Diclofenac (patch)

Diclofenac (patch)
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

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

WARNING: CARDIOVASCULAR AND GASTROINTESTINAL RISK: See full prescribing information for complete Boxed Warning. Cardiovascular Risk: Nonsteroidal anti-inflammatory drugs (NSAIDs) may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk [See WARNINGS AND PRECAUTIONS AND (5.1)]. Flector Patch is contraindicated in the peri-operative setting of coronary artery bypass graft (CABG) surgery Gastrointestinal Risk: NSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events

Overview

Diclofenac (patch) is a nonsteroidal anti-inflammatory drug that is FDA approved for the treatment of acute pain due to minor strains, sprains, and contusions. 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)

Indications

• Flector® Patch is indicated for the topical treatment of acute pain due to minor strains, sprains, and contusions.

Dosage

General Instructions The recommended dose of Flector Patch is one (1) patch to the most painful area twice a day.

2.2 Special Precautions Patients should be informed that, if Flector Patch begins to peel-off, the edges of the patch may be taped down. If problems with adhesion persist, patients may overlay the patch with a mesh netting sleeve, where appropriate (e.g. to secure patches applied to ankles, knees, or elbows). The mesh netting sleeve (e.g. Curad® Hold Tite™, Surgilast® Tubular Elastic Dressing) must allow air to pass through and not be occlusive (non-breathable). Do not apply Flector Patch to non-intact or damaged skin resulting from any etiology e.g. exudative dermatitis, eczema, infected lesion, burns or wounds. Do not wear a Flector Patch when bathing or showering. Wash your hands after applying, handling or removing the patch. Avoid eye contact.

DOSAGE FORMS AND STRENGTHS

Patch (10 × 14 cm) containing 180 mg of diclofenac epolamine, embossed with "FLECTOR PATCH <DICLOFENAC EPOLAMINE TOPICAL PATCH> 1.3%"

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Diclofenac (patch) in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Diclofenac (patch) in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

• safety and efficacy not established in pediatric patients

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Diclofenac (patch) in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Diclofenac (patch) in pediatric patients.

Contraindications

• Condition1

Warnings

WARNING: CARDIOVASCULAR AND GASTROINTESTINAL RISK: See full prescribing information for complete Boxed Warning. Cardiovascular Risk: Nonsteroidal anti-inflammatory drugs (NSAIDs) may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk [See WARNINGS AND PRECAUTIONS AND (5.1)]. Flector Patch is contraindicated in the peri-operative setting of coronary artery bypass graft (CABG) surgery Gastrointestinal Risk: NSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events

• Description

Precautions

• Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Diclofenac (patch) 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 Diclofenac (patch) 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 Diclofenac (patch) in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Diclofenac (patch) during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Diclofenac (patch) with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Diclofenac (patch) with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Diclofenac (patch) with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Diclofenac (patch) with respect to specific gender populations.

Race

There is no FDA guidance on the use of Diclofenac (patch) with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Diclofenac (patch) in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Diclofenac (patch) in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Diclofenac (patch) in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Diclofenac (patch) in patients who are immunocompromised.

Administration and Monitoring

Administration

• Oral

• Intravenous

Monitoring

There is limited information regarding Monitoring of Diclofenac (patch) in the drug label.

• Description

IV Compatibility

There is limited information regarding IV Compatibility of Diclofenac (patch) in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

• Description

Management

• Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Diclofenac (patch) in the drug label.

Pharmacology

There is limited information regarding Diclofenac (patch) Pharmacology in the drug label.

Mechanism of Action

Structure

File:Diclofenac (patch)01.png

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Diclofenac (patch) in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Diclofenac (patch) in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Diclofenac (patch) in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Diclofenac (patch) in the drug label.

How Supplied

Storage

There is limited information regarding Diclofenac (patch) Storage in the drug label.

Images

Drug Images

{{#ask: Page Name::Diclofenac (patch) |?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::Diclofenac (patch) |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

Patient Counseling Information

There is limited information regarding Patient Counseling Information of Diclofenac (patch) in the drug label.

Precautions with Alcohol

• Alcohol-Diclofenac (patch) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

• ®

Look-Alike Drug Names

• A® — B®

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

{{#subobject:

 |Page Name=Diclofenac (patch)
 |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=Diclofenac (patch)
 |Label Name=Diclofenac (patch)11.png

}}

{{#subobject:

 |Label Page=Diclofenac (patch)
 |Label Name=Diclofenac (patch)11.png

}}