Bondrova 150 mg

Description

Indications Bondrova is prescribed for the following conditions:

• Treatment of osteoporosis in women, particularly postmenopausal women.
• Prevention of osteoporosis in postmenopausal women.
• Prevention and treatment of osteoporosis in men.

Criteria for Osteoporosis Treatment: Osteoporosis treatment is determined based on low bone mass (T-score < -2.0 SD) along with the presence or history of osteoporotic fractures. Alternatively, treatment is considered when bone mass is significantly low (T-score < -2.5 SD) even without prior osteoporotic fractures.

(Use only as directed by a registered physician.)

Pharmacology Ibandronic acid, the active ingredient in Bondrova, is a potent inhibitor of bone resorption. It works by preventing bone degradation caused by hormonal changes, retinoids, tumors, or tumor extracts. In experimental studies, ibandronic acid has demonstrated a strong ability to inhibit osteoclastic activity, preventing excessive bone loss.

Animal studies confirm that ibandronic acid is a highly selective agent that binds to hydroxyapatite in bone tissue, inhibiting osteoclast activity without interfering with osteoclast recruitment. By reducing bone resorption, ibandronic acid helps restore bone turnover rates to premenopausal levels in postmenopausal women, leading to increased bone mass and a reduced risk of fractures.

Dosage & Administration

• The recommended dosage for osteoporosis treatment is one 150 mg film-coated tablet taken once a month.
• The tablet should be taken on the same date each month.
• It must be taken at least 60 minutes before consuming food, beverages (other than water), or any other oral medications (including calcium supplements).
• Swallow the tablet whole with a full glass of plain water (180-240 ml) while standing or sitting upright.
• Avoid lying down for at least 60 minutes after ingestion.
• Do not chew or suck the tablet to prevent oropharyngeal ulceration.
• If dietary intake of calcium or vitamin D is insufficient, supplementation should be considered.

Missed Dose:

• If a dose is missed, take one 150 mg tablet the next morning unless the next scheduled dose is within seven days.
• If the next dose is within seven days, skip the missed dose and continue the regular schedule.
• Do not take two tablets within the same week.

(Use only as directed by a registered physician.)

Drug Interactions

• Calcium supplements, antacids, and certain oral medications containing aluminum, magnesium, or iron may interfere with the absorption of Bondrova. Wait at least 60 minutes after taking Bondrova before consuming these medications.
• No significant interactions have been reported with tamoxifen, hormone replacement therapy, melphalan, or prednisolone.
• Co-administration with IV ranitidine may increase ibandronic acid bioavailability by approximately 20%, but no dosage adjustment is necessary.
• Bondrova does not significantly interact with hepatic cytochrome P450 enzymes and is primarily eliminated via renal excretion.

Contraindications Bondrova should not be used in:

• Patients with known hypersensitivity to ibandronic acid or any excipients.
• Individuals with uncorrected hypocalcemia.
• Patients with esophageal abnormalities such as stricture or achalasia.
• Individuals who cannot sit or stand upright for at least 60 minutes.

Side Effects Common side effects include:

• Digestive issues such as dyspepsia, nausea, diarrhea, and abdominal pain.
• Musculoskeletal pain.
• Headaches and dizziness.

Use During Pregnancy & Lactation

• Pregnancy: Not recommended during pregnancy due to potential reproductive toxicity. No human data are available.
• Lactation: Not advised for breastfeeding mothers. Studies in rats show that ibandronic acid is excreted in breast milk.

Precautions & Warnings

• Ensure hypocalcemia and other bone metabolism disorders are treated before initiating therapy.
• Adequate calcium and vitamin D intake should be maintained.
• Bondrova may cause irritation of the upper gastrointestinal tract and should be used with caution in patients with esophageal disorders, gastritis, duodenitis, or ulcers.
• Severe esophageal reactions, including esophagitis, ulcers, and perforations, have been reported. Patients experiencing difficulty swallowing, pain upon swallowing, chest pain, or worsening heartburn should discontinue use and seek medical attention.
• Osteonecrosis of the jaw (ONJ) has been reported, primarily in cancer patients undergoing dental procedures. Patients should maintain good oral hygiene and inform their dentist about bisphosphonate use.
• Concomitant use of NSAIDs may increase the risk of gastrointestinal irritation.

Use in Special Populations

• Renal Impairment: No dose adjustment is necessary for patients with mild or moderate renal impairment (creatinine clearance ≥30 ml/min). Use in severe renal impairment should be based on individual risk-benefit assessment.
• Hepatic Impairment: No dosage adjustment required.
• Elderly Patients: No dosage modification is needed.
• Pediatric Patients: Safety and efficacy have not been established in individuals under 18 years old.

Overdose Management

• Symptoms of overdose may include gastrointestinal disturbances such as stomach upset, heartburn, esophagitis, gastritis, or ulcers.
• Milk or antacids can be administered to bind the drug and reduce absorption.
• Vomiting should not be induced due to the risk of esophageal irritation. Patients should remain upright.

Therapeutic Class Bisphosphonate preparations.

Storage Conditions

• Store below 30°C in a dry place away from light and moisture.
• Keep out of reach of children.-