Carbamide: Difference between revisions

Carbamide
	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

VisualWikitext

Revision as of 13:28, 9 March 2015

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

Disclaimer

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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

Carbamide is a OTC emollient that is FDA approved for the treatment of excessive ear wax. Common adverse reactions include allergic reactions.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

For occasional use as an aid to soften, loosen, and remove excessive ear wax.

Dosage

FOR USE IN THE EAR ONLY. Adults and children over 12 years of age: tilt head sideways and place 5 to 10 drops into ear. Tip of applicator should not enter ear canal. Keep drops in ear for several minutes by keeping head tilted or placing cotton in ear. Use twice daily for up to four days if needed, or as directed by a doctor. Any wax remaining after treatment may be removed by gently flushing the ear with warm water, using a soft rubber bulb ear syringe. Children under 12 years of age: consult a doctor.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Indications

For occasional use as an aid to soften, loosen, and remove excessive ear wax.

Dosage

FOR USE IN THE EAR ONLY. Adults and children over 12 years of age: tilt head sideways and place 5 to 10 drops into ear. Tip of applicator should not enter ear canal. Keep drops in ear for several minutes by keeping head tilted or placing cotton in ear. Use twice daily for up to four days if needed, or as directed by a doctor. Any wax remaining after treatment may be removed by gently flushing the ear with warm water, using a soft rubber bulb ear syringe. Children under 12 years of age: consult a doctor.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Contraindications

There is limited information regarding Carbamide Contraindications in the drug label.

Warnings

Do not use: if you have ear drainage or discharge, ear pain, irritation or rash in the ear, or are dizzy; consult a doctor. If you have an injury or perforation (hole) of the eardrum or after ear surgery, unless directed by a doctor. For more than four consecutive days. When using this product: avoid contact with the eyes. Stop use and ask a doctor if: excessive ear wax remains after use of this product for four consecutive days.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. If accidental contact with eyes occurs, flush eyes with water and consult a doctor.

Adverse Reactions

Clinical Trials Experience

allergic reactions

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Carbamide 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

There is limited information regarding Carbamide 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 Carbamide in women who are pregnant.

Labor and Delivery

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

Nursing Mothers

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

Pediatric Use

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

Geriatic Use

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

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

topical ear drops

Monitoring

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

IV Compatibility

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

Overdosage

There is limited information regarding Overdose of Carbamide in the drug label.

Pharmacology

There is limited information regarding Carbamide Pharmacology in the drug label.

Mechanism of Action

Structure

Active Ingredient

Carbamide Peroxide 6.5%

Inactive ingredients

Glycerin, Oxyquinoline, Aloe Barbadensis Leaf Extract, Anthemis Nobilis Flower Oil

Pharmacodynamics

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

Pharmacokinetics

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

Nonclinical Toxicology

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

Clinical Studies

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

How Supplied

Storage

There is limited information regarding Carbamide Storage in the drug label.

Images

Drug Images

{{#ask: Page Name::Carbamide |?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

PRINCIPAL DISPLAY PANEL Ear Wax Cleansing Kit

Step 1 Ear Wax Removing Drops

Step 2 Ear Cleansing Spray

This image is provided by the National Library of Medicine.

Ingredients and Appearance

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

Patient Counseling Information

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

Precautions with Alcohol

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

Brand Names

EAR WAX REMOVING DROPS CARBAMIDE PEROXIDE®^[1]

Look-Alike Drug Names

There is limited information regarding Carbamide Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

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

↑ "CARBAMIDE PEROXIDE".

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[1] "CARBAMIDE PEROXIDE".

[1]

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-|adverseReactions=<!--Black Box Warning-->
+|adverseReactions=allergic reactions
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+* For occasional use as an aid to soften, loosen, and remove excessive ear wax.
-* Dosing Information
+====Dosage====
+* FOR USE IN THE EAR ONLY.  Adults and children over 12 years of age:  tilt head sideways and place 5 to 10 drops into ear.  Tip of applicator should not enter ear canal.  Keep drops in ear for several minutes by keeping head tilted or placing cotton in ear.  Use twice daily for up to four days if needed, or as directed by a doctor.  Any wax remaining after treatment may be removed by gently flushing the ear with warm water, using a soft rubber bulb ear syringe.  Children under 12 years of age:  consult a doctor.
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-* Dosing Information
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-* Developed by:
+====Dosage====
+* FOR USE IN THE EAR ONLY.  Adults and children over 12 years of age:  tilt head sideways and place 5 to 10 drops into ear.  Tip of applicator should not enter ear canal.  Keep drops in ear for several minutes by keeping head tilted or placing cotton in ear.  Use twice daily for up to four days if needed, or as directed by a doctor.  Any wax remaining after treatment may be removed by gently flushing the ear with warm water, using a soft rubber bulb ear syringe.  Children under 12 years of age:  consult a doctor.
-* Class of Recommendation:
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+When using this product: avoid contact with the eyes.
-====Precautions====
+Stop use and ask a doctor if: excessive ear wax remains after use of this product for four consecutive days.
-* Description
-<!--Adverse Reactions-->
-<!--Clinical Trials Experience-->
-|clinicalTrials=There is limited information regarding <i>Clinical Trial Experience</i> of {{PAGENAME}} in the drug label.
-=====Body as a Whole=====
-=====Cardiovascular=====
-=====Digestive=====
-=====Endocrine=====
+Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.  If accidental contact with eyes occurs, flush eyes with water and consult a doctor.
+|clinicalTrials=* allergic reactions
-=====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.
@@ Line 244: / Line 107: @@
 <!--Drug Interactions-->
-|drugInteractions=* Drug
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-:* Description
 <!--Use in Specific Populations-->
@@ Line 264: / Line 126: @@
 <!--Administration and Monitoring-->
-|administration=* Oral
+|administration=* topical ear drops
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-* Intravenous
-|monitoring=There is limited information regarding <i>Monitoring</i> of {{PAGENAME}} in the drug label.
-* Description
 <!--IV Compatibility-->
@@ Line 275: / Line 135: @@
 <!--Overdosage-->
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-====Signs and Symptoms====
-* Description
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-* Description
-===Chronic Overdose===
-There is limited information regarding <i>Chronic Overdose</i> of {{PAGENAME}} in the drug label.
 <!--Pharmacology-->
@@ Line 296: / Line 144: @@
 <!--Structure-->
-|structure=*
+|structure=* Active Ingredient
+Carbamide Peroxide 6.5%
+Inactive ingredients
+Glycerin, Oxyquinoline, Aloe Barbadensis Leaf Extract, Anthemis Nobilis Flower Oil
-: [[File:{{PAGENAME}}01.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]
 <!--Pharmacodynamics-->
@@ Line 314: / Line 168: @@
 <!--How Supplied-->
 |howSupplied=*
-|packLabel=<!--Patient Counseling Information-->
+|packLabel=PRINCIPAL DISPLAY PANEL
+Ear Wax Cleansing Kit
+Step 1 Ear Wax Removing Drops
+Step 2 Ear Cleansing Spray
+: [[File:Carbamide PDP.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]
+====Ingredients and Appearance====
+: [[File:Carbamide Ing and App.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]
+<!--Patient Counseling Information-->
 |fdaPatientInfo=There is limited information regarding <i>Patient Counseling Information</i> of {{PAGENAME}} in the drug label.
@@ Line 321: / Line 188: @@
 <!--Brand Names-->
-|brandNames=* ®<ref>{{Cite web | title =  | url = }}</ref>
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 <!--Look-Alike Drug Names-->
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-<!--Drug Shortage Status-->
 |drugShortage=
 }}

Carbamide: Difference between revisions

Revision as of 13:28, 9 March 2015

Disclaimer

Overview

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

Dosage

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Non–Guideline-Supported Use

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Indications

Dosage

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Non–Guideline-Supported Use

Contraindications

Warnings

Adverse Reactions

Clinical Trials Experience

Postmarketing Experience

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

Use in Specific Populations

Pregnancy

Labor and Delivery

Nursing Mothers

Pediatric Use

Geriatic Use

Gender

Race

Renal Impairment

Hepatic Impairment

Females of Reproductive Potential and Males

Immunocompromised Patients

Administration and Monitoring

Administration

Monitoring

IV Compatibility

Overdosage

Pharmacology

Mechanism of Action

Structure

Pharmacodynamics

Pharmacokinetics

Nonclinical Toxicology

Clinical Studies

How Supplied

Storage

Images

Drug Images

Package and Label Display Panel

Ingredients and Appearance

Patient Counseling Information

Precautions with Alcohol

Brand Names

Look-Alike Drug Names

Drug Shortage Status

Price

References

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