Description
release form
tablets.
Packing
4 pcs.
Pharmacological action
Fosamax is an inhibitor of bone resorption in osteoporosis. Sodium alendronate refers to bisphosphonates – compounds that, localized in areas of active bone resorption, under osteoclasts, inhibit the process of bone resorption caused by osteoclasts, without directly affecting the formation of new bone tissue. Since bone resorption and the formation of new bone tissue are interconnected, bone formation also decreases, but to a lesser extent than resorption, which leads to a progressive increase in bone mass. During treatment with sodium alendronate, normal bone tissue forms, into the matrix of which alendronate is embedded, remaining pharmacologically inactive. In therapeutic doses, alendronate does not cause osteomalacia.
Indications
– treatment of osteoporosis in postmenopausal women to prevent fractures, incl.
hip fractures and compression spinal fractures – treatment of osteoporosis in men to prevent fractures.
Contraindications
– damage to the esophagus that slows its emptying (including narrowing or achalasia)
– inability to stand or sit upright for 30 minutes after taking
– increased sensitivity to the components of the
drug – hypocalcemia.
Use during pregnancy and lactation
The drug is not prescribed during pregnancy and lactation due to the lack of sufficient clinical observations.
Special instructions
The patient should be informed that with symptoms of a gastrointestinal tract (for example, pain when swallowing or behind the sternum, the appearance or intensification of heartburn) it is necessary to stop taking the drug and consult a doctor.
The risk of developing severe adverse reactions from the esophagus increases in patients who violate the rules for taking the drug (they are in a horizontal position after taking Fosamax, drink with an incomplete glass of water, continue to take Fosamax after the onset of symptoms of irritation of the esophagus). Therefore, the patient should be clearly informed about the rules for taking the drug.
Fosamax should be used with caution in patients with exacerbation of diseases of the upper gastrointestinal tract (dysphagia, diseases of the esophagus, gastritis, duodenitis, ulcers) due to the possible irritating effect of Fosamax on the mucous membrane and worsening of the course of the underlying disease.
Patient should be informed that that if you accidentally skip a dose of the drug once a week, you should take 1 tablet in the morning of the next day. You should not take 2 tablets in 1 day, but in the future you need to continue to take 1 tablet on that day of the week, which was chosen to be taken from the very beginning of treatment.
Before starting treatment with Fosamax, the blood calcium level should be normalized and vitamin D deficiency should be compensated.
Due to the fact that Fosamax increases the mineral content in bones, there may be a slight asymptomatic decrease in serum calcium and phosphate levels (including in patients receiving corticosteroids, in which calcium absorption may be reduced).
Patients should take dietary supplements containing calcium and vitamin D if they are not sufficiently ingested.
In clinical trials, there were no age-related differences in the efficacy or safety profile of Fosamax.
In double-blind, multicenter, controlled trials, 18% and 10% of patients taking Fosamax and 12% and 3% of patients receiving placebo showed an asymptomatic, mild, and transient decrease in serum calcium and phosphate levels. However, the frequency of a decrease in calcium content of less than 8 mg / dl and phosphate less than 2 mg / dl was the same in both groups.
Composition
1 tab. contains alendronate sodium trihydrate 91.37 mg, respectively. the content of alendronic acid 70 mg.
Dosage and administration of
For the treatment of osteoporosis in women and men, the drug is prescribed 70 mg once a week.
For elderly patients, patients with mild or moderate renal failure (CC from 35 to 60 ml / min) dose adjustment is not required.
The use of Fosamax in patients with severe renal failure (CC less than 35 ml / min) is not recommended due to the lack of clinical observations.
Rules for taking the drug
Fosamax must be taken at least 30 minutes before the first meal, drink or medicine, washed down with plain water only. Other drinks (including mineral water), food and certain medicines may decrease the absorption of Fosamax. To facilitate entry into the stomach and thereby reduce irritation of the esophagus, Fosamax should be taken only after rising from bed, washed down with a full glass of water. After this, patients should not go to bed for at least 30 minutes. Fosamax should not be taken before bedtime or before getting out of bed. Failure to follow these instructions may increase the risk of adverse reactions from the esophagus.
Side effects of the
Digestive system: abdominal pain, dyspepsia, esophageal ulcer, dysphagia, flatulence, constipation, diarrhea, sour belching, nausea, taste distortion, gastritis rarely (1/10 000,
From the musculoskeletal system : myalgia, pain in bones, joints rarely (1/10 000,
From the nervous system: headache, dizziness.
From the organ of vision: rarely (1/10 000,
Dermatological reactions: rare (1/10 000,
Allergic reactions: hypersensitivity reactions, including urticaria rarely (1/10 000,
Metabolism: hypocalcemia, also decreased levels of serum calcium and phosphates (usually mild, asymptomatic and transient) by 18% and 10%, respectively
Drug Interactions
The absorption of Fosamax may be impaired while being used with calcium preparations (including nutritional supplements) and antacids.
The interval between taking Fosamax and other drugs should be at least 30 minutes.
The combined use of hormone replacement therapy (estrogen ± progestin) and Fosamax was studied in two clinical trials lasting 1 or 2 years with the participation of postmenopausal women with osteoporosis. The use of this combination led to a greater increase in bone mass and a more significant decrease in bone resorption compared to the separate use of the first or second method of treatment. In these studies, the safety and tolerability of combination therapy were consistent with those for each of these treatment methods alone.
No specific studies on interaction with other drugs have been conducted.
Overdose
Symptoms: overdosage may develop hypocalcemia, hypophosphatemia, upset stomach, heartburn, esophagitis, stomach ulcers.
Treatment: No specific information. For alendronate binding, the patient should drink milk or take antacids. Due to the risk of irritation of the esophagus, vomiting should not be caused. The patient should maintain a vertical position.
Storage Conditions
The product should be stored at room temperature (15-30 ° C) in a dry, dark place.
Shelf life
2 years.
Deystvuyushtee substance
Alendronovaya Chisloth
drugstore conditions
drugstore
dosage form
tablets
Possible product names
FOSAMAX 0.07 N4 TABLES
Fosamax 70 mg No. 4 tablet
Fosamax 70mg Tab. X4 (R)
Fosamax 70mg Tab. X4 (R) $
Fosamax 70mg Tab. X4 (R) /! Until 09.13g /
Merck Sharp and Doom BV, USA
