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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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

Package and Label Display Panel

Dyclonine ingredients and appearance.png
This image of the FDA label is provided by the National Library of Medicine.
Dyclonine image.jpg
This image of the FDA label is provided by the National Library of Medicine.

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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