Dyclonine hydrochloride: Difference between revisions
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|warnings= | |warnings='''Stop use and ask a doctor if''' | ||
* Sore throat is severe, lasts for more than 2 days, occurs with or is followed by [[fever]], [[headache]], [[rash]], [[nausea]], or [[vomiting]] | |||
* | * 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. | |||
|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. | ||
Revision as of 14:32, 18 February 2015
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 {{{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 throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting
- 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
- 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
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
{{#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
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
- ®[1]
Look-Alike Drug Names
- A® — B®[2]
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.
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- ↑ "http://www.ismp.org". External link in
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