Introduction

Local anesthetic.

Uses for Dyclonine

Oral/Throat Analgesia/Anesthesia

Self-medication for the short-term relief of minor sore throat pain and mouth and gum irritation.

In fixed combination with menthol as self-medication for temporary relief of occasional minor irritation, pain, or soreness of mouth or throat, and for cough associated with a cold or inhaled irritants.

Local Anesthesia

Has been used as a local anesthetic agent prior to laryngoscopy, bronchoscopy, esophagoscopy, or endotracheal intubation. However, oral solutions no longer are commercially available in the US.

Dyclonine Dosage and Administration

Administration

Oral Administration

Administer orally as a lozenge.

Allow the lozenge to slowly dissolve in the mouth; do not bite or chew it.

Dosage

Pediatric Patients

Oral/Throat Pain

Oral

Children ≥2 years of age: 1 lozenge (1.2, 2, or 3 mg); repeat after 2 hours if necessary.

Adults

Oral/Throat Pain

Oral

1 lozenge (1.2, 2, or 3 mg); repeat after 2 hours if necessary.

Prescribing Limits

Pediatric Patients

Oral/Throat Pain

Oral

Children ≥2 years of age: Maximum 10 lozenges daily. Not for self-medication of sore throat for >2 days or sore mouth >7 days.

Adults

Oral/Throat Pain

Oral

Maximum 10 lozenges daily. Not for self-medication of sore throat for >2 days or sore mouth >7 days.

Special Populations

No special population dosage recommendations at this time.

Contraindications

• Known hypersensitivity to dyclonine or any ingredient in the formulation.

Warnings/Precautions

Sensitivity Reactions

Allergic Reactions

Use with caution in patients with a known allergy to dyclonine.

Sensitization and allergic reactions are infrequent. Possible hypersensitivity reactions to anesthetics may manifest as cutaneous lesions with delayed onset, urticaria, swelling, and edema.

General Precautions

Systemic Effects

Systemic (e.g., CNS, cardiovascular) effects possible with excessive dosage or rapid absorption of dyclonine.

Adverse CNS effects may include excitation and/or depression, nervousness, dizziness, blurred vision, or tremors followed by seizures, unconsciousness, drowsiness, and possibly respiratory arrest.

Adverse cardiovascular effects may include myocardial depression, hypotension, bradycardia, and cardiac arrest.

Patient Monitoring

If sore throat is severe or persistent (e.g., >2 days) or occurs with or is followed by a high fever, persistent headache, rash, swelling, irritation, and nausea, discontinue the drug and consult a clinician.

If sore mouth symptoms do not improve after 7 days, discontinue the drug and consult a clinician.

Infection or Trauma

Use with extreme caution in areas with traumatized mucosa and/or when sepsis is present in the region of intended application.

Use of Fixed Combination

When used in fixed combination with other agents, consider the cautions, precautions, and contraindications associated with the concomitant agents.

Specific Populations

Pregnancy

Safety has not been established in pregnant women. Manufacturers state that pregnant women should consult a clinician prior to use.

Lactation

Manufacturers state that nursing women should consult a clinician prior to use.

Pediatric Use

Safety of dyclonine lozenges not established in children <2 years of age; consult a clinician or dentist prior to use in such patients.

Common Adverse Effects

Irritation, stinging.

Administration

Oral Administration

Administer orally as a lozenge.

Allow the lozenge to slowly dissolve in the mouth; do not bite or chew it.

Dosage

Pediatric Patients

Oral/Throat Pain

Oral

Children ≥2 years of age: 1 lozenge (1.2, 2, or 3 mg); repeat after 2 hours if necessary.

Adults

Oral/Throat Pain

Oral

1 lozenge (1.2, 2, or 3 mg); repeat after 2 hours if necessary.

Prescribing Limits

Pediatric Patients

Oral/Throat Pain

Oral

Children ≥2 years of age: Maximum 10 lozenges daily. Not for self-medication of sore throat for >2 days or sore mouth >7 days.

Adults

Oral/Throat Pain

Oral

Maximum 10 lozenges daily. Not for self-medication of sore throat for >2 days or sore mouth >7 days.

Special Populations

No special population dosage recommendations at this time.