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Logo DOCTRIM (SUSPENSION)

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

DOCTRIM (SUSPENSION)

COMPOSITION:
Each 5 mL of suspension contains:

Trimethoprim        40 mg
Sulphamethoxazole 200 mg
Nipastat (as preservative) 0.3% m/v
Ethanol 96% 0.5% v/v
Contains Sugar.

PHARMACOLOGICAL CLASSIFICATION:
A.20.2 Antimicrobial (chemotherapeutic) agents other than antibiotics.

PHARMACOLOGICAL ACTION:
DOCTRIM is a combination of trimethoprim and sulphamethoxazole and results in synergistic effect causing a bactericidal action. The action of co-trimoxazole is achieved by the sequential blocking of two enzymes essential in folinic acid synthesis in the organism.

INDICATIONS:
The treatment of infections of the upper and lower respiratory tract, the urinary tract and the alimentary and genital tract in both sexes, and skin infections caused by sensitive organisms.

CONTRA-INDICATIONS:
DOCTRIM is contra-indicated in patients with known sulphonamide or trimethoprim hypersensitivity or who are suffering from porphyria. It should not be used in patients suffering from liver parenchymal damage, or severe renal insufficiency. Co-trimoxazole should not be used during pregnancy. Use of the substance in premature or newborn infants during the first few weeks of life, is contra-indicated. Should not be given to lactating women. Should not be given to patients with megaloblastic anaemia, blood dyscrasia. Contra-indicated in the presence of vitamin B12 and folic acid deficiency states.

WARNINGS:
Erythema multiforme, toxic dermal necrolysis or allergic vasculitis may occur. Treatment should be discontinued immediately when a rash appears because of the danger of severe allergic reactions.
A high incidence of side-effects occurs in immunocompromised patients as those suffering from AIDS or patients receiving immunosuppressive therapy. The adverse effects include skin rash, recurrent fever, neutropenia, thrombocytopenia and raised liver enzyme values.

INTERACTIONS:
Cross-sensitivity has been observed between sulphamethoxazole and chemically related medicines such as diuretics, particularly acetazolamide and thiazides and the sulphonylurea hypoglycaemic agents. Sulphamethoxazole may potentiate the effects of some medicines such as oral anticoagulants, methotrexate and phenytoin; this may be due to displacement of the plasma protein binding sites or inhibition of metabolism. High doses of sulphamethoxazole may have a hypoglycaemic effect; the antidiabetic effect of the sulphonylurea compounds may be enhanced by the concomitant administration of sulphamethoxazole. The action of sulphamethoxazole may be antagonised by para-aminobenzoic acid and compounds derived from it, particularly the procaine group of local anaesthetics. Paraldehyde has been reported to increase the acetylation of sulphamethoxazole with subsequent increased risk of crystalluria. Sulphamethoxazole may interfere with some diagnostic tests including those of urea, creatinine, and urinary glucose and urobilinogen. Trimethoprim may potentiate the anticoagulant effect of warfarin. It also prolongs the half-life of phenytoin. Trimethoprim has been reported to interact with a number of medicines by interfering with their clearance; such medicines include digoxin, procainamide and tolbutamide.
Reversible deterioration in renal function has been reported in patients given trimethoprim and cyclosporin following renal transplantation.
Trimethoprim may interfere with some diagnostic test including serum methotrexate assay where dihydrofolate reductase is used and the Jaffe reaction for creatinine.

PREGNANCY AND LACTATION:
Co-trimoxazole should not be used during pregnancy. Use of the substance in premature or newborn infants during the first few weeks of life, is contra-indicated. Should not be given to lactating women.

DOSAGE AND DIRECTIONS FOR USE:
Infants
- 8 weeks to 5 months: Half a medicine measureful (2.5 mL) every 12 hours.
Children
- 6 months to 5 years: One medicine measureful (5 mL) every 12 hours.
- 6 years to 12 years: Two medicine measurefuls (10 mL) every 12 hours.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Hypersensitivity reactions particularly involving the skin are among the most common adverse effects of co-trimoxazole and are usually due to the sulphamethoxazole components. The Stevens-Johnson and Lyell’s syndromes have been reported.
Adverse effects on the gastro-intestinal tract may also occur fairly frequently.
Sulphamethoxazole:
Sulphamethoxazole may cause nausea, vomiting and diarrhoea.
Hypersensitivity reactions may occur. Those involving the skin include rashes, photosensitivity reactions, exfoliative dermatitis, toxic epidermal necrolysis (Lyell’s syndrome), and erythema nodosum. A severe, potentially fatal form of erythema multiforme, associated with widespread lesions of the skin and mucous membranes, termed the Stevens-Johnson syndrome, may occur.
Systemic lupus erythematosus, particularly exacerbations of pre-existing disease, has also been reported. Nephrotoxic reactions, which may result in renal failure, have been attributed to hypersensitivity to sulphamethoxazole. Lumbar pain, haematuria, oliguria and anuria may also occur due to crystallisation in the urine of sulphamethoxazole or it’s less soluble acetylated metabolite.
Blood disorders may occur and include agranulocytosis, aplastic anaemia, thrombocytopenia, leucopenia, hypoprothrombinaemia and eosinophilia. Acute haemolytic anaemia associated with glucose-6-phosphate dehydrogenase deficiency may occur. Other side-effects which may be manifestations of a generalised hypersensitivity reaction to sulphamethoxazole include a syndrome resembling serum sickness, hepatotoxic reactions, myocarditis, pancreatitis, pulmonary eosinophilia and vasculitis including polyarteritis nodosa. Anaphylaxis has been reported. Sulphamethoxazole may cause cyanosis due to methaemoglobinaemia or sulphaemoglobinaemia. Other side-effects on the eyes such as optic neuropathy or transient myopia, fever, hypothyroidism and neurological reactions including ataxia, dizziness, fatigue, headache, insomnia, peripheral neuritis and vertigo. Sulphamethoxazole may cause alterations of the bacterial flora in the gastro-intestinal tract. There is, therefore, the possibility that pseudomembranous colitis may occur. Slow acetylators of sulphamethoxazole may be a greater risk of adverse reactions than fast acetylators.
Trimethoprim:
Side-effects caused by trimethoprim include pruritis, skin rash, fever, nausea, vomiting and sore mouth.

Precautions:
DOCTRIM
should be given with caution to patients with actual or possible folate deficiency because of possible interference with human folate metabolism by trimethoprim, and administration of folinic acid could be considered. DOCTRIM should also be used with caution in patients receiving pyrimethamine as they may develop megaloblastic anaemia due to the trimethoprim component.
Adverse effects on the blood may be more severe in malnourished or elderly patients; there also appears to be an increased risk of thrombocytopenia in elderly patients concurrently receiving diuretics, mainly thiazides. All patients receiving prolonged treatment with DOCTRIM should be given regular blood examinations.
DOCTRIM should be used cautiously and in reduced dosage in patients with impaired renal function. Because of the risk of crystalluria, an adequate fluid intake should be maintained and the administration of alkalis may be necessary if very large doses are used.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Nausea, vomiting, cyanosis, haematuria, oliguria, or anuria and allergic skin reactions (skin rashes, anaphylaxis, etc.). If megaloblastic changes occur, folinic acid must be given. Treatment is supportive and symptomatic.

IDENTIFICATION
A white, opaque viscous suspension.

PRESENTATION:
Plastic bottles of 50 mL, 100 mL and 500 mL.

STORAGE INSTRUCTIONS:
Store in a cool place, below 25ºC. Protect from light and heat.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
28/20.2/0378

NAME AND BUSINESS ADDRESS OF THE HOLDER OF THE CERTIFICATE OF REGISTRATION:
GULF DRUG COMPANY (PTY) LTD
22 BURNSIDE DRIVE
OLD MILL INDUSTRIAL PARK
MOUNT EDGECOMBE, 4300

www.gulfdrug.co.za

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
March 1994

P/280378/2

New addition to this site: July 2010
Source: Pharmaceutical Industry

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