Forosa, pills 70mg, 12pcs

Composition

1 film coated tablet contains:

sodium alendronate trihydrate is 91.350 mg, which corresponds to an alendronic acid content of 70 mg.

Auxiliary substances:

microcrystalline cellulose,

colloidal anhydrous silicon dioxide,

croscarmellose sodium,

magnesium stearate.

Shell composition:

Lustre Clear LC 103 (microcrystalline cellulose, carrageenan, macrogol 8000).

Pharmacological action

Phorose is a nonhormonal specific inhibitor of osteoclastic bone resorption that suppresses the activity of osteoclasts.

It stimulates osteogenesis, restores a positive balance between bone resorption and recovery, increases bone mineral density (regulates phosphorus-calcium metabolism), and promotes the formation of bone tissue with a normal histological structure.

Indications

– Treatment of osteoporosis in postmenopausal women, including to reduce the risk of compression fractures of the spine and hip fractures.

– Treatment of osteoporosis in men to prevent fractures.

– Treatment of osteoporosis caused by prolonged use of corticosteroids.

Use during pregnancy and lactation

The drug is contraindicated during pregnancy and lactation.

Contraindications

-Strictures or achalasia of the esophagus and other conditions that lead to a slowdown in the movement of food through the esophagus. – Inability of the patient to stand or sit for 30 minutes-Hypocalcemia. – Severe renal insufficiency ( creatinine clearance less than 35 ml / min). – Severe disorders of mineral metabolism. – Pregnancy. – The period of lactation (breastfeeding). – Children’s age (efficacy and safety of use have not been established). – Hypersensitivity to alendronate or other components of the drug. With caution, the drug should be prescribed to patients with: – Diseases of the gastrointestinal tract: dysphagia, gastritis, duodenitis, peptic ulcer in the acute stage, active gastrointestinal bleeding or surgery on the upper gastrointestinal tract in the anamnesis. – Hypovitaminosis D.

Interaction

Concomitant use of calcium supplements (including dietary supplements) and antacids impairs the absorption of alendronate.

In this regard, it is recommended to take other medications no earlier than 30 minutes after taking the drug Forosa.

NSAIDs (including acetylsalicylic acid) may increase the gastrointestinal side effects of alendronic acid.

Despite the fact that no specific drug interaction studies have been conducted, the use of alendronate in clinical trials with a large number of widely used drugs was not accompanied by the development of a clinically significant interaction.

How to take, course of use and dosage

Tablets should be taken in the morning, no later than 30 minutes before the first meal, drink or other medication, washed down with a full glass of ordinary water (at least 200 ml).

Tablets should not be chewed.

Do not take a horizontal body position for at least 30 minutes after taking the drug.

Do not take the drug before going to bed or before getting out of bed in the morning.

The recommended dose is 70 mg (1 tablet) once a week.

For elderly patients and patients with moderate renal impairment (creatinine clearance greater than 35 ml / min), no dose adjustment is required.

Overdose

Symptoms: abdominal pain, dyspeptic disorders, dysphagia, heartburn, esophagitis, gastritis; hypocalcemia and hypophosphatemia may develop.

Treatment: symptomatic.

Milk and antacids have been shown to bind alendronate. Due to the risk of damage to the esophagus, do not induce vomiting, the patient should be in an upright position.

Special instructions

Tablets should be washed down only with plain water, because other beverages (including mineral water, tea, coffee, fruit juices) impair the absorption of the drug. Taking alendronate at bedtime or in a horizontal position increases the risk of esophagitis.

Hypocalcemia and other metabolic disorders (such as vitamin D deficiency) should be corrected before starting therapy with Forosa. Due to an increase in bone mineral density during alendronate therapy, there may be a slight clinically asymptomatic decrease in serum calcium and phosphate levels, especially in patients receiving corticosteroids, in which calcium absorption may be reduced.

Therefore, ensuring that sufficient amounts of calcium and vitamin D are absorbed into the body is especially important in patients receiving corticosteroids. Patients should be warned that if they accidentally miss taking the drug at a dosage of 1 time a week, they should take 1 tablet in the morning of the next day (it is unacceptable to take 2 tablets in one day). In the future, you should continue to take 1 tablet on the day of the week that was chosen at the beginning of therapy.

When prescribing other bisphosphonates, osteonecrosis of the jaw was rarely observed. Most cases have been reported in cancer patients during dental procedures, with a few cases occurring in patients with postmenopausal osteoporosis or other medical conditions. Risk factors for developing osteonecrosis of the jaw include an established cancer diagnosis, concomitant therapy (chemotherapy, radiation therapy, corticosteroids), and other disorders (anemia, coagulopathy, infection, gum disease).

Most cases were observed with intravenous use of bisphosphonates, but some cases were observed in patients who received the drugs orally. Surgical dental intervention on the background of bisphosphonate therapy can increase the manifestations of osteonecrosis of the jaw.

It is not known whether the elimination of bisphosphonates reduces the risk of osteonecrosis of the jaw. The decision on treatment should be made for each patient individually after assessing the risk / benefit ratio.

Form of production

Film-coated tablets

Storage conditions

Store in a dry place, protected from light, at a temperature not exceeding 25 °C

Shelf life

3 years

Active ingredient

Alendronic Acid

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Description

For adults as prescribed by a doctor, For women in the menopausal period, For postmenopausal women

Indications

Menopause, Osteoporosis