- Indications and Usage Sodium oligomannate capsules are indicated for the treatment of mild to moderate Alzheimer’s disease (AD) in adults.
- Dosage and Administration Recommended Dosage: The recommended dosage is 2.0 g (ten 200 mg capsules) taken orally three times daily. Administration: The capsules should be taken with water, preferably 30 minutes before meals. Treatment Duration: Treatment should continue until disease progression or unacceptable toxicity. Special Populations: No dosage adjustment is required for patients with mild or moderate renal impairment. However, sodium oligomannate is not recommended for patients with severe renal impairment.
- Mechanism of Action Sodium oligomannate (GV-971) exerts its therapeutic effect primarily by modulating the gut microbiome. It alters the composition of gut bacteria, reducing the abundance of pro-inflammatory bacteria and increasing anti-inflammatory bacteria. This shifts the metabolite profile in the gut, leading to a reduction in neuroinflammation, attenuation of microglial activation in the brain, and improvement in synaptic plasticity and cognitive function.
- Safety and Warnings Hypersensitivity: Immediate hypersensitivity reactions, including angioedema and anaphylaxis, have been reported. Renal Impairment: Use with caution in patients with mild to moderate renal impairment. Pregnancy and Lactation: Safety and efficacy have not been established in pregnant or breastfeeding women; use only if the potential benefit justifies the potential risk to the fetus or infant.
- Adverse Reactions and Clinical Research Common Adverse Reactions: The most common adverse reactions include diarrhea, nausea, vomiting, abdominal pain, and dizziness. Clinical Research: Efficacy and safety were established in a Phase 3 clinical trial (DOMINO trial), which demonstrated significant improvements in cognitive function (measured by the ADCOMS score) compared to placebo after 96 weeks of treatment.
- Drug Interactions Impact of Antibiotics: Concomitant use of antibiotics may alter the gut microbiome composition and potentially diminish the therapeutic effect of sodium oligomannate. Other Drugs: No specific pharmacokinetic drug interactions have been identified, as the drug acts primarily through the gut-brain axis rather than systemic metabolism.
- Pharmaceutical Information Composition: The active ingredient is sodium oligomannate. Appearance: The capsules are opaque hard gelatin capsules containing white to off-white powder. Storage: Store in a tightly closed container at controlled room temperature, protected from moisture.
JiuqiYi Sodium Oligomannate Capsules
Brand Name: 九期一 ®（JiuqiYi®）
Generic Name: Sodium Oligomannate
Strength: 150 mg per capsule; standard package: 42 capsules per box
Manufacturer: Shanghai Green Valley Pharmaceutical Co., Ltd.
Marketing Authorization Holder: Shanghai Green Valley Pharmaceutical Co., Ltd.
Approval Date in China: November 2, 2019
Registration Number:国药准字 H20190031
Storage: Seal tightly, protect from light and moisture, store at temperature not exceeding 25°C. Keep out of reach of children. Refer to the full package insert for detailed storage specifications.
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