local anaesthetics, antagonise the action of the sulphonamides, and should not be given during sulphonamide treatment. Derivatives of p-aminobenzoic acid also occur in purulence.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Nausea, vomiting or allergic reactions (skin rashes, anaphylaxis) may occur after acute overdosage in sensitive individuals. If overdosage is discovered within 3 hours of ingestion, gastric lavage should be performed and folic acid and Vitamin B administered intramuscularly. Liver function tests should be performed once a week for 3 weeks and full blood counts twice a week for 3 weeks. If anaphylaxis occurs, the usual supportive measures (i.v. infusion of cortisone or adrenaline) should be administered. It may cause a depression of haemopoiesis due to interference with the metabolism of folic acid.

CONDITIONS OF REGISTRATION:
Advertising to the professions only.

IDENTIFICATION:
Spectrim Capsules: Yellow capsules.
Spectrim DS Tablets: White, scored, capsule-shaped tablet.

PRESENTATION:
Capsules: 20, 10 and 500 capsules in polyethylene containers.
Tablets: Packed into containers of 10 and 50 tablets.

STORAGE INSTRUCTIONS:
Store in well-closed containers in a dark place, below 25°C.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
SPECTRIM CAPSULES: K/20.2.1/335
SPECTRIM DS TABLETS: W/20.2.1/68

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Geo Schwulst Labs. Limited
1 Manchester Road
Wadeville
1407

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
December 1989

PSO-27-2/92
PSO-51-2/92

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