Fosamax tablets 70mg, No. 4

• Treatment and prevention of osteoporosis in postmenopausal women.

• Treatment of osteoporosis in men with the aim of increasing bone mass.

• Treatment of osteoporosis caused by the use of corticosteroids in men and women.

• Paget's disease (bone damage) in men and women.

The recommended dose is one 70 mg tablet once a week. The optimal duration of bisphosphonate therapy for osteoporosis has not been established. The need to continue bisphosphonate therapy should be assessed on a regular basis based on the benefits / risks of using FOSAMAXЃ for each patient, especially after 5 or more years of use.

To ensure sufficient absorption of alendronate:
FOSAMAXЃ must be taken at least 30 minutes before the first meal. beverages or medicines daily taken with plain water only. Other drinks (including mineral water), food, and certain medicines can reduce the absorption of alendronate.

To facilitate the entry of the tablet into the stomach and reduce the likelihood of local and esophageal irritation / adverse events:

• FOSAMAXЃ should be taken only after getting out of bed with a full glass of water (at least 200 ml);

• Patients should swallow the FOSAMAXЃ tablet whole. The tablet should not be crumbled, chewed or sucked in the mouth due to the possible formation of ulcers in the mouth and pharynx;

• Patients should not go to bed before the first meal, which should be at least 30 minutes after taking the pill;

• Patients should not lie down for at least 30 minutes after taking FOSAMAXЃ;

• FOSAMAXЃ should not be taken at bedtime or before getting out of bed.

Patients should additionally take calcium and vitamin D supplements if their intake with food is insufficient.

Use in elderly patients: in clinical studies, there was no difference in the efficacy or safety profiles of alendronate depending on age. Therefore, dose adjustment for elderly patients is not required.

Application for renal failure: No dose adjustment is required for patients with a glomerular filtration rate (GFR) of more than 35 ml / min. Alendronate is not recommended for patients with renal impairment with a GFR of less than 35 ml / min due to insufficient data on its use.
The study of the use of the drug FOSAMAXЃ 70 mg once per week in the treatment of osteoporosis induced by glucocorticoids has not been carried out.

The tablets are white or almost white, oval, with a bone outline on one side and the code number '31' on the other.

1 tab. alendronate sodium 91.37 mg,

which corresponds to the content of alendronic acid 70 mg

Excipients: microcrystalline cellulose - 140 mg, anhydrous lactose - 113.4 mg, croscarmellose sodium - 3.5 mg, magnesium stearate - 1.75 mg.

• Esophageal stricture

• achalasia,

• inability of the patient to stand or sit for 30 minutes after taking the drug,

• hypocalcemia,

• hypersensitivity to alendronic acid.

pharmachologic effect

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 approximately 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.

Side effect

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

From the side of metabolism: asymptomatic hypocalcemia.

Dermatological reactions: skin rash, erythema.

Others: headache, myalgia.

Application during pregnancy and lactation

Adequate and strictly controlled clinical studies of the safety of the use of alendronic acid during pregnancy and lactation have not been conducted. If necessary, 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 more than 5 mg / kg / day, a decrease in fetal weight was noted.

Application for impaired renal function

Not recommended for severe renal impairment.

Application in children

Not recommended for use in children.

special instructions

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

Use with caution in diseases of the gastrointestinal tract in the acute phase.

Before starting treatment, patients with mineral metabolism disorders should be fully corrected.

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

Drug interactions

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

In postmenopausal women who received estrogens, there were no side effects associated with the use of alendronic acid.

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