Aceclofenac

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]

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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 Aceclofenac 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 Aceclofenac during pregnancy and lactation, the use of Aceclofenac 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

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

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Package and Label Display Panel

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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

• Acent
• Acenal
• Acelofan
• Acelom

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.

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