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ACTION AND MECHANISM Combination of broad-spectrum antiseptic (chlorhexidine) and ester-type local anesthetic (benzocaine). SPECIAL WARNINGS - In patients with periodontitis, chlorhexidine causes an increase in supragingival calculus. PATIENT ADVICE - Administration is not recommended in children under 3 years of age (regular and mint forte tablets) or under 6 years of age (orange-flavored forte tablets). - The tablets should not be chewed or swallowed, as their action is local. - May permanently stain fillings if the surface or margins are rough. - Maintain good oral hygiene with a special anti-tartar toothpaste to reduce tartar buildup and staining caused by chlorhexidine. CONTRAINDICATIONS - Allergy to any of the components, [ALLERGY TO ESTER-TYPE LOCAL ANESTHETICS] such as PABA, parabens or paraphenylenediamine (a hair dye). - Children under 6 years of age, due to their special sensitivity to the systemic toxicity of benzocaine, which may cause methemoglobinemia. PREGNANCY There is insufficient data on the use of chlorhexidine and benzocaine in pregnant women. Chlorhexidine: No fertility disorders, fetotoxic effects, or peri-postnatal toxicity have been reported in animal studies. Benzocaine: No problems with benzocaine have been reported during pregnancy. INDICATIONS - Symptomatic relief of mild throat infections without fever, such as [PHARYNGITIS], [SORE THROAT] or [HOARSENESS]. INTERACTIONS Due to the presence of benzocaine, it interferes with: - Cholinesterase inhibitors: inhibit the metabolism of the local anesthetic, with the risk of increased systemic toxicity. - Sulfonamides: benzocaine metabolites can antagonize the antibacterial activity of sulfonamides. LACTATION It is unknown whether chlorhexidine is excreted in breast milk. No problems have been reported with benzocaine during breastfeeding. CHILDREN Due to its benzocaine content, it should not be administered to children under 6 years of age. Children are more sensitive to the systemic toxicity of benzocaine, which can cause methemoglobinemia. GUIDELINES FOR PROPER ADMINISTRATION Allow to dissolve slowly in the mouth; without chewing or swallowing. POSOLOGY - Adults: 1 tablet as needed, leaving at least 2 hours between doses. Maximum dose: 8 tablets per day - Children over 6 years old: the same dose as the adult. - Children under 6 years: Not recommended for use. If symptoms worsen or persist for more than 2 days, or if they are accompanied by high fever, headache, nausea or vomiting, the clinical situation will be evaluated. PRECAUTIONS - Intolerance to PABA, parabens or paraphenylenediamine (a hair dye). These patients may also be intolerant to benzocaine. - Children, the elderly, acutely ill, or debilitated patients: these are more sensitive to the systemic toxicity of benzocaine, which can lead to methemoglobinemia. - Local infection in the treatment area: the pH is altered, thus decreasing the local anesthetic effect. - Severe mucosal trauma: the absorption of the anesthetic increases. - Fillings in incisor teeth: if the surface of the filling or its margins are rough, they may acquire permanent discoloration with chlorhexidine, requiring replacement for aesthetic reasons. - Periodontitis: chlorhexidine causes an increase in supragingival calculus. - It is recommended to maintain adequate oral hygiene with a special anti-tartar toothpaste to reduce tartar buildup and tooth discoloration caused by chlorhexidine. - The tablets should not be chewed or swallowed, as their action is entirely local and their activity is only evident if the product is in direct contact. with the affected area.- If symptoms persist for more than 2 days or worsen or are accompanied by high fever, headache, nausea or vomiting, consult a doctor as soon as possible. ADVERSE REACTIONS Adverse effects are generally mild and transient. The most common are: - Occasionally, brown discoloration of the teeth, fillings, dentures, and other oral appliances, as well as the tongue. Tongue discoloration disappears spontaneously and is not dangerous. Tooth discoloration is not permanent and can be removed by oral hygiene. Discoloration of fillings may be permanent. - Temporary alterations in taste and a burning sensation in the mouth may occur at the start of treatment. - Increased tartar buildup. - Rare cases of oral irritation due to scaly lesions, sometimes painful (especially in children between 10 and 18 years old), have been reported. This is usually temporary, as is irritation of the tip of the tongue. - Also, in rare cases, local allergic reactions occurred, sometimes accompanied by nasal congestion, itching, and skin rash. - Burning, itching, swelling, or redness inside or around the mouth. Adverse reactions that may arise from the presence of benzocaine are due to excessive dosage or rapid absorption, as well as the patients idiosyncrasy, and include contact sensitization and angioedema (due to allergic reaction or contact dermatitis). OVERDOSE At the proposed doses, an overdose is unlikely. - Symptoms: Due to chlorhexidine, especially in children, symptoms of alcohol intoxication may occur (slurred speech, drowsiness, or unsteady gait). Symptoms due to benzocaine include CNS stimulation (symptoms include blurred or double vision, dizziness, seizures, ringing in the ears, and agitation), followed by CNS depression (drowsiness), cardiovascular depression, increased sweating, low blood pressure, or slow or irregular heartbeat. Methemoglobinemia may also occur (difficulty breathing, dizziness, fatigue, tiredness, and weakness). - Treatment: Treatment for chlorhexidine is primarily symptomatic. Administer oxygen or initiate assisted respiration, and for circulatory depression, administer a vasoconstrictor and intravenous fluids. Treatment for methemoglobinemia: methylene blue. COMPOSITION BENZOCAINE (DENTAL): 5 MILLIGRAMS CHLORHEXIDINE (STOMATOLOGICAL): 5 MILLIGRAMS - DICHLORHYDRATE
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