Active substanceAlendronic acidAlendronic acid
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  • Dosage form: & nbsppills
    Composition:Each tablet contains:

    active substance: alendronate sodium trihydrate 91.37 mg, equivalent to 70 mg of alendronic acid;

    auxiliary substances: lactose monohydrate - 110.84 mg, microcrystalline cellulose - 138.54 mg, croscarmellose sodium -3,50 mg, povidone-14,00 mg, magnesium stearate-1.75 mg.

    Description:Tablets are white in color, round.
    Pharmacotherapeutic group:Bone resorption inhibitor-bisphosphonate
    ATX: & nbsp

    M.05.B.A.04   Alendronic acid

    Pharmacodynamics:

    Non-hormonal specific inhibitor of osteoclastic bone resorption (from the group of aminobisphosphonates - synthetic analogues of pyrophosphate, binding hydroxyapatite, located in the bone), suppresses osteoclasts. Stimulates osteogenesis, restores a positive balance between resorption and bone restoration, progressively increases bone mineral density (regulates phosphorus-calcium metabolism), promotes the formation of bone tissue with a normal histological structure.

    Pharmacokinetics:

    Bioavailability of alendronic acid when administered in fasting at a dose of 70 mg directly for 2 hours before breakfast in women is 0.64%, in men it is 0.6%. At reception for 30 and 60 minutes before meal bioavailability decreases to 0,46% and 0,39% accordingly. Admission 2 hours after a meal on bioavailability is not affected. After consuming coffee and orange juice, bioavailability is reduced by 60%.

    The relationship of alendronic acid with serum proteins is about 78 %.

    The drug is distributed into soft tissues, and then quickly redistributed into the bone, where it is fixed, or excreted by the kidneys.The concentration of the drug in the blood plasma after ingestion at the therapeutic dose is below the possible limit of measurement (<5 ng / ml).

    Not subject to biotransformation. Removal of the drug is carried out in an unchanged form and is characterized by a rapid decrease in the concentration of the drug in the blood plasma and extremely slow release from bone tissue. The elimination half-life is more than 10 years.

    Indications:

    Postmenopausal osteoporosis - (prevention of bone fractures, including proximal femur and spine).

    Contraindications:

    Hypersensitivity to the components of the drug; hypocalcemia; stricture or achalasia of the esophagus and other conditions that lead to a slowing of food progress along the esophagus; severe renal failure (with a creatinine clearance (CK) of less than 35 ml / min, the risk of cumulation of the drug increases); the patient's inability to sit or stand upright for 30 minutes; pregnancy; lactation period; childhood; severe disturbances in mineral metabolism. The preparation contains lactose. Patients suffering from hereditary intolerance to galactose, a deficiency of lactase or malabsorption of glucose-galactose, the drug is contraindicated.

    Carefully:

    Diseases of the gastrointestinal tract (GIT) in the acute phase (dysphagia, esophagitis, gastritis, duodenitis, gastric ulcer and 12 duodenal ulcers), gastrointestinal bleeding, vitamin deficiencies D.

    Pregnancy and lactation:

    The use of the drug during pregnancy and lactation is contraindicated.

    Dosing and Administration:

    Inside, once a week. A tablet taken as a whole, in the morning on an empty stomach, drinking a glass of water, not less than 30 minutes before the first meal, drink or use of other drugs. Wash down with plain water only, as other beverages, foods and some medications can reduce the absorption of the drug.

    Tablets can not be chewed or rassasyvat.

    After taking the drug, the patient should maintain a vertical position (standing or sitting) for at least 30 minutes. Do not take the drug before going to bed or before the morning rise from bed.

    Side effects:

    Alendronic acid is generally well tolerated, side effects are usually mild and did not require discontinuation of therapy.

    In clinical trials, the following side effects occurred with a frequency> 1%:

    Gastrointestinal tract: abdominal pain, indigestion, ulcerative disease of the esophagus, dysphagia, flatulence, constipation, diarrhea, acidic eructations, nausea, gastritis, peptic ulcer, including peptic ulcer complicated by bleeding (melena).

    Musculoskeletal system: myalgia, pain in the bones, joint pain, muscle cramps.

    Nervous system: headache.

    In the broad clinical practice, the following side effects have been reported:

    Gastrointestinal tract: erosion or ulcers of the esophagus, nausea, vomiting, gastritis, melena, esophagitis, esophageal stricture, perforation, oropharyngeal ulcer, rarely ulcerative diseases of the stomach and duodenum (although there is no connection with the drug), local osteonecrosis of the jaw associated mainly with prior extraction of the tooth and / or local infection (including osteomyelitis), often with slow recovery.

    Musculoskeletal system: myalgia, pain in the bones, pain in the joints, rarely - heavy: swelling of the joints, hip fractures.

    Skin reactions are rare: skin rash, erythema.

    Organism as a whole: hypersensitivity reactions, including urticaria and rarely angioedema, transient symptoms of acute phase reaction at the beginning of treatment (myalgia, malaise, asthenia, rarely - fever), hypocalcemia.Rarely, peripheral edema.

    Skin reactions: rash, photosensitivity, itching, alopecia, rarely severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis.

    Sense organs: rarely - uveitis, scleritis, episcleritis.

    Nervous system: dizziness, systemic dizziness, a violation of taste sensations.

    Overdose:

    Symptoms: hypocalcemia, hypophosphatemia, gastrointestinal side effects: diarrhea, heartburn, esophagitis or erosive-ulcerative lesions of the gastrointestinal tract.

    Treatment: milk or calcium-containing antacids to bind the drug (because of the risk of developing esophageal irritation, do not induce vomiting). The patient should be in an upright position.

    Interaction:

    It is not allowed to simultaneously receive alendronic acid with preparations containing calcium, antacids or other drugs for oral administration because of a possible decrease in the absorption of alendronic acid.

    The interval between alendronic acid and other medications should be at least 30 minutes.

    Non-steroidal anti-inflammatory drugs (incl. acetylsalicylic acid) can increase the side effect of alendronic acid on the gastrointestinal tract.

    The combined use of alendronic acid (but not simultaneous administration) with estrogen preparations is not accompanied by a change in their action and the development of side effects.

    The intake of prednisolone by mouth is not accompanied by clinically significant changes in the bioavailability of alendronic acid.

    Special instructions:

    Drink only with normal water, as other beverages (including mineral water, coffee, tea, orange juice) reduce absorption.

    Special attention should be paid to any signs of the occurrence of adverse reactions in the esophagus.

    The patient should be informed of the need to stop taking the drug or contact a doctor for dysphagia, pain when swallowing, chest pain, or heartburn.

    It is necessary to inform the patient about the possible risk of damage to the mucous membrane of the esophagus when not following the instructions for medical use.

    In connection with the danger of irritation of the mucous membrane of the mouth and esophagus and the risk of aggravation of the underlying disease, it is recommended to take precautions when prescribing the drug to patients withdiseases of the gastrointestinal tract, such as dysphagia, diseases of the esophagus, gastritis, duodenal ulcer in the stage of exacerbation.

    To reduce the irritating effect on the esophagus, the drug should be taken immediately after the morning ascent, with a full glass of water, after taking it, it should remain in the vertical position for 30 minutes (dangerous to use if the patient is unable to stand or sit for 30 minutes). Admission before bed or in the horizontal position increases the risk of esophagitis.

    In case the patient forgets to take a weekly tablet of the drug, you should immediately take the pill the next morning. Do not take two tablets at the same time. The drug is taken one tablet once a week on the same set day.

    In the presence of hypocalcemia before the start of treatment with alendronic acid, it is necessary to carry out corrective therapy of mineral metabolism disorders, including hypovitaminosis D. In the process of treatment, there may be a slight asymptomatic decrease in the concentration of calcium in blood serum and phosphates due to the positive effect of alendronic acid on the bone mineral density, which is of particular importance for patients,treated with glucocorticosteroid drugs, because they may have a decreased absorption of calcium.

    When taking alendronic acid (especially in combination with glucocorticosteroid drugs) it is necessary to ensure adequate intake of calcium and vitamin D with food or in the composition of medicines.

    When appointing bisphosphonates, there was rarely osteonecrosis of the jaw. Most cases have been reported in cancer patients during dental procedures, several cases in patients with postmenopausal osteoporosis or other diseases. Risk factors for the development of osteonecrosis of the jaw include an established diagnosis of cancer, concomitant therapy (chemotherapy, radiation therapy, corticosteroid drugs) and other disorders (anemia, coagulopathy, infection, diseases gums). Most cases were noted with the intravenous administration of bisphosphonates, but individual cases were observed in patients receiving drugs inward.

    Surgical dental intervention against the background of bisphosphonate therapy can enhance the manifestations of the osteonecrosis of the jaw. It is unknown whether the risk of osteonecrosis reduces the elimination of bisphosphonates.The decision to conduct treatment should be taken for each patient individually after assessing the risk / benefit ratio. Patients at risk (for example, with oncological diseases, undergoing chemotherapy, radiation taking glucocorticosteroid drugs that do not follow oral hygiene) should undergo a dental examination and visit a specialist before starting treatment with bisphosphonate.

    Effect on the ability to drive transp. cf. and fur:

    Effects on the ability to drive vehicles and other mechanisms that require concentration of attention is not noted.

    Form release / dosage:Tablets of 70 mg.
    Packaging:4 tablets per contour cell pack.
    1 circuit cell pack together with the instruction for use is placed in a pack of cardboard.
    Storage conditions:

    In a dry, the dark place at a temperature of no higher than 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    3 years.

    Do not use after the specified time on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:LP-000091
    Date of registration:15.12.2010
    The owner of the registration certificate:Kern Pharma S.L.Kern Pharma S.L. Spain
    Manufacturer: & nbsp
    Representation: & nbspINDUKERN-RUS LLCINDUKERN-RUS LLCRussia
    Information update date: & nbsp18.09.2015
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