Alendra (alendronic acid) tablets 70 mg. №4

active ingredient: alendronic acid;

1 tablet contains alendronate sodium in terms of alendronic acid 70 mg;

other ingredients: microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, magnesium stearate, anhydrous colloidal silicon dioxide.

Drug that affect the structure and mineralization of bones. ATX code M05B A04.

Sodium alendronate belongs to the group of aminobisphosphonates. It is a synthetic analogue of natural pyrophosphate. It inhibits the precipitation of calcium phosphate, blocks its transformation into hydroxyapatite, delays the aggregation of apatite crystals with the formation of larger crystals and accelerates the reverse dissolution of these crystals. The selective action is due to the high affinity of bisphosphonates with the mineral components of bones. Acts as an effective non-hormonal specific inhibitor of osteoclast-mediated bone resorption. The exact mechanisms of this process are not fully understood. Restores a positive balance between bone resorption and repair. Increases the mineral density of the bones of the spine, pelvis, promotes the formation of bone tissue with a normal histological structure. Prevents new bone fractures. Reduces the level of calcium in the blood serum by inhibiting bone resorption and reducing the release of calcium from bone tissue. The calcium-reducing effect of the drug, mediated by inhibition of osteoclasts, is observed after 1-2 days.

Sodium alendronate is absorbed in the gastrointestinal tract by 25%. Absolute bioavailability for tablets (5 to 10 mg) taken on an empty stomach 2 hours before meals is 0.64% for women and 0.59% for men. Bioavailability is reduced (approximately 40%) when alendronate sodium is taken half an hour to an hour before a regular breakfast. The bioavailability of alendronate sodium is negligible when taken with food or within two hours of eating. Co-administration of alendronate sodium with other drinks (including mineral water, coffee, orange juice) reduces its bioavailability by 60%. Animal studies have shown that when administered intravenously at a dose of 1 mg/kg sodium alendronate is temporarily distributed in soft tissues, but then quickly redistributed. Half of the absorbed dose is excreted mainly by the kidneys unchanged within 72 hours, and the rest accumulate in the bone tissue for a long time, being eliminated very slowly due to the connection with the bone tissue. The half-life of alendronate sodium from bones is several years.

Approximately 78% of alendronate binds to plasma proteins and is not metabolized. The concentration of the drug in the blood plasma is insignificant (less than 5 ng / ml) and decreases by 95% within 6 hours after intravenous infusion.

After a single injection of 10 mg of alendronate, its renal clearance was 71 ml/min, and systemic clearance did not exceed 200 ml/min.

Treatment of postmenopausal osteoporosis. The drug reduces the risk of fractures of the spine and femur.

• Hypersensitivity to alendronate sodium or to any other component of the drug;
• pathology of the esophagus (stricture or achalasia), causing a delay in the evacuation of the contents of the esophagus;
• inability to stand or sit up straight for at least 30 minutes;
• hypocalcemia;
• severe renal failure (creatinine clearance <35 ml/min).

Recommended dose: 1 tablet 70 mg once a week.

The optimal duration of bisphosphonate treatment for osteoporosis has not been established. The decision on the need to continue treatment with alendronate sodium is made by the doctor individually for each patient on the basis of a periodic assessment of the benefit / risk ratio (especially after 5 or more years of using the drug).

The tablet must be taken with water at least 30 minutes before the first meal, drink or other medication. Other drinks (including mineral water), food and some drugs may reduce the absorption of alendronate sodium (see section “Interaction with other medicinal products and other forms of interaction”)

To facilitate the entry of the drug into the stomach and thus reduce its irritating effect on the mucous membrane of the oral cavity, pharynx and esophagus, it is necessary:

• take the drug with a glass of water (at least 200 ml) in the morning after waking up;
• do not chew the tablet due to the possibility of ulcers of the oral cavity and pharynx;
• the first daily meal – only 30 minutes after taking the pill;
• after taking the tablets, patients should not lie down for at least 30 minutes;
• the drug should not be taken at bedtime or before getting up in the morning.

The interval between taking alendronic acid and other drugs taken by mouth should be at least 30 minutes.

Additionally, calcium and vitamin D should be taken if the intake of these substances with food is not enough.

The drug should be taken on the same day of the week. If you accidentally skip taking the drug, you must take 1 tablet in the morning of the next day. In the future, continue taking it as usual – take the next tablet on the day that was chosen for taking from the very beginning of treatment.

Use in elderly patients

There is no need to adjust the dose for elderly patients.

kidney failure

For patients whose creatinine clearance is more than 35 ml / min, there is no need to adjust the dose.

Patients with creatinine clearance less than 35 ml/min are not recommended to take alendronate due to lack of experience in the use of the drug for the treatment of such patients.

The effect of alendronic acid in the treatment of osteoporosis caused by corticosteroids has not been studied.