Universal reference book for medicines
Product name: TEVANATE ® (TEVANATE)

Active substance: alendronic acid

Type: Inhibitor of bone resorption in osteoporosis

Manufacturer: Teva Pharmaceutical Industries (Israel)
Composition, form of production and packaging
Tablets are
white or almost white, biconvex, without risks.

1 tab.

alendronate sodium monohydrate 11.6 mg,

which corresponds to the content of alendronic acid 10 mg

[PRING] low-substituted hydroxypropyl cellulose, hydroxypropylcellulose, silicon dioxide colloid, sodium stearyl fumarate.

10 pieces.
- blisters (3) - packs of cardboard.
Tablets are white or almost white, round, flat, chamfered, engraved "T" on one side and even on the other.

1 tab.

alendronate sodium monohydrate 81.2 mg,

which corresponds to the content of alendronic acid 70 mg

[PRING] microcrystalline cellulose, sodium croscarmellose, magnesium stearate.

4 things.
- blisters (1) - packs of cardboard.
4 things.
- blisters (3) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2011.

PHARMACHOLOGIC EFFECT

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

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%.
Distribution

The binding of alendronic acid with plasma proteins is about 78%.
The drug is distributed into soft tissues, and then quickly redistributed into the bone, where it fixes, or is excreted in the urine.
The concentration of the drug in the blood plasma after ingestion at the therapeutic dose is below the possible limit of detection (<5 ng / ml).

Metabolism

Not subject to biotransformation.

Excretion

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.
The final T 1/2 is more than 10 years, which reflects the release of the drug from the bone tissue.

INDICATIONS

- treatment of postmenopausal osteoporosis;

- Osteoporosis caused by the use of GCS.

DOSING MODE

To ensure the normal absorption of the drug and reduce the risk of adverse reactions should strictly follow the recommendations for use and dosage.

The drug Tevanat ® appoint inside 1 tab.
10 mg 1 time / day or 1 tab. 70 mg once a week.
The tablet is taken as a whole, with a glass of water at least 30 minutes before the first meal, drinks or other medicines.
The drug is taken with ordinary water only, since other drinks (including mineral water), foods and some medicines can reduce the bioavailability of alendronic acid. Tablets can not be chewed or rassasyvat.
After taking the drug, the patient should maintain a vertical position (standing or sitting) for at least 30 minutes.
Do not take the drug before going to bed or before going to bed early.
SIDE EFFECT

The frequency of adverse events is indicated in accordance with the following gradation: often (? 1/100, <1/10);
infrequently (? 1/1000, <1/100); rarely (? 1/10 000, <1/1000).
On the part of the digestive system: often - pain in the stomach, indigestion, acidic eructation, nausea, constipation, diarrhea, dysphagia, flatulence, gastritis, stomach ulcer, ulceration of the mucosa of the esophagus;
infrequently - nausea, vomiting, gastritis, esophagitis, erosion of the esophagus, melena; rarely - stricture of the esophagus, ulceration of the oropharynx, perforation, ulcers, bleeding in the upper GI tract, although a causal relationship is not established.
From the musculoskeletal system: often - bone, muscle and joint pain, muscle cramps;
rarely - osteonecrosis. There are reports of osteonecrosis of the jaw in patients taking bisphosphonates. Most of the reports refer to oncological patients, but similar cases have also been observed in patients on therapy for osteoporosis.
From the nervous system: often - a headache.

Dermatological reactions: infrequent - rash, itching, erythema;
rarely a rash with photosensitivity; in some cases - severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis.
Allergic reactions: rarely - hypersensitivity reactions, including hives and angioedema.

From the side of the organ of vision: rarely - uveitis, scleritis, episcleritis.

On the part of the body as a whole: rarely - transient symptoms similar to those in the acute phase of the disease (myalgia, malaise and rarely fever), usually at the beginning of treatment;
Symptomatic hypocalcemia, usually associated with predisposing states.
CONTRAINDICATIONS

- hypocalcemia;

- 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;

- renal failure of severe degree (CK less than 35 ml / min);

- severe disturbances in mineral metabolism;

- childhood;

- Pregnancy;

- the period of lactation (breastfeeding);

- Hypersensitivity to the components of the drug.

With caution should be used in cases of gastrointestinal diseases in the phase of exacerbation (dysphagia, esophagitis, gastritis, duodenitis, peptic ulcer and duodenal ulcer), hypovitaminosis D.

PREGNANCY AND LACTATION

The drug is contraindicated in pregnancy and lactation (breastfeeding).

APPLICATION FOR FUNCTIONS OF THE LIVER

Contraindicated in renal failure of severe degree (CK less than 35 ml / min).

APPLICATION FOR CHILDREN

Contraindicated: children's age.

SPECIAL INSTRUCTIONS

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, or the appearance or intensification of heartburn.
It is necessary to inform the patient about the possible risk of damage to the mucous membrane of the esophagus if the instructions for use are not observed.

In connection with the risk of irritation of the mucous membrane of the upper gastrointestinal tract, as well as the aggravation of the underlying disease, caution should be exercised in prescribing patients with gastrointestinal diseases such as dysphagia, esophagitis, gastritis, duodenitis, peptic ulcer of the stomach and duodenal ulcer,

recently transferred (during the previous year) diseases of the digestive tract (peptic ulcer of the stomach and duodenum, active bleeding in the gastrointestinal tract, surgical intervention in the upper gastrointestinal tract, except for pyloroplasty).

Patients should be informed that if you miss a drug, take 1 tablet in the morning after they remember it.

In patients with hypocalcemia, prior to the initiation of Tevant®, correction of mineral metabolism disorders, including
hypovitaminosis D and hypoparathyroidism. In the course of treatment, due to the positive effect of alendronic acid on the bone mineral density, there may be a slight asymptomatic decrease in the concentration of calcium and phosphate in the blood serum. In addition, there are rare reports of symptomatic hypocalcemia, sometimes severe, which is common in patients with hypoparathyroidism, hypovitaminosis D, and impaired calcium absorption.
When taking Tevant ® (especially with concomitant GCS therapy), adequate calcium and vitamin D intake should be provided with food or in the form of medications.

Absorption of bisphosphonates is significantly reduced by simultaneous intake of food.

Osteonecrosis of the jaw, usually associated with tooth extraction and / or local infection (including osteomyelitis), has been reported in cancer patients who received mostly IV bisphosphonates.
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.

Before the appointment of bisphosphonate therapy to patients with concomitant risk factors (eg cancer, chemotherapy, radiation therapy, SCS, insufficient oral hygiene), it is necessary to undergo dental examination with appropriate preventive dentistry.

Patients on treatment with bisphosphonates should avoid invasive dental procedures whenever possible.
In patients who are on therapy with bisphosphonates, with developed osteonecrosis of the jaw, dental surgical interventions 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.

Influence on the ability to manage motor vehicles and work with mechanisms

The drug does not affect the ability to drive vehicles and work with mechanisms.

OVERDOSE

Symptoms: hypocalcemia, hypophosphatemia, diarrhea, heartburn, esophagitis, erosive-ulcerative gastrointestinal lesions.

Treatment: taking milk or antacids to bind alendronic acid.
Due to the risk of irritation of the esophagus, do not induce vomiting. The patient should be in an upright position.
DRUG INTERACTION

The combined use of alendronic acid (but not simultaneous administration) with estrogen preparations is not accompanied by a change in their action and the development of side effects.

It is not allowed simultaneous reception of alendronic acid with preparations containing calcium, antacids or other medicines for oral administration because of a possible decrease in the absorption of alendronic acid.
In this regard, it is necessary to observe the interval of at least 30 minutes after taking alendronic acid and before ingesting other medications.
The intake of prednisolone by mouth is not accompanied by clinically significant changes in the bioavailability of alendronic acid.

NSAIDs increase the side effect of alendronic acid on the digestive tract.

TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

List B. The drug should be stored out of reach of children at a temperature of no higher than 30 ° C.
Shelf life of the drug in the form of tablets 10 mg - 3 years, in the form of tablets 70 mg - 2.5 years.
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