Aceclofenac

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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.

• 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.

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

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

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

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

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

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.

• 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.

• 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.

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

• 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.

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.

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

• 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.

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

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

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

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

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

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

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

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

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

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

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

• 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.

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

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

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

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

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

• 10 Blister Packs with 10 Tablets in each Blister Pack

• 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.

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

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

• Acent
• Acenal
• Acelofan
• Acelom

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

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