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Tongfang Pharmaceutical Group Co., Ltd

复方利多卡因乳膏, Fufang Liduokayin Rugao, Compound Lidocaine Cream, 10g, Topical Anesthesia for Cutaneous Surgeries or for Premature Ejaculation (PE) in Males

复方利多卡因乳膏, Fufang Liduokayin Rugao, Compound Lidocaine Cream, 10g, Topical Anesthesia for Cutaneous Surgeries or for Premature Ejaculation (PE) in Males

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Drug Name
复方利多卡因乳膏
Compound Lidocaine Cream
Fufang Liduokayin Rugao

Ingredients
This product is a compound preparation containing prilocaine and lidocaine. Each gram of cream contains 25 mg of prilocaine and 25 mg of lidocaine.

Physical Characteristics
White cream.

Indications
This product is indicated for superficial cutaneous anesthesia in the following situations:
(1) Needle puncture procedures, such as catheter insertion or blood sampling.
(2) Minor surgical procedures.

Specifications
Each gram of cream contains 25 mg of prilocaine and 25 mg of lidocaine.

Dosage and Administration
For Skin Application:
Apply a thick layer of cream to the skin surface and cover with an occlusive dressing.

  • Adults and children over 1 year of age: Approximately 1.5 g per 10 cm², up to 2 g for minor procedures. Application time: minimum 1 hour, maximum 5 hours.
  • For extensive skin procedures: Approximately 1.5–2 g per 10 cm². Application time: minimum 2 hours, maximum 5 hours.
  • Infants aged 3–12 months: Maximum 2 g of cream applied to a 16 cm² area. Application time: approximately 1 hour.

For Genital Mucosa Application:
Apply 5–10 g of cream to the mucosa. Application time: approximately 5–10 minutes. No occlusive dressing is required before starting the procedure.

Pharmacology and Toxicology
When applied to intact skin and covered with an occlusive dressing, lidocaine and prilocaine are released into the dermis and epidermis. They accumulate at cutaneous pain receptors and nerve endings, stabilizing neuronal membranes by blocking ion fluxes required for nerve impulse generation and conduction, thereby producing local anesthesia. Lidocaine and prilocaine are amide-type local anesthetics.

Pharmacokinetics
The systemic absorption of lidocaine and prilocaine from this cream depends on the dose, application duration, skin thickness at the application site, and skin condition.

  • Intact Skin Application:
    • Adult thigh application (60 g/400 cm²): Approximately 5% of lidocaine and prilocaine are absorbed after 3 hours. Peak plasma concentrations are reached after 2–6 hours, averaging 0.12 μg/mL for lidocaine and 0.07 μg/mL for prilocaine.
    • Facial application (10 g/100 cm²): Systemic absorption is approximately 10% after 2 hours. Peak plasma concentrations are reached after 1.5–3 hours, averaging 0.16 μg/mL for lidocaine and 0.6 μg/mL for prilocaine.
  • Genital Mucosa Application:
    • Application of 10 g to vaginal mucosa: Peak plasma concentrations are reached after 20–45 minutes, averaging 0.18 μg/mL for lidocaine and 0.15 μg/mL for prilocaine.

Storage
Store below 25°C in a tightly sealed container. Do not freeze.

Packaging
Aluminum tube. 10 g/tube.

Expiration
36 months.

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