Ibandron 150 mg (Tablet)
Medicine Details
| Category | Details |
|---|---|
| Generic | Ibandronic acid |
| Company | Aristopharma ltd |
Product Title
- Ibandron 150mg Film-Coated Tablets
Categories
- Medicine
- Osteoporosis Treatment
- Bisphosphonate Preparations
Description
Ibandron is indicated for the treatment and prevention of osteoporosis in women (specially postmenopausal), prevention and treatment of osteoporosis in men. It acts by inhibiting bone resorption and does not interfere with osteoclast recruitment. The recommended dosage is one 150 mg tablet once a month, to be taken 60 minutes before the first meal or drink of the day. It should be administered with caution in patients with upper gastrointestinal problems, and hypocalcemia should be corrected before initiating therapy. Ibandron is contraindicated in patients with known hypersensitivity to ibandronate acid, uncorrected hypocalcemia, and in those who are unable to sit or stand upright for at least 60 minutes. It may cause dyspepsia, nausea, diarrhea, abdominal pain, muscle aches, headaches, and dizziness as side effects. Its use during pregnancy and lactation is not recommended. No specific information is available on the treatment of overdosage with Ibandron, and it should be stored below 30°C, away from light and moisture.
Dosage
- One 150mg film-coated tablet once a month. Tablet should be taken 60 minutes before the first food or drink of the day.
Administration
- Tablets should be swallowed whole with a full glass of plain water (180 to 240 ml) while the patient is sitting or standing in an upright position.
Usability Features
- Monthly dosing regimen for increased flexibility
- Film-coated tablet for ease of swallowing
Technical Specifications
- Inhibition of bone resorption
- High potency and therapeutic margin
- Low affinity for hydroxyapatite
- Reduces bone turnover levels towards premenopausal levels
- Reduces levels of serum and urinary biochemical markers of bone turnover
- Selectively acts on bone tissue without interfering with osteoclast recruitment
- Eliminated by renal excretion only
Indications
- Treatment and prevention of osteoporosis in women (specially postmenopausal)
- Prevention and treatment of osteoporosis in men
Mode of Action
- Inhibition of bone resorption
- Prevents experimentally induced bone destruction
- Highly potent inhibitor of osteoclastic activity
- No evidence of impaired mineralization even at high doses
Interaction
- Likely interference with the absorption of calcium supplements, antacids, and some oral medications containing multivalent cations
- No interaction potential with tamoxifen or hormone replacement therapy
- No dosage adjustment required when administered with H2-antagonists or other drugs increasing gastric pH
Contraindications
- Known hypersensitivity to ibandronic acid or any of the excipients
- Uncorrected hypocalcemia
- Abnormalities of the esophagus delaying esophageal emptying
- Inability to sit or stand upright for at least 60 minutes
Side Effects
- Dyspepsia
- Nausea
- Diarrhea
- Abdominal pain
- Muscle aches
- Headaches
- Dizziness
Pregnancy & Lactation
- Not recommended for use during pregnancy or lactation
- No clinical experience in pregnant women
- Contraindicated in lactating mothers
Precautions & Warnings
- Treat hypocalcemia and other disturbances of bone and mineral metabolism before starting therapy
- Caution in patients with active upper gastrointestinal problems
- Risk of severe esophageal adverse experiences
- Risk of gastric and duodenal ulcers
- Risk of osteonecrosis of the jaw (ONJ)
- No increased risk observed in controlled clinical trials for ONJ
- Caution in concomitant medication with NSAIDs
Use in Special Populations
- No dosage adjustment necessary for patients with mild or moderate renal impairment
- Decision to administer in severe renal impairment should be based on individual risk-benefit assessment
- No dosage adjustment necessary for hepatic impairment
- No dosage adjustment necessary for elderly patients
- Safety and efficacy not established in patients less than 18 years old
Overdose Effects
- May result in upper gastrointestinal adverse events
- Milk or antacids should be given to bind Ibandron
- Vomiting should not be induced, and the patient should remain fully upright
Therapeutic Class
- Bisphosphonate preparations
Storage Conditions
- Keep below 30°C temperature
- Away from light & moisture
- Keep out of the reach of children