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Osteonate Uses |
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Osteonate 10 mg: Treatment of osteoporosis in postmenopausal women to prevent fractures; osteoporosis in men to prevent fractures; glucocorticoid-induced osteoporosis and prevention of bone loss in men and women considered at risk of developing the disease; prevention of osteoporosis in those postmenopausal women considered at risk of developing the disease.
Risk factors often associated with the development of osteoporosis include thin body build, family history of osteoporosis, early menopausal, moderately low bone mass and long-term glucocorticoid therapy, especially with high doses (15 mg/day).
Osteonate 70 mg: Treatment of postmenopausal osteoporosis. Osteonate reduces the risk of vertebral and hip fractures.
Prevention and treatment of post-menopausal osteoporosis in women.
Osteonate may be used in some cancers and diseases to slow down the activity of osteoclasts, the cells that break down bone. Increased activity of these cells increases the levels of calcium in the blood. Paget’s disease of the bone.
Osteonate (Osteonate) is a nitrogen-containing, second generation bisphosphonate. Bisphosphonates were first used to treat Paget’s disease in 1971. This class of medications is comprised of inorganic pyrophosphate analogues that contain non-hydrolyzable P-C-P bonds. Similar to other bisphosphonates, Osteonate has a high affinity for bone mineral and is taken up during osteoclast resorption. Osteonate inhibits farnesyl pyrophosphate synthetase, one of the enzymes in the mevalonic acid pathway involved in producing isoprenoid compounds that are essential for post-translational modification of small guanosine triphosphate (GTP)-binding proteins, such as Rho, Ras and Rab. Inhibition of this process interferes with osteoclast function and survival. Osteonate is used for the treatment of osteoporosis and Paget’s disease.
Osteoporosis in Postmenopausal Women: Recommended Dose: 10 mg once a day or 70 mg once weekly.
Osteoporosis in Men: Recommended Dose: 10 mg once a day.
Treatment and Prevention of Glucocorticoid-Induced Osteoporosis: Postmenopausal Women Not Receiving Hormone Therapy Replacement (HRT) With An Oestrogen: Recommended Dose: 10 mg once a day.
Others (ie, Men, Premenopausal Women and Postmenopausal Women Receiving HRT With An Oestrogen): Recommended Dose: 5 mg once a day.
Prevention of Osteoporosis in Postmenopausal Women: Recommended Dose: 5 mg once a day.
Elderly: In clinical studies, there was no age-related difference in the efficacy or safety profiles of Osteonate. Therefore, no dosage adjustment is necessary for the elderly.
Renal Impairment: No dosage adjustment is necessary for patients with glomerular filtration rate (GFR) >35 mL/min. Osteonate is not recommended for patients with renal impairment where GFR is <35 mL/min, due to lack of experience.
Administration: To Permit Adequate Absorption of Osteonate: Osteonate must be be taken at least 30 min before the 1st 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 Osteonate.
To facilitate delivery to the stomach and thus reduce the potential for local and oesophageal irritation/adverse experiences : Osteonate should only be swallowed upon arising for the day with a full glass of water (not <200 mL or fl. oz.).
Patients should not chew the tablet or allow the tablet to dissolve in their mouths because of a potential for oropharyngeal ulceration.
Patients should not lie down for at least 30 min after taking Osteonate.
Osteonate should not be taken at bedtime or before arising for the day.
Patients should receive supplemental calcium and vitamin D if dietary intake is inadequate.
If taken at the same time it is likely that calcium supplements, antacids and other oral medications will interfere with absorption of Osteonate. Therefore, patients must wait at least ½ hr after taking Osteonate before taking any other oral medication.
No other drug interaction of clinical significance are anticipated.
Concomitant use of HRT and Osteonate was assessed in 2 clinical studies of 1 or 2 years' duration in postmenopausal osteoporotic women. Combined use of Osteonate and HRT resulted in greater increases in bone mass, together with greater decreases in bone turnover, than seen with either treatment alone. In these studies, the safety and tolerability profile of the combination was consistent with those of the individual treatments.
In clinical studies, the incidence of upper GI adverse events was increased in patients receiving daily therapy with dosages of Osteonate >10 mg and aspirin-containing products. However, this was not observed in studies with Osteonate 70 mg once weekly.
The following adverse experiences have been reported during clinical studies and/or post-marketing use: Common (1% and <10%): Gastrointestinal: Abdominal pain, dyspepsia, constipation, diarrhoea, flatulence, oesophageal ulcer, dysphagia, abdominal distention, acid regurgitation.
Musculoskeletal: Musculoskeletal (bone, muscle or joint) pain.
Neurological: Headache.
Uncommon (0.1% and <1%): Body as a Whole: Rash, pruritus, erythema.
Gastrointestinal: Nausea, vomiting, gastritis, oesophagitis, oesophageal erosions, melaena.
Rare (0.01% and <0.1%): Body as a Whole: Hypersensitivity reactions including urticaria and angioedema. Transient symptoms as in acute-phase response (myalgia, malaise, and rarely, fever), typically in association with initiation of treatment. Rash with photosensitivity. Symptomatic hypocalcaemia, occasionally severe, often in association with predisposing conditions.
Gastrointestinal: Oesophageal stricture, oropharyngeal ulceration, upper gastrointestinal perforation, ulcers, bleeding (PUBs), although a casual relationship cannot be ruled out. Localised osteonecrosis of the jaw, generally associated with tooth extraction and/or local infection, often with delayed healing.
Musculoskeletal: Severe musculoskeletal (bone, muscle or joint) pain.
Special Senses: Uveitis, scleritis, episcleritis.
Very Rare, Including Isolated Cases: Skin: Severe skin reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis.
Adverse experiences reported by the investigators as possibly, probably or definitely drug-related are presented as follows if they occured in 1% in either treatment group in the 1-year study, or in 1% patients treated with Osteonate 10 mg/day and at a greater incidence than in patients given placebo in the 3-year studies.
Laboratory Test Findings: In clinical studies, asymptomatic, mild and transient decreases in serum calcium and phosphate were observed in approximately 18 and 10%, respectively, of patients taking Osteonate versus approximately 12 and 3% of those taking placebo. However, the incidences of decreases in serum calcium to <8 mg/dL (2 mmol/L) and serum phosphate to 2 mg/dL (0.65 mmol/L) were similar in both treatment groups.
Hypersensitivity to Osteonate or to any of the excipients of Osteonate.
Use in pregnancy: Osteonate should not be used during pregnancy.
Use in lactation: It is not known whether Osteonate is excreted into human breast milk. Osteonate should not be used by breastfeeding women.
Alendronic Acid in Argentina.
Alendronate sodium in Argentina.
Risedronate sodium in Indonesia.
List of Osteonate substitutes (brand and generic names) | Sort by popularity |
Unit description / dosage (Manufacturer) | Price, USD |
Osteonat (Greece) | |
Osteonate 10 | |
Osteonate 70 | |
Osteonato 70 (Uruguay) | |
Osteonet | |
Osteonet 35 mg Tablet (Sun Pharmaceutical Industries Ltd.) | $ 0.24 |
Osteoral (Brazil) | |
Osteos (Greece) | |
Osteosan (Peru) | |
Tablet, Film-Coated; Oral; Alendronic Acid / Alendronate Sodium 70 mg (Silesia) | |
Ostepor (Macedonia) | |
Osterepar (Russian Federation) | |
Ostertrin (Colombia) | |
Osteve (Oman) | |
Ostex (Colombia) | |
Ostex inj 3 mg/3 mL 1's (Nang Kuang Pharma) | |
Ostogee | |
Ostogee 70 mg Tablet (Swiss Pharma Pvt. Ltd.) | $ 0.30 |
Ostolek (Poland) | |
Ostomax (Bangladesh) | |
Ostomir (Vietnam) | |
Ostomir 70 mg x 1 Blister x 4 Tablet | |
Ostrat (Brazil) | |
Oxtalen (Ecuador) | |
Pamoseo (Argentina) | |
Pasodron (Chile) | |
Tablet; Oral; Alendronic Acid / Alendronate Sodium Trihydrate 70 mg (Rider) | |
Pharmadronate (Vietnam) | |
Pharmadronate 1 Blister x 4 Tablet | |
Pharmadronate 70 mg x 1 Blister x 4 Tablet | |
Pharmadronate FC 70mg (Vietnam) | |
PHL-Alendronate | |
Tablet; Oral; Alendronic Acid / Alendronate Sodium 70 mg | |
PHL-alendronate tablet 70 mg (Pharmel Inc (Canada)) | |
PHL-Alendronate-FC | |
Tablet; Oral; Alendronic Acid / Alendronate Sodium 70 mg | |
Phostarac (Argentina) | |
PMS-Alendronate (Canada) | |
Tablet; Oral; Alendronic Acid / Alendronate Sodium 70 mg | |
PMS-alendronate tablet 70 mg (Pharmascience Inc (Canada)) | |
PMS-Alendronate-FC | |
Tablet; Oral; Alendronic Acid / Alendronate Sodium 70 mg | |
PMS-alendronate-FC tablet 70 mg (Pharmascience Inc (Canada)) | |
Polerixen (Sweden) | |
Poris (Peru) | |
Porocalm (Greece) | |
Porodron (Italy) | |
Poronil (India) | |
Poronil 10mg TAB / 10 | |
10 mg x 10's | |
Porosal (Venezuela) | |
Porosimax (Algeria) | |
Porosin (Dominican Republic) | |
Poroxifen (Bosnia & Herzegowina) | |
See 1193 substitutes for Osteonate |
Users | % | ||
---|---|---|---|
> 60 | 3 | 75.0% | |
30-45 | 1 | 25.0% |
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Information checked by Dr. Sachin Kumar, MD Pharmacology
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