Остемакс

General characteristics. Structure:

Active agent: alendronovy acid of 70 mg

Other ingredients: lactoses monohydrate, cellulose microcrystallic, sodium of a kroskarmelloz, magnesium stearate, silicon colloid anhydrous.

Pharmacological properties:

Alendronovy acid — бисфосфонат, oppressing an osteoklastny resorption of bones without direct effect on their formation. In preclinical trials the drug tropnost to places of an active resorption of a bone is revealed.
Average bioavailability of an alendronat at women at intake in the morning on an empty stomach for 2 h to food (in the range of doses from 5 to 70 mg) makes 0,64%. Bioavailability decreased to 0,46 and 0,39% at reception of an alendronat for 1 h or for ½ h to food. In general efficiency of drug is sufficient if it to accept at least for ½ h before the first meal.
Bioavailability is insignificant if it алендронат is accepted during a breakfast or during 2 h after it. At reception of an alendronat with coffee or orange juice bioavailability decreases approximately by 60%.
Oral administration of Prednisonum (on 20 mg 3 times a day within 5 days) did not cause clinically significant change of bioavailability of an alendronat in healthy volunteers (the last increased on average by 20–44%).
The average volume of distribution in a condition of equilibrium concentration (except for bones) at the person makes at least 28 l. Concentration of drug in a blood plasma after oral administration in a therapeutic dose is too small for analytical definition (<5 ng/ml). Linkng with proteins of a blood plasma makes about 78%. In a human body it is not metabolized.

Indications to use:

Treatment of postclimacteric osteoporosis, decrease in risk of developing of vertebralny and/or femoral fractures.

Route of administration and doses:

The recommended dose — inside on 1 tablet (70 mg) once a week. Drug is appointed only the adult. The pill needs to be taken at least in 30 min. prior to the first meal, drink, or it is accepted in the afternoon, washing down with water. Other drinks (including mineral water), food and some medicines can reduce absorption of an alendronat.
On a mucous membrane of an oral cavity and a gullet it is necessary for decrease in irritant action of drug:

• to accept drug, washing down with a full glass of water (not less than 200 ml) in the morning after the patient got up;
• it is impossible to chew or rassasyvat a tablet in an oral cavity as at the same time there is a risk of developing of ulcers of an oral cavity and a throat;
• the first meal is possible only in 30 min. after reception of a tablet;
• after reception of a tablet patients should not lie at least 30 more min.;
• drug cannot be accepted before going to bed or lying in a bed after a night dream;
• it is necessary to accept in addition drugs of calcium and vitamin D at insufficient intake of these substances with food.
Patients with clearance of creatinine have ≥35 ml/min., and also elderly people (> 65 years) have no need for dose adjustment of drug. The patient with clearance of creatinine <35 ml/min. are not recommended to accept drug due to the lack of experience of its use for such patients. Effect of drug at children was not studied therefore it is not necessary to appoint it by it. Did not investigate effect of drug and at treatment of the osteoporosis caused by reception of GKS.

Features of use:

It is necessary to stop administration of drug if the patient had symptoms of irritation of a gullet, such as dysphagy, pain when swallowing or pain behind a breast, developed heartburn or the current of already existing worsened.
If the patient missed administration of drug, it is necessary to take 1 pill in the morning after he remembers it. It is impossible to take 2 pill in 1 days, but it is necessary to resume administration of drug in the day chosen earlier once a week.
In case of a hypocalcemia it is necessary to fill calcium reserves in an organism prior to treatment alendronaty. In the course of treatment alendronaty the level of calcium and phosphates in a blood plasma can decrease. This decrease usually insignificant and asymptomatic. However it was reported about a symptomatic hypocalcemia, sometimes heavy and usually at patients with the corresponding contributing factors (for example with the accompanying hypoparathyrosis, deficit of vitamin D or malabsorption of calcium). Adequate reception of calcium and vitamin D is especially important for the patients accepting GKS.
Drug is not appointed the patient with rare hereditary diseases — intolerance of a galactose, deficit of lactase or glyukozo-galaktozny malabsorption.
Drug does not influence ability to manage vehicles and to work with potentially dangerous mechanisms.

Side effects:

- From a GIT — a dysphagy, an esophagitis, an abdominal pain, dyspepsia, a lock, diarrhea, a meteorism. Seldom — nausea, vomiting, gastritis, a melena, a stricture of a gullet, an ulcer of a mucous membrane of an oral cavity and throat, a gullet ulcer, perforation of an ulcer of a gullet with bleeding.
- From a musculoskeletal system — an ostealgia, muscles and joints.
- From a nervous system — a headache.
- From an organ of sight — a uveitis, a sclerite.
- Allergic reactions — a small tortoiseshell, a Quincke's disease; it was reported about isolated cases of emergence of syndromes of Stephens — Johnson and Layell.
- Other — rash, an itch, an erythema, a photodermatosis, a symptomatic hypocalcemia.
- Data of laboratory researches — insignificant and passing decrease in levels of calcium and phosphates in a blood plasma.
- Typical symptoms in connection with an initiation of treatment — a mialgiya, an indisposition, it is rare — fever.

Interaction with other medicines:

Food and drinks (including mineral water), nutritional supplements, calciferous, antacids and some medicines can worsen absorption of an alendronat at the combined reception. Patients have to wait at least 30 min. after administration of drug before accepting any other peroral medicine. Other clinically significant interactions are not revealed.
During reception of an alendronat in clinical tests some patients received estrogensoderzhashchy medicines (vaginalno, transdermalno or orally). Any side effects connected with their concomitant use are not revealed.

Contraindications:

Period of pregnancy and feeding by a breast, stricture or achalasia of a gullet; inability of the patient to stand or sit directly within at least 30 min.; intolerance of components of drug; hypocalcemia.

Overdose:

It is shown by a hypocalcemia, a hypophosphatemia, an esophagitis, gastritis or an ulcer of an upper part of a GIT. The patient has to be in vertical position and drink milk or antacids. Due to the risk of irritation of a gullet you should not cause vomiting.

Storage conditions:

In the dry, protected from light place at a temperature not above 25 °C.

Issue conditions:

Without recipe

Packaging:

Tab. of 70 mg, No. 4.