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

• The recommended initial dosage for adults is 2 to 4 tablets (100-200 mg). Two tablets (100 mg) should be given every 12 hours until the desired dose response is obtained.
• The recommended maintenence dosage for adults is one-half to 1 tablet (25-50 mg) one to three times daily.
• In acute angle-closure glaucoma, it may be used together with miotics and osmotic agents in an attempt to reduce intraocular pressure rapidly.

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

Symptoms of overdosage or toxicity may include drowsiness, anorexia, nausea, vomiting, dizziness, paresthesias, ataxia, tremor and tinnitus. In the event of overdosage, induce emesis or perform gastric lavage. The electrolyte disturbance most likely to be encountered from overdosage is hyperchloremic acidosis that may respond to bicarbonate administrations. Potassium supplementation may be required. The patient should be carefully observed and given supportive treatment.

Pharmacology

Mechanism of Action

Carbonic anhydrase inhibitors reduce intraocular pressure by partially suppressing the secretion of aqueous humor (inflow), although the mechanism by which they do this is not fully understood. Evidence suggests that bicarbonate ions are produced in the ciliary body by hydration of carbon dioxide under the influence of carbonic anhydrase and diffuse into the posterior chamber with sodium ions. The aqueous fluid contains more sodium and bicarbonate ions than does plasma and consequently is hypertonic. Water is attracted to the posterior chamber by osmosis. Systemic administration of a carbonic anhydrase inhibitor has been shown to inactivate carbonic anhydrase in the ciliary body of the rabbit's eye and to reduce the high concentration of bicarbonate ions in ocular fluids. As is the case with all carbonic anhydrase inhibitors, DARANIDE® (dichlorphenamide tablets USP) in high doses causes some decreases in renal blood flow and glomerular filtration rate.

Structure

DARANIDE® (dichlorphenamide tablets USP) is an oral carbonic anhydrase inhibitor. Dichlorphenamide, a dichlorinated benzenedisulfonamide, is known chemically as 4,5-dichloro-1,3-benzenedisulfonamide. Its empirical formula is C6H6Cl2N2O4S2 and its structural formula is:

Dichlorphenamide USP is a white or practically white, crystalline compound with a molecular weight of 305.16. It is very slightly soluble in water but soluble in dilute solutions of sodium carbonate and sodium hydroxide. Dilute alkaline solutions of dichlorphenamide are stable at room temperature. DARANIDE® (dichlorphenamide tablets USP) is supplied as tablets, for oral administration, each containing 50 mg dichlorphenamide. Inactive ingredients are D&C yellow lake #10, lactose monohydrate, magnesium stearate and pregelatinized starch.

Pharmacodynamics

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

Pharmacokinetics

In man, DARANIDE® (dichlorphenamide tablets USP) begins to act within an hour and maximal effect is observed in two to four hours. The lowered intraocular tension may be maintained for approximately 6 to 12 hours.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term studies in animals have not been performed to evaluate the effects upon fertility or carcinogenic potential of DARANIDE® (dichlorphenamide tablets USP).

Clinical Studies

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

How Supplied

Each DARANIDE® (dichlorphenamide tablets USP), 50 mg - round, yellow tablet, scored on one side, engraved with "TARO" on one side and on the other side "D" above the score and "50" below the score. DARANIDE® (dichlorphenamide tablets USP) is supplied as follows:

File:Diclofenamide how supplied 01.jpg

Storage

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

Patients should be advised that adverse reactions common to all sulfonamide derivatives may occur, including anaphylaxis, fever, rash (including erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis), crystalluria, renal calculus, bone marrow depression, thrombocytopenic purpura, hemolytic anemia, leucopenia, pancytopenia, and agranulocytosis. If such reactions occur, the drug should be discontinued and appropriate therapy instituted. Patients should be advised on the potential for anorexia, tachypnea, lethargy, coma, and death with the concomitant use of high-dose aspirin and DARANIDE® (dichlorphenamide tablets USP). Dichlorphenamide may cause drowsiness/fatigue and myopia in some patients. Patients should be cautioned on the potential for impaired ability to drive and operate machinery.

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.

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