AZAMUN Film coated tablet (2022)

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

Azamun 25 mg, 50 mg, 75 mg, 100mg, Film coated tablet.

2. Qualitative and quantitative composition

Azamun 25 mg: each tablet contains 25 mg azathioprine. Azamun 50 mg: each tablet contains 50 mg azathioprine. Azamun 75 mg: each tablet contains 75 mg azathioprine. Azamun 100 mg: ...

3. Pharmaceutical form

Azamun 25 mg: Light yellow, circular, biconvex tablet engraved AZA and 25 on one side and plain on the other side. Azamun 50 mg: Light yellow, circular, biconvex tablet engraved AZA' break-line ...

4.1. Therapeutic indications

Azamun is used as an immunosuppressant anti-metabolite either alone, or more commonly in combination with other agents (usually corticosteroids) and procedures that influence the immune response. The therapeutic ...

4.2. Posology and method of administration

Azathioprine is a potent immunosuppressive agent and should be used under the direction of a physician familiar with the risk associated with this type of therapy. The patient should be evaluated carefully ...

4.3. Contraindications

Hypersensitivity to azathioprine or 6-mercaptopurine. Chickenpox, existing or recent (including recent exposure). Herpes zoster. Pregnancy should be considered a contraindication.

4.4. Special warnings and precautions for use

Monitoring There are potential hazards in the use of Azathioprine. It should be prescribed only if the patient can be adequately monitored for toxic effects throughout the duration of therapy. Particular ...

4.5. Interaction with other medicinal products and other forms of interaction

Allopurinol / oxipurinol / thiopurinol Xanthine oxidase activity is inhibited by allopurinol, oxipurinol and thiopurinol which results in reduced conversion of biologically active 6-thioinosinic acid to ...

4.6. Pregnancy and lactation

Pregnancy Pregnancy category D. Azathioprine should not be given to patients who are pregnant or likely to become pregnant in the near future without careful assessment of risk versus benefit. Evidence ...

4.7. Effects on ability to drive and use machines

There are no data on the effect of azathioprine on driving performance or the ability to operate machinery. A detrimental effect on these activities cannot be predicted from the pharmacology of the drug. ...

4.8. Undesirable effects

For this product, there is no modern clinical documentation which can be used as support for determining the frequency of undesirable effects. Undesirable effects may vary in their incidence depending ...

4.9. Overdose

Symptoms Unexplained infection, ulceration of the throat, bruising and bleeding are the main signs of overdosage with azathioprine and result from bone marrow depression which may be maximal after 9-14 ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: immunosuppressant ATC code: L04AX01 Azathioprine is an imidazolyl derivative of 6-mercaptopurine (6-MP). It is rapidly broken down invivo into 6-MP and a methylnitroimidazole ...

5.2. Pharmacokinetic properties

Azathioprine appears to be well absorbed from the upper gastrointestinal tract. Studies in mice with 35S-azathioprine showed no unusually large concentration in any particular tissue, but there was very ...

5.3. Preclinical safety data

Teratogenicity Studies in pregnant rats, mice and rabbits using azathioprine in dosages from 5-15 mg/kg body weight/day over the period of organogenesis have shown varying degrees of foetal abnormalities. ...

6.1. List of excipients

Azamun contains cellulose microcrystalline, mannitol, povidone, maize starch, croscarmellose sodium, sodium stearyl fumarate in the tablet core. The tablet coating contains Opadry clear OY7240 (macrogol ...

6.2. Incompatibilities

Not known.

6.3. Shelf life

36 months.

6.4. Special precautions for storage

Azamun 25 mg and 50 mg: Store at or below 30°C and protect from light and moisture. Azamun 75 mg and 100 mg: Store at or below 25°C and protect from light and moisture.

6.5. Nature and contents of container

Azamun 25 mg: 30, 60 and 100 tablets in PVC/PVDC-Aluminium foil blister strips. Azamun 50 mg, 75 mg, 100 mg: 100 tablets in PVC/PVDC-Aluminium foil blister strips. Not all strengths or pack ...

6.6. Special precautions for disposal and other handling

Any unused medicine or waste material should be disposed of in accordance with local requirements.

7. Marketing authorization holder

Douglas Pharmaceuticals Ltd, P O Box 45 027, Auckland 0651, New Zealand Phone: (09) 835 0660

9. Date of first authorization / renewal of the authorization

Date of first approval: Azamun 50 mg: 13 August 1998 Azamun 25 mg, 75 mg, 100 mg: 26 June 2014

10. Date of revision of the text

11 October 2022

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