Avanafil: Difference between revisions

Avanafil
	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 17:13, 11 March 2015

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1];

Disclaimer

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Black Box Warning

ConditionName:

See full prescribing information for complete Boxed Warning.

ConditionName:

Content

Overview

Avanafil is a {{{drugClass}}} that is FDA approved for the treatment of {{{indication}}}. There is a Black Box Warning for this drug as shown here. Common adverse reactions include .

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Condition1

Dosing Information

Dosage

Condition2

Dosing Information

Dosage

Condition3

Dosing Information

Dosage

Condition4

Dosing Information

Dosage

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 Avanafil in adult patients.

Non–Guideline-Supported Use

Condition1

Dosing Information

Dosage

Condition2

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

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Condition1

Dosing Information

Dosage

Condition2

There is limited information regarding FDA-Labeled Use of Avanafil in pediatric patients.

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 Avanafil in pediatric patients.

Non–Guideline-Supported Use

Condition1

Dosing Information

Dosage

Condition2

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

Contraindications

Condition1

Warnings

ConditionName:

See full prescribing information for complete Boxed Warning.

ConditionName:

Content

Description

Precautions

Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Avanafil 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 Avanafil 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 Avanafil in women who are pregnant.

Labor and Delivery

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

Nursing Mothers

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

Pediatric Use

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

Geriatic Use

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

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

Oral

Intravenous

Monitoring

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

Description

IV Compatibility

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

Overdosage

Acute Overdose

Signs and Symptoms

Description

Management

Description

Chronic Overdose

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

Pharmacology

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

Mechanism of Action

Structure

File:Avanafil01.png

This image is provided by the National Library of Medicine.

Pharmacodynamics

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

Pharmacokinetics

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

Nonclinical Toxicology

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

Clinical Studies

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

How Supplied

Storage

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

Images

Drug Images

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

Patient Counseling Information

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

Precautions with Alcohol

Alcohol-Avanafil 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.

↑ Empty citation (help)
↑ "http://www.ismp.org". External link in |title= (help)

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{{#subobject:

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{{#subobject:

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[1] Empty citation (help)

[www.ismp.org-2] "http://www.ismp.org". External link in |title= (help)

[1]

[2]

@@ Line 1: / Line 1: @@
-{{drugbox
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-| IUPAC_name        = 4-[(3-Chloro-4-methoxybenzyl)amino]-2-
+|aOrAn=a
-[2-(hydroxymethyl)-1-pyrrolidinyl]-N-
+|indicationType=treatment
-(2-pyrimidinylmethyl)-5-pyrimidinecarboxamide
+|hasBlackBoxWarning=Yes
-| image=Avanafil.svg
+|adverseReactions=<!--Black Box Warning-->
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-| ATC_suffix        =
-| PubChem           = 9869929
+* Content
-| DrugBank          =
-| C=23|H=26|Cl=1|N=7|O=3
+<!--Adult Indications and Dosage-->
-| molecular_weight  = 483.951 g/mol
-| bioavailability   =
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+|fdaLIADAdult======Condition1=====
-| metabolism        =
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+:* Dosage
-| pregnancy_US      =  <!-- A / B            / C / D / X -->
-| pregnancy_category=
+=====Condition2=====
-| legal_AU          =  <!-- Unscheduled / S2 / S3 / S4 / S5 / S6 / S7 / S8 / S9 -->
-| legal_CA          =  <!--             / Schedule I, II, III, IV, V, VI, VII, VIII -->
+* Dosing Information
-| legal_UK          =  <!-- GSL         / P       / POM / CD / Class A, B, C -->
-| legal_US          =  <!-- OTC                   / Rx-only  / Schedule I, II, III, IV, V -->
+:* Dosage
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-| routes_of_administration = Oral
+=====Condition3=====
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+* Developed by:
+* Class of Recommendation:
+* Strength of Evidence:
+* Dosing Information
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+=====Condition2=====
+There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
+<!--Non–Guideline-Supported Use (Adult)-->
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+* 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=====
+* 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)-->
+<!--Guideline-Supported Use (Pediatric)-->
+|offLabelPedGuideSupport======Condition1=====
+* Developed by:
+* Class of Recommendation:
+* Strength of Evidence:
+* Dosing Information
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+=====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=====
+* 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
+<!--Warnings-->
+|warnings=* Description
+====Precautions====
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+<!--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=====
+=====Miscellaneous=====
+<!--Postmarketing Experience-->
+|postmarketing=There is limited information regarding <i>Postmarketing 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=====
+=====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.
+|useInPed=There is no FDA guidance on the use of {{PAGENAME}} with respect to pediatric patients.
+|useInGeri=There is no FDA guidance on the use of {{PAGENAME}} with respect to geriatric 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.
+|useInRenalImpair=There is no FDA guidance on the use of {{PAGENAME}} in patients with renal impairment.
+|useInHepaticImpair=There is no FDA guidance on the use of {{PAGENAME}} in patients with hepatic impairment.
+|useInReproPotential=There is no FDA guidance on the use of {{PAGENAME}} in women of reproductive potentials and males.
+|useInImmunocomp=There is no FDA guidance one the use of {{PAGENAME}} in patients who are immunocompromised.
+<!--Administration and Monitoring-->
+|administration=* Oral
+* Intravenous
+|monitoring=There is limited information regarding <i>Monitoring</i> of {{PAGENAME}} in the drug label.
+* Description
+<!--IV Compatibility-->
+|IVCompat=There is limited information regarding <i>IV Compatibility</i> of {{PAGENAME}} in the drug label.
+<!--Overdosage-->
+|overdose====Acute Overdose===
+====Signs and Symptoms====
+* Description
+====Management====
+* Description
+===Chronic Overdose===
+There is limited information regarding <i>Chronic Overdose</i> of {{PAGENAME}} in the drug label.
+<!--Pharmacology-->
+<!--Drug box 2-->
+|drugBox=<!--Mechanism of Action-->
+|mechAction=*
+<!--Structure-->
+|structure=*
+: [[File:{{PAGENAME}}01.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]
+<!--Pharmacodynamics-->
+|PD=There is limited information regarding <i>Pharmacodynamics</i> of {{PAGENAME}} in the drug label.
+<!--Pharmacokinetics-->
+|PK=There is limited information regarding <i>Pharmacokinetics</i> of {{PAGENAME}} in the drug label.
+<!--Nonclinical Toxicology-->
+|nonClinToxic=There is limited information regarding <i>Nonclinical Toxicology</i> of {{PAGENAME}} in the drug label.
+<!--Clinical Studies-->
+|clinicalStudies=There is limited information regarding <i>Clinical Studies</i> of {{PAGENAME}} in the drug label.
+<!--How Supplied-->
+|howSupplied=*
+|packLabel=<!--Patient Counseling Information-->
+|fdaPatientInfo=There is limited information regarding <i>Patient Counseling Information</i> of {{PAGENAME}} in the drug label.
+<!--Precautions with Alcohol-->
+|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>
+<!--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=
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+{{LabelImage
+|fileName={{PAGENAME}}11.png
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+}}
+<!--Pill Image-->
+<!--Label Display Image-->
-'''Avanafil''' is a [[PDE5 inhibitor]] being developed for [[erectile dysfunction]].
-{{Urologicals}}
-{{Phosphodiesterase inhibitors}}
-[[Category:Phosphodiesterase inhibitors]]
+<!--Category-->
-[[Category:PDE5 inhibitors]]
-{{WH}}
+[[Category:Drug]]
-{{WS}}