NBP Application Scope

Butylphthalide (NBP) is indicated for the treatment of acute ischemic stroke (AIS) and for improving neurological function in the recovery phase after ischemic stroke.

NBP Characteristics

Ingredients: Butylphthalide
Properties:
- Soft capsules: Yellow to deep-yellow oily liquid inside gelatin soft capsule.
- Injection: Transparent solution containing butylphthalide (25 mg) plus sodium chloride 0.9 g per 100 mL bag (specification).
Packaging Specification:
- Soft capsules: Commonly 0.1 g per capsule (pack sizes vary; typical blister packs/boxes; check local package).
- Injection: 100 mL per bag containing 25 mg butylphthalide + 0.9 g sodium chloride.
Storage: Store sealed; keep in a cool, dry place away from light
Expiry Date: 24 months
Executive Standard: Product quality and testing follow the approved product standard filed with the National Medical Products Administration
Approval Number:
- Butylphthalide Soft Capsules: NMPA Approval No. 国药准字H20050299.
- Butylphthalide and Sodium Chloride Injection: NMPA Approval No. 国药准字H20100041.
Date of Revision: The most recent revision date appears on the printed package insert / electronic product information
Manufacturer: CSPC Enbipu Pharmaceutical Co., Ltd.

Guidelines for the Use of NBP

Dosage and Administration:
- Recommended Dose:
  - Soft capsules: Oral, on an empty stomach or as per label/physician instructions.
  - Injection: Intravenous infusion as described above; use appropriate infusion materials.
- Administration:
  - Butylphthalide Soft Capsules (oral): Recommended dose (common regimen): 0.2 g (two 0.1 g capsules) three times daily (i.e., 200 mg TID). A typical course is often reported as 20 days per treatment cycle or as directed by physician.
  - Butylphthalide and Sodium Chloride Injection (IV): Recommended dose (common regimen): 25 mg (in 100 mL) intravenously, twice daily; infusion duration not less than 50 minutes per dose; interval between doses ≥6 hours; typical course 14 days. Treatment is generally started within 48 hours of stroke onset when indicated. Use PE infusion set (avoid PVC due to adsorption).
- Missed Dose: General guidance: take missed oral dose as soon as remembered; do not double the next dose to make up. For IV dosing in hospital, follow clinician instructions.
Adverse Reactions:
- Common Adverse Reactions:
  - Gastrointestinal: Nausea, abdominal discomfort, diarrhea (uncommon).
  - Hepatic: Transient elevation of liver enzymes (ALT/AST), usually reversible on discontinuation.
  - Dermatologic: Rash, pruritus (uncommon).
  - Others reported in trials: Dizziness, headache, transient changes in heart rate, and infusion-related local reactions for injection.
- Serious Adverse Reactions: Serious adverse events are uncommon. Large randomized trials found similar rates of serious adverse events between butylphthalide and control groups; symptomatic intracranial hemorrhage and mortality rates were comparable in major studies. However, clinicians must monitor for bleeding complications and other serious events during acute stroke care.
Contraindications:
- Known hypersensitivity/allergy to butylphthalide or any excipient.
- Other contraindications may be listed on the local product label—consult the package insert.
Precautions:
- Liver function: Monitor liver enzymes during treatment; use with caution in patients with hepatic impairment.
- Bleeding risk / Hemorrhagic stroke: Use caution when assessing for hemorrhagic risk; safety beyond studied windows is not established.
- Cardiac conduction: Exercise caution in patients with severe bradycardia or sick sinus syndrome.
- Renal impairment: Follow local label cautions—certain excipients may affect dosing in severe renal dysfunction.
- Infusion materials: For the injection formulation, use PE infusion sets only (PVC tubing may adsorb the drug).

NBP Interactions

Drug-drug interaction data are limited. No major, well-established pharmacokinetic interactions have been widely reported in label documents. In clinical practice, Butylphthalide has been used concomitantly with standard antiplatelet agents (aspirin, clopidogrel), thrombolysis, and statins in stroke care; monitor for combined safety effects (e.g., bleeding risk) as per clinical context.

Note:

If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
This content is for reference only. Prescription drugs must be used under a doctor’s guidance and purchased from authorized sources.