Bonfix 150 mg (Tablet)
1 tablet kit: ৳ 1,200.00
Medicine Details
Category | Details |
---|---|
Generic | Ibandronic acid |
Company | Opsonin pharma ltd |
Indications
- Treatment of osteoporosis in women (specially postmenopausal)
- Prevention of osteoporosis in women (specially postmenopausal)
- Treatment of osteoporosis in men
- Confirmation of osteoporosis by low bone mass
- History of osteoporotic fracture
- Low bone mass in absence of pre-existing osteoporotic fracture
Pharmacology
- Inhibition of bone resorption
- Prevention of experimentally induced bone destruction
- Inhibition of osteoclastic activity
- No evidence of impaired mineralization in rats
- High affinity for hydroxyapatite
- Reduction of bone resorption with no effect on bone formation
- Reduction of bone turnover in postmenopausal women
Dosage & Administration
- Recommended dose of one 150 mg film-coated tablet once a month
- Tablet should be taken with plain water, 60 minutes before food or drink
- Supplemental calcium or vitamin D for inadequate dietary intake
- Instructions for missed dose
- No consumption of two tablets within the same week
Interaction
- Interference of calcium supplements and antacids with absorption
- Absence of interaction potential with tamoxifen or hormone replacement therapy
- Increase in bioavailability with ranitidine
- No inhibition of major human hepatic P450 isoenzymes
- Low plasma protein binding
- Elimination by renal excretion
- Similar incidence of upper gastrointestinal events with aspirin or NSAIDs
Contraindications
- Known hypersensitivity to ibandronic acid or excipients
- Uncorrected hypocalcemia
- Abnormalities of the esophagus delaying esophageal emptying
- Inability to stand or sit upright for at least 60 minutes
Side Effects
- Dyspepsia
- Nausea
- Diarrhea
- Abdominal pain
- Muscle aches
- Headaches
- Dizziness
Pregnancy & Lactation
- Not to be used during pregnancy
- No evidence of direct fetal toxic or teratogenic effect
- No clinical experience in pregnant women
- Not to be used during lactation
- Low concentration in breast milk
Precautions & Warnings
- Treatment of hypocalcemia before therapy
- Importance of calcium and vitamin D intake
- Caution in patients with active upper gastrointestinal problems
- Possible irritant effects on upper gastrointestinal mucosa
- Attention to signs of possible esophageal reaction
- Caution with concomitant medication with NSAIDs
- Risk factors for osteonecrosis of the jaw
- Individual management plan for dental procedures
Use in Special Populations
- No dosage adjustment for mild or moderate renal impairment
- Individual risk-benefit assessment for creatinine clearance below 30 ml/min
- No dosage adjustment for hepatic impairment
- No dosage adjustment for elderly
- Safety and efficacy not established in patients less than 18 years old
Overdose Effects
- Upper gastrointestinal adverse events
- Use of milk or antacids to bind ibandronic acid
- Avoidance of inducing vomiting
- Remaining fully upright
Therapeutic Class
- Bisphosphonate preparations
Storage Conditions
- Temperature below 30°C
- Away from light & moisture
- Keep out of the reach of children