Topical gel Nani Pre Dental 5% 2x10 ml ACTION AND MECHANISM It works by locally blocking sensory receptors in the mucous membranes. It does not penetrate deeper, so it is ineffective in inflammatory or dental pain that originates in the deeper areas of the teeth and gums. Benzocaine has a very low pKa of 3.5, which makes it effective for superficial anesthesia. The onset of action is 30-60 seconds, and the effect lasts 10-15 minutes. ADVICE FOR PATIENTS ADVICE FOR PATIENTS: - Do not administer to children under 4 months. - Do not use for more than 7 consecutive days. - Do not apply this medicine more than 4 times a day, using the lowest dose that relieves pain symptoms. - Do not chew food or gum while the numbness persists, due to the risk of biting your tongue or the lining of your mouth. - Oral application of benzocaine may cause swallowing problems and therefore a risk of aspiration. It is recommended not to eat for one hour after application and to avoid spraying into the throat. - If you use products containing benzocaine, be aware of signs or symptoms of methemoglobinemia, such as pale, gray or bluish discoloration of the skin, lips and nails, difficulty breathing, fatigue, confusion, headache, dizziness and rapid heart rate. CONTRAINDICATIONS - Hypersensitivity to benzocaine, [ALLERGY TO ESTER LOCAL ANESTHETICS] or other p-aminobenzoic acid (PABA) derivatives. Cross-allergies may exist between benzocaine and other ester local anesthetics and with sulfonamides. - Should not be administered to children under 4 months of age. PHARMACOKINETICS Benzocaine is absorbed in very small amounts through mucous membranes. It is hydrolyzed to PABA-containing metabolites by plasma cholinesterases and, to a much lesser extent, by hepatic cholinesterases. Excretion is predominantly renal, mainly in the form of metabolites. Directions - [Teething]: Temporary and symptomatic relief of gingival discomfort in the early stages of teething, in children from 4 months of age. INTERACTIONS - Sulfonamides: PABA, a product of benzocaine metabolism, may inhibit the action of sulfonamides. Avoid concomitant administration. dOSAGE Gingival use. - Children over 4 months: Apply a small amount of gel, equivalent to a grain of rice, to a clean finger or gauze pad and apply to the childs gums, on the eruptive or painful areas, up to 3-4 times a day. - Do not use for more than 7 consecutive days. PRECAUTIONS - [METHEMOGLOBINEMIA]: Cases of methemoglobinemia have been described in patients (mostly children under 4 years of age) who were administered benzocaine gel or liquid for the relief of toothache. In most cases, the product was used incorrectly or excessively, although some cases involved appropriate use. Children under four years of age, elderly patients, and patients with certain congenital malformations, such as glucose-6-phosphodiesterase deficiency, hemoglobin M disease, NADH-methemoglobin reductase (diaphorase 1) deficiency, and pyruvate kinase deficiency, may also be at increased risk of developing methemoglobinemia. PRECAUTIONS REGARDING EXCIPIENTS - This medicine contains propylene glycol, so it may cause skin irritation. ADVERSE REACTIONS With prolonged use of benzocaine, hypersensitivity reactions (<1%) may occur, consisting of contact dermatitis. Other hypersensitivity reactions, such as rash, urticaria, edema or anaphylaxis, are extremely rare. Prolonged contact of benzocaine with mucous membranes may cause dehydration of the epithelium and hardening of the mucous membranes. A burning sensation in the mouth has been reported. Prolonged use has resulted in the following reported adverse reactions: [DYSGEUSIA], unpleasant taste, dehydration of mucous membranes and difficulty swallowing. In rare cases, benzocaine has been associated with methemoglobinemia, characterized by cyanosis. Most cases of methemoglobinemia in children occur due to overdose, accidental ingestion, and misuse of benzocaine preparations. COMPOSITION BENZOCAINE (DENTAL): 50 MILLIGRAMS PROPYLENE GLYCOL (EXCIPIENT): 0 Presentation : 2 x 10 ml