Template:DrugProjectFormSinglePage: Difference between revisions
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|drugClass= | |drugClass= | ||
|indication= | |indication= | ||
|indicationType= | |||
|commonAdverseReactions= | |commonAdverseReactions= | ||
|hasBlackBoxWarning= | |||
|blackBoxWarningTitle= | |blackBoxWarningTitle= | ||
|blackBoxWarningBody= | |blackBoxWarningBody= | ||
|fdaLIADAdult= | |fdaLIADAdult= | ||
|offLabelAdultGuideSupport= | |offLabelAdultGuideSupport= | ||
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|offLabelPedGuideSupport= | |offLabelPedGuideSupport= | ||
|offLabelPedNoGuideSupport= | |offLabelPedNoGuideSupport= | ||
|contraindications= | |contraindications= | ||
|warnings= | |warnings= | ||
Line 37: | Line 25: | ||
|postmarketing= | |postmarketing= | ||
|drugInteractions= | |drugInteractions= | ||
|FDAPregCat= | |||
|useInPregnancyFDA= | |useInPregnancyFDA= | ||
|AUSPregCat= | |||
|useInPregnancyAUS= | |useInPregnancyAUS= | ||
|useInLaborDelivery= | |useInLaborDelivery= | ||
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|useInReproPotential= | |useInReproPotential= | ||
|useInImmunocomp= | |useInImmunocomp= | ||
|othersTitle= | |||
|useInOthers= | |||
|administration= | |administration= | ||
|monitoring= | |monitoring= | ||
|IVCompat= | |IVCompat= | ||
|overdose= | |overdose= | ||
|drugBox= | |drugBox= | ||
|mechAction= | |mechAction= | ||
Line 64: | Line 51: | ||
|PK= | |PK= | ||
|nonClinToxic= | |nonClinToxic= | ||
|clinicalStudies= | |clinicalStudies= | ||
|howSupplied= | |howSupplied= | ||
|NDC= | |NDC= | ||
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|manBy= | |manBy= | ||
|distBy= | |distBy= | ||
|drugImages= | |drugImages= | ||
|packLabel= | |packLabel= | ||
|fdaPatientInfo= | |fdaPatientInfo= | ||
|nlmPatientInfo= | |nlmPatientInfo= | ||
|alcohol= | |alcohol= | ||
|brandNames= | |||
|lookAlike= | |lookAlike= | ||
|drugShortage= | |drugShortage= | ||
|price= | |price= | ||
}} | }} | ||
</pre> | </pre> | ||
Edit the page to see the template text.</noinclude><includeonly>[[Page has default form::DrugProjectForm| ]][[Is of Type::Drug| ]]{{ | Edit the page to see the template text.</noinclude><includeonly>[[Page has default form::DrugProjectForm| ]][[Is of Type::Drug| ]]{{#if: {{{hasBlackBoxWarning|}}}|{{DrugPageSideBlackBox}}|{{ | ||
<div style="width: 80%"> | DrugPageSideNoBlackBox}} }}<div style="width: 80%">__NOTOC____NOEDITSECTION__ | ||
{{CMG}} {{ | {{CMG}}; {{#if: {{{authorTag|}}} | {{AE}} }} {{{authorTag|}}} | ||
==[[Drug project disclaimer|{{fontcolor|#000000|Disclaimer}}]]== | ==[[Drug project disclaimer|{{fontcolor|#000000|Disclaimer}}]]== | ||
{{DrugProjectDisclaimer}} | |||
{{#if: {{{hasBlackBoxWarning|}}} | | {{#if: {{{OTC|}}} | | ||
<BR><SMALL>{{fontcolor|#0F4D8B|'''''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.'''''}}</SMALL> | |||
{{BlackBoxTemplate|blackBoxWarningTitle={{{blackBoxWarningTitle}}}|blackBoxWarningBody={{{blackBoxWarningBody}}}}} | }}{{#if: {{{hasBlackBoxWarning|}}} |<h2><span style="color:#FF0000; background:#000000;">Black Box Warning</span></h2> | ||
{{BlackBoxTemplate|blackBoxWarningTitle={{{blackBoxWarningTitle}}}|blackBoxWarningBody={{{blackBoxWarningBody}}}}}| | |||
}} | }} | ||
==Overview== | ==Overview== | ||
{{PAGENAME}} is | {{PAGENAME}} is {{{aOrAn}}} {{{drugClass}}} that is FDA approved for the {{{indicationType}}} of {{{indication}}}. {{#if: {{{hasBlackBoxWarning|}}}| There is a Black Box Warning for this drug as shown {{BlackBoxHere}}.}} Common adverse reactions include {{{adverseReactions}}}. | ||
==Adult Indications and Dosage== | ==Adult Indications and Dosage== | ||
===FDA-Labeled Indications and Dosage (Adult)=== | ===FDA-Labeled Indications and Dosage (Adult)=== | ||
{{#if: {{{fdaLIADAdult|}}} | | |||
{{{fdaLIADAdult}}} | {{{fdaLIADAdult|}}} | | ||
There is limited information regarding {{PAGENAME}} ''FDA-Labeled Indications and Dosage (Adult)'' in the drug label. | |||
}} | |||
===Off-Label Use and Dosage (Adult)=== | ===Off-Label Use and Dosage (Adult)=== | ||
{{#if: {{{offLabelAdultGuideSupport|}}} | | |||
====Guideline-Supported Use==== | ====Guideline-Supported Use==== | ||
{{{offLabelAdultGuideSupport}}} | {{{offLabelAdultGuideSupport}}} | ||
}} | |||
{{#if: {{{offLabelAdultNoGuideSupport|}}} | | |||
====Non–Guideline-Supported Use==== | ====Non–Guideline-Supported Use==== | ||
{{{offLabelAdultNoGuideSupport|}}} | |||
{{{offLabelAdultNoGuideSupport}}} | }} | ||
==Pediatric Indications and Dosage== | ==Pediatric Indications and Dosage== | ||
===FDA-Labeled Indications and Dosage (Pediatric)=== | ===FDA-Labeled Indications and Dosage (Pediatric)=== | ||
{{#if: {{{fdaLIADPed|}}} | | |||
{{{fdaLIADPed}}} | {{{fdaLIADPed|}}} | | ||
There is limited information regarding {{PAGENAME}} ''FDA-Labeled Indications and Dosage (Pediatric)'' in the drug label. | |||
}} | |||
===Off-Label Use and Dosage (Pediatric)=== | ===Off-Label Use and Dosage (Pediatric)=== | ||
{{#if: {{{offLabelPedGuideSupport|}}} | | |||
====Guideline-Supported Use==== | ====Guideline-Supported Use==== | ||
{{{offLabelPedGuideSupport|}}} | |||
{{{offLabelPedGuideSupport}}} | }} | ||
{{#if: {{{offLabelPedNoGuideSupport|}}} | | |||
====Non–Guideline-Supported Use==== | ====Non–Guideline-Supported Use==== | ||
{{{offLabelPedNoGuideSupport|}}} | |||
{{{offLabelPedNoGuideSupport}}} | }} | ||
==Contraindications== | ==Contraindications== | ||
{{#if: {{{contraindications|}}} | | |||
{{{contraindications}}} | {{{contraindications|}}} | | ||
There is limited information regarding {{PAGENAME}} ''Contraindications'' in the drug label. | |||
}} | |||
==Warnings== | ==Warnings== | ||
{{#if: {{{hasBlackBoxWarning|}}} | | {{#if: {{{hasBlackBoxWarning|}}} | | ||
{{BlackBoxTemplate|blackBoxWarningTitle={{{blackBoxWarningTitle}}}|blackBoxWarningBody={{{blackBoxWarningBody}}}}} | {{BlackBoxTemplate|blackBoxWarningTitle={{{blackBoxWarningTitle}}}|blackBoxWarningBody={{{blackBoxWarningBody}}}}} | ||
}} | }} | ||
{{#if: {{{warnings|}}}| | |||
{{{warnings}}} | {{{warnings|}}} | | ||
There is limited information regarding {{PAGENAME}} ''Warnings' in the drug label. | |||
}} | |||
==Adverse Reactions== | ==Adverse Reactions== | ||
===Clinical Trials Experience=== | ===Clinical Trials Experience=== | ||
{{#if: {{{clinicalTrials|}}} | | |||
{{{clinicalTrials}}} | {{{clinicalTrials|}}} | | ||
There is limited information regarding {{PAGENAME}} ''Clinical Trials Experience'' in the drug label. | |||
}} | |||
===Postmarketing Experience=== | ===Postmarketing Experience=== | ||
{{#if: {{{postmarketing|}}} | | |||
{{{postmarketing}}} | {{{postmarketing|}}} | | ||
There is limited information regarding {{PAGENAME}} ''Postmarketing Experience'' in the drug label. | |||
}} | |||
==Drug Interactions== | ==Drug Interactions== | ||
{{#if: {{{drugInteractions|}}} | | |||
{{{drugInteractions}}} | {{{drugInteractions|}}} | | ||
There is limited information regarding {{PAGENAME}} ''Drug Interactions'' in the drug label. | |||
}} | |||
==Use in Specific Populations== | ==Use in Specific Populations== | ||
====Pregnancy==== | ====Pregnancy==== | ||
'''[[Pregnancy category#United States|Pregnancy Category (FDA)]]: {{{FDAPregCat|}}}''' | |||
{{#if: {{{useInPregnancyFDA|}}} | | {{#if: {{{useInPregnancyFDA|}}} | | ||
{{{useInPregnancyFDA}}} | | {{{useInPregnancyFDA|}}} | | ||
There is no FDA guidance on usage of {{PAGENAME}} in women who are pregnant. | There is no FDA guidance on usage of {{PAGENAME}} in women who are pregnant. | ||
}} | }} | ||
<BR> | |||
'''[[Pregnancy category#Australia|Pregnancy Category (AUS)]]: {{{AUSPregCat|}}}''' | |||
{{#if: {{{useInPregnancyAUS|}}} | | {{#if: {{{useInPregnancyAUS|}}} | | ||
{{{useInPregnancyAUS}}} | | {{{useInPregnancyAUS|}}} | | ||
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of {{PAGENAME}} in women who are pregnant. | There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of {{PAGENAME}} in women who are pregnant. | ||
}} | }} | ||
====Labor and Delivery==== | ====Labor and Delivery==== | ||
{{#if: {{{useInLaborDelivery|}}} | | {{#if: {{{useInLaborDelivery|}}} | | ||
{{{useInLaborDelivery}}} | | {{{useInLaborDelivery|}}} | | ||
There is no FDA guidance on use of {{PAGENAME}} during labor and delivery. | There is no FDA guidance on use of {{PAGENAME}} during labor and delivery. | ||
}} | }} | ||
====Nursing Mothers==== | ====Nursing Mothers==== | ||
{{#if: {{{useInNursing|}}} | | {{#if: {{{useInNursing|}}} | | ||
{{{useInNursing}}} | | {{{useInNursing|}}} | | ||
There is no FDA guidance on the use of {{PAGENAME}} in women who are nursing. | There is no FDA guidance on the use of {{PAGENAME}} in women who are nursing. | ||
}} | }} | ||
====Pediatric Use==== | ====Pediatric Use==== | ||
{{#if: {{{useInPed|}}} | | {{#if: {{{useInPed|}}} | | ||
{{{useInPed}}} | | {{{useInPed|}}} | | ||
There is no FDA guidance on the use of {{PAGENAME}} in pediatric settings. | There is no FDA guidance on the use of {{PAGENAME}} in pediatric settings. | ||
}} | }} | ||
====Geriatic Use==== | ====Geriatic Use==== | ||
{{#if: {{{useInGeri|}}} | | {{#if: {{{useInGeri|}}} | | ||
{{{useInGeri}}} | | {{{useInGeri|}}} | | ||
There is no FDA guidance on the use of {{PAGENAME}} in geriatric settings. | There is no FDA guidance on the use of {{PAGENAME}} in geriatric settings. | ||
}} | }} | ||
====Gender==== | ====Gender==== | ||
{{#if: {{{useInGender|}}} | | {{#if: {{{useInGender|}}} | | ||
{{{useInGender}}} | | {{{useInGender|}}} | | ||
There is no FDA guidance on the use of {{PAGENAME}} with respect to specific gender populations. | There is no FDA guidance on the use of {{PAGENAME}} with respect to specific gender populations. | ||
}} | }} | ||
====Race==== | ====Race==== | ||
{{#if: {{{useInRace|}}} | | {{#if: {{{useInRace|}}} | | ||
{{{useInRace}}} | | {{{useInRace|}}} | | ||
There is no FDA guidance on the use of {{PAGENAME}} with respect to specific racial populations. | There is no FDA guidance on the use of {{PAGENAME}} with respect to specific racial populations. | ||
}} | }} | ||
====Renal Impairment==== | ====Renal Impairment==== | ||
{{#if: {{{useInRenalImpair|}}} | | {{#if: {{{useInRenalImpair|}}} | | ||
{{{useInRenalImpair}}} | | {{{useInRenalImpair|}}} | | ||
There is no FDA guidance on the use of {{PAGENAME}} in patients with renal impairment. | There is no FDA guidance on the use of {{PAGENAME}} in patients with renal impairment. | ||
}} | }} | ||
====Hepatic Impairment==== | ====Hepatic Impairment==== | ||
{{#if: {{{useInHepaticImpair|}}} | | {{#if: {{{useInHepaticImpair|}}} | | ||
{{{useInHepaticImpair}}} | | {{{useInHepaticImpair|}}} | | ||
There is no FDA guidance on the use of {{PAGENAME}} in patients with hepatic impairment. | There is no FDA guidance on the use of {{PAGENAME}} in patients with hepatic impairment. | ||
}} | }} | ||
====Females of Reproductive Potential and Males==== | ====Females of Reproductive Potential and Males==== | ||
{{#if: {{{useInReproPotential|}}} | | {{#if: {{{useInReproPotential|}}} | | ||
{{{useInReproPotential}}} | | {{{useInReproPotential|}}} | | ||
There is no FDA guidance on the use of {{PAGENAME}} in women of reproductive potentials and males. | There is no FDA guidance on the use of {{PAGENAME}} in women of reproductive potentials and males. | ||
}} | }} | ||
====Immunocompromised Patients==== | ====Immunocompromised Patients==== | ||
{{#if: {{{useInImmunocomp|}}} | | {{#if: {{{useInImmunocomp|}}} | | ||
{{{useInImmunocomp}}} | | {{{useInImmunocomp|}}} | | ||
There is no FDA guidance one the use of {{PAGENAME}} in patients who are immunocompromised. | There is no FDA guidance one the use of {{PAGENAME}} in patients who are immunocompromised. | ||
}} | }} | ||
{{#if: {{{othersTitle|}}}| | |||
===={{{othersTitle|}}}==== | |||
{{{useInOthers|}}} | | |||
}} | |||
==Administration and Monitoring== | ==Administration and Monitoring== | ||
====Administration==== | ====Administration==== | ||
{{#if: {{{administration|}}} | | |||
{{{administration}}} | {{{administration|}}} | | ||
There is limited information regarding {{PAGENAME}} ''Administration'' in the drug label. | |||
}} | |||
====Monitoring==== | ====Monitoring==== | ||
{{#if: {{{monitoring|}}} | | |||
{{{monitoring|}}} | | |||
There is limited information regarding {{PAGENAME}} ''Monitoring'' in the drug label. | |||
}} | |||
==IV Compatibility== | |||
==IV | |||
{{#if: {{{IVCompat|}}} | | {{#if: {{{IVCompat|}}} | | ||
{{{IVCompat}}} | | {{{IVCompat|}}} | | ||
There is limited information | There is limited information regarding the compatibility of {{PAGENAME}} and IV administrations. | ||
}} | }} | ||
==Overdosage== | ==Overdosage== | ||
{{#if: {{{overdose|}}} | | {{#if: {{{overdose|}}} | | ||
{{{overdose}}} | | {{{overdose|}}} | | ||
There is limited information | There is limited information regarding {{PAGENAME}} overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately. | ||
}} | }} | ||
==Pharmacology== | ==Pharmacology== | ||
{{drugBox}} | {{#if: {{{drugBox|}}} | | ||
{{{drugBox|}}} | | |||
There is limited information regarding {{PAGENAME}} ''Pharmacology'' in the drug label. | |||
}} | |||
===Mechanism of Action=== | ===Mechanism of Action=== | ||
{{#if: {{{mechAction|}}} | | |||
{{{mechAction}}} | {{{mechAction|}}} | | ||
There is limited information regarding {{PAGENAME}} ''Mechanism of Action'' in the drug label. | |||
}} | |||
===Structure=== | ===Structure=== | ||
{{#if: {{{structure|}}} | | |||
{{{structure}}} | {{{structure|}}} | | ||
There is limited information regarding {{PAGENAME}} ''Structure'' in the drug label. | |||
}} | |||
===Pharmacodynamics=== | ===Pharmacodynamics=== | ||
{{#if: {{{PD|}}} | | |||
{{{PD}}} | {{{PD|}}} | | ||
There is limited information regarding {{PAGENAME}} ''Pharmacodynamics'' in the drug label. | |||
}} | |||
===Pharmacokinetics=== | ===Pharmacokinetics=== | ||
{{#if: {{{PK|}}} | | |||
{{{PK}}} | {{{PK|}}} | | ||
There is limited information regarding {{PAGENAME}} ''Pharmacokinetics'' in the drug label. | |||
}} | |||
===Nonclinical Toxicology=== | ===Nonclinical Toxicology=== | ||
{{#if: {{{nonClinToxic|}}} | | |||
{{{nonClinToxic}}} | {{{nonClinToxic|}}} | | ||
There is limited information regarding {{PAGENAME}} ''Nonclinical Toxicology'' in the drug label. | |||
}} | |||
==Clinical Studies== | ==Clinical Studies== | ||
{{{clinicalStudies}}} | {{#if: {{{clinicalStudies|}}} | | ||
{{{clinicalStudies|}}} | | |||
There is limited information regarding {{PAGENAME}} ''Clinical Studies'' in the drug label. | |||
}} | |||
==How Supplied== | ==How Supplied== | ||
{{ | {{#if: {{{howSupplied|}}} | | ||
{{{howSupplied|}}} | | |||
There is limited information regarding {{PAGENAME}} ''How Supplied'' in the drug label. | |||
}} | |||
===Storage=== | |||
{{#if: {{{storage|}}} | | |||
{{{storage|}}} | | |||
There is limited information regarding {{PAGENAME}} ''Storage'' in the drug label. | |||
}} | |||
==Images== | ==Images== | ||
===Drug Images=== | ===Drug Images=== | ||
{{{drugImages|}}} | |||
{{{drugImages}}} | {{#ask: [[Page Name::{{PAGENAME}}]] | ||
|?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=== | ===Package and Label Display Panel=== | ||
{{{packLabel}}} | {{{packLabel|}}} | ||
{{#ask: [[Label Page::{{PAGENAME}}]] | |||
== | |?Label Name | ||
|format=template | |||
|template=DrugLabelImages | |||
{{{fdaPatientInfo}}} | |mainlabel=- | ||
|sort=Label Page | |||
}} | |||
==Patient Counseling Information== | |||
{{#if: {{{fdaPatientInfo|}}} | | |||
{{{fdaPatientInfo|}}} | | |||
There is limited information regarding {{PAGENAME}} ''Patient Counseling Information'' in the drug label. | |||
}} | |||
==Precautions with Alcohol== | ==Precautions with Alcohol== | ||
{{#if: {{{alcohol|}}} | | {{#if: {{{alcohol|}}} | | ||
{{{alcohol}}} | | {{{alcohol|}}} | | ||
Alcohol-{{PAGENAME}} interaction has not been established. Talk to your doctor | Alcohol-{{PAGENAME}} interaction has not been established. Talk to your doctor regarding the effects of taking alcohol with this medication. | ||
}} | |||
==Brand Names== | |||
{{#if: {{{brandNames|}}} | | |||
{{{brandNames|}}} | | |||
There is limited information regarding {{PAGENAME}} ''Brand Names'' in the drug label. | |||
}} | }} | ||
==Look-Alike Drug Names== | ==Look-Alike Drug Names== | ||
{{{ | {{#if: {{{lookAlike|}}} | | ||
{{{lookAlike|}}} | | |||
There is limited information regarding {{PAGENAME}} ''Look-Alike Drug Names'' in the drug label. | |||
}} | }} | ||
==[http://www.fda.gov/ | ==[http://www.accessdata.fda.gov/scripts/drugshortages/default.cfm Drug Shortage Status]== | ||
{{{drugShortage}}} | {{{drugShortage|}}} | ||
==Price== | ==Price== | ||
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==References== | ==References== | ||
The contents of this FDA label are provided by the National Library of Medicine. | |||
{{reflist|2}} | |||
</div> | </div> | ||
</includeonly> | |||
Latest revision as of 17:13, 1 August 2017
This is the "Drug Project Form" template. It should be called in the following format:
{{DrugProjectForm |authorTag= |genericName= |drugClass= |indication= |indicationType= |commonAdverseReactions= |hasBlackBoxWarning= |blackBoxWarningTitle= |blackBoxWarningBody= |fdaLIADAdult= |offLabelAdultGuideSupport= |offLabelAdultNoGuideSupport= |fdaLIADPed= |offLabelPedGuideSupport= |offLabelPedNoGuideSupport= |contraindications= |warnings= |adverseReactions= |clinicalTrials= |postmarketing= |drugInteractions= |FDAPregCat= |useInPregnancyFDA= |AUSPregCat= |useInPregnancyAUS= |useInLaborDelivery= |useInNursing= |useInPed= |useInGeri= |useInGender= |useInRace= |useInRenalImpair= |useInHepaticImpair= |useInReproPotential= |useInImmunocomp= |othersTitle= |useInOthers= |administration= |monitoring= |IVCompat= |overdose= |drugBox= |mechAction= |structure= |PD= |PK= |nonClinToxic= |clinicalStudies= |howSupplied= |NDC= |storage= |manBy= |distBy= |drugImages= |packLabel= |fdaPatientInfo= |nlmPatientInfo= |alcohol= |brandNames= |lookAlike= |drugShortage= |price= }}
Edit the page to see the template text.