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Alendronic acid

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Available since: 2019-09-19

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Clinical Pharmacology

Alendronate is an inhibitor of bone resorption. Aminobisphosphonate, is an analogue of pyrophosphate. The mechanism of action is associated with the suppression of osteoclast activity. Restores a positive balance between resorption and restoration of bone, progressively increases bone mineral density (regulates phosphorus-calcium metabolism), promotes the formation of bone tissue with a normal histological structure.

Indications

- osteoporosis in postmenopausal women (prevention of bone fractures, including hip and spine);
- osteoporosis in men;
- osteoporosis caused by prolonged use of glucocorticosteroid drugs; Paget's disease.

Composition

1 tablet contains alendronic acid 10 or 70 mg;
Excipients: corn starch, lactose (milk sugar), magnesium stearate, MCC.

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Dosage and Administration

Alendronate is applied orally, once a day, without chewing, on an empty stomach, preferably 2 hours (but not less than 30 minutes) before the first meal, water or other drugs. You should drink only ordinary water, because other drinks, including mineral water, coffee, tea, orange juice) reduce absorption. pills can not be chewed or rassasyvat.

The recommended dose is 1 tablet (10 mg) by mouth once a day or 1 tablet (70 mg) by mouth once a week.

For the treatment of osteoporosis in women (postmenopausal) and in men, as well as osteoporosis caused by prolonged use of glucocorticosteroid drugs, Alendronate is taken at 10 mg / day. or 70 mg once a week.

When Paget's disease is applied in a dose of 40 mg / day for 6 months. If you accidentally skip the drug in the mode once a week, you must take one pill in the morning of the next day. You should not take two pills on the same day, but later you should continue to take one pill on that day of the week, which was chosen for admission from the very beginning of treatment.

Adverse reactions

From the gastrointestinal tract: dysphagia, esophagitis, abdominal pain, heartburn, dyspepsia, constipation, diarrhea, flatulence. Rarely - nausea, vomiting, gastritis, melena, stricture of the esophagus, ulcers of the oral mucosa and pharynx, esophageal ulcer, perforation of the esophagus ulcer with bleeding.

From the musculoskeletal system: pain in bones, muscles and joints. From the nervous system: headache. On the part of the organ of vision: uveitis, scleritis.

Allergic reactions:rarely - urticaria, angioedema; reported on isolated cases of Stevens-Johnson and Lyell syndromes. Others: rash, pruritus, erythema, photodermatosis, symptomatic hypocalcemia. Cases of osteonecrosis of the upper and lower jaw are described mainly in patients with cancer against the background of antitumor treatment, including bisphosphonates. Risk factors for osteonecrosis are cancer, chemotherapy, radiation therapy, treatment with glucocorticosteroids, inadequate oral hygiene, and local infectious and inflammatory processes, including osteomyelitis. In most of the cases described, the patient was extracted with a bisphosphonate.

Laboratory data: slight and transient decrease in calcium and phosphate concentrations.

Typical symptoms at the beginning of treatment - myalgia, malaise and, rarely, - fever.

Contraindications

- hypersensitivity to the drug;
- hypocalcemia;
- the inability of the patient to stand upright (stand or sit straight) for at least 30 minutes;
- severe renal failure (creatinine clearance less than 35 ml / min);
- severe violations of mineral metabolism;
- strictures or achalasia of the esophagus and other conditions leading to difficulty in moving food through the esophagus;
- severe hypoparathyroidism;
- Calcium malabsorption;
- lactose intolerance, lactase deficiency, glucose-galactose malabsorption;
- pregnancy;
- lactation period;
- childhood.

Carefully
Diseases of the gastrointestinal tract (GIT) in the acute phase (dysphagia, esophagitis, gastritis, duodenitis, gastric ulcer and 12 duodenal ulcer), vitamin D deficiency

Special instructions

The absorption of bisphosphonates is significantly reduced with simultaneous ingestion of food.

To reduce the irritating effect on the esophagus, Alendronate should be taken immediately after the morning rise, drinking a full glass of water. After taking, you should be in an upright position (standing or sitting) for 30 minutes (it is dangerous to use the drug if the patient is unable to stand or sit upright for a specified time).Taking Alendronate before bedtime or in a horizontal position increases the risk of esophagitis.

The patient should be informed of the need to discontinue Alendronate and seek medical attention if dysphagia develops, pain occurs when swallowing, chest pain or heartburn occurs.

When hypocalcemia is necessary to carry out its correction before treatment. Including it is necessary to eliminate violations of mineral metabolism, leading to hypocalcemia (vitamin D deficiency, hypoparathyroidism, calcium malabsorption). Therapy should be carried out on the background of a diet enriched with calcium salts.

When taking bisphosphonates (especially with concomitant therapy with glucocorticosteroid drugs) it is necessary to ensure the supply of adequate amounts of calcium and vitamin D with food or in the form of medicines.

In the course of treatment, due to the positive effect of alendronic acid on bone mineral density, a slight asymptomatic decrease in serum calcium and phosphate concentrations can be observed.

Before prescribing bisphosphonates, patients with concomitant risk factors (for example, cancer, chemotherapy, radiation therapy, glucocorticosteroid drugs, insufficient oral hygiene) must undergo a dental examination with appropriate preventive dental treatment. Patients undergoing bisphosphonate treatment should avoid invasive dental procedures as much as possible. Osteonecrosis of the jaw was reported, usually associated with tooth extraction and / or local infection (including osteomyelitis) in oncological patients who received intravenous bisphosphonates (many of them were also given chemotherapy and glucocorticosteroid drugs). There are reports of the development of osteonecrosis of the jaw in patients with osteoporosis with the use of bispho-sonata inside.

In patients with osteonecrosis of the jaw and being treated with bisphosphonates, dental surgery can lead to a deterioration of the condition. If necessary, surgical interventions should be borne in mind that there is no data on the possibility of reducing the risk of osteonecrosis of the jaw after the withdrawal of bisphosphonate.

Appointments and recommendations of the attending physician should be based on an individual assessment of the benefit / risk ratio for each patient.