Binosto (Tablets) Instructions for Use

Marketing Authorization Holder

Polipharm, LLC (Russia)

Manufactured By

Svissko Servicez AG (Switzerland)

ATC Code

M05BA04 (Alendronic acid)

Active Substance

Alendronic acid (Rec.INN registered by WHO)

Dosage Form

Binosto

Effervescent tablets 70 mg: 4 pcs.

Dosage Form, Packaging, and Composition

Effervescent tablets white or almost white, round, flat, with beveled edges, with a strawberry smell.

2 pcs. – strips (2) – cartons.

Clinical-Pharmacological Group

Bone resorption inhibitor for osteoporosis

Pharmacotherapeutic Group

Bone resorption inhibitor – bisphosphonate

Pharmacological Action

Inhibitor of bone resorption. An aminobisphosphonate, it is an analog of pyrophosphate. The mechanism of action is associated with the suppression of osteoclast activity.

It stimulates osteogenesis, restores a positive balance between bone resorption and restoration, progressively increases bone mineral density (regulates phosphorus-calcium metabolism), and 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 sodium alendronate is reduced by approximately 60%.

After oral administration at therapeutic doses, the plasma concentration of alendronate is usually below the lowest detectable concentration (less than 5 ng/ml).

It is temporarily distributed in soft tissues, then rapidly redistributes to bones or is excreted in the urine.

Plasma protein binding is approximately 78%.

It is not metabolized. It is excreted mainly by the kidneys.

The T_1/2 in the terminal phase can be more than 10 years, which is associated with the release of the active substance from the bones.

Indications

Treatment and prevention of osteoporosis in postmenopausal women.

Treatment of osteoporosis in men to increase bone mass.

Treatment of glucocorticoid-induced osteoporosis in men and women.

Paget’s disease (bone lesion) in men and women.

ICD codes

Dosage Regimen

Take one 70 mg effervescent tablet once weekly.

Dissolve the tablet in at least 120 ml (half a cup) of plain water at room temperature. Do not use mineral water or other liquids.

Wait until effervescence stops and the solution is clear. Stir the solution and consume immediately.

Take the solution at least 30 minutes before the first food, beverage, or other medication of the day.

Take immediately upon rising for the day. Do not take at bedtime or before rising.

After taking the solution, remain in an upright position (sitting or standing). Do not lie down for at least 30 minutes after ingestion.

Swallow the solution. Do not chew or suck the effervescent tablet.

For postmenopausal osteoporosis treatment and prevention, the dose is 70 mg once weekly.

For glucocorticoid-induced osteoporosis, the dose is 70 mg once weekly.

For Paget’s disease of bone, the recommended treatment regimen is 40 mg once daily for six months.

Ensure adequate calcium and vitamin D intake as part of the overall management of osteoporosis.

Do not take two tablets on the same day if a dose is missed. Take only one tablet on the next scheduled day.

Adverse Reactions

From the digestive system pain in the epigastric region; rarely – constipation, diarrhea, flatulence, dysphagia.

From the metabolism asymptomatic hypocalcemia.

Dermatological reactions skin rash, erythema.

Other headache, myalgia.

Contraindications

Esophageal stricture, achalasia, inability of the patient to stand or sit upright for at least 30 minutes after taking the drug, hypocalcemia, hypersensitivity to alendronic acid.

Use in Pregnancy and Lactation

Adequate and strictly controlled clinical studies on the safety of alendronic acid use during pregnancy and lactation have not been conducted. If use during lactation is necessary, breastfeeding should be discontinued.

In experimental studies on rats, it was shown that Alendronic acid at doses of 2 mg/kg/day and higher causes discoordination of labor due to hypocalcemia; at doses above 5 mg/kg/day, a decrease in fetal weight was noted.

Use in Renal Impairment

Use is not recommended in severe renal impairment.

Pediatric Use

Use in children is not recommended.

Special Precautions

Use is not recommended in severe renal impairment, as well as in children.

Use with caution in gastrointestinal diseases in the acute phase.

Before starting treatment, patients with mineral metabolism disorders should undergo their complete correction.

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

Drug Interactions

When taken orally simultaneously with other drugs and products containing calcium, the absorption of alendronic acid is impaired.

In postmenopausal women receiving estrogens, no side effects associated with the use of alendronic acid were noted.

In clinical studies, an increase in the frequency of adverse reactions from the digestive system was observed when alendronic acid was used at a dose of more than 10 mg/day against the background of acetylsalicylic acid therapy.

Storage Conditions

Store at 2°C (36°F) to 30°C (86°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.