Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
SPRAY
**Posology and method of administration** Xylocaine pump spray provides surface anaesthesia of mucous membranes, which lasts for approximately 10–15 minutes. The anaesthesia usually occurs within 1–5 minutes, depending on 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. The degree of absorption from mucous membranes is variable but especially high from the bronchial tree. Application only to areas below the vocal cords may result in excessive plasma concentrations because of less transfer to the intestine and less first-pass loss. Each actuation of the metered-dose valve delivers 10 mg Xylocaine base. It is unnecessary to dry the site prior to application. Xylocaine spray 10% should not be used on cuffs of endotracheal tubes (ETT) made of plastic. - Otorhinolaryngology: 3 metered doses for puncture of the maxillary sinus or other minor surgical procedures. - Obstetrics – During delivery: Up to 20 metered doses (200 mg lidocaine base). - Introduction of instruments, tubes and catheters into the respiratory and digestive tract: Up to 20 metered doses (200 mg lidocaine base) for procedures in pharynx, larynx and trachea. During prolonged procedures up to 400 mg of lidocaine may be administered. In addition, when combined with other lidocaine products, the total dose should not exceed 400 mg. With applications mainly to the larynx, trachea and bronchi, the dose should not exceed 20 metered doses (200 mg lidocaine base). - Dental practice: 1–5 metered doses to the mucous membranes. 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 less than 12 years of age the dose should not exceed 3 mg/kg (e.g. 6 metered doses in an infant weighing 20 kg). When used mainly in the larynx and trachea the dose should be reduced to 1.5 mg/kg. In children less than 3 years of age less concentrated lidocaine solutions are recommended.
TOPICAL
Medical Information
**Therapeutic indications** For the prevention of pain associated with the following procedures: _Otorhinolaryngology_ - Puncture of the maxillary sinus and minor surgical procedures in the oral and nasal cavity, pharynx and epipharynx. _Obstetrics_ During the final stages of delivery and before episiotomy and perineal suturing as supplementary pain control. _Introduction of instruments, tubes and catheters into the respiratory and digestive tract_ Provides surface anaesthesia for the oropharyngeal and tracheal areas to reduce reflex activity, attenuate haemodynamic responses and facilitate insertion of the tube or the passage of instruments during endotracheal intubation and endoscopic procedures of the airways and upper gastrointestinal tract. _Dental practice_ Before injections, dental impressions, X-ray photography, removal of calculus.
**Contraindications** Known hypersensitivity to local anaesthetics of the amide type or to any of the excipients.
N01BB02
lidocaine
Manufacturer Information
DCH AURIGA SINGAPORE
ASTRAZENECA AB
Active Ingredients
Documents
Package Inserts
1.4.3 - Package Insert Proposed (Clean).pdf
Approved: November 21, 2018