Oralis Pain Relief Gel

A transparent and colourless gel with orange flavour.
Active Ingredients: Lidocaine Hydrochloride 0.33% w/w, Cetylpyridinium Chloride 0.1% w/w.

Pharmacology: Cetylpyridium Chloride is a cationic disinfectant which is used for minor wounds, treating superficial infections of the mouth and preserving the product.
Lidocaine Hydrochloride is a local anaesthetic. It works by blocking nerve conduction when applied topically to nerve tissue. It acts on any part of the nervous system and on every type of nerve fibre. For example, when it is applied to the motor cortex, impulse transmission from that area stops, and when it is injected into the skin it prevents the initiation and the transmission of the sensory impulses. A local anaesthetic in contact with a nerve trunk can cause both sensory and motor paralysis in the area innervated. Many kinds of compounds interfere with conduction, but they often permanently damage the nerve cells. The great practical advantage of the local anaesthetics is that their use is reversible, their use is followed by complete recovery in nerve function with no evidence of structural damage to nerve fibres or cells.
Lidocaine produces more prompt, more intense, longer-lasting and more intense anaesthesia than does an equal concentration of procaine. Unlike procaine it is an aminoethylamide. It is an agent of choice, therefore, in individuals sensitive to ester-type local anaesthetics. Lidocaine is relatively quickly absorbed. Lidocaine is metabolised in the liver by mixed function oxidases by dealkylation to monoethyl glycine and xylidide. The latter compound retains significant local anaesthetic and toxic activity. In man about 75% of xylidide is excreted in the urine as the further metabolite 4-hydroxy-2,6-dimethylaniline. The typical dose of Oralis Pain Relief Gel is about 150 mg containing about 0.5 mg of lidocaine hydrochloride (which approximates to about 0.1 mg/kg of bodyweight). Martindale recommends that the total dose of lidocaine hydrochloride should not exceed 200 mg (3 mg per kg of bodyweight). Thus the dosage of Oralis Pain Relief Gel is well within this level.

Oralis Pain Relief Gel has a local anaesthetic action that acts quickly to relieve pain and soothe the gums.

Directions of Use: Place a small quantity of Oralis Pain Relief Gel on a pad of cotton wool or a clean fingertip and rub gently on the gum. Repeat after 20 minutes if necessary. Use when necessary during the teething period.

Serious adverse reactions are rare when applied topically, but may occur in connection with absolute overdose or ingestion. The symptoms consistent with taking a very large overdose are; the excitation of the central nervous system causing restlessness, excitement, nervousness, dizziness, tinnitus, blurred vision, nausea and vomiting, muscle twitching, tremors and convulsion. In the event any of these symptoms appear, seek medical attention immediately.

Hypersensitivity to the active substances or to any of the excipients.

Oralis Pain Relief Gel should be used with caution in patients with severely traumatized mucosa and sepsis in the region of application. The application of the gel for prolonged periods or to extensive areas should be avoided.
If symptoms persist, consult a doctor.

Not applicable.

None known.

None known.

Store below 30°C. Protect from light. Keep cap tightly closed.
Shelf Life: 3 years from the date of manufacture.

Preparations for Oral Ulceration & Inflammation

A01AD11 - various ; Belongs to the class of other agents for local oral treatment.

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