Description
Indication & Scope
XinTuoAn® Sitokiren Malate Tablets provides long-term blood pressure reduction for adult patients diagnosed with primary hypertension.
- Mechanism: Selective direct renin inhibitor. It binds circulating renin enzyme, blocks conversion of angiotensinogen to angiotensin I, suppresses the entire renin-angiotensin-aldosterone system (RAAS), dilates peripheral blood vessels and lowers systemic arterial blood pressure.
- Drug class: Oral direct renin inhibitor / Antihypertensive small-molecule tablet.
- Clinical use: Monotherapy for mild-to-moderate primary hypertension; can be combined with calcium channel blockers or thiazide diuretics for synergistic blood pressure control.
| Generic Name | Sitokiren Malate Tablets |
| Brand Name | XinTuoAn |
| Ingredient | Sitokiren Malate |
| Dosage Form | Tablets |
| Package | 50mg*14 tablets/box |
| Conditions Treated | Primary hypertension in adult patients |
| Taboos | Pregnant women in second and third trimesters; severe hypersensitivity to sitokiren malate or tablet excipients; patients with bilateral renal artery stenosis; hyperkalemia patients with serum potassium >5.5 mmol/L |
| Place of origin | China |
| Prescription type | Prescription-only |
| Storage Conditions | Store sealed blister packs at controlled room temperature between 15°C and 30°C, protected from humidity and strong light |
| Manufacturer | ShangYaoXinYi Pharmaceutical, Ltd. |
| Registration Authority | National Medical Products Administration (NMPA), China |
| Approval number | H20250067 |
| Approval Date | Apr 13, 2026 |
| Shelf Life | 36 months |
How to use ?
Recommended Dose: Standard starting dose 150 mg oral once daily; titrate to maximum 300 mg once daily if blood pressure target not achieved after 4 weeks.
Time: Take orally once daily at fixed time, may be administered with or without food.
Instructions for use: Swallow whole tablet with plain water without crushing or chewing; monitor serum creatinine and potassium levels within 2 weeks after dose escalation.
Interaction: Potassium-sparing diuretics or oral potassium supplements significantly raise hyperkalemia risk; nonsteroidal anti-inflammatory drugs reduce antihypertensive efficacy and worsen renal function.
Side effects:
1. Common: mild diarrhea, fatigue, dizziness, back pain, nasal congestion.
2. Severe rare adverse reactions: severe hyperkalemia, acute renal impairment, angioedema of face and throat.
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 cardiovascular system pathway does Sitokiren Malate Tablets inhibit to lower blood pressure?
It directly blocks renin activity in the renin-angiotensin-aldosterone RAAS pathway.
Which patient group is strictly contraindicated to take Sitokiren Malate Tablets during pregnancy?
Pregnant women in their second and third trimesters of gestation.
What routine lab tests need monitoring after dose increases of Sitokiren Malate Tablets?
Serum blood potassium concentration and renal creatinine function tests.
What two drug categories increase hyperkalemia risk when combined with Sitokiren Malate Tablets?
Potassium-sparing diuretics and oral potassium supplement tablets.
XinTuoAn® | Sitokiren Malate Tablets | Primary Hypertension | DengYueRX
INN: Sitokiren Malate Tablets
Indications: Primary hypertension
Dosage Form: Tablets
Strength: 50mg/tablet
