Dentesgel (Gel) Instructions for Use

Marketing Authorization Holder

Tula Pharmaceutical Factory, LLC (Russia)

ATC Code

N01BB52 (Lidocaine in combination with other drugs)

Active Substances

Lidocaine (Rec.INN registered by WHO)

Cetylpyridinium chloride (Rec.INN registered by WHO)

Dosage Form

Dentesgel

Gum application gel (for children) 3.3 mg+1 mg/1 g: jars or tubes 5 g, 10 g, 15 g, 20 g, 25 g, 30 g, 35 g, 40 g, 50 g, 60 g, 70 g, 80 g, 90 g, or 100 g jars or tubes

Dosage Form, Packaging, and Composition

Gum application gel [for children] yellowish-brown in color, homogeneous, soft, with a characteristic odor, free from granules, lumps, and foreign particles.

Excipients: sorbitol solution 70% non-crystallizing – 210 mg, xylitol – 140 mg, ethanol 95% – 93.6 mg, glycerol – 70 mg, hydroxyethylcellulose – 25 mg, macrogol glyceryl hydroxystearate – 10 mg, lauromacrogol 600 – 3.3 mg, macrogol 300 – 3.3 mg, sodium saccharin – 1 mg, levomenthol – 0.6 mg, herbal flavor (honey flavor:chamomile flavor (1:1)) – 4.8 mg, caramel E150 – 1 mg, sodium citrate – 8.3 mg, citric acid monohydrate – 1.05 mg, purified water – up to 1000 mg.

5 g – jars (1) – cardboard packs.
10 g – jars (1) – cardboard packs.
15 g – jars (1) – cardboard packs.
20 g – jars (1) – cardboard packs.
25 g – jars (1) – cardboard packs.
30 g – jars (1) – cardboard packs.
35 g – jars (1) – cardboard packs.
40 g – jars (1) – cardboard packs.
50 g – jars (1) – cardboard packs.
60 g – jars (1) – cardboard packs.
70 g – jars (1) – cardboard packs.
80 g – jars (1) – cardboard packs.
90 g – jars (1) – cardboard packs.
100 g – jars (1) – cardboard packs.
5 g – tubes (1) – cardboard packs.
10 g – tubes (1) – cardboard packs.
15 g – tubes (1) – cardboard packs.
20 g – tubes (1) – cardboard packs.
25 g – tubes (1) – cardboard packs.
30 g – tubes (1) – cardboard packs.
35 g – tubes (1) – cardboard packs.
40 g – tubes (1) – cardboard packs.
50 g – tubes (1) – cardboard packs.
60 g – tubes (1) – cardboard packs.
70 g – tubes (1) – cardboard packs.
80 g – tubes (1) – cardboard packs.
90 g – tubes (1) – cardboard packs.
100 g – tubes (1) – cardboard packs.

Clinical-Pharmacological Group

Local anesthetic for superficial anesthesia

Pharmacotherapeutic Group

Anesthetics; local anesthetics; amides

Pharmacological Action

Combined preparation for topical use, contains an antiseptic agent and a local anesthetic agent.

Cetylpyridinium chloride is an antiseptic from the group of quaternary ammonium compounds, it has bactericidal activity against gram-positive and, to a lesser extent, gram-negative bacteria. It alters the permeability of the bacterial cytoplasmic membrane and disrupts the internal oxidative mechanisms of bacterial respiration, leading to their death. Cetylpyridinium chloride has antifungal and antiviral activity against enveloped viruses.

Lidocaine hydrochloride is a local anesthetic from the amide group; in inflammatory processes, it relieves sore throat when swallowing. Lidocaine impairs the permeability of the cell membrane to sodium ions, which leads to anesthesia as a result of blocking nerve impulse conduction.

Pharmacokinetics

Cetylpyridinium chloride is practically not absorbed through the oral mucosa.

Lidocaine hydrochloride is poorly absorbed through the oral mucosa. When taken orally, it is absorbed, undergoing metabolism during the “first pass” through the liver. Its oral bioavailability is about 35%. Metabolites are excreted in the urine, less than 10% of the substance is excreted unchanged.

Indications

Infectious and inflammatory diseases of the oral cavity and pharynx: pharyngitis; laryngitis; catarrhal tonsillitis; stomatitis; ulcerative gingivitis; tonsillitis (as an auxiliary agent).

Pain during teething, gum irritation.

ICD codes

Dosage Regimen

Apply the gel topically to the affected gum areas every 3-4 hours, or as needed for pain relief.

Use a pea-sized amount of gel, approximately 0.25-0.5 grams, for each application.

Apply the gel using a clean fingertip or a cotton swab, gently massaging it into the inflamed gum tissue.

For teething pain in children, apply the gel no more than six times per day.

Avoid applying the gel immediately before or after eating or drinking to maintain local anesthetic and antiseptic efficacy.

Do not use for more than 7 consecutive days without consulting a physician.

For infectious and inflammatory conditions of the oral cavity, use as an adjunctive treatment following a doctor’s diagnosis.

Do not exceed the recommended application frequency or duration of use.

Thoroughly wash hands before and after each application to prevent contamination.

Adverse Reactions

From the digestive system: rarely – nausea; very rarely – diarrhea.

From the skin and subcutaneous tissues: very rarely – skin rash, itching.

Local reactions rarely – local irritation of the oral and throat mucosa.

Contraindications

First trimester of pregnancy; breastfeeding period; children under 5 months of age, children under 6 years of age (for dosage forms intended for children over 6 years and adults), hypersensitivity to the components of the drug.

With caution

Open wounds of the oral mucosa.

Use in Pregnancy and Lactation

Use is contraindicated in the first trimester of pregnancy. Use in the second and third trimesters of pregnancy is possible under medical supervision, if the expected benefit to the mother outweighs the potential risk to the fetus.

Not recommended for use during breastfeeding.

Pediatric Use

Use is contraindicated in children under 5 months of age; in children under 6 years of age (for dosage forms intended for children over 6 years and adults).

Special Precautions

Should not be taken immediately before meals and simultaneously with milk. Simultaneous intake with milk and food may reduce the local antiseptic and anesthetic effects.

Alcohol increases the absorption of cetylpyridinium chloride, therefore alcohol should not be consumed during treatment.

Cetylpyridinium chloride slows down wound healing.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.