Generic drug of the therapeutic class: Rheumatology
active ingredients: Etidronate disodium
laboratory: Warner Chilcott France
Box of 14
- Curative treatment of postmenopausal osteoporosis, with at least one vertebral collapse.
- Prevention of bone loss in patients requiring prolonged systemic corticosteroid treatment longer than 3 months and at a dose greater than 7.5 mg / day of prednisone equivalent.
Dosage DIDRONEL 400 mg Tablet Box of 14
Oral route - Reserved for adults.
- Etidronate is administered cyclically with calcium every 3 months.
- The administration is done according to the following diagram:
. Etidronate 1 tablet at 400 mg daily for 14 days,
. then for 2 months and a half after taking etidronate, a calcium intake at a sufficient dose (usually 1000 mg per day) and possibly vitamin D at physiological dose (usually 800 IU / day) is recommended.
- Efficacy data for postmenopausal osteoporosis are based on 3-year studies.
Administration mode :
Etidronate should be taken 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.
Ingesting calcium in drug or food form (milk, cheese, etc.) should be avoided when taking etidronate (see section on interactions).
- 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.