Active substanceAlendronic acidAlendronic acid
Similar drugsTo uncover
  • Alendercourne
    pills inwards 
    Kern Pharma S.L.     Spain
  • Alendronate
    pills inwards 
    VERTEKS, AO     Russia
  • Alendronate
    pills inwards 
  • Alendronate
    pills inwards 
  • Alendronate Pliva
    pills inwards 
  • Binosto
    pills inwards 
    Polypharm, LLC     Russia
  • Ostalon®
    pills inwards 
    GEDEON RICHTER, OJSC     Hungary
  • Osterepar®
    pills inwards 
  • Strongos
    pills inwards 
    VEROPHARM SA     Russia
  • Tevanat®
    pills inwards 
  • Forosa®
    pills inwards 
    Lek dd     Slovenia
  • Fosamax®
    pills inwards 
    Merck Sharp and Doum B.V.     Netherlands
  • Dosage form: & nbsppills
    Composition:

    1 tablet, contains:

    active substance:

    Alendronate 10 mg. Contains active substance alendronata sodium trihydrate 13.05 mg, calculated on alendronic acid 10.00 mg.

    Alendronate 70 mg. Contains active substance alendronata sodium trihydrate 91.36 mg, in terms of alendronic acid 70.00 mg.

    Excipients:

    Alendronate 10 mg: corn starch 40 mg, lactose (sugar milk) 37.95 mg, magnesium stearate 1 mg, cellulose microcrystalline 108 mg.

    Alendronate 70 mg.corn starch 50 mg, lactose (milk sugar) 45.44 mg, magnesium stearate 1.8 mg, microcrystalline cellulose 171.4 mg.

    Description:

    Tablets of white or almost white color, flat-cylindrical form with a facet or with a facet and a risk (a dosage of 70 mg). Allowed a slight marbling.

    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. It restores a positive balance between bone resorption and 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 on an empty stomach 2 hours before meals - 0.64% (in women) and 0.6% (in men); when taken on an empty stomach for 1-1,5 hours before eating, it decreases by 40%. Coffee and orange juice reduces bioavailability by 60%.

    Distribution:

    The average volume of distribution in a state of equilibrium concentration (excluding bones) in man is at least 28 liters. The concentration of the drug in the blood plasma after oral administration in a therapeutic dose is too low for analytical determination (<5 ng / ml). Binding to plasma proteins is approximately 78%.

    Metabolism:

    The human body is not metabolized.

    Excretion:

    Outputs unchanged. The elimination process is characterized by a rapid decrease in the concentration of alendronic acid in the blood plasma and extremely slow release from the bones. When administered orally after 6 hours, the plasma concentration is reduced by more than 95%. The half-life is approximately 10 years, which indicates the removal of alendronate from bone tissue. Absorbed, but not embedded in the bone tissue alendronate, is quickly excreted by the kidneys. Kidney clearance - 71 ml / min, systemic - 200 ml / min.

    Indications:

    - Osteoporosis in postmenopausal women (prevention of bone fractures, including hip and spine);

    - osteoporosis in men;

    - osteoporosis, caused by prolonged use of glucocorticosteroid preparations; Paget's disease.

    Contraindications:

    - Hypersensitivity to the components of the drug;

    - hypocalcemia;

    - the patient's inability to stand upright (stand or sit upright) for at least 30 minutes;

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

    - severe disturbances in mineral metabolism;

    - stricture or achalasia of the esophagus and other conditions leading to difficulty in moving food through the esophagus;

    - severe hypoparathyroidism;

    - calcium malabsorption;

    - lactose intolerance, lactase deficiency, glucose-galactose malabsorption;

    - pregnancy;

    - lactation period;

    - childhood.

    Carefully:

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

    Dosing and Administration:

    Alendronate is administered orally, once a day, without chewing, on an empty stomach, preferably 2 hours (but not less than 30 minutes) before the first meal, water or other medications. It should be washed down with plain water, as other beverages, including mineral water, coffee, tea, orange juice) reduce absorption.

    Tablets can not be chewed or rassasyvat.

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

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

    For treatment of osteoporosis in women (in postmenopause) and in men, as well as osteoporosis caused by prolonged use of glucocorticosteroid drugs, alendronate is taken at 10 mg / day. or 70 mg once a week.

    With Paget's disease is used at a dose of 40 mg / day for 6 months.

    If you miss an appointment once a week, take one pill in the morning of the next day. Do not take two tablets in one day, but in the future you should continue to take one tablet on the day of the week that was chosen for admission from the beginning of treatment.

    Side effects:

    From the gastrointestinal tract: Dysphagia, esophagitis, abdominal pain, heartburn, indigestion, constipation, diarrhea, flatulence. Rarely - nausea, vomiting, gastritis, melena, esophageal stricture, ulcers of the oral cavity and pharynx, ulcer of the esophagus, perforation of the ulcer of the esophagus with bleeding.

    From the musculoskeletal system: pain in the bones, muscles and joints.

    From the nervous system: headache.

    From the side of the organ of vision: uveitis, scleritis.

    Allergic reactions: rarely - hives, angioedema; reported on isolated cases of the syndrome of Stevens-Johnson and Lyell.

    Others: rash, itching, erythema, photodermatosis, symptomatic hypocalcemia.

    The cases of development of osteonecrosis of the upper and lower jaw are described mainly in patients with oncological diseases against the background of antitumor treatment including bisphosphonates. Risk factors for osteonecrosis are cancer, chemotherapy, radiation therapy, glucocorticosteroid treatment, inadequate oral hygiene, local infectious inflammatory process, including osteomyelitis. In most of the cases described, patients undergoing bisphosphonate treatment underwent tooth extraction.

    Laboratory test data: a slight and transient decrease in the concentration of calcium and phosphate.

    Typical symptoms at the beginning of treatment are myalgia, malaise and, rarely, fever.
    Overdose:

    Symptoms: hypocalcemia, hypophosphatemia, gastrointestinal waste (GIT) side-effects - heartburn, esophagitis, erosive-ulcerative gastrointestinal lesions, diarrhea.

    Treatment: Milk or calcium-containing antacids for binding alendronic acid. Due to the risk of irritation of the esophagus, do not induce vomiting. The patient should be in an upright position.

    Interaction:

    Simultaneous use of calcium preparations (including antacids), reduces the absorption of alendronic acid. The interval between taking alendronic acid and other medicines should be at least 30 minutes.

    Non-steroidal anti-inflammatory drugs (including acetylsalicylic acid) can increase the side effects of alendronic acid from the digestive tract.

    The intake of glucocorticosteroid preparations inside is not accompanied by clinically significant changes in the bioavailability of alendronic acid.

    Special instructions:

    To drink Alendronate should be only ordinary water, since other beverages (including mineral water, coffee, tea, orange juice) reduce the absorption of alendronic acid.

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

    To reduce the irritating effect on the esophagus, Alendronate must be taken immediately after the morning ascent, with a full glass of water. After taking, you should be in a vertical position (standing or sitting) for 30 minutes (it is dangerous to use the drug in case the patient is unable to stand or sit for a specified time). Taking alendronate before bed or in a horizontal position increases the risk of esophagitis.

    The patient should be informed of the need to stop taking Alendronate and contact a doctor when developing dysphagia, the appearance of pain during swallowing, chest pain, or heartburn.

    With hypocalcemia, it is necessary to correct it before starting treatment. Including it is necessary to eliminate the disturbances of mineral metabolism, leading to hypocalcemia (vitamin deficiency D, hypoparathyroidism, calcium malabsorption). Therapy should be carried out against a background of a diet enriched with calcium salts.

    When taking bisphosphonates (especially with concomitant therapy with glucocorticosteroid drugs), it is necessary to ensure the intakeadequate amounts of calcium and vitamin D with food or in the form of medicines.

    In the course of treatment, due to the positive effect of alendronic acid on the bone mineral density, there may be a slight asymptomatic decrease in the concentration of calcium and phosphate in the blood serum.

    Prior to the appointment of bisphosphonate therapy to patients with concomitant risk factors (eg cancer, chemotherapy, radiation therapy, intake of glucocorticoid preparations, insufficient oral hygiene), a dental examination with appropriate preventive dental treatment should be performed.

    Patients on bisphosphonate treatment should avoid invasive dental procedures whenever possible. Osteonecrosis of the jaw, usually associated with tooth extraction and / or local infection (including osteomyelitis), has been reported in cancer patients who received bisphosphonates intravenously (many of whom also received chemotherapy and glucocorticosteroid medications). There are reports of the development of osteonecrosis of the jaw in patients with osteoporosis in the background of the use of bisphosphonates inside.

    In patients with osteonecrosis of the jaw and those on bisphosphonate therapy, dental surgical interventions can lead to deterioration. If surgical intervention is necessary, it should be taken into account that there is no data on the possibility of reducing the risk of developing an osteonecrosis of the jaw after the bisphosphonate has been withdrawn.

    The appointments and recommendations of the attending physician should be based on an individual assessment of the benefit / risk ratio for each patient.

    Form release / dosage:Tablets 10 mg and 70 mg.
    Packaging:

    For 10, 30 tablets (for dosages of 10 mg) or 2, 4, 10 tablets (for a dosage of 70 mg) into a contiguous cell pack of a polyvinylchloride film and aluminum foil printed lacquer.

    According to 2, 3, 4, 5 contour cell packs of 2 tablets or 1, 2 contour cell packs of 4 tablets or 1, 3, 6 contiguous cell packs of 10 tablets or 1.2 circuit packs of 30 tablets together with instructions for use put in a pack of cardboard.

    Storage conditions:

    List B. In a dry, the dark place at a temperature of no higher than 25 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-009874/09
    Date of registration:04.12.2009 / 29.02.2012
    Expiration Date:Unlimited
    The owner of the registration certificate:CANONFARMA PRODUCTION, CJSC CANONFARMA PRODUCTION, CJSC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp06.07.2017
    Illustrated instructions
      Instructions
      Up