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

    Each tablet contains:

    Active substance: alendronate sodium trihydrate in an amount equivalent to 70 mg of alendronic acid.

    Excipients: cellulose microcrystalline 216.63, mg, lactose (lactopress) 35.0 mg, carboxymethyl starch sodium (sodium starch glycolate, primogel) 3.5 mg, magnesium stearate 3.5 mg.

    Description:Tablets are round white or almost white in color, flat-cylindrical with a facet and a risk.
    Pharmacotherapeutic group:Bone resorption inhibitor-bisphosphonate
    ATX: & nbsp

    M.05.B.A.04   Alendronic acid

    Pharmacodynamics:

    Alendronate refers to bisphosphonates - compounds that, at the cellular level, are localized primarily in areas of active bone resorption, under osteoclasts. Alendronate does not affect the attachment of osteoclasts, but inhibits their activity, thereby inhibiting the process of bone resorption without directly affecting the education process new bone tissue. During treatment with the drug, normal bone tissue is formed, in the matrix of which alendronate is built. When alendronate is included in the bone matrix, it is pharmacologically inactive, and therefore alendronate must be used continuously to suppress osteoclasts on newly formed resorption surfaces. Treatment with alendronate reduces bone remodeling (i.e., the number of sites in which the bone is remodeled), while osteogenesis at remodeling sites exceeds bone resorption, which leads to an increase in bone mass.

    Pharmacokinetics:

    Suction:

    Bioavailability of alendronic acid in women with fasting intakes at least 2 hours before breakfast at a dose of 70 mg is 0.64%; in men it is 0.6%.At reception for 30-60 mines before meal bioavailability decreases on 40% in comparison with the dose accepted for 2 hours before meal. The bioavailability of alendronic acid is significantly reduced if the drug is taken less than 30 minutes before a meal or liquid, bioavailability is minimal when taken with food or, or within two hours after a meal. Joint intake of alendronic acid with coffee or orange juice reduces its bioavailability by approximately 60%.

    Distribution:

    The average volume of distribution of alendronic acid in an equilibrium state (excluding bone tissue) is at least 28 liters. When you receive therapeutic doses, the concentration of alendronic acid in the blood plasma is negligible (less than 5 ng / ml). The binding of alendronic acid with plasma proteins is approximately 78%.

    Metabolism:

    There is no evidence that alendronic acid is metabolized in humans or animals.

    Excretion:

    After a single intravenous injection of alendronic acid labeled with carbon atoms 14C, approximately 50% is excreted by the kidneys within 72 hours; the excretion of the labeled substance with feces was not determined or was insignificant.After a single intravenous injection of 10 mg of alendronic acid, its renal clearance was 71 ml / min, and the systemic clearance did not exceed 200 ml / min. After 6 hours after intravenous administration, the concentration in the blood plasma is reduced by more than 95%. The final half-life is more than 10 years, which reflects the release of alendronic acid from stagnant tissue.

    Alendronic acid is excreted by the kidneys. A somewhat greater accumulation of alendronic acid in bone tissue can be expected in patients with impaired renal function.

    Indications:Osteoporosis in postmenopausal women (prevention of bone fractures, including hip fractures and compression fractures spine), treatment of osteoporosis in men in order to prevent the occurrence of fractures.
    Contraindications:

    Lesions of the esophagus slowing its emptying, for example, stricture (constriction) or achalasia.

    Inability to stand or sit upright at for 30 minutes after taking the drug. Hypersensitivity to the components of the drug.

    Hypocalcemia, malabsorption of calcium, severe hypoparathyroidism.

    Chronic renal failure (with a clearance of creatinine of less than 35 ml / min, the risk of cumulation of alendronic acid increases).

    Pregnancy and lactation.The drug should not be given to pregnant and lactating women, because this contingent has not been studied.

    Childhood. The drug should not be given to children, since this contingent has not been studied.

    Deficiency of lactase, lactose intolerance, glucose-galactose malabsorption.

    Carefully:

    Apply for diseases of the upper gastrointestinal tract in the phase of exacerbation (dysphagia, esophagitis, gastritis, duodenitis, peptic ulcer disease stomach and duodenum), predisposition to hypocalcemia (mild to moderate hypoparathyroidism, vitamin deficiency D).

    Pregnancy and lactation:Alendronate is contraindicated in pregnant and lactating women.
    Dosing and Administration:

    For the treatment of osteoporosis in women and men, the drug is prescribed in a dose of 70 mg 1 once a week. Alendronate must be taken in the morning, inside, not liquid, preferably for 2 hours, but not less than 30 minutes before the first meal, drinking or taking other medicinal products, with only pure non-mineralized water. Other drinks (including mineral water), food and certain medicines can reduce the absorption of alendronic acid. You can not chew or resorb a tablet in the oral cavity, since there is a risk of ulcers of the oral cavity and pharynx. To facilitate intake into the stomach and, thereby, reduce the irritation of the esophagus, Alendronate should be taken in the morning immediately after lifting from the bed, with a full glass of water. After this, patients should not lie down until the first meal, which should be made at least 30 minutes after taking the drug.

    Alendronate should not be taken in a horizontal position, before going to bed or before rising from bed. Failure to follow these instructions can increase the risk of adverse reactions from the esophagus.

    For the elderly patients and patients with mild and moderate renal insufficiency (creatinine clearance from 35 to 60 ml / min) dose adjustment is not required. Due to the lack of data, alendronate is not recommended for use in patients with more severe renal insufficiency (creatinine clearance <35 mL / min).

    Side effects:

    From the gastrointestinal tract: abdominal pain, indigestion, acidic eructation, nausea, vomiting, constipation, diarrhea, dysphagia, flatulence, gastritis, stomach ulcer, including including peptic ulcer disease,complicated by bleeding (melena), erosion or ulcers of the esophagus, esophagitis, esophageal stricture, esophagus perforation, oropharyngeal ulcer, local osteonecrosis of the jaw associated mainly with previous tooth extraction and / or local infection (including osteomyelitis), often with slow recovery.

    From the musculoskeletal system: myalgia, pain in the bones, pain in the joints, rarely - severe muscle cramps, swelling joints, low-energy fractures of the body of the femur.

    From the nervous system: headache, dizziness, systemic dizziness, a violation of taste.

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

    From the sense organs: uveitis, scleritis, episcleritis.

    Organism as a whole: hypersensitivity reactions, including hives and rarely angioedema, transient symptoms of acute phase reactions at the beginning of treatment (myalgia, malaise, asthenia, rarely fever), hypocalcemia. Rarely, peripheral edema.
    Overdose:In case of an oral overdose, hypocalcemia, hypophosphatemia and side reactions from the upper gastrointestinal tract, such as digestive disorders, heartburn, esophagitis, gastritis, gastric or esophageal ulcers, may occur. For binding alendron acid should be given to drink milk or take calcium-containing antacids. In connection with the risk of irritation of the esophagus, vomiting should not be caused, and the patient should maintain a completely vertical position.
    Interaction:

    Absorption of alendronic acid may be impaired if it is taken concomitantly with calcium preparations (including dietary supplements) and antacids and other oral medications. In this regard, the interval between taking Alendronate and other medications taken orally should be at least 30 minutes. The combined use of hormone replacement therapy with preparations containing estrogen ± progestin and alendronic acid in women with osteoporosis during the menopause for safety and tolerability is comparable to individual treatment with each of these drugs.

    It is known that intravenous administration of ranitidine doubles the bioavailability of alendronic acid in oral administration.

    Non-steroidal anti-inflammatory drugs, including acetylsalicylic acid, can enhance the side effects of alendronic acid from the side gastrointestinal tract.

    Special instructions:

    Alendronic acid, like other bisphosphonates for oral administration, can cause local irritation of the mucosa of the upper gastrointestinal tract. In this regard, it is necessary to use Alendronate with caution in patients with problems of the upper gastrointestinal tract (such as Barrett's esophagus, dysphagia, other diseases of the esophagus, gastritis, duodenitis, or ulcers).

    Patients taking alendronic acid are noted to have such side effects reactions like esophagitis, oesophageal ulcer and erosion of the esophagus, sometimes with bleeding, occasionally leading to the occurrence of strictures or perforation of the esophagus. In some cases, these adverse events can be severe and require hospitalization.

    Therefore, doctors should closely monitor any symptoms, indicating a possible response from the esophagus. Patients should to warn about the need to stop taking Alendronate and consult a doctor in the occurrence of dysphagia, pain when swallowing or behind the sternum, the appearance or intensification of heartburn.

    The risk of severe adverse events on the part of the esophagus is higher in patients who disobey the recommendations for taking the drug: you can not take a horizontal position after using the drug and / or take it without squeezing, according to recommendations, a full glass of water (170 - 230 ml), and / or continue to take it when symptoms of esophageal irritation appear. Patients who can not follow the dosing instructions due to mental illness should Take Alendronate treatment under appropriate control.

    If you miss a regular weekly dose of the drug should take 1 tablet of Alendronate on the next day, in the morning. It is not recommended to take 2 tablets in 1 day. In the future, you should return to taking Alendronate once a week, on the same day of the week that was chosen for taking the drug from the beginning.

    In the presence of hypocalcemia, the level of calcium in the blood should be normalized before treatment with Alendronate. Other disorders of mineral metabolism (eg, vitamin deficiency D) should also be eliminated. In patients with these disorders during treatment with Alendronate, it is necessary to control the content calcium in the serum and symptoms of hypocalcemia. Due to alendronic acid increases the content of mineral substances in the bone tissue, there may be a slight asymptomatic decrease in the concentration, calcium and phosphates in the blood serum, especially with Paget's bone disease, with initially significantly increased metabolic rate of bone tissue, as well as in patients receiving glucocorticoids, which is accompanied by a possible decrease in absorption calcium. It is especially important to ensure adequate intake of calcium and vitamin D in these patients. In rare cases, hypocalcemia can be severe, usually in patients with predisposition to this complication (hypoparathyroidism, vitamin D deficiency, calcium malabsorption).

    Stomatology.

    In patients taking bisphosphonates, including alendronic acid, there were cases of local osteonecrosis of the jaw associated mainly with previous tooth extraction and / or local infection (including osteomyelitis), often with slow recovery. In most cases, local osteonecrosis of the jaw against the background of bisphosphonate reception occurs in cancer patients receiving bisphosphonates intravenously. Risk factors for local osteonecrosis of the jaw include invasive dental procedures (for example, tooth extraction, dental, implants, bone surgery), oncological disease, concomitant therapy (eg chemotherapy, radiation therapy, corticosteroids), poor oral hygiene, concomitant pathologies for example, periodontal disease and / or other diseases teeth / anemia, coagulopathy, infection, improperly seated dentures) and smoking. In patients for whom invasive dental procedures are necessary, discontinuing bisphosphonate treatment may reduce the risk of osteonecrosis of the jaw.When preparing a treatment plan for each patient, it is necessary to follow the clinical judgment of the attending physician. and / or a dental surgeon, taken on the basis of an individual benefit / risk ratio estimate. Patients who developed local osteonecrosis of the jaw during treatment with bisphosphonate should be monitored by a dental surgeon. The condition of these patients can be exacerbated by extensive dental surgery for the treatment of osteonecrosis of the jaw. Consideration should be given to the need to discontinue bisphosphonate therapy, based on an individual benefit / risk ratio estimate.

    Musculoskeletal pain.

    Strong, sometimes disabling pains in the bones, joints and / or muscles of patients taking bisphosphonates (including alendronic acid), prescribed for the treatment of osteoporosis, most of them in women in the post-menopausal period. Symptoms appear between one day and several months after starting the drug. With the development of severe symptoms the drug should be discontinued. Most patients have symptoms after discontinuation of the drug.

    When strong musculoskeletal patient should be inform the doctor about this.

    Atypical susceptible and diaphyseal fractures of the femur.

    There are data on atypical, low-energy, or low-traumatic fractures of the diaphysis of the femur in patients receiving bisphosphonate treatment. Such fractures can be localized anywhere in the femoral diaphysis, from a fracture directly under the small trochanter of the femur to the epicondylar fracture, and are transverse or oblique in the direction without signs of fragmentation. Causal dependence has not been established, as these fractures also occur in patients suffering from osteoporosis who are not receiving bisphosphonate treatment.

    Atypical fractures of the femur often occur with minimal damage to the affected area or in its absence. They can be bilateral, and in many patients there are prodromal pains in the affected area, usually manifested as a dull, aching pain in the thigh, felt for several weeks to months before a complete fracture.In several cases, it was noted that patients also received glucocorticoid therapy at the time of the fracture.

    In all patients receiving Alendronate, with complaints of pain in the thigh or in the groin, it is necessary to exclude an atypical or incomplete fracture of the thigh.

    Patients with an atypical fracture should also be examined for symptoms and signs of fracture in the contralateral limb. Consideration should be given to discontinuing bisphosphonate therapy based on an individual benefit / risk ratio estimate.
    Effect on the ability to drive transp. cf. and fur:There is no information on the effect of alendronic acid on the ability to drive and other mechanisms.
    Form release / dosage:Tablets of 70 mg.
    Packaging:

    For 4 or 10 tablets per contour cell package; 1 contour Packaging together with instructions for medical use are placed in a pack of cardboard.

    For 28 tablets in a can of polymer with a lid. Each bank, together with instructions for medical use, is placed in a cardboard pack.
    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:

    2 years.

    Do not use the product after the expiry date printed on the package.
    Terms of leave from pharmacies:On prescription
    Registration number:LP-000801
    Date of registration:03.10.2011
    The owner of the registration certificate:Berezovsky Pharmaceutical Plant, ZAO Berezovsky Pharmaceutical Plant, ZAO Russia
    Manufacturer: & nbsp
    Information update date: & nbsp16.09.2015
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