TEVABON 70MG PILLS №12 + 1MKG CAPSULES

Composition

Sodium alendronate monohydrate

Excipients: microcrystalline cellulose, croscarmellose sodium, Magnesium stearate.

 
Alfacalcidol

Excipients: citric acid, propyl gallate, α-tocopherol, ethanol, peanut oil, gelatin, glycerol 85%, antirisorb 85/70 (sorbitol, sorbitan, mannitol, higher polyols, water), titanium dioxide (E171), black ink A10379 ( shellac, iron dye black oxide, ethanol denatured (methylated alcohol), isopropanol, 1-butanol, ethyl acetate).

Mechanism of action

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 tropism for 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, there is an increase in bone mineralization and an improvement in its quality characteristics.

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 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 and usage

- postmenopausal osteoporosis;

- osteoporosis caused by the use of corticosteroids.

Contraindications

- conditions leading to slower movement of food through the esophagus (including strictures or achalasia of the esophagus);

- the 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);

- severe renal dysfunction (CC <<35 ml / min);

- 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.

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 drugs 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

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, a stricture of the esophagus, ulceration of the mucous membrane of the oropharynx, perforation of the esophagus, bleeding from the upper GI 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, such cases were also 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.

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.

Cardiovascular: rarely - tachycardia.

From the musculoskeletal system: infrequently - moderate pain in muscles, bones, joints.

Allergic reactions: rarely - skin rash, itching; very rarely, anaphylactic shock associated with peanut butter.

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.

Oral intake of prednisolone is not accompanied by clinically significant changes in the bioavailability of alendronic acid.

GCS enhance the side effects 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).

The absorption of alfacalcidol is reduced when it is combined with mineral oil (for a long time), Kolestiramine, 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 women in perimenopause, 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 intestine, increasing its reabsorption in the kidneys.

During therapy with alfacalcidol, it is not necessary to prescribe other drugs of vitamin D and its derivatives due to the possible additive interaction and an increased risk of hypercalcemia.

At a temperature not higher than 25 ° С.

2.5 years