FOROZA®

Active material: Alendronate
When ATH: M05BA04
CCF: An inhibitor of bone resorption in osteoporosis
ICD-10 codes (testimony): M80, M81.0, M81.1, M81.4
When CSF: 16.04.04.01
Manufacturer: LEK d.d. (Slovenia)

Pharmaceutical form, composition and packaging

Pills, Film-coated white, round, lenticular.

Excipients: microcrystalline cellulose, Colloidal anhydrous silica, Croscarmellose sodium, magnesium stearate.

The composition of the shell: Lustre Clear LC 103 (microcrystalline cellulose, karraginan, macrogol 8000).

2 PC. – blisters (1) – packs cardboard.
2 PC. – blisters (2) – packs cardboard.
2 PC. – blisters (3) – packs cardboard.
2 PC. – blisters (4) – packs cardboard.
2 PC. – blisters (6) – packs cardboard.
4 PC. – blisters (1) – packs cardboard.
4 PC. – blisters (2) – packs cardboard.
4 PC. – blisters (3) – packs cardboard.
4 PC. – blisters (4) – packs cardboard.
4 PC. – blisters (6) – packs cardboard.

Pharmacological action

Non-hormonal specific osteoklasticheskoj bone resorption inhibitor, overwhelming activity osteoclastov. It stimulates bone formation, restores a positive balance between resorption and bone repair, increases bone mineral density (regulates calcium and phosphorus metabolism), contributes to the formation of bone tissue with normal histological structure.

Pharmacokinetics

Absorption

Bioavailability of Alendronate in a dose 70 mg when administered on an empty stomach 2 hours before a standard breakfast was in women 0.64%, males – 0.59% . When hiring for 1 or h 30 minutes before breakfast bioavailability Alendronate decreased to 0.46% and 0.39%, respectively. In clinical studies confirmed the efficacy of Alendronate in the application of not less than, than 30 minutes before the first meal or drinks. Bioavailability of Alendronate is insignificant when it is received with food or for 2 hours after meals. When coupled with the coffee or orange juice reduces bioavailability of approximately 60%. The concentration of the drug in plasma is negligible (less 5 ng / ml).

Distribution

Alendronate after in/in the dose of 1 mg/kg temporarily distributed in soft tissue and then quickly redeployed in bone tissue or excreted in the urine. Average V_d at equilibrium, not counting the bone tissue, is a person about 28 l. Plasma protein binding – about 78%.

Metabolism

No data, confirmatory, What is Alendronate is metabolizmu in human body.

Deduction

After a single on/in the introduction of Alendronate, Guard carbon atoms [¹⁴FROM], during 72 h kidneys return about 50% and a small number of – through the intestine. After a single on/in the dose of Alendronate 10 mg kidney klirens is 71 ml / min, and systemic clearance does not exceed 200 ml / min. Through 6 h after the/in the concentration of plasma reduced by more than 95%.

Testimony

— treatment of osteoporosis in postmenopausal women, incl. to reduce the risk of spinal compression fractures and hip fractures;

— treatment of osteoporosis in men with the aim of preventing fractures;

— treatment of osteoporosis, caused by the long-term use of CORTICOSTEROIDS.

Dosage regimen

The tablets should be taken in the morning, not later, than 30 min before the first meal, beverage or other drug, drinking a full glass of usual water (no less 200 ml). Canines pills. Should not take horizontal body position, at least, during 30 minutes after administration. Do not take medication before bedtime or before the morning lifting from the bed.

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

To older patients and patients with moderate renal impairment (QC more 35 ml / min) dose adjustment is required.

Side effect

From the digestive system: stomach ache, dyspeptic disorders (constipation or diarrhea, flatulence, nausea, vomiting), dysphagia, heartburn, esophagitis, disorders of the stomach, pitting oral mucosa, throat, esophagus, stomach and duodenum, ground.

From the nervous system: headache, irritability.

On the part of the musculoskeletal system: ostealgias, muscles and joints, in the treatment of osteonecrosis of the jaw has been observed rarely bisfosfonatami.

On the part of the organ of vision: uveitis, scleritis.

Allergic reactions: hypersensitivity reactions (including flushing of the skin, krapivnicu, angioedema).

Other: photosensitivity, asymptomatic transient hypocalcemia and hypophosphatemia.

Contraindications

— or an achalasia of an esophageal stricture and other conditions, lead to slower moving food to the esophagus;

-failure patient stand or sit during the 30 m;

- Hypocalcemia;

- Severe renal insufficiency (CC less than 35 ml / min);

- Severe disorders of mineral metabolism;

- Pregnancy;

- Lactation (breast-feeding);

- Children's age (efficacy and safety have not been established);

-hypersensitivity to alendronatu or other components of the drug.

FROM caution should appoint drug patients with gastrointestinal diseases (dysphagia, gastritis, duodenitis, peptic ulcer disease in acute stage, Active gastrointestinal bleeding or surgery on the upper gastrointestinal divisions in history), Hypovitaminosis D.

Pregnancy and lactation

The drug is contraindicated in pregnancy and during breastfeeding.

Cautions

The tablets should be taken with plain water only, tk. other drinks (including mineral water, tea, coffee, fruit juices) impair the absorption of the drug.

Reception of Alendronate before bedtime or in horizontal position increases the risk of esophagitis.

Before the start of therapy with Foroza^® a correction of hypocalcemia and other metabolic disturbances (such as vitamin D deficiency). In connection with the increase of alendronatom therapy on bone mineral density may have slight clinically asymptomatic lower levels of calcium and phosphate in serum, especially in patients, receiving corticosteroids, which intake of calcium may be reduced. Therefore, ensuring dostochnogo the amount of calcium and vitamin D in the body, It is especially important in patients, receiving corticosteroids.

Patients should notify, What if you accidentally pass receiving medication in dosage 1 Once a week they should take 1 tab. in the morning the nearest day (It is unacceptable to take 2 tab. one day). Subsequently, should continue to take 1 tab. on the day of the week, which was selected at the beginning of therapy.

When assigning other bisphosphonate rarely celebrated osteonecrosis jaw. Most of the cases registered in cancer patients during dental procedures, several cases – in patients with postmenopauznym osteoporosis or other conditions. Risk factors for osteonekroza jaw include established the diagnosis of cancer, concomitant therapy (chemotherapy, radiotherapy, corticosteroids) and other violations (anemia, koagulopatiju, infection, gum disease). The majority of the cases noted in the on/in the appointment of bisphosphonate, but individual cases have been observed in patients, treated with drugs inside.

Surgical dental intervention on bisfosfonatami therapy can strengthen the manifestations of osteonekroza jaw. Unknown, reduces the risk of jaw osteonekroza cancel bisphosphonate. The decision to hold the treatment needs to be taken for each patient individually after assessing the risk/benefit ratio.

Overdose

Symptoms: stomach ache, dyspeptic disorders, dysphagia, heartburn, esophagitis, gastritis; can develop hypocalcemia and hypophosphatemia.

Treatment symptomatic. Demonstrates the use of milk and antacids to associate Alendronate. The risk of esophageal lesions should not induce vomiting, the patient should be upright.

Drug Interactions

Simultaneous application of calcium preparations (including food additives) and antacids worsens suction Alendronate. It is therefore recommended to take other medications not earlier, than 30 minutes after taking the drug Foroza^®.

NSAIDs (including acetylsalicylic acid) may increase the side effects of alendronova acid from the stomach.

Despite, that special studies on drug interaction was not held, use of Alendronate in clinical trials with a large number of widely used drugs was not accompanied by the development of clinically significant interactions.

Conditions of supply of pharmacies

The drug is released under the prescription.

Conditions and terms

The drug should be stored in a dry, protected from light, inaccessible to children at temperature not exceeding 25 ° C. Shelf life – 2 year.