- Indications and Usage Pradefovir Mesylate Tablets are indicated for the treatment of adult patients with chronic hepatitis B (CHB).
- Dosage and Administration Recommended Dosage: The recommended dosage is 45 mg orally once daily. Administration: The tablets can be taken with or without food. Renal Impairment: For adult patients with mild renal impairment (creatinine clearance ≥50 mL/min), no dosage adjustment is required. There is no safety and efficacy data for patients with creatinine clearance <50 mL/min. Hepatic Impairment: For adult patients with mild hepatic impairment (Child-Pugh class A), no dosage adjustment is required. There is no safety and efficacy data for patients with moderate or severe hepatic impairment (Child-Pugh class B or C).
- Mechanism of Action Pradefovir is a prodrug that is converted intracellularly to its active metabolite, which acts as a nucleotide analog. It inhibits the hepatitis B virus (HBV) reverse transcriptase, thereby blocking viral replication and reducing HBV DNA levels.
- Safety and Warnings Hepatic Adverse Events: Elevations in liver enzymes (ALT and AST) have been observed, often occurring 4-8 weeks after initiation and typically resolving with continued antiviral treatment. Renal Adverse Events: Monitoring for urinary protein, serum creatinine, and cystatin C is recommended. Musculoskeletal and Bone Disorders: Adverse events such as hypophosphatemia, decreased bone mineral density, osteoporosis, and bone pain have been reported.
- Adverse Reactions and Clinical Research The most common adverse reactions (incidence ≥5%) include various laboratory test abnormalities, such as elevated liver enzymes, elevated creatine kinase MB, and decreased blood phosphorus.
- Drug Interactions No specific drug-drug interaction studies have been conducted. Caution is advised when co-administering with other drugs known to affect renal or bone function.
- Pharmaceutical Information Composition: The active ingredient is Pradefovir Mesylate. Excipients include microcrystalline cellulose, colloidal silicon dioxide, pregelatinized starch, silica, stearic acid, and film coating premix. Appearance: White to off-white film-coated tablets. Storage: Store at controlled room temperature in the original packaging.
Xinshumu Pradefovir Mesylate Tablets
Brand Name: 新舒沐 ®（Xinshumu®）
Generic Name: Pradefovir Mesylate
Strength: 45 mg per tablet, 30 tablets per box
Manufacturer: Xi’an Gelan Xintong Pharmaceutical Co., Ltd.
Marketing Authorization Holder: Xi’an Gelan Xintong Pharmaceutical Co., Ltd.
Approval Date in China: October 28, 2024
Registration Number: 国药准字H20240036
Storage: Store tightly sealed at temperature not exceeding 30°C, keep away from direct sunlight and high temperature. Keep out of reach of children. Refer to the full package insert for detailed storage specifications.
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