what is Bifosa-35?
Question:
Answers:
Bifosa is Alendronate sodium and is indicated for:
• Treatment and prevention of osteoporosis in postmenopausal women.
• For the treatment of osteoporosis, alendronate sodium increases bone mass and reduces the incidence of fractures, including those of the hip and spine (vertebral compression fractures). Osteoporosis may be confirmed by the finding of low bone mass (for example, at least 2 standard deviations below the premenopausal mean) or by the presence or history of osteoporotic fracture. (See CLINICAL PHARMACOLOGY, Pharmacodynamics.)
• For the prevention of osteoporosis, alendronate sodium may be considered in postmenopausal women who are at risk of developing osteoporosis and for whom the desired clinical outcome is to maintain bone mass and to reduce the risk of future fracture. Bone loss is particularly rapid in postmenopausal women younger than age 60. Risk factors often associated with the development of postmenopausal osteoporosis include early menopause; moderately low bone mass (for example, at least 1 standard deviation below the mean for healthy young adult women); thin body build; Caucasian or Asian race; and family history of osteoporosis. The presence of such risk factors may be important when considering the use of alendronate sodium for prevention of osteoporosis.
• Treatment to increase bone mass in men with osteoporosis.
• Treatment of glucocorticoid-induced osteoporosis in men and women receiving glucocorticoids in a daily dosage equivalent to 7.5 mg or greater of prednisone and who have low bone mineral density (see PRECAUTIONS, Glucocorticoid-Induced Osteoporosis ). Patients treated with glucocorticoids should receive adequate amounts of calcium and vitamin D.
• Treatment of Paget's disease of bone in men and women.
• Treatment is indicated in patients with Paget's disease of bone having alkaline phosphatase at least 2 times the upper limit of normal, or those who are symptomatic, or those at risk for future complications from their disease.
Non-FDA Approved Indications
Preliminary data have shown alendronate to reduce bone turnover in early rheumatoid arthritis. Alendronate has been used in patients with severe secondary hyperparathyroidism to prevent postparathyroidectomy induced hypocalcemia.
Contraindications:
• Abnormalities of the esophagus which delay esophageal emptying such as stricture or achalasia.
• Inability to stand or sit upright for at least 30 minutes.
• Patients at increased risk of aspiration should not receive alendronate sodium oral solution.
• Hypersensitivity to any component of this product.
• Hypocalcemia
Dosing Instructions
Patients should be instructed that the expected benefits of alendronate sodium may only be obtained when it is taken with plain water the first thing upon arising for the day at least 30 minutes before the first food, beverage, or medication of the day. Even dosing with orange juice or coffee has been shown to markedly reduce the absorption of alendronate sodium (see CLINICAL PHARMACOLOGY, Pharmacokinetics, Absorption).
To facilitate delivery to the stomach and thus reduce the potential for esophageal irritation patients should be instructed to swallow each tablet of alendronate sodium with a full glass of water (6-8 oz). To facilitate gastric emptying patients should drink at least 2 oz (a quarter of a cup) of water after taking alendronate sodium oral solution. Patients should be instructed not to lie down for at least 30 minutes and until after their first food of the day. Patients should not chew or suck on the tablet because of a potential for oropharyngeal ulceration. Patients should be specifically instructed not to take alendronate sodium at bedtime or before arising for the day. Patients should be informed that failure to follow these instructions may increase their risk of esophageal problems. Patients should be instructed that if they develop symptoms of esophageal disease (such as difficulty or pain upon swallowing, retrosternal pain or new or worsening heartburn) they should stop taking alendronate sodium and consult their physician.
Patients should be instructed that if they miss a dose of once weekly alendronate sodium, they should take 1 dose on the morning after they remember. They should not take 2 doses on the same day but should return to taking 1 dose once a week, as originally scheduled on their chosen day.
Source(s):
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http://www.mosbysdrugconsult.com/DrugConsult/Top_200/Drugs/e3232.html#s003232-dosad
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