Dyclonine hydrochloride

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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]

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Overview

Dyclonine hydrochloride is a local anesthetic that is FDA approved for the treatment of {{{indication}}}. Common adverse reactions include rash, Urticaria.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

Dental procedure - Local anesthesia Local anesthesia Pain in throat Pharyngeal gag reflex finding Stomatitis

Dosing

Dental procedure - Local anesthesia: 0.5% solution ORALLY as a spray or gargle [1] Local anesthesia: dosage varies and depends upon the area to be anesthetized, vascularity of the tissues, individual tolerance, and the technique of anesthesia Local anesthesia: 4 to 20 mL of 1% spray TOPICALLY to accessible mucous membranes; MAX dose 300 mg; single dose MAX 200 mg [1] Local anesthesia: apply 0.5% solution TOPICALLY as wet compresses or as a spray to episiotomy or perineorrhaphy wounds [1] Local anesthesia: apply pledgets of cotton or sponges moistened with 0.5% solution TOPICALLY to postoperative wounds following proctology procedures [1] Pain in throat: one 2- to 3-mg lozenge ORALLY dissolved in mouth slowly every 2 hours as needed 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]

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Condition1
  • Developed by:
  • Class of Recommendation:
  • Strength of Evidence:
  • Dosing Information
  • Dosage
Condition2

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

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

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)

Dosing

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

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Condition1
  • Developed by:
  • Class of Recommendation:
  • Strength of Evidence:
  • Dosing Information
  • Dosage
Condition2

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

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

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

Contraindications

  • Condition1

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.

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

There is limited information regarding Postmarketing Experience of Dyclonine hydrochloride 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

  • Drug
  • Description

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
  • Intravenous

Monitoring

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

  • Description

IV Compatibility

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

Overdosage

Acute Overdose

Signs and Symptoms

  • Description

Management

  • Description

Chronic Overdose

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

Structure

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This image is provided by the National Library of Medicine.

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

Storage

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

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of Dyclonine hydrochloride in the drug label.

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

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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