Rizendros 35 (risedronic acid) coated tablets 35 mg. №4

Description

Rizendros 35 (risedronic acid) coated tablets 35 mg. №4

Composition

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).

Medicinal form

Coated tablets.

Main physico-chemical properties: orange or light orange round biconvex tablets covered with a shell.

Pharmacotherapeutic group

Means affecting the structure and mineralization of bones. Bisphosphonates.
ATX code M05B A07.

Pharmacological properties

Risedronate sodium is a pyridinyl bisphosphonate that binds to bone hydroxyapatite and inhibits osteoblast-mediated bone resorption. At the same time, bone tissue remodeling is reduced, while osteoblast activity and bone mineralization remain unchanged.

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 pill must be taken on the same day of the week.

Application method
The absorption of risedronate sodium is affected by food, so to ensure proper absorption, patients should take Risendros® 35 before breakfast at least 30 minutes before the first meal, other medicines or drinks (except plain water).

Patients should be instructed that in the event of a missed dose of the drug, the Risendros® 35 tablet can be taken on the day the patient remembers the drug. Then patients should return to taking the drug according to the scheme of 1 tablet 1 time per week on the day when the drug was usually taken. Do not take two tablets on the same day.

The tablet should be swallowed whole, without dissolving or chewing it. To facilitate the entry of the tablet into the stomach, the drug Risendros® 35 should be swallowed in a standing position, drinking a glass of plain water (at least 120 ml). Patients should not lie down for 30 minutes after taking the pill.

It is necessary to weigh the expediency 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 further continuation of risedronate sodium should be periodically reassessed, taking into account the benefits and potential risks of such treatment in the individual patient, especially after treatment of 5 years or more.

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.