Tevanat
Tevanat: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Method of application and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. Application during pregnancy and lactation
- 10. Use in childhood
- 11. In case of impaired renal function
- 12. Use in the elderly
- 13. Drug interactions
- 14. Analogs
- 15. Terms and conditions of storage
- 16. Terms of dispensing from pharmacies
- 17. Reviews
- 18. Price in pharmacies
Latin name: Tevanate
ATX code: M05BA04
Active ingredient: alendronic acid (alendronic acid)
Manufacturer: Teva Pharmaceutical Industries, Ltd. (Israel)
Description and photo updated: 20.11.2018
Prices in pharmacies: from 542 rubles.
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Tevanat is a bone resorption inhibitor.
Release form and composition
Dosage form Tevanata - tablets: round, flat, beveled, almost white or white, with an engraving "T" on one side (dosage 10 mg: in blisters of 10 pcs., In a cardboard box 3 blisters; dosage 70 mg: in blisters of 4 pcs., in a cardboard box 1 or 3 blisters).
The composition of one Tevanat tablet:
- active substance: alendronic acid (in the form of sodium alendronate monohydrate) - 10 or 70 mg;
- auxiliary components: microcrystalline cellulose, croscarmellose sodium, magnesium stearate.
Pharmacological properties
Pharmacodynamics
Alendronic acid belongs to the group of aminobisphosphonates. Localized in foci of bone resorption, the substance lowers the activity of the main cells involved in the resorption process - osteoclasts, thereby inhibiting bone destruction. Since resorption and the formation of new bone tissue are interconnected, bone repair is also reduced, but this occurs to a lesser extent than destruction. As a result, a positive balance is restored and a progressive increase in bone mass occurs.
Alendronate sodium stimulates an increase in bone mineral density of the spine and other elements of the skeleton and contributes to the formation of a normal histological structure during bone restoration.
Pharmacokinetics
- absorption: when the drug is taken orally on an empty stomach 2 hours before breakfast in a dose of 5 to 70 mg, the bioavailability of sodium alendronate is 0.6% in men, 0.64% in women. If the medicine is taken on an empty stomach 1-1.5 hours before breakfast, the bioavailability of alendronic acid is reduced by about 40%. After drinking orange juice and coffee, bioavailability decreases by about 60%. The level of concentration of the active substance in blood plasma after oral administration of a therapeutic dose of the drug is below the limit of possible determination (less than 5 ng / ml);
- distribution: about 78% of alendronic acid binds to blood plasma proteins. The substance is distributed into soft tissues, after which it is quickly redistributed in bone tissue, where it is fixed or excreted by the kidneys;
- metabolism: alendronic acid is not biotransformed;
- excretion: the drug is excreted unchanged, with excretion there is a rapid decrease in the concentration of sodium alendronate in the blood plasma, and the substance is released from the bones extremely slowly. The final T 1/2 (half-life) is more than 10 years.
Indications for use
Tevanat is indicated for use in postmenopausal osteoporosis (to reduce the risk of developing fractures of the femoral neck and compression fractures of the spine), as well as in osteoporosis caused by the use of glucocorticosteroids.
Contraindications
Absolute:
- conditions characterized by slow movement of food through the esophagus (including achalasia of the cardia or stricture of the esophagus);
- low calcium content in blood plasma;
- severe renal dysfunction (creatinine clearance less than 35 ml / min);
- inability to sit or stand up straight for 30 minutes or more;
- severe disorders of mineral metabolism;
- pregnancy and lactation;
- childhood;
- increased individual sensitivity to any component of the drug.
The use of Tevanat requires caution in diseases of the gastrointestinal tract (GIT) in the acute phase (including dysphagia, gastritis, esophagitis, gastroesophageal reflux disease, gastric ulcer and duodenal ulcer, duodenitis), with recent (during the previous year) gastrointestinal diseases, surgical interventions in the upper gastrointestinal tract (except for pyloroplasty), as well as with vitamin D deficiency.
Instructions for use of Tevanat: method and dosage
Tevanat tablets are taken orally, swallowing whole with 200 ml of water, at least 30 minutes before the first meal, drinks or other medications. The drug should be taken with plain water, as other drinks (including mineral water), as well as food and some medications can reduce the bioavailability of the active substance. Do not dissolve or chew tablets.
The recommended dosage regimen is one 10 mg tablet once a day or one 70 mg tablet once a week.
After taking Tevanat, you must maintain an upright position (sitting or standing) for at least 30 minutes. You cannot take the pill in the morning before getting out of bed or before going to bed.
Side effects
Systemic and organ side effects and their frequency according to the classification of the World Health Organization [very often (≥1 / 10), often (≥1 / 100 to <1/10), infrequently (≥1 / 1000 to < 1/100), rare (≥1 / 10,000 to <1/1000), very rare (<1/10 000), frequency unknown (cannot be estimated due to insufficient data)]:
- Gastrointestinal tract: often - dyspepsia, abdominal pain, constipation, diarrhea, sour belching, flatulence, dysphagia, gastritis, ulceration of the esophageal mucosa, stomach ulcer; infrequently - nausea, vomiting, esophagitis, gastritis, erosion of the esophagus, stomach ulcer (including those complicated by bleeding); rarely - ulceration of the oropharyngeal mucosa, esophageal stricture, esophageal perforation, bleeding from the upper gastrointestinal tract (a causal relationship with the use of alendronic acid has not been established);
- musculoskeletal system: often - pain in joints, muscles and bones, convulsions; rarely - osteonecrosis of the jaw (as a rule, in patients with cancer, but there have been cases in patients undergoing treatment for osteoporosis); frequency unknown - trauma-related or non-trauma-related stress fracture of the proximal femur;
- metabolism: rarely - hypophosphatemia, symptomatic hypocalcemia (usually associated with predisposing conditions);
- central nervous system: often - dizziness, headache, impaired taste;
- sense organs: rarely - scleritis, episcleritis, uveitis;
- allergic reactions: infrequently - itching, rash, erythema; rarely - urticaria, rash (associated with photosensitivity), angioedema; very rarely - severe skin reactions, including Stevens-Johnson syndrome (exudative erythema multiforme) and Lyell's syndrome (toxic epidermal necrolysis);
- others: rarely - malaise, myalgia, fever and other transient symptoms similar to those of the acute phase of the disease (usually at the beginning of therapy).
Overdose
In case of an overdose of Tevanat, the following symptoms may occur: heartburn, diarrhea, hypophosphatemia, esophagitis, hypocalcemia, erosive and ulcerative lesions of the gastrointestinal mucosa.
Treatment consists of milk or an antacid containing calcium to bind alendronic acid. Vomiting is not recommended due to the risk of irritation of the esophageal mucosa. The patient should be in an upright position.
special instructions
During treatment with Tevanat, it is necessary to strictly observe the recommended method of application and dosing in order to ensure normal absorption of the drug and reduce the risk of developing adverse reactions.
In the event that the patient has forgotten to take a pill, it must be drunk in the morning of the next day and continue to take one pill once a week on the day that was chosen from the very beginning of therapy. Do not take two tablets in one day.
The absorption of bisphosphonates is significantly reduced with simultaneous food intake.
The patient should be informed about the probable risk of damage to the esophagus if the recommendations for use are not followed, the need to stop taking Tevanat and consult a doctor in case of pain when swallowing, dysphagia, heartburn, chest pain, as well as any signs of side effects in the esophagus …
In Barrett's syndrome, treatment with Tevanat should be initiated after a careful assessment of the relationship between the expected benefit and the likely risk of esophageal cancer.
In some cases, patients with cancer receiving bisphosphonates (primarily intravenous) have experienced cases of osteonecrosis of the jaw, usually associated with tooth extraction and / or local infection (including osteomyelitis). Most of these patients also received corticosteroids and chemotherapy. There have also been reports of osteonecrosis of the jaw in osteoporotic patients taking oral bisphosphonates. Based on this, if there are associated risk factors (for example, cancer, radiation therapy, chemotherapy, corticosteroid treatment, poor oral hygiene), you should undergo a dental examination with appropriate dental treatment before using Tevanat. Patients taking bisphosphonates are advised to avoid invasive dental procedures whenever possible. With osteonecrosis of the jaw during therapy with alendronic acid, dental surgical procedures can lead to a complication of the condition. If it is necessary to carry out surgical interventions, it should be borne in mind that there is no data on reducing the risk of developing osteonecrosis of the jaw after discontinuation of bisphosphonates. When making appointments and recommendations, the attending physician should be based on an individual patient-specific assessment of the benefit-risk ratio. When making appointments and recommendations, the attending physician should be based on an individual patient-specific assessment of the benefit-risk ratio. When making appointments and recommendations, the attending physician should be based on an individual patient-specific assessment of the benefit-risk ratio.
Patients with hypocalcemia, hypoparathyroidism and hypovitaminosis D need to undergo corrective treatment of mineral metabolism disorders before starting Tevanat therapy. Since alendronic acid has a positive effect on bone mineral density, asymptomatic slight decreases in serum phosphorus and calcium levels may occur during therapy. There have been reports of isolated cases of symptomatic hypocalcemia, sometimes with a severe course, usually in patients with a predisposition to it (for example, hypoparathyroidism, calcium malabsorption, vitamin D deficiency).
During therapy with Tevanat, especially with concomitant treatment with glucocorticosteroids, it is extremely important to ensure that vitamin D and calcium are supplied to the body in sufficient quantities with food or in dosage form.
Cases of stress fractures of the proximal femur during long-term treatment with Tevanat (from 18 months to 10 years), which occurred as a result of minimal or no trauma, have been reported. Some patients initially felt pain in the proximal thigh, which persisted for several weeks to several months, then this symptom ended in a fracture of the femur. Bilateral fractures were common. Therefore, in the event of a fracture in a patient of one femur, the condition of the other femur should be carefully monitored.
Influence on the ability to drive vehicles and complex mechanisms
According to the instructions, Tevanat does not affect the ability to drive vehicles and other complex mechanisms.
Application during pregnancy and lactation
During pregnancy and breastfeeding, the appointment of Tevanat is prohibited.
Pediatric use
Tevanat is not used in pediatrics.
With impaired renal function
Severe renal failure (creatinine clearance less than 35 ml / min) is a contraindication to Tevanat's use.
In case of moderate and mild renal dysfunction (creatinine clearance more than 35 ml / min), dose adjustment is not required.
Use in the elderly
For elderly patients, there is no need to adjust the Tevanat dose.
Drug interactions
- estrogen preparations (joint use, but not simultaneous administration): there is no change in their action and the development of side effects;
- prednisolone: no clinically significant changes in the bioavailability of alendronic acid are observed;
- non-steroidal anti-inflammatory drugs: increased side effects of alendronic acid on the gastrointestinal tract;
- food, beverages containing calcium (including mineral water), food additives, antacids and other medicinal products for oral administration: possible impairment of absorption of alendronic acid. In this regard, it is necessary to take alendronic acid with any food, calcium-containing drinks, other oral medications at intervals of at least 30 minutes.
Analogs
Tevanat's analogues are: Alendrokern, Alendronat, Alendronat Pliva, Ostalon, Osterepar, Strongos, Fosamax and others.
Terms and conditions of storage
Store at a temperature not exceeding 30 ° C.
Keep out of the reach of children.
Shelf life is 3 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews about Tevanat
In reviews of Tevanate, users note that the effect of using the drug does not occur immediately, but with prolonged use (at least 6 months). The emerging adverse events from the gastrointestinal tract force many to refuse treatment or to take forced breaks for several months, and then continue therapy again. Side effects such as heartburn, belching, heaviness in the stomach, pain in joints and muscles occur to varying degrees in most patients, especially with prolonged use of Tevanat.
The price of Tevanat in pharmacies
The price of Tevanat for one package is approximately: 4 tablets - 700 rubles, 12 tablets - 2050 rubles.
Tevanat: prices in online pharmacies
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Drug name Price Pharmacy |
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Tevanat 70 mg tablets 4 pcs. 542 r Buy |
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Tevanat 70 mg tablets 12 pcs. 1738 RUB Buy |
Maria Kulkes Medical journalist About the author
Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
