Template:DrugProjectFormSinglePage: Difference between revisions
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<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> | <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> | ||
}}{{#if: {{{hasBlackBoxWarning|}}} |<h2><span style="color:#FF0000; background:#000000;">Black Box Warning</span></h2> | }}{{#if: {{{hasBlackBoxWarning|}}} |<h2><span style="color:#FF0000; background:#000000;">Black Box Warning</span></h2> | ||
{{BlackBoxTemplate|blackBoxWarningTitle={{{blackBoxWarningTitle}}}|blackBoxWarningBody= | {{BlackBoxTemplate|blackBoxWarningTitle={{{blackBoxWarningTitle}}}|blackBoxWarningBody={{{blackBoxWarningBody}}}}}| | ||
}} | }} | ||
==Overview== | ==Overview== | ||
{{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}}}. | {{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)=== | ||
{{{fdaLIADAdult}}} | {{#if: {{{fdaLIADAdult|}}} | | ||
{{{fdaLIADAdult|}}} | | |||
There is limited information regarding {{PAGENAME}} ''FDA-Labeled Indications and Dosage (Adult)'' in the drug label. | |||
}} | }} | ||
| Line 98: | Line 99: | ||
{{{offLabelAdultNoGuideSupport|}}} | {{{offLabelAdultNoGuideSupport|}}} | ||
}} | }} | ||
==Pediatric Indications and Dosage== | ==Pediatric Indications and Dosage== | ||
===FDA-Labeled Indications and Dosage (Pediatric)=== | ===FDA-Labeled Indications and Dosage (Pediatric)=== | ||
{{{fdaLIADPed|}}} | {{#if: {{{fdaLIADPed|}}} | | ||
{{{fdaLIADPed|}}} | | |||
There is limited information regarding {{PAGENAME}} ''FDA-Labeled Indications and Dosage (Pediatric)'' in the drug label. | |||
}} | }} | ||
| Line 110: | Line 111: | ||
{{#if: {{{offLabelPedGuideSupport|}}} | | {{#if: {{{offLabelPedGuideSupport|}}} | | ||
====Guideline-Supported Use==== | ====Guideline-Supported Use==== | ||
{{{offLabelPedGuideSupport|}}} | {{{offLabelPedGuideSupport|}}} | ||
}} | }} | ||
| Line 119: | Line 119: | ||
==Contraindications== | ==Contraindications== | ||
{{{contraindications|}}} | {{#if: {{{contraindications|}}} | | ||
{{{contraindications|}}} | | |||
There is limited information regarding {{PAGENAME}} ''Contraindications'' in the drug label. | |||
}} | |||
==Warnings== | ==Warnings== | ||
| Line 125: | Line 128: | ||
{{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=== | ||
{{{clinicalTrials|}}} | {{#if: {{{clinicalTrials|}}} | | ||
{{{clinicalTrials|}}} | | |||
There is limited information regarding {{PAGENAME}} ''Clinical Trials Experience'' in the drug label. | |||
}} | |||
===Postmarketing Experience=== | ===Postmarketing Experience=== | ||
{{{postmarketing|}}} | {{#if: {{{postmarketing|}}} | | ||
{{{postmarketing|}}} | | |||
There is limited information regarding {{PAGENAME}} ''Postmarketing Experience'' in the drug label. | |||
}} | |||
==Drug Interactions== | ==Drug Interactions== | ||
{{{drugInteractions|}}} | {{#if: {{{drugInteractions|}}} | | ||
{{{drugInteractions|}}} | | |||
There is limited information regarding {{PAGENAME}} ''Drug Interactions'' in the drug label. | |||
}} | |||
==Use in Specific Populations== | ==Use in Specific Populations== | ||
| Line 143: | Line 157: | ||
====Pregnancy==== | ====Pregnancy==== | ||
'''[[Pregnancy category#United States|Pregnancy Category (FDA)]]: {{{FDAPregCat|}}}''' | '''[[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|}}}''' | '''[[Pregnancy category#Australia|Pregnancy Category (AUS)]]: {{{AUSPregCat|}}}''' | ||
{{#if: {{{useInPregnancyAUS|}}} | | {{#if: {{{useInPregnancyAUS|}}} | | ||
{{{useInPregnancyAUS|}}} | | {{{useInPregnancyAUS|}}} | | ||
| Line 187: | Line 199: | ||
====Race==== | ====Race==== | ||
{{#if: {{{useInRace|}}} | | {{#if: {{{useInRace|}}} | | ||
{{{useInRace|}}} | | {{{useInRace|}}} | | ||
| Line 218: | Line 229: | ||
{{#if: {{{othersTitle|}}}| | {{#if: {{{othersTitle|}}}| | ||
===={{{othersTitle|}}}==== | ===={{{othersTitle|}}}==== | ||
{{{useInOthers|}}} | {{{useInOthers|}}} | | ||
}} | }} | ||
==Administration and Monitoring== | ==Administration and Monitoring== | ||
====Administration==== | ====Administration==== | ||
{{{administration|}}} | {{#if: {{{administration|}}} | | ||
{{{administration|}}} | | |||
There is limited information regarding {{PAGENAME}} ''Administration'' in the drug label. | |||
}} | |||
====Monitoring==== | ====Monitoring==== | ||
{{{monitoring|}}} | {{#if: {{{monitoring|}}} | | ||
{{{monitoring|}}} | | |||
There is limited information regarding {{PAGENAME}} ''Monitoring'' in the drug label. | |||
}} | |||
==IV Compatibility== | ==IV Compatibility== | ||
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{{#if: {{{overdose|}}} | | {{#if: {{{overdose|}}} | | ||
{{{overdose|}}} | | {{{overdose|}}} | | ||
There is limited information regarding {{PAGENAME}} | 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=== | ||
{{{mechAction|}}} | {{#if: {{{mechAction|}}} | | ||
{{{mechAction|}}} | | |||
There is limited information regarding {{PAGENAME}} ''Mechanism of Action'' in the drug label. | |||
}} | |||
===Structure=== | ===Structure=== | ||
{{{structure|}}} | {{#if: {{{structure|}}} | | ||
{{{structure|}}} | | |||
There is limited information regarding {{PAGENAME}} ''Structure'' in the drug label. | |||
}} | |||
===Pharmacodynamics=== | ===Pharmacodynamics=== | ||
{{{PD|}}} | {{#if: {{{PD|}}} | | ||
{{{PD|}}} | | |||
There is limited information regarding {{PAGENAME}} ''Pharmacodynamics'' in the drug label. | |||
}} | |||
===Pharmacokinetics=== | ===Pharmacokinetics=== | ||
{{{PK|}}} | {{#if: {{{PK|}}} | | ||
{{{PK|}}} | | |||
There is limited information regarding {{PAGENAME}} ''Pharmacokinetics'' in the drug label. | |||
}} | |||
===Nonclinical Toxicology=== | ===Nonclinical Toxicology=== | ||
{{{nonClinToxic|}}} | {{#if: {{{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== | ||
{{{howSupplied|}}} | {{#if: {{{howSupplied|}}} | | ||
{{{howSupplied|}}} | | |||
There is limited information regarding {{PAGENAME}} ''How Supplied'' in the drug label. | |||
}} | |||
===Storage=== | ===Storage=== | ||
{{{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}}]] | {{#ask: [[Page Name::{{PAGENAME}}]] | ||
|?Pill Name | |?Pill Name | ||
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===Package and Label Display Panel=== | ===Package and Label Display Panel=== | ||
{{{packLabel|}}} | {{{packLabel|}}} | ||
{{#ask: [[Label Page::{{PAGENAME}}]] | {{#ask: [[Label Page::{{PAGENAME}}]] | ||
|?Label Name | |?Label Name | ||
| Line 299: | Line 340: | ||
|sort=Label Page | |sort=Label Page | ||
}} | }} | ||
==Patient Counseling Information== | ==Patient Counseling Information== | ||
{{{fdaPatientInfo|}}} | {{#if: {{{fdaPatientInfo|}}} | | ||
{{{fdaPatientInfo|}}} | | |||
There is limited information regarding {{PAGENAME}} ''Patient Counseling Information'' in the drug label. | |||
}} | |||
==Precautions with Alcohol== | ==Precautions with Alcohol== | ||
| Line 310: | Line 353: | ||
==Brand Names== | ==Brand Names== | ||
{{{brandNames|}}} | {{#if: {{{brandNames|}}} | | ||
{{{brandNames|}}} | | |||
There is limited information regarding {{PAGENAME}} ''Brand Names'' in the drug label. | |||
}} | |||
==Look-Alike Drug Names== | ==Look-Alike Drug Names== | ||
{{{lookAlike|}}} | {{#if: {{{lookAlike|}}} | | ||
{{{lookAlike|}}} | | |||
There is limited information regarding {{PAGENAME}} ''Look-Alike Drug Names'' in the drug label. | |||
}} | |||
==[http://www.accessdata.fda.gov/scripts/drugshortages/default.cfm Drug Shortage Status]== | ==[http://www.accessdata.fda.gov/scripts/drugshortages/default.cfm Drug Shortage Status]== | ||
| Line 323: | Line 372: | ||
==References== | ==References== | ||
The contents of this FDA label are provided by the National Library of Medicine. | The contents of this FDA label are provided by the National Library of Medicine. | ||
{{reflist|2}} | {{reflist|2}} | ||
</div> | </div> | ||
</includeonly> | </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.