Nedocromil: Difference between revisions

Nedocromil
	Black Box Warning
	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 14:59, 12 February 2015

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

Black Box Warning

ConditionName:

See full prescribing information for complete Boxed Warning.

ConditionName:

Content

Overview

Nedocromil is a mast cell stabilizer, ophthalmologic agent that is FDA approved for the treatment of allergic conjunctivitis. There is a Black Box Warning for this drug as shown here. Common adverse reactions include headache, ocular burning, irritation and stinging, unpleasant taste, nasal congestion, conjunctivitis, eye redness, photophobia, and rhinitis..

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

ALOCRIL® ophthalmic solution is indicated for the treatment of itching associated with allergic conjunctivitis.

Dosing Information

The recommended dosage is one or two drops in each eye twice a day. ALOCRIL® ophthalmic solution should be used at regular intervals.

Treatment should be continued throughout the period of exposure (i.e., until the pollen season is over or until exposure to the offending allergen is terminated), even when symptoms are absent.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

ALOCRIL® ophthalmic solution is indicated for Allergic conjunctivitis age 3 yr and older.

Dosing Information

1 to 2 drops in each eye twice daily

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Contraindications

ALOCRIL® ophthalmic solution is contraindicated in those patients who have shown hypersensitivity to nedocromil sodium or to any of the other ingredients.

Warnings

ConditionName:

See full prescribing information for complete Boxed Warning.

ConditionName:

Content

There is limited information regarding Warnings of Nedocromil in the drug label.

Adverse Reactions

Clinical Trials Experience

The most frequently reported adverse experience was headache (~40%).

Ocular burning, irritation and stinging, unpleasant taste, and nasal congestion have been reported to occur in 10 – 30% of patients. Other events occurring between 1 – 10% included asthma, conjunctivitis, eye redness, photophobia, and rhinitis.

Some of these events were similar to the underlying ocular disease being studied.

Postmarketing Experience

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

Drug Interactions

There is limited information regarding Drug Interactions of Nedocromil in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): B

Reproduction studies performed in mice, rats and rabbits using a subcutaneous dose of 100 mg/kg/day (more than 1600 times the maximum human daily ocular dose on a mg/kg basis) revealed no evidence of teratogenicity or harm to the fetus due to nedocromil sodium. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, ALOCRIL® ophthalmic solution should be used during pregnancy only if clearly needed.

Pregnancy Category (AUS):

Australian Drug Evaluation Committee (ADEC) Pregnancy Category

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

Labor and Delivery

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

Nursing Mothers

After intravenous administration to lactating rats, nedocromil was excreted in milk. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when ALOCRIL® ophthalmic solution is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in children below the age of 3 years have not been established.

Geriatic Use

No overall differences in safety or effectiveness have been observed between elderly and younger patients.

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

Ophthalmic solution

Monitoring

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

Description

IV Compatibility

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

Overdosage

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

Pharmacology

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

Mechanism of Action

Nedocromil sodium is a mast cell stabilizer. Nedocromil sodium inhibits the release of mediators from cells involved in hypersensitivity reactions. Decreased chemotaxis and decreased activation of eosinophils have also been demonstrated.

In vitro studies with adult human bronchoalveolar cells showed that nedocromil sodium inhibits histamine release from a population of mast cells having been defined as belonging to the mucosal sub type and inhibits beta-glucuronidase release from macrophages.

Structure

ALOCRIL® (nedocromil sodium ophthalmic solution) 2% is a clear, yellow, sterile solution for topical ophthalmic use.

Nedocromil sodium is represented by the following structural formula:

File:Nedocromil01.png

This image is provided by the National Library of Medicine.

Pharmacodynamics

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

Pharmacokinetics

Nedocromil sodium exhibits low systemic absorption. When administered as a 2% ophthalmic solution in adult human volunteers, less than 4% of the total dose was systemically absorbed following multiple dosing. Absorption is mainly through the nasolacrimal duct rather than through the conjunctiva. It is not metabolized and is eliminated primarily unchanged in urine (70%) and feces (30%).

Nonclinical Toxicology

A two-year inhalation carcinogenicity study of nedocromil sodium at a dose of 24 mg/kg/day (approximately 400 times the maximum recommended human daily ocular dose on a mg/kg basis) in Wistar rats showed no carcinogenic potential.

Nedocromil sodium showed no mutagenic potential in the Ames Salmonella/microsome plate assay, mitotic gene conversion in Saccharomyces cerevisiae, mouse lymphoma forward mutation and mouse micronucleus assays.

Reproduction and fertility studies in mice and rats showed no effects on male and female fertility at a subcutaneous dose of 100 mg/kg/day (more than 1600 times the maximum recommended human daily ocular dose).

Clinical Studies

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

How Supplied

ALOCRIL® (nedocromil sodium ophthalmic solution) 2% is supplied sterile in opaque white LDPE plastic bottles with dropper tips and white high impact polystyrene (HIPS) caps as follows:

5 mL in 10 mL bottle NDC 0023-8842-05

Rx only

Revised: 12/2012

71761US12

Storage

Storage: Store at 2º–25º C (36º–77º F).

Images

Drug Images

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

NDC 0023-8842-05

Alocril® (nedocromil sodium ophthalmic solution) 2%

STERILE

For topical application in the eye

5 mL

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

Patient Counseling Information

Patients should be advised to follow the patient instructions listed on the Information for Patients sheet.

Users of contact lenses should refrain from wearing lenses while exhibiting the signs and symptoms of allergic conjunctivitis.

Patients should be instructed to avoid allowing the tip of the dispensing container to contact the eye, surrounding structures, fingers, or any other surface in order to avoid contamination of the solution by common bacteria known to cause ocular infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions.

Precautions with Alcohol

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

Brand Names

Alocril®

Look-Alike Drug Names

There is limited information regarding Nedocromil 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.

{{#subobject:

 |Page Name=Nedocromil
 |Pill Name=No image.jpg
 |Drug Name=
 |Pill Ingred=|+sep=;
 |Pill Imprint=
 |Pill Dosage={{{dosageValue}}} {{{dosageUnit}}}
 |Pill Color=|+sep=;
 |Pill Shape=
 |Pill Size (mm)=
 |Pill Scoring=
 |Pill Image=
 |Drug Author=
 |NDC=

}}

{{#subobject:

 |Label Page=Nedocromil
 |Label Name=Nedocromil11.png

}}

{{#subobject:

 |Label Page=Nedocromil
 |Label Name=Nedocromil11.png

}}

@@ Line 1: / Line 1: @@
 {{DrugProjectFormSinglePage
 |authorTag={{AJ}}
+|genericName=Nedocromil sodium
 |aOrAn=a
+|drugClass=mast cell stabilizer, ophthalmologic agent
+|indicationType=treatment
+|indication=[[allergic conjunctivitis]]
 |hasBlackBoxWarning=Yes
-|adverseReactions=<!--Black Box Warning-->
+|adverseReactions=[[headache]], ocular burning, irritation and stinging, unpleasant taste, [[nasal congestion]],  [[conjunctivitis]], eye redness, [[photophobia]], and [[rhinitis]].
 |blackBoxWarningTitle=<span style="color:#FF0000;">ConditionName: </span>
 |blackBoxWarningBody=<i><span style="color:#FF0000;">ConditionName: </span></i>
@@ Line 12: / Line 16: @@
 <!--FDA-Labeled Indications and Dosage (Adult)-->
-|fdaLIADAdult======Condition1=====
+|fdaLIADAdult=* ALOCRIL® ophthalmic solution is indicated for the treatment of itching associated with allergic conjunctivitis.
-* Dosing Information
+====Dosing Information====
-:* Dosage
+* The recommended dosage is one or two drops in each eye twice a day. ALOCRIL® ophthalmic solution should be used at regular intervals.
-=====Condition2=====
+* Treatment should be continued throughout the period of exposure (i.e., until the pollen season is over or until exposure to the offending allergen is terminated), even when symptoms are absent.
+|offLabelAdultGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
-* Dosing Information
-:* Dosage
-=====Condition3=====
-* Dosing Information
-:* Dosage
-=====Condition4=====
-* Dosing Information
-:* Dosage
-<!--Off-Label Use and Dosage (Adult)-->
-<!--Guideline-Supported Use (Adult)-->
-|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=====
+|offLabelAdultNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
-* 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)-->
-|fdaLIADPed======Condition1=====
+|fdaLIADPed=* ALOCRIL® ophthalmic solution is indicated for Allergic conjunctivitis age 3 yr and older.
-* Dosing Information
-:* Dosage
-=====Condition2=====
-There is limited information regarding <i>FDA-Labeled Use</i> of {{PAGENAME}} in pediatric patients.
-<!--Off-Label Use and Dosage (Pediatric)-->
+====Dosing Information====
+* 1 to 2 drops in each eye twice daily
-<!--Guideline-Supported Use (Pediatric)-->
+|offLabelPedGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
-|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=====
+|offLabelPedNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
-* Dosing Information
-:* Dosage
-=====Condition2=====
-There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
 <!--Contraindications-->
-|contraindications=* Condition1
+|contraindications=* ALOCRIL® ophthalmic solution is contraindicated in those patients who have shown hypersensitivity to nedocromil sodium or to any of the other ingredients.
+|warnings=There is limited information regarding <i>Warnings</i> of {{PAGENAME}} in the drug label.
-<!--Warnings-->
+|clinicalTrials=* The most frequently reported adverse experience was headache (~40%).
-|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.
-=====Body as a Whole=====
-=====Cardiovascular=====
-=====Digestive=====
-=====Endocrine=====
-=====Hematologic and Lymphatic=====
-=====Metabolic and Nutritional=====
-=====Musculoskeletal=====
-=====Neurologic=====
-=====Respiratory=====
-=====Skin and Hypersensitivy Reactions=====
-=====Special Senses=====
-=====Urogenital=====
+* Ocular burning, irritation and stinging, unpleasant taste, and nasal congestion have been reported to occur in 10 – 30% of patients. Other events occurring between 1 – 10% included asthma, conjunctivitis, eye redness, photophobia, and rhinitis.
+* Some of these events were similar to the underlying ocular disease being studied.
-=====Miscellaneous=====
-<!--Postmarketing Experience-->
 |postmarketing=There is limited information regarding <i>Postmarketing Experience</i> of {{PAGENAME}} in the drug label.
-=====Body as a Whole=====
+|drugInteractions=There is limited information regarding <i>Drug Interactions</i> of {{PAGENAME}} in the drug label.
+|FDAPregCat=B
+|useInPregnancyFDA=* Reproduction studies performed in mice, rats and rabbits using a subcutaneous dose of 100 mg/kg/day (more than 1600 times the maximum human daily ocular dose on a mg/kg basis) revealed no evidence of teratogenicity or harm to the fetus due to nedocromil sodium. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, ALOCRIL® ophthalmic solution should be used during pregnancy only if clearly needed.
-=====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'''
 |useInPregnancyAUS=* '''Australian Drug Evaluation Committee (ADEC) Pregnancy Category'''
 There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of {{PAGENAME}} in women who are pregnant.
 |useInLaborDelivery=There is no FDA guidance on use of {{PAGENAME}} during labor and delivery.
-|useInNursing=There is no FDA guidance on the use of {{PAGENAME}} with respect to nursing mothers.
+|useInNursing=* After intravenous administration to lactating rats, nedocromil was excreted in milk. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when ALOCRIL® ophthalmic solution is administered to a nursing woman.
-|useInPed=There is no FDA guidance on the use of {{PAGENAME}} with respect to pediatric patients.
+|useInPed=* Safety and effectiveness in children below the age of 3 years have not been established.
-|useInGeri=There is no FDA guidance on the use of {{PAGENAME}} with respect to geriatric patients.
+|useInGeri=* No overall differences in safety or effectiveness have been observed between elderly and younger patients.
 |useInGender=There is no FDA guidance on the use of {{PAGENAME}} with respect to specific gender populations.
 |useInRace=There is no FDA guidance on the use of {{PAGENAME}} with respect to specific racial populations.
@@ Line 264: / Line 68: @@
 <!--Administration and Monitoring-->
-|administration=* Oral
+|administration=* Ophthalmic solution
-* Intravenous
 |monitoring=There is limited information regarding <i>Monitoring</i> of {{PAGENAME}} in the drug label.
@@ Line 275: / Line 77: @@
 <!--Overdosage-->
-|overdose====Acute Overdose===
+|overdose=There is limited information regarding <i>Chronic Overdose</i> of {{PAGENAME}} in the drug label.
-====Signs and Symptoms====
-* Description
-====Management====
-* Description
-===Chronic Overdose===
-There is limited information regarding <i>Chronic Overdose</i> of {{PAGENAME}} in the drug label.
 <!--Pharmacology-->
@@ Line 293: / Line 83: @@
 <!--Drug box 2-->
 |drugBox=<!--Mechanism of Action-->
-|mechAction=*
+|mechAction=* Nedocromil sodium is a mast cell stabilizer. Nedocromil sodium inhibits the release of mediators from cells involved in hypersensitivity reactions. Decreased chemotaxis and decreased activation of eosinophils have also been demonstrated.
+* In vitro studies with adult human bronchoalveolar cells showed that nedocromil sodium inhibits histamine release from a population of mast cells having been defined as belonging to the mucosal sub type and inhibits beta-glucuronidase release from macrophages.
 <!--Structure-->
-|structure=*
+|structure=*  ALOCRIL® (nedocromil sodium ophthalmic solution) 2% is a clear, yellow, sterile solution for topical ophthalmic use.
-: [[File:{{PAGENAME}}01.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]
+* Nedocromil sodium is represented by the following structural formula:
+[[File:{{PAGENAME}}01.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]
 <!--Pharmacodynamics-->
@@ Line 304: / Line 98: @@
 <!--Pharmacokinetics-->
-|PK=There is limited information regarding <i>Pharmacokinetics</i> of {{PAGENAME}} in the drug label.
+|PK=* Nedocromil sodium exhibits low systemic absorption. When administered as a 2% ophthalmic solution in adult human volunteers, less than 4% of the total dose was systemically absorbed following multiple dosing. Absorption is mainly through the nasolacrimal duct rather than through the conjunctiva. It is not metabolized and is eliminated primarily unchanged in urine (70%) and feces (30%).
+|nonClinToxic=* A two-year inhalation carcinogenicity study of nedocromil sodium at a dose of 24 mg/kg/day (approximately 400 times the maximum recommended human daily ocular dose on a mg/kg basis) in Wistar rats showed no carcinogenic potential.
-<!--Nonclinical Toxicology-->
+* Nedocromil sodium showed no mutagenic potential in the Ames Salmonella/microsome plate assay, mitotic gene conversion in Saccharomyces cerevisiae, mouse lymphoma forward mutation and mouse micronucleus assays.
-|nonClinToxic=There is limited information regarding <i>Nonclinical Toxicology</i> of {{PAGENAME}} in the drug label.
-<!--Clinical Studies-->
+* Reproduction and fertility studies in mice and rats showed no effects on male and female fertility at a subcutaneous dose of 100 mg/kg/day (more than 1600 times the maximum recommended human daily ocular dose).
 |clinicalStudies=There is limited information regarding <i>Clinical Studies</i> of {{PAGENAME}} in the drug label.
 <!--How Supplied-->
-|howSupplied=*
+|howSupplied=ALOCRIL® (nedocromil sodium ophthalmic solution) 2% is supplied sterile in opaque white LDPE plastic bottles with dropper tips and white high impact polystyrene (HIPS) caps as follows:
-|packLabel=<!--Patient Counseling Information-->
-|fdaPatientInfo=There is limited information regarding <i>Patient Counseling Information</i> of {{PAGENAME}} in the drug label.
-<!--Precautions with Alcohol-->
+mL in 10 mL bottle NDC 0023-8842-05
+ Rx only
+Revised: 12/2012
+© 2013 Allergan, Inc.
+Irvine, CA 92612, U.S.A.
+® marks owned by Allergan, Inc.
+Made in the U.S.A.
+US12
+|storage=* Storage: Store at 2º–25º C (36º–77º F).
+|packLabel=====PRINCIPAL DISPLAY PANEL====
+NDC 0023-8842-05
+Alocril®
+(nedocromil sodium
+ophthalmic solution) 2%
+STERILE
+For topical application in the eye
+mL
+ALLERGAN
+|fdaPatientInfo=* Patients should be advised to follow the patient instructions listed on the Information for Patients sheet.
+* Users of contact lenses should refrain from wearing lenses while exhibiting the signs and symptoms of allergic conjunctivitis.
+* Patients should be instructed to avoid allowing the tip of the dispensing container to contact the eye, surrounding structures, fingers, or any other surface in order to avoid contamination of the solution by common bacteria known to cause ocular infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions.
 |alcohol=* Alcohol-{{PAGENAME}} interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
 <!--Brand Names-->
-|brandNames=* ®<ref>{{Cite web | title =  | url = }}</ref>
+|brandNames=* Alocril®
-<!--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=
 }}

Nedocromil: Difference between revisions

Revision as of 14:59, 12 February 2015

Disclaimer

Black Box Warning

Overview

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Dosing Information

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Non–Guideline-Supported Use

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Dosing Information

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Non–Guideline-Supported Use

Contraindications

Warnings

Adverse Reactions

Clinical Trials Experience

Postmarketing Experience

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

PRINCIPAL DISPLAY PANEL

Patient Counseling Information

Precautions with Alcohol

Brand Names

Look-Alike Drug Names

Drug Shortage Status

Price

References

Navigation menu