Medicinal Products

DISULONE 100 mg / 200 mg

Generic drug of the therapeutic class: Infectiology - Parasitology
active ingredients: Dapsone, Iron oxalate
laboratory: Sanofi-Aventis France

Tablet breackable
Box of 100
All forms

Indication

- Treatment of leprosy (Hansen's disease).
- Treatment of certain neutrophil-mediated dermatoses.
- Treatment of atrophic polychondritis.
- Treatment of autoimmune bullous dermatoses, such as dermatitis herpetiformis, autoimmune bullosa dermatitis with linear IgA, mucous membrane pemphigoid ...
- Bullous lupus.
- Primary and secondary prophylaxis of pneumocystosis in case of intolerance to cotrimoxazole.
Official recommendations concerning the appropriate use of antibacterials should be taken into account.

Dosage DISULONE 100 mg / 200 mg Breakable tablet Box of 100

The dosage varies according to pathology, age and individual susceptibility.
In children, the dose of 2 mg / kg / day should not be exceeded.
In children under 6 years of age, given the inherent risk of misbehavior, the tablets should be carefully crushed and mixed with liquid or yoghurt.
- Treatment of leprosy (Hansen's disease):
In the treatment of Hansen's disease, this drug should never be prescribed alone, but in combination with other anti-lepers :
. rifampicin in paucibacillary forms (microscopically negative bacillary index in all specimens),
. rifampicin and clofazimine in multibacillary forms (bacillary index greater than or equal to 1 +, ie 1 to 10 bacilli or more in 100 fields on microscopic examination of the different samples).
. In adults : dapsone is usually prescribed at a dose of 100 mg (1 tablet) per day.
. In children :
In children under 10 years, dapsone is prescribed at a dose of 25 mg / day.
In children aged 10 to 14, dapsone is prescribed at a dose of 50 mg / day.
Combinations of anti-lepers are the same as in adults at doses adapted to the child.
- Treatment of autoimmune bullous dermatoses such as dermatitis herpetiformis and autoimmune bullous disease with linear IgA.
- Treatment of neutrophil-mediated dermatoses, including Sweet's syndrome.
- Bullous lupus:
The average dosage is 100 mg daily.
This treatment will be continued for several years.
A gluten-free diet will eventually be associated with the treatment of dermatitis herpetiformis.
- Treatment of atrophic polychondritis:
100 to 300 mg daily, administered over a prolonged period.
- Primary and secondary prophylaxis of pneumocystosis in case of intolerance to cotrimoxazole:
50 to 100 mg daily.
In patients intolerant to cotrimoxazole, there is cross-intolerance in 30-40% of cases.
Dapsone can also be used at a dose of 50 mg / day in combination with pyrimethamine (50 mg / week) and folinic acid.

Against indications

CONTRAINDICATED:
This medicine is CONTRAINDICATED in the following situations:
- Hyper-sensitivity to one of the compounds,
- anemia (Hb less than 9 g / 100 ml),
- methemoglobinemia.
NOT RECOMMENDED :
This drug is generally NOT RECOMMENDED in the following cases:
- hepatic or renal insufficiency,
- G6PD deficit.
Breast-feeding: Dapsone passes into breast milk at non-negligible concentrations. If possible, avoid breastfeeding if treated with this medicine.

Adverse effects Disulone

Commonly observed, dose-related adverse effects:
- Hemolysis is almost constant in patients receiving Disulone regardless of the dose as evidenced by haptoglobin dosages.
Hemolytic anemia is more rare and occurs at doses greater than or equal to 200 mg / day and in G6PD deficient subjects receiving at least 50 mg / day.
- methemoglobinemia. It must be searched systematically on the 8th day of treatment.
Unusually observed, dose-independent adverse reactions:
- Allergic manifestations: the classic picture is that of a syndrome of hypersensitivity appearing most often during the first 2 months of treatment.
This syndrome must be evoked in the presence of one or more clinical and biological symptoms, such as:
. hyperthermia of sudden onset, often inaugural, with tachycardia,
. erythematous, maculopapular rash, often generalized, sometimes itchy; epidermal detachments are possible,
. polyadenopathy,
. Hepatic (cholestatic hepatitis, cytolytic or potentially serious mixed hepatitis).
Late-onset granulomatous hepatitis has been reported.
. haematological disorders (polynucleosis, hypereosinophilia, haemolytic anemia, inflammatory syndrome),
. other visceral disorders: pulmonary (interstitial pneumonitis), cardiac, renal, digestive (abdominal pain), osteoarticular (arthralgia, myalgia).
These manifestations may exceptionally occur outside of a hypersensitivity syndrome.
Evolution is usually favorable to stopping treatment. However, fatal cases by visceral involvement have been reported. - Other cutaneous complications such as pruritus, urticaria, erythroderma and photosensitivity. - Other haematological complications: agranulocytosis, occurring mainly during the first 3 months of treatment, macrocytosis with or without anemia, sulfhemoglobinemia.
- Neurological complications such as headache, irritability, manic state.
Few cases of axonal neuropathies (motor and / or sensory disorders) affecting the extremities of the four limbs. These neuropathies are usually slowly reversible at the end of treatment, sometimes definitive.
- Digestive disorders: diarrhea, black stools, nausea, vomiting.
- Other: hypo-albuminemia, very rare kidney problems.

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