Osteofos Tablets (Generic Fosamax) - Active Ingredient And Chemical structure
The active ingredient contained in Osteofos Tablets is Alendronate Sodium. Alendronate sodium is a white, crystalline, nonhygroscopic powder. It is soluble in water, very slightly soluble in alcohol, and practically insoluble in chloroform. The structure is shown below
Generic Forms and Brand names of Fosamax
Osteofos Tablets manufactured by Cipla Ltd., India is used for treatment and prevention of osteoporosis in postmenopausal women. Fosamax which has the active ingredient Alendronate Sodium is also sold under various other brand names.
Osteofos Tablets Preparations
Osteofos is available as tablets of 10 mg, 35 mg and 70 mg . Each uncoated tablet of Osteofos for oral administration contains Sodium Alendronate BP equivalent to Alendronic acid 10 mg, 35 mg and 70 mg respectively as well as inactive ingredients.
Osteofos Tablets - Storage Requirements
Osteofos Tablets are to be stored at room temperature (15°C to 30°C). Store away from heat, moisture, and light.
Generic Fosamax (Osteofos Tablets) - Uses
Generic Fosamax in the form of Osteofos Tablets is used for:
Treatment and prevention of osteoporosis in postmenopausal women
For the treatment of osteoporosis, Generic Fosamax 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 or by the presence or history of osteoporotic fracture.
For the prevention of osteoporosis , Osteofos Tablets 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.
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. 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 two times the upper limit of normal, or those who are symptomatic, or those at risk for future complications from their disease.
Osteofos Tablets - Contraindications
Osteofos Tablets (Generic Fosamax) is contraindicated in the following cases:
- Abnormalities of the esophagus which delay esophageal emptying such as stricture or achalasia
- Inability to stand or sit upright for at least 30 minutes
- Hypersensitivity to Alendronate Sodium or any inactive ingredient of this medication.
- Hypocalcemia
Osteofos Tablets - Dosage
Osteofos Tablets must be taken at least half an hour before the first food, beverage, or medication of the day with plain water only. Other beverages (including mineral water), food, and some medications are likely to reduce the absorption of Osteofos. Waiting less than 30 minutes, or taking Osteofos with food, beverages (other than plain water) or other medications will lessen the effect of Osteofos by decreasing its absorption into the body.
Generic Fosamax should only be taken upon arising for the day. To facilitate delivery to the stomach and thus reduce the potential for esophageal irritation, an Osteofos tablet should be swallowed with a full glass of water (6-8 oz). Patients should not lie down for at least 30 minutes and until after their first food of the day. Osteofos should not be taken at bedtime or before arising for the day.
Failure to follow these instructions may increase the risk of esophageal adverse experiences Patients should receive supplemental calcium and vitamin D, if dietary intake is inadequate No dosage adjustment is necessary for the elderly or for patients with mild-to-moderate renal insufficiency (creatinine clearance 35 to 60 mL/min). Osteofos is not recommended for patients with more severe renal insufficiency (creatinine clearance less than 35 mL/min) due to lack of experience.
The recommended dosage of Osteofos for the treatment of various indications is given below:
Treatment of osteoporosis in postmenopausal women
The recommended dosage is:
• one 70 mg tablet once weekly
or
• one 10 mg tablet once daily
Treatment to increase bone mass in men with osteoporosis
The recommended dosage is:
• one 70 mg tablet once weekly
or
• one 10 mg tablet once daily
Prevention of osteoporosis in postmenopausal women
The recommended dosage is:
• one 35 mg tablet once weekly
or
one 5 mg tablet once daily
The safety of treatment and prevention of osteoporosis with Osteofos has been studied for up to 7 years.
Treatment of glucocorticoid-induced osteoporosis in men and women
The recommended dosage is one 5 mg tablet once daily, except for postmenopausal women not receiving estrogen, for whom the recommended dosage is one 10 mg tablet once daily.
Paget’s disease of bone in men and women
The recommended treatment regimen is 40 mg once a day for six months.
Retreatment of Paget’s disease
In clinical studies in which patients were followed every six months, relapses during the 12 months following therapy occurred in 9% (3 out of 32) of patients who responded to treatment with Osteofos.
Side Effects Of Osteofos Tablets (Generic Fosamax)
The most common side effects of are given below:
Gastrointestinal
abdominal pain, nausea, dyspepsia, constipation, diarrhea, flatulence, acid regurgitation, esophageal ulcer, vomiting, dysphagia, abdominal distention and gastritis
Musculoskeletal
musculoskeletal (bone, muscle or joint) pain, muscle cramp
Nervous System/Psychiatric
headache, dizziness
Special Senses
taste perversion
Rarely, rash and erythema have occurred.
Further Information
Additional Info: Prescribing Information
