Description
Indication & Scope
Treatment of painful diabetic peripheral neuropathy in adult patients.
- Mechanism: Selective ligand of voltage-gated calcium channel α2-δ subunit. It reduces excitatory neurotransmitter release in peripheral sensory nerves, inhibits neuropathic pain signal transmission and relieves nerve pain.
- Drug class: Alpha-2-delta ligand, neuropathic pain analgesic, prescription central nervous system agent
- Clinical use: First-line treatment for moderate to severe painful diabetic peripheral neuropathy to relieve persistent neural pain.
| Generic Name | Crisugabalin Besilate Capsules |
| Brand Name | SiMeiNing |
| Ingredient | Crisugabalin Besilate Capsules |
| Dosage Form | Capsules |
| Package | 20mg*8 capsules/box |
| Conditions Treated | Painful diabetic peripheral neuropathy in adults |
| Taboos | 1. Hypersensitivity to crisugabalin besilate or capsule excipients
2. Severe renal failure without dialysis support 3. Known history of angioedema to gabapentin/pregabalin class drugs |
| Place of origin | China |
| Prescription type | Prescription-only |
| Storage Conditions | Store tightly sealed below 30°C, dry and away from direct sunlight. |
| Manufacturer | HaiSiKe Pharmaceutical Co., Ltd |
| Registration Authority | National Medical Products Administration (NMPA), China |
| Approval number | H20240018 |
| Date of Revision | 2024 |
| Shelf Life | 24 months |
How to use ?
Recommended Dose: 75 mg twice daily; titrate up to maximum 300 mg twice daily based on pain relief and tolerability.
Time: Administer morning and evening at fixed 12-hour intervals, can be taken with or without meals.
Instructions for use:
1. Titrate dosage gradually to minimize dizziness and somnolence onset.
2. Renal function dose adjustment is required for patients with impaired kidney function.
3. Do not discontinue abruptly; taper dose gradually to avoid rebound pain.
4. Avoid driving or high-precision operation during dose titration period.
Interaction:
1. Central nervous system depressants (opioids, sedatives) amplify drowsiness and dizziness.
2. No significant CYP450 metabolic interactions with most common medications.
3. Antihypertensive drugs may slightly increase peripheral edema risk.
Side effects:
1. Common: Dizziness, somnolence, peripheral edema, dry mouth, blurred vision, weight gain.
2. Severe: Severe allergic angioedema, suicidal ideation (rare), worsening renal edema in patients with renal insufficiency.
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 the mechanism of action of Crisugabalin Besilate?
It is a novel GABA analog that binds to the α2δ subunit of voltage-gated calcium channels, reducing calcium influx and decreasing the release of excitatory neurotransmitters involved in pain signaling.
What are the approved indications for Crisugabalin Besilate?
It is indicated for the treatment of adult diabetic peripheral neuropathic pain (DPNP) and postherpetic neuralgia (PHN).
What is the typical route of administration and dosing schedule for Crisugabalin Besilate?
It is administered orally, usually twice daily, with doses titrated to the patient’s response and renal function.
Why is renal function an important consideration when prescribing Crisugabalin Besilate?
The drug is primarily excreted unchanged by the kidneys, so dose adjustments are required in patients with renal impairment to prevent accumulation and adverse effects.
SiMeiNing® | Crisugabalin Besilate Capsules | Adult Diabetes Peripheral Neuropathic Pain | DengYueRX
INN: Crisugabalin Besilate Capsules
Indications: Treat painful diabetic peripheral neuropathy in adult patients
Dosage Form: Capsules
Strength: 20mg/capsule
