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

Logo SALAZOPYRIN® 500 Tablets
SCHEDULING STATUS:
S4

PROPRIETARY NAME:
(and dosage form)

SALAZOPYRIN® 500 Tablets

COMPOSITION:
Each SALAZOPYRIN 500 tablet contains sulphasalazine 500 mg

PHARMACOLOGICAL CLASSIFICATION:
A 20.2.1 Sulphonamides

PHARMACOLOGICAL ACTION:
Sulphasalazine is broken down by the intestinal bacteria in the colonic lumen. Salicylazosulphapyridine is split into two main metabolites, sulphapyridine, an active sulphonamide, and 5-aminosalicylic acid. The latter is responsible for the anti-inflammatory effect.

INDICATIONS:
Ulcerative colitis: For the treatment of acute ulcerative colitis. For maintenance of remission in ulcerative colitis.
Crohn's disease: For the treatment of acute Crohn's disease. Maintenance of remission of Crohn's disease.

CONTRA-INDICATIONS:
Should not be used in cases of existing gastric and duodenal ulcers.
Safety during pregnancy and lactation has not been established.
Sensitivity to sulphonamides or salicylates. Porphyria.
Should not be used in cases of haemorrhagic diathesis, severe renal failure or hepatic failure.
SALAZOPYRIN 500 Tablets should not be given to infants and children under two years of age.

WARNINGS:
Adequate fluid intake, 1 200 mL to 1 500 mL daily, is necessary to reduce the risk of crystalluria. If this cannot be accomplished, sodium bicarbonate may be given.
Treatment should be discontinued immediately when a rash appears because of the danger of severe allergic reactions such as the Stevens-Johnson syndrome.

DOSAGE AND DIRECTIONS FOR USE:
The dosage should be adjusted according to the response to the treatment and the patient’s tolerance to the medicine. The tablets should be taken at regular intervals during the day, preferably with meals. Night time intervals between doses should not exceed eight hours.
Patients not previously treated with sulphasalazine are advised to raise the dose gradually during the first few weeks. Patients experiencing gastro-intestinal side-effects to the uncoated SALAZOPYRIN 500 tablets, are advised to use SALAZOPYRIN EN 500 tablets or a lower dose.
Ulcerative colitis/Crohn's disease:
Adults:
Acute attacks: Two to four tablets every six hours with a maximum of 12 g daily.
Remission: The dose must be reduced to 2 g daily.
Children:       
Acute attacks: 40 mg-60 mg/kg body weight daily, in three to six divided doses.
Remission: 20 mg to 30 mg/kg body weight.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Frequently encountered side-effects:
General: Headache, fever, loss of appetite.
Blood: Leucopenia (following bone marrow depression), acute haemolytic anaemia, red cell abnormalities.
GI: Gastric distress and abdominal pain, nausea, vomiting, diarrhoea.
Liver: Transient elevation of liver enzymes.
Skin: Exanthema, urticaria, erythema, pruritus.
Other: Reversible oligospermia.
Urogenital: The urine may be coloured orange-yellow.
Less frequent side-effects:
General: Dizziness, periorbital oedema.
Blood: Agranulocytosis, megaloblastic anaemia, thrombocytopenia, eosinophilia, methaemoglobinaemia, hypoprothrombinaemia, aplastic anaemia, cyanosis.
Eye: Yellow staining of soft contact lenses, optic neuropathy, transient myopia.
Ear: Tinnitus.
GI: Pancreatitis, Pseudomonas colitis (as a result of alteration of the intestinal bacterial flora).
Liver: Hepatitis.
Musculo-skeletal:Arthralgia.
Neurological: Ataxia, fatigue, insomnia, peripheral neuritis, vertigo, peripheral neuropathy, aseptic meningitis (in patients with rheumatoid disease), convulsions, hallucinations, multiple sclerosis and chorea.
Psychiatric:Mental depression.
Respiratory:Fibrosing alveolitis, dyspnoea and cough.
Skin:Skin rashes, photosensitivity, yellow skin discolouration, dermatitis on contact with the skin, alopecia, exfoliative dermatitis, toxic epidermal necrolysis.
Urogenital:Nephrotoxic reactions, Stevens-Johnson syndrome (due to crystalluria), proteinuria, haematuria.
Other:Systemic lupus erythematosus, erythema nodosum, hypothyroidism, stomatitis, parotitis, hypoglycaemic effect (with high doses).
Manifestations of a generalised hypersensitivity reaction to sulphonamides include a syndrome resembling serum sickness, hepatotoxic reactions, myocarditis, pulmonary eosinophilia, and vasculitis including polyarteritis nodosa. Anaphylaxis has been reported.
Special precautions:
Sulphasalazine should be administered under medical supervision before and during therapy. Complete blood counts and urinalysis should also be performed before and during treatment. In cases of renal damage adequate fluid intake must be maintained in order to prevent crystalluria and stone formation.
If serious toxic or hypersensitivity reactions occur, the medicine should be discontinued immediately. Some weeks after discontinuation sulphasalazine may be re-introduced beginning with a low dose followed by small increases in dosage regimen.
Patients, especially those with glucose-6-phosphate dehydrogenase deficiency, should be observed closely for signs of haemolytic anaemia.
Oligospermia and infertility in men treated with sulphasalazine has been reported but withdrawal of the medicine appears to reverse these effects.
Patients with AIDS may have a greater incidence of adverse effects than do non-AIDS patients, especially rash, fever and leucopenia.
Patients with slow acetylator phenotype are more likely to show adverse effects due to sulphapyridine.
Reduction of dosage may be required in patients with renal impairment.
Complete blood counts and urinalyses should be carried out particularly during prolonged therapy.
Interactions:
The blood-sugar reducing effect of sulphonylureas may be enhanced. Interactions with coumarins, methotrexate, probenecid, sulfinpyrazone, spironolactone, furosemide and rifampicin may occur.
Potentiation of undesirable glucocorticoid effects on the stomach may occur.
Sulphasalazine chelates iron and interferes with its absorption.
The action of sulphonamides 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 sulphonamides with subsequent increased risk of crystalluria.
Reduced absorption of folate and digoxin have been reported when used concomitantly with sulphasalazine.
Concomitant antibiotic therapy may possibly alter the patient's response to sulphasalazine.
Sulphonamides may potentiate the effects of oral coagulants, methotrexate and phenytoin.
The administration of compounds which acidify the urine may increase the risk of crystalluria; the risk may be reduced with alkaline urine.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Symptoms of overdosage include those of salicylism and overdosage with sulphonamides. Treatment is symptomatic and supportive.

IDENTIFICATION:
SALAZOPYRIN 500 Tablets are yellow-orange, round tablets, scored with 'KPh' on one side and '101' on the other.

PRESENTATION:
Securitainers of 100 tablets.

STORAGE INSTRUCTIONS:
Store below 30°C. Protect from moisture.
Keep out of reach of children.

REGISTRATION NUMBER:
E/20.2.1/909

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Pharmacia South Africa (Pty) Limited
Alphen West G
George Street
Midrand
1685

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
September 1993

New addition to this site: January 2005
Source: Pharmaceutical Industry

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