Sandbox drug2: Difference between revisions

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{{DrugProjectFormSinglePage
|authorTag=<!--Overview-->
|authorTag=<!--Overview-->
|OTC=
|aOrAn=a
|aOrAn=a
|indicationType=treatment
|indicationType=
|indication=
|hasBlackBoxWarning=Yes
|hasBlackBoxWarning=Yes
|adverseReactions=<!--Black Box Warning-->
|adverseReactions=<!--Black Box Warning-->
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<!--Drug box 2-->
<!--Drug box 2-->
|drugBox=<!--Mechanism of Action-->
|drugBox=<!--Mechanism of Action-->
|mechAction=* After topical ocular dosing, nepafenac penetrates the cornea and is converted by ocular tissue hydrolases to amfenac, a nonsteroidal anti-inflammatory drug. Nepafenac and amfenac are thought to inhibit the action of prostaglandin H synthase (cyclooxygenase), an enzyme required for prostaglandin production.
|mechAction=*  


<!--Structure-->
<!--Structure-->
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<!--Pharmacokinetics-->
<!--Pharmacokinetics-->
|PK=Following bilateral topical ocular once-daily dosing of ILEVRO* (nepafenac ophthalmic suspension), 0.3%, the concentrations of nepafenac and amfenac peaked at a median time of 0.5 hour and 0.75 hour, respectively on both Day 1 and Day 4. The mean steady-state Cmax for nepafenac and for amfenac were 0.847 ± 0.269 ng/mL and 1.13 ± 0.491 ng/mL, respectively.
|PK=There is limited information regarding <i>Pharmacokinetics</i> of {{PAGENAME}} in the drug label.


Nepafenac at concentrations up to 3000 ng/mL and amfenac at concentrations up to 1000 ng/mL did not inhibit the in vitro metabolism of 6 specific marker substrates of cytochrome P450 (CYP) isozymes (CYP1A2, CYP2C9, CYP2C19, CYP2D6, CYP2E1, and CYP3A4). Therefore, drug-drug interaction.
<!--Nonclinical Toxicology-->
|nonClinToxic=There is limited information regarding <i>Nonclinical Toxicology</i> of {{PAGENAME}} in the drug label.
|nonClinToxic=There is limited information regarding <i>Nonclinical Toxicology</i> of {{PAGENAME}} in the drug label.


<!--Clinical Studies-->
<!--Clinical Studies-->
|clinicalStudies=In two double masked, randomized clinical trials in which patients were dosed daily beginning one day prior to cataract surgery, continued on the day of surgery and for the first two weeks of the postoperative period, ILEVRO* (nepafenac ophthalmic suspension), 0.3% demonstrated superior clinical efficacy compared to its vehicle in treating postoperative pain and inflammation.
|clinicalStudies=There is limited information regarding <i>Clinical Studies</i> of {{PAGENAME}} in the drug label.
 
Treatment effect over vehicle for resolution of ocular pain occurred as early as day 1 post-surgery. Treatment effect over vehicle for resolution of inflammation was significantly better than vehicle in both studies at day 7 and day 14 post-surgery.
: [[File:{{PAGENAME}}01.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]
 


<!--How Supplied-->
|howSupplied=*
|howSupplied=*
|packLabel=<!--Patient Counseling Information-->
|packLabel=<!--Patient Counseling Information-->
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<!--Brand Names-->
<!--Brand Names-->
|brandNames=*ILEVRO ®<ref>{{Cite web | title = ILEVRO - nepafenac suspension | url =http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6c212466-ff8d-ecfc-ede2-ef8bdcaaf114 }}</ref>
|brandNames=* ®<ref>{{Cite web | title =  | url = }}</ref>


<!--Look-Alike Drug Names-->
<!--Look-Alike Drug Names-->

Revision as of 16:00, 18 February 2015

|authorTag= |OTC= |aOrAn=a |indicationType= |indication= |hasBlackBoxWarning=Yes |adverseReactions= |blackBoxWarningTitle=ConditionName: |blackBoxWarningBody=ConditionName:

  • Content


|fdaLIADAdult======Condition1=====

  • Dosing Information
  • Dosage
Condition2
  • Dosing Information
  • Dosage
Condition3
  • Dosing Information
  • Dosage
Condition4
  • Dosing Information
  • Dosage


|offLabelAdultGuideSupport======Condition1=====

  • Developed by:
  • Class of Recommendation:
  • Strength of Evidence:
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Sandbox drug2 in adult patients.

|offLabelAdultNoGuideSupport======Condition1=====

  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Sandbox drug2 in adult patients.


|fdaLIADPed======Condition1=====

  • Dosing Information
  • Dosage
Condition2

There is limited information regarding FDA-Labeled Use of Sandbox drug2 in pediatric patients.


|offLabelPedGuideSupport======Condition1=====

  • Developed by:
  • Class of Recommendation:
  • Strength of Evidence:
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Sandbox drug2 in pediatric patients.

|offLabelPedNoGuideSupport======Condition1=====

  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Sandbox drug2 in pediatric patients.

|contraindications=* Condition1

|warnings=* Description

Precautions

  • Description


|clinicalTrials=There is limited information regarding Clinical Trial Experience of Sandbox drug2 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=There is limited information regarding Postmarketing Experience of Sandbox drug2 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

|drugInteractions=* Drug

  • Description

|useInPregnancyFDA=* Pregnancy Category |useInPregnancyAUS=* Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Sandbox drug2 in women who are pregnant. |useInLaborDelivery=There is no FDA guidance on use of Sandbox drug2 during labor and delivery. |useInNursing=There is no FDA guidance on the use of Sandbox drug2 with respect to nursing mothers. |useInPed=There is no FDA guidance on the use of Sandbox drug2 with respect to pediatric patients. |useInGeri=There is no FDA guidance on the use of Sandbox drug2 with respect to geriatric patients. |useInGender=There is no FDA guidance on the use of Sandbox drug2 with respect to specific gender populations. |useInRace=There is no FDA guidance on the use of Sandbox drug2 with respect to specific racial populations. |useInRenalImpair=There is no FDA guidance on the use of Sandbox drug2 in patients with renal impairment. |useInHepaticImpair=There is no FDA guidance on the use of Sandbox drug2 in patients with hepatic impairment. |useInReproPotential=There is no FDA guidance on the use of Sandbox drug2 in women of reproductive potentials and males. |useInImmunocomp=There is no FDA guidance one the use of Sandbox drug2 in patients who are immunocompromised.

|administration=* Oral

  • Intravenous

|monitoring=There is limited information regarding Monitoring of Sandbox drug2 in the drug label.

  • Description

|IVCompat=There is limited information regarding IV Compatibility of Sandbox drug2 in the drug label.

|overdose====Acute Overdose===

Signs and Symptoms

  • Description

Management

  • Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Sandbox drug2 in the drug label.


|drugBox= |mechAction=*

|structure=*

File:Sandbox drug201.png
This image is provided by the National Library of Medicine.

|PD=There is limited information regarding Pharmacodynamics of Sandbox drug2 in the drug label.

|PK=There is limited information regarding Pharmacokinetics of Sandbox drug2 in the drug label.

|nonClinToxic=There is limited information regarding Nonclinical Toxicology of Sandbox drug2 in the drug label.

|clinicalStudies=There is limited information regarding Clinical Studies of Sandbox drug2 in the drug label.

|howSupplied=* |packLabel= |fdaPatientInfo=There is limited information regarding Patient Counseling Information of Sandbox drug2 in the drug label.

|alcohol=* Alcohol-Sandbox drug2 interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

|brandNames=* ®[1]

|lookAlike=* A® — B®[2]

|drugShortage= }} {{#subobject: 

 |Page Name=Sandbox drug2
 |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=Sandbox drug2
 |Label Name=Sandbox drug211.png

}}

{{#subobject: 

 |Label Page=Sandbox drug2
 |Label Name=Sandbox drug211.png

}}

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