Alendronat

General characteristics. Structure:

Active ingredient: 70 mg of alendronovy acid.

Excipients: microcrystallic cellulose, monohydrate of lactose, sodium of a kroskarmeloz, magnesium stearate.

Pharmacological properties:

Pharmacodynamics. Inhibitor of a bone resorption. Aminobisfosfonat, is a pyrophosphate analog. The mechanism of action is connected with suppression of activity of osteoclasts. Stimulates bone formation, recovers positive balance between a resorption and recovery of a bone, progressively increases the mineral density of bones (regulates phosphorus-calcium exchange), promotes formation of a bone tissue with normal histologic structure.

Pharmacokinetics. Reception of alendronovy acid just before, in time or after food leads to bioavailability reduction. At reception with coffee or orange juice bioavailability of an alendronat of sodium decreases approximately by 60%.

After intake in therapeutic doses concentration of an alendronat in a blood plasma usually below the smallest concentration which is giving in to definition (less than 5 ng/ml).

It is temporarily distributed in soft tissues, then quickly redistributed in a bone or removed with urine. Linkng with proteins of plasma makes about 78%. It is not metabolized. It is removed mainly by kidneys. T1/2 in a final phase can make more than 10 years that is connected with release of active agent from bones.

Indications to use:

Treatment and prevention of osteoporosis at women in the period of a postmenopause. Treatment of osteoporosis at men for the purpose of increase in bone weight. Treatment of the osteoporosis caused by use of GKS for men and women. Pedzhet's disease (damage of bones) at men and women.

Route of administration and doses:

The recommended dose – 70 mg once a week. The pill of 70 mg is taken entirely in the morning on an empty stomach not less than in 30 minutes before the first meal. Wash down only with a full glass of usual water as other drinks can reduce absorption of alendronovy acid. It is not necessary to chew or suck tablets. After reception of alendronovy acid it is not necessary to lay down, at least, 30 minutes.

Features of use:

Use at pregnancy and feeding by a breast. Adequate and strictly controlled clinical trials of safety of use of alendronovy acid at pregnancy and in the period of a lactation it is not carried out. In need of use in the period of a lactation breastfeeding should be stopped.

In pilot studies on rats it is shown that alendronovy acid in doses of 2 mg/kg/days and causes the diskoordination of patrimonial activity caused by a hypocalcemia above; at doses more than 5 mg/kg/days are noted reduction of weight of a fruit.

Use at renal failures. Use at heavy renal failures is not recommended.

Use for children. Use for children is not recommended.

Use at heavy renal failures is not recommended, and also at children.

With care apply at gastrointestinal diseases in an aggravation phase.

Before an initiation of treatment patients with disturbances of mineral exchange should carry out their full correction.

Between reception of alendronovy acid and other drugs the interval has to make not less than 1 h.

Side effects:

From the alimentary system: pains in epigastric area; seldom - a lock, diarrhea, a meteorism, a dysphagy.

From a metabolism: symptomless hypocalcemia.

Dermatological reactions: skin rash, erythema.

Others: headache, mialgiya.

Interaction with other medicines:

At a concomitant use inside with other medicines and means, calciferous, absorption of alendronovy acid is broken.

At the women in the period of a postmenopause receiving estrogen the side effects connected using alendronovy acid were not noted.

In clinical trials increase in frequency of side reactions from the alimentary system at use of alendronovy acid in a dose was observed more than 10 mg/days against the background of therapy by acetylsalicylic acid.

Contraindications:

Gullet stricture, achalasia, inability of the patient to stand or sit directly at least 30 min. after administration of drug, a hypocalcemia, hypersensitivity to alendronovy acid.

Storage conditions:

To store at a temperature not above 25 °C in the places not available to children. Period of validity 2 years.

Issue conditions:

According to the recipe

Packaging:

On 4 tablets in a blister strip packaging, on 1, 2 or 3 packagings in a cardboard pack. On 10 tablets in a blister strip packaging, on 1 packaging in a cardboard pack.