Dynexan (Gel) Instructions for Use

Marketing Authorization Holder

Kreussler Chemische Fabrik & Co., GmbH (Germany)

ATC Code

A01AD11 (Other drugs)

Active Substance

Lidocaine (Rec.INN registered by WHO)

Dosage Form

Dynexan

Gel for topical application 2%: tube 10 g

Dosage Form, Packaging, and Composition

Gel for topical application white in color, aromatic, soft, homogeneous.

Excipients: benzalkonium chloride – 0.1 g, glycerol – 1.07 g, purified water – 6.2125 g, titanium dioxide (E171) – 0.05 g, liquid paraffin – 0.68 g, white soft paraffin – 1.2 g, colloidal silicon dioxide – 0.2575 g, thymol – 0.005 g, sodium saccharin – 0.005 g, guar gum – 0.27 g, aromatic oils – 0.04 g (fennel fruit oil – 0.0096 g, star anise fruit oil – 0.0136 g, partially dementholized peppermint leaf oil – 0.0156 g, peppermint leaf oil – 0.0012 g).

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

Clinical-Pharmacological Group

Agent for topical anesthesia in dentistry

Pharmacotherapeutic Group

Local anesthetic agent

Pharmacological Action

Local anesthetic for superficial anesthesia. The action is due to the blockade of voltage-gated sodium channels, which prevents the generation of impulses in the endings of sensory nerves and the conduction of pain impulses along nerve fibers.

When applied topically, it dilates blood vessels and does not have a local irritant effect. It has an analgesic effect.

Pharmacokinetics

The time to reach C_max when applied to the oral mucosa is 10-20 minutes.

Indications

For pain relief in inflammatory diseases of the oral cavity. Irritation of the mucous membrane and chafing when wearing dentures. For superficial anesthesia at the injection site. During dental calculus removal.

ICD codes

Dosage Regimen

Apply a pea-sized amount of gel to the painful and inflamed areas of the oral mucosa.

Use the gel two to three times daily, or as directed by a dentist or physician.

Ensure the application site is clean and dry before use.

Apply with a cotton swab or clean fingertip, gently dabbing the affected area.

Do not rub the gel vigorously into the mucosa.

Avoid applying the gel immediately before eating or drinking to ensure proper contact time.

The maximum single application for adults should not exceed half the length of the tube.

Do not exceed a total dose of 300 mg of lidocaine within a 12-hour period.

Do not use for more than seven days unless directed by a healthcare professional.

Discontinue use and consult a physician if symptoms persist or worsen.

Thoroughly wash hands before and after application.

Avoid contact with eyes.

Do not apply to large areas of broken or damaged skin or mucosa.

Adverse Reactions

Rarely allergic reactions.

Contraindications

Hypersensitivity to lidocaine, children under 12 years of age.

With caution

Pregnancy, breastfeeding period.

Use in Pregnancy and Lactation

If local anesthesia is necessary and there is no safer treatment, Lidocaine can be used during pregnancy.

Lidocaine is excreted in breast milk, but after topical application in usual therapeutic doses, the amount excreted in milk is too small to cause any harm to the breastfed infant.

Use in Hepatic Impairment

The drug should be used with caution in case of impaired liver function.

Use in Renal Impairment

In chronic renal failure, accumulation of metabolites is possible.

Pediatric Use

Use in children under 12 years of age is contraindicated.

Geriatric Use

Should be used with caution in elderly patients.

Special Precautions

Use with caution in patients with epilepsy, as well as with bradycardia, conduction disorders in the heart, impaired liver function and severe shock, especially when significant absorption of the drug can be expected when treating large tissue areas with high doses.

It is important to prevent lidocaine from entering the respiratory tract (risk of aspiration).

If sensitivity of the tongue and buccal mucosa is impaired, the risk of biting them increases.

Caution should be exercised when applying lidocaine to damaged mucosa and/or infected areas.

Lower doses should be used in debilitated and elderly patients.

Effect on the ability to drive vehicles and operate machinery

During treatment, caution must be exercised when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

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

Over-the-Counter

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.