Drug Class Description

Generic Name

Drug Description

Presentation

Indications

Adult Dosage

Oral.

General

Olsalazine taken on an empty stomach may sometimes lead to loose stools or diarrhoea. By taking the drug at the end of a meal, this may be avoided.

Acute Mild Disease

Adults including the elderly: Commence on 1 g daily in divided doses taken at the end of meals. Depending on the patient's response, the dose may be titrated upwards over a period of one week to a maximum of 3g daily.

A single dose should not exceed 1 g.

Remission

Adults including the elderly:A dose of 0.5g should be taken twice daily, at the end of meals.

Olsalazine has been used concomitantly with gluco-corticosteroids.

Child Dosage

Contra Indications

Hypersensitivity to olsalazine or other salicylates or any other of the excipients.

There is no experience of the use of olsalazine in patients with significant renal impairment. Olsalazine is contra-indicated in patients with significant renal impairment.

Special Precautions

It is recommended to monitor patients with impaired kidney or liver function.

Patients suffering from severe allergy or asthma should be observed for signs of worsening of these conditions.

Serious blood dyscrasias have been reported very rarely with olsalazine. Haematological investigations should be performed if the patient develops unexplained bleeding, bruising, purpura, anaemia, fever or sore throat. Treatment should be stopped if there is a suspicion or evidence of a blood dyscrasia.

Interactions

The coadministration of salicylates and low molecular weight heparins or heparinoids may result in an increased risk of bleeding, more specifically hematomas following neuraxial anesthesia. Salicylates should be discontinued prior to the initiation of a low molecular weight heparin or heparinoid. If this is not possible, it is recommended to monitor patients closely for bleeding.

Increased prothrombin time in patients taking concomitant warfarin has been reported.

The coadministration of olsalazine and 6-mercaptopurine or thioguanine may result in an increased risk of myelosuppression. If coadministered with 6-mercaptopurine, it is recommended to use the lowest possible doses of each drug and to monitor the patient, especially for leukopenia. In case of coadministration with thioguanine, careful monitoring of blood counts is recommended.

It is recommended not to give salicylates for six weeks after the varicella vaccine to avoid a possible increased risk of developing Reye's syndrome.

Adverse Reactions

The most common side effect is diarrhoea which is usually transient. Where it does not, taking the drug at the end of a more substantial meal, dose titration or dose reduction are usually effective. Withdrawal in clinical studies when the drug was taken at the end of meals was around 3%. Where diarrhoea persists, the drug should be stopped.

In addition, the following undesirable effects have been reported:

General disorders and administration site conditions : headache, pyrexia

Blood and lymphatic system disorders : aplastic anaemia, eosinophilia, haemolytic anemia, leukopenia, neutropenia, pancytopenia, thrombocytopenia

Gastrointestinal disorders : abdominal pain upper, diarrhoea, dyspepsia, nausea, pancreatitis, vomiting

Hepatobiliary disorders : hepatic enzyme increased, hepatitis, increased bilirubin

Skin and subcutaneous tissue disorders : alopecia, angioneurotic oedema, photosensitivity reaction, pruritus, rash, urticaria,

Cardiac disorders : myocarditis, palpitations, pericarditis, tachycardia

Renal and urinary disorders : interstitial nephritis

Respiratory, thoracic and mediastinal disorders : dyspnoea

Musculoskeletal and connective tissue disorders : arthralgia, myalgia

Nervous system disorders : dizziness, paraesthesia

Eye disorders : vision blurred

Manufacturer

Drug Availability

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