Rizendros 35 (risedronic acid) coated tablets 35 mg. N4

$56.00

Treatment of postmenopausal osteoporosis to reduce the risk of vertebral fractures. Treatment of confirmed postmenopausal osteoporosis to reduce the risk of hip fractures. Treatment of osteoporosis in men with a high risk of fractures.

Category: Manufacturer: Czech Republic

Description

Rizendros 35 Storage
active substance: risedronic acid;
1 tablet contains risedronate sodium 35 mg, which is equivalent to 32.5 mg of risedronic acid;
Excipients: microcrystalline cellulose, crospovidone, magnesium stearate, hypromellose, talc, macrogol 6000, titanium dioxide (E 171), iron oxide red (E 172), iron oxide yellow (E 172).

Dosage form
Coated tablets.

Rizendros 35 Pharmacological properties
Mechanism of action
Risedronate sodium is a pyridinyl bisphosphonate that binds to bone hydroxyapatite and inhibits osteoblast-mediated bone resorption. This reduces bone remodeling, while osteoblast activity and bone mineralization remain unchanged.
Pharmacodynamic effects
Preclinical studies with risedronate sodium have shown potent antiosteoclast and antiresorptive activity of the drug and dose-dependent increase in bone mass and skeletal biomechanical strength. The activity of risedronate sodium was confirmed by determining the content of biochemical markers of bone remodeling in pharmacodynamic and clinical studies. In postmenopausal women, a decrease in the content of biochemical markers of bone metabolism was observed within 1 month of drug use and reached a maximum after 3-6 months from the start of its use. The decrease in biochemical markers of bone metabolism 12 months after the start of the drug in the 35 mg once-weekly risedronate group and in the 5 mg daily risedronate group was similar.
In men with osteoporosis, a decrease in the content of biochemical markers of bone remodeling was observed not earlier than 3 months after the start of the drug, and continued to be observed after 24 months of its use.

Indication:

  • Treatment of postmenopausal osteoporosis: to reduce the risk of vertebral fractures.
  • Treatment of confirmed postmenopausal osteoporosis: to reduce the risk of femoral fractures.
  • Treatment of osteoporosis in men at high risk of fractures.

Contraindication:

  • Hypersensitivity to the active substance or to any of the excipients.
  • Hypocalcemia.
  • Severe renal impairment (creatinine clearance <30 ml / min).
  • Pregnancy or breastfeeding

Method of application and dosage
Dosage
The recommended dose for adults is 1 tablet of 35 mg orally once a week. The tablet should be taken on the same day of the week.

Application method
Risedronate sodium is affected by food, so patients should take Rizendros® 35 at least 30 minutes before breakfast, other medicines or beverages (other than plain water) before breakfast to ensure proper absorption.
Patients should be instructed that in the event of a missed dose, Rizendros® 35 tablets may be taken on the day the patient recalls the drug. Then patients should return to the drug according to the scheme 1 tablet 1 time per week on the day when the drug is usually taken. You cannot take two tablets on the same day.
The tablet should be swallowed whole without swallowing or chewing. To facilitate the entry of the tablet into the stomach, the drug Rizendros® 35 should be swallowed in a standing position, drinking a glass of plain water (at least 120 ml). Patients should not take a supine position for 30 minutes after taking the pill.
It is necessary to consider the feasibility of additional intake of calcium and vitamin D, if the intake of these substances with food is insufficient.
The optimal duration of treatment of osteoporosis with bisphosphonates has not yet been determined. The need for continued discontinuation of risendronate sodium should be periodically reassessed, taking into account the benefits and potential risks of such treatment in a particular patient, especially after treatment for 5 years or more.

Special categories of patients
Elderly patients. There is no need for dosage adjustment, as the bioavailability, distribution and excretion of the drug in the elderly (over 60 years) were similar compared to younger patients. The same applies to people over the age of 75 in the postmenopausal period.
Patients with impaired renal function. No dosage adjustment is required for patients with mild to moderate renal impairment. Patients with severe renal insufficiency (creatinine clearance below 30 ml / min) use of the drug is contraindicated.
Individuals taking acetylsalicylic acid / NSAIDs.
Among patients who took acetylsalicylic acid or NSAIDs regularly (3 or more days a week), the incidence of upper gastrointestinal side effects in the risedronate sodium group was similar to that in the control group.

Children
As data on the safety and efficacy of risendronate sodium in children under 18 years of age are insufficient, the drug should not be used in children.

Overdose
There is currently no information on any specific treatment for risedronate sodium overdose.

After a significant overdose of the drug can be expected to reduce serum calcium levels. Some of these patients may also have signs and symptoms of hypocalcemia.

Milk or antacids containing magnesium, calcium or aluminum should be given to the patient to bind risedronate sodium and reduce its absorption. In the event of a significant overdose of the drug, gastric lavage may be appropriate to remove aspirated sodium risedronate.

Side effects:

  • From the nervous system: headache.
  • From the eyes: inflammation of the iris.
  • From the gastrointestinal tract: constipation, dyspepsia, nausea, abdominal pain, diarrhea.
  • From the musculoskeletal system and connective tissue: pain in muscles, joints and bones.
  • The results of laboratory studies: changes in liver function.
  • Laboratory data: Some patients had early temporary asymptomatic mild decreases in serum calcium and phosphate levels.

Expiration date
2 years.

Storage conditions Rizendros 35
Does not require special storage conditions. Keep out of reach of children.