Ibandronic Acid

Ibandronic Acid is a bisphosphonate that inhibits bone resorption by suppressing osteoclast activity, the cells responsible for bone destruction. It has high affinity for hydroxyapatite in the bone mineral matrix. In postmenopausal women, it reduces the elevated rate of bone turnover, leading to a progressive net gain in bone mass and decreased incidence of fractures.

• Treatment of osteoporosis in women (especially postmenopausal)
• Prevention of osteoporosis in women (especially postmenopausal)
• Prevention and treatment of osteoporosis in men

Adult Dose (Oral):

• Treatment of osteoporosis: 150 mg film-coated tablet once monthly (on the same date each month)
• Take 60 minutes before first food or drink of the day on empty stomach
• Swallow tablet whole with a full glass of plain water (180-240 ml)
• Take while standing or sitting upright
• Do not lie down for 60 minutes after taking
• Do not chew or suck the tablet

Missed Dose: If remembered, take the next morning (if next scheduled dose is not within 7 days); if within 7 days, wait until next dose; do not take two 150 mg tablets within the same week.

Child Dose: Safety and efficacy not established in patients less than 18 years

Common Side Effects:

• Headache
• Musculoskeletal (bone, muscle or joint) pain
• Dyspepsia
• Heartburn
• Diarrhea
• Abdominal pain
• Nausea
• Dizziness
• Back pain
• Flatulence
• Constipation

Serious: Severe bone, joint and/or muscle pain; osteonecrosis of the jaw; esophagitis, esophageal ulcers or erosions; hypocalcemia

Precautions:

• Treat hypocalcemia and other disturbances of bone and mineral metabolism before starting therapy
• Caution in patients with active upper gastrointestinal problems (Barrett's esophagus, dysphagia, gastritis, duodenitis, ulcers)
• Discontinue and seek medical attention if esophageal irritation symptoms develop
• Risk factors for osteonecrosis of the jaw: cancer, chemotherapy, radiotherapy, corticosteroids, pre-existing dental disease
• Not recommended in severe renal impairment (CrCl <30 ml/min)

Contraindications:

• Known hypersensitivity to ibandronic acid or any excipients
• Uncorrected hypocalcemia
• Abnormalities of the esophagus which delay esophageal emptying (stricture or achalasia)
• Unable to stand or sit upright for at least 60 minutes

Drug Interactions:

• Calcium supplements, antacids and oral medications containing multivalent cations (aluminium, magnesium, iron) interfere with absorption
• Wait 60 minutes after taking Ibandronic Acid before taking other oral medications
• H2-antagonists (ranitidine) increase bioavailability by about 20% (no dose adjustment required)
• No increased GI events with aspirin or NSAIDs co-administration

Food Interactions: Caution is advised when consuming alcohol with Ibandronic Acid; consult your doctor.

Use in Pregnancy: Should not be used during pregnancy; no clinical experience in pregnant women; no direct fetal toxic or teratogenic effects in animal studies.

Use in Lactation: Should not be used during lactation; found in breast milk in rat studies.

Renal Impairment: No dosage adjustment for mild or moderate impairment (CrCl ≥30 ml/min); decision for CrCl <30 ml/min based on individual risk-benefit assessment.

Hepatic Impairment: No dosage adjustment necessary.

Overdose: Oral overdose may result in upper gastrointestinal adverse events (upset stomach, heartburn, esophagitis, gastritis, ulcer); milk or antacids should be given to bind ibandronic acid; do not induce vomiting due to risk of esophageal irritation; patient should remain fully upright.