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Active ingredients
Alendronic acid
Release form
Pills
Composition
The composition on one bottle: Active substance: Octreotide acetate in terms of octreotide 10.0 excipients: DL-lactic and glycolic acid copolymer 270.0 mg, D-Mannitol 85.0 mg, carmellose sodium 30.0 m, Polysorbate-80 2.0 Solvent for suspension preparation - Mannitol, solution 0.8% Composition per 1 ml: D-Mannitol 8.0 mg Water for injection to 1.0 ml
Pharmacological effect
A non-hormonal inhibitor of bone resorption from the group of bisphosphonates - analogues of pyrophosphates. Localized under osteoclasts in the areas of bone resorption and inhibits this process. In its chemical structure there is a P-O-P-bond, with the help of which it is incorporated into the tissue and suppresses osteoclasts. Resorption and the formation of new bone tissue occur in parallel, so the process of bone formation is also reduced, but less than the resorption and as a result an increase in bone tissue occurs. FOSAMAX stimulates osteogenesis, increases bone mineral density (BMD), has a beneficial effect on the formation of normal bone tissue, reduces the risk of fractures in osteoporosis. In therapeutic doses does not cause osteomalacia. Its efficacy in osteoporosis in men and women caused by taking glucocorticoids, as well as in osteoporosis in men has been proved. Reverse development of osteoporosis when taking this drug has been proven by studies - the bone acquires normal structure and mineralization, decreases the decay of bone collagen and calcium in the urine. The effectiveness of the drug does not depend on age, kidney function and the initial rate of metabolic processes in bone tissue.
Pharmacokinetics
When taken on an empty stomach 2 hours before meals, the bioavailability is 0.64%, if the drug is taken 1 hour before breakfast, the bioavailability is reduced by 40%. Simultaneous intake of coffee reduces bioavailability by 60%. Prednisolone does not affect the bioavailability of the drug. Protein binding is 78%. After i / v administration in the blood after 6 h, the concentration is reduced by 95%. With urine, 50% of the drug is excreted. The final half-life is 10 years.
Indications
Postmenopausal osteoporosis in women (preventing the development of fractures, in particular the femur,spinal compression fractures); prevention of osteoporosis at risk of its occurrence in women during menopause (reducing the likelihood of fractures); treatment of osteoporosis in men (preventing the development of fractures); treatment of glucocorticoid-induced osteoporosis; Paget's bone disease therapy
Contraindications
Diseases of the upper GI tract (achalasia, dysphagia, esophageal stricture, duodenitis, peptic ulcer); hypocalcemia (hypoparathyroidism, calcium malabsorption, vitamin D deficiency); pregnancy, breastfeeding; childhood; severe renal impairment; hypersensitivity to the drug
Use during pregnancy and lactation
Contraindicated
Dosage and administration
Is taken orally, once a day. preferably in the morning, without chewing, 2 hours before meals. It is necessary to wash down the pill only with water, since other drinks reduce absorption. With Paget's disease, 40 mg for at least 6 months. For the prevention of osteoporosis prescribe 5 mg / day. With osteoporosis in postmenopause - 10 mg / day. There is a release form in pills of 70 mg, which are taken 1 time per week. For a weekly reception, there is also a combined drug with vitamin D. Acceptance of 10 mg of the drug in terms of effectiveness and the appearance of adverse reactions is equivalent to a weekly dose of 70 mg. Instructions for use Fosamax contains a warning that in order to reduce the irritating effect of the drug on the esophagus it is necessary to take a pill in the morning with a glass of water, after which it is impossible to lie down for 30 minutes. If you take a pill before bedtime, the risk of esophagitis and other diseases of the esophagus increases. Treatment must be combined with a diet rich in salts of Ca2 +.
Side effects
• Urticaria, rash, itching, rarely - angioedema; • dizziness, vertigo; • bone pain, myalgia, arthralgia; • asthenia; • peripheral edema; • esophagitis, ulcers of the esophagus, oropharynx, stomach.
Overdose
Manifesting symptoms: hypocalcemia, hypophosphatemia, gastrointestinal complications (dyspepsia, heartburn, gastritis, esophagitis, gastric and esophageal ulcers). Specific therapy does not exist. To bind alendronate, take milk or antacids. Do not induce vomiting
Interaction with other drugs
When combined with antacids, calcium preparations, impaired absorption of alendronate is noted, therefore, it is necessary to take the intake of these drugs in time. Ranitidine increases the bioavailability of FOSAMAX by 2 times. Gastrointestinal adverse events increase if Fosamax is taken along with acetylsalicylic acid and other NSAIDs. When used together with estrogen, the safety of the treatment corresponds to the safety when using each drug independently.
special instructions
When using FOSAMAX and analogues, there is a risk of damage to the upper GI tract. Patients should be warned of this risk. If characteristic symptoms appear, medical assistance is required. The risk of severe damage to the gastrointestinal tract is significantly higher in patients who violate the recommendations on the use of FOSAMAX or continue to receive it after the onset of the first symptoms of gastrointestinal mucosa. If you accidentally skip the next dose of Fosamax (1 tablet per week), it is recommended to take the next tablet the next morning. Subsequently, it is recommended to return to the selected schedule of the drug. You can not take 2 pills in one day. FOSAMAX is used exclusively on prescription and under strict medical supervision.