Rizendros - Instructions For Use, Price, Reviews, Tablet Analogs

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Risendros

Rizendros: instructions for use and reviews

1. 1. Release form and composition
2. 2. Pharmacological properties
3. 3. Indications for use
4. 4. Contraindications
5. 5. Method of application and dosage
6. 6. Side effects
7. 7. Overdose
8. 8. Special instructions
9. 9. Application during pregnancy and lactation
10. 10. Use in childhood
11. 11. In case of impaired renal function
12. 12. Use in the elderly
13. 13. Drug interactions
14. 14. Analogs
15. 15. Terms and conditions of storage
16. 16. Terms of dispensing from pharmacies
17. 17. Reviews
18. 18. Price in pharmacies

Latin name: Risendros

ATX code: M05BA07

Active ingredient: risedronic acid (Risedronic acid)

Manufacturer: Zentiva k.s. (Zentiva, ks) (Czech Republic); Saneka Pharmaceuticals A. S. (Saneca Pharmaceuticals, as) (Slovak Republic)

Description and photo update: 2019-05-07

Risendros is a bisphosphonate, a bone resorption inhibitor.

Release form and composition

Dosage form - film-coated tablets: round, biconvex, orange (2 pcs. In blisters, in a cardboard box 1 blister; 4 pcs. In blisters, in a cardboard box 1, 2 or 3 blisters; in each pack also contains instructions for the use of Rizendros).

Composition of 1 tablet:

• active substance: sodium risedronate - 35 mg;
• auxiliary components: magnesium stearate, crospovidone, microcrystalline cellulose;
• film shell: macrogol 6000, talc, hypromellose 2910/5, titanium dioxide, iron dye yellow oxide (E172), iron dye red oxide (E172).

Pharmacological properties

Pharmacodynamics

The active ingredient of Rizendros, sodium risedronate, is a bone resorption inhibitor belonging to the bisphosphonate group.

Rizendros reduces the process of destruction of bone tissue with the direct participation of osteoclasts, regulates phosphorus-calcium metabolism, and stimulates osteogenesis. Risedronic acid binds to hydroxyapatite at the cellular level, inhibits osteoclast function, and reduces bone resorption.

The maximum therapeutic effect develops within 3-6 months, the duration of action is 12 months.

Pharmacokinetics

After oral administration, sodium risedronate is absorbed relatively quickly (within 1 hour). Bioavailability averages 0.63%. With the simultaneous intake of Rizendros with food, this figure decreases slightly.

It binds to plasma proteins at a level of 24%. The volume of distribution is 6.3 l / kg.

The presence of systemic metabolism in risedronic acid has not been established.

Approximately half of the absorbed dose of the drug is excreted within 24 hours by the kidneys. Average total clearance - 122 ml / min. The average renal clearance does not depend on the concentration of the drug and is 105 ml / min. There was a linear relationship between renal clearance and creatinine clearance (CC).

Unabsorbed risedronic acid is excreted unchanged through the intestines.

Indications for use

• diagnosed postmenopausal osteoporosis in women;
• osteoporosis in men, accompanied by a high risk of fractures.

Contraindications

Absolute:

• severe renal impairment (CC <30 ml / min);
• hypocalcemia;
• age up to 18 years;
• pregnancy;
• lactation period;
• hypersensitivity to the components of Rizendros.

Rizendros tablets should be used with caution in patients with erosive and ulcerative lesions of the mucous membrane of the gastrointestinal tract currently or in history (including an established diagnosis of Barrett's esophagus) and in patients with a history of esophageal dysfunction that slows down esophageal transit or emptying (such as achalasia, stricture). Particular care is required for patients who are unable to stand upright for at least 30 minutes after taking the pill. Precautions are required due to the fact that the use of bisphosphonates is associated with the development of gastritis, esophagitis, gastroduodenal ulcers and esophageal ulcers.

Risendros, instructions for use: method and dosage

Rizendros tablets should be taken orally, swallowed whole and washed down with water (at least 120 ml), at least half an hour before the first meal, any drink (excluding ordinary water) or any other medicine. It is advisable to take the drug while standing and not lie down for at least 30 minutes.

Adult patients are prescribed 1 tablet once a week.

In case of missing the next dose, the drug should be taken on the day when the patient remembers this, then - take Rizendros according to the usual scheme. You can not take 2 tablets in one day.

During the period of therapy, it is recommended to adhere to a diet with a sufficient content of calcium and vitamin D, if necessary, it is possible to prescribe drugs with their content.

The optimal duration of bisphosphonate use for the treatment of osteoporosis has not been established. The doctor determines the duration of therapy individually, taking into account the benefits and risks, especially after 5 years of taking Rizendros.

Side effects

Side effects, divided into groups according to the frequency of development (very often - ≥ 10%, often - from ≥ 1% to <10%, infrequently - from ≥ 0.1% to <1%, rarely - from ≥ 0.01% to <0.1%, very rare - <0.01%, unspecified frequency - cannot be estimated from available data):

• from the immune system: unspecified frequency - urticaria, angioedema, anaphylactic reaction;
• from the musculoskeletal system: often - musculoskeletal pain; rarely - cramps of the calf muscles; very rarely - osteonecrosis of the jaw (after inflammation of the oral cavity or tooth extraction);
• on the part of the senses: infrequently - iritis (pain in the eyes, redness of the sclera); rarely - dryness of the mucous membrane of the eyes, blurred vision, amblyopia, ringing in the ears;
• from the nervous system: often - headache; rarely - increased fatigue, dizziness, asthenia;
• from the digestive system: often - abdominal pain, nausea, diarrhea, constipation, dyspepsia; infrequently - duodenitis, esophagitis, gastritis, esophageal ulcer, dysphagia; rarely - glossitis, esophageal stricture; unspecified frequency - severe liver dysfunction (mainly with the simultaneous use of other drugs that can cause functional liver dysfunction);
• on the part of the skin and subcutaneous tissues: unspecified frequency - toxic epidermal necrolysis, Stevens-Johnson syndrome, leukocytoclastic vasculitis;
• others: increased blood pressure, infections (including urinary tract); unspecified frequency - slight decrease in serum phosphate and calcium concentrations, hair loss.

Most of the emerging effects noted in clinical trials were mild or moderate and did not require Risendros to be discontinued.

Overdose

It is assumed that in the event of an overdose of Rizendros, hypocalcemia may develop.

It is recommended to drink milk, take antacids containing aluminum, magnesium or calcium. In case of a significant overdose, the stomach should be flushed to remove the unabsorbed drug.

special instructions

The efficacy of bisphosphonates in postmenopausal osteoporosis has been confirmed in patients with low bone mineral density and / or pre-existing fractures. However, the presence of clinical fracture risk factors and advanced age alone are not absolute indications for therapy.

Before taking Rizendros, it is necessary to correct hypocalcemia and other pathologies that can affect mineral and bone metabolism, such as vitamin D deficiency and functional impairment of the parathyroid glands. If the patient does not have the ability to provide an adequate intake of calcium and vitamin D from food, these nutrients should be prescribed additionally in the form of drugs.

Bisphosphonates can cause esophagitis, gastritis, ulcers of the esophagus and gastroduodenal ulcers, therefore patients are advised to strictly follow the instructions for use of Rizendros, and also consult a doctor immediately if signs of irritation of the esophagus appear, such as pain when swallowing, dysphagia, chest pain, aggravated or for the first time appeared heartburn.

Medicines containing polyvalent cations (magnesium, calcium, aluminum, iron), food and drinks (with the exception of ordinary water) prevent the absorption of sodium risedronate, therefore, are contraindicated for use simultaneously with Rizendros.

In some cases, during the period of use of bisphosphonates, atypical sub-abdominal and diaphyseal fractures of the hip occurred, especially in patients with osteoporosis who took the drug for a long time. These fractures occurred with or without minor trauma. If an atypical hip fracture is suspected, it is necessary to consider the feasibility of continuing to take Rizendros and assess the balance of benefits and risks. Patients are advised to seek medical attention if any pain occurs in the hip, thigh, or groin area. Every patient with such symptoms in the clinical picture should be carefully examined.

Cases of osteonecrosis of the jaw after tooth extraction and / or local infection (including osteomyelitis) have been reported in cancer patients. For this reason, it is necessary to conduct a dental examination with appropriate therapeutic dental treatment in patients with concomitant risk factors such as cancer, poor oral hygiene, chemotherapy or radiation therapy, and the use of corticosteroids. Such patients should avoid invasive dental procedures if possible while taking Rizendros.

Influence on the ability to drive vehicles and complex mechanisms

There were no reports of a negative effect of Rizendros on reaction speed and ability to concentrate. However, in rare cases, the drug can cause increased fatigue and dizziness, so patients should be careful when driving a car and performing any potentially dangerous work.

Application during pregnancy and lactation

There is insufficient information on the use of risedronate sodium in pregnant women. In experimental studies on animals, the reproductive toxicity of the drug was revealed. The potential risk to humans has not been identified. In a small amount, the drug passes into breast milk.

Rizendros is contraindicated for use during pregnancy and lactation.

Pediatric use

In childhood and adolescence, Rizendros is not prescribed due to the lack of data on the safety and effectiveness of its use in patients under 18 years of age.

With impaired renal function

With mild to moderate renal failure (CC> 30 ml / min), there is no need to adjust the dose of the drug. Risendros is contraindicated in patients with severe renal impairment (CC <30 ml / min).

Use in the elderly

In people over 60 years old (including older people over 75 years old), the distribution, bioavailability and excretion of sodium risedronate do not differ significantly from those in young patients. In this regard, the correction of the dosage regimen of Rizendros is not required.

Data on the effectiveness of the drug in women over 80 years of age are limited.

Drug interactions

The absorption of risedronate sodium can be reduced by preparations containing polyvalent cations such as aluminum, magnesium, calcium and iron.

There are no clinically significant drug interactions with the concomitant use of non-steroidal anti-inflammatory drugs (including acetylsalicylic acid), H ₂ -histamine receptor blockers, antacids, beta-blockers, proton pump inhibitors, slow calcium channel blockers, anticoagulants, glucocorticoid glycosoids, cardiac thiotropic glycosides anticonvulsants.

Risendros is compatible with other medications for hormone replacement therapy.

Analogs

The analogues of Rizendros are Aklasta, Alendronat, Binosto, Bonviva, Bondronat, Bonefos, Veroclast, Zoledronic acid, Zolendrex, Zoleriks, Zometa, Klobir, Xidifon, Ostalon, Pomegara, Resorba, Strongos, Tevanat, Forosa, Fosamax.

Terms and conditions of storage

Keep out of the reach of children. Compliance with any special conditions is not required.

Shelf life is 2 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Rizendros

During menopause, women are susceptible to diseases of the musculoskeletal system, an increased risk of traumatic injuries and fractures, which is due to a lack of calcium in the bone tissue against the background of hormonal changes. According to medical experts, risedronic acid is successfully used in the treatment of osteoporosis: it prevents calcium loss, reduces bone resorption and slows down the progression of the disease.

Patients also leave positive reviews about Rizendros: if the recommendations are followed, the drug is well tolerated, easy to use (once a week), and is not addictive. Treatment is usually effective, albeit prolonged.

Of the negative aspects, the development of esophagitis and gastritis due to irritation of the esophageal mucosa in patients who are unable to stand in a standing position for at least 30 minutes after taking Rizendros is mentioned. The disadvantage is also the high cost, given the small number of tablets in the package and the long duration of therapy (several months or even years).

Price for Rizendros in pharmacies

Approximate prices for Rizendros (35 mg coated tablets) are: 948-982 rubles. per pack of 4 pcs., 2398–2775 rubles. per pack of 12 pcs.

Maria Kulkes Medical journalist About the author

Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!