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

    1 tablet contains:

    active substance alendronic acid (alendronate sodium monohydrate) 70 (81.2) mg;

    Excipients: cellulose microcrystalline 113.8 mg, croscarmellose sodium 3.0 mg, magnesium stearate 2.0 mg.

    Description:White or almost white flat round tablets with a facet and an engraving "T" on one side.
    Pharmacotherapeutic group:Bone resorption inhibitor-bisphosphonate
    ATX: & nbsp

    M.05.B.A.04   Alendronic acid

    Pharmacodynamics:

    Alendronic acid acts as a specific inhibitor of osteoclast-mediated bone resorption, lowers the activity of osteoclasts, inhibits the resorption of bone tissue. Restores a positive balance between resorption and bone repair. Increases the mineral density of the bones of the spine and other bones of the skeleton, promotes the formation of bone tissue with a normal histological structure.

    Pharmacokinetics:

    Suction. When administered on an empty stomach in the dose range from 5 to 70 mg immediately after 2 hours before breakfast, the bioavailability of alendronic acid in women is 0.64%, in men it is 0.6%. The bioavailability of alendronic acid decreases by 40% when administered on an empty stomach for 1-1.5 h before breakfast. After consuming coffee and orange juice, bioavailability is reduced by about 60%. The concentration of alendronic acid in the blood plasma after oral administration at the therapeutic dose is below the possible detection limit (less than 5 ng / ml).

    Distribution. The binding of alendronic acid with plasma proteins is about 78%. Alendronic acid distributed into soft tissues,and then quickly redistributed into the bone, where it is fixed, or is excreted through the kidneys.

    Metabolism. Not subject to biotransformation.

    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.

    Indications:

    Postmenopausal osteoporosis (reduced risk of compression fractures of the spine and fractures of the femoral neck).

    Contraindications:

    Hypersensitivity to alendronic acid and other components of the drug; hypocalcemia; conditions that lead to a slowing of food movement along the esophagus (including stricture or achalasia of the esophagus); the patient's inability to stand or sit for at least 30 minutes; severe renal failure (creatinine clearance (CK) less than 35 ml / min); severe disturbances in mineral metabolism; childhood; period of pregnancy and breastfeeding.

    Carefully:Diseases of the gastrointestinal tract (GIT) in the phase of exacerbation (including dysphagia, gastroesophageal reflux disease, Barrett's esophagus, gastritis, duodenitis, peptic ulcer and duodenal ulcer), hypovitaminosis D.
    Pregnancy and lactation:Due to insufficient data on the use of alendronic acid, Tevanat® is contraindicated in pregnancy and during breastfeeding.
    Dosing and Administration:

    To ensure normal absorption and reduce the risk of adverse reactions, the recommendations for use and dosage should be strictly observed.

    Inside 1 tablet (70 mg) 1 time a week, with a glass of water, at least 30 minutes before the first meal, drinks or other medicines. Drink only with ordinary water, since other beverages (including mineral water), foods and some medicines can reduce the bioavailability of Tevanat®. Tablets can not be chewed or rassasyvat.

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

    Elderly patients. Correction of the dose is not required.

    Renal failure. With QC more than 35 ml / min dose adjustment is not required.
    Side effects:

    The incidence of side effects is classified according to the recommendations of the World Health Organization: very often - not less than 10%; often - not less than 1%, but less than 10%; infrequently - not less than 0,1%,but less than 1%; rarely - not less than 0.01%, but less than 0.1%; very rarely - less than 0.01%.

    From the gastrointestinal tract: often - abdominal pain; dyspepsia; sour belch; diarrhea; constipation; dysphagia; flatulence; gastritis; stomach ulcer; ulceration of the mucosa of the esophagus; infrequently - nausea, vomiting, gastritis, esophagitis, erosion of the esophagus mucosa; stomach ulcer, including peptic ulcer, complicated by bleeding (melena); rarely - stricture of the esophagus, ulceration of the mucous membrane of the oropharynx, perforation of the esophagus, bleeding from the upper sections of the gastrointestinal tract (no connection with alendronic acid).

    From the musculoskeletal system: often - pain in the bones, muscles, joints, convulsions; rarely - osteonecrosis of the jaw, mainly in cancer patients who took bisphosphonates, however, similar cases were observed in patients undergoing therapy for osteoporosis; unknown frequency - stress fracture of the proximal femur, connected or unrelated to trauma.

    From the side of metabolism: rarely symptomatic hypocalcemia, usually associated with predisposing conditions, hypophosphataemia.

    From the central nervous system (CNS): often a headache, dizziness, a violation of taste.

    From the sense organs: rarely - uveitis, scleritis, episcleritis.

    Allergic reactions: infrequent - rash, itching, erythema; rarely - a rash associated with photosensitivity, urticaria, angioedema; very rarely - severe skin reactions, including erythema multiforme exudative (Stevens-Johnson syndrome) and toxic epidermal necrolysis (Lyell's syndrome).

    Other: rarely - transient symptoms similar to those in the acute phase of the disease (myalgia, malaise and rarely fever), usually at the beginning of the treatment.

    Overdose:

    Symptoms: possible hypocalcemia, hypophosphatemia, diarrhea, heartburn, esophagitis, erosive and ulcerative lesions of the mucous membrane of the gastrointestinal tract.

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

    Interaction:

    When simultaneous administration with food, beverages containing calcium (including mineral water), nutritional supplements, antacids, and other drugs for oral administration may malabsorption alendronic acid.

    In this regard, the interval between taking alendronic acid and other oral preparations should be at least 30 minutes.

    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.

    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 emergence of side effects. reactions in the esophagus. The patient should be informed of the possible risk of damage to the mucous membrane of the esophagus if the instructions for use are not complied with and the need to stop taking Tevant® and contact a doctor for dysphagia, pain when swallowing, chest pain, or the appearance or intensification of heartburn.

    In connection with the existing risk of irritation of the mucous membrane of the upper part of the gastrointestinal tract, as well as aggravation of the course of the underlying disease,caution should be exercised when prescribing Tevant® to patients with gastrointestinal disorders in the exacerbation phase, including dysphagia, gastroesophageal reflux disease, gastritis, duodenitis, peptic ulcer and duodenal ulcer, and recent (during the previous year) gastrointestinal diseases (ulcerative stomach and duodenal ulcers, active bleeding from the digestive tract, surgical intervention in the upper gastrointestinal tract, except pyloroplasty).

    In patients with Barrett's esophagus, therapy with Tevanat® should be started only after a thorough assessment of the relationship between the intended benefit and the possible risk of esophageal cancer.

    There are reports of cases of osteonecrosis of the jaw, usually associated with tooth extraction and / or local infection (including osteomyelitis), in patients with oncological diseases receiving treatment regimens including bisphosphonates (BF) (primarily intravenous). Many of these patients also received chemotherapy and corticosteroids. There are also reports of osteonecrosis of the jaw in patients with osteoporosis receiving oral bisphosphonates.Prior to the use of bisphosphonates, patients with concomitant risk factors (eg, cancer, chemotherapy, radiation therapy, corticosteroid therapy, insufficient oral hygiene) should undergo dental examination with appropriate preventive dental treatment. Patients in the treatment of BF should, whenever possible, avoid invasive dental procedures. In patients with osteonecrosis of the jaw, who are on therapy with BF, dental surgical interventions can lead to deterioration. If it is necessary to perform surgical interventions, 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 abolition of the BF. The appointments and recommendations of the attending physician should be based on an individual assessment of the benefit / risk ratio for each patient.

    If the patient forgot to take the Tevanat® pill, then it should be taken the next morning. Do not take two tablets in one day, you need to continue taking 1 tablet once a week on the day that was chosen for admission from the beginning of treatment.

    In patients with hypocalcemia, hypovitaminosis D and hypoparathyroidism, it is necessary to carry out corrective therapy of mineral metabolism disorders before the beginning of treatment with Tevanat®. Due to the positive effect of alendronic acid on bone mineral density during treatment, there may be a slight asymptomatic decrease in the concentration of calcium and phosphorus in the blood serum. There are isolated reports of symptomatic hypocalcemia, sometimes severe, usually in patients with a predisposition to it (eg, hypoparathyroidism, vitamin deficiency D, malabsorption of calcium).

    There are reports of stress fractures in the proximal femur with prolonged treatment with Tevanat®. (from 18 months to 10 years). Fractures occurred after minimal injury or without it. Some patients initially experienced pain in the proximal part of the thigh that persisted for several weeks or even months before the symptom ended with a fracture of the femur. Often fractures were bilateral, so when fracture of one femur in the patient, it is necessary to monitor the condition of the other femur.

    In patients taking Tevanat ®, especially with concomitant therapy with glucocorticosteroid drugs, it is extremely important to ensure sufficient intake of calcium and vitamin D with food or in the form of medicines.

    Absorption of BF is significantly reduced with simultaneous intake of food.
    Effect on the ability to drive transp. cf. and fur:Effects on the ability to manage transport and work with technology associated with an increased risk of injury, not noted.
    Form release / dosage:Tablets of 70 mg.
    Packaging:

    For 4 tablets in a blister of PVC / PVDC / aluminum foil.

    1 or 3 blisters together with instructions for use in a cardboard bundle.

    Storage conditions:

    At a temperature of no higher than 30 ° C.

    Keep out of the reach of children.

    Shelf life:

    3 years.

    Do not use after the expiration date printed on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:LS-002267
    Date of registration:18.11.2011
    The owner of the registration certificate:Teva Pharmaceutical Enterprises Co., Ltd.Teva Pharmaceutical Enterprises Co., Ltd. Israel
    Manufacturer: & nbsp
    Representation: & nbspTeva Teva Israel
    Information update date: & nbsp16.09.2015
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