Medicinal Products

DIDRONEL 200 mg

Generic drug of the therapeutic class: Rheumatology
active ingredients: Etidronate disodium
laboratory: Warner Chilcott France

Compressed
Box of 60
All forms

Indication

- Paget's disease of the adult, painful or not, in evolutionary or complicated thrust.
- Malignant hypercalcemia in reliance on treatment with an injectable bisphosphonate.

Dosage DIDRONEL 200 mg Tablet Box of 60

Dosage:
Oral route - Reserved for adults.
- Paget's disease:
. the recommended starting dose for most patients is 5 mg / kg / day, or about 2 tablets per day, for a maximum of 6 months.
- doses greater than 10 mg / kg / day should be avoided, except in special cases, because of the risk of osteomalacia: increased medical supervision is required and the duration of treatment should not exceed 3 months.
. the second treatment will be undertaken only after a weaning period of at least three months and after evidence of the reactivation of the disease by the biochemical indices (as soon as these have risen substantially or have reapproached values obtained before the first treatment).
In no case should the value of this second treatment exceed that of the initial treatment.
A second premature treatment is not recommended.
- Malignant hypercalcemia:
20 mg / kg / day administered the day after the last dose of bisphosphonate IV for 30 days.
The duration of treatment should not exceed 30 days.
Administration mode :
- Etidronate should be administered in a single dose, at least 2 hours before or after a meal (at 10 am, for example).
- The tablets are swallowed with a large glass of water or fruit juice. Calcium should not be taken at the same time as etidronate. Any food, especially that rich in calcium, such as milk, should be avoided when taking the drug (see section on interactions).

Against indications

CONTRAINDICATED:
- Known hypersensitivity to the product.
- In the absence of clinical data, do not use etidronate in patients with severe renal impairment.
- Ostéomalacie patent.
- Breast-feeding: If treated with this medicine, breast-feeding is contraindicated.
NOT RECOMMENDED :
This drug should generally not be used during pregnancy: studies in animals have shown a teratogenic effect at high doses, with bone alterations affecting the skeleton and teeth. When administered throughout pregnancy, this drug causes bone mineralization disorders, mainly affecting the long bones and resulting in angular deformities. Most often, these abnormalities are observed at high doses and are reversible after farrowing. This effect is likely to account for the mechanism of action of the molecule, by chelation of calcium. In clinical practice, there are currently no data of sufficient relevance to assess the possible malformative or foetotoxic effect of this drug when administered during pregnancy. As a result, the use of etidronate is not recommended during pregnancy. This element does not constitute the argument for counseling a termination of pregnancy but leads to an attitude of caution and oriented antenatal surveillance.

Didronel side effects

- Gastrointestinal effects:
. nausea and diarrhea may occur. Their incidence increases when etidronate is administered at doses greater than 5 mg / kg / day.
. gastralgia especially in predisposed subjects.
- Other effects:
. osteomalacia related to a posology too high (see heading posology),
. skin reactions (pruritus, urticaria, follicular rash, macular or maculopapular rash),
. possibility of asthma attack in asthmatic patients,
. unknown frequency: osteonecrosis of the jaw, usually associated with dental extraction and / or local infection, often with delayed healing (see section on warnings and precautions for use).
- Very rare side effects:
. arthralgia, paresthesia, abnormal sensations of the tongue,
. vesiculobullous rashes,
. attacks of the white line have been reported, without the causal relationship with the product being established.

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