Tevabon set of capsules and tablets 1mkg kaps.n28 + 70mg tab. 4 things

Description

Composition
Active substance:
1 tablet contains: Sodium alendronate monohydrate 81.2 mg, which corresponds to the content of alendronic acid 70 mg.
1 capsule contains: alfacalcidol 1 mcg.
Excipients:
1 tablet contains: microcrystalline cellulose, croscarmellose sodium, magnesium stearate.
1 capsule contains: citric acid, propyl gallate, alpha-tocopherol, ethanol, peanut oil, gelatin, glycerol 85%, anidrisorb 85/70 (sorbitol, sorbitan, mannitol, higher polyols, water), titanium dioxide (E171), black ink A10379 (shellac, black iron oxide colorant, denatured ethanol (alcohol methylated), isopropanol, 1-butanol, ethyl acetate).
Description:
A set of tablets and capsules:
Tablets white or almost white, round, flat, bevelled, engraved “T” on one side.
Soft gelatin capsule, oval, white, or nearly white, opaque, labeled “1.0” black ink; Capsule contents – pale yellow oily solution.
Product form:
Tablets and capsules set.
1 tablet and 7 capsules in blisters of aluminum foil; 2, 4 or 12 blisters together with instructions for use in a cardboard package.
Contraindications
Conditions leading down the esophagus promoting food (including stricture or achalasia of the esophagus);
the patient’s inability to stand or sit upright for at least 30 minutes;
hypocalcemia;
hypercalcemia;
Burnett syndrome and / or milk-alkali syndrome (plasma calcium concentration> 2.6 mmol / l, calcium phosphate> 3.7 mmol / l, pH> 7.44);
violation severe renal function (creatinine clearance less than 35 mL / min);
patients on hemodialysis;
hypervitaminosis D;
hyperphosphatemia (except hyperphosphatemia during hypoparathyroidism);
gipermagniemiya;
deficit sucrase / isomaltase, fructose intolerance, glucose malabsorption / galactose;
childhood;
during pregnancy;
lactation (breast feeding);
Hypersensitivity to alendronic acid, alfacalcidol and other ingredients.
Carefully:
in diseases of the gastrointestinal tract in the acute phase, including dysphagia, esophagitis, gastritis, duodenitis, gastric ulcer and duodenal ulcers,
hypoparathyroidism, hypovitaminosis D, calcium malabsorption, nephrolithiasis, atherosclerosis, renal dysfunction (creatinine clearance greater than 35 mL / min)
chronic heart failure, in patients with an increased risk of hypercalcaemia, including leukemia, lymphoma, sarcoidosis, pulmonary tuberculosis (active form).
Dosage
1 g + 70 mg
Indications
Postmenopausal osteoporosis;
osteoporosis caused by the use of corticosteroids.
Interaction with other drugs
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 doses of alendronic acid and other oral medications must be at least 30 minutes.
Combined use of alendronate (but not simultaneous reception) with estrogen drugs, are not accompanied by a change in their actions and the development of side effects.
Receiving oral prednisolone is not accompanied by a clinically significant changes in bioavailability of alendronic acid.
Corticosteroids increases the side effects of alendronate on the gastrointestinal tract.
With simultaneous use of alfacalcidol with cardiac glycosides increases the risk of arrhythmia.
Inductors of microsomal liver enzymes (including phenytoin and phenobarbital) decrease and inhibitors – alfacalcidol increase the concentration in plasma (possibly change its effectiveness).
Suction alfacalcidol reduced by combining it with mineral oil (for a long time), colestyramine, colestipol, sucralfate, antacids, medications based on albumin.
In this connection, not to be taken simultaneously with the capsule alfacalcidol antacids that contain aluminum, the interval between administration of these drugs must be at least 2 hours.
Antacids increases the risk of hypermagnesemia and giperalyuminiemiya. Toxic effects of impaired retinol, tocopherol, ascorbic acid, pantothenic acid, thiamine, riboflavin.
For women in perimenopause effects of alfacalcidol may be exacerbated by estrogens. Calcitonin, derivatives etidronovoy and pamidronic acid, plicamycin and corticosteroids reduce alfacalcidol effect.
Alfacalcidol increases the absorption of phosphorus-containing drugs and the risk of hyperphosphataemia.
Simultaneous use of calcium preparations with alfacalcidol, thiazide diuretics may cause hypercalcemia by raising the calcium absorption in the intestine, increasing its reabsorption in the kidney.
The therapy should not be prescribed alfacalcidol other drugs of vitamin D and its derivatives because of possible additive interaction and increase the risk of hypercalcemia.
Overdose
alendronic acid
Symptoms may hypocalcemia, hypophosphatemia, diarrhea, heartburn, esophagitis, erosive and ulcerative lesions of the gastrointestinal mucosa.
Treatment: receiving milk or antacids to bind alendronic acid. Due to the risk of irritation of the esophagus should not induce vomiting. The patient must be in a vertical position.
alfacalcidol
Early hypervitaminosis symptoms D (due to hypercalcemia): diarrhea, constipation, nausea, vomiting, dry mouth, anorexia, metallic taste in the mouth, hypercalciuria, polyuria, polydipsia, pollakiuria / nocturia, headache, fatigue, weakness, myalgia, pain in bones.
Late symptoms of hypervitaminosis D: dizziness, confusion, drowsiness, heart rhythm disturbance, itchy skin, increased blood pressure, conjunctival hyperemia, nephrolithiasis, weight loss, photophobia, pancreatitis, gastralgia; rarely – change of mind and mood.
Symptoms of chronic intoxication with vitamin D: calcification of soft tissues, blood vessels, and internal organs (kidney, lung), kidney failure, cardiovascular failure, impaired growth in children.
Treatment: stop the drug. In the early stages of acute overdose can have a positive effect designation mineral oil (which helps to reduce absorption and increase alfacalcidol excretion with feces). In severe cases, the hydration is carried out with the introduction of infusion of saline solutions, designate “loop” diuretics, corticosteroids, bisphosphonates, calcitonin, hemodialysis is carried out with the use of solutions with low calcium content. It should control the content of electrolytes in the blood, heart and kidney function (ECG data), especially in patients receiving digoxin. There is no specific antidote.
pharmachologic effect
Pharmacological group:
Osteoporosis treatment agent combined (bone resorption inhibitor + calcium-phosphorus metabolism regulator).
Pharmacodynamics:
A combined preparation for the treatment of osteoporosis.
Alendronic acid, being a bisphosphonate active process inhibits bone resorption caused by osteoclasts without exerting a direct effect on new bone formation. Having tropism for hydroxyapatite bone alendronic acid accumulates predominantly in areas of its active resorption. The mechanism of action is associated with the suppression of functional activity and stimulation of apoptosis of osteoclasts. During therapy with alendronic acid is an increase in bone mineralization, and the improvement of its quality characteristics.
Alfacalcidol – regulator calcium-phosphorus metabolism, a precursor of the active metabolite of vitamin D3 – calcitriol. Increases the absorption of calcium and phosphorus in the intestine, increases their reabsorption in the kidneys, restores a positive calcium balance in the treatment of calcium malabsorption syndrome, reduces blood levels of parathyroid hormone. Acting on both sides of the bone remodeling processes (resorption and synthesis), alfacalcidol not only increase bone mineralization but improves its elasticity by stimulating the synthesis of bone matrix proteins, bone morphogenetic proteins, bone growth factors. When treating alfacalcidol formed bone structure with normal histology, increasing strength of bone tissue in all parts of the skeleton.
Alendronic acid and alfacalcidol increase bone strength, and their synergistic effects due to different mechanisms of action. Inhibition of alendronic acid catabolic processes in the bones of a bone anabolic effect is supplemented alfacalcidol, which leads to the formation of normal bone structure. Due to the pharmacological effects of both substances, the use of them in combination to reduce the potential risk of developing hypocalcemia, hypercalcemia and hypercalciuria. A significant reduction in the risk of fracture is achieved not only by increasing bone strength, but also because vnekostnomu (pleiotropic) alfacalcidol effect – increasing muscle strength, accelerate the speed of muscle reaction.
Pharmacokinetics:
Alendronic acid.
Suction.
When administered on an empty stomach in the dose range of 5 to 70 mg directly for 2 hours before breakfast bioavailability of alendronate in women was 0.64% for men – 0.6%. Bioavailability alendronic acid is reduced by 40% in the fasting state for 1-1.5 hours before breakfast. After consumption of coffee and orange juice reduced bioavailability by approximately 60%. alendronic acid concentration in blood plasma after oral administration in a therapeutic dose is below the determination limit possible (less than 5 ng / ml).
Distribution.
alendronic acid binding to plasma proteins is approximately 78%. Alendronic acid is distributed in soft tissues, and then rapidly redistributed to bone, where it is fixing or eliminated via the kidneys.
Metabolism and excretion.
Not biotransformation.
Excreted unchanged. The process is characterized by a rapid decrease in excretion of alendronic acid concentration in blood plasma and extremely slow release from the bone.
Alfacalcidol.
Suction.
After oral alfacalcidol is rapidly absorbed from the gastrointestinal tract. Cmax is reached after 8-12 hours after a single dose of alfacalcidol. Oral bioavailability is about 100%.
Metabolism.
Pharmacological effects alfacalcidol implemented after its conversion in the body into the calcitriol. Conversion alfacalcidol, calcitriol occurs in the liver through hydroxylation at carbon atom 25, wherein the hydroxylation process occurs very rapidly (has a substrate-dependent manner) and does not depend on the functional state of the liver. The maximum concentration of calcitriol in the body is achieved after 8-12 hours after a single dose of alfacalcidol. Unlike native vitamin D alfacalcidol needs no hydroxylation in the kidneys is therefore effective even in patients with reduced activity of renal 1 alpha-hydroxylase activity (renal failure, advanced age).
Withdrawal.
Calcitriol excreted by the kidneys and liver in about equal proportions, T1 / 2 is about 35 hours.
Pregnancy and breast-feeding
Due to insufficient data on the use of alendronic acid and / or at risk of drug overdose alfacalcidol Tevabon contraindicated in pregnancy and lactation.
Conditions of supply of pharmacies
On prescription.
side effects
Side effects classified in accordance with the following frequency:
very often – more than 10%;
often – more than 1% but less than 10%;
infrequently – more than 0.1% but less than 1%;
rarely – more than 0.01% but less than 0.1%;
very rarely – less than 0.01%, including isolated cases.
In applying alendronic acid
From the digestive system: often – abdominal pain, indigestion, acid regurgitation, diarrhea, dysphagia, flatulence, gastritis, gastric ulcer, ulceration of the mucous membrane of the esophagus; infrequently – nausea, vomiting, constipation, gastritis, esophagitis, esophageal mucosal erosion, melena; rarely – esophageal stricture, ulceration of the mucosa of the oropharynx, esophagus perforation, bleeding of upper gastrointestinal tract (the connection with the reception of alendronic acid is not installed).
On the part of the musculoskeletal system: often – pain in the bones, muscles, joints, muscle cramps; rarely – osteonecrosis of the jaw, mainly in cancer patients treated with bisphosphonates, however, such cases were noted in patients on therapy for osteoporosis; unknown frequency – stress fracture of the proximal femur associated or not associated with an injury.
On the part of metabolism: rarely – a symptomatic hypocalcemia, usually associated with predisposing conditions, hypophosphatemia.
CNS: often – headache.
From the sensory organs: rarely – uveitis, scleritis, episcleritis.
Allergic reactions: seldom – rash, pruritus, erythema; rarely – rash associated with photosensitivity, urticaria, angioneurotic edema; 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 symptoms in the acute phase of the disease (myalgia, malaise, and fever), usually at the beginning of treatment.
In applying alfacalcidol
On the part of metabolism: rarely – hypercalcemia; very rarely – a slight increase in HDL concentrations in the blood plasma. Patients with significant renal dysfunction may develop hyperphosphatemia, heterotopic calcification in the cornea and blood vessels.
From the digestive system: rarely – anorexia, vomiting, heartburn, abdominal pain, nausea, dry mouth, discomfort in the epigastric region, constipation, diarrhea; seldom – a slight increase in liver enzymes in plasma (ALT, AST).
CNS: rarely – weakness, fatigue, dizziness, drowsiness.
With the cardiovascular system: rarely – tachycardia.
On the part of the musculoskeletal system: rarely – moderate pain in the muscles, bones and joints.
Allergic reactions: seldom – skin rash, itching; very rarely – anaphylactic shock in communication with the peanut butter.
Due to the influence multidirectional alendronic acid and alfacalcidol on serum calcium concentrations, use of a combination of these drugs allows to avoid sharp fluctuations in serum calcium concentration.
special instructions
For use of alendronic acid
It is necessary to pay special attention to any signs of adverse reactions in the area of ​​the esophagus. The patient should be informed of the need to stop taking the drug and contact your doctor if you develop dysphagia, pain on swallowing, chest pain, new or worsening heartburn.
In connection with the existing mucosal risk of irritation of the upper GI, as well as worsening of the underlying disease, it is advisable to be careful when administering the drug to patients with diseases of the gastrointestinal tract in an exacerbation phase, such as dysphagia, esophagitis, gastritis, duodenitis, gastric ulcer and duodenal ulcer, and recently transferred (within the previous year), gastrointestinal disorders (gastric ulcer and duodenal ulcer, active bleeding from the gastrointestinal tract, surgical intervention is on top It gastrointestinal except pyloroplasty).
There are reported cases of osteonecrosis of the jaw, generally associated with tooth extraction and / or local infection (including osteomyelitis), in patients with cancer receiving treatment regimens including bisphosphonate (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 bisphosphonate. Prior to use bisphosphonate patients with underlying risk factors (e.g., cancer, chemotherapy, radiation therapy, GCS therapy, insufficient oral hygiene) must undergo dental examination with appropriate preventive dentistry. Patients who are on bisphosphonate treatment, it should be possible to avoid invasive dental procedures. In patients with osteonecrosis of the jaw, are on bisphosphonate therapy, dental surgery may lead to a deterioration. When the need for surgical intervention should be considered that the data on the possibility of reducing the risk of osteonecrosis of the jaw after the abolition of bisphosphonate absent. Appointments and recommendations of the treating physician should be based on an individual assessment of benefit / risk ratio for each patient.
Time of occurrence of pain in the bones, joints and muscles in patients during therapy bisphosphonate ranged from 1 day to several months after starting treatment. In most patients after discontinuation of treatment was a decrease in the severity of pain in some patients, the pain reappeared when resuming therapy with the same or another bisphosphonate.
If the patient has forgotten to take a tablet of alendronate, then it should be taken the next morning. Do not take 2 tablets on the same day, you must continue to take 1 tablet 1 time per week on the day that you have selected to receive from the beginning of treatment.
Patients with hypocalcaemia, hypovitaminosis D and hypoparathyroidism necessary to carry out corrective therapy disorders of mineral metabolism before treatment of alendronic acid. Вследствие положительного воздействия алендроновой кислоты на минеральную плотность костной ткани во время лечения может наблюдаться незначительное бессимптомное снижение концентрации кальция и фосфора в сыворотке крови. Имеются единичные сообщения о симптоматической гипокальциемии, иногда тяжело протекающей, обычно у пациентов с предрасположенностью к ней (например, при гипопаратиреозе, дефиците витамина D, мальабсорбции кальция.
Имеются сообщения о возникновении стресс-переломов проксимального отдела бедренной кости при продолжительном лечении алендроновой кислотой (от 18 месяцев до 10 лет).
Переломы возникали после минимальной травмы или без нее. У некоторых пациентов сначала появлялась боль в проксимальной части бедра, которая сохранялась в течение нескольких недель или даже месяцев, прежде чем этот симптом завершался переломом бедренной кости. Часто переломы были двусторонними, поэтому при переломе одной бедренной кости у пациента необходимо контролировать состояние другой бедренной кости.
У пациентов, принимающих алендроновую кислоту, особенно при сопутствующей терапии ГКС, крайне важно обеспечить достаточное поступление в организм кальция и витамина D с пищей или в виде лекарственных препаратов.
Абсорбция бисфосфанатов значительной степени снижается при одновременном приеме пищи.
Для применения альфакальцидола
Альфакальцидол может усиливать гиперкальциемию и/или гиперкальциурию при его назначении пациентам с заболеванием, связанным с неконтролируемой гиперпродукцией кальцитриола (например, при лейкозе, лимфоме, саркоидозе), а также может усиливать гиперфосфатемию. При концентрации кальция в плазме более 2.6 ммоль/л необходимо исключить прием других содержащих кальций препаратов. При отсутствии эффекта следует прекратить прием капсул альфакальцидола до нормализации концентрации кальция в сыворотке крови (2.2-2.6 ммоль/л). Контроль концентрации кальция и фосфатов в крови проводят до лечения альфакальцидолом и при необходимости проводят корригирующую терапию. При лечении альфакальцидолом концентрацию электролитов в начале определяют 1 раз в неделю, при достижении Cmax и в течение всего периода лечения – каждые 3-5 нед, а также контролируют активность щелочной фосфатазы (при нарушении функции почек (КК более 35 мл/мин) – еженедельный контроль). Арахисовое масло в редких случаях может вызывать тяжелые аллергические реакции. Пациентам с наследственной непереносимостью фруктозы или мальабсорбцией фруктозы не следует назначать препарат Тевабон, поскольку в набор входят капсулы альфакальцидола, содержащие сорбитол.
Effects on ability to drive vehicles and management mechanisms.
В связи с возможностью развития побочного действия со стороны ЦНС в период лечения необходимо соблюдать осторожность при вождении автотранспорта, а также при других потенциально опасных видах деятельности, требующих повышенной концентрации внимания и быстроты психомоторных реакций.
Storage conditions
Препарат следует хранить в недоступном для детей месте при температуре не выше 25 С.
Dosing and Administration
Препарат Тевабон состоит из двух лекарственных форм: таблеток алендроновой кислоты и капсул альфакальцидола.
Для обеспечения нормального всасывания и снижения риска развития побочных реакций следует строго соблюдать рекомендации по применению и дозированию.
Алендроновая кислота.
Назначают внутрь по 1 таблетке (70 мг) 1 раз в неделю, запивая стаканом воды, не менее чем за 30 мин до первого приема пищи, напитков или других лекарственных средств. Запивают только обычной водой, поскольку другие напитки (включая минеральную воду), пищевые продукты и некоторые лекарственные средства могут снижать биодоступность алендроновой кислоты. Таблетки нельзя разжевывать или рассасывать.
После приема таблетки пациент должен сохранять вертикальное положение (стоя или сидя) в течение не менее 30 мин. Нельзя принимать таблетку перед сном или до утреннего подъема с постели.
Older patients a dose adjustment is required.
При нарушениях функции почек ( КК > 35 мл/мин)- коррекции дозы не требуется.
Альфакальцидол.
Назначают внутрь по 1 капс. (1 мкг) 1 раз/ вечером ежедневно. Капсулы следует проглатывать целиком, запивая достаточным количеством жидкости.
Препарат Тевабон предназначен для длительного применения.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist