Strontium ranelate
When ATH:
M05BX03
Pharmacological action.
Stimulate bone formation.
Application.
Postmenopausal osteoporosis.
Contraindications.
Hypersensitivity, pregnancy, lactation, age to 18 years (efficacy and safety have not been established), severe chronic renal failure (Cl creatinine <30 ml / min).
Restrictions apply.
Chronic renal failure, incl. progressive, higher risk of developing venous thromboembolism (incl. episodes of venous thromboembolism).
Pregnancy and breast-feeding.
Clinical data on the effect of strontium ranelate in pregnancy missing. In animal experiments show, that the use of strontium ranelate in high doses during pregnancy leads to the development of reversible bone strains in the progeny. If the drug was wrongly appointed during pregnancy, Treatment should be stopped immediately.
Strontium is excreted in breast milk, therefore should not be administered during breastfeeding.
Side effects.
The most common side effects were nausea and diarrhea (mainly in the early treatment).
The frequency of side effects: Often (>10%), often (>1%, <10%), sometimes (>0,1%, <1%), rarely (>0,01%, <0,1%), rarely (<0,01%).
From the nervous system: often - headache; more often, compared to placebo, marked — a violation of consciousness (2,5 and 2% respectively), memory decline (2,4 and 1,9%) and cramps (0,3 and 0,1%).
From the digestive system: often, nausea, diarrhea, scatacratia.
For the skin: often-Dermatitis, eczema.
Laboratory findings: transient sharp increase in the activity of creatine phosphokinase (musculo-skeletal fraction) more than 3 times (in most cases, automatically returns to normal with continued treatment and does not require correction therapy).
Cardio-vascular system: the annual incidence of venous thromboembolism after 4 year of treatment was 0,7% with a relative risk 1,42 compared to placebo.
Cooperation.
Food, incl. dairy, and PM, containing Ca2+, Strontium ranelate reduces the bioavailability of 60-70% (interval in admission-not less than 2 no). Reception Al3+, Mg2+-containing antacids for 2 hours before receiving strontium ranelate, or simultaneously with, reduces the absorption of strontium ranelate (AUC decrease by 20-25%), while when receiving via antacids 2 hours after administration of strontium ranelate absorption rate is practically unchanged. Tetracyclines and quinolones reduce absorption.
Overdose.
A single dose of the drug in doses of up to 11 g, multiple dose (the maximum length 147 d) dose 4 r is not accompanied by the development of any specific symptoms.
Treatment: receiving milk or antacid drugs (to reduce the absorption of the active substance in the gastrointestinal tract), induction of vomiting.
Dosing and Administration.
Inside (diluted powder 1 teacup), preferably at bedtime, in between meals or after 2 h postprandial, milk, dairy products and / or food supplements or drugs Ca2+. The daily dose - 2 g. The course of treatment lasting. The finished suspension should be taken immediately after preparation. Dosage adjustment based on age, as well as chronic renal (Cl creatinine 30-70 ml / min) and hepatic insufficiency requires.
Precautions.
Results from clinical studies indicate that, Strontium ranelate treatment that is accompanied by an increase in the annual incidence of venous thromboembolism, including pulmonary embolism. The reason for this phenomenon is currently not installed. When treating patients at risk for venous thromboembolism, or patients with a possible increased risk, special attention should be paid to the specific signs and symptoms of venous thromboembolism, as well as carrying out adequate prevention of complications.
Strontium affect the results of the colorimetric methods for assessing the concentration of Ca2+ in blood and urine. For a more accurate assessment is necessary to use such methods, as atomic emission spectrometry with inductively coupled plasma and atomic absorption spectrometry.
Preparation soderzhit phenylalanine, which should be considered in patients with phenylketonuria.
It is intended only for the treatment of postmenopausal women.
