Description
Latin name
Tevabon
Release form
Set of tablets and capsules.
packaging 12 tablets, 84 capsules
Pharmacological action
Tevabon – a set of tablets and capsules. Alendronic acid, being a bisphosphonate (BP), inhibits the process of active bone resorption caused by osteoclasts, without directly affecting the formation of new bone tissue. Having tropism for bone hydroxyapatite, alendronic acid accumulates mainly in areas of its active resorption. The mechanism of action is associated with the suppression of functional activity and the stimulation of apoptosis of osteoclasts. Against the background of alendronic acid therapy, there is an increase in bone mineralization and an improvement in its quality characteristics. Alfacalcidol is a regulator of calcium-phosphorus metabolism, and the precursor of the active metabolite of vitamin D 3 is 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 the concentration of parathyroid hormone in the blood. Acting on both parts of the bone remodeling process (resorption and synthesis), alfacalcidol not only increases bone mineralization, but also increases its elasticity by stimulating the synthesis of bone matrix proteins, bone morphogenetic proteins, bone growth factors. In the treatment with alfacalcidol, a bone with a normal histological structure is formed, bone strength increases in all parts of the skeleton. Alendronic acid and alfacalcidol increase bone strength, while their effects are synergistic, thanks to various mechanisms of action. Inhibition of catabolic processes in bones by alendronic acid is supplemented by the bone anabolic effect of alfacalcidol, which leads to the formation of a normal bone structure. Due to the pharmacological effects of both substances, their use in combination can reduce the potential risk of developing hypocalcemia, hypercalcemia and hypercalciuria. A significant reduction in fracture risk is achieved not only by increasing bone strength, but also due to the extra-bone (pleiotropic) effect of alfacalcidol – an increase in muscle strength, acceleration of the speed of muscle reaction.
Indications
Postmenopausal osteoporosis.
Osteoporosis caused by the use of glucocorticosteroid drugs.
Contraindications
Hypersensitivity to alendronic acid, alfacalcidol and other components of the drug.
– Conditions that slow down the movement of food through the esophagus (including strictures or achalasia of the esophagus).
– The patient’s inability to stand or sit upright for at least 30 minutes.
– Hypocalcemia.
– Hypercalcemia.
– Burnett’s syndrome and / or milk-alkaline syndrome (plasma calcium concentrations of more than 2.6 mmol / l, calcium phosphate more than 3.7 (mmol / l) 2, pH more than 7.44).
– Severe renal impairment (creatinine clearance (CC) less than 35 ml / min).
– Patients on hemodialysis.
– Hypervitaminosis D.
– Hyperphosphatemia (with the exception of hyperphosphatemia with hypoparathyroidism).
– Hypermagnesemia.
– Sucrose / isomaltase deficiency.
– Fructose Intolerance.
– Glucose-galactose malabsorption.
– Children’s age.
– The period of pregnancy and breastfeeding.
Precautions:
Gastrointestinal diseases in the acute phase, including: – Dysphagia.
– Esophagitis.
– Gastritis.
– Duodenitis.
– Peptic ulcer of the stomach and duodenum.
Use during pregnancy and lactation
Due to insufficient data on the use of alendronic acid and / or the risk of an overdose of alfacalcidol, the drug Tevabon is contraindicated during pregnancy and during breastfeeding.
Composition of
1 tablet contains: Sodium alendronate monohydrate 81.2 mg, Which corresponds to 70 mg of alendronic acid
Excipients: Microcrystalline cellulose, croscarmellose sodium, magnesium
stearate 1 capsule: Alfacal Citric acid, propyl gallate, alpha-tocopherol, ethanol, peanut butter, gelatin, glycerol 85%, anidrisorb 85/70 (sorbitol, sorbitan, mannitol, higher polyols, water), titanium dioxide E171, black ink A10379 (shellac, iron dye oxide the black, denatured ethanol (methylated alcohol), isopropanol, 1-butanol, ethyl acetate)
Dosage and Administration
Inside. The drug Tevabon consists of two dosage forms: alendronic acid tablets and alfacalcidol capsules. To ensure normal absorption and reduce the risk of adverse reactions, the recommendations for use and dosage should be strictly observed. Alendronic acid – 1 tablet (70 mg) once a week, washed down with a glass of water, not less than 30 minutes before the first meal, drinks or other medicines. It is washed down with plain water only, since other drinks (including mineral water), foodstuffs and certain medicines can reduce the bioavailability of alendronic acid. Do not chew or dissolve tablets. After taking the pill, the patient should maintain an upright position (standing or sitting) for at least 30 minutes. You can not take the pill before bedtime or before the morning rise from bed. Elderly patients do not need dose adjustment. With renal insufficiency, more than 35 ml / min dose adjustment is not required. Alfacalcidol – 1 capsule (1 μg) once a day in the evening every day. Capsules should be swallowed whole with a sufficient amount of liquid. The drug Tevabon is intended for prolonged use
Side effects
Side effects are classified according to the following frequency: very often – 10% often – 1%, but <10% infrequently - 0.1%, but <1% rarely - 0.01%, but <0.1% very rarely - <0.01%, including isolated cases. When using alendronic acid From the digestive system: often – abdominal pain, dyspepsia, sour belching, diarrhea, dysphagia, flatulence, gastritis, gastric ulcer, ulceration of the esophagus, often nausea, vomiting, constipation, gastritis, gastritis, gastritis, gastritis esophagus membranes, melena rarely – stricture of the esophagus, ulceration of the mucous membrane of the oropharynx, perforation of the esophagus, bleeding from the upper gastrointestinal tract (a connection with the intake of alendronic acid has not been established). From the musculoskeletal system: often – pain in bones, muscles, joints, muscle cramps rarely – osteonecrosis of the jaw, mainly in cancer patients taking bisphosphonates, however, similar cases were noted in patients undergoing treatment osteoporosis unknown frequency – stress fracture of the proximal femur, associated or not associated with trauma. From the side of metabolism: rarely – symptomatic hypocalcemia, usually associated with predisposing conditions, hypophosphatemia. From the side of the central nervous system: often – headache. On the part of the sensory organs: rarely – uveitis, scleritis, episcleritis. Allergic reactions: infrequently – rash, itching, erythema rarely – photosensitization rash, urticaria, angioedema very rare – 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 fever), usually at the beginning of treatment. When using alfacalcidol From the side of metabolism: rarely – hypercalcemia is very rare – a slight increase in the concentration of HDL in the blood plasma. In patients with severe renal impairment, hyperphosphatemia, heterotopic calcifications in the cornea of the eye and blood vessels are possible. From the digestive system: infrequently – anorexia, vomiting, heartburn, abdominal pain, nausea, dry mouth, discomfort in the epigastric region, constipation, diarrhea rarely – a slight increase in the activity of liver enzymes in plasma (ALT, AST). From the side of the central nervous system: rarely – weakness, fatigue, dizziness, drowsiness. From the cardiovascular system: rarely – tachycardia. From the musculoskeletal system: infrequently – moderate pain in the muscles, bones, joints. Allergic reactions: rarely – skin rash, itching very rarely – anaphylactic shock, associated with peanut butter. Due to the multidirectional effect of alendronic acid and alfacalcidol on the concentration of calcium in the blood serum, the use of a combination of these drugs avoids sharp fluctuations in the concentration of calcium in the serum. Overdose Alendronic acid: Symptoms: possible hypocalcemia, hypophosphatemia, diarrhea, heartburn, esophagitis, erosive and ulcerative lesions of the gastrointestinal mucosa. Treatment: administration of milk or antacid for alendronic acid binding. Because of the risk of esophageal irritation, no vomiting should be caused. The patient should be upright. Alfacalcidol: Symptoms: hypervitaminosis D, early symptoms (caused by hypercalcemia) diarrhea, constipation, nausea, vomiting, dry mouth, anorexia, metallic taste in the mouth, hypercalciuria, polyuria, polydipsia, pollukia, polydipsia , myalgia, bone pain. Late symptoms of hypervitaminosis D: dizziness, confusion, drowsiness, cardiac arrhythmias, skin itching, increased blood pressure, conjunctival hyperemia, nephrolithiasis, weight loss, photophobia, pancreatitis, and gastralgia are rare – mood changes. Symptoms of chronic intoxication with vitamin D: calcification of soft tissues, blood vessels and internal organs (kidneys, lungs), kidney failure, cardiovascular failure, growth disorders in children. Treatment: cancel the drug. In the early stages of acute overdose, the appointment of mineral oil (which helps to reduce the absorption and increase the excretion of alfacalcidol with feces) can have a positive effect. In severe cases, hydration is performed with the introduction of infusion saline solutions, appoint “loop” diuretics, glucocorticosteroid drugs (GCS), bisphosphonates, calcitonin, conduct hemodialysis with the use of solutions with low calcium content. The electrolyte content of the blood, the function of the kidneys and the heart (according to ECG data) should be monitored, especially in patients receiving digoxin. There is no specific antidote. Storage conditions Store at a temperature not exceeding 25C. Expiration Tablets – 2.5 years, capsules – 3 years. Active ingredient alendronic acid, alfacalcidol set Conditions of supply of pharmacies Prescription dosage form dosage form capsules Teva Pharmaceutical Enterprise Co., Ltd., Israel
