Tevanat: Instructions for use: Description of the drug: Price on EUROLAB

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Manufacturers: Teva (Pharmaceutical company)

Active ingredients

Alendronic acid

Disease class

Postmenopausal osteoporosis
Drug-induced osteoporosis

Clinical and pharmacological group

Not indicated. See instructions

Pharmacological action

Inhibiting bone resorption

Pharmacological group

Correctors of bone and cartilage tissue metabolism

Tevanate oral tablets

Instructions for medical use of the drug

Description of pharmacological action

Tevanate® is a drug from the group of aminobisphosphonates - synthetic analogues of pyrophosphate, which binds to hydroxyapatite, which is part of bone tissue. Increases the mineral density of the bones of the spine and other skeletal bones. The mechanism of antiresorptive action is associated with suppression of osteoclast function. Promotes the formation of bone tissue with normal histological structure.

Indications for use

— treatment of postmenopausal osteoporosis; - osteoporosis caused by the use of glucocorticosteroid drugs.

Release form

tablets 10 mg; blister 10, cardboard pack 3; tablets 70 mg; blister 4, cardboard pack 1; tablets 70 mg; blister 4, cardboard pack 3; Warehouse Tablets 1 tab. active formulation: sodium alendronate monohydrate 11.6 mg (supposedly 10 mg of aledronic acid) additional formulations: hydroxypropylcellulose, low-substituted; hydroxypropyl cellulose; silicon dioxide; sodium stearyl fumarate active formulation: sodium alendronate monohydrate 81.2 mg (supposedly 70 mg aledronic acid) additional formulations: MCC; sodium croscarmellose; magnesium stearate in a blister 10 pcs.; There are 3 blisters in a cardboard pack (10 mg tablets) or 4 pcs in a blister; in a cardboard pack there are 1 or 3 blisters (70 mg tablets).

Pharmacodynamics

Tevanate® is a drug from the group of aminobisphosphonates - synthetic analogues of pyrophosphate, which is associated with hydroxyapatite, which enters the bone tissue. The greater mineral density of the ridge bones and other skeletal bones. The mechanism of antiresorptive action due to osteoclast suppression. It molds bone tissue with a normal histological structure.

Pharmacokinetics

The bioavailability of alendronic acid at a dose of 5-70 mg when taken halfway through the heart 2 years before consumption is 0.64% in women and 0.6% in men. When taken 1-1.5 years before consumption, the bioavailability of the drug decreases by 40%. After drinking kava and orange juice, bioavailability is reduced by approximately 60%. The binding of alendronic acid to blood serum proteins is approximately 78%. The drug is distributed in the soft tissues, and then quickly redistributed into the cysts, where it is fixed or excreted. The concentration of the drug in the blood plasma after taking the drug in therapeutic doses is lower than possible between modifications (It is not biotransformable. When administered, the drug acts in an unchanged form and is characterized by a liquid lower concentrations of the drug in blood plasma and higher concentrations from the cysts. 10 consequences of the development of the drug from cystic tissue.

Use during pregnancy

Vagility and the period of lactation are contraindicated before taking Tevanat®.

Contraindications for use

- increased sensitivity to any of the components of the drug; — hypocalcemia; - strictures or achalasia in the duct and other conditions that lead to increased insertion of the skin along the duct; — the patient’s inability to stand or sit straight for at least 30 minutes; — severe nitric deficiency (Cl creatinine less than 35 ml/min); - important disruption of mineral metabolism; - child's age; - vagusness; - lactation period. With caution: disease of the scilial-intestinal tract in the gastrointestinal phase (dysphagia, esophagitis, gastritis, duodenitis, varicose vein disease of the scutum and duodenum), hypovitaminosis D.

Side effects

Parts (not less than 1/100, less than 1/10): On the side of the scutulo-intestinal tract: pain in the scutum, dyspepsia, sour stomach, boredom, constipation, diarrhea, dysphagia, flatulence, gastritis, varicose veins, mucous membrane tract. On the side of meats, cysts and tissue: cystic, meat and lobular pains, vessels in meats. On the side of the nervous system: headache. Unfrequently (not less than 1/1000, less than 1/100): Zagalni: visip, itching, erythema. On the side of the scolio-intestinal tract: vomiting, gastritis, esophagitis, esophageal erosions, melena. Rare (not less than 1/10000, less than 1/1000): Zagalny: hypersensitivity reactions, including urticaria and angioneurotic swelling; past symptoms similar to those in the acute phase of illness (pain in the muscles, weakness and rarely fever), call for treatment; visip for light sensitivity; symptomatic hypocalcemia, which is associated with debilitating conditions. On the side of the scutulo-intestinal tract: stricture of the oropharynx, perforation, lacerations, bleeding in the upper part of the scutulo-intestinal tract, although no causal link has been established. On the side of the organ: uveitis, scleritis, episcleritis. On the sides of the muscles and cysts: osteonecrosis. Є information about osteonecrosis of the cleft in patients who took bisphosphonates. Most of the symptoms occur in cancer patients, but similar episodes have also been reported in patients undergoing treatment for osteoporosis. Occasional episodes of severe skin reactions have been reported, including Stevens-Johnson syndrome and toxic epidermal necrolysis.

Directions for use and doses

In the middle. To ensure normal absorption of the drug and reduce the risk of developing side effects, strictly follow the instructions for dosing and dosing of the drug. The recommended dose is 1 tablet. (10 mg) 1 time per day or 1 tablet. (70 mg) 1 time per week. Take the tablet whole, with a glass of water at least 30 minutes before the first dose, drinking or taking other medications. Take the drug with plenty of water; other drinks (including mineral water), food products and other medications may reduce the absorption of Tevanat®. The tablets cannot be dispensed or disseminated. After taking the drug, the patient is required to maintain an upright position of the body (standing or sitting) with a length of at least 30 minutes. You cannot take the drug before bedtime or before bedtime.

Overdose

In case of overdose, there may be development of hypercalcemia, hypophosphatemia, as well as adverse reactions in the scolio-intestinal tract (diarrhea, liver disease, esophagitis or virulent disease of the scolio-intestinal tract). Treatment: milk or an antacid to bind alendronic acid. As a result, the rhizik’s guilty teasing to the traveler is not a trace of vomiting. The patient is responsible for staying in an upright position.

Interactions with other drugs

The combined use of alendronic acid (or not overnight use) with estrogen preparations is not accompanied by a change in their action or the development of side effects. It is not allowed to take alendronic acid hour after hour with calcium supplements, antacids or other oral medications due to the possibility of decreased absorption of alendronic acid. It is necessary to take a break from this relationship for at least 30 minutes after taking alendronic acid and before taking any other medications. Taking prednisolone daily is not associated with clinically significant changes in the bioavailability of alendronate. NPZZ potentiate the by-product of alendronic acid on the thyroid gland.

Special instructions for use

Please pay special attention to any signs of adverse reactions in the field of navigation. The patient is responsible for being informed about the need to take the drug and contact a doctor if dysphagia develops, pain when walking, pain behind the sternum, or severe swelling. It is necessary to inform the patient about the possible risk of deterioration of the mucous membrane in the passage if the instructions are not followed due to stagnation. Due to the risk of deterioration of the mucous membrane of the upper scutulo-intestinal tract, as well as the intensification of the main disease, it is recommended to exercise caution when administering the drug to patients with diseases of the scutulo-intestinal tract, such as dysphagia, esophagitis, gastritis, duodenitis, sciatica viracova and twelve-fingered disease intestines in the stage of congestion, as well as with recently suffered (stretching the anterior rock) diseases of the scylculo-intestinal tract (virulent disease of the scutulum and duodenum, active bleeding in the GCT, surgical insertion in the upper part of the scutulo-intestine tract, cream of pyloroplasty). Patients must be informed that if they miss a dose, they should take 1 tablet. lies after they knew about it. In patients with hypocalcemia, prior treatment with alendronic acid, it is necessary to carry out corrective therapy for disruption of mineral metabolism, incl. hypovitaminosis D and hypoparathyroidism. During the treatment process, following the positive infusion of alendronic acid on the mineral density of the bone tissue, a slight asymptomatic decrease in the concentration of calcium and phosphates in the blood serum may be avoided. In addition, there is information about symptomatic hypocalcemia, which is important and often occurs in patients with hypoparathyroidism, hypovitaminosis D, and impaired no calcium. When taking the drug Tevanat® (especially with concomitant therapy with GCS), it is necessary to ensure adequate calcium and vitamin D in the skin or in the appearance of medicinal drugs. The absorption of bisphosphonates is significantly reduced with one-hour administration of urchin. Osteonecrosis of the fissure, caused by a damaged tooth and / or local infection (including osteomyelitis), has been reported in cancer patients who were treated with bisphosphonates mainly intravenously. Many of these patients also received chemotherapy and corticosteroids. There is also information about osteonecrosis of the cleft in patients with osteoporosis who are treated with oral bisphosphonates. Before initiating bisphosphonate therapy, patients with concomitant risks (such as cancer, chemotherapy, replacement therapy, corticosteroids, lack of oral hygiene) must undergo dental treatment with a qualified professional. Preservation of teeth. Patients on bisphosphonate treatment may not have to undergo invasive dental procedures. In patients on bisphosphonate therapy with advanced osteonecrosis of the slit, dental surgical procedures may lead to deterioration. If it is necessary to carry out surgical procedures, the patient should be advised that there is evidence of the possibility of reducing the risk of developing osteonecrosis of the cleft after the use of bisphosphonates daily. The doctor's prescription and recommendations should be based on an individual assessment of the skin tissue/risk for the patient. Filling into the building with a car and other mechanisms: does not flow.

Storage conditions

List B.: At a temperature not exceeding 30 ° C.

Best before date

30 months

ATX classification:

M Musculoskeletal system

M05 Preparations for the treatment of bone diseases

M05B Drugs affecting bone mineralization

M05BA Bisphosphonates

M05BA04 Alendronic acid

Tevanat, 12 pcs., 70 mg, tablets

Particular attention should be paid to any signs of adverse reactions in the esophagus. The patient should be informed about the possible risk of damage to the mucous membrane of the esophagus if the instructions for use are not followed and about the need to stop taking the drug Tevanat® and consult a doctor if dysphagia, pain when swallowing, chest pain, or the appearance or worsening of heartburn develops.

Due to the existing risk of irritation of the mucous membrane of the upper gastrointestinal tract, as well as aggravation of the underlying disease, it is recommended to be careful when prescribing the drug Tevanat® to patients with gastrointestinal diseases in the acute phase, incl. dysphagia, gastroesophageal reflux disease, gastritis, duodenitis, peptic ulcer of the stomach and duodenum, as well as recent (within the previous year) diseases of the gastrointestinal tract (peptic ulcer of the stomach and duodenum, active bleeding from the gastrointestinal tract, surgery in the upper gastrointestinal tract, except pyloroplasty).

In patients with Barrett's esophagus, therapy with Tevanate should only be started after a careful assessment of the expected benefit versus the possible risk of developing esophageal cancer.

Cases of osteonecrosis of the jaw, usually associated with tooth extraction and/or local infection (including osteomyelitis), have been reported in patients with cancer receiving treatment regimens containing bisphosphonates (primarily IV). Many of these patients also received chemotherapy and corticosteroids. There have also been reports of osteonecrosis of the jaw in patients with osteoporosis receiving oral bisphosphonates. Before using bisphosphonates, patients with underlying risk factors (eg, cancer, chemotherapy, radiation therapy, corticosteroid therapy, poor oral hygiene) should undergo a dental examination with appropriate preventative dental treatment. Patients being treated with bisphosphonates should avoid invasive dental procedures whenever possible. In patients with osteonecrosis of the jaw who are on bisphosphonate therapy, dental surgery may worsen the condition. If surgical interventions are necessary, it should be taken into account that there is no data on the possibility of reducing the risk of developing osteonecrosis of the jaw after discontinuation of bisphosphonates. Prescriptions and recommendations of the attending physician should be based on an individual assessment of the benefit/risk ratio for each patient.

If the patient forgot to take a Tevanat® tablet, it should be taken the next morning. You should not take 2 tablets. on day 1, you must continue to take 1 tablet. 1 time per week on the day that was chosen for administration from the very beginning of treatment.

In patients with hypocalcemia, hypovitaminosis D and hypoparathyroidism, it is necessary to carry out corrective therapy for disorders of mineral metabolism before starting treatment with Tevanat®. Due to the positive effect of alendronic acid on bone mineral density, a slight asymptomatic decrease in serum calcium and phosphorus concentrations may be observed during treatment. There are isolated reports of symptomatic hypocalcemia, sometimes severe, usually in patients with a predisposition to it (for example, hypoparathyroidism, vitamin D deficiency, calcium malabsorption).

There are reports of stress fractures of the proximal femur during long-term treatment with Tevanat® (from 18 months to 10 years). Fractures occurred after minimal or no trauma. Some patients first develop pain in the proximal femur and persist for weeks or even months before culminating in a femoral fracture. Often the fractures were bilateral, so if a patient has a fracture of one femur, it is necessary to monitor the condition of the other femur.

In patients taking Tevanat®, especially with concomitant therapy with corticosteroids, it is extremely important to ensure sufficient intake of calcium and vitamin D from food or in the form of medications.

Absorption of bisphosphonates is significantly reduced when administered concomitantly with food.

Impact on the ability to drive vehicles and work with equipment.

There was no effect on the ability to drive vehicles and work with equipment associated with an increased risk of injury.

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Tevanate®

Due to the existing risk of irritation of the mucous membrane of the upper gastrointestinal tract, as well as aggravation of the underlying disease, it is recommended to be careful when prescribing the drug Tevanat® to patients with gastrointestinal diseases in the acute phase, including dysphagia, gastroesophageal reflux disease, gastritis, duodenitis , peptic ulcer of the stomach and duodenum, as well as recently suffered (within the previous year) diseases of the gastrointestinal tract (peptic ulcer of the stomach and duodenum, active bleeding from the gastrointestinal tract, surgery in the upper gastrointestinal tract, except pyloroplasty).

In patients with Barrett's esophagus, therapy with Tevanate should only be started after a careful assessment of the expected benefit versus the possible risk of developing esophageal cancer.

There have also been reports of osteonecrosis of the jaw in patients with osteoporosis receiving oral bisphosphonates. Before using bisphosphonates, patients with underlying risk factors (eg, cancer, chemotherapy, radiation therapy, corticosteroid therapy, poor oral hygiene) should undergo a dental examination with appropriate preventive dental treatment. Patients being treated for FD should avoid invasive dental procedures if possible. In patients with osteonecrosis of the jaw who are on FD therapy, dental surgery may lead to a worsening of the condition. If surgical interventions are necessary, it should be taken into account that there is no data on the possibility of reducing the risk of developing osteonecrosis of the jaw after discontinuation of BF. Prescriptions and recommendations of the attending physician should be based on an individual assessment of the benefit/risk ratio for each patient.

An adverse event reported was osteonecrosis of the external auditory canal, which was predominantly associated with long-term use of alendronate. Possible risk factors for osteonecrosis of the external auditory canal include steroid use, chemotherapy, infection, and trauma.

If the patient forgot to take a Tevanat® tablet, it should be taken the next morning. You should not take two tablets on the same day, you should continue to take 1 tablet once a week on the day you chose to take from the very beginning of treatment.

In patients taking Tevanat®, especially with concomitant therapy with glucocorticosteroid drugs, it is extremely important to ensure sufficient intake of calcium and vitamin D from food or in the form of medications.

Absorption of BF is significantly reduced by simultaneous food intake.