Nani Pre Dental 5% Topical Gel 10 Ml

Nani Pre Dental 5% Topic Gel 10 Ml

ACTION AND MECHANISM

It acts by blocking the sensory receptors of the mucous membranes, locally. It does not penetrate inside, making it ineffective in inflammatory or dental pains originating in deep areas of the teeth and gums.
Benzocaine has a pK of 3.5, really low, which makes it provide adequate superficial anesthesia. The latency period or onset of action is 30-60 seconds, the duration of the effect being 10 to 15 minutes.

PHARMACOKINETICS

Benzocaine is absorbed in very small amounts through the mucous membranes. It is hydrolyzed to metabolites containing PABA by plasma cholinesterases and, to a much lesser extent, by hepatic cholinesterases. Excretion is primarily via the renal route, mainly as metabolites.

INDICATIONS

- [DENTITION]: Temporary and symptomatic relief of gum discomfort in the primary phases of the dentition, in children from 4 months of age.

POSOLOGY

Gingival use.
- Children over 4 months: Place a small amount of gel, equivalent to a grain of rice, on the finger or gauze, and apply on the gums of the child, at points of eruption or pain, up to 3-4 times up to date.
- Do not use for more than 7 consecutive days.

CONTRAINDICATIONS

- Hypersensitivity to benzocaine, [LOCAL ANESTHETIC ALLERGY ESTER-TYPE] or to other derivatives of p-aminobenzoic acid (PABA). There may be cross-allergy between benzocaine and other local ester-type anesthetics and sulfonamides.
- It should not be given to children younger than 4 months.

PRECAUTIONS

- [METAHEMOGLOBINEMIA]: Methemoglobinemia cases have been described in patients (mostly children younger than 4 years) who were given benzocaine in gel or liquid to relieve toothaches. In most cases the product had been used incorrectly or excessively, although there were also with an appropriate use. Children younger than four years, elderly patients, and patients with certain congenital malformations such as glucose-6-phosphodiesterase deficiency, M-hemoglobin deficiency, NADH-methemoglobin reductase deficiency (diaphorase 1), and pyruvate kinase deficiency may also have increased risk of methemoglobinemia development.

PRECAUTIONS CONCERNING EXCIPIENTS

- This medicinal product contains propylene glycol, therefore may cause skin irritation.

PATIENT TIPS

ADVICE TO THE PATIENT:
- It should not be given to children younger than 4 months.
- Do not use for more than 7 consecutive days.
- Do not apply this medication more than 4 times a day, at the lowest dose that relieves pain symptoms.
- Do not chew food or chewing gum while numbing persists due to the risk of biting the tongue or oral mucosa.
- The oral application of benzocaine can cause problems in swallowing and therefore risk of aspiration. So it is recommended not to eat in the hour after its application and to avoid spraying in the throat.
- If benzocaine products are used, be alert for signs or symptoms of methaemoglobinemia such as pale, grayish or bluish color on the skin, lips and nails, difficulty breathing, fatigue, confusion, headache, dizziness, and heart rhythm accelerated.

INTERACTIONS

- Sulfamides: PABA, the product of the metabolism of benzocaine, may inhibit the action of sulphonamides. Avoid joint administration

ADVERSE REACTIONS

- With prolonged use of benzocaine, [HYPERSENSITIVITY REACTIONS] (<1%) consisting of [CONTACT DERMATITIS] may occur. Other hypersensitivity reactions such as [EXTREMATIC ERUPTIONS], [URTICARIA], [EDEMA] or [ANAFILAXIA] are extremely rare.
- Prolonged contact of the benzocaine with the mucous membranes can cause dehydration of the epithelium and hardening of the mucous membranes. A burning sensation has been reported.
- For prolonged use have been reported: [DISGEUSIA], bad taste in the mouth, dehydration of the mucous membranes and difficulty swallowing.
- Exceptionally, benzocaine has been linked to the production of [METAHEMOGLOBINEMIA], characterized by [CYANOSIS]. Most cases of methemoglobinemia in children occur due to overdose, accidental ingestion and misuse of benzocaine preparations.

See leaflet Nani Pre Dental 5% Topical Gel 10 Ml

See Technical Data Sheet Nani Pre Dental 5% Topical Gel 10 Ml