- Indications and Usage Osteoporosis in Postmenopausal Women: Indicated for the treatment of osteoporosis in postmenopausal women.
- Dosage and Administration Recommended Dosage: 50 mg once weekly. Administration Details: The tablet must be taken with a full glass of plain water (approximately 180 mL) upon waking in the morning, at least 30 minutes before the first food, beverage, or other medication of the day. Post-Dosing Precautions: Patients must remain in an upright position (sitting or standing) for at least 30 minutes after administration. They must not lie down, consume food (water excepted), or take other oral medications during this period. The tablet should be swallowed whole; chewing or sucking the tablet may cause oral or pharyngeal irritation. Missed Dose: If a dose is missed, it may be taken on the next morning, followed by resumption of the original weekly schedule. Two tablets must not be taken on the same day.
- Mechanism of Action Osteoclast Inhibition: Minodronic acid is a nitrogen-containing bisphosphonate that binds with high affinity to hydroxyapatite in the bone. Mevalonate Pathway Blockade: Upon osteoclast-mediated uptake, it inhibits the enzyme farnesyl pyrophosphate synthase (FPPS) in the mevalonate pathway. This prevents the prenylation of small GTPases, leading to the loss of osteoclast function and induction of osteoclast apoptosis, thereby suppressing bone resorption.
- Safety and Warnings Hypocalcemia: Pre-existing hypocalcemia must be corrected before initiating therapy. Supplementation with calcium and vitamin D is often required during treatment. Osteonecrosis of the Jaw: Osteonecrosis of the jaw has been reported with bisphosphonates, particularly following invasive dental procedures. A dental examination is recommended prior to treatment. Atypical Femoral Fractures: Non-typical fractures of the femoral shaft and subtrochanteric region may occur with long-term use. Gastrointestinal Disorders: The drug can cause esophageal irritation, esophagitis, gastritis, or ulcers. It is contraindicated in patients with esophageal strictures, achalasia, or those unable to remain upright. Severe Renal Impairment: The drug is contraindicated in patients with severe renal impairment (creatinine clearance rate <30 mL/min).
- Adverse Reactions and Clinical Research Most Common Adverse Reactions: Gastrointestinal disorders (abdominal pain, dyspepsia, nausea), hypocalcemia, musculoskeletal pain, and headache. Clinical Research Highlights: Clinical trials in postmenopausal women have demonstrated that weekly 50 mg administration significantly increases bone mineral density and reduces the risk of vertebral and non-vertebral fractures compared to placebo.
- Drug Interactions Polyvalent Cations: Concomitant use of oral calcium, iron, magnesium, aluminum, or antacids can form insoluble complexes with minodronic acid, significantly reducing its absorption. These agents must be administered at least 30 minutes after minodronic acid (ideally hours apart). NSAIDs: Non-steroidal anti-inflammatory drugs (NSAIDs) may exacerbate gastrointestinal irritation caused by minodronic acid and should be used with caution.
- Pharmaceutical Information Chemical Composition: Active ingredient: Minodronic acid monohydrate. Appearance: Film-coated tablets, typically pale pink and oval-shaped. Packaging: Supplied in blister packs. Storage: Store at room temperature (25°C). Protect from moisture.
Difumi Minodronic Acid Tablets
Brand Name:蒂复密 ®（Difumi®）
Generic Name: Minodronic Acid
Strength: 1 mg per tablet; 10 tablets per blister, 1 blister per box
Manufacturer: Jiangsu Tasly Diyi Pharmaceutical Co., Ltd.
Marketing Authorization Holder: Jiangsu Tasly Diyi Pharmaceutical Co., Ltd.
Approval Date in China: December 29, 2020
Registration Number: 国药准字H20203736
Storage: Store tightly sealed in a dry place below 25°C, avoid high temperature and humidity. Refer to the full package insert for detailed storage specifications.
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