Calgel^® (Gel) Instructions for Use

Marketing Authorization Holder

GlaxoSmithKline Trading, JSC (Russia)

Manufactured By

Delpharm Poznan, S.A. (Poland)

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

Calgel®

Dental gel 3.3 mg+1 mg/1 g: 10 g tube

Dosage Form, Packaging, and Composition

Dental gel of yellowish-brown color, soft, homogeneous, with a characteristic odor.

Excipients : sorbitol solution 70% non-crystallizing – 210 mg, xylitol – 140 mg, ethanol 96% – 93.6 mg, glycerol – 70 mg, hydroxyethylcellulose 5000 cP – 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 – 4.8 mg, caramel (E150) – 1 mg, sodium citrate – 8.3 mg, citric acid monohydrate – 1.05 mg, purified water – up to 1000 mg.

10 g – aluminum varnished tubes (1) – cardboard packs with first opening control.

Clinical-Pharmacological Group

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

Pharmacotherapeutic Group

Local anesthetic agent

Pharmacological Action

The drug Calgel^® is an analgesic agent applied to the oral mucosa.

Lidocaine exerts a local anesthetic effect when applied to the mucosa.

Cetylpyridinium chloride possesses antiseptic properties.

Pharmacokinetics

Absorption

Lidocaine is rapidly absorbed from the mucous membrane.

Cetylpyridinium chloride is poorly absorbed through the oral mucosa.

Distribution

Lidocaine binds to plasma proteins, including α₁-acid glycoprotein (AAG).

The degree of binding varies and is about 66%.

The binding of lidocaine to plasma proteins depends on the concentrations of lidocaine and AAG.

Any change in AAG concentration can significantly affect the plasma concentration of lidocaine.

Metabolism

Lidocaine is extensively metabolized in the liver.

Hepatic metabolism proceeds rapidly.

About 90% of the administered lidocaine undergoes dealkylation to form monoethylglycinexylidide and glycinexylidide.

Excretion

Lidocaine metabolites are excreted by the kidneys, with less than 10% of lidocaine excreted unchanged.

Indications

• For rapid relief of teething pain and reduction of gum irritation severity.

The drug Calgel^® also has a weak antiseptic effect.

ICD codes

Dosage Regimen

For application to the mucous membrane.

The drug Calgel^® is intended for children aged 5 months and older.

A small amount of gel (about 7.5 mm) is applied to the tip of a clean finger and gently rubbed into the child’s inflamed gum area.

If necessary, the gel can be reapplied at 20-minute intervals, but no more than 6 times/day.

The use of the drug in patients with impaired renal and/or hepatic function has not been studied.

Adverse Reactions

When using the drug Calgel^® in accordance with the instructions for use, adverse reactions are unlikely.

Nevertheless, isolated cases of hypersensitivity to lidocaine after local injections in adults and children over 12 years of age have been reported.

The hypersensitivity that occurred in these cases was manifested as localized edema accompanied by slight difficulty breathing or a generalized rash.

The small content of chamomile in the herbal flavor may cause allergic reactions, which is documented.

Hypersensitivity to substances contained in chamomile manifests as difficulty breathing in atopy-prone individuals.

Anaphylactic reactions have been reported with the intake of herbal tea containing chamomile.

Individuals with hypersensitivity may show a positive skin reaction when using preparations containing chamomile.

If any adverse reactions occur, it is necessary to discontinue the use of the drug Calgel^® and consult a doctor.

Contraindications

• Hypersensitivity to lidocaine, other amide anesthetics, cetylpyridinium, or any other component of the drug;
• Rare hereditary fructose intolerance;
• Children under 5 months of age.

Use in Pregnancy and Lactation

Not applicable.

Use in Hepatic Impairment

The use of the drug in patients with impaired hepatic function has not been studied.

Use in Renal Impairment

The use of the drug in patients with impaired renal function has not been studied.

Pediatric Use

Contraindicated in children under 5 months of age.

Special Precautions

Do not exceed the recommended doses.

Effect on ability to drive vehicles and operate machinery

Not applicable.

Overdose

Symptoms

Cetylpyridinium

Ingestion of large doses of cetylpyridinium may cause gastric upset and CNS depression.

Concentrations at which overdose symptoms were noted were 70 times higher than the concentration of cetylpyridinium chloride in this drug.

Lidocaine

Systemic toxic effects of local anesthetics (with any form of application) may include effects on the CNS and heart.

Analysis of post-registration data for this medicinal product did not reveal symptoms of overdose.

Treatment

If symptoms of overdose occur, it is necessary to discontinue the use of the drug and consult a doctor.

Patient management should be carried out according to clinical indications.

Drug Interactions

There are no data on the interaction of the drug Calgel^® with other medicinal products.

There are data on the interaction of lidocaine (with IV administration) with the following drugs when taken orally: procainamide, phenytoin as monotherapy or in combination with phenobarbital, primidone, or carbamazepine, propranolol and potassium-sparing diuretics, including bumetanide, furosemide, as well as thiazide diuretics.

Storage Conditions

The drug should be stored out of the reach of children at a temperature not exceeding 25°C (77°F).

Shelf Life

The shelf life is 3 years. Do not use after the expiration date printed on the package.

Dispensing Status

The drug is dispensed by prescription.

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.