Description
Indication & Scope
XinTuoAn® (Sitokiren Malate) is indicated for the treatment of primary hypertension in adults.
Mechanism:
Sitokiren Malate is a direct renin inhibitor that suppresses plasma renin activity and inhibits activation of the renin–angiotensin–aldosterone system (RAAS), thereby lowering blood pressure.
Drug Class:
Direct renin inhibitor.
Clinical Use:
Treatment of adult patients with primary hypertension.
| Generic Name | Sitokiren Malate Tablets |
| Brand Name | XinTuoAn® |
| Ingredient | Sitokiren Malate |
| Dosage Form | Tablet |
| Package | 50 mg × 14 tablets/box |
| Conditions Treated | Primary hypertension |
| Taboos | Hypersensitivity to Sitokiren Malate or any excipient; pregnancy. |
| Place of origin | China |
| Prescription type | Prescription Drug (Rx) |
| Storage Conditions | Store below 30°C in a tightly closed container, protected from light. |
| Manufacturer | Shanghai Shangpharma Xinyi Pharmaceutical Co., Ltd. |
| Registration Authority | National Medical Products Administration (NMPA), China |
| Approval number | H20250067 |
| Date of Revision | 2025 |
| Shelf Life | Refer to the approved package labeling. |
How to use ?
Recommended Dose: 100 mg (two 50 mg tablets) administered orally once daily according to the approved prescribing information.
Time: Administer once daily at approximately the same time each day. The tablets may be taken with or without food.
Instructions for use: Swallow the tablets whole with water. Mild hepatic or renal impairment does not require dose adjustment. The use of Sitokiren Malate is not recommended in patients with moderate or severe hepatic impairment or moderate to severe renal impairment because of limited clinical data.
Interaction: Sitokiren Malate has not demonstrated clinically significant CYP450-mediated interactions. However, concomitant use with strong CYP3A inhibitors should be approached with caution, and the safety and efficacy of combination therapy with other antihypertensive agents have not been fully established in the approved labeling.
Side effects: Common adverse reactions include dizziness, flushing, fatigue, and mild gastrointestinal discomfort. Less common reactions include transient elevations in liver enzymes and peripheral edema. Most adverse events reported in clinical studies were mild to moderate in severity.
Important Notice
This product should be administered only by qualified healthcare professionals in accordance with the approved prescribing information and local clinical guidelines. Dosage and administration may vary depending on patient condition, indicatiaon, and regional regulatory requirements.
Packaging & Shipping
Packaging
Original manufacturer’s packaging with secure export carton. Customized export packaging is available upon request.
Shipping Methods
Express Courier (EMS, DHL, FedEx, UPS), Air Freight, and Sea Freight. Cold-chain transportation is available for products requiring temperature-controlled logistics.
Export Support
Certificate of Analysis
GMP Certificate
Commercial Invoice
Packing List & CPP
Cold Chain Logistics
Customs Documentation
Scientific and regulatory sources
FAQ
What is XinTuoAn® (Sitokiren Malate)?
XinTuoAn® is an oral direct renin inhibitor indicated for the treatment of adult patients with primary hypertension.
What is XinTuoAn® used for?
It is used to lower blood pressure in adults with primary hypertension.
How does Sitokiren Malate work?
It directly inhibits renin, reducing activation of the RAAS pathway and helping to control blood pressure.
What precautions should be considered?
Blood pressure should be monitored regularly during treatment. The drug is contraindicated during pregnancy and should be used cautiously in patients with significant hepatic or renal impairment.
XinTuoAn® | Sitokiren Malate | Primary Hypertension | DengYueRX
INN: Sitokiren Malate
Indications: Primary hypertension
Dosage Form: Tablet
Strength: 50 mg/Tablet
