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Dyclonine: Pediatric drug information

Dyclonine: Pediatric drug information
(For additional information see "Dyclonine: Drug information" and see "Dyclonine: Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Therapeutic Category
  • Local Anesthetic, Oral
Dosing: Pediatric

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

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Adult

(For additional information see "Dyclonine: Drug information")

Mouth/throat symptoms: Oral topical: Lozenge: Slowly dissolve 1 lozenge in mouth every 2 hours as needed (maximum: 10 lozenges/day)

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Generic Equivalent Available: US

Yes

Administration: Pediatric

Topical: Allow lozenges to slowly dissolve in mouth.

Administration: Adult

Allow lozenge to slowly dissolve in mouth.

Storage/Stability

Store at room temperature; avoid storing at high temperature (>38°C [>100°F]).

Use

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.

Medication Safety Issues
Sound-alike/look-alike issues:

Dyclonine may be confused with dicyclomine

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

Frequency not defined.

Central nervous system: Feeling hot, localized numbness, localized warm feeling, sensation of cold

Gastrointestinal: Burning sensation of mouth

Hypersensitivity: Hypersensitivity reaction

Local: Local irritation, local pain

Warnings/Precautions

Other warnings/precautions:

• Self-medication (OTC use): When used for self-medication (OTC), discontinue use and contact health care provider if sore throat is severe, sore mouth symptoms last >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.

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.

Warnings: Additional Pediatric Considerations

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).

Metabolism/Transport Effects

None known.

Drug Interactions

Bupivacaine: Local Anesthetics may enhance the adverse/toxic effect of Bupivacaine. Management: Avoid using any additional local anesthetics within 96 hours after insertion of the bupivacaine implant (Xaracoll) or bupivacaine and meloxicam periarticular solution (Zynrelef) or within 168 hours after subacromial infiltration (Posimir brand). Risk C: Monitor therapy

Methemoglobinemia Associated Agents: May enhance the adverse/toxic effect of Local Anesthetics. Specifically, the risk for methemoglobinemia may be increased. Risk C: Monitor therapy

Mechanism of Action

Local anesthetic that produces reversible loss of sensation by preventing or diminishing the conduction of nerve impulses near application site.

Brand Names: International
  • Da Ji Su (CN)


For country abbreviations used in Lexicomp (show table)

REFERENCES

  1. Carnel SB, Blakeslee DB, Oswald SG, Barnes M. Treatment of radiation- and chemotherapy-induced stomatitis. Otolaryngol Head Neck Surg. 1990;102(4):326-330. [PubMed 2113258]
  2. Gargiulo AV, Burns GM, Huck CP. Dyclonine hydrochloride--a topical agent for managing pain. Ill Dent J. 1992;61(4):303-304. [PubMed 1286862]
  3. "Inactive" ingredients in pharmaceutical products: update (subject review). American Academy of Pediatrics Committee on Drugs. Pediatrics. 1997;99(2):268-278. [PubMed 9024461]
  4. Kinzie BJ. Treatment of stomatitis associated with antineoplastic drug therapy. Clin Pharm. 1988;7:14-17.
  5. Nelson LA. Nonprescription drug screening. Dyclonine hydrochloride. Am Pharm. 1987;NS27(9):27-29. [PubMed 3425542]
  6. Shehab N, Lewis CL, Streetman DD, Donn SM. Exposure to the pharmaceutical excipients benzyl alcohol and propylene glycol among critically ill neonates. Pediatr Crit Care Med. 2009;10(2):256-259. [PubMed 19188870]
  7. Sucrets Sore Throat (dyclonine) [prescribing information]. Langhorne, PA: Insight Pharmaceuticals; no date.
  8. Sucrets Sore Throat & Cough (dyclonine) [prescribing information]. Langhorne, PA: Insight Pharmaceuticals; no date.
  9. Sucrets Sore Throat, Cough & Dry Mouth (dyclonine) [prescribing information]. Langhorne, PA: Insight Pharmaceuticals; no date.
  10. Zar T, Graeber C, Perazella MA. Recognition, treatment, and prevention of propylene glycol toxicity. Semin Dial. 2007;20(3):217-219. [PubMed 17555487]
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