Diclofenamide

Diclofenamide
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: Sheng Shi, M.D. [2]

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Overview

Diclofenamide is a Adrenergic receptor agonist that is FDA approved for the {{{indicationType}}} of elevated intraoculr pressure. Common adverse reactions include anorexia, nausea, vomiting, drowsiness, paresthesias..

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Elevated Intraoculr Pressure

• Dosing Information

• Recommended initial dosage: 100-200 mg PO bid
• Recommended maintenence dosage: 25-50 mg PO qd or bid or tid

Off-Label Use and Dosage (Adult)

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Diclofenamide FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Contraindications

• Hepatic Insufficiency

• DARANIDE® (dichlorphenamide tablets USP) is contraindicated in hepatic insufficiency.

• Electrolyte Imbalance

• DARANIDE® is contraindicated in renal failure, adrenocortical insufficiency, hyperchloremic acidosis, or in conditions in which serum levels of sodium or potassium are depressed.

• Obstructive Pulmonary Disease

• DARANIDE should not be used in patients with severe pulmonary obstruction who are unable to increase their alveolar ventilation since their acidosis may be increased.

• Hypersensitivity

• DARANIDE® is contraindicated in patients who are hypersensitive to this product.

Warnings

Hypokalemia

Potassium excretion is increased by DARANIDE (dichlorphenamide tablets USP) and hypokalemia may develop. Interference with adequate oral electrolyte intake will also contribute to hypokalemia. Hypokalemia can sensitize or exaggerate the response of the heart to the toxic effects of digitalis (e.g., increased ventricular irritability). Hypokalemia may be avoided or treated by use of potassium supplements such as foods with a high potassium content.

Adverse Reactions

Clinical Trials Experience

The most common adverse reactions include gastrointestinal disturbances (anorexia, nausea, and vomiting), drowsiness and paresthesias. Certain adverse reactions characteristic of carbonic anhydrase inhibitors may result with DARANIDE® (dichlorphenamide tablets USP), particularly with increasing doses. The following are adverse reactions which have been reported with systemic carbonic anhydrase inhibitors. The pharmacological similarities among the carbonic anhydrase inhibitors make it advisable to consider the following reactions when dichlorphenamide is administered: agranulocytosis, ataxia, confusion, constipation, depression, disorientation, dizziness, electrolyte imbalance (hypokalemia, hyperchloremia), fever, globus hystericus, headache, hepatic insufficiency, hyperuricemia, kidney stones, lassitude, leucopenia, metabolic acidosis, nervousness, phosphaturia, pruritus, renal colic, skin eruptions, thrombocytopenia, tinnitus, tremor, urinary frequency, weakness, and weight loss.

Postmarketing Experience

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

Drug Interactions

• High-dose Aspirin

• Anorexia, tachypnea, lethargy and coma have been rarely reported due to a possible drug interaction with high-dose aspirin.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): C Pregnancy Category C. Dichlorphenamide has been shown to be teratogenic in the rat (skeletal anomalies) when given in doses 100 times the human dose. There are no adequate and well-controlled studies in pregnant women. DARANIDE® (dichlorphenamide tablets USP) should not be used in women of childbearing age or in pregnancy, especially during the first trimester, unless the potential benefits outweigh the potential risks.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Diclofenamide in women who are pregnant.

Labor and Delivery

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

Nursing Mothers

It is not known whether dichlorphenamide is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when dichlorphenamide is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Geriatic Use

Metabolic acidosis, which can be severe, may occur in the elderly with reduced renal function.

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

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

Monitoring

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

IV Compatibility

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

Overdosage

There is limited information regarding Diclofenamide overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

There is limited information regarding Diclofenamide Pharmacology in the drug label.

Mechanism of Action

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

Structure

There is limited information regarding Diclofenamide Structure in the drug label.

Pharmacodynamics

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

Pharmacokinetics

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

Nonclinical Toxicology

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

Clinical Studies

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

How Supplied

There is limited information regarding Diclofenamide How Supplied in the drug label.

Storage

There is limited information regarding Diclofenamide Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

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

Precautions with Alcohol

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

Brand Names

There is limited information regarding Diclofenamide Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Diclofenamide 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.