Composition, form of production and packaging
The tablets covered with a film cover of orange color, round, biconcave.
1 tab.
risedronate sodium 35 mg
[PRING] microcrystalline cellulose - 230.5 mg, crospovidone - 8.0 mg, magnesium stearate - 1.5 mg.
The composition of the film membrane: hypromellose 2910/5 - 5.57 mg, talc - 2.388 mg, macrogol 6000 - 0.82 mg, titanium dioxide - 1.1 mg, iron dye red oxide (E172) - 0.02 mg, iron oxide yellow oxide (E172) - 0.102 mg .
2 pcs. - blisters (1) - packs of cardboard.
4 things. - blisters (1) - packs of cardboard.
4 things. - blisters (2) - packs of cardboard.
4 things. - blisters (3) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2015.
PHARMACHOLOGIC EFFECT
Inhibitor of bone resorption. Refers to the group of bisphosphonates, regulates phosphorus-calcium metabolism, reduces bone resorption, stimulates osteogenesis.
Risedronic acid 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.
PHARMACOKINETICS
Suction
Absorption of the drug after ingestion is relatively fast, and is approximately 1 hour. The average bioavailability of the drug is 0.63%, it decreases with food intake.
Distribution and Metabolism
Plasma protein binding is 24%. V d - 6.3 l / kg. There is no evidence to confirm the systemic metabolism of risedronic acid.
Excretion
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. Kidney clearance is independent of the concentration of the drug, there is a linear relationship between renal clearance and creatinine clearance.
Unabsorbed risedronic acid is excreted through the intestine in unchanged form.
INDICATIONS
- Treatment of established postmenopausal osteoporosis;
- Treatment of osteoporosis in men with a high risk of fractures.
DOSING MODE
The drug is taken orally. The tablet should be swallowed whole, without chewing, and washed down with plain water (> 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.
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 В® should be at least 30 minutes before the first meal, another medicine or drink (other than water).
Adults prescribe the drug at a dose of 35 mg once a week.
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 recommended compliance with an adequate diet with sufficient calcium and vitamin D. If necessary, additional prescription of calcium and vitamin D.
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 RisendrosВ®, especially after 5 years of use.
In elderly patients, dose adjustment is not required; the bioavailability, distribution and excretion of the drug in 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).
In patients with mild and moderate renal insufficiency (CK> 30 ml / min) , dose adjustment and dosage regimen are not required. In patients with severe renal insufficiency (CC <30 ml / min), the use of the drug is contraindicated.
In children and adolescents under the age of 18, the use of the drug is contraindicated because of insufficient data on its effectiveness and safety.
SIDE EFFECT
Most of the adverse effects observed in clinical trials were mild to moderate, and, as a rule, did not require discontinuation of therapy.
Adverse events are listed below with a conditional breakdown into the following groups: very often (? 10%), often (? 1% and <10%), infrequently (? 0.1% and <1%), rarely (? 0.01% and <0.1% ), very rarely (<0.01%), the frequency is unknown (can not be established based on available data).
From the digestive system: often - constipation, dyspepsia, nausea, abdominal pain, diarrhea; infrequently - gastritis, esophagitis, dysphagia, duodenitis, ulcer of the esophagus; rarely - glossitis, stricture of the esophagus; frequency is unknown - severe violations of the liver (in most reported cases, patients also received other drugs that could cause liver dysfunction).
From the nervous system: often - headache; rarely - dizziness, asthenia, increased fatigue.
From the musculoskeletal system: often - musculoskeletal pain; rarely - spasms of calf muscles; very rarely - osteonecrosis of the jaw (after extraction of the tooth or inflammation of the oral cavity).
From the sense organs: infrequently iritis (flushing of the sclera, pain in the eyes); rarely - amblyopia, blurred vision, dry eye mucosa, ringing in the ears.
From the skin and subcutaneous tissues: the frequency is unknown - leukocytoclastic vasculitis, Stevens-Johnson syndrome and toxic epidermal necrolysis.
Allergic reactions: the frequency is unknown - angioedema, hives, anaphylactic reaction.
Other: infections (including urinary tract), increased blood pressure; frequency unknown - hair loss, a slight decrease in serum calcium and phosphate concentrations.
CONTRAINDICATIONS
- hypocalcemia;
- severe renal dysfunction (CK <30 ml / min);
- Pregnancy;
- the period of lactation (breastfeeding);
- children and adolescence under 18;
- Hypersensitivity to the components of the drug.
With caution:
- with erosive and ulcerative lesions of the mucous membrane of the gastrointestinal tract (including in the anamnesis), in patients with a history of esophageal disorder (such as stricture or achalasia);
- if it is impossible to stay in an upright position for at least 30 minutes after taking the pill.
PREGNANCY AND LACTATION
There is insufficient data on the use of risedronate sodium 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.
Risedronate sodium should not be used during pregnancy and during lactation.
APPLICATION FOR FUNCTIONS OF THE LIVER
In patients with mild and moderate renal insufficiency (CK> 30 ml / min) , dose adjustment and dosage regimen are not required. In patients with severe renal insufficiency (CC <30 ml / min), the use of the drug is contraindicated.
APPLICATION FOR CHILDREN
In children and adolescents under the age of 18, the use of the drug is contraindicated because of insufficient data on its effectiveness and safety.
APPLICATION IN ELDERLY PATIENTS
In elderly patients, dose adjustment is not required; the bioavailability, distribution and excretion of the drug in 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 risedronate, in elderly women (> 80 years) are limited.
SPECIAL INSTRUCTIONS
Before starting therapy with the drug, it is necessary to correct hypocalcemia, as well as other pathologies that affect bone and mineral metabolism (eg, parathyroid dysfunction, vitamin D deficiency). 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.
Data on the effectiveness of bisphosphonates, including risedronate, in elderly women (> 80 years) are limited.
The use of bisphosphonates is associated with the occurrence of esophagitis, gastritis, ulcers of the esophagus and gastroduodenal ulcers. Therefore, Risendros В®should be used with caution:
- in patients who have a history of abnormal esophagus, slowing esophageal transit or emptying (eg, stricture or achalasia of the esophagus);
- in patients who can not remain in an upright position for at least 30 minutes after taking the pill;
- in patients with active or recent diseases of the esophagus or upper gastrointestinal tract (including the established diagnosis of Barrett's esophagus).
Patients should be advised to strictly follow the dosage instructions for Risendros В® and be wary of any signs or symptoms from the side 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 RisendrosВ®.
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 bisphosphonates, 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 adverse effect of Risendros В® on the ability to drive vehicles and engage in activities that require concentration and speed of psychomotor reactions have not been 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.
OVERDOSE
Symptoms (potentially possible): hypocalcemia.
Treatment: milk intake, administration of antacids containing magnesium, calcium or aluminum. With a significant overdose to remove the unabsorbed drug, it is recommended to wash the stomach.
DRUG INTERACTION
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 NSAIDs (including acetylsalicylic acid), H2-histamine receptor blockers, proton pump inhibitors, antacid drugs, slow calcium channel blockers, beta adrenoblockers, thiazide diuretics, GCS, anticoagulants, anticonvulsant drugs , cardiac glycosides.
The drug is compatible with preparations for HRT.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
The preparation does not require special storage conditions. Keep out of the reach of children. Shelf life - 2 years.
