Instructions for Osterepar (Alendronic acid) 70 mg 4 tablets
Release form
Tablets
Description:
White pills, oblong, double-convex.
1 tab.
sodium alendronate trihydrate 91.36 mg,
which is what alendronic acid is 70 mg
Auxiliary substances: lactose monohydrate - 128.64 mg,
cellulose microcrystalline - 65 mg,
sodium croscarmellose - 15 mg,
magnesium stearate - 3 mg,
silicon dioxide colloidal anhydrous - 2 mg.
4 pcs. - blister packs (1) - cardboard packs.
ATC codes
M05BA04 Alendronic acid
Clinical-pharmacological groups / Group affiliation:
Bone tissue resorption inhibitor. Bisphosphonate
Active substance
alendroic acid
Pharmacotherapy group:
Bone resorption inhibitor-bisphosphonate
Storage Conditions
The drug should be stored in a place inaccessible to children at a temperature not higher than 25 ° C.
Best before date
Shelf life is 3 years. Do not apply after expiry date.
Testimony:
treatment of osteoporosis in postmenopausal women to prevent the development of fractures, including hip fractures and compression fractures of the spine;
Treatment of osteoporosis in men to prevent fractures.
Method of use, course and dosage:
The preparation is ingested without chewing, being washed with drinking water for at least 30 minutes prior to the first ingestion of food, liquid or medicinal preparations. Other beverages (including mineral water), food, and some medicines may reduce the absorption of Osterepar®.
To reduce the risk of esophageal irritation, Osterepar® should be taken following the following guidelines:
take in the morning immediately after getting out of bed;
A full glass of water to ease the entry of the pill into the stomach;
Do not chew pills or suck them in the mouth because of possible ulcers in the mouth and throat;
patients should stay up until the first meal, which should be taken at least 30 minutes after taking Osterepar®;
The drug Alendronic acid should not be taken before going to bed or before getting out of bed.
Patients should also take calcium and vitamin D if the food intake is not sufficient.
Treatment of osteoporosis in postmenopausal women: The recommended dose is -1 tabb. (70 mg) once a week.
Treatment of osteoporosis in men: The recommended dose is -1 tabb. (70 mg) once a week.
The optimal duration of use of the drug Alendronic acid is not established. The need for continued therapy with bisphosphonates should be assessed on a regular basis, especially after 5 years or more of use.
For elderly patients and patients with mild to moderate kidney failure (QC of 35 to 60 ml/min), no dose correction is required. The drug Osterepar® is not recommended for patients with severe renal failure (QC less than 35 ml/min) due to the lack of experience of use in these patients.
Due to the lack of a wedge
Application for kidney disorders
The use of the preparation for chronic renal insufficiency (QC of less than 35 ml/min) is contraindicated.
For patients with mild to moderate kidney failure (QC of 35 to 60 ml/min), no dose correction is required.
Use in liver disorders
In patients with liver dysfunction, there is no need to adjust the dose of alendronic acid, as it is not metabolized or eliminated with bile.
Terms of Sale
The drug Alendronic acid is prescription.
Application in elderly patients
No dose correction is required for elderly patients.
Use in children
Due to the lack of clinical data, children are not prescribed the drug Alendronic acid.
Nosology (ICD codes)
M80.0
Postmenopausal osteoporosis with pathological fracture
M80.1
Osteoporosis with pathological fracture after ovarian removal
M80.4
Drug osteoporosis with pathological fracture
M80.5
Idiopathic osteoporosis with pathological fracture
M80.8
Another osteoporosis with a pathological fracture
M81.0
Postmenopausal osteoporosis
M81.1
Osteoporosis after ovarian removal
M81.4
Drug osteoporosis
M81.5
Idiopathic osteoporosis
M81.8
Other osteoporosis (senile osteopause)
Pharmacological effect Osterepar:
Bone resorption inhibitor. Sodium alendronate is a bisphosphonate, a synthetic analog of pyrophosphate, which binds bone tissue hydroxyapatite. Being a non-hormonal specific inhibitor of osteoclasts activity, it prevents bone tissue resorption. It does not affect bone formation processes. It stimulates osteogenesis, restoring a positive balance between resorption and bone restoration. It progressively increases the mineral density of bones (regulates phosphorus-calcium exchange), promotes the formation of bone tissue of normal composition and structure.
Pharmacokinetics:
Absorption; After a single dose of 70 mg in the morning, the absorption is 0.64% after 2 hours before breakfast. With a shortened break between the drug Alendronic acid and food - 0.46-0.39%. This reduction in absorption has no significant effect on the effectiveness of the drug Alendronic acid. Simultaneous coffee or orange juice reduces bioavailability by 60%.;Distribution;Once ingested, temporarily distributed in soft tissues, then quickly distributed into bone tissue. Plasma protein binding 78%
There is no evidence of alendronate metabolism in humans.;Withdrawal;Absorbed but not embedded in bone, alendronate is rapidly excreted by the kidneys. Despite the lack of evidence, in kidney disease it is likely to reduce the elimination of alendronate with increased accumulation in bone tissue.
