Universal reference book for medicines
Name of the drug: TEVABONE (TEVABONE)

Active substance: alendronic acid, alfacalcidol

Type: Combined drug for the treatment of osteoporosis

Manufacturer: Teva Pharmaceutical Industries (Israel) manufactured (tablets) Teva Pharmaceutical Industries (Israel) manufactured (capsules) RPSCHERER (Germany)
Composition, form of production and packaging
A set of tablets and capsules:

Tablets white or almost white, round, flat, with a facet, with engraving "T" on one side.

1 tab.

sodium alendronate monohydrate 81.2 mg,

which corresponds to the content of alendronic acid 70 mg

[PRING] microcrystalline cellulose - 113.8 mg, croscarmellose sodium - 3 mg, magnesium stearate - 2 mg.

Capsules soft gelatinous, oval, white or almost white, opaque, with the inscription "1.0" in black ink;
the contents of the capsules are a pale yellow oil solution.
1 caps.

alfacalcidol 1 μg

[PRING] citric acid - 0.015 mg, propyl gallate - 0.02 mg,? -tocopherol - 0.02 mg, ethanol - 1.144 mg, peanut oil - 98.8 mg.

The composition of the capsule shell: gelatin - 48.27 mg, glycerol 85% - 11.78%, anhydrizor 85/70 (sorbitol 25-40%, sorbitan 20-30%, mannitol 0-6%, higher polyols 12.5-19%, water 15-17 %) - 7.88 mg, titanium dioxide (E171) - 0.68 mg.

Composition of black ink A10379: shellac, iron dye, black oxide, ethanol denatured (methylated alcohol), isopropanol, 1-butanol, ethyl acetate.

1 piece (tab.) - blisters (1) + 7 pcs. (Caps.) - blisters (1) - cardboard envelope (4) - cardboard packs.

1 pcs (tab.) - blisters (1) + 7 pcs. (Caps.) - blisters (1) - cardboard envelope (12) - cardboard packs.

INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2013.

PHARMACHOLOGIC EFFECT

Combined drug for the treatment of osteoporosis.

Alendronic acid , being a bisphosphonate, inhibits the active bone resorption process caused by osteoclasts without directly affecting the formation of new bone tissue.
Having tropicity 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 osteoplast apoptosis. Against the background of therapy with alendronic acid, the bone mineralization is increasing and its qualitative characteristics are improved.
Alfacalcidol is a regulator of calcium-phosphorus metabolism, the precursor of the active metabolite of vitamin D 3 -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. Influencing both parts of the bone remodeling process (resorption and synthesis), alfacalcidol not only increases the mineralization of bone tissue, but increases its elasticity by stimulating the synthesis of bone matrix proteins, bone morphogenetic proteins, bone growth factors. In the treatment of alfacalcidol, bone with a normal histological structure is formed, bone strength increases in all parts of the skeleton.
Alendronic acid and alfacalcidol increase the strength of bone tissue, while their effects are synergistic due to various mechanisms of action.
Inhibition of catabolic processes in bones by alendronic acid is supplemented with bone anabolic effect of alfacalcidol, which leads to the formation of a normal bone structure. Thanks to the pharmacological effects of both substances, their use in combination can reduce the potential risk of hypocalcemia, hypercalcaemia 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-ocular (pleiotropic) effect of alfacalcidol - increasing muscle strength, speeding up the speed of muscle reaction.
PHARMACOKINETICS

Alendronic acid

Suction

When administered on an empty stomach in the dose range from 5 to 70 mg immediately after 2 hours before breakfast, the bioavailability of alendronic acid in women is 0.64%, in men it is 0.6%.
The bioavailability of alendronic acid is reduced by 40% when administered on an empty stomach for 1-1.5 h before breakfast.After consuming coffee and orange juice, bioavailability is reduced by about 60%. The concentration of alendronic acid in the blood plasma after oral administration at the therapeutic dose is below the possible detection limit (less than 5 ng / ml).
Distribution

The binding of alendronic acid with plasma proteins is about 78%.
Alendronic acid is distributed in soft tissues, and then quickly redistributed into the bone, where it fixes, or is excreted through the kidneys.
Metabolism and excretion

Not subject to biotransformation.

Outputs unchanged.
The elimination process is characterized by a rapid decrease in the concentration of alendronic acid in the blood plasma and extremely slow release from the bones.
Alfacalcidol

Suction

After oral administration, alfacalcidol is rapidly absorbed from the digestive tract.
C max is achieved in 8-12 hours after a single intake of alfacalcidol. Bioavailability with oral administration is about 100%.
Metabolism

Pharmacological effects of alfacalcidol are realized after its transformation into the body in calcitriol.
The conversion of alfacalcidol to calcitriol occurs in the liver by hydroxylation at the 25th carbon atom, the process of hydroxylation occurring very quickly (it has a substrate-dependent character) and does not depend on the functional state of the liver. The maximum concentration of calcitriol in the body is reached 8-12 hours after a single intake of alfacalcidol. Unlike native vitamin D, alfacalcidol does not need hydroxylation in the kidneys, so it is effective even in patients with decreased renal 1-alpha hydroxylase activity (renal pathology, elderly age).
Excretion

Calcitriol is excreted by the kidneys and liver in approximately equal parts, T 1/2 is about 35 hours.

INDICATIONS

- postmenopausal osteoporosis;

- Osteoporosis caused by the use of GCS.

DOSING MODE

The drug Tevabon consists of two medicinal forms: tablets of alendronic acid and capsules of alfacalcidol.

To ensure normal absorption and reduce the risk of adverse reactions, the recommendations for use and dosage should be strictly observed.

Alendronic acid

Assign inside 1 tab.
(70 mg) once a week, with a glass of water, at least 30 minutes before the first meal, drinks or other medicines. Drink only with ordinary water, since other beverages (including mineral water), foods and some medicines can reduce the bioavailability of alendronic acid. Tablets can not be chewed or rassasyvat.
After taking the pill, the patient should maintain a vertical position (standing or sitting) for at least 30 minutes.
Do not take the pill before going to bed or before going to bed early.
Elderly patients do not need dose adjustment.

With violations of the kidney KK> 35 ml / min dose adjustment is not required.

Alfacalcidol

Assign inside 1 caps.
(1 mcg) 1 time / day in the evening every day. Capsules should be swallowed whole, with enough liquid.
The drug Tevabon is intended for long-term use.

SIDE EFFECT

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, acidic eructation, diarrhea, dysphagia, flatulence, gastritis, stomach ulcer, ulceration of the mucosa of the esophagus;
infrequently - nausea, vomiting, constipation, gastritis, esophagitis, erosion of the esophagus mucosa, melena; rarely - stricture of the esophagus, ulceration of the mucous membrane of the oropharynx, perforation of the esophagus, bleeding from the upper sections of the gastrointestinal tract (the connection with the reception of alendronic acid is not established).
From the musculoskeletal system: often - pain in the bones, muscles, joints, muscle cramps;
rarely - osteonecrosis of the jaw, mainly in cancer patients taking bisphosphonates, but similar cases have also been observed in patients undergoing therapy for osteoporosis; unknown frequency - stress fracture of the proximal femur, connected or unrelated to trauma.
From the side of 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: infrequent - rash, itching, erythema;
rarely - a rash associated with photosensitivity, urticaria, angioedema; very rarely - severe skin reactions, including multiforme exudative erythema (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;
very rarely - a slight increase in the concentration of HDL in the blood plasma. In patients with severe renal dysfunction, hyperphosphatemia may develop, and heterotopic calcifications in the cornea of ​​the eye and blood vessels.
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 activity of hepatic 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: infrequent - moderate pain in muscles, bones, joints.

Allergic reactions: rarely - skin rash, itching;
very rarely - anaphylactic shock, which is associated with peanut butter.
In connection with 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 sudden fluctuations in the serum calcium concentration.

CONTRAINDICATIONS

- conditions leading to a slowing of the food movement along the esophagus (including stricture or achalasia of the esophagus);

- the patient's inability to stand or sit for at least 30 minutes;

- hypocalcemia;

- hypercalcemia;

- Burnett's syndrome and / or milk-alkaline syndrome (calcium concentrations in the plasma> 2.6 mmol / l, calcium phosphate> 3.7 mmol / l, pH> 7.44);

- impaired renal function of severe degree (CC <less than 35 ml / min);

- Patients on hemodialysis;

- hypervitaminosis D;

- Hyperphosphatemia (with the exception of hyperphosphatemia in hypoparathyroidism);

- hypermagnesia;

- deficiency of sugar / isomaltase, intolerance to fructose, malabsorption of glucose / galactose;

- childhood;

- Pregnancy;

- the period of lactation (breastfeeding);

- Hypersensitivity to alendronic acid, alfacalcidol and other components of the drug.

With caution should prescribe the drug for gastrointestinal diseases in the phase of exacerbation, incl.
Dysphagia, esophagitis, gastritis, duodenitis, peptic ulcer of the stomach and duodenum; hypoparathyroidism, hypovitaminosis D, malabsorption of calcium, nephrolithiasis, atherosclerosis, renal dysfunction (KC more than 35 ml / min), chronic heart failure, patients with an increased risk of hypercalcaemia, incl. with leukemia, lymphoma, sarcoidosis, pulmonary tuberculosis (active form).
PREGNANCY AND LACTATION

Due to the lack of data on the use of alendronic acid and / or the risk of an overdose of alfacalcidol, Tevabon is contraindicated in pregnancy and during breastfeeding.

APPLICATION FOR FUNCTIONS OF THE LIVER

With violations of the kidney KK> 35 ml / min dose adjustment is not required.

Contraindication: impairment of renal function of severe degree (CK <less than 35 ml / min);
patients on hemodialysis


APPLICATION FOR CHILDREN

Contraindication: children's age.

APPLICATION IN ELDERLY PATIENTS

Elderly patients do not need dose adjustment.

SPECIAL INSTRUCTIONS

For the use of alendronic acid

Special attention should be paid to any signs of the occurrence of adverse reactions in the esophagus.
The patient should be informed of the need to stop taking the drug and contact a doctor when developing dysphagia, pain when swallowing, chest pain, the appearance or intensification of heartburn.
In connection with the risk of irritation of the mucous membrane of the upper gastrointestinal tract, as well as aggravation of the course of the underlying disease, caution should be exercised when prescribing the drug to patients with gastrointestinal diseases during the exacerbation phase (such as dysphagia, esophagitis, gastritis, duodenitis, peptic ulcer and duodenal ulcer) , and also recently transferred (during the previous year) diseases of the digestive tract (peptic ulcer of the stomach and duodenum, active bleeding from the gastrointestinal tract, surgical intervention on the stomach
Khnemu gastrointestinal except pyloroplasty).
There are reports of cases of osteonecrosis of the jaw, usually associated with tooth extraction and / or local infection (including osteomyelitis), in patients with oncological diseases receiving treatment regimens, including bisphosphonates (primarily IV).
Many of these patients also received chemotherapy and GCS. There are also reports of osteonecrosis of the jaw in patients with osteoporosis receiving oral bisphosphonates. Prior to the use of bisphosphonates, patients with concomitant risk factors (eg, cancer, chemotherapy, radiation therapy, GCS therapy, insufficient oral hygiene) should undergo a dental examination with appropriate preventive dental treatment. Patients on treatment with bisphosphonates should avoid invasive dental procedures whenever possible. In patients with osteonecrosis of the jaw, who are on bisphosphonate therapy, dental surgical procedures can lead to deterioration. If surgical intervention is necessary, it should be taken into account that there is no data on the possibility of reducing the risk of developing an osteonecrosis of the jaw after the bisphosphonate has been withdrawn. The 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 pain in the bones, joints, and muscles in patients during therapy with bisphosphonates ranged from 1 day to several months after initiation of treatment.
In most patients, after the cessation of treatment, there was a decrease in the severity of the pain, in some patients the pain reappeared with the resumption of therapy with the same or another bisphosphonate.
If the patient forgot to take a tablet of alendronic acid, then it should be taken the next morning.
Do not take 2 tablets. in one day, you must continue taking 1 tablet. 1 time per week on the day that was chosen for admission from the very beginning of treatment.
In patients with hypocalcemia, hypovitaminosis D and hypoparathyroidism, corrective therapy of mineral metabolism disorders prior to treatment with alendronic acid is necessary.
Due to the positive effect of alendronic acid on bone mineral density during treatment, there may be a slight asymptomatic decrease in the concentration of calcium and phosphorus in the blood serum. There are isolated reports of symptomatic hypocalcemia, sometimes severe, usually in patients with a predisposition to it (eg, hypoparathyroidism, vitamin D deficiency, calcium malabsorption).
There are reports of stress fractures in the proximal femur with prolonged treatment with alendronic acid (18 months to 10 years).

Fractures occurred after minimal injury or without it.
Some patients initially experienced pain in the proximal part of the thigh that persisted for several weeks or even months before the symptom ended with a fracture of the femur. Often, the fractures were bilateral, so if a fracture of one femur in the patient is necessary to monitor the condition of another femur.
In patients taking alendronic acid, especially with concomitant therapy with GCS, it is extremely important to ensure sufficient intake of calcium and vitamin D in the body with food or in the form of medications.

Absorption of bisphosphonates significantly decreases with simultaneous intake of food.

For the use of alfacalcidol

Alfacalcidol may increase hypercalcaemia and / or hypercalciuria when assigned to patients with a disease associated with uncontrolled hyperproliferation of calcitriol (eg, in leukemia, lymphoma, sarcoidosis), and may also increase hyperphosphatemia.
At a calcium concentration in the plasma of 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 capsules of alfacalcidol before the normalization of the concentration calcium in the blood serum (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, corrective therapy is performed.
In the treatment with alfacalcidol, the concentration of electrolytes at the beginning is determined once a week, when C max is reached and every 3-5 weeks during the entire treatment period, and the activity of the alkaline phosphatase is monitored (if the renal function is impaired (KC more than 35 ml / min) - weekly control).

Peanut butter in rare cases can cause severe allergic reactions.
Patients with hereditary fructose intolerance and fructose malabsorption should not be administered the drug Tevabon, since the set includes alfacalcidol capsules containing sorbitol.
Impact on the ability to drive vehicles and manage mechanisms

Due to the possibility of side effects from the CNS in the period of treatment must be careful when driving, as well as other potentially hazardous activities that require high concentration and psychomotor speed reactions.
OVERDOSE

Alendronic acid
Symptoms may hypocalcemia, hypophosphataemia, diarrhea, heartburn, oesophagitis, erosive and ulcerative lesions gastrointestinal mucosa.
Treatment: receiving milk or antacids to bind alendronic acid. Due to the risk of oesophageal irritation should not induce vomiting. The patient must be in a verticalposition.
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 the bones.
Late symptoms of hypervitaminosis D:dizziness, confusion, drowsiness, heart rhythm disturbance, itchy skin, increased blood pressure, conjunctival hyperemia, nephrolithiasis, weight loss, photophobia, pancreatitis, gastralgia; rarely - change of mind and mood.
Symptoms of chronic intoxication with vitamin D: calcification of soft tissues, blood vessels, and internal organs (kidney, lung), kidney failure, cardiovascular failure, impaired growth in children.
Treatment:cancel product. In the early stages of acute overdose can have a positive effect designation mineral oil (which helps to reduce absorption and increase excretion with feces alfacalcidol). In severe cases, the hydration is carried out with the introduction of infusion of saline solutions, designate "loop" diuretics, corticosteroids, bisphosphonates, calcitonin, hemodialysis is carried out with the use of solutions with low calcium content. It should control the content of electrolytes in the blood, kidney and cardiac function (ECG data), especially in patients receiving digoxin.
There is no specific antidote.
DRUG INTERACTION

When simultaneous administration with food, beverages containing calcium (including mineral water), nutritional supplements, antacids, and other drugs for oral administration may malabsorption alendronic acid. In this regard, the interval between doses of alendronic acid and other oral medications must be at least 30 minutes.
Combined use of alendronic acid (but not simultaneous reception) is not accompanied by a change of their action and the development of side effects of estrogen therapy.
Receiving oral prednisolone is not accompanied by a clinically significant changes in bioavailability of alendronic acid.
Corticosteroids increases the side effects of alendronate on the gastrointestinal tract.
With simultaneous use of alfacalcidol with cardiac glycosides increases the risk of arrhythmia.
Inductors microsomal liver enzymes (including phenytoin and phenobarbital) decrease and inhibitors - alfacalcidol increase the concentration in plasma (possibly change its effectiveness).
Suction alfacalcidol reduced by combining it with mineral oil (for a long time), colestyramine, colestipol, sucralfate, antacids, medications based on albumin.
In this connection, not to be taken simultaneously with the capsule alfacalcidol antacids that contain aluminum, the interval between administration of these drugs must be at least 2 hours.
Antacids increases the risk of hypermagnesemia and giperalyuminiemiya. Toxic effects of impaired retinol, tocopherol, ascorbic acid, pantothenic acid, thiamine, riboflavin.
For women in perimenopause effects of alfacalcidol may be exacerbated by estrogens. Calcitonin, derivatives etidronovoy and pamidronic acid, plicamycin and corticosteroids reduce alfacalcidol effect.
Alfacalcidol increases the absorption of phosphorus-containing drugs and the risk of hyperphosphataemia.
Simultaneous use of calcium preparations with alfacalcidol, thiazide diuretics may cause hypercalcemia by raising the calcium absorption in the intestine, increasing its reabsorption in the kidney.
The therapy should not be prescribed alfacalcidol other drugs of vitamin D and its derivatives because of possible additive interaction and increase the risk of hypercalcemia.
TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

The drug should be stored out of reach of children at a temperature of no higher than 25 ° C.
Shelf life - 3 years.
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