XYLOCAINE OINTMENT 5% [SIN05683P]

Product Info

XYLOCAINE OINTMENT 5%

[SIN05683P]

Therapeutic indications

Xylocaine ointment is indicated as topical anaesthesia for

• the alleviation of pain during examination and instrumentation, e.g. endotracheal intubation, proctoscopy, sigmoidoscopy, cystoscopy.

• dentistry: surface anaesthesia of the gums prior to injection, and before deep scaling.

• anaesthesia of mucous membranes, e.g. various anal conditions such as haemorrhoids and fissures.

• temporary relief of pain associated with minor burns and abrasions of the skin, e.g. sunburn, herpes zoster and labialis, pruritus, sore nipples, insect bites.

Posology and method of administration

Lidocaine ointment is absorbed following application to mucous membranes or damaged skin, but probably only to a minimum extent when applied to intact skin. Absorption occurs most rapidly after intratracheal administration.

Following topical administration of lidocaine ointment in the oral mucosa, the onset of action occurs within 30 sec to 2 minutes. The onset on genital and anorectal mucosa is likely to occur within 5 minutes.

The duration of analgesia for burn wound pain and postoperative analgesia after circumcision is about 4 hours.

The application of gauze over the cream may provide a slow release effect and prolonged duration in burn wounds.

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 ointment should be applied in a thin layer for adequate control of symptoms. A sterile gauze pad is recommended for application to broken and burned tissue.

Apply 1–2 g to tube prior to endotracheal intubation.

In dentistry, apply to previously dried oral mucosa. Allow at least 3–5 minutes for the anaesthesia to become effective.

For sore nipples, apply on a small piece of gauze. The ointment must be washed away before the next feed.

After a maximum endotracheal dose or application to mucous membranes the next dose should not be applied until 4 hours later. Not more than 20 g of the ointment should be administered in any 24-hour period to healthy adults. Xylocaine ointment can be used in the elderly without dose reduction. Xylocaine ointment should be used with caution in patients with traumatised mucosa. Debilitated or acutely ill patients, patients with sepsis, severe liver disease or cardiac failure, and children over 12 years of age weighing less than 25 kg should be given doses commensurate with their weight and physiological condition.

No plasma concentration data are available in children. Hence, for safety reasons, in children less than 12 years of age 100% bioavailability should be assumed following application to mucous membranes and broken skin, and a single dose should not exceed 0.1 g ointment/kg body weight (corresponding to 5 mg lidocaine/kg body weight). The minimum dosing interval in children should be 8 hours.

Contraindications

Known history of hypersensitivity to local anaesthetics of the amide type or to other components of the ointment.