Остемакс 70th comfort

General characteristics. Structure:

Active agent: an alendronata of sodium trihydrate (70 mg of acid alendronovy are equivalent).

Excipients: lactoses monohydrate; cellulose microcrystallic; sodium of a kroskarmelloz; silicon dioxide colloid anhydrous; magnesium stearate.

Pharmacological properties:

Pharmacokinetics. Alendronat after use is distributed in soft tissues, then quickly redistributed in a bone tissue or brought with urine. Concentration of drug in a blood plasma is insignificant (less than 5 ng/ml). In a blood plasma about 78% of an alendronat contacts proteins. It is absorbed in a GIT of 25%. T1/2 is no more than 10 h. Renal clearance - 71 ml/min., system - 200 ml/min. It is removed by kidneys. There are no instructions on what алендронат is exposed to metabolism.

Pharmacodynamics. Non-hormonal specific inhibitor of an osteoklastichesky bone resorption from group of aminobiphosphonates - synthetic analogs of the pyrophosphate connecting the hydroxyapatite which is in a bone. 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 normal bone tissue with normal histologic structure.

Indications to use:

- treatment of osteoporosis at women in the postclimacteric period

- treatment of osteoporosis at men (senile osteoporosis)

Route of administration and doses:

Adults. Остемакс the 70th comfort is applied inside on 1 tablet of 70 mg once a week.

It is necessary to take drug not less than for half an hour before the first meal, drinks or intake of other medicines, washing down with a glass of boiled water. Other drinks (including mineral water), food and some medicines can reduce absorption of a medicinal product.

For simplification and acceleration of receipt of a tablet in a stomach and by that reduction of risk of local irritation of a gullet, and also undesirable effects it is necessary to adhere to the following recommendations:

- drug of Ostemaks the 70th comfort should be accepted in the morning, right after rise from a bed, washing down with a full glass of boiled water (not less than 200 ml),

- the tablet should be swallowed entirely, it is impossible to chew a tablet or to allow it dissolution in a mouth because of risk of a possible ulceration of a mucous oral cavity and a throat,

- after a tablet proglatyvaniye the patient should not lay down, at least, within 30 min., before the first meal which has to be not earlier than in 30 minutes after reception of a tablet,

- the medicinal product should not be accepted before going to bed or before getting up after awakening.

During treatment patients should use necessary amount of calcium with food, and in case of its insufficient receipt with food – to accept in addition drugs of calcium and vitamin D (it is especially important during treatment by glucocorticosteroids). It is also recommended to refuse smoking and to be engaged regularly in physical activity.

Use for patients of advanced age and at a renal failure. Correction of dosing is not required from patients of advanced age and from patients with easy degree of a renal failure (coefficient of glomerular filtering more than 35 ml/min.).

If the coefficient of glomerular filtering is less than 35 ml/min., use of an alendronat is not recommended.

Features of use:

Use of Ostemaks the 70th comfort can cause local irritation of a mucous membrane of a gullet. Therefore patients should show care at purpose of drug with active diseases of an upper part of digestive tract, such as dysphagy, esophagitis, gastritis and (or) duodenitis, erosive cankers of digestive tract or to patients with recently postponed (in the previous year) a serious illness of digestive tract, such as peptic ulcer of a stomach and (or) duodenum, gastrointestinal bleeding, and also to the patients who transferred surgical intervention on an upper part of digestive tract (does not treat a pyloroplasty). At patients with the established diagnosis of a gullet of Barrett, the doctor has to estimate an advantage ratio to potential risk of use of an alendronat individually, at each patient.

It is necessary to draw the attention of patients which it is appointed алендронат, to all symptoms which can indicate undesirable effects from a gullet, such as development of an esophagitis, ulcerations and erosion of a gullet also an esophageal stenosis. They can sometimes take a severe form and be the cause of hospitalization. In case of development of a dysphagy, pain when swallowing, a retrosternal pain, emergence or an exacerbation of heartburn the patient has to stop reception of a medicinal product and see a doctor.

The risk of emergence of serious undesirable effects from a gullet increases at those patients who at reception of an alendronat depart from recommendations of the doctor and (or) continue his reception, despite emergence of the symptoms testimonial of irritation of a gullet. It is necessary to inform the patient information that non-compliance with recommendations can lead to increase in risk of emergence of disturbances from a gullet.

At patients (for example, the patients with oncological diseases taking a course of chemotherapy or radiotheraphy, accepting corticosteroids, an appropriate way not following rules of hygiene of an oral cavity or patients with diseases of a parodont) before an initiation of treatment biphosphonates it is necessary to execute careful inspection from group of the increased risk and to carry out necessary preventive dental procedures.

Such patients during treatment have to avoid invasive dental interventions whenever possible. It is necessary to develop treatment planning for each patient separately on the basis of individual assessment of a ratio advantage/risk.

At the patients receiving biphosphonates osteoalgiya, arthralgias and (or) mialgiya are noted. These symptoms seldom had a severe form and (or) resulted in immobilization. Time before emergence of these symptoms was variously – from one day to several months after an initiation of treatment. At many patients these symptoms disappeared after treatment cancellation. However when resuming treatment alendronaty or other biphosphonates there can be a disease recurrence.

It is necessary to explain to patients that in a situation of the admission of a dose of the alendronat accepted once a week the pill should be taken in the morning next day, right after that as the patient will remember need of reception of a tablet. It is impossible to take two pill in one day. Further, it is necessary to take one pill once a week according to the scheme of dosing which was established in an initiation of treatment.

It is necessary to consider as well other reasons of osteoporosis, except deficit of estrogen and age.

Before an initiation of treatment it is necessary to carry out full correction of the broken calcic exchange in an organism. It is necessary to compensate also other disturbances of mineral exchange (such as deficit of vitamin D and hypoparathyroidism). During treatment alendronaty at patients with such disturbances it is necessary to control calcium level in blood serum and hypocalcemia symptomatology.

During treatment alendronaty small asymptomatic decrease in level of calcium and phosphates in serum, especially at the patients receiving glucocorticosteroids at which calcium absorption can be reduced can take place. However there are messages on a symptomatic hypocalcemia which in certain cases had difficult character and was often shown at patients with the contributing disturbances (for example, with a hypoparathyroidism, deficit of vitamin D and disturbance of absorption of calcium).

During treatment alendronaty (especially at the patients receiving glucocorticosteroids) it is necessary to provide adequate amount of calcium and vitamin D (respectively from 1000 mg/days to 1500 mg/days and from 400 ME/days to 800 ME/days).

Tension changes. Cases of the changes of tension (called also changes from loadings) in proximal department of a femur at patients on long therapy were noted by alendronovy acid (in most cases this time made from 18 months to 10 years).

Changes occurred after the minimum injury or without injury, and some patients felt hip pain with the accompanying changes in diagnostic testings several months prior to a complete fracture of a femur. Changes were more often bilateral; therefore it is necessary to diagnose a femur of other extremity for patients, treated biphosphonates at which the femur fracture is noted. There are also messages on the slowed-down union of changes. It is recommended to stop treatment by biphosphonates at patients with tension change before carrying out repeated inspection and definition of an individual ratio advantage/risk.

Остемакс the 70th comfort contains lactose. Patients cannot appoint a medicinal product with seldom found hereditary intolerance of a galactose, deficit of lactase (like Lapp) or a glucose galactose sprue.

Use for patients of advanced age. It is not established differences in safety and efficiency of use of an alendronat for patients of advanced age in comparison with young patients, however it is impossible to exclude manifestation of higher sensitivity to a medicinal product at elderly patients.

Features of influence on ability to driving or potentially dangerous mechanisms. There are no data on influence of drug on ability to drive the car and other mechanisms. However some side effects observed after reception of an alendronat can worsen ability to control of vehicles and service of mechanisms at some patients. Individual reaction on medicinal drug can be various.

Side effects:

Often:

- headache

- abdominal pains, dyspepsia, locks, diarrhea, meteorism, gullet ulceration, dysphagy, gastroesophagal reflux

- osteomialgiya (ostealgia, muscles or joints)

Infrequently:

- nausea, vomiting, gastritis, esophagitis, gullet ulcers, tar-like chair

- rash, itch, erythema

Seldom:

- hypersensitivity reactions, including a small tortoiseshell and a Quincke's disease

- the symptomatic hypocalcemia which is often connected with the contributing disturbances

- uveitis, sclerite, episcleritis

- gullet strictures, an ulceration of a mucous oral cavity and a throat, perforation, a peptic ulcer of a stomach and (or) duodenum and bleeding from an upper part of digestive tract

- photosensitization

- development of a necrosis of a bone of a jaw in the patients receiving biphosphonates

- tranzitorny symptoms, as in reaction of an acute phase (mialgiya, feeling sick and seldom fever) which are usually connected with an initiation of treatment

Very seldom:

- isolated cases of severe forms of skin reaction, including Stephens-Johnson's syndrome and toxic epidermal necrolysis.

Frequency is unknown:

- dizzinesses, including labyrinth origin, disorder of taste

- alopecia

- hypostasis of joints

- adynamy, peripheral hypostasis.

Interaction with other medicines:

There is a probability that calcium drugs (including mineral water), antiacid drugs and some other medicines at joint reception can worsen absorption of an alendronat, medicine can be taken inside not earlier than in 30 minutes after administration of drug.

With care it is necessary to apply алендронат along with nonsteroid antiinflammatory medicines, in view of their irritant action on digestive tract.

Contraindications:

- hypersensitivity to an alendronat or any of excipients

- anomalies and diseases of a gullet which are slowing down passing through it such as narrowing or achalasia of a gullet

- inability to keep a standing position or sitting within not less than 30 minutes

- hypocalcemia

- pregnancy and period of a lactation

- children's age up to 18 years

Overdose:

Symptoms: a hypocalcemia, a hypophosphatemia and symptomatology from an upper part of digestive tract, such as dyspepsia, heartburn, esophagitis, gastritis or stomach ulcer.

Treatment: for binding of alendronovy acid the patient should drink milk or to accept antiacid drugs. Due to the risk of irritation of a gullet vomiting should not be caused. The patient has to keep vertical position (sitting or standing).

Storage conditions:

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

To store in the place, unavailable to children!

Issue conditions:

According to the recipe

Packaging:

On 4 tablets place in a blister strip packaging from a film of polyvinyl chloride and aluminum foil.

On 1 planimetric packaging together with the instruction on a medical use in the state and Russian languages put in a pack from a cardboard.