Osteofos Tablets (Generic Alendronate Sodium Tablets)

1. Osteofos Tablets (Generic Alendronate Sodium Tablets) © The Swiss Pharmacy

2. Osteofos Tablets (Generic Alendronate Sodium Tablets) Osteofos (Generic Alendronate Sodium Tablets) is a bisphosphonate which is used for treatment and prevention of osteoporosis in postmenopausal women, treatment to increase bone mass in men with osteoporosis, treatment of glucocorticoid-induced osteoporosis and treatment of Paget's disease of bone. © The Swiss Pharmacy

3. Osteofos Tablets (Generic Alendronate Sodium Tablets) Osteofos Tablets are manufactured by Cipla Limited, India in the strengths of 10 mg, 35 mg and 70 mg. © The Swiss Pharmacy

4. Osteofos Tablets (Generic Alendronate Sodium Tablets) Chemical Structure © The Swiss Pharmacy

5. Osteofos Tablets (Generic Alendronate Sodium Tablets) The active ingredient contained in Osteofos tablets is Alendronate Sodium. Each uncoated Osteofos tablet contains Alendronate Sodium, BP, equivalent to 10mg, 35mg or 70mg of Alendronic Acid. © The Swiss Pharmacy

6. Osteofos Tablets (Generic Alendronate Sodium Tablets) Uses of Osteofos 10 mg, 35 mg and 70 mg Tablets: Osteofos tablets (Generic Alendronate Sodium tablets) is used to prevent and treat osteoporosis (thinning of the bone) in women after menopause. This medicine may also be used to increase bone mass in men who have osteoporosis, and in men and women to prevent and treat osteoporosis caused by long-term use of corticosteroids (cortisone-like medicine). It may also be used to treat Paget's disease of the bone. Treatment of Osteoporosis in Postmenopausal Women: Osteofos (Generic Alendronate Sodium tablets) are used for the treatment of osteoporosis in postmenopausal women. In postmenopausal women, Alendronate Sodium tablets increase bone mass and reduce the incidence of fractures, including those of the hip and spine (vertebral compression fractures). © The Swiss Pharmacy

7. Osteofos Tablets (Generic Alendronate Sodium Tablets) Uses of Osteofos 10 mg, 35 mg and 70 mg Tablets: Prevention of Osteoporosis in Postmenopausal Women: Alendronate sodium tablets are indicated for the prevention of postmenopausal osteoporosis. Treatment to Increase Bone Mass in Men with Osteoporosis: Alendronate Sodium tablets are indicated for treatment to increase bone mass in men with osteoporosis. Treatment of Glucocorticoid-Induced Osteoporosis: Osteofos (Generic Alendronate Sodium tablets) are used for the 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. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9671_Osteofos-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9671_Osteofos-Tablets.html © The Swiss Pharmacy

8. Osteofos Tablets (Generic Alendronate Sodium Tablets) Uses of Osteofos 10 mg, 35 mg and 70 mg Tablets: Treatment of Paget's Disease of Bone: Alendronate Sodium tablets are indicated for the treatment of Paget’s disease of bone in men and women. Treatment is indicated in patients with Paget's disease of bone who have 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. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9671_Osteofos-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9671_Osteofos-Tablets.html © The Swiss Pharmacy

9. Osteofos Tablets (Generic Alendronate Sodium Tablets) Uses of Osteofos 10 mg, 35 mg and 70 mg Tablets: Important Limitations of Use: The optimal duration of use has not been determined. The safety and effectiveness of alendronate sodium tablets for the treatment of osteoporosis are based on clinical data of four years duration. All patients on bisphosphonate therapy should have the need for continued therapy re-evaluated on a periodic basis. Patients at low-risk for fracture should be considered for drug discontinuation after 3 to 5 years of use. Patients who discontinue therapy should have their risk for fracture re-evaluated periodically. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9671_Osteofos-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9671_Osteofos-Tablets.html © The Swiss Pharmacy

10. Osteofos Tablets (Generic Alendronate Sodium Tablets) Recommended Adult Dosage The recommended dose of Osteofos Tablets Alendronate Tablets) for 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. Prevention of Osteoporosis in Postmenopausal Women: The recommended dosage is one 35 mg tablet once weekly or one 5 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 Osteofos Tablets (Generic URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9671_Osteofos-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9671_Osteofos-Tablets.html © The Swiss Pharmacy

11. Osteofos Tablets (Generic Alendronate Sodium Tablets) Recommended Adult Dosage Treatment of Glucocorticoid-Induced Osteoporosis: 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. Treatment of Paget's Disease of Bone: The recommended treatment regimen is 40 mg once a day for six months. Re-treatment of Paget’s Disease: Re-treatment with Osteofos (Generic Alendronate Sodium Tablets) may be considered, following a six-month post-treatment evaluation period in patients who have relapsed, based on increases in serum alkaline phosphatase, which should be measured periodically. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9671_Osteofos-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9671_Osteofos-Tablets.html © The Swiss Pharmacy

12. Osteofos Tablets (Generic Alendronate Sodium Tablets) Recommended Adult Dosage The dose must be taken with 6 to 8 oz plain water at least 30 minutes before the first food, drink, or medication of the day. Do not lie down for at least 30 minutes after taking Alendronate Sodium tablets (Osteofos) and until after food. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9671_Osteofos-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9671_Osteofos-Tablets.html © The Swiss Pharmacy

13. Osteofos Tablets (Generic Alendronate Sodium Tablets) Contraindications ➔Osteofos is contraindicated in patients with a known hypersensitivity to Alendronate Sodium or any component of the tablet. Hypersensitivity reactions including urticaria and angioedema have been reported. ➔Abnormalities of the esophagus which delay esophageal emptying such as stricture or achalasia. ➔Inability to stand or sit upright for at least 30 minutes. ➔Hypocalcemia. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9671_Osteofos-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9671_Osteofos-Tablets.html © The Swiss Pharmacy

14. Osteofos Tablets (Generic Alendronate Sodium Tablets) Storage Instructions Osteofos Tablets (Generic Alendronate Sodium Tablets) have to be stored at controlled room temperature i.e. from 20°C to 25°C (68°F to 77°F) with excursions permitted between 15° to 30°C (59° to 86°F). Keep this as well as all other medicines away from children and pets. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9671_Osteofos-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9671_Osteofos-Tablets.html © The Swiss Pharmacy

15. Osteofos Tablets (Generic Alendronate Sodium Tablets) Warnings Severe irritation of upper gastrointestinal (GI) mucosa can occur. Follow dosing instructions. Use caution in patients with active upper GI disease. Discontinue if new or worsening symptoms occur. Hypocalcemia can worsen and must be corrected prior to use. Other disorders affecting mineral metabolism (such as vitamin D deficiency) should also be effectively treated. Severe bone, joint, muscle pain may occur. In post-marketing experience, severe and occasionally incapacitating bone, joint, and/or muscle pain has been reported in patients taking bisphosphonates that are approved for the prevention and treatment of osteoporosis. Discontinue use if severe symptoms develop. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9671_Osteofos-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9671_Osteofos-Tablets.html © The Swiss Pharmacy

16. Osteofos Tablets (Generic Alendronate Sodium Tablets) Warnings Osteonecrosis of the jaw has been reported. Known risk factors for osteonecrosis of the jaw include invasive dental procedures (e.g., tooth extraction, dental implants, boney surgery), diagnosis of cancer, concomitant therapies (e.g., chemotherapy, corticosteroids, angiogenesis inhibitors), poor oral hygiene, and co-morbid disorders (e.g., periodontal and/or other pre-existing dental disease, anemia, coagulopathy, infection, ill-fitting dentures). The risk of ONJ may increase with duration of exposure to bisphosphonates. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9671_Osteofos-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9671_Osteofos-Tablets.html © The Swiss Pharmacy

17. Osteofos Tablets (Generic Alendronate Sodium Tablets) Warnings Atypical femur fractures have been reported. Evaluate new thigh or groin pain to rule out an incomplete femoral fracture. These fractures can occur anywhere in the femoral shaft from just below the lesser trochanter to above the supracondylar flare and are transverse or short oblique in orientation without evidence of comminution. Alendronate sodium is not recommended for patients with creatinine clearance less than 35 mL/min. The risk versus benefit of alendronate for treatment at daily dosages of glucocorticoids less than 7.5 mg of Prednisone or equivalent has not been established. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9671_Osteofos-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9671_Osteofos-Tablets.html © The Swiss Pharmacy

18. Osteofos Tablets (Generic Alendronate Sodium Tablets) Possible Side Effects Most common Alendronate sodium tablets (Osteofos tablets) side effects with an incidence rate of greater than or equal to 3% are abdominal pain, acid regurgitation, constipation, diarrhea, dyspepsia, musculoskeletal pain, nausea. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9671_Osteofos-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9671_Osteofos-Tablets.html © The Swiss Pharmacy

19. Osteofos Tablets (Generic Alendronate Sodium Tablets) Possible Side Effects The following side effects occurred during post-approval use of Alendronate Sodium tablets: Body as a Whole: hypersensitivity reactions including urticaria and rarely angioedema. Transient symptoms of myalgia, malaise, asthenia and rarely, fever have been reported with Alendronate Sodium, typically in association with initiation of treatment. Rarely, symptomatic hypocalcemia has occurred, generally in association with predisposing conditions. Rarely, peripheral edema. Gastrointestinal: esophagitis, esophageal erosions, esophageal ulcers, rarely esophageal stricture or perforation, and oropharyngeal ulceration. Gastric or duodenal ulcers, some severe and with complications, have also been reported. Localized osteonecrosis of the jaw, generally associated with tooth extraction and/or local infection with delayed healing, has been reported rarely. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9671_Osteofos-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9671_Osteofos-Tablets.html © The Swiss Pharmacy

20. Osteofos Tablets (Generic Alendronate Sodium Tablets) Possible Side Effects The following side effects occurred during post-approval use of Alendronate Sodium tablets: Musculoskeletal: bone, joint, and/or muscle pain, occasionally severe, and rarely incapacitating; joint swelling; low-energy femoral shaft and subtrochanteric fractures. Nervous System: dizziness and vertigo. Skin: rash (occasionally with photosensitivity), pruritus, alopecia, rarely severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis. Special Senses: rarely uveitis, scleritis or episcleritis. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9671_Osteofos-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9671_Osteofos-Tablets.html © The Swiss Pharmacy

21. Osteofos Tablets (Generic Alendronate Sodium Tablets) Osteofos Tablets Overdosage Significant lethality after single oral doses was seen in female rats and mice at 552 mg/kg and 966 mg/kg respectively. In males, these values were slightly higher. No specific information is available on the treatment of overdosage with Alendronate Sodium (Osteofos tablets). Hypocalcemia, hypophosphatemia, and upper gastrointestinal adverse events, such as upset stomach, heartburn, esophagitis, gastritis, or ulcer, may result from oral overdosage. Milk or antacids should be given to bind Alendronate. Due to the risk of esophageal irritation, vomiting should not be induced and the patient should remain fully upright. Dialysis would not be beneficial. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9671_Osteofos-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9671_Osteofos-Tablets.html © The Swiss Pharmacy

22. Osteofos Tablets (Generic Alendronate Sodium Tablets) Osteofos Tablets During Pregnancy Alendronate Sodium (Osteofos tablets) has been classified by the US FDA as Pregnancy Category C. There are no studies in pregnant women. Alendronate Sodium (Osteofos tablets) should be used during pregnancy only if the potential benefit justifies the potential risk to the mother and fetus. Bisphosphonates are incorporated into the bone matrix, from which they are gradually released over a period of years. The amount of bisphosphonate incorporated into adult bone, and hence, the amount available for release back into the systemic circulation, is directly related to the dose and duration of bisphosphonate use. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9671_Osteofos-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9671_Osteofos-Tablets.html © The Swiss Pharmacy

23. Osteofos Tablets (Generic Alendronate Sodium Tablets) Osteofos Tablets During Pregnancy There are no data on fetal risk in humans. However, there is a theoretical risk of fetal harm, predominantly skeletal, if a woman becomes pregnant after completing a course of bisphosphonate therapy. Reproduction studies in rats showed decreased post-implantation survival and decreased body weight gain in normal pups at doses less than half of the recommended clinical dose. Sites of incomplete fetal ossification were statistically significantly increased in rats beginning at approximately 3 times the clinical dose in vertebral (cervical, thoracic, and lumbar), skull, and sternebral bones. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9671_Osteofos-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9671_Osteofos-Tablets.html © The Swiss Pharmacy

24. Osteofos Tablets (Generic Alendronate Sodium Tablets) Osteofos Tablets Osteofos Tablets (Generic Alendronate Sodium Tablets) are manufactured by Cipla Limited, India. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9671_Osteofos-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9671_Osteofos-Tablets.html © The Swiss Pharmacy