Strongos (Tablets) Instructions for Use

ATC Code

M05BA04 (Alendronic acid)

Active Substance

Alendronic acid (Rec.INN registered by WHO)

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 concentration of alendronate in blood plasma 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 osteoporosis caused by the use of glucocorticoids in men and women. Paget’s disease (bone lesions) in men and women.

ICD codes

Dosage Regimen

Take one 70 mg tablet once weekly for the treatment of osteoporosis. Take one 35 mg tablet once weekly for the prevention of osteoporosis. For Paget’s disease, take 40 mg once daily for six months.

Take the tablet immediately upon rising for the day. Take with a full glass of plain water (180-240 ml). Do not take with mineral water, coffee, tea, or juice.

Swallow the tablet whole. Do not suck or chew the tablet. Do not lie down after taking the tablet. Remain fully upright (sitting or standing) for at least 30 minutes after ingestion. Do not eat or drink anything other than plain water during this time.

Wait at least 30 minutes after taking the tablet before consuming your first food, beverage, or any other oral medication, including calcium, antacids, and vitamins.

If a weekly dose is missed, take one tablet on the morning after it is remembered. Do not take two tablets on the same day. Resume the regular weekly schedule on the chosen day.

Do not take the tablet at bedtime or before rising for the day. Discontinue use and consult a physician if you develop symptoms of esophageal irritation, such as difficulty or pain upon swallowing, retrosternal pain, or new or worsening heartburn.

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, the patient’s inability 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 it is necessary to use during lactation, 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 is not recommended in children.

Special Precautions

Use is not recommended in severe renal impairment, and also 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

With simultaneous oral administration with other drugs and agents 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 25°C (77°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.