Tevabon
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Clinical Pharmacology
TEVABON - a combined drug for the treatment of osteoporosis.
Alendronic acid, being a bisphosphonate, inhibits the process of active resorption of bone tissue caused by osteoclasts, without having a direct effect on the formation of new bone tissue. Having a tropic to hydroxyapatite bone, alendronic acid accumulates mainly in the areas of its active resorption. The mechanism of action is associated with the suppression of functional activity and the stimulation of osteoclast apoptosis. During therapy with alendronic acid, bone mineralization increases and its quality characteristics improve.
Alfacalcidol is a regulator of calcium-phosphorus metabolism, the precursor of the active metabolite of vitamin D3 - calcitriol. Increases the absorption of calcium and phosphorus in the intestines, increases their reabsorption in the kidneys, restores the positive calcium balance in the treatment of calcium malabsorption, reduces the concentration of parathyroid hormone in the blood. By acting on both parts of the bone remodeling process (resorption and synthesis), alfacalcidol not only increases the mineralization of bone tissue, but also increases its elasticity by stimulating the synthesis of proteins of the bone matrix, bone morphogenetic proteins, and bone growth factors. In the treatment with alfacalcidol, a bone with a normal histological structure is formed, the strength of bone tissue 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 alendronic acid catabolic processes in the bones is complemented 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 reduces the potential risk of hypocalcemia, hypercalcemia and hypercalciuria. A significant reduction in the risk of fractures is achieved not only by increasing the strength of the bone, but also due to the extra-bone (pleiotropic) effect of alfacalcidol — an increase in muscle strength, and an acceleration of the speed of the muscle response.
Indications
- postmenopausal osteoporosis;
- osteoporosis caused by the use of corticosteroids.
Composition
Pills
Sodium alendronate monohydrate
Excipients: microcrystalline cellulose, croscarmellose sodium, magnesium stearate.
Capsules
Alfacalcidol
Excipients: citric acid, propyl gallate, α-tocopherol, ethanol, peanut oil, gelatin, glycerol 85%, anidribsor 85/70 (sorbitol, sorbitan, mannitol, higher polyols, water), titanium dioxide (E171), black ink A10379 (shellac, iron dye black oxide, denatured ethanol (methylated alcohol), isopropanol, 1-butanol, ethyl acetate).
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Dosage and Administration
The drug Tevabon consists of two dosage forms: alendronic acid pills and alfacalcidol capsules.
To ensure normal absorption and reduce the risk of adverse reactions should strictly follow the recommendations for use and dosing.
Alendronic acid
Assign inside of 1 tab. (70 mg) once a week with a glass of water, at least 30 minutes before the first meal, drink or other medicines. They wash down only with ordinary water, since other beverages (including mineral water), food products, and some medicines may decrease the bioavailability of alendronic acid. pills can not be chewed or rassasyvat.
After taking the pill, the patient must maintain a vertical position (standing or sitting) for at least 30 minutes. You can not take a pill before bedtime or until the morning rise from the bed.
Dose adjustment is not required to elderly patients.
With impaired renal function QC> 35 ml / min, dose adjustment is not required.
Alfacalcidol
Assign the inside of 1 caps. (1 mcg) 1 time per day in the evening daily. Capsules should be swallowed whole, washed down with a sufficient amount of liquid.
The drug Tevabon intended for prolonged use.
Adverse reactions
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
On the part of the digestive system: often - abdominal pain, dyspepsia, sour belching, diarrhea, dysphagia, flatulence, gastritis, gastric ulcer, ulceration of the esophageal mucosa; infrequently - nausea, vomiting, constipation, gastritis, esophagitis, erosion of the esophageal mucosa, melena; rarely - esophageal stricture, ulceration of the mucous membrane of the oropharynx, esophageal perforation, bleeding from the upper gastrointestinal tract (connection with the administration of alendronic acid has not been established).
From the musculoskeletal system: often - pain in the bones, muscles, joints, muscle cramps; 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, associated or not associated with injury.
On the part of the metabolism: rarely - symptomatic hypocalcemia, usually associated with predisposing conditions, hypophosphatemia.
From the side of the central nervous system: often - a headache.
From the senses: rarely - uveitis, scleritis, episcleritis.
Allergic reactions: rarely - rash, itching, erythema; rarely, photosensitization rash, 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 fever), usually at the beginning of treatment.
When using alfacalcidol
Metabolism: rarely - hypercalcemia; very rarely - a slight increase in the concentration of HDL in the blood plasma. In patients with severe impaired renal function, hyperphosphatemia may develop, heterotopic calcifications in the cornea and blood vessels.
On the part of the digestive system: rarely - anorexia, vomiting, heartburn, abdominal pain, nausea, dry mouth, feeling of discomfort in the epigastric region, constipation, diarrhea; rarely - a slight increase in liver enzyme activity in plasma (ALT, AST).
From the side of the central nervous system: rarely - weakness, fatigue, dizziness, drowsiness.
Since 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 effects of alendronic acid and alfacalcidol on serum calcium concentration, the use of a combination of these drugs avoids sharp fluctuations in serum calcium concentration.
Contraindications
- conditions leading to slower movement of food through the esophagus (including strictures or achalasia of the esophagus);
- inability of the patient to stand or sit upright for at least 30 minutes;
- hypocalcemia;
- hypercalcemia;
- Burnett syndrome and / or milk-alkaline syndrome (plasma calcium concentration> 2.6 mmol / l, calcium phosphate> 3.7 mmol / l, pH> 7.44);
- impaired renal function severe (CC <<35 ml="" min="" br="">
- patients on hemodialysis;
- hypervitaminosis D;
- hyperphosphatemia (with the exception of hyperphosphatemia in hypoparathyroidism);
- hypermagnesium;
- deficiency of sucrase / isomaltase, fructose intolerance, glucose / galactose malabsorption;
- childhood;
- the period of pregnancy;
- lactation period (breastfeeding);
- Hypersensitivity to alendronic acid, alfacalcidol and other components of the drug.
Drug interactions
When taken simultaneously with food, drinks containing calcium (including mineral water), food additives, antacids and other drugs for oral administration, absorption of alendronic acid may be impaired. In this regard, the interval between taking alendronic acid and other oral medications should be at least 30 minutes.
The combined use of alendronic acid (but not simultaneous use) with estrogen preparations is not accompanied by a change in their action and the development of side effects.
Intake of prednisolone is not accompanied by clinically significant changes in the bioavailability of alendronic acid.
GCS enhance the side effect of alendronic acid on the gastrointestinal tract.
With the simultaneous use of alfacalcidol with cardiac glycosides increases the risk of arrhythmias.
Inductors of liver microsomal enzymes (including phenytoin and phenobarbital) reduce, and inhibitors increase the concentration of alfacalcidol in plasma (possibly changing its effectiveness).
Absorption of alfacalcidol decreases when it is combined with mineral oil (for a long time), colestiramine, colestipol, sucralfate, antacids, and albumin-based preparations.
In this regard, do not take alfacalcidol capsules simultaneously with antacids containing aluminum, the interval between taking these medicines should be at least 2 hours.
Acceptance of antacids increases the risk of hypermagneemia and hyperaluminiemia. Toxic effect weaken retinol, tocopherol, ascorbic acid, pantothenic acid, thiamine, riboflavin.
In perimenopausal women, the effect of alfacalcidol may be enhanced by estrogen. Calcitonin, derivatives of etidronic and pamidronic acids, plicamycin and corticosteroids reduce the effect of alfacalcidol.
Alfacalcidol increases the absorption of phosphorus-containing drugs and the risk of hyperphosphatemia.
The simultaneous use of alfacalcidol with calcium preparations, thiazide diuretics can cause hypercalcemia, by increasing the absorption of calcium in the intestines, increasing its reabsorption in the kidneys.
During therapy with alfacalcidol, it is not necessary to prescribe other drugs of vitamin D and its derivatives because of the possible additive interaction and an increased risk of hypercalcemia.
Special instructions
For the use of alendronic acid
Special attention should be paid to any signs of adverse reactions in the esophagus.The patient should be informed about the need to discontinue the drug and see a doctor when developing dysphagia, pain when swallowing, pain behind the sternum, appearance or strengthening of heartburn.
In connection with the existing risk of irritation of the mucous membrane of the upper GI tract, as well as aggravation of the underlying disease, it is recommended to be careful when prescribing the drug to patients with gastrointestinal diseases in the acute phase, such as dysphagia, esophagitis, gastritis, duodenitis, peptic ulcer and duodenal ulcer, and also recently transferred (during the previous year) diseases of the gastrointestinal tract (gastric ulcer and duodenal ulcer, active bleeding from the gastrointestinal tract, surgery to the top his department of the digestive tract, except for pyloroplasty).
Cases of osteonecrosis of the jaw, usually associated with tooth extraction and / or local infection (including osteomyelitis), have been reported in cancer patients receiving treatment regimens that include bisphosphanates (primarily intravenous). Many of these patients also received chemotherapy and SCS. Osteonecrosis of the jaw has also been reported in patients with osteoporosis receiving oral bisphosphanates. Patients with concomitant risk factors (for example, cancer, chemotherapy, radiation therapy, GCS therapy, and poor oral hygiene) must be undergoing a dental examination with appropriate preventive dental treatment before using bisphosphonates. Patients undergoing treatment with bisphosphonates should avoid invasive dental procedures as much as possible. In patients with osteonecrosis of the jaw, being treated with bisphosphonates, dental surgery can lead to a deterioration. If necessary, surgical interventions should be borne in mind that data on the possibility of reducing the risk of osteonecrosis of the jaw after the abolition of bisphosphonates are not available. Appointments and recommendations of the attending physician should be based on an individual assessment of the benefit / risk ratio for each patient.
The time of appearance of pain in bones, joints and muscles in patients during therapy with bisphosphonates varied from 1 day to several months after the start of treatment. In the majority of patients, after the cessation of treatment, pain was reduced, in some patients pain reappeared when therapy with the same or another bisphosphonate was resumed.
If the patient forgot to take a pill of alendronic acid, then it should be taken the next morning. Do not take 2 tab. on one day, you must continue to take 1 tab. Once a week on the day that was selected for admission from the very beginning of treatment.
In patients with hypocalcemia, hypovitaminosis D and hypoparathyroidism, it is necessary to carry out corrective therapy of disorders of mineral metabolism prior to the start of treatment with alendronic acid. Due to the positive effects of alendronic acid on bone mineral density during treatment, a slight asymptomatic decrease in serum calcium and phosphorus concentrations may be observed. There are isolated reports of symptomatic hypocalcemia, sometimes severe, usually in patients with a predisposition to it (for example, in hypoparathyroidism, vitamin D deficiency, calcium malabsorption.
There are reports of the occurrence of stress fractures of the proximal femur with long-term treatment with alendronic acid (from 18 months to 10 years).
Fractures occurred with or without minimal injury. Some patients first had pain in the proximal femur, which persisted for several weeks or even months before this symptom ended with a fracture of the femur.Often the fractures were bilateral, so when a fracture of one femur in a patient is necessary to monitor the condition of the other femur.
In patients taking alendronic acid, especially with concomitant therapy of corticosteroids, it is extremely important to ensure adequate intake of calcium and vitamin D with food or in the form of drugs.
The absorption of bisphosphonates decreases significantly with simultaneous ingestion of food.
For the use of alfacalcidol
Alfacalcidol may intensify hypercalcemia and / or hypercalciuria when prescribed to patients with a disease associated with uncontrolled calcitriol hyperproduction (for example, in case of leukemia, lymphoma, sarcoidosis), and may also increase hyperphosphatemia. When plasma calcium concentration is more than 2.6 mmol / l, it is necessary to exclude the use of other calcium-containing drugs. If there is no effect, stop taking alfacalcidol capsules until normalization of serum calcium concentration (2.2-2.6 mmol / l). Control of the concentration of calcium and phosphate in the blood is carried out before treatment with alfacalcidol and, if necessary, carry out corrective therapy. In the treatment with alfacalcidol, the concentration of electrolytes at the beginning is determined once a week, when Cmax is reached and during the entire treatment period - every 3-5 weeks, and alkaline phosphatase activity is controlled (in case of impaired renal function (CC more than 35 ml / min) - weekly control). Peanut butter in rare cases can cause severe allergic reactions. Patients with hereditary fructose intolerance or fructose malabsorption should not be prescribed Tevabon, since the kit contains alfacalcidol capsules containing sorbitol.
Influence on ability to drive motor transport and control mechanisms
In connection with the possibility of side effects from the central nervous system during the period of treatment, care must be taken when driving vehicles, as well as other potentially hazardous activities that require increased concentration and psychomotor speed.
Overdosage
Alendronic acid
Symptoms: hypocalcemia, hypophosphatemia, diarrhea, heartburn, esophagitis, erosive and ulcerative lesions of the gastrointestinal mucosa are possible.
Treatment: taking milk or antacid to bind alendronic acid. Due to the risk of irritation of the esophagus should not induce vomiting. The patient should be upright.
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, abnormal heart rhythm, pruritus, increased blood pressure, conjunctival hyperemia, nephrolithiasis, weight loss, photophobia, pancreatitis, gastralgia; rarely - a change in psyche and mood.
Symptoms of chronic vitamin D intoxication: calcification of soft tissues, blood vessels and internal organs (kidneys, lungs), renal failure, cardiovascular insufficiency, growth disorder in children.
Treatment: cancel the drug. In the early stages of acute overdose, the appointment of mineral oil may have a positive effect (which helps to reduce absorption and increase excretion of alfacalcidol with feces). In severe cases, carry out the hydration with the introduction of infusion of saline solutions, prescribed "loop" diuretics, GCS, bisphosphonates, calcitonin, conduct hemodialysis using solutions with a low calcium content. Blood levels of electrolytes, renal and cardiac function (according to ECG data) should be monitored, especially in patients receiving digoxin.There is no specific antidote.
- Brand name: Tevabon
- Active ingredient: Alendronic acid, Alfacalcidol set
- Dosage form: Capsules and pills.
- Manufacturer: Teva
- Country of Origin: Israel