Aceclofenac: Difference between revisions

Aceclofenac
	File:Aceclofenac.png
Clinical data
ATC code	M01AB16 (WHO) ;
Identifiers
	IUPAC name 2-[2-[2-[(2,6-dichlorophenyl)amino]phenyl]acetyl]oxyacetic acid;
PubChem CID	71771;
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
Formula	C16H13Cl2NO4
Molar mass	354.18472 g/mol

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

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Revision as of 17:17, 25 February 2015

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 dyspepsia, abdominal pain, nausea, rash, ruber, urticaria, symptoms of enuresis, headache, dizziness, and drowsiness.

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

Aceclofenac is contraindicated in patients with:

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

Patients with symptoms indicative of gastro-intestinal disorders, with a history of gastric ulceration. Patients with severe hepatic impairment or cardiac or renal impairment. Patients under the medication of diuretics. Patients in recovery after surgical treatment.

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


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 atom Template:OrganicBox atom Template:OrganicBox Template:OrganicBox Template:OrganicBox Template:OrganicBox Template:OrganicBox atom Template:OrganicBox Template:OrganicBox Template:OrganicBox Template:OrganicBox Template:OrganicBox Template:OrganicBox Template:OrganicBox atom Template:OrganicBox Template:OrganicBox atom Template:OrganicBox Template:OrganicBox Template:OrganicBox Template:OrganicBox Template:OrganicBox Template:OrganicBox Template: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 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

Template:Pharma-stub

Aceclofenac

@@ Line 6: / Line 6: @@
 |indicationType=treatment
 |indication=[[rheumatoid arthritis]], [[ankylosing spondylitis]], [[osteoarthritis]] and [[periarthritis]] of scapulohumerous, [[lumbago]], [[ischiadynia]], pain caused by nonaticular rheutism
+|adverseReactions=[[dyspepsia]], [[abdominal pain]], [[nausea]], [[rash]], [[ruber]], [[urticaria]], symptoms of [[enuresis]], [[headache]], [[dizziness]], and [[drowsiness]]
 |blackBoxWarningTitle=<b><span style="color:#FF0000;">TITLE</span></b>
 |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.
 |offLabelAdultNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of Aceclofenac in adult patients.
@@ Line 14: / Line 15: @@
 |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.
-|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='''Aceclofenac is contraindicated in patients with:'''
-|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.
+*Patients with allergy to these drugs or other analogues ([[diclofenac]]).
-|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]].
+*Patients with [[asthma]].
-|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.
+*Like [[NSAIDS]], [[acetylsalicylic acid]] and other drugs which inhibit [[prostagladin]]-synthesis may precipitate attacks of [[asthma]], acute [[rhinitis]] or [[urticaria]].
-|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.
+*Patients with active [[peptic ulcer]].
-|useInPed=The dosage and indication is not established yet for children with less than 6 years old.
+|warnings=*Patients with symptoms indicative of gastro-intestinal disorders, with a history of [[gastric ulceration]].  Patients with severe [[hepatic impairment]] or cardiac or [[renal impairment]].  Patients under the medication of [[diuretics]].  Patients in recovery after surgical treatment.
-|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]].
+|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]].
+|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.
+|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]].
 |drugBox={{Drugbox2
 | Verifiedfields = changed
@@ Line 79: / Line 85: @@
 }}
 |structure=[[file:Aceclofenac structure.png|none|250px]]
-|howSupplied=10 Blister Packs with 10 Tablets in each Blister Pack
+|howSupplied=*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.
+|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.
 |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.

v t e Nonsteroidal anti-inflammatory drugs (NSAIDs) (primarily M01A and M02A, also N02BA)
Pyrazolones / Pyrazolidines	Aminophenazone Ampyrone Azapropazone Clofezone Difenamizole Famprofazone Feprazone Kebuzone Metamizole Mofebutazone Morazone Nifenazone Oxyphenbutazone Phenazone Phenylbutazone Propyphenazone Sulfinpyrazone Suxibuzone^‡
Salicylates	Aspirin (acetylsalicylic acid)^# Aloxiprin Benorylate Carbasalate calcium Diflunisal Dipyrocetyl Ethenzamide Guacetisal Magnesium salicylate Methyl salicylate Salsalate Salicin Salicylamide Salicylic acid (salicylate) Sodium salicylate
Acetic acid derivatives and related substances	Aceclofenac Acemetacin Alclofenac Amfenac Bendazac Bromfenac Bumadizone Bufexamac Diclofenac Difenpiramide Etodolac Felbinac Fenclozic acid Fentiazac Indometacin Indometacin farnesil Isoxepac Ketorolac Lonazolac Oxametacin Prodolic acid Proglumetacin Sulindac Tiopinac Tolmetin Zomepirac^†
Oxicams	Ampiroxicam Droxicam Isoxicam Lornoxicam Meloxicam Piroxicam Tenoxicam
Propionic acid derivatives (profens)	Alminoprofen Benoxaprofen^† Carprofen^‡ Dexibuprofen Dexketoprofen Fenbufen Fenoprofen Flunoxaprofen Flurbiprofen Ibuprofen^# Ibuproxam Indoprofen^† Ketoprofen Loxoprofen Miroprofen Naproxen Oxaprozin Pirprofen Suprofen Tarenflurbil Tepoxalin^‡ Tiaprofenic acid Vedaprofen^‡ Zaltoprofen COX-inhibiting nitric oxide donator: Naproxcinod
N-Arylanthranilic acids (fenamates)	Azapropazone Clonixin Etofenamate Flufenamic acid Flunixin Meclofenamic acid Mefenamic acid Morniflumate Niflumic acid Tolfenamic acid Flutiazin
Coxibs	Apricoxib Celecoxib Cimicoxib^‡ Deracoxib^‡ Etoricoxib Firocoxib^‡ Lumiracoxib^† Mavacoxib^‡ Parecoxib Robenacoxib^‡ Rofecoxib^† Valdecoxib^†
Other	Aminopropionitrile Benzydamine Chondroitin sulfate Diacerein Fluproquazone Glucosamine Glycosaminoglycan Hyperforin Nabumetone Nimesulide Oxaceprol Proquazone Superoxide dismutase/Orgotein Tenidap
Items listed in bold indicate initially developed compounds of specific groups. ^#WHO-EM ^†Withdrawn drugs. ^‡Veterinary use medications.

Clinical data
File:Aceclofenac.png
ATC code	M01AB16 (WHO)
Identifiers
IUPAC name 2-[2-[2-[(2,6-dichlorophenyl)amino]phenyl]acetyl]oxyacetic acid
PubChem CID	71771
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
Formula	C₁₆H₁₃Cl₂NO₄
Molar mass	354.18472 g/mol

Aceclofenac: Difference between revisions

Revision as of 17:17, 25 February 2015

Disclaimer

Overview

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Non–Guideline-Supported Use

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Non–Guideline-Supported Use

Contraindications

Warnings

Adverse Reactions

Clinical Trials Experience

Postmarketing Experience

Drug Interactions

Use in Specific Populations

Pregnancy

Labor and Delivery

Nursing Mothers

Pediatric Use

Geriatic Use

Gender

Race

Renal Impairment

Hepatic Impairment

Females of Reproductive Potential and Males

Immunocompromised Patients

Administration and Monitoring

Administration

Monitoring

IV Compatibility

Overdosage

Pharmacology

Mechanism of Action

Structure

Pharmacodynamics

Pharmacokinetics

Nonclinical Toxicology

Clinical Studies

How Supplied

Storage

Images

Drug Images

Package and Label Display Panel

Patient Counseling Information

Precautions with Alcohol

Brand Names

Look-Alike Drug Names

Drug Shortage Status

Price

References

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