Expiration date: 01/2025
Clinico-pharmacological group
(An inhibitor of bone resorption in osteoporosis)
Release form, composition and packaging
Tablets, film-coated orange, round, lenticular.
Excipients: cellulose microcrystalline - 230.5 mg, crospovidon - 8.0 mg magnesium stearate - 1.5 mg. the film Composition of the shell: hypromellose 2910/5 - 5.57 mg, talc - 2.388 mg, macrogol 6000 - 0.82 mg titanium dioxide 1.1 mg, colorant iron oxide red (E172) - 0.02 mg, dye iron oxide yellow (E172) - 0.102 mg. 2 PCs. - packaging sells contoured (1) - packs of cardboard.
4 PCs. - packaging sells contoured (1) - packs of cardboard.
4 PCs. - packaging sells contoured (3) - packs cardboard.
4 PCs. - packaging sells contoured (2) - packs of cardboard.
Tablets, film-coated orange, round, lenticular.Excipients: cellulose microcrystalline 230.5 mg, crospovidone 8.0 mg magnesium stearate 1.5 mg. the film Composition of the shell: hypromellose 2910/5 5.57 mg, 2.388 mg talc,macrogol 6000, 0.82 mg titanium dioxide 1.1 mg, colorant iron oxide red (E172) 0.02 mg, dye iron oxide yellow (E172) 0.102 mg. 2 PCs. - packaging sells contoured (1) - packs of cardboard.
4 PCs. - packaging sells contoured (1) - packs of cardboard.
4 PCs. - packaging sells contoured (3) - packs cardboard.
4 PCs. - packaging sells contoured (2) - packs of cardboard.
Pharmacological tastierista bone resorption. Risedronic acid binds to hydroxyapatite on the cellular level and inhibits the function of osteoclasts, reduces bone resorption. The time to maximum therapeutic effect 3-6 months, the duration of therapeutic action - 12 months.
Pharmacokinetics
Suction
Suction of the drug after ingestion is relatively quick, approximately 1 hour The average bioavailability of the drug - 0.63%, is reduced when eating.Distribution and metabolismthe plasma proteins - 24%. The volume of distribution is 6.3 l/kg. there is No evidence of systemic metabolism Risedronic acid.Videnablyudenie half the absorbed dose is excreted by the kidneys within 24 hours the Average renal clearance is 105 ml/min and the average total clearance is 122 ml/min. Renal clearance is independent of drug concentration, a linear relationship between renal clearance and creatinine clearance.
Unabsorbed Risedronic acid is excreted through the intestines in unchanged form.Dozirovocnami the drug is administered at a dose of 35 mg 1 time per week. The pill must be taken on the same day of the week. Suction Risedronic acid depends on the food intake, so to ensure adequate suction make Risedronate at least 30 minutes before the first meal, other medicinal product or drink (other than water).In the case of pass receiving medication should take it the day when the patient remembered about it. You should then return to taking 1 tablet once a week 1 day regular admission. You should not take 2 tablets on the same day.The tablet should be taken as a whole and not to chew, better standing and wash down with plain water (>,,120 ml). After taking the tablet, patients should not lie down for 30 min. During treatment, it is recommended that the maintenance of adequate diet with sufficient calcium and vitamin D. the possible extra the prescribing of calcium and vitamin D.
Overdose (potential): hypocalcemia.
Treatment: reception of milk, administration of antacids containing magnesium, calcium or aluminum. In large overdose to remove unabsorbed drug is recommended to perform gastric lavage.Vzaimodeistvuyuschikh medicinal products containing polyvalent cations such as calcium, magnesium, iron and aluminium may reduce the absorption of the drug.No clinically significant interaction with NSAID's (including azetilsalicilovaya acid), blockers of H2-histamine receptors, proton pump inhibitors, antacid drugs, blockers slow calcium channels, beta-blockers, thiazide diuretics, corticosteroids, anticoagulants, anticonvulsants, cardiac glycosides.The product is compatible with HRT.
Pregnancy and lactationally sufficient data on the use of risedronate sodium in pregnant women. Tests on animals showed the presence of reproductive toxicity. The potential risk for humans is unknown. Animal tests indicate that a small number of risedronate sodium passes into breast milk. Risedronate sodium should not be used during pregnancy and the breastfeeding period.
Side deactivable of the undesirable effects observed in clinical trials were mild to moderate severity and usually did not require discontinuation of therapy.Adverse events are listed below with conditional division into the following groups: very often (? 10%), frequent (? 1% and <,,10%), 0="" 1="" 01="" p="">,
From the digestive system:
Frequent: constipation, dyspepsia, nausea, abdominal pain, diarrhea.
Infrequent: gastritis, oesophagitis, dysphagia, duodenitis, ulcer of the esophagus.
Rare: glossitis, esophageal stricture.
From the nervous system:
Frequent: headache.
Rare: dizziness, asthenia, fatigue.
From the muscular-skeletal system:
Frequent: musculoskeletal pain.
Rare: convulsions gastrocnemius muscles.
Very rare: osteonecrosis of the jaw (after extraction of a tooth or inflammation of the mouth).
From the senses:
Infrequent: iritis (redness of the sclera, pain in the eyes).
Rare: amblyopia, blurred vision, dry mucous membranes of the eyes, ringing in the ears.
Other: infections (including urinary tract), increased blood pressure.
Unknown: frequency cannot be established on the basis of the available data:
• hair loss,
• allergic reactions like: angioedema, urticaria,
• disorders of the skin: leukocytoclastic vasculitis, Stevens-Johnson syndrome and toxic epidermal necrolysis,
• anaphylactic reaction
• serious hepatic disorders (in most reported cases, patients also received other drugs that can cause hepatic disorders),
• a slight decrease in serum concentrations of calcium and phosphate.
Terms and conditions storage
The drug requires no special storage conditions. It should be kept out of the reach of children. Shelf life - 2 years.
Testimony
— treatment of established postmenopausal osteoporosis,
— treatment of osteoporosis in men at high risk of fractures.
Contraindications
— hypersensitivity to the drug component
— hypocalcemia,
— severe impaired renal function (clearance of creatinine less than 30 ml/min),
— pregnancy and breastfeeding (lactation),
— children up to age 18 years
With caution:
— when erosive-ulcerative lesions of the mucous membrane of the gastrointestinal tract (including history), in patients with impaired esophageal disease (such as stricture or aclasia),
— if it is impossible to be upright at least 30 minutes after pills.
Special instructions
Before the start of drug therapy should be correction of hypocalcemia, as well as other pathologies affecting bone and mineral metabolism (for example, dysfunction of the parathyroid glands, vitamin D deficiency). If insufficient intake of dietary calcium and vitamin D needed their extra time.
The application of a number of bisphosphonates are accompanied by esophagitis and ulcerative lesions of the esophagus. Therefore, patients must strictly observe the instructions for dosage and method of application (see section "Method of application and dosage"). The special importance of recommendations for the drug are for patients with such diseases of the oesophagus, as a stricture and achalasia. Patients who are not able to reside within 30 minutes upright after taking the drug, risedronate sodium should be used with caution due to limited clinical experience of its use in such patients.
Reported cases of osteonecrosis of the jaw after tooth extraction and/or local infection (including osteomyelitis) in cancer patients. Before treatment with bisphosphonates in patients with concomitant risk factors (e.g. cancer, chemotherapy, radiotherapy, corticosteroids, poor hygiene of the oral cavity) should be performed a dental examination with appropriate therapeutic dental treatment. During treatment these patients should avoid invasive dental procedures. Food, drink (except plain water) and medicinal products containing polyvalent cations (such as calcium, magnesium, iron and aluminium) interfere with the absorption of bisphosphonates and should not be taken simultaneously with risedronate sodium.
Effects on ability to drive vehicles and management mechanisms
About the adverse effects of the drug, Lisandro on the ability to drive vehicles and engage in other activities that require concentration and speed of psychomotor reactions have not been reported. But since the drug in rare cases may cause dizziness, asthenia and fatigue.
