Version July 2025
Mouth/throat symptoms: Approved ages varies by product; product-specific dosing:
Lozenge 2 mg: Children ≥6 years and Adolescents: Oral topical: Slowly dissolve one lozenge in mouth every 2 hours as needed; maximum daily dose: 10 lozenges/day
Lozenge 2 mg (with menthol 5 mg and pectin 6 mg): Children ≥4 years and Adolescents: Oral topical: Slowly dissolve one lozenge in mouth every 2 hours as needed; maximum daily dose: 10 lozenges/day
Lozenge 3 mg (with menthol 6 mg): Children ≥4 years and Adolescents: Oral topical: Slowly dissolve one lozenge in mouth every 2 hours as needed; maximum daily dose: 10 lozenges/day
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
(For additional information see "Dyclonine: Drug information")
Anesthesia, topical: Note: Dosage varies based on the area to be anesthetized, vascularity of the tissues, patient tolerance, and technique of anesthesia; use lowest effective dose. Maximum dose: 300 mg (30 mL) of 1% solution; satisfactory anesthesia is usually produced within a range of 40 to 200 mg (4 to 20 mL) of the 1% solution. For the 0.5% solution, appropriate anesthesia can often be produced by a lower dose as well (ie, less than the maximum dose of 300 mg).
Proctology: 0.5% dyclonine solution: Apply pledgets of cotton or sponges moistened with solution to postoperative wounds.
Gynecology: 0.5% dyclonine solution: Apply solution as a wet compress or spray to relieve discomfort.
Oncology-radiology:
Inflamed or ulcerated mucous membranes of the mouth due to chemotherapy or radiation therapy: 0.5% dyclonine solution: Apply solution as a rinse or swab to inflamed or ulcerated mucous membranes.
Lesions of the esophagus: 0.5% dyclonine solution: Swallow 25 to 75 mg (5 to 15 mL).
Otorhinolaryngology:
Suppress gag reflex: 0.5% dyclonine solution: Spray or gargle solution to suppress the gag reflex.
Oral lesions (eg, aphthous stomatitis, herpetic stomatitis): 0.5% dyclonine solution: Apply solution as a rinse or swab.
Dental: 0.5% dyclonine solution: Use solution as a mouthwash or gargle to suppress the gag reflex during the positioning of x-ray films, making prosthetic impressions, or surgical procedures in the molar areas; may also apply to mucous membranes as a preinjection anesthetic or to the gums prior to scaling; expectorate excess solution.
Cough and mouth/throat symptoms (OTC): Oral topical: Lozenge: Slowly dissolve 1 lozenge in mouth every 2 hours as needed (maximum: 10 lozenges/day).
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
The following adverse drug reactions are derived from product labeling unless otherwise specified. Reactions listed may be based on reports for other agents in this same pharmacologic class and may not be specifically reported for dyclonine.
Frequency not defined:
Cardiovascular: Bradycardia, circulatory shock, hypotension
Hypersensitivity: Hypersensitivity reaction (including nonimmune anaphylaxis)
Local: Application-site reaction (including local irritation, stinging sensation, urethritis)
Nervous system: Central nervous system depression, central nervous system stimulation, drowsiness
DycloPro: Hypersensitivity to local anesthetics or to any component of the formulation.
Concerns related to adverse effects:
• Systemic toxicity: Use topical solution with caution in patients with sepsis or severely traumatized mucosa in the area of application; rapid systemic absorption may occur.
Disease-related concerns:
• Cardiovascular disease: Use topical solution with caution in patients with severe shock or heart block.
Special populations:
• Acutely ill/debilitated patients: Administer topical solution in reduced dosages, commensurate with age and physical condition, to debilitated and/or acutely ill patients.
• Older adult: Administer topical solution in reduced dosages, commensurate with age and physical condition, to older adults.
• Pediatric: Administer topical solution in reduced dosages, commensurate with age and physical condition, to pediatric patients.
Dosage forms specific issues:
• Propylene glycol: Some dosage forms may contain propylene glycol; large amounts are potentially toxic and have been associated hyperosmolality, lactic acidosis, seizures, and respiratory depression; use caution (AAP 1997; Zar 2007). See manufacturer's labeling.
• Tartrazine: Some formulations may contain FD&C yellow #5 (tartrazine), which may cause allergic-type reactions (including bronchial asthma) in susceptible individuals, particularly those with aspirin sensitivity.
Other warnings/precautions:
• Administration: Topical solution: Avoid use in the eyes and do not inject into tissue; highly irritant properties. When used in mouth or throat, topical anesthesia may impair swallowing and increase aspiration risk. Avoid food for ≥60 minutes following oral or throat application. This is especially important in the pediatric population. Numbness may increase the danger of tongue/buccal biting trauma; ingesting food or chewing gum should be avoided while mouth or throat is anesthetized.
• Appropriate use: Topical solution: To avoid serious adverse effects and high plasma levels, use the lowest dosage resulting in effective anesthesia. Repeated doses may cause significant increases in blood levels due to the possibility of accumulation of the drug or its metabolites. Dosage recommendations should not be exceeded.
• Self-medication (OTC use): Lozenge: When used for self-medication (OTC), discontinue use and contact health care provider if sore throat is severe, lasts >2 days, or occurs with or following fever, headache, rash, nausea, or vomiting; sore mouth symptoms lasting for >7 days; irritation, pain, or redness persists or worsens; or swelling, rash or fever develops; cough lasts >7 days, comes back, or occurs with fever or persistent headache. Consult a health care provider before use for cough that lasts or is chronic (eg, cough that occurs with smoking, asthma, emphysema) or cough that occurs with too much mucous.
• Trained personnel: Clinicians using local anesthetic agents should be well trained in diagnosis and management of emergencies that may arise from the use of these agents. Resuscitative equipment, oxygen, and other resuscitative drugs should be available for immediate use.
Some dosage forms may contain propylene glycol; in neonates, large amounts of propylene glycol delivered orally, intravenously (eg, >3,000 mg/day), or topically have been associated with potentially fatal toxicities, which can include metabolic acidosis, seizures, renal failure, and CNS depression; toxicities have also been reported in children and adults including hyperosmolality, lactic acidosis, seizures, and respiratory depression; use caution (AAP 1997; Shehab 2009).
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Lozenge, Oral, as hydrochloride:
Sucrets: 2 mg (18s) [contains menthol]
Solution, Topical, as hydrochloride:
DycloPro: 0.5% (30 mL)
Yes
Topical: Allow lozenges to slowly dissolve in mouth.
Oral: Allow lozenge to slowly dissolve in mouth.
Topical: For topical use only; avoid use in the eyes and do not inject into tissue. Avoid food for ≥60 minutes following oral or throat application; ingesting food or chewing gum should be avoided while mouth or throat is anesthetized.
Lozenge: Store at room temperature; avoid storing at high temperature (>38°C [>100°F]).
Topical solution: Store at 20°C to 25°C (68°F to 77°F). Avoid storing at high temperature (>40°C [>104°F]); do not freeze. Discard open solution after 7 days.
Temporary relief of pain and minor irritation of mouth and throat (OTC products: FDA approved in ages ≥4 years and adults). Note: Approved ages may vary with products; consult product specific labeling.
Dyclonine may be confused with dicyclomine
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program
Articaine: May increase adverse/toxic effects of Local Anesthetics. Risk C: Monitor
Methemoglobinemia Associated Agents: May increase adverse/toxic effects of Local Anesthetics. Specifically, the risk for methemoglobinemia may be increased. Risk C: Monitor
ROPivacaine: May increase adverse/toxic effects of Local Anesthetics. Risk C: Monitor
Animal reproduction studies have not been conducted.
Local anesthetic that produces reversible loss of sensation by preventing or diminishing the conduction of nerve impulses near application site.
Onset of action: Topical solution: 2 to 10 minutes.
Duration of action: Topical solution: ~30 minutes.
