Treatment of postmenopausal osteoporosis to reduce the risk of vertebral fractures

Treatment of osteoporosis, post-menopausal to reduce the risk of hip fractures

Prevention of osteoporosis in postmenopausal women at high risk of osteoporosis (see section 5.1)
Maintain or increase bone mass in postmenopausal women taking long-term systemic corticosteroids (over 3 months) at doses ≥ 7.5 mg / day of prednisone or prednisone equivalent

In adults, the recommended dose is one tablet, 5 mg daily, orally. The absorption of risedronate monosodium is affected by food, too, to ensure adequate absorption, patients should take ACTONEL

· Before breakfast: at least 30 minutes before the absorption of the first foods, other medicines, or drinks (other than flat water) of the day. >

If taken before breakfast is not practical ACTONEL can be taken between meals or in the evening at the same time each day, strictly adhering to the following instructions to ensure that ACTONEL is taken when , The stomach is empty

· Between meals: ACTONEL should be taken at least 2 hours before and at least 2 hours after any food, beverages (other than plain water) or medication. >

· In the evening: ACTONEL should be taken at least 2 hours after the last foods, beverages (other than plain water) or medicines of the day. ACTONEL should be taken at least 30 minutes before going to bed.

· If a take is forgotten, ACTONEL can be taken before, breakfast, between meals or in the evening, according to the instructions detailed above. Code>
The ACTONEL tablet should be swallowed whole, without being chewed and without allowing it to melt in the mouth.

To facilitate transit through the stomach, the ACTONEL tablet should be swallowed in a sitting or standing position with a large glass of flat water (≥ 120 ml). >

Patients should not lie down within 30 minutes of taking the tablet (see Warnings and Precautions for Use). >
Calcium and vitamin D supplementation should be considered if the dietary intake is inadequate

No dosage adjustment is necessary because bioavailability, distribution and elimination are identical in the elderly (> 60 years of age) and in the younger subjects

Renal impairment is not required in patients with mild to moderate renal impairment. The use of risedronate, monosodium is contraindicated in patients with severe renal insufficiency (creatinine clearance

Children: The safety and efficacy of ACTONEL have not been demonstrated in children and adolescents

Duration of the processing

The optimal duration of bisphosphonate treatment for osteoporosis has not been established. The need to continue treatment should be regularly re-evaluated on a case-by-case basis according to the benefits and risks of ACTONEL, especially after 5 years or more treatment
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Film-coated tablet, yellow, oval, with RSN on one side and 5 mg on the other.

Class: Pharmacotherapeutic: bisphosphonates, ATC code: M05, BA07.

Risedronate monosodium is a pyridinil bisphosphonate which binds to bone hydroxyapatite and inhibits bone resorption induced by the osteoclast.
Bone remodeling is reduced, while osteoblastic activity and bone mineralization are preserved.

In preclinical studies, risedronate, monosodium revealed a potent anti-resorptive and anti-osteoclastic activity, and increased, dose-dependent, bone mass and biomechanical strength of the skeleton. The activity of risedronate monosodium was confirmed by measuring the biochemical markers of bone remodeling in pharmacodynamic and clinical studies. In studies in postmenopausal women, decreases in biochemical markers of bone remodeling were observed in 1 month of treatment and peaked in 3-6 months.
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Treatment of osteoporosis, postmenopausal

Risk factors commonly associated with osteoporosis, postmenopausal include: low bone mass, low bone mineral density, existence of previous fractures, early menopause, history of smoking, alcohol consumption and a family history of osteoporosis . Fracture is the clinical consequence of osteoporosis. The risk of fracture increases with the number of risk factors.

The clinical development of monosodium risedronate administered on a daily basis has examined the effect of risedronate sodium on the risk of hip fractures and vertebral fractures and has included recently postmenopausal women or menopausal women with or without fracture.

Daily doses of 2.5 mg and 5 mg were studied and all groups, including placebo groups, received calcium, and vitamin D (when levels, at baseline, were low) .

The absolute and relative risks of new vertebral and hip fractures were estimated by a "date of occurrence of the first event" type analysis.
· Two placebo-controlled trials (n = 3,661) included menopausal women under 85 years of age with vertebral fractures at inclusion. >
Risedronate monosodium 5 mg administered daily for 3 years reduced the risk of new vertebral fractures compared to the placebo group. In women with at least 1 or 2 fractures and vertebral fractures, the relative risk reduction was 41 and 49% (incidence of new, vertebral fractures under risedronate monosodium, 11.3% and 18.1%, respectively). Placebo 16.3% and 29.0%, respectively).
The efficacy of the treatment was observed early, from the end of the first year. Beneficial effects have also been demonstrated in women with multiple fractures at baseline. Risedronate monosodium, 5 mg per day, also reduced annual height loss compared to the control group population.
This drug contains lactose Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or malabsorption syndrome, glucose and galactose should not take this drug

No specific study of interactions has been carried out. However, no clinically relevant drug interaction has been found during clinical trials.

33% and 45% of patients who participated in Phase III studies in osteoporosis with monosodium risedronate in daily intake used acetylsalicylic acid or NSAIDs. >

If necessary, risedronate monosodium may be used in combination with an estrogen replacement therapy.
Simultaneous administration of medicines containing polyvalent cations (eg, calcium, magnesium, iron, and aluminum) may interfere with absorption of risedronate sodium (see section 4.4). Br>

Risedronate monosodium is not systemically metabolized, does not lead to enzymatic induction of cytochrome P450 and has a low level of binding to proteins

Without object.

No specific information on the treatment of overdosage with risedronate monosodium is available

In some patients, signs and symptoms of hypocalcaemia may also be observed.

In order to fix risedronate and reduce its absorption, milk or anti-acids containing magnesium, calcium or aluminum must be administered. In the event of significant overdosage, gastric lavage may be considered in order to eliminate risedronate, unabsorbed monosodium.
There are no data available on the use of risedronate, monosodium in pregnant women. Studies in animals have shown reproductive toxicity (see section Preclinical safety data). The potential risk for women is not known. Animal studies have shown that a small amount of risedronate monosodium passes through the milk.

Risedronate sodium should not be used in pregnant or lactating women.

Risedronate monosodium was studied in Phase III clinical trials on more than 15,000 patients.

In these clinical trials, the severity of the majority of adverse effects observed was mild to moderate and generally did not necessitate discontinuation of treatment.
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Adverse events reported in Phase III clinical trials in postmenopausal women, osteoporotics treated up to 36 months with risedronate monosodium 5 mg / d (n = 5020) or placebo (n = 5048) and (Incidence of adverse events versus placebo noted in parentheses): very common (≥ 1/10), frequent (≥ 1 / (