Friday, September 23, 2016

Dyclonine Hydrochloride


Class: Local Anesthetics
ATC Class: R02AD04
VA Class: DE700
CAS Number: 536-43-6
Brands: Sucrets, Sucrets Complete

Introduction

Local anesthetic.100 a b


Uses for Dyclonine Hydrochloride


Oral/Throat Analgesia/Anesthesia


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


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.100


Local Anesthesia


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


Dyclonine Hydrochloride Dosage and Administration


Administration


Oral Administration


Administer orally as a lozenge.100 a b


Allow the lozenge to slowly dissolve in the mouth; do not bite or chew it.100 a b


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.100 a


Adults


Oral/Throat Pain

Oral

1 lozenge (1.2, 2, or 3 mg); repeat after 2 hours if necessary.100 a b


Prescribing Limits


Pediatric Patients


Oral/Throat Pain

Oral

Children ≥2 years of age: Maximum 10 lozenges daily.a b Not for self-medication of sore throat for >2 days or sore mouth >7 days.100 a


Adults


Oral/Throat Pain

Oral

Maximum 10 lozenges daily.a b Not for self-medication of sore throat for >2 days or sore mouth >7 days.100 a b


Special Populations


No special population dosage recommendations at this time.a


Cautions for Dyclonine Hydrochloride


Contraindications



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



Warnings/Precautions


Sensitivity Reactions


Allergic Reactions

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


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


General Precautions


Systemic Effects

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


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


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


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.100 a b


If sore mouth symptoms do not improve after 7 days, discontinue the drug and consult a clinician.100 b


Infection or Trauma

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


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.a Manufacturers state that pregnant women should consult a clinician prior to use.100 b


Lactation

Manufacturers state that nursing women should consult a clinician prior to use.100 b


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.100 b


Common Adverse Effects


Irritation,a stinging.a


Dyclonine Hydrochloride Pharmacokinetics


Absorption


Onset


Following topical application of a 0.5 or 1% solution of dyclonine (both no longer commercially available in the US) to mucous membranes, local anesthesia occurs within 2–10 minutes.a


Duration


Following topical application of a 0.5 or 1% solution of dyclonine, anesthesia persists for approximately 30 minutes.a


Stability


Storage


Oral


Lozenges

Protect from excessive heat (temperatures >38°C).100 a


ActionsActions



  • Local anesthetic and analgesic.100 a b



Advice to Patients



  • Advise patients to suck rather than chew or bite the lozenge.100 a b




  • Advise patients to consult a clinician prior to use for a chronic cough secondary to smoking, asthma, or emphysema or a cough accompanied by excessive phlegm.100 b




  • Advise patients to discontinue the drug and consult a clinician if sore throat symptoms or cough do not improve after 2 days or if sore mouth symptoms do not improve after 7 days.100 b




  • If irritation, pain, or hypersensitivity occurs, discontinue use and consult a clinician or dentist.100 a b




  • Importance of informing clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.100 b




  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.100 b




  • Importance of informing patients of other important precautionary information.100 b (See Cautions.)



Preparations


Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.


* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name























Dyclonine Hydrochloride

Routes



Dosage Forms



Strengths



Brand Names



Manufacturer



Oral



Lozenges



1.2 mg*



Sucrets Children’s



Insight



2 mg*



Sucrets Regular Strength



Insight



3 mg*



Sucrets Maximum Strength



Insight













Dyclonine Hydrochloride Combinations

Routes



Dosage Forms



Strengths



Brand Names



Manufacturer



Oral



Lozenges



3 mg with Menthol 6 mg



Sucrets Complete



Insight



Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.


The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions February 2008. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.




References



100. Insight Pharmaceuticals. Sucrets Complete Lozenge patient information. Langhorne, PA; Undated.



a. AHFS drug information 2007. McEvoy GK, ed. Dyclonine. Bethesda, MD: American Society of Health-System Pharmacists; 2007: pages 2846-7.



b. Insight Pharmaceuticals. Sucrets Lozenge patient information. Langhorne, PA; Undated.



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