OSTIMARO [Alendronic Acid] 70 mg Tablets

OSTIMARO

instructions for the medical use of the medicinal product

Tradename

Ostimaro, Остимаро

International non-proprietary name or generic name

Alendronic acid, Алендроновая кислота

Composition

Each film coated tablet contains:

Active substance: Alendronic Acid (as Sodium Alendronate) 70 mg.

Excipients: lactose, starch, Avicel 102, PVP K-30, talc, magnesium stearate, povidone.

Dosage form

Tablets.

Pharmacotherapeutic group

Bone resorption inhibitor - bisphosphonate.

Pharmacological properties

Pharmacodynamics

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

Pharmacokinetics

Taking alendronic acid immediately before, during or after a meal leads to a decrease in bioavailability. When taken with coffee or orange juice, the bioavailability of alendronate sodium is reduced by about 60%.

After oral administration in therapeutic doses, the concentration of alendronate in blood plasma is usually below the lowest concentration that can be determined (less than 5 ng / ml).

It is temporarily distributed in soft tissues, then quickly redistributed into the bones or excreted in the urine. Plasma protein binding is approximately 78%. Not metabolized. It is excreted mainly by the kidneys. T1 / 2 in the final phase can be more than 10 years, which is associated with the release of the active substance from the bones.

Indications for use

Treatment of osteoporosis in postmenopausal women in order to prevent the development of fractures, including hip fractures and compression fractures of the spine.

Treatment of osteoporosis in men to prevent fractures.

Contraindications

Hypersensitivity to alendronic acid and other components of the drug; strictures or achalasias of the esophagus and other conditions leading to difficulty in moving food through the esophagus; inability of the patient to be in an upright position (standing or sitting upright) for at least 30 minutes; severe renal failure (creatinine clearance less than 35 ml / min); severe disorders of mineral metabolism; hypocalcemia; pregnancy and the period of breastfeeding.; children under 18 years of age.

Method of administration and dosage

Inside, 30 minutes before the first meal, liquid or medication, with only water. The tablets should not be chewed or sucked.

For adults: The recommended dose is: 1 tablet 70 mg once a week.

The optimal duration of the drug has not been established. The need for continued therapy with bisphosphonates should be assessed by the attending physician on a regular basis, especially after 5 or more years of use.

Special instructions and precautions

To reduce the risk of irritation of the esophagus, the drug should be taken according to the rules listed below.

The drug should be taken with only plain water, since other drinks (including mineral water, coffee, tea, orange juice) reduce the absorption of alendronic acid.

To reduce the irritating effect on the esophagus, Ostimaro should be taken immediately after waking up in the morning with a full glass of water.

After taking it, you should be in an upright position (standing or sitting) for 30 minutes. Taking the drug before bedtime or in a horizontal position increases the risk of developing esophagitis.

Patients should take additional calcium and vitamin D supplements if dietary intake of these substances is insufficient.

If dysphagia develops, pain when swallowing, chest pain or heartburn occurs, consult a doctor immediately.

In case of hypocalcemia, it is necessary to correct it before starting treatment. In particular, it is necessary to eliminate violations of mineral metabolism leading to hypocalcemia (vitamin D deficiency, hypoparathyroidism, calcium malabsorption). Therapy should be carried out against the background of a diet enriched with calcium salts.

It is not recommended for use in severely impaired renal function, as well as in children.

It is used with caution in diseases of the gastrointestinal tract in the acute phase (dysphagia, esophagitis, gastritis, duodenitis, gastric ulcer and duodenal ulcer).

Patients with associated risk factors (eg, cancer, chemotherapy, radiation therapy, glucocorticosteroid medication, poor oral hygiene) should undergo a dental examination with appropriate prophylactic dental treatment prior to prescribing bisphosphonate therapy.

The interval between taking Ostimaro and other drugs should be at least 1 hour.

Influence on the ability to drive vehicles and mechanisms

Given the possibility of adverse reactions, care should be taken when driving vehicles, precise mechanisms and refrain from performing these activities in the event of side effects.

Application during pregnancy and during breastfeeding

Contraindicated for use during pregnancy and during breastfeeding.

Interaction with other medicinal products

The simultaneous use of calcium preparations (including food additives) and antacids impairs the absorption of alendronic acid. In this regard, it is recommended to take other medications no earlier than 30 minutes after taking the drug Ostimaro.

NSAIDs (including acetylsalicylic acid) can increase the side effects of alendronic acid from the gastrointestinal tract.

Side effect

From the digestive system: abdominal pain, dyspeptic disorders (constipation or diarrhea, flatulence), dysphagia, heartburn, nausea, vomiting, esophagitis, gastritis, esophageal strictures, ulceration of the oral mucosa, pharynx, esophagus, stomach and duodenum, bleeding from upper gastrointestinal tract, melena, esophageal perforation.

From the nervous system: headache, dizziness, taste perversion, irritability.

From the side of the organ of vision: scleritis, uveitis (inflammation of the choroid of the eye) and inflammation of the episcleral connective tissue.

Skin and subcutaneous tissue disorders: alopecia, itching, rash, erythema, hypersensitivity reactions (including skin hyperemia, urticaria, angioedema, severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis), photosensitivity.

Musculoskeletal and connective tissue disorders: pain in muscles, bones, joints, osteonecrosis of the jaw, diaphyseal fractures of the hip, swelling of the joints.

Laboratory indicators: asymptomatic transient hypocalcemia and hypophosphatemia.

If any of the side effects indicated in the instructions are aggravated, or you notice any other side effects not listed in the instructions, inform your doctor.

Overdose

Symptoms: possible development of hypocalcemia, hypophosphatemia, as well as side reactions from the gastrointestinal tract (diarrhea, heartburn, esophagitis or erosive and ulcerative lesions of the gastrointestinal tract).

Treatment: milk or antacid to bind alendronic acid. Due to the risk of irritation of the esophagus, vomiting should not be induced. The patient must be in an upright position.

Storage conditions

Store in a dry and dark place, at a temperature not exceeding 25°C.

Keep out of the reach of children!

Shelf life

2 years. Do not use after the expiration date printed on the package.

Vacation conditions

Dispensed by prescription.

Release form

4 tablets in an aluminum foil blister. 1 blister with instructions for use in a cardboard box.