Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
GEL
**Dosage and method of administration** Xylocaine jelly 2% provides prompt and profound anaesthesia of mucous membranes, giving effective anaesthesia of long duration (approx. 20–30 min). Anaesthesia usually occurs rapidly (within 5 min depending upon the area of application). As with any local anaesthetic, the safety and effectiveness of lidocaine depend on the proper dosage, the correct technique, adequate precautions and readiness for emergencies. The following dosage recommendations should be regarded as a guide. The clinician’s experience and knowledge of the patient’s physical status are of importance in calculating the required dose. Absorption from mucous membranes is variable but especially high from the bronchial tree. The absorption of lidocaine jelly from the nasopharynx is usually lower than with other lidocaine products. Blood concentrations of lidocaine after instillation of the jelly in the intact urethra and bladder in doses up to 800 mg are fairly low and below toxic levels. Debilitated or elderly patients, children over 12 years of age, acutely ill patients or patients with sepsis should be given doses commensurate with their age, weight and physical condition. In children under the age of 12 years the dose should not exceed 4 mg/kg. No more than four doses should be given in a 24 hour period. **Urethral anaesthesia** Surface anaesthesia of the male adult urethra: for adequate analgesia in males 20 ml (= 400 mg lidocaine hydrochloride) jelly is required. The jelly is instilled slowly until the patient has a feeling of tension or until almost half the tube (10 ml = 200 mg lidocaine hydrochloride) has been emptied. A penile clamp is then applied for several minutes at the corona, after which the rest of the jelly is instilled. When anaesthesia is especially important, e.g. during sounding or cystoscopy, a larger quantity of jelly (e.g. 30–40 ml) may be instilled in 3–4 portions and allowed to act for 10 minutes before insertion of the instrument. The jelly instilled into the bladder is also effective for procedures in this region. Surface anaesthesia of the female adult urethra: instill 5–10 ml in small portions to fill the whole urethra. In order to obtain adequate anaesthesia, several minutes should be allowed to elapse prior to performing urological procedures. **Endoscopy** The instillation of 10–20 ml is recommended for adequate analgesia and a small amount may be applied to the lubricating instrument. When combined with other lidocaine products (e.g. for bronchoscopy), the total dose of lidocaine should not exceed 400 mg. **Lubrication for endotracheal intubation** About 2 ml applied to the surface of the tube just prior to insertion. Care should be taken to avoid introducing the product into the lumen of the tube.
TOPICAL
Medical Information
**Indications** Xylocaine jelly is indicated as a surface anaesthetic and lubricant for: - The male and female urethra during cystoscopy, catheterisation, exploration by sound and other endourethral procedures. - Nasal and pharyngeal cavities in endoscopic procedures such as gastroscopy and bronchoscopy. - During proctoscopy and rectoscopy. - Tracheal intubation. - Symptomatic treatment of pain in connection with cystitis and urethritis.
**Contraindications** Hypersensitivity to local anaesthetics of the amide type, or to any of the excipients. Hypersentivity to methyl and/or propyl hydroxybensoate (methyl-/propyl paraben), or to their metabolite para amino benzoic acid (PABA). Formulations of lidocaine containing parabens should be avoided in patients allergic to ester local anaesthetics or their metabolite PABA.
N01BB02
lidocaine
Manufacturer Information
DCH AURIGA SINGAPORE
Recipharm Karlskoga AB
Active Ingredients
Documents
Package Inserts
1.4.3 - Package Insert Proposed (Clean).pdf
Approved: November 22, 2018