Alendronat

Alendronat – biophosphonate, non-hormonal inhibitor of an osteoklastichesky bone resorption, stimulates bone formation, suppresses osteoclasts, increases the mineral density of bones, promotes formation of a bone tissue with normal histologic structure.

Form of release and structure

Dosage form – tablets: round, ploskotsilindrichesky, 10 mg – with a facet, 70 mg – with dividing risky and a facet, almost white or white color, with an insignificant mramornost (10 mg – on 10 pieces in a blister strip packaging, in a cardboard pack 1 or 3 packagings; 70 mg – on 4 pieces in a blister strip packaging, in a cardboard pack 1, 2 or 3 packagings; on 10 pieces in a blister strip packaging, in a cardboard pack 1 packaging).

Contains in 1 tablet of Alendronat:

• Active ingredient: алендронат sodium (in terms of alendronovy acid) – 10 mg or 70 mg;
• Auxiliary components: lactoses monohydrate, potato starch, silicon dioxide colloid, calcium stearate, povidone (polyvinylpirrolidone low-molecular).

Indications to use

• Pedzhet's disease;
• Osteoporosis at women in a postmenopause (for prevention of fractures of bones, including a backbone and proximal department of a hip);
• Osteoporosis at men.

Contraindications

• Gullet pathologies, the detaining processes of its emptying (including an achalasia, strictures);
• Hypocalcemia;
• Lack of ability to sit or to stand directly within 30 minutes and more;
• Lactose intolerance, syndrome of glyukozo-galaktozny malabsorption, deficit of lactase;
• The chronic renal failure, at the clearance of creatinine (CC) is less than 35 ml/min.;
• Period of pregnancy and breastfeeding;
• Children's and teenage age up to 18 years;
• Hypersensitivity to drug components.

With care patients are recommended to appoint drug in the period of an exacerbation of diseases of the digestive tract (DT): gastritis, dysphagy, duodenitis, esophagitis, peptic ulcer of a stomach and duodenum; with heavy pathologies of a GIT, such as gastrointestinal bleeding, round ulcer, surgery on upper parts of a GIT (except a pyloroplasty), postponed within the previous 12 months; with predisposition to a hypocalcemia (calcium malabsorption, a hypothyroidism); with oncological diseases, deficit of vitamin D and other disturbances of mineral exchange; at simultaneous use of corticosteroids and other drugs, himio-and/or radiation therapy; with bad hygiene of an oral cavity (including diseases of teeth, periodontitis), a coagulopathy, anemia, the accompanying infectious and other pathologies.

Route of administration and dosage

Pill is taken inside, swallowing entirely, it is desirable in 2 hours, but later than in 0,5 hours, before the first reception of water, food or other medicines. It is necessary to wash down only with simple water as tea, mineral water, orange juice or coffee reduce absorption.

Alendronat's use should be accompanied with reception of vitamin D and calcium in the dose providing daily requirement.

The optimum duration of therapy of a bisfosfonatama is not established. It is defined by the doctor, on a regular basis, especially at patients is after use for five years and more.

The recommended dosing:

• Osteoporosis postmenopauzny at women, and osteoporosis at men: on 70 mg once a week or 10 mg of 1 times a day;
• Pedzhet's disease: on 40 mg of 1 times a day, a therapy course half a year.

For patients at advanced age, patients with functional disturbance of a liver and/or a slight and moderate renal failure (KK of 35-60 ml/min.) of dose adjustment are not required.

In case of the admission of the next administration of drug in the determined day (at reception once a week), the pill should be taken in the morning of the next day provided that it will not be reception of two tablets at the same time. Further to continue use according to the established scheme.

Side effects

In general Alendronat's use is transferred well, expressiveness of side effects usually has easy temper and does not demand drug withdrawal.

Undesirable effects of drug with a development frequency more than at 1% of patients established at conduct of clinical trials:

• Alimentary system: nausea, abdominal pains, lock, diarrhea, acid eructation, dyspepsia, dysphagy, peptic ulcer of a gullet, gastritis, meteorism, peptic ulcer of a stomach, melena;
• Nervous system: headache;
• Musculoskeletal system: ostealgias, muscular spasms, mialgiya, joint pains.

The side effects recorded in broad clinical practice:

• Nervous system: dizziness, disturbance of flavoring feelings, rotatory vertigo;
• Alimentary system: nausea, vomiting, erosion or ulcer of a gullet, perforation, gastritis, melena, gullet stricture, stomatopharynx ulcer, esophagitis; seldom – a peptic ulcer of a stomach and duodenum (communication with drug is not confirmed), the jaw osteonecrosis (local) more often connected with the previous local infection (including osteomyelitis) and/or extraction of tooth;
• Metabolism: hypocalcemia; seldom – peripheral hypostases;
• Musculoskeletal system: mialgiya, joint pains and/or bones; seldom – severe forms of a swelling of joints, hip fractures;
• Allergic reactions: a small tortoiseshell, it is rare – a Quincke's disease;
• Sense bodys: seldom – a sclerite, a uveitis, an episcleritis;
• Dermatological reactions: skin itch, rash, alopecia, photosensitization; seldom – an erythema, a toxic epidermal necrolysis, Stephens-Johnson's syndrome and other heavy skin reactions;
• Others: adynamy, indisposition, mialgiya; seldom – fever (have passing character, appear at the beginning of therapy).

Special instructions

At Alendronat's appointment the doctor has to inform the patient on Regulations of Admission of tablets and effects of failure to follow the stated recommendations in detail.

For decrease in irritant action on a gullet the pill needs to be taken right after morning rise, to wash down with a full glass of water and within 0,5 hours after reception not to accept horizontal position (risk of development of an esophagitis).

The patient has to show special attention to signs of undesirable reactions from a gullet. At emergence of heartburn, pain behind a breast, the dysphagy or pain when swallowing need to stop administration of drug and to see a doctor.

Due to positive impact of drug on the mineral density of a bone tissue insignificant asymptomatic decrease in blood serum of level of concentration of calcium and phosphates can be observed. Special value has it for the patients who are on glucocorticosteroid therapy as they can have a reduced absorption of calcium.

Treat risk factors of development of an osteonecrosis of a jaw: the accompanying therapy (chemotherapy, radiation therapy, corticosteroid drugs), the diagnosed cancer, diseases of gums, anemia, infections, a coagulopathy.

Surgical dental manipulations can promote strengthening of manifestations of an osteonecrosis of a jaw.

The decision on expediency of use of drug needs to be made after assessment of a ratio of the expected advantage of therapy and possible risk for each patient individually.

Influence of alendronovy acid on ability of the patient to control of vehicles and mechanisms is not established.

Medicinal interaction

At simultaneous use with medicines for intake, including antacids and kaltsiysoderzhashchy drugs, absorption of alendronovy acid can decrease therefore these combinations should not be allowed. If the accompanying therapy is necessary, then the interval between Alendronat's reception and other drugs has to make 0,5 hours and more.

Its combination to acetylsalicylic acid and other non-steroidal anti-inflammatory drugs can strengthen side effects of alendronovy acid on a GIT.

The combination therapy with drugs of estrogen (with observance of an interval between receptions) does not cause change of their action and development of side effects.

Bioavailability of alendronovy acid is not influenced by oral administration of Prednisolonum.

Terms and storage conditions

To store in the place protected from light, at a temperature up to 25 °C. To protect from children.

Period of validity – 2 years.