Phostarac indications
Phostarac 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).
Phostarac 70 mg: Treatment of postmenopausal osteoporosis. Phostarac reduces the risk of vertebral and hip fractures.
Uses of Phostarac in details
Prevention and treatment of post-menopausal osteoporosis in women.
Phostarac 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.
Phostarac description
Phostarac (alendronate) 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, alendronate has a high affinity for bone mineral and is taken up during osteoclast resorption. Alendronate 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. Alendronate is used for the treatment of osteoporosis and Paget’s disease.
Phostarac dosage
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 Phostarac. 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. Phostarac 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 Phostarac: Phostarac 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 Phostarac.
To facilitate delivery to the stomach and thus reduce the potential for local and oesophageal irritation/adverse experiences : Phostarac 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 Phostarac.
Phostarac 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.
Phostarac interactions
If taken at the same time it is likely that calcium supplements, antacids and other oral medications will interfere with absorption of Phostarac. Therefore, patients must wait at least ½ hr after taking Phostarac before taking any other oral medication.
No other drug interaction of clinical significance are anticipated.
Concomitant use of HRT and Phostarac was assessed in 2 clinical studies of 1 or 2 years' duration in postmenopausal osteoporotic women. Combined use of Phostarac 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 Phostarac >10 mg and aspirin-containing products. However, this was not observed in studies with Phostarac 70 mg once weekly.
Phostarac side effects
Cardiovascular
Nasal spray
Angina pectoris, hypertension (1% to 3%).
CNS
Nasal spray: Fatigue, depression, dizziness, paresthesia (1% to 3%). Injectable: Poor appetite; abdominal pain.
Dermatologic
Nasal spray
Erythematous rash (1% to 3%).
Injectable
Pruritus of ear lobes; skin rash.
EENT
Nasal spray
Rhinitis (12%); abnormal lacrimation, conjunctivitis (1% to 3%).
Injectable
Eye pain.
GI
Nasal spray
Abdominal pain, constipation, diarrhea, dyspepsia, nausea (1% to 3%).
Injectable
Nausea with or without vomiting (10%); salty taste.
Genitourinary
Nasal spray
Cystitis (1% to 3%).
Injectable
Nocturia.
Hematologic-Lymphatic
Nasal spray
Infection, lymphadenopathy (1% to 3%).
Local
Injectable
Inflammation at subcutaneous or IM site (10%).
Musculoskeletal
Nasal spray
Back pain (5%); arthralgia (4%); arthrosis, myalgia (1% to 3%).
Respiratory
Nasal spray
Epistaxis (4%); bronchospasm, sinusitis, upper respiratory tract infection (1% to 3%).
Miscellaneous
Nasal spray
Influenza-like symptoms (1% to 3%).
Injectable
Death caused by anaphylaxis (1 case), feet edema, feverish sensation.
Phostarac contraindications
Hypersensitivity to alendronate or to any of the excipients of Phostarac.
Use in pregnancy: Phostarac should not be used during pregnancy.
Use in lactation: It is not known whether Phostarac is excreted into human breast milk. Phostarac should not be used by breastfeeding women.
Active ingredient matches for Phostarac:
Alendronic Acid in Argentina.
Alendronate sodium in Argentina.
List of Phostarac substitutes (brand and generic names) | Sort by popularity |
| Unit description / dosage (Manufacturer) | Price, USD |
| PHL-Alendronate-FC | |
| Tablet; Oral; Alendronic Acid / Alendronate Sodium 70 mg | |
| 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) | |
| Promass (Bosnia & Herzegowina) | |
| Ralenost (Estonia, India, Latvia, Lithuania) | |
| Ralenost 70 mg x 1 x 4's (Sun Pharma) | |
| Ralenost tab 10 mg 10's (Sun Pharma) | |
| Ralenost tab 70 mg 4's (Sun Pharma) | |
| Ralenost-10 (India) | |
| Ralenost-10 10mg TAB / 10 (Ranbaxy (Consumer HC)) | $ 0.60 |
| 10 mg x 10's (Ranbaxy (Consumer HC)) | $ 0.60 |
| RALENOST-10 tab 10 mg x 10's (Ranbaxy (Consumer HC)) | $ 0.60 |
| RAN-Alendronate (Canada) | |
| Ran-alendronate tablet 10 mg (Ranbaxy Pharmaceuticals Canada Inc. (Canada)) | |
| Ran-alendronate tablet 70 mg (Ranbaxy Pharmaceuticals Canada Inc. (Canada)) | |
| Ran-alendronate tablet 5 mg (Ranbaxy Pharmaceuticals Canada Inc. (Canada)) | |
| Ranos (Romania) | |
| ratio-Alendronate (Canada) | |
| Tablet; Oral; Alendronic Acid / Alendronate Sodium 70 mg | |
| Realen (Italy) | |
| Recalfe (Brazil) | |
| Regenesis (Argentina, Ecuador) | |
| Regenesis 70 (Argentina) | |
| Rekostin (Poland) | |
| RESTOFOS (India) | |
| RESTOFOS Capsule/ Tablet / 70mg / 4 units (Sun) | $ 1.47 |
| RESTOFOS Capsule/ Tablet / 10mg / 10 units (Sun) | $ 0.70 |
| 10 mg x 10's (Sun) | $ 0.70 |
| 70 mg x 4's (Sun) | $ 1.47 |
| Restofos 10mg TAB / 10 (Sun) | $ 0.70 |
| Restofos 70mg TAB / 4 (Sun) | $ 1.47 |
| RESTOFOS 10MG TABLET 1 strip / 10 tablets each (Sun) | $ 0.75 |
| RESTOFOS 70MG TABLET 1 strip / 4 tablets each (Sun) | $ 1.86 |
| RESTOFOS tab 10 mg x 10's (Sun) | $ 0.70 |
| RESTOFOS tab 70 mg x 4's (Sun) | $ 1.64 |
See 1108 substitutes for Phostarac | |
References
- DailyMed. "ALENDRONATE SODIUM: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- PubChem. "ALENDRONIC ACID". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
- DrugBank. "ALENDRONIC ACID". http://www.drugbank.ca/drugs/DB00630 (accessed September 17, 2018).
Reviews
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Information checked by Dr. Sachin Kumar, MD Pharmacology
