Rizendros, 35 mg, film-coated tablets, 4 pcs.

Pharmacokinetics

Suction

Absorption of the drug after oral administration is relatively rapid, and is approximately 1 hour. The average bioavailability of the drug is 0.63%, and decreases with food intake.

Distribution and metabolism

Plasma protein binding - 24%. Volume of distribution - 6.3 l/kg. There are no data to support the systemic metabolism of risedronic acid.

Removal

Approximately half of 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; there is a linear relationship between renal clearance and creatinine clearance.

Unabsorbed risedronic acid is excreted through the intestines in unchanged form.

Dosage regimen

For adults, the drug is prescribed at a dose of 35 mg once a week. The tablet must be taken on the same day of the week. The absorption of risedronic acid is dependent on food intake, therefore, to ensure adequate absorption, risedros® should be taken at least 30 minutes before the first meal, other drug or drink (other than water).

If a drug dose is missed, it must be taken on the day the patient remembers. Then you should return to taking 1 tablet once a week on the day of your usual intake. Do not take 2 tablets on the same day.

The tablet should be taken whole and not chewed, preferably standing and washed down with plain water (>120 ml). After taking the tablet, patients should not lie down for 30 minutes.

During treatment, it is recommended to follow an adequate diet with sufficient calcium and vitamin D. If necessary, additional prescription of calcium and vitamin D supplements is possible.

Rizendros, 35 mg, film-coated tablets, 4 pcs.

Mechanism of action

A drug for the treatment of osteoporosis, belongs to the group of bisphosphonates, regulates phosphorus-calcium metabolism, reduces bone resorption, stimulates osteogenesis.

Risedronic acid is a pyridinyl bisphosphonate that binds to hydroxyapatite crystals of bone tissue. The effect of risedronic acid on bone turnover is associated with inhibition of osteoclasts and a decrease in bone resorption mediated by them. At the same time, the activity of osteoblasts and the process of mineralization of bone tissue are maintained.

Clinical efficacy and safety

Treatment of osteoporosis in postmenopause

A number of risk factors are associated with postmenopausal osteoporosis, including decreased bone mass, decreased bone mineral density (BMD), early menopause, a history of smoking, and a family history of osteoporosis. Clinical consequences of osteoporosis include fractures. The risk of fractures increases with the number of risk factors.

The results of a one-year, double-blind, multicenter clinical trial in postmenopausal women with osteoporosis showed that changes in lumbar spine BMD when taking risedronic acid at a dose of 35 mg once a week (n = 485) and when taking 5 mg once a week day (n=480) were similar.

The once-daily risedronic acid clinical trial program examined the effects of risedronic acid on the risk of hip and vertebral fractures in early and late postmenopausal women with and without fractures. Daily doses of 2.5 mg and 5 mg were studied in all groups, including control groups receiving calcium supplements and vitamin D (if baseline values ​​were low). The absolute and relative risks of new vertebral and hip fractures were assessed by analyzing the time to first event.

— Two placebo-controlled studies (n=3661) included postmenopausal women younger than 85 years with vertebral fractures. Taking risedronic acid at a dose of 5 mg per day for 3 years reduced the risk of new vertebral fractures compared to the control group. The relative risk reduction in women with at least 2 fractures or 1 vertebral fracture was 49% and 41%, respectively (the incidence of new vertebral fractures was 18.1% and 11.3% in the risedronic acid groups and 29.0% and 16.3% in placebo groups, respectively). The therapeutic effect was observed already at the end of the first year of treatment. Risedronic acid at a dose of 5 mg per day also reduced the annual decline in patient height compared to the control group.

— Two further placebo-controlled studies included postmenopausal women over 70 years of age with or without vertebral fractures. Women aged 70–79 years were included with a BMD T-score <-3 standard deviations (SD) at the femoral neck (manufacturer's range, i.e. -2.5 SD using NHANES III (National Health and Nutrition Examination Survey) criteria )) and at least one additional risk factor. Women aged ≥80 years were eligible to be included based on the presence of at least one non-bone risk factor for hip fracture or decreased BMD at the femoral neck. Statistical significance of the effectiveness of risedronic acid compared to placebo is achieved only when combining the results of the two treatment groups - with doses of 2.5 mg and 5 mg per day. The following results are based only on subgroup analyzes based on clinical practice data and the current definition of osteoporosis:

— In the subgroup of patients with a T-score BMD <-2.5 SD for the femoral neck (NHANES III) and the presence of at least one vertebral fracture at baseline, risedronic acid when taken for 3 years reduced the risk of hip fractures by 46% compared with control group (the incidence of hip fractures in the risedronic acid groups with doses of 2.5 mg and 5 mg per day was 3.8%, the incidence in the placebo group was 7.4%);

— These studies suggest that less protection than that reported above may be observed in very elderly patients (≥80 years). This may be due to the increasing importance of non-bone risk factors for hip fracture with increasing age.

“In these studies, the secondary endpoint data analyzed indicated a reduction in the risk of new vertebral fractures in patients with low femoral neck BMD without vertebral fractures and in patients with low femoral neck BMD with or without vertebral fractures.

With the use of risedronic acid at a dose of 5 mg per day for 3 years, an increase in BMD in the lumbar spine, femoral neck, greater trochanter and carpal bones was noted, as well as stability in BMD in the radial diaphysis.

According to a one-year observational study conducted after the cessation of three years of treatment with risedronic acid at a dose of 5 mg per day, there was a rapid reversal of the inhibitory effect of risedronic acid on the rate of bone turnover.

Bone biopsies obtained from postmenopausal women treated with risedronic acid 5 mg daily for 2 to 3 years showed the expected modest reduction in markers of bone turnover. The bone tissue formed during treatment with risedronic acid had a normal lamellar structure and degree of mineralization. These data, along with a reduction in the incidence of osteoporosis-related vertebral fractures in women, indicate that risedronic acid does not have a deleterious effect on bone composition. An endoscopic study of a number of patients with moderate and severe complaints from the gastrointestinal tract, both in patients who used risedronic acid and in control patients in any of the groups, did not reveal signs of ulcers of the stomach, duodenum and esophagus caused by the therapy, but in the group cases of duodenitis have been reported infrequently with risedronic acid.

Treatment of osteoporosis in men

Risedronic acid 35 mg once weekly demonstrated efficacy in men with osteoporosis (age range 36 to 84 years) in a two-year, double-blind, placebo-controlled study of 284 patients (risedronic acid 35 mg, n=191). All patients received additional treatment with vitamin D and calcium supplements. An increase in BMD was observed already 6 months after the start of treatment. Risedronic acid 35 mg per week was associated with increases in BMD at the lumbar spine, femoral neck, greater trochanter, and total hip compared with placebo after two years of treatment.

The therapeutic effect of risedronic acid (increase in BMD and decrease in biochemical markers of bone turnover) was similar in men and women.

Contraindications to the use of the drug RISENDROS®

• hypersensitivity to the components of the drug;
• hypocalcemia;
• severe renal impairment (creatine clearance less than 30 ml/min);
• pregnancy and breastfeeding (lactation);
• children under 18 years of age;

Carefully:

• with erosive and ulcerative lesions of the mucous membrane of the gastrointestinal tract (including a history), in patients with a history of dysfunction of the esophagus (such as stricture or achlasia);
• if it is impossible to remain in an upright position for at least 30 minutes after taking the tablet.

Side effects

The following adverse reactions were noted in clinical studies. side effects are given using the following frequency assessment criteria: very often (≥1/10), often (≥1/100 to 1/10); uncommon (≥1/1000 1/100), rare (from ≥1/10,000, 1/1000), very rare (1/10,000).

From the nervous system: often - headache.

From the side of the organ of vision: infrequently - inflammation of the iris.

From the gastrointestinal tract: often - constipation, dyspepsia, nausea, abdominal pain, diarrhea; uncommon - gastritis, esophagitis, dysphagia, duodenitis, esophageal ulcers; rarely - glossitis, esophageal stricture.

From the musculoskeletal system and connective tissue: often - pain in muscles, joints and bones.

Laboratory test results: rarely - changes in liver function tests.

Some patients experienced early, temporary, asymptomatic, mild decreases in plasma calcium and phosphate levels.

During post-marketing use, the following additional adverse reactions have been reported (frequency unknown):

from the organ of vision: frequency unknown - inflammation of the iris, uveitis.

From the musculoskeletal system and connective tissue: rarely - atypical subtrochanteric and diaphyseal fractures of the femur; frequency unknown - osteonecrosis of the lower jaw.

From the skin and subcutaneous tissue: frequency unknown - hypersensitivity reactions and skin reactions, including angioedema, generalized rash, urticaria, as well as bullous skin reactions and leukocytoclastic vasculitis (sometimes severe reactions were observed, including isolated cases of Stevens-Johnson syndrome and toxic epidermal necrolysis), hair loss.

From the immune system: frequency unknown - anaphylactic reactions.

From the hepatobiliary system: frequency unknown - serious liver disorders. In most cases, patients were also treated with other drugs known to cause liver problems.

special instructions

Before starting drug therapy, it is necessary to correct hypocalcemia, as well as other pathologies that affect bone and mineral metabolism (for example, dysfunction of the parathyroid glands, vitamin D deficiency). If the dietary intake of calcium and vitamin D is insufficient, their additional intake is necessary.

The use of a number of bisphosphonates is accompanied by esophagitis and ulcerative lesions of the esophagus. Therefore, patients must strictly follow the instructions for dosage and method of administration (see section “Dosage and Administration”). Recommendations for taking the drug are of particular importance for patients with diseases of the esophagus such as stricture and achalasia. In patients who are unable to remain upright for 30 minutes after taking the drug, risedronate sodium should be used with extreme caution due to limited clinical experience with its use in such patients.

Cases of osteonecrosis of the jaw following tooth extraction and/or local infection (including osteomyelitis) have been reported in cancer patients. Before initiating bisphosphonate treatment, patients with concomitant risk factors (eg, cancer, chemotherapy, radiation therapy, corticosteroids, poor oral hygiene) should undergo a dental examination with appropriate therapeutic dental treatment. During treatment, these patients should avoid invasive dental procedures whenever possible. Foods, drinks (except plain water), and medications containing polyvalent cations (such as calcium, magnesium, iron, and aluminum) interfere with the absorption of bisphosphonates and should not be taken at the same time as risedronate sodium.

Overdose

Information on any specific treatment for acute risedronate overdose is not yet available.

After a significant overdose of the drug, a decrease in the level of calcium in the blood plasma may be observed. Some patients also experience signs and symptoms of hypocalcemia.

The patient should be given milk or antacids containing magnesium, calcium, or aluminum to bind risedronate and reduce its absorption. In case of a significant overdose of the drug, it is advisable to lavage the stomach to remove risedronate, which has not yet been absorbed.

Drug interactions

Medicines containing polyvalent cations such as calcium, magnesium, iron and aluminum may reduce the absorption of the drug.

There are no clinically significant interactions with NSAIDs (including acetylsalicylic acid), H2-histamine receptor blockers, proton pump inhibitors, antacid drugs, slow calcium channel blockers, beta-blockers, thiazide diuretics, glucocorticosteroids, anticoagulants, anticonvulsants, cardiac glycosides.

The drug is compatible with drugs for HRT.

Note!

Description of the drug Rizendros 35 tablets. p/o 35 mg No. 4 on this page is a simplified author’s version of the apteka911 website, created on the basis of the instructions for use.
Before purchasing or using the drug, you should consult your doctor and read the manufacturer's original instructions (attached to each package of the drug). Information about the drug is provided for informational purposes only and should not be used as a guide to self-medication. Only a doctor can decide to prescribe the drug, as well as determine the dose and methods of its use.