Alendronate-Vertex, tablets 70 mg 4 pcs

Alendronate is an inhibitor of bone resorption.

Aminobisphosphonate is an analogue of pyrophosphate.

The mechanism of action is connected with inhibition of osteoclast activity.

It restores positive balance between bone resorption and regeneration, progressively increases bone mineral density (regulates phosphorus-calcium exchange), promotes formation of bone tissue with normal histological structure.

Indications

– Osteoporosis in postmenopausal women (prevention of bone fractures, including hip and spine);
– Osteoporosis in men;
– Osteoporosis caused by long-term use of glucocorticosteroid drugs; Pejeta disease.

Active ingredient

Composition

1 tablet contains:

Active substance:

Alendronic acid 70 mg;

Associated substances:

Corn starch,

Lactose (milk sugar),

Magnesium stearate,

MCC.

How to take, the dosage

Alendronate is taken orally, once daily, without chewing, on an empty stomach, preferably 2 hours (but not less than 30 minutes) before the first meal, water or other medication. Only plain water should be washed down, because other drinks, including mineral water, coffee, tea, orange juice) reduce absorption. The tablets should not be chewed or crushed.

The recommended dose is 1 tablet (10 mg) orally once daily or 1 tablet (70 mg) orally once weekly.

For the treatment of osteoporosis in women (postmenopausal) and men, as well as osteoporosis caused by long-term use of glucocorticosteroid drugs, Alendronate is taken 10 mg daily or 70 mg weekly.

In Paget’s disease, it is taken at a dose of 40 mg/day for 6 months. If you accidentally miss a once-a-week regimen, take one tablet on the morning of the next day. Two pills should not be taken on the same day, but you should continue to take one pill on the day of the week that you have chosen to take it since the start of treatment.

Special Instructions

Absorption of bisphosphonates is significantly reduced with concomitant food intake.

In order to reduce the irritant effect on the esophagus, Alendronate should be taken immediately after rising in the morning, with a full glass of water. After intake, stay upright (standing or sitting) for 30 minutes (it is dangerous to use the drug if the patient is unable to stand or sit upright for the specified time). Taking Alendronate before sleeping or in a horizontal position increases the risk of esophagitis.

The patient should be informed to stop taking Alendronate and see a physician if dysphagia, swallowing pain, sore throat pain, or heartburn occur.

If hypocalcemia occurs, it should be corrected before treatment begins. It is necessary to eliminate the disorders of mineral metabolism which lead to hypocalcemia (vitamin D deficiency, hypoparathyroidism, calcium malabsorption). Therapy should be carried out with a diet rich in calcium salts.

When taking bisphosphonates (especially with concomitant therapy with glucocorticosteroid drugs), adequate intake of calcium and vitamin D with food or in the form of medications should be provided.

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 may be observed.

Patients with underlying risk factors (e.g., cancer, chemotherapy, radiation therapy, glucocorticosteroid drugs, poor oral hygiene) should have a dental workup with appropriate preventive dental care prior to bisphosphonate therapy. Patients on bisphosphonate treatment should avoid invasive dental procedures if possible. Osteonecrosis of the jaw, usually associated with tooth extraction and/or local infection (including osteomyelitis), has been reported in cancer patients who received bisphosphonates intravenously (many also received chemotherapy and glucocorticosteroids). There have been reports of osteonecrosis of the jaw in patients with osteoporosis with oral bisphosphonates.

In patients with osteonecrosis of the jaw and who are on bisphosphonate therapy, dental surgical interventions may lead to a worsening of the condition. If surgical interventions are necessary, consider that there are no data on the possibility of reducing the risk of jaw osteonecrosis after bisphosphonate withdrawal.

The prescribing and recommendations of the treating physician must be based on an individual benefit-risk assessment for each patient.

Contraindications

– hypersensitivity to the preparation components;
– hypocalcemia;
– inability to stand upright (stand or sit upright) for at least 30 minutes;
– severe renal insufficiency (creatinine clearance less than 35 ml/min);
– severe mineral metabolism disorders;

Side effects

Gastrointestinal tract disorders:dysphagia, esophagitis, abdominal pain, heartburn, dyspepsia, constipation, diarrhea, flatulence. Rarely – nausea, vomiting, gastritis, melena, esophageal stricture, oral and pharyngeal mucosa ulcers, esophageal ulcer perforation with bleeding.

Muscular system disorders:bone, muscle and joint pain. Nervous system disorders: headache. Eye: uveitis, scleritis.

Allergic reactions: frequently – urticaria, angioedema; single cases of Stevens-Johnson and Lyell syndrome have been reported.

Others: rash, pruritus, erythema, photodermatosis, symptomatic hypocalcemia. Cases of osteonecrosis of the upper and lower jaw have been described mainly in patients with cancer against the background of antitumor treatment including bisphosphonates. Risk factors of osteonecrosis development are cancer diseases, chemotherapy, radiation therapy, treatment with glucocorticosteroids, insufficient oral hygiene, local infection-inflammatory process including osteomyelitis. In the majority of the cases described, the patients underwent tooth extraction during bisphosphonate treatment.

Laboratory findings:significant and transient decrease in calcium and phosphate concentrations.

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

Similarities