Osterepar, tablets 70 mg 4 pcs

Alendronate sodium is a bisphosphonate, a synthetic analog of pyrophosphate binding hydroxyapatite of bone tissue. Being a non-hormonal specific inhibitor of osteoclast activity, it prevents bone tissue resorption. It does not influence bone tissue formation processes.
Stimulates osteogenesis, restores positive balance between resorption and bone regeneration.
Progressively increases bone mineral density (regulates phosphorus-calcium exchange), promotes formation of bone tissue of normal composition and structure.

Indications

Treatment of postmenopausal osteoporosis to prevent spine and hip fractures.

Active ingredient

Composition

Active ingredient: alendronate sodium trihydrate 91.37 mg (corresponding to 70 mg of alendronic acid);

Auxiliary substances: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, colloidal anhydrous silica.

How to take, the dosage

The drug Osteepar is taken orally. The recommended dose is 70 mg once a week. To ensure optimal absorption, the drug should be taken in the morning on an empty stomach 2 h (at least 30 min) before the first meal or liquid, with plain drinking water. Other drinks, including mineral water, food, a number of drugs may impair absorption of alendronate.
In order to avoid local irritation of the oral cavity and esophagus in the morning immediately after getting up from the bed you should drink at least 200 ml of plain water, then take the tablet without chewing and not letting it dissolve in the mouth, after this period the patient should not lie down for 30 min and take breakfast. The tablet should not be taken in the morning before getting out of bed or in the evening after going to bed.
Treatment with alendronate should be supplemented with calcium and vitamin D.
Dose adjustment is not required in elderly patients.
Dose adjustment is not required in CKR > 35 ml/min. In renal insufficiency with CK < 35 ml/min, the drug should not be prescribed due to lack of clinical experience.

Interaction

Calcium, antacids, some oral medications, food, drinks, including mineral waters affect absorption of alendronate. Medicinal products can be taken orally not earlier than 1 hour after taking alendronate.

Other types of interaction, except for change of absorption, are unlikely.

Ranitidine increases bioavailability of alendronate (clinical significance is unknown).

NSAIDs increase the adverse effects of alendronate.

Special studies on drug interactions have not been conducted, but studies with alendronate involved patients taking other oral medications simultaneously. They did not have any adverse reactions associated with concomitant administration of other drugs.

Contraindications

High sensitivity to any of the components of the drug;
anomalies of the esophagus and other factors that complicate the patency of the esophagus (achalasia, stricture, etc.).The following indications should be noted:
unable ability to stand upright for at least 30 minutes sitting upright; hypocalcemia, chronic renal insufficiency (creatinine clearance: 35 ml/min),
pregnancy, lactation, children, vitamin D deficiency, severe mineral metabolism disorders.
With caution: diseases of the digestive tract in the acute phase (dysphagia, esophageal diseases, gastritis, duodenitis, ulcers, serious gastrointestinal disease in the previous 12 months, such as peptic ulcer, gastrointestinal bleeding, surgery, except for operations on spastic pylorus of the stomach).

Side effects

Organism in general: hypersensitivity reactions, including urticaria and rare cases of angioedema; transient symptoms of myalgia, malaise, asthenia and, rarely, cases of fever, usually at the beginning of treatment; rarely – peripheral edema.

Gastrointestinal organs: esophagitis, erosions and ulcers of the esophagus; rarely – stenosis or perforation of the esophagus, oropharyngeal ulcers, stomach or duodenal ulcers; rarely reported cases of localized osteonecrosis of the jaw, usually associated with tooth extraction and/or local infection, often with delayed healing.

Motor system: pain in bones, joints and/or muscles, sometimes severe and, rarely, leading to disability.

Nervous system and sensory system: dizziness, vertigo; rarely uveitis, scleritis or episcleritis.

Skin: rash (sometimes with photosensitivity), itching; rarely – severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis.

Overdose

Symptoms: hypocalcemia, hypophosphatemia, adverse reactions from the upper gastrointestinal tract (heartburn, esophagitis, gastritis, ulcers).

Treatment: there is no specific treatment. The intake of milk and antacids is recommended. To avoid irritation of the esophagus, do not induce vomiting, the patient should take an upright position (standing or sitting).

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