Lident Baby (Gel) Instructions for Use

Marketing Authorization Holder

Akrikhin Chemical and Pharmaceutical Plant, JSC (Russia)

Contact Information

AKRIKHIN JSC (Russia)

ATC Code

A01AD11 (Other drugs)

Active Substances

Lidocaine (Rec.INN registered by WHO)

Cetylpyridinium chloride (Rec.INN registered by WHO)

Dosage Form

Lident Baby

Dental gel 0.33%+0.1%: 5 g or 10 g tubes

Dosage Form, Packaging, and Composition

Dental gel from light yellow to yellow with a brownish tint; a slight characteristic odor is allowed.

Excipients: liquid non-crystallizing sorbitol, xylitol, 96% ethyl alcohol, glycerol, hyetellose (hydroxyethylcellulose), macrogola glyceryl hydroxystearate (macrogol 40 glyceryl hydroxystearate), lauromacrogol 600 (macrogol lauryl ether), macrogol-300, sodium saccharin, levomenthol, chamomile flavor, caramel (E150a), sodium citrate, citric acid, purified water.

5 g – aluminum tubes (1) – cardboard packs.
10 g – aluminum tubes (1) – cardboard packs.

Clinical-Pharmacological Group

A drug with local anesthetic and antimicrobial action for topical application in dentistry

Pharmacotherapeutic Group

Local anesthetic agent

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, has bactericidal activity against gram-positive and, to a lesser extent, gram-negative bacteria.

It alters the permeability of the cytoplasmic membrane of bacteria, disrupts the internal oxidative mechanisms of bacterial respiration, which leads 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 the conduction of nerve impulses.

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.

When taken orally, its 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 areas of the oral mucosa or gums.

For pain during teething in infants, apply a pea-sized amount of gel to the inflamed gum area.

For infectious and inflammatory diseases of the oral cavity, apply a thin layer to the affected mucous membranes.

Use the gel every 3-4 hours, or as needed for pain relief.

Apply the gel after meals and before bedtime.

Avoid applying the gel immediately before eating or drinking to ensure prolonged contact with the mucosa.

Do not exceed 6 applications per 24 hours.

For children under 3 years of age, application should be performed by an adult using a clean finger or a cotton swab.

Do not rub the gel vigorously into the mucosa.

Duration of use is typically 3 to 5 days; if symptoms persist, consult a physician.

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 of age and adults), hypersensitivity to the components of the drug.

With caution

Open wounds of the oral mucosa.

Use in Pregnancy and Lactation

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

Contraindicated in children under 5 months of age; in children under 6 years of age (for dosage forms intended for children over 6 years of age 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.