Bone-Guard 150 mg (Tablet)
1 tablet kit: ৳ 510.00
Medicine Details
Category | Details |
---|---|
Generic | Ibandronic acid |
Company | Incepta pharmaceuticals ltd |
Title and Categories
- Bone-Guard Tablet
- Medicine
- Health & Personal Care
- Osteoporosis Treatment
- Bisphosphonate Preparations
Dimensions
- Film-coated tablet: 150 mg
- Packaging size: 30 tablets per pack
Color Options
- White tablet
- Blue packaging
Function
- Treatment of osteoporosis in women (specially postmenopausal)
- Prevention of osteoporosis in women (specially postmenopausal)
- Prevention and treatment of osteoporosis in men
- Inhibition of bone resorption
- Increased bone mass
- Flexible dosing regimens
- Intermittent treatment with long drug-free intervals
- Prevents experimentally induced bone destruction
- Reduces elevated rate of bone turnover
- Leads to a progressive net gain in bone mass
Material
- Ibandronic acid
- Film coating material
Technical Specifications
- Highly potent bisphosphonate belonging to the nitrogen-containing group of bisphosphonates
- High affinity for hydroxyapatite
- Reduces bone resorption with no direct effect on bone formation
- Reduced bone resorption as reflected in serum and urinary biochemical markers of bone turnover
- Increased BMD
- Low plasma protein binding at therapeutic concentrations
- Eliminated by renal excretion only
- Does not inhibit the major human hepatic P450 isoenzymes
- Does not induce the hepatic cytochrome P450 system in rats
Design Elements
- Plain white tablet with brand name imprint
- Protective blue packaging
- Clearly marked dosage instructions on packaging
Usability Features
- Monthly dosing regimen for convenience
- Tablets should be swallowed whole with plain water (180 to 240 ml)
- Patients should not lie down for 60 minutes after taking the tablet
- Instructions for missed doses
- Advisory on not chewing or sucking the tablet
- Requirement for supplemental calcium or vitamin D if dietary intake is inadequate
- Storage temperature and conditions for product longevity
Interaction
- Interference with calcium supplements, antacids, and some oral medications containing multivalent cations
- Absorption interference with some oral medications
- No interaction potential with tamoxifen or hormone replacement therapy (estrogen)
- No interaction observed with melphalan/prednisolone
- Increase in bioavailability with i.v. ranitidine
- No drug interactions of clinical significance considered likely
- No inhibition of major human hepatic P450 isoenzymes
- Low plasma protein binding at therapeutic concentrations
Contraindications
- Known hypersensitivity to ibandronic acid or any of the excipients
- Uncorrected hypocalcemia
- Abnormalities of the esophagus which delay 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 for use during pregnancy
- No clinical experience with pregnant women
- Not for use during lactation
Precautions & Warnings
- Treatment of hypocalcemia and other disturbances of bone and mineral metabolism before therapy
- Caution in patients with active upper gastrointestinal problems
- Possible esophageal adverse experiences
- Risk of gastric and duodenal ulcers
- Osteonecrosis of the jaw (ONJ) risk factors and reporting
- Effectiveness in patients with renal and hepatic impairment
- No established safety and efficacy in patients less than 18 years old
Use in Special Populations
- No dosage adjustment for mild or moderate renal impairment (creatinine clearance ≥30 ml/min)
- No dosage adjustment for mild or moderate hepatic impairment
- No dosage adjustment for elderly patients
- Safety and efficacy not established in patients less than 18 years old
Overdose Effects
- Possible upper gastrointestinal adverse events
- Use of milk or antacids to bind Bone-Guard
- Avoid inducing vomiting
- Remain fully upright if an overdose occurs
Therapeutic Class
- Bisphosphonate preparations
Storage Conditions
- Keep below 30°C temperature
- Away from light & moisture
- Keep out of the reach of children