Risendros - instructions for use, reviews, analogs and formulations (35 mg tablets) of the drug for the treatment of osteoporosis in men, postmenopausal and after removal of ovaries in women, children and pregnancy. Composition

In this article, you can read the instructions for using the drug Riesendros. Presented are reviews of visitors to the site - consumers of this medication, as well as opinions of doctors specialists on the use of Risendros in their practice. A big request is to actively add their feedback on the drug: the medicine helped or did not help get rid of the disease, which were observed complications and side effects, possibly not declared by the manufacturer in the annotation. Analogues of Riesendros with available structural analogues. Use for the treatment of osteoporosis in men, postmenopausal and after removal of ovaries in women, children, as well as during pregnancy and lactation. Composition of the preparation.

Riesendros - inhibitor of bone resorption. Refers to the group of bisphosphonates, regulates phosphorus-calcium metabolism, reduces bone resorption, stimulates osteogenesis.

Risedronic acid (active ingredient of Risendros) binds to hydroxyapatite at the cellular level and suppresses the function of osteoclasts, reduces bone resorption. The time to reach the maximum therapeutic effect is 3-6 months, the duration of the therapeutic action is 12 months.

Composition

Risedronic acid + auxiliary substances.

Pharmacokinetics

The absorption of the drug after ingestion is relatively rapid, and is approximately 1 hour. The average bioavailability of the drug is 0.63%, it decreases with food intake. Plasma protein binding is 24%. There is no evidence to confirm the systemic metabolism of risedronic acid. Approximately half of the absorbed dose is excreted by the kidneys within 24 hours. Unabsorbed risedronic acid is excreted through the intestine in unchanged form.

Indications

• established postmenopausal osteoporosis in women;
• osteoporosis in men with a high risk of fractures;
• osteoporosis after removal of ovaries in women.

Forms of release

The tablets covered with a cover of 35 mg.

Instructions for use and dosing regimen

Risendros is taken internally. The tablet should be swallowed whole, without chewing, and with ordinary water (more than 120 ml). It is preferable to take the drug while standing. After taking the pill, the patient should not take a horizontal position for 30 minutes. Adults prescribe the drug at a dose of 35 mg once a week.

The drug must be taken on the same day of the week. The absorption of risedron acid depends on the intake of food, so take Risendros should be at least 30 minutes before the first meal, taking another medication or drink other than water.

If you miss a drug, you must take it on the day the patient recalled it. Then you should return to taking 1 tablet once a week on the day of usual reception. Do not take 2 tablets on the same day.

During treatment with Risendrosom, an adequate diet with sufficient calcium and vitamin D. is recommended. If necessary, supplementation with calcium and vitamin D supplementation is possible.

The optimal duration of osteoporosis treatment with bisphosphonates has not been established. The need for continuation of therapy should be determined individually for each patient on the basis of an assessment of the benefit / risk ratio of using Risendros, especially after 5 or more years of use.

Side effect

• constipation, diarrhea;
• dyspepsia, nausea;
• abdominal pain (abdominal pain);
• gastritis (inflammation of the gastric mucosa);
• esophagitis (inflammation of the mucosa of the esophagus);
• dysphagia (disorder swallowing act);
• duodenitis (inflammation of the mucous membrane of the duodenum);
• ulcer of the esophagus;
• glossitis (inflammation of the mucous membrane of the tongue);
• stricture (constriction) of the esophagus;
• headache, dizziness;
• asthenia, increased fatigue;
• musculoskeletal pain;
• cramps of the calf muscles;
• iritis (flushing of the sclera, pain in the eyes);
• amblyopia, blurred vision;
• dryness of the eye mucosa;
• tinnitus;
• Stevens-Johnson syndrome and toxic epidermal necrolysis;
• angioedema, hives, anaphylactic reaction;
• infection (including urinary tract);
• increased blood pressure (BP);
• hair loss;
• a slight decrease in serum calcium and phosphate concentrations.

Contraindications

• hypocalcemia;
• severe renal dysfunction (creatinine clearance less than 30 ml per minute);
• pregnancy and lactation (breastfeeding);
• children and adolescents under 18;
• hypersensitivity to the components of the drug;
• with caution in case of erosive and ulcerative lesions of the gastrointestinal mucosa (GI tract), including in anamnesis, and in patients with a history of esophageal disorder (such as stricture or achalasia);
• with caution if it is impossible to stay in a vertical position for at least 30 minutes after taking the pill.

Application in pregnancy and lactation

There is insufficient data on the use of Risendros in pregnant women. Experimental studies in animals showed the presence of reproductive toxicity. The potential risk to humans is unknown.

In experimental studies in animals, it was noted that a small amount of risedronate sodium is excreted in breast milk.

Risendros should not be used during pregnancy and lactation.

Use in children

In children and adolescents under the age of 18, the use of Risendros is contraindicated because of insufficient data on its effectiveness and safety.

Application in elderly patients

In elderly patients, dose adjustment is not required, since the bioavailability, distribution and excretion rates of this group of patients (over 60 years of age) do not differ significantly from the corresponding parameters in young patients. Similar indicators were recorded in very elderly patients (aged 75 and over).

Data on the effectiveness of bisphosphonates, including Risendros, in elderly women (over 80 years) are limited.

special instructions

Before starting therapy with Risendros, correction of hypocalcaemia and other pathology affecting bone and mineral metabolism (eg, parathyroid dysfunction, vitamin D deficiency) should be done. If there is insufficient intake of calcium and vitamin D with food, their additional reception is necessary.

The efficacy of bisphosphonates in the treatment of postmenopausal osteoporosis has been demonstrated in patients with low bone mineral density and / or previous fractures.Elderly age or the presence of clinical risk factors for fractures in themselves are not sufficient criteria for starting osteoporosis treatment with bisphosphonates.

Patients should be advised to strictly follow the dosage instructions for Risendros and be wary of any signs or symptoms on the part of the esophagus. Patients should be instructed to promptly seek medical help if they develop symptoms of esophageal irritation, such as dysphagia, swallowing pain, chest pain, or first time heartburn that has become worse / worse.

Cases of osteonecrosis of the jaw after extraction of the tooth and / or local infection (including osteomyelitis) in cancer patients have been reported. Before the start of treatment with bisphosphonates in patients with concomitant risk factors (for example, oncological disease, chemotherapy, radiation therapy, corticosteroid therapy, poor oral hygiene), a dental examination with appropriate therapeutic dentistry should be performed.During treatment, such patients should avoid invasive dental interventions whenever possible.

Foods, drinks (other than plain water) and drugs containing polyvalent cations (such as calcium, magnesium, iron and aluminum) interfere with the absorption of bisphosphonates, so they should not be taken concomitantly with Risendros.

Against the background of bisphosphonate therapy, atypical subatmospheric and diaphyseal fractures of the femur were reported mainly in patients receiving long-term treatment for osteoporosis. These fractures occurred after minimal trauma or without it. During the examination of the patient, if there is a suspicion of having an atypical hip fracture, consideration should be given to discontinuing bisphosphonate therapy based on an individual assessment of the benefit-risk ratio.

During treatment with Risendros, the patient should be advised to report any pain in the area of ​​the thigh, hip, or groin. Each patient with a clinical picture of such symptoms should be examined for atypical fracture of the hip.

Impact on the ability to drive vehicles and manage mechanisms

The unfavorable effect of the drug Risendros on the ability to drive vehicles and engage in activities that require concentration and speed of psychomotor reactions, was not reported. However, the drug in rare cases can cause dizziness, asthenia and fatigue, so you should be careful when driving vehicles and working with mechanisms.

Drug Interactionsue

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

There are no clinically significant interactions with non-steroidal anti-inflammatory drugs (NSAIDs), including acetylsalicylic acid; blockers of H2-histamine receptors, proton pump inhibitors, antacid drugs, slow calcium channel blockers, beta-adrenoblockers, thiazide diuretics, glucocorticosteroids (GCS), anticoagulants, anticonvulsant drugs, cardiac glycosides.

The drug is compatible with drugs for hormone replacement therapy (HRT).

Analogues of Riesendros

Structural analogs for the active substance:

• Actonel;
• Rizarteva.

Analogues of medicinal preparation Risendros on pharmacological group (correctors of metabolism of bone and cartilaginous tissue):

• Adelon;
• Aklast;
• Actonel;
• Alendercourne;
• Alendronate;
• Alflutop;
• Heredia;
• Artogistan;
• Artradol;
• Biartrin;
• Bivalos;
• Binosto;
• Bonefos;
• Veprena;
• Veroclast;
• Videchol;
• Gialgan Phidias;
• Glucosamine;
• Zemplar;
• Zolerix;
• Zometa;
• Klobir;
• Xidifon;
• Miakaltsik;
• Mukosat;
• Ossin;
• Ostalon;
• Osteover;
• Ostererepair;
• Pimegar;
• Prolia;
• Resoclastine;
• Resorb;
• Rizarteva;
• Rockaltrol;
• Rumalon;
• Sinoarth;
• Skelid;
• Strometta;
• Stringos;
• Structum;
• Sustilac;
• Tazan;
• Tahistin;
• Tevanath;
• Tridin;
• Fitin;
• Forosa;
• Forste;
• Fosamax;
• Chondraktiv;
• Chondramine;
• Chondroitin;
• Chondroxide;
• Chondrolon;
• Honsat;
• Honsurid;
• Exidgiva;
• Ethalph;
• The Unium.

Response of a gynecologist

Almost all women who survive the postmenopausal period or have had an operation to remove the ovaries suffer from osteoporosis. It is not always possible to reduce the risk of bone fractures by prescribing only hormone replacement therapy.Many patients receive correctors of bone tissue metabolism, to which the Risendros drug belongs. Its advantages are that it is compatible with the preparations of HRT and take it only once a week, which is convenient. But the trouble is that many patients forget to take the pill on that day and the hour when it should. Often, women complain that sometimes it is difficult to comply with the condition that after taking the pill should stay in a vertical position for half an hour. Many of them complain that they forget that within 30 minutes after taking the medicine you can not drink and eat. It is necessary to observe many conditions and conventions when using this medication.

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