Ostalon 70mg N4 coated pills
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Description
white, round, biconvex, engraved with "M14" on one side.
Active ingredients
Release form
Composition
1 tablet contains:alendronate sodium trihydrate 91.35 mg, which corresponds to the content of alendronic acid 70 mg.
Excipients: microcrystalline cellulose, colloidal silicon dioxide, croscarmellose sodium, magnesium stearate.Shell composition: Chandelier Klear LS 103 (microcrystalline cellulose, carrageenan, macrogol 8000)
Pharmacological effect
Bone resorption inhibitor for osteoporosis. Sodium elendronate is a bisphosphonate, a synthetic analogue of pyrophosphate that binds bone hydroxyapatite.
Being a non-hormonal specific inhibitor of osteoclast activity, it prevents bone resorption. Does not affect the formation of bone tissue. Stimulates osteogenesis, restores a positive balance between resorption and restoration of bone. Progressively increases bone mineral density (regulates phosphoric-calcium metabolism), promotes the formation of bone tissue of normal composition and structure.
Pharmacokinetics
Suction
After a single dose of the drug inside the morning on an empty stomach (2 hours before breakfast) in a dose of 35 mg or 70 mg, the absorption is 0.64%; with a shortened break between taking the drug and food - 0.46-0.39%. Such a decrease in absorption does not significantly affect the effectiveness of the drug. The simultaneous intake of coffee or orange juice reduces the bioavailability of alendronate sodium by 60%.
Distribution
After ingestion, alendronate sodium is temporarily distributed into soft tissues, then quickly incorporated into bone tissue. Plasma protein binding - 78%.
Metabolism
There is no data confirming the metabolism of alendronate in the human body.
Removal
Absorbed, but not embedded in the bone tissue, sodium alendronate is rapidly excreted in the urine. The maximum saturability of bone tissue in animals could not be established with the on / in the introduction of a cumulative daily dose of 35 mg / kg. Despite the lack of evidence, in kidney diseases, a decrease in the elimination of alendronate is likely, with increased accumulation in bone tissue.
Indications
- treatment of osteoporosis in postmenopausal women (reducing the risk of developing fractures of the spinal vertebrae, the head of the hip bone);
- treatment of osteoporosis in men (reducing the risk of fractures of the dorsal vertebrae, pelvic bones);
- osteoporosis caused by prolonged use of corticosteroids.
Contraindications
- anomalies of the esophagus and other factors impeding the patency of the esophagus (including achalasia, stricture);
- hypocalcemia;
- chronic renal failure (CC <35 ml / min);
- vitamin D deficiency;
- severe violations of mineral metabolism;
- the inability of the patient to remain upright, even sitting, for 30 minutes;
- pregnancy;
- lactation period (breastfeeding);
- childhood;
- hypersensitivity to the drug.
WITH caution the drug should be used for gastrointestinal diseases in the acute phase (dysphagia, esophagus, gastritis, duodenitis, ulcer; in the previous 12 months - peptic ulcer, gastrointestinal bleeding, surgery, except for operations on the spastic pylorus).
Use during pregnancy and lactation
The use of Ostalon during pregnancy and during breastfeeding is contraindicated.
Dosage and administration
The drug should be taken at 70 mg 1 time per week. To ensure optimal absorbability, Ostalon® should be taken in the morning on an empty stomach 2 hours (at least 30 minutes) before the first meal or liquid with simple drinking water. Other beverages (including mineral water), food, a number of medicines may affect the absorption of alendronate.
In order to avoid local irritation of the oral mucosa and esophagus in the morning, immediately after getting out of bed, drink at least 200 ml of plain water, then take a pill without chewing and preventing it from dissolving in the mouth. For the next 30 minutes you cannot take a horizontal body position . After this period, you should have breakfast.
You can not take a pill 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.
Haveelderly patients dose adjustment of the drug is not required.
AtCC> 35 ml / min, dose adjustment is not required whensevere renal failureprescribe the drug is not recommended due to lack of clinical experience.
Side effects
From the digestive system: often (≥1 / 100, <1/10) - abdominal pain, dyspepsia, constipation, diarrhea, flatulence, esophageal ulcer, dysphagia, abdominal distension, heartburn; sometimes (≥1 / 1000, <1/100) - nausea, vomiting, gastritis, esophagitis, esophageal erosion, melena; rarely (≥1 / 10 000, <1/1000) - narrowing of the esophagus, oropharyngeal ulcer, perforation of the upper GI tract, ulcer, bleeding (connection with treatment is not always unambiguous).
From the musculoskeletal system: often (≥1 / 100, <1/10) - ostalgia, arthralgia, myalgia.
From the side of the central nervous system: often (≥1 / 100, <1/10) - headache, irritability.
From the senses: rarely (≥1 / 10 000, <1/1000) - uveitis, scleritis.
Dermatological reactions: sometimes (≥1 / 1000, <1/100) - itching, skin flushing, rash; rarely (1/10 000, <1/1000) - photosensitization.
Metabolism: rarely (≥1 / 10 000, <1/1000) - hypocalcemia (often accompanied by predisposing factors), hypophosphatemia.
Allergic reactions: rarely (≥1 / 10 000, <1/1000) - urticaria, angioedema, Stevens-Johnson syndrome, toxic epidermal necrolysis.
Other: rarely (≥1 / 10 000, <1/1000) - transient symptoms resembling an acute reaction phase (myalgia, weakness, feeling unwell, rarely - high body temperature), most often develop at the beginning of treatment.
Overdose
Symptoms: hypocalcemia, hypophosphatemia, adverse reactions from the upper GI tract (heartburn, esophagitis, gastritis, ulcer).
Treatment: There is no specific treatment, it is recommended to take milk, antacids. In order to avoid irritation of the esophagus, one should not induce vomiting, the patient should be given a vertical position (standing or sitting).
Interaction with other drugs
Calcium, antacids, some preparations for ingestion, food, drinks (including mineral waters) affect the absorbability of alendronate - medicines can be ingested not earlier than 1 hour after taking Ostalon.
Other, with the exception of changes in absorbability, the interaction is unlikely.
Ranitidine increases bioavailability (clinical significance is unknown).
NSAIDs increase the adverse effects of alendronic acid.
Special studies of drug interactions were not performed, however, in studies with alendronate, patients who received other drugs were ingested. At the same time, no side effects associated with the simultaneous intake of other drugs were observed.
special instructions
Alendronate may cause local irritation of the gastrointestinal tract.The course of diseases of the upper GI tract may worsen during treatment with Ostalon.
There are cases of adverse reactions from the esophagus (esophagitis, ulcer or erosion of the esophagus), sometimes proceeding in a severe form, requiring inpatient treatment, and complicated by the formation of a stricture. Patients should be especially aware that if there is evidence of irritation of the esophagus (dysphagia, chest pain when swallowing, the onset or worsening of heartburn attacks), the drug should be stopped and consult a doctor. The risk of damage to the esophagus is higher in patients who do not comply with the rules of the drug, or continue treatment despite the appearance of signs of irritation of the esophagus.
The patient should be warned that in case of skipping the next dose of the drug, the missed pill should be taken the next morning. In no case should not take 2 pills in one day.
Treatment can begin only after the elimination of hypocalcemia, disorders of mineral and vitamin exchanges (for example, vitamin D deficiency). The use of alendronate leads to an increase in the content of mineral salts in the bone tissue, the process may be accompanied by asymptomatic changes in the levels of calcium and phosphorus. Ensuring proper intake of calcium and vitamin D is especially important in the case of simultaneous treatment of a patient with GCS.
Treatment should be combined with a diet rich in calcium salts.
Influence on ability to drive motor transport and control mechanisms:
The drug does not affect the ability to drive and perform work associated with a high risk of injury, but in the presence of adverse reactions from the organ of sight, driving and working mechanisms are contraindicated until the complete disappearance of adverse reactions.