Forosa, 70 mg 12 pcs

Forose is a non-hormonal specific inhibitor of osteoclastic bone resorption, inhibiting the activity of osteoclasts.

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

Indications

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

– Treatment of osteoporosis in men to prevent fractures.

– Treatment of osteoporosis caused by long-term use of GCS.

Active ingredient

Composition

1 film-coated tablet contains:

Alendronate sodium trihydrate 91.350 mg, which corresponds to the content of alendronic acid 70 mg.

Auxiliary substances:

Cellulose microcrystalline,

colloidal anhydrous silica,

croscarmellose sodium,

magnesium stearate.

Coating composition:

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

How to take, the dosage

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

The tablets must not be chewed.

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

The drug should not be taken before going to bed or before getting out of bed in the morning.

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

In elderly patients and patients with moderate renal dysfunction (CK greater than 35 ml/min), no dose adjustment is required.

Interaction

Simultaneous use of calcium preparations (including dietary supplements) and antacids impairs absorption of alendronate.

In this regard, it is recommended to take other medicinal products not earlier than 30 minutes after taking Foroz.

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

While no specific studies on drug interactions have been conducted, the use of alendronate in clinical trials with a large number of commonly used drugs was not accompanied by the development of clinically significant interactions.

Special Instructions

The tablets should be swallowed only with plain water, because other drinks (including mineral water, tea, coffee, fruit juices) impair absorption of the drug. Taking alendronate before bedtime or in a horizontal position increases the risk of esophagitis.

Before starting the therapy with Foroza it is necessary to correct hypocalcemia and other metabolic disorders (such as vitamin D deficiency). Due to increased bone mineral density with Alendronate therapy a mild clinically asymptomatic decrease of serum calcium and phosphate levels is possible especially in patients receiving GCS when calcium absorption may be decreased.

Hence, ensuring adequate intake of calcium and vitamin D is especially important in patients receiving GCS. Patients should be advised that if the once weekly dosage is accidentally missed, they should take 1 tablet on the morning of the next day (no 2 pills should be taken on the same day). Thereafter, they should continue to take 1 tablet on the day of the week that was chosen at the beginning of therapy.

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

The majority of cases have been reported with bisphosphonates administered by injection, but isolated cases have been observed in patients receiving oral medications. Dental surgery during bisphosphonate therapy may exacerbate osteonecrosis of the jaw.

It is not known whether withdrawal of bisphosphonates reduces the risk of osteonecrosis of the jaw. The decision to treat needs to be made for each patient individually after assessing the risk/benefit ratio.

Contraindications

– Esophageal strictures or achalasia and other conditions resulting in delayed movement of food through the esophagus.
– Patient’s inability to stand or sit for 30 minutes.
– Hypocalcemia.
– Severe renal insufficiency (CKR less than 35 ml/min).
– Severe disorders of mineral metabolism.
– Pregnancy.
– The period of lactation (breast-feeding).
– Childhood age (effectiveness and safety of use have not been determined).
– Hypersensitivity to alendronate or other components of the drug.
The drug should be administered with caution to patients with:
– Gastrointestinal diseases: dysphagia, gastritis, duodenitis, peptic ulcer in the acute stage, active gastrointestinal bleeding or upper GI surgery in the anamnesis.
– Hypovitaminosis D.

Overdose

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

Treatment: symptomatic.

The use of milk and antacid drugs to bind alendronate is indicated. Due to the risk of esophageal damage, vomiting should not be induced, the patient should be in an upright position.

Pregnancy use

The drug is contraindicated in pregnancy and during breastfeeding.

Similarities