Dyclonine hydrochloride: Difference between revisions

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|drugClass=local anesthetic
|drugClass=local anesthetic
|indicationType=treatment
|indicationType=treatment
|indication=[[pain]],minor irritation,sore mouth,sore throat
|adverseReactions=[[rash]], [[Urticaria]]
|adverseReactions=[[rash]], [[Urticaria]]
|blackBoxWarningTitle=<span style="color:#FF0000;">ConditionName: </span>
|blackBoxWarningTitle=<span style="color:#FF0000;">ConditionName: </span>
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<!--FDA-Labeled Indications and Dosage (Adult)-->
<!--FDA-Labeled Indications and Dosage (Adult)-->
|fdaLIADAdult===Indications==
|fdaLIADAdult===Indications==
Dental procedure - Local anesthesia
Local anesthesia
Pain in throat
Pharyngeal gag reflex finding
Stomatitis


==Dosing==
* For the temporary relief of the following occasional mouth and throat symptoms:
Dental procedure - Local anesthesia: 0.5% solution ORALLY as a spray or gargle [1]
:*Pain
Local anesthesia: dosage varies and depends upon the area to be anesthetized, vascularity of the tissues, individual tolerance, and the technique of anesthesia
:*Minor irritation
Local anesthesia: 4 to 20 mL of 1% spray TOPICALLY to accessible mucous membranes; MAX dose 300 mg; single dose MAX 200 mg [1]
:*Sore mouth
Local anesthesia: apply 0.5% solution TOPICALLY as wet compresses or as a spray to episiotomy or perineorrhaphy wounds [1]
:*Sore throat
Local anesthesia: apply pledgets of cotton or sponges moistened with 0.5% solution TOPICALLY to postoperative wounds following proctology procedures [1]
|offLabelAdultGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
Pain in throat: one 2- to 3-mg lozenge ORALLY dissolved in mouth slowly every 2 hours as needed
|offLabelAdultNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
Pain in throat: 4 sprays of 0.1% spray ORALLY with swallow; may be used as gargle or rinse on the affected area for 15 seconds (and spit out) 6 times a day as needed
Pharyngeal gag reflex finding: 0.5% solution ORALLY as mouthwash or gargle [1]
Stomatitis: 5 to 15 mL of 0.5% solution ORALLY with swallow for lesions of the esophagus; as a rinse or swab applied to inflamed or ulcerated mucous membranes of the mouth [1]
|offLabelAdultGuideSupport======Condition1=====


* Developed by:


* Class of Recommendation:
* Strength of Evidence:
* Dosing Information
:* Dosage
=====Condition2=====
There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
<!--Non–Guideline-Supported Use (Adult)-->
|offLabelAdultNoGuideSupport======Condition1=====
* Dosing Information
:* Dosage
=====Condition2=====
There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
<!--Pediatric Indications and Dosage-->


<!--FDA-Labeled Indications and Dosage (Pediatric)-->
<!--FDA-Labeled Indications and Dosage (Pediatric)-->
|fdaLIADPed===Dosing==
|fdaLIADPed===Indications==
safety and effectiveness in children younger than 2 years has not been established [1]
Pain in throat: (aged 2 years or older) one 1.2-mg lozenge ORALLY every 2 hours as needed
Pain in throat: (ages 2 years or older) 4 sprays of 0.1% spray ORALLY with swallow; may be used as gargle or rinse on the affected area for 15 seconds (and spit out) 6 times a day as needed
|offLabelPedGuideSupport======Condition1=====
 
* Developed by:
 
* Class of Recommendation:
 
* Strength of Evidence:
 
* Dosing Information
 
:* Dosage
 
=====Condition2=====
 
There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
 
<!--Non–Guideline-Supported Use (Pediatric)-->
|offLabelPedNoGuideSupport======Condition1=====


* Dosing Information
* For the temporary relief of the following occasional mouth and throat symptoms:
:*Pain
:*Minor irritation
:*Sore mouth
:*Sore throat
|offLabelPedGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
|offLabelPedNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
|warnings='''Stop use and ask a doctor if'''


:* Dosage
* Sore throat is severe, lasts for more than 2 days, occurs with or is followed by [[fever]], [[headache]], [[rash]], [[nausea]], or [[vomiting]]


=====Condition2=====
* Sore mouth symptoms last more than 7 days, or irritation, pain, or redness continues or worsens


There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
'''If pregnant or breast-feeding''', ask a health professional before use.


<!--Contraindications-->
'''Keep out of reach of children'''. In case of overdose, get medical help or contact a Poison Control Center right away.
|contraindications=* Condition1
 
<!--Warnings-->
|warnings=* Description
 
====Precautions====
 
* Description
 
<!--Adverse Reactions-->
 
<!--Clinical Trials Experience-->
|clinicalTrials=There is limited information regarding <i>Clinical Trial Experience</i> of {{PAGENAME}} in the drug label.
|clinicalTrials=There is limited information regarding <i>Clinical Trial Experience</i> of {{PAGENAME}} in the drug label.
=====Body as a Whole=====
=====Cardiovascular=====
=====Digestive=====
=====Endocrine=====
=====Hematologic and Lymphatic=====
=====Metabolic and Nutritional=====
=====Musculoskeletal=====
=====Neurologic=====
=====Respiratory=====
=====Skin and Hypersensitivy Reactions=====
=====Special Senses=====
=====Urogenital=====
=====Miscellaneous=====
<!--Postmarketing Experience-->
|postmarketing=There is limited information regarding <i>Postmarketing Experience</i> of {{PAGENAME}} in the drug label.
|postmarketing=There is limited information regarding <i>Postmarketing Experience</i> of {{PAGENAME}} in the drug label.
=====Body as a Whole=====
=====Cardiovascular=====
=====Digestive=====
=====Endocrine=====
=====Hematologic and Lymphatic=====
=====Metabolic and Nutritional=====
=====Musculoskeletal=====
=====Neurologic=====
=====Respiratory=====
=====Skin and Hypersensitivy Reactions=====
=====Special Senses=====
=====Urogenital=====
=====Miscellaneous=====
<!--Drug Interactions-->
|drugInteractions=* Drug
:* Description
<!--Use in Specific Populations-->
|useInPregnancyFDA=* '''Pregnancy Category'''
|useInPregnancyFDA=* '''Pregnancy Category'''
|useInPregnancyAUS=* '''Australian Drug Evaluation Committee (ADEC) Pregnancy Category'''
|useInPregnancyAUS=* '''Australian Drug Evaluation Committee (ADEC) Pregnancy Category'''
Line 245: Line 62:
|useInReproPotential=There is no FDA guidance on the use of {{PAGENAME}} in women of reproductive potentials and males.
|useInReproPotential=There is no FDA guidance on the use of {{PAGENAME}} in women of reproductive potentials and males.
|useInImmunocomp=There is no FDA guidance one the use of {{PAGENAME}} in patients who are immunocompromised.
|useInImmunocomp=There is no FDA guidance one the use of {{PAGENAME}} in patients who are immunocompromised.
<!--Administration and Monitoring-->
|administration=* Oral
|administration=* Oral
* Intravenous
|monitoring=There is limited information regarding <i>Monitoring</i> of {{PAGENAME}} in the drug label.
|monitoring=There is limited information regarding <i>Monitoring</i> of {{PAGENAME}} in the drug label.
* Description
<!--IV Compatibility-->
|IVCompat=There is limited information regarding <i>IV Compatibility</i> of {{PAGENAME}} in the drug label.
|IVCompat=There is limited information regarding <i>IV Compatibility</i> of {{PAGENAME}} in the drug label.
 
|overdose=There is limited information regarding <i>Chronic Overdose</i> of {{PAGENAME}} in the drug label.
<!--Overdosage-->
|overdose====Acute Overdose===
 
====Signs and Symptoms====
 
* Description
 
====Management====
 
* Description
 
===Chronic Overdose===
 
There is limited information regarding <i>Chronic Overdose</i> of {{PAGENAME}} in the drug label.
 
<!--Pharmacology-->
 
<!--Drug box 2-->
|drugBox=<!--Mechanism of Action-->
|mechAction=*
 
<!--Structure-->
|structure=*
 
: [[File:{{PAGENAME}}01.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]
 
<!--Pharmacodynamics-->
|PD=There is limited information regarding <i>Pharmacodynamics</i> of {{PAGENAME}} in the drug label.
|PD=There is limited information regarding <i>Pharmacodynamics</i> of {{PAGENAME}} in the drug label.
<!--Pharmacokinetics-->
|PK=There is limited information regarding <i>Pharmacokinetics</i> of {{PAGENAME}} in the drug label.
|PK=There is limited information regarding <i>Pharmacokinetics</i> of {{PAGENAME}} in the drug label.
<!--Nonclinical Toxicology-->
|nonClinToxic=There is limited information regarding <i>Nonclinical Toxicology</i> of {{PAGENAME}} in the drug label.
|nonClinToxic=There is limited information regarding <i>Nonclinical Toxicology</i> of {{PAGENAME}} in the drug label.
<!--Clinical Studies-->
|clinicalStudies=There is limited information regarding <i>Clinical Studies</i> of {{PAGENAME}} in the drug label.
|clinicalStudies=There is limited information regarding <i>Clinical Studies</i> of {{PAGENAME}} in the drug label.
|fdaPatientInfo=* Adults and children 6 years of age and older: allow lozenge to dissolve slowly in mouth. May be repeated every 2 hours as needed or as directed by a dentist or doctor. Do not take more than 10 lozenges per day.


<!--How Supplied-->
* Children under 6 years of age: ask a dentist or doctor.
|howSupplied=*
|packLabel=<!--Patient Counseling Information-->
|fdaPatientInfo=There is limited information regarding <i>Patient Counseling Information</i> of {{PAGENAME}} in the drug label.
 
<!--Precautions with Alcohol-->
|alcohol=* Alcohol-{{PAGENAME}} interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
|alcohol=* Alcohol-{{PAGENAME}} interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
 
|brandNames=* SUCRETS BLACK CHERRY
<!--Brand Names-->
|lookAlike=*
|brandNames=* ®<ref>{{Cite web | title =  | url = }}</ref>
 
<!--Look-Alike Drug Names-->
|lookAlike=* A® — B®<ref name="www.ismp.org">{{Cite web  | last =  | first =  | title = http://www.ismp.org | url = http://www.ismp.org | publisher =  | date =  }}</ref>
 
<!--Drug Shortage Status-->
|drugShortage=
|drugShortage=
}}
}}
{{PillImage
{{PillImage}}
|fileName=No image.jpg
}}
{{LabelImage
{{LabelImage
|fileName={{PAGENAME}}11.png
|fileName=Dyclonine ingredients and appearance.png
}}
}}
{{LabelImage
{{LabelImage
|fileName={{PAGENAME}}11.png
|fileName=Dyclonine image.jpg
}}
}}
<!--Pill Image-->
<!--Pill Image-->
Line 332: Line 96:


<!--Category-->
<!--Category-->
 
[[Category:Antiseptics]]
[[Category:Drug]]
[[Category:Drug]]

Latest revision as of 20:17, 18 August 2015

Dyclonine hydrochloride
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Kiran Singh, M.D. [2]

Disclaimer

WikiDoc MAKES NO GUARANTEE OF VALIDITY. WikiDoc is not a professional health care provider, nor is it a suitable replacement for a licensed healthcare provider. WikiDoc is intended to be an educational tool, not a tool for any form of healthcare delivery. The educational content on WikiDoc drug pages is based upon the FDA package insert, National Library of Medicine content and practice guidelines / consensus statements. WikiDoc does not promote the administration of any medication or device that is not consistent with its labeling. Please read our full disclaimer here.
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Overview

Dyclonine hydrochloride is a local anesthetic that is FDA approved for the treatment of pain,minor irritation,sore mouth,sore throat. Common adverse reactions include rash, Urticaria.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

  • For the temporary relief of the following occasional mouth and throat symptoms:
  • Pain
  • Minor irritation
  • Sore mouth
  • Sore throat

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Dyclonine hydrochloride in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Dyclonine hydrochloride in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Indications

  • For the temporary relief of the following occasional mouth and throat symptoms:
  • Pain
  • Minor irritation
  • Sore mouth
  • Sore throat

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Dyclonine hydrochloride in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Dyclonine hydrochloride in pediatric patients.

Contraindications

There is limited information regarding Dyclonine hydrochloride Contraindications in the drug label.

Warnings

Stop use and ask a doctor if

  • Sore mouth symptoms last more than 7 days, or irritation, pain, or redness continues or worsens

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Dyclonine hydrochloride in the drug label.

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Dyclonine hydrochloride in the drug label.

Drug Interactions

There is limited information regarding Dyclonine hydrochloride Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

  • Pregnancy Category


Pregnancy Category (AUS):

  • Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Dyclonine hydrochloride in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Dyclonine hydrochloride during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Dyclonine hydrochloride with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Dyclonine hydrochloride with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Dyclonine hydrochloride with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Dyclonine hydrochloride with respect to specific gender populations.

Race

There is no FDA guidance on the use of Dyclonine hydrochloride with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Dyclonine hydrochloride in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Dyclonine hydrochloride in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Dyclonine hydrochloride in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Dyclonine hydrochloride in patients who are immunocompromised.

Administration and Monitoring

Administration

  • Oral

Monitoring

There is limited information regarding Monitoring of Dyclonine hydrochloride in the drug label.

IV Compatibility

There is limited information regarding IV Compatibility of Dyclonine hydrochloride in the drug label.

Overdosage

There is limited information regarding Chronic Overdose of Dyclonine hydrochloride in the drug label.

Pharmacology

There is limited information regarding Dyclonine hydrochloride Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Dyclonine hydrochloride Mechanism of Action in the drug label.

Structure

There is limited information regarding Dyclonine hydrochloride Structure in the drug label.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Dyclonine hydrochloride in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Dyclonine hydrochloride in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Dyclonine hydrochloride in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Dyclonine hydrochloride in the drug label.

How Supplied

There is limited information regarding Dyclonine hydrochloride How Supplied in the drug label.

Storage

There is limited information regarding Dyclonine hydrochloride Storage in the drug label.

Images

Drug Images

{{#ask: Page Name::Dyclonine hydrochloride |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}

Package and Label Display Panel

{{#ask: Label Page::Dyclonine hydrochloride |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

Patient Counseling Information

  • Adults and children 6 years of age and older: allow lozenge to dissolve slowly in mouth. May be repeated every 2 hours as needed or as directed by a dentist or doctor. Do not take more than 10 lozenges per day.
  • Children under 6 years of age: ask a dentist or doctor.

Precautions with Alcohol

  • Alcohol-Dyclonine hydrochloride interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

  • SUCRETS BLACK CHERRY

Look-Alike Drug Names

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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