Medicinal Products

AZATHIOPRIN EG 50 mg

Imurel Generic Drug
Therapeutic class: Immunology
active ingredients: Azathioprine
laboratory: EG Labo

Coated tablet
Box of 100
All forms

Indication

- Organ Transplantation : Prevention of graft rejection in combination with corticosteroids or other immunosuppressive agents.
- Dysimmunitary diseases : treatment of systemic lupus erythematosus, severe rheumatoid arthritis, autoimmune hepatitis (excluding viral diseases), idiopathic thrombocytopenic purpura, autoimmune haemolytic anemia, dermatomyositis, polymyositis, systemic vasculitis (with the exception of viral diseases), pemphigus, Crohn's disease and ulcerative colitis.
AZATHIOPRINE EG is indicated in the severe forms of these diseases, in patients who are intolerant to corticosteroids or corticosteroids or whose therapeutic response is insufficient despite high doses of corticosteroids.

Dosage AZATHIOPRINE EG 50 mg Film-coated tablet Box of 100

- It is advisable to take this medicine during meals, to avoid gastrointestinal disorders.
- The dosage and duration of treatment vary according to the indications.
- Organ transplants - Adults and children: The dosage is 1-3 mg / kg / day (usually not exceeding 150 mg / d) and should be adjusted according to clinical response and haematological tolerance.
Dysimmunity Diseases - Adults and Children:
The dosage is 1 to 3 mg / kg / day (not to exceed 150 mg / day) depending on the current clinical condition, the patient's individual response, and hematologic tolerance.
The maintenance dosage will be kept to a minimum consistent with the persistence of efficacy. If no improvement in the patient's condition occurs within 6 months, discontinuation of treatment should be considered. - Hepatic impairment - Hepatic insufficiency - Elderly:
It is recommended to use the minimum dosages recommended above.

Against indications

CONTRAINDICATED:
- Breast-feeding is contraindicated in patients treated with azathioprine because 6-MP has been found in colostrum and breast milk: adverse effects on the newborn can not be excluded, breastfeeding is contraindicated in women treated with azathioprine.
- This medicine is contraindicated:
. in patients with known hypersensitivity to azathioprine, 6-mercaptopurine, or any of the drug components.
. in association with :
* the vaccine against yellow fever,
* Allopurinol
- As with any cytotoxic chemotherapy, contraceptive measures should be considered if one of the partners is treated with azathioprine.
- Contraindicated combinations: other myelotoxic therapies.
NOT RECOMMENDED :
- Lesch-Nyhan syndrome: Administration of azathioprine is not recommended in patients with hypoxanthine-guanine-phosphoribosyl transferase deficiency.
- Associations advised against : phenytoin, fosphenytoin; live attenuated vaccines (except yellow fever).

Adverse effects Azathioprine EG

- The most common adverse effects are of hematological nature (see section warnings and precautions for use) and gastrointestinal. These effects are dose-dependent and reversible upon discontinuation of treatment.
- The incidence of side effects may vary depending on the indication. The classification of adverse reactions by frequency uses the following convention:
Very common (> 1/10), common (> 1/100, 1/1000, 1/10000, <1/1000), very rare (<1/10000).
- Infections and infestations:
. Very common : Viral, mycotic and bacterial infections in transplant patients treated with azathioprine in combination with other immunosuppressants.
. Uncommon : Viral, mycotic and bacterial infections in other non-transplant patients, potentially severe, sometimes fatal.
Opportunistic infections have been reported (see section on warnings and precautions for use).
- Benign and malignant tumors (including cysts and polyps):
Rare : tumors including non-Hodgkin's lymphoma, skin cancer, (melanomas or others), sarcomas (Kaposi's sarcoma or others), cancer in situ of the cervix, as well as acute myeloid leukemias and myelodysplasias (some cases are related to chromosomal abnormalities) (see section on warnings and precautions for use).
- Hematological and lymphatic system disorders:
. Very common : leukopenia, myelosuppression.
. Frequent : thrombocytopenia
. Uncommon : anemia, macrocytosis.
. Rare : agranulocytosis, pancytopenia, aplastic anemia, megaloblastosis, medullary aplasia.
Azathioprine may be responsible for dose-dependent bone marrow involvement, usually reversible upon discontinuation of therapy.
. These effects can be reported more particularly in patients predisposed to myelotoxicity, ie in case of genetic deficiency of thiopurine methyltransferase, or renal or hepatic insufficiency, or in the absence of reduction of azathioprine dosage. in case of treatment associated with allopurinol (see section warnings and precautions for use and section interactions).
- Immune system disorders:
Uncommon : manifestations of hypersensitivity.
They usually result in hyperthermia most often associated with hypotension, dizziness, nausea, vomiting, chills, rash, vasculitis, myalgia, arthralgia, pancreatitis, changes in renal function and liver function, or even pneumopathy regressing generally at discontinuation of treatment.
These manifestations require the immediate and definitive cessation of treatment and the implementation of symptomatic treatment.
- Gastrointestinal disorders:
. Frequent : nausea (during the first administrations of azathioprine). Taking the tablets after the meal seems to reduce nausea.
. Uncommon : pancreatitis (especially renal transplant patients and patients with inflammatory digestive diseases).
. Very rare : vomiting, severe complications like colitis, diverticulosis and intestinal perforations in transplant patients treated with immunosuppressive drugs (nevertheless, the etiology is not clearly established, high doses of corticosteroids could be implicated), severe diarrhea during treatment for intestinal inflammatory disease.
- Hepatobiliary disorders:
. Uncommon : cholestasis and impaired hepatic function (usually reversible upon discontinuation of treatment), cholestatic, mixed or cytolytic hepatitis, jaundice.
. Rare : potentially life-threatening liver disease in transplant patients treated chronically with azathioprine manifested by either biological cholestatic disease or a clinical picture of portal hypertension (veno-occlusive liver disease, peliosis hepatis, nodular regenerative hyperplasia).
In some cases discontinuation of treatment may temporarily or permanently improve the symptoms and histology of the liver.
- Skin and subcutaneous tissue disorders:
Rare : Alopecia in some patients treated with azathioprine combined with other immunosuppressive agents, usually with spontaneous resolution.

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