DENTOL 7.5 %

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT DENTOL 7.5%, 10% (DENTOL 7.5%, 10%)

Composition:

Active substance: benzocaine;

Dentol 7.5%, 1 g of gel contains 75 mg of benzocaine;

Excipients: glycerol, polyethylene glycol 75, polyethylene glycol 8, sodium saccharin, sorbic acid, purified water, FD&C Red No. 40 lake dye (E 129), cherry flavor (propylene glycol, purified water, Red No. 2 lake dye, sodium benzoate (E 211), ethanol, artificial flavor).

Dentol 10%, 1 g of gel contains 100 mg of benzocaine;

Excipients: glycerol, polyethylene glycol 75, polyethylene glycol 8, sodium saccharin, sorbic acid, purified water, cherry flavor (propylene glycol, purified water, Red No. 2 lake dye, sodium benzoate (E 211), ethanol, artificial flavor).

Pharmaceutical form. Gel for the gums.

Main physicochemical properties: pale pink gel with a mild fruity odor, of uniform consistency.

Pharmacotherapeutic group. Local anesthetics.

ATC code: N01BA05.

Pharmacological properties.

Pharmacodynamics.

Benzocaine is a local anesthetic that reduces membrane permeability to sodium ions and blocks the conduction of nerve impulses.

Pharmacokinetics.

Benzocaine is poorly absorbed; its effect begins within 1 minute after application and lasts for 15–20 minutes. The absorbed drug is rapidly hydrolyzed by plasma and liver cholinesterases and is excreted by the kidneys.

Clinical Characteristics.

Indications.

Dentol 7.5 %:

• for rapid relief of pain in children from 4 months of age and older during teething;
• as a temporary first-aid measure for toothache in children of younger and older age;
• for pain relief during dental treatment, minor injuries of the oral mucosa, and aphthous stomatitis.

Dentol 10 %:

• for rapid relief of toothache in adults and children aged 6 years and older;
• as a temporary first-aid measure, prior to consulting a physician, for painful gums, during dental treatment and prosthetics, and in case of minor injuries of the oral mucosa;
• as an anesthetic agent during dental procedures.

Contraindications.

Individual hypersensitivity to benzocaine, other local anesthetics; local infection and multiple injuries of the oral mucosa.

Interaction with other medicinal products and other forms of interaction.

Cholinesterase inhibitors may suppress benzocaine metabolism, increasing the risk of systemic toxicity. Benzocaine may inhibit the antibacterial activity of sulfonamides.

Special precautions for use

Do not exceed the recommended dose, frequency, or duration of administration. The product should not be used more than 4 times daily or for longer than 7 consecutive days.

If symptoms persist for more than 7 days, or if irritation, pain, or redness persists or worsens, or if swelling, rash, or fever develops, consult a physician immediately.

There have been reports that products containing benzocaine may cause methemoglobinemia. Symptoms such as cyanosis of the skin, lips, and nail beds, headache, dizziness, shortness of breath (difficulty breathing), weakness, and tachycardia observed during treatment may indicate potentially life-threatening methemoglobinemia and require immediate medical intervention.

Use during pregnancy or breastfeeding

Use with caution during pregnancy or breastfeeding, taking into account the benefit-risk ratio.

Ability to affect reaction speed when driving or operating machinery

The product does not impair the ability to drive or operate machinery.

Method of Administration and Dosage.

Wash hands, open the cap, cut the tip of the tube, and apply a small amount of the gel to the gums where teeth are erupting. In case of toothache, apply the gel around the affected tooth and into its cavity. The procedure may be repeated 3–4 times a day.

The product should not be used for longer than 7 consecutive days.

Children. Do not use the product in children under 4 months of age.

Use of the product in children under 2 years of age is recommended under the supervision of a physician or medical personnel.

Overdose.

Overdose is unlikely when following all recommendations. However, in individual cases, toxic effects on the central nervous system (visual disturbances, seizures, tinnitus, drowsiness, sensation of heat or cold, excitement, confusion, dizziness, numbness, anxiety, restlessness) may occur; depression of the cardiovascular system (sweating, arterial hypotension, pallor, arrhythmia, cardiac arrest); development of methemoglobinemia.

Treatment. In case of overdose, rinse mouth with warm soda solution and seek immediate medical advice. Treatment is symptomatic.

Adverse reactions.

Adverse effects may occur due to exceeding the recommended doses, increased absorption rate, or hypersensitivity, including allergic contact dermatitis (skin rash, redness, itching, or urticaria); angioneurotic edema (swelling of the skin or mucous membranes of the mouth and throat); burning sensation, fever. If the listed symptoms occur, discontinue use of the product and consult a physician.

Very rarely, benzocaine use may lead to methemoglobinemia (cyanosis of the skin, lips, and nail beds, headache, dizziness, dyspnea, weakness, tachycardia).

Shelf life. 4 years.

Storage conditions.

Store in a place inaccessible to children, at a temperature not exceeding 30 °C.

Packaging.

15 g in a tube, 1 tube in a cardboard box.

Availability. Over-the-counter (without prescription).

Manufacturer. Pharmascience Inc./Pharmascience Inc.

Manufacturer's address and place of business.

6111 Royalmount Avenue, 100, Montreal, Quebec H4P 2T4, Canada /
6111 Royalmount Avenue, 100, Montreal, Quebec H4P 2T4, Canada.