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FOSAMAX (alendronate sodium)
alendronate sodium: sodium alendronate, FOSAMAX.
FOSAMAX
FOSAMAX – proofreader metabolism of bone tissue, an effective inhibitor of bone resorption. It is used to treat osteoporosis in postmenopausal women and osteoporosis in men, Paget’s disease (deforming osteo), malignant hypercalcemia.
Latin name:
FOSAMAX / FOSAMAX.
The composition and the form of:
FOSAMAX tablets of 28 pcs. in the package.
1 tablet of FOSAMAX contains alendronate sodium trihydrate, which corresponds to the content alendronovoy acid 10 mg.
FOSAMAX tablets of 4 pcs. in the package.
1 tablet of FOSAMAX contains alendronate sodium trihydrate, which corresponds to the content alendronovoy acid 70 mg.
Active-active substance:
Alendronate sodium / Alendronate sodium.
Pharmacological properties:
FOSAMAX – proofreader bone metabolism, is the amino-bisphosphonate, which acts as an effective specific inhibitor of bone resorption caused by osteoclasts.
Bisphosphonates are synthetic analogs of pyrophosphate, hydroxyapatite binding, located in the bone.
Indications:
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treatment of osteoporosis in postmenopausal women to prevent fractures, including fractures of the hip and spine (compression fractures);
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treatment of osteoporosis in men to prevent fractures;
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Paget’s disease (deforming osteo);
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malignant hypercalcemia (additional treatment).
Dosage and administration:
Treatment of osteoporosis in postmenopausal women and men: The recommended dosage is 70 mg once a week or 10 mg once a day.
In Paget’s disease – 40 mg / day for 6 months.
FOSAMAX should take at least half an hour before the first eating, drinking or drugs, just drinking a full glass of plain water because other drinks (including mineral water), food and some medications may decrease the absorption of FOSAMAX.
In order to ensure getting medication tablets in the stomach and thus reduce the potential irritant effect of the drug to the esophagus, FOSAMAX should be taken after the morning rise from bed, with a full glass of water. In this patient, after taking the drug should not put at least 30 minutes before the first day meal. FOSAMAX should not be taken at bedtime or before the morning rise from bed. Failure to comply with the conditions the drug may increase the risk of negative effects on the esophagus.
All patients with osteoporosis should receive adequate amounts of calcium from food.
Dosage adjustments are not required either for elderly patients or patients with mild to moderate renal insufficiency (creatinine clearance from 35 to 60 ml / min). In the absence of data FOSAMAX is not recommended for use in patients with more severe renal insufficiency (creatinine clearance <35 ml / min).
Overdose:
Specific information on the treatment of overdose FOSAMAX is not available.
In case of overdose can occur hypocalcemia, hypophosphatemia, as well as side effects of localization in the upper gastrointestinal tract, such as indigestion, heartburn, esophagitis, gastritis or ulcers.
In these cases, the designated milk or antacids to bind alendronate, being symptomatic therapy. Because of the risk of irritation of the esophagus should not cause vomiting, the patient should remain in an upright position.
Contraindications:
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esophageal disease in which there is a delay passage of food, such as stricture or achalasia;
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inability to stand or sit upright for at least 30 minutes;
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hypersensitivity to any component of this medication;
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severe renal impairment;
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hypocalcemia, pregnancy, breastfeeding, childhood.
Use during pregnancy and lactation:
Study of FOSAMAX in pregnant women has not been, and it should not appoint them.
FOSAMAX has not been studied in women who are breastfeeding, and it should not appoint them.
Side effects:
In clinical studies FOSAMAX was generally well tolerated. Side effects were generally mild and did not require the abolition of therapy.
The researchers reported the following side effects, possibly, probably or definitely associated with receiving FOSAMAX in one or more of patients:
FOSAMAX 70 mg / once a week. FOSAMAX 10 mg / once a day. pain in the bones, muscles or joints 2,9% 3,2% abdominal pain 3,7% 3,0% dyspepsia 2,7% 2,2% burp 1,9% 2,4% Nausea 1.9% 2 , 4% bloating 1,0% 1,4% 0,8% constipation flatulence 0,4% 1,6% 1,6% muscle cramps 0,2% 1,1% gastritis 0,2% 1,1% ulcer 0,0% 1,1%
Possible hypersensitivity reactions, including urticaria and rarely angioedema, photosensitivity.
Occasionally, stenosis or perforation of the esophagus, oropharyngeal ulcers, gastric ulcers and duodenal ulcers, some severe illness and complications, although their causal relationship to drug not established.
Perhaps the reduction of calcium and phosphate in the blood serum.
Precautions and special instructions:
FOSAMAX, like other bisphosphonates, may cause local irritation of the upper gastrointestinal tract.
Reported adverse reactions to the esophagus such as esophagitis, ulceration and erosion of the esophagus in patients treated with FOSAMAX.
In some cases, side effects were pronounced and required hospitalization. In this connection it is necessary to examine with special attention to any signs or symptoms suggestive of possible reaction from the esophagus. Patients should be informed of the need to stop taking FOSAMAX and seek medical help in case of dysphagia, pain when swallowing or pain behind the breastbone.
The risk of serious adverse effects on the esophagus, probably higher in patients who lie down after taking FOSAMAX and / or take medication is not washing it down with a full glass of water and / or continue receiving the drug after developing symptoms characteristic of the irritation of the esophagus. Thus, it seems very important clarification of the rules of patients taking the drug and to draw attention to the need for full compliance.
In connection with the possible irritant FOSAMAX the mucosa of the upper gastrointestinal tract, caution must be exercised in the appointment of FOSAMAX patients with acute diseases of the upper gastrointestinal tract, such as dysphagia, esophageal disease, gastritis, duodenitis or peptic ulcer disease.
In order to ensure getting medication tablets directly into the stomach and thus reduce the potential irritant effect of the drug to the esophagus, the patient must take FOSAMAX with a full glass of water and do not go for at least 30 minutes before the first day meal . Patients should not chew or suck the tablets. Especially not encouraged to take FOSAMAX at bedtime or before rising in the morning from bed. Failure to comply with the conditions the drug may increase the risk of negative effects on the esophagus. Patients should stop taking FOSAMAX and seek medical help in case of developing symptoms of esophageal disease (difficulty or pain when swallowing, pain behind the breastbone, the emergence or worsening heartburn).
FOSAMAX is not recommended to patients with creatinine clearance below 35 ml / min.
It should take into account other causes of osteoporosis, is not associated with estrogen deficiency and aging.
In the presence of hypocalcemia should be its correction before the treatment drug. Patients with other disorders of mineral metabolism (such as deficiency of vitamin D) should be fully appropriate treatment.
FOSAMAX has not been studied in children, and it should not appoint them.
In clinical studies, there was no age-related differences in the effectiveness and safety of the drug.
Drug Interactions:
Calcium, antacids and some other means, taken orally, can affect the absorption of FOSAMAX if taken at the same time. Therefore, patients must wait at least half an hour after taking FOSAMAX before taking another drug inside.
NSAIDs increase gastrotoksichnost.
Other drug interactions with clinical significance, not assumed.
Special studies FOSAMAX interaction with other drugs have not been. FOSAMAX was used together with a number of drugs is often administered in clinical trials in women with postmenopausal osteoporosis. Thus any adverse interactions were observed.
