Aceclofenac: Difference between revisions

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|drugClass=[[Non Steroidal Anti-inflamatory Drug]] ([[NSAID]])
|drugClass=[[Non Steroidal Anti-inflamatory Drug]] ([[NSAID]])
|indicationType=treatment
|indicationType=treatment
|indication=[[rheumatoid arthritis]], [[ankylosing spondylitis]], [[osteoarthritis]] and [[periarthritis]] of scapulohumerous, [[lumbago]], [[ischiadynia]], pain caused by nonaticular rheutism.
|indication=[[rheumatoid arthritis]], [[ankylosing spondylitis]], [[osteoarthritis]] and [[periarthritis]] of scapulohumerous, [[lumbago]], [[ischiadynia]], pain caused by nonaticular rheutism
|blackBoxWarningTitle=<b><span style="color:#FF0000;">TITLE</span></b>
|blackBoxWarningTitle=<b><span style="color:#FF0000;">TITLE</span></b>
|blackBoxWarningBody=<i><span style="color:#FF0000;">Condition Name:</span></i> (Content)
|blackBoxWarningBody=<i><span style="color:#FF0000;">Condition Name:</span></i> (Content)
|fdaLIADAdult=The recommended dose is 200 mg daily, taken as one dose (every 24 hours).  However, the dose and dose frequency of Aceclofenac can be modified under the supervison of physician or pharmacist.
|fdaLIADAdult=The recommended dose is 200 mg daily, taken as one dose (every 24 hours).  However, the dose and dose frequency of Aceclofenac can be modified under the supervison of physician or pharmacist.
|offLabelAdultGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of Aceclofenac in adult patients.
|offLabelAdultGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of Aceclofenac in adult patients.
|offLabelAdultNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of Aceclofenac in adult patients.
|offLabelAdultNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of Aceclofenac in adult patients.
|fdaLIADPed=The dosage and indication is not established yet for children with less than 6 years old.
|fdaLIADPed=The dosage and indication is not established yet for children with less than 6 years old.
|offLabelPedGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of Aceclofenac in pediatric patients.
|offLabelPedGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of Aceclofenac in pediatric patients.
|offLabelPedNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of Aceclofenac in pediatric patients.
|offLabelPedNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of Aceclofenac in pediatric patients.
|contraindications=Patients with allergy to these drugs or other analogues (diclofenac). Patients with asthma. Like NSAIDS, acetylsalicylic acid and other drugs which inhibit prostagladin-synthesis may precipitate attacks of asthma, acute rhinitis or urticaria. Patients with active peptic ulcer.
|contraindications=Patients with allergy to these drugs or other analogues (diclofenac). Patients with asthma. Like NSAIDS, acetylsalicylic acid and other drugs which inhibit prostagladin-synthesis may precipitate attacks of asthma, acute rhinitis or urticaria. Patients with active peptic ulcer.
|clinicalTrials=The majority of side effects observed have been reversible and of a minor nature and include gastro-intestinal disorders ([[dyspepsia]], [[abdominal pain]], [[nausea]]), [[rash]], [[ruber]], [[urticaria]], symptoms of [[enuresis]], [[headache]], [[dizziness]], and [[drowsiness]].  To report suspected adverse reactions, call 1-800-FDA-1088.
|clinicalTrials=The majority of side effects observed have been reversible and of a minor nature and include gastro-intestinal disorders ([[dyspepsia]], [[abdominal pain]], [[nausea]]), [[rash]], [[ruber]], [[urticaria]], symptoms of [[enuresis]], [[headache]], [[dizziness]], and [[drowsiness]].  To report suspected adverse reactions, call 1-800-FDA-1088.
 
|drugInteractions=There has been no drug interactions reported, but close monitoring of patients on combination with [[lithium]] and [[digoxin]], oral [[anti diabetic agents]], [[anticoagulants]], [[diuretics]], and other [[analgesics]].
|drugInteractions=There has been no drug interactions reported, but close monitoring of patients on combination with [[lithium]] and [[digoxin]], oral [[anti diabetic agents]], [[anticoagulants]], [[diuretics]], and other [[analgesics]].  
 
|useInPregnancyFDA=Since there is no information on the safe use of CLANZA CR during pregnancy and lactation, the use of Aclofenac should therefore be avoided in pregnancy and lactation.
|useInPregnancyFDA=Since there is no information on the safe use of CLANZA CR during pregnancy and lactation, the use of Aclofenac should therefore be avoided in pregnancy and lactation.
|useInNursing=Since there is no information on the safe use of CLANZA CR during pregnancy and lactation, the use of CLANZA CR should therefore be avoided in pregnancy and lactation.
|useInNursing=Since there is no information on the safe use of CLANZA CR during pregnancy and lactation, the use of CLANZA CR should therefore be avoided in pregnancy and lactation.
|useInPed=The dosage and indication is not established yet for children with less than 6 years old.
|useInPed=The dosage and indication is not established yet for children with less than 6 years old.
|overdose=There are no human data available on the consequences of Aceclofenac overdosage.  If overdosage is observed, therapeutic measures should be taken according to symptoms; supportive and symptomatic treatment should be given for complications such as [[hypotension]], [[gastrointestinal irritation]], respiratory [[depression]], and [[convulsions]].
|overdose=There are no human data available on the consequences of Aceclofenac overdosage.  If overdosage is observed, therapeutic measures should be taken according to symptoms; supportive and symptomatic treatment should be given for complications such as [[hypotension]], [[gastrointestinal irritation]], respiratory [[depression]], and [[convulsions]].
|drugBox={{Drugbox2
|drugBox={{Drugbox2
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|packLabel=[[file:Aceclofenac Appearance.png|none|400px]]
|packLabel=[[file:Aceclofenac Appearance.png|none|400px]]
|alcohol=Alcohol-Aceclofenac interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
|alcohol=Alcohol-Aceclofenac interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
|brandNames=*[[Acent]]
*[[Acenal]]
*[[Acelofan]]
*[[Acelom]]
}}
}}
{{LabelImage
{{LabelImage

Revision as of 16:48, 16 January 2015

Aceclofenac
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: Alberto Plate [2]

Disclaimer

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Overview

Aceclofenac is a Non Steroidal Anti-inflamatory Drug (NSAID) that is FDA approved for the treatment of rheumatoid arthritis, ankylosing spondylitis, osteoarthritis and periarthritis of scapulohumerous, lumbago, ischiadynia, pain caused by nonaticular rheutism. Common adverse reactions include {{{adverseReactions}}}.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

The recommended dose is 200 mg daily, taken as one dose (every 24 hours). However, the dose and dose frequency of Aceclofenac can be modified under the supervison of physician or pharmacist.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

The dosage and indication is not established yet for children with less than 6 years old.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Contraindications

Patients with allergy to these drugs or other analogues (diclofenac). Patients with asthma. Like NSAIDS, acetylsalicylic acid and other drugs which inhibit prostagladin-synthesis may precipitate attacks of asthma, acute rhinitis or urticaria. Patients with active peptic ulcer.

Warnings

There is limited information regarding Aceclofenac Warnings' in the drug label.

Adverse Reactions

Clinical Trials Experience

The majority of side effects observed have been reversible and of a minor nature and include gastro-intestinal disorders (dyspepsia, abdominal pain, nausea), rash, ruber, urticaria, symptoms of enuresis, headache, dizziness, and drowsiness. To report suspected adverse reactions, call 1-800-FDA-1088.

Postmarketing Experience

There is limited information regarding Aceclofenac Postmarketing Experience in the drug label.

Drug Interactions

There has been no drug interactions reported, but close monitoring of patients on combination with lithium and digoxin, oral anti diabetic agents, anticoagulants, diuretics, and other analgesics.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): Since there is no information on the safe use of CLANZA CR during pregnancy and lactation, the use of Aclofenac should therefore be avoided in pregnancy and lactation.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Aceclofenac in women who are pregnant.

Labor and Delivery

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

Nursing Mothers

Since there is no information on the safe use of CLANZA CR during pregnancy and lactation, the use of CLANZA CR should therefore be avoided in pregnancy and lactation.

Pediatric Use

The dosage and indication is not established yet for children with less than 6 years old.

Geriatic Use

There is no FDA guidance on the use of Aceclofenac in geriatric settings.

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

There is limited information regarding Aceclofenac Administration in the drug label.

Monitoring

There is limited information regarding Aceclofenac Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Aceclofenac and IV administrations.

Overdosage

There are no human data available on the consequences of Aceclofenac overdosage. If overdosage is observed, therapeutic measures should be taken according to symptoms; supportive and symptomatic treatment should be given for complications such as hypotension, gastrointestinal irritation, respiratory depression, and convulsions.

Pharmacology

Template:Px
Aceclofenac
Systematic (IUPAC) name
2-[2-[2-[(2,6-dichlorophenyl)amino]phenyl]acetyl]oxyacetic acid
Identifiers
CAS number 89796-99-6
ATC code M01AB16 M02AA25 (WHO)
PubChem 71771
Chemical data
Formula Template:OrganicBox atomTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox 
Mol. mass 354.18472 g/mol
SMILES eMolecules & PubChem
Pharmacokinetic data
Bioavailability ?
Metabolism ?
Half life ?
Excretion ?
Therapeutic considerations
Pregnancy cat.

?

Legal status

POM(UK)

Routes oral, topical

Mechanism of Action

There is limited information regarding Aceclofenac Mechanism of Action in the drug label.

Structure

Pharmacodynamics

There is limited information regarding Aceclofenac Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Aceclofenac Pharmacokinetics in the drug label.

Nonclinical Toxicology

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

Clinical Studies

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

How Supplied

10 Blister Packs with 10 Tablets in each Blister Pack

Storage

Preserve in tight containers. Store at room temperature not exceeding 30oC. Three (3) years from manufacturing date. Do not exceed the expiry date for use printed on the box.

Images

Drug Images

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

Patient Counseling Information

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

Precautions with Alcohol

Alcohol-Aceclofenac interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

Look-Alike Drug Names

There is limited information regarding Aceclofenac Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

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

{{#subobject: 

 |Label Page=Aceclofenac
 |Label Name=Aceclofenac Package.png

}}

Aceclofenac
File:Aceclofenac.png
Clinical data
ATC code
Identifiers
PubChem CID
E number{{#property:P628}}
ECHA InfoCard{{#property:P2566}}Lua error in Module:EditAtWikidata at line 36: attempt to index field 'wikibase' (a nil value).
Chemical and physical data
FormulaC16H13Cl2NO4
Molar mass354.18472 g/mol

Aceclofenac is a non-steroidal anti-inflammatory drug.

How does it work?

Aceclofenac belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). It works by blocking the action of a substance in the body called cyclo-oxygenase. Cyclo-oxygenase is involved in the production of various chemicals in the body, some of which are known as prostaglandins. Prostaglandins are produced in response to injury or certain diseases and would otherwise go on to cause pain, swelling and inflammation. Arthritic conditions are one example of this. Aceclofenac is used to relieve pain and inflammation in arthritic conditions. All the medicines in this group reduce inflammation caused by the body's own immune system and are effective pain killers. What is it used for?



A form of arthritis (ankylosing spondylitis) Inflammatory disease of the joints Osteoarthritis Warning!



This medicine may cause dizziness. Avoid driving and operating machinery if affected. Individuals receiving long-term treatment with this medicine should be regularly monitored (kidney and liver function tests, blood counts). There is no experience with the use of this medicine in children. Use with caution in



A type of life long inherited blood disease caused by a defect in the liver (hepatic porphyria) Bleeding tendencies Blood disorders Crohn's disease Decreased heart function Elderly people History of peptic ulcers Inflammation of the bowel and back passage Mildly decreased kidney function People who have recently had major surgery People with symptoms of stomach or intestinal disorders Severely decreased liver function Not to be used in



Active peptic ulcer Bleeding from the stomach or intestines Moderate to severely decreased kidney function People in whom aspirin or other medicines in this class (NSAIDs), cause attacks of asthma, itchy rash (urticaria) or nasal inflammation (rhinitis) Suspected peptic ulcer This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy. If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

Pregnancy and Breastfeeding

Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.


The safety of this medicine for use during pregnancy has not been established. It is not recommended for use in pregnancy unless considered essential by your doctor. Seek medical advice from your doctor. It is not known if this medicine passes into breast milk. It is not recommended for use during breastfeeding unless considered essential by your doctor. Seek medical advice from your doctor. Label warnings


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Aceclofenac

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