Active substanceAlendronic acidAlendronic acid
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  • Dosage form: & nbsppills
    Composition:

    One 10 mg tablet contains:

    Active substance:

    alendronate sodium (in terms of alendronic acid) - 10 mg;

    Excipients:

    Microcrystalline cellulose, anhydrous lactose, sodium carboxymethyl starch (primogel), magnesium stearate.

    One 70 mg tablet contains:

    Active substance:

    Alendronate sodium (in terms of alendronic acid) - 70 mg;

    Excipients:

    Microcrystalline cellulose, anhydrous lactose, sodium carboxymethyl starch (primogel), magnesium stearate.

    Description:

    Tablets 10 mg: tablets are white, round, biconvex, without risks.

    Tablets 70 mg: tablets are white, oval without risk.

    Pharmacotherapeutic group:Bone resorption inhibitor-bisphosphonate
    ATX: & nbsp

    M.05.B.A.04   Alendronic acid

    Pharmacodynamics:

    Stringos is a drug from the group of aminobisphosphonates - synthetic analogues of pyrophosphate, which binds to hydroxyapatite, which is part of the bone tissue. Increases the mineral density of the bones of the spine and other bones of the skeleton. The mechanism of antiresorptive action is associated with suppression functions of osteoclasts. Promotes the formation of bone tissue with a normal histological structure.

    Pharmacokinetics:

    Bioavailability of alendronic acid in a dose of 5-70 mg when administered on an empty stomach directly 2 hours before breakfast in women is 0.64% and 0.6% in men. When administered on an empty stomach for 1-1.5 hours before breakfast, the bioavailability of the drug is reduced by 40%. After consuming coffee and orange juice, bioavailability is reduced by about 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 fixes, or is excreted in the urine. 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 the bones. The final half-life is more than 10 years, which reflects the release of the drug from the bone tissue.

    Indications:

    Treatment of postmenopausal osteoporosis.

    Osteoporosis caused by the use of glucocorticosteroid drugs.
    Contraindications:

    hypersensitivity to any of 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;

    the patient's inability to stand or sit for at least 30 minutes;

    severe renal failure (creatinine clearance less than 35 ml / min);

    severe disturbances in mineral metabolism;

    childhood;

    pregnancy;

    lactation period.

    Carefully:

    Diseases of the gastrointestinal tract (GIT) in the phase of exacerbation (dysphagia, esophagitis, gastritis, duodenitis, peptic ulcer and duodenal ulcer), hypovitaminosis D.

    Pregnancy and lactation:

    Pregnancy and lactation are contraindications to the use of Strongos.

    Dosing and Administration:

    To ensure the normal absorption of the drug and reduce the risk of side effects should strictly follow the recommendations below for the use and dosage of the drug.

    The recommended dose is 1 tablet (10 mg) orally once a day or 1 tablet (70 mg) orally once a week.

    The tablet is taken whole, in the morning on an empty stomach, with a glass of water at least 30 minutes before the first meal, drinking drinks or other medications. Drink the drug only with normal water, since other beverages (including mineral water), foods and some medications can reduce the absorption of Strongos. Tablets can not be chewed or rassasyvat.

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

    Side effects:

    When using alendronic acid, abdominal pain, dyspeptic disorders (constipation or diarrhea, flatulence, nausea and vomiting), dysphagia, ulceration of the esophagus mucosa, stomach dystonia, melena, heartburn may be observed; bone, muscle and joint pain; headache.

    Among the rare side effects of Strongos, as well as other drugs of the bisphosphonate group, are: erythema; esophagitis, erosion of the mucosa of the esophagus, ulceration of the mucous membrane of the mouth and throat, stomach and duodenum; hypersensitivity reactions (skin rash), uveitis, scleritis, etc. From the central nervous system: irritability. From the skin: skin hyperemia, rash (sometimes with photosensitization).

    Other: asymptomatic hypocalcemia and hypophosphatemia.

    In the treatment of bisphosphonates, the osteonecrosis of the jaw was rarely observed.

    Overdose:

    In case of an overdose it is possible to develop hypocalcemia, hypophosphatemia, as well as adverse reactions from the digestive tract: diarrhea, heartburn, esophagitis or erosive-ulcerative gastrointestinal lesions.

    Treatment: Milk or antacid to bind alendronic acid.Due to the risk of irritation of the esophagus, do not induce vomiting. The patient should be in an upright position.

    Interaction:

    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.

    It is not allowed simultaneous reception of alendronic acid with preparations containing calcium, antacids or other medicines for oral administration because of a possible decrease in the absorption of alendronic acid. In this regard, it is necessary to take a break, at least 30 minutes after taking alendronic acid and before ingesting other medications.

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

    Nonsteroidal anti-inflammatory drugs increase the side effect of alendronic acid on the gastrointestinal tract.

    Special instructions:

    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 and contact a doctor when developing 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 use.

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

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

    When taking Strongos (especially with glucocorticosteroids) it is necessary to ensure adequate intake of calcium and vitamin D with food or in the form of medicines.

    Absorption of bisphosphonates is significantly reduced by simultaneous intake of food.

    When appointing other 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 osteonecrosis of the jaw include establishing a diagnosis of cancer, concomitant therapies (chemotherapy, radiotherapy, corticosteroids) and other disorders (anemia, coagulopathy, infection, gum disease). 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.

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

    Does not affect.

    Form release / dosage:

    Tablets of 10 mg.

    TablThe 70 mg each.

    Packaging:

    Tablets of 10 mg.

    For 7, 10 or 14 tablets in a planar cell pack. For 28 tablets in a can of lightproof glass.

    2 contour packs of 14 tablets, 3 contour packs of 10 tablets each, or 4 contourcell packs of 7 tablets, or each bank along with the instructions for use are placed in a pack of cardboard.

    Tablets of 70 mg.

    For 4 or 10 tablets in a planar cell pack. For 28 tablets in a can of lightproof glass.

    For 1 or 3 out-of-round cell packs of 10 tablets, 1 or 7 contour packs with 4 tablets, or each bank along with the instructions for use are placed in a pack of cardboard.

    Storage conditions:

    List B. In a dry place at a temperature of 15 to 30 ° C Keep out of the reach of children.

    Shelf life:

    2 years.

    Do not use after the expiration date.

    Terms of leave from pharmacies:On prescription
    Registration number:LSR-002134/08
    Date of registration:27.03.2008
    The owner of the registration certificate:VEROPHARM SA VEROPHARM SA Russia
    Manufacturer: & nbsp
    Information update date: & nbsp18.09.2015
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