displayName: Description section
FDA Article Code: 34089-3
Diclofenac sodium, is a benzene-acetic acid derivative, designated chemically as 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid, monosodium salt. The structural formula is:
C14H10Cl2NNaO2 M.W. 318.14
Diclofenac sodium is a faintly yellowish white to light beige, virtually odorless, slightly hygroscopic crystalline powder. It is freely soluble in methanol, soluble in ethanol, sparingly soluble in water and practically insoluble in chloroform and in dilute acid. The n-octanol/water partition coefficient is 13.4 at pH 7.4 and 1545 at pH 5.2. Diclofenac sodium has a dissociation constant (pKa) of 4.0 ± 0.2 at 25°C in water.Each enteric-coated tablet, for oral administration, contains 25 mg, 50 mg, or 75 mg of diclofenac sodium. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, enteric-coating (black iron oxide, FD&C Blue No. 2, FD&C Red No. 40, FD&C Yellow No. 6, methacrylic acid copolymer, methylparaben, n-butyl alcohol, polysorbate 80, potassium sorbate, propylene glycol, propylparaben, sodium citrate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate, and xanthan gum), lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, and stearic acid.
INDICATIONS AND USAGE
displayName: Indications section
FDA Article Code: 34067-9
Diclofenac sodium delayed-release tablets are indicated for the acute and chronic treatment of the signs and symptoms of rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis.
displayName: Contraindications section
FDA Article Code: 34070-3
Diclofenac sodium delayed-release tablets are contraindicated in patients with hypersensitivity to the product. Diclofenac should not be given to patients who have experienced asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to diclofenac have been reported in such patients.
displayName: Adverse Reactions section
FDA Article Code: 34084-4
Adverse reaction information is derived from blinded, controlled and open-label clinical trials as well as worldwide marketing experience. In the description below, rates of more common events represent clinical study results; rarer events are derived principally from marketing experience and publications, and accurate rate estimates are generally not possible.The incidence of common adverse reactions (greater than 1%) is based upon controlled clinical trials in 1543 patients treated up to 13 weeks with diclofenac sodium delayed-release tablets. By far the most common adverse effects were gastrointestinal symptoms, most of them minor, occurring in about 20%, and leading to discontinuation in about 3%, of patients. Peptic ulcer or G.I. bleeding occurred in clinical trials in 0.6% (95%-confidence interval: 0.2% to 1%) of approximately 1800 patients during their first 3 months of diclofenac treatment and 1.6% (95%-confidence interval: 0.8% to 2.4%) of approximately 800 patients followed for 1 year.Gastrointestinal symptoms were followed in frequency by central nervous system side effects such as headache (7%) and dizziness (3%).Meaningful (exceeding 3 times the Upper Limit of Normal) elevations of ALT (SGPT) or AST (SGOT) occurred at an overall rate of approximately 2% during the first 2 months of diclofenac sodium treatment. Unlike aspirin-related elevations, which occur more frequently in patients with rheumatoid arthritis, these elevations were more frequently observed in patients with osteoarthritis (2.6%) than in patients with rheumatoid arthritis (0.7%). Marked elevations (exceeding 8 times the ULN) were seen in 1% of patients treated for 2 to 6 months (see WARNINGS: Hepatic Effects).The following adverse reactions were reported in patients treated with diclofenac:
displayName: Overdosage section
FDA Article Code: 34088-5
Worldwide reports on overdosage with diclofenac cover 66 cases. In approximately one-half of these reports of overdosage, concomitant medications were also taken. The highest dose of diclofenac was 5 g in a 17-year-old male who suffered loss of consciousness, increased intracranial pressure, aspiration pneumonitis, and died 2 days after overdose. The next highest doses of diclofenac were 4 g and 3.75 g. The 24-year-old female who took 4 g and the 28- and 42-year-old females, each of whom took 3.75 g, did not develop any clinically significant signs or symptoms. However, there was a report of a 17-year-old female who experienced vomiting and drowsiness after an overdose of 2.37 g of diclofenac.Animal LD50 values show a wide range of susceptibilities to acute overdosage, with primates being more resistant to acute toxicity than rodents (LD50 in mg/kg–rats, 55; dogs, 500; monkeys, 3200).In case of acute overdosage it is recommended that the stomach be emptied by vomiting or lavage. Forced diuresis may theoretically be beneficial because the drug is excreted in the urine. The effect of dialysis or hemoperfusion in the elimination of diclofenac (99% protein-bound, see CLINICAL PHARMACOLOGY) remains unproven. In addition to supportive measures, the use of oral activated charcoal may help to reduce the absorption of diclofenac.
DOSAGE AND ADMINISTRATION
displayName: Dosage and Administration section
FDA Article Code: 34068-7
Diclofenac sodium may be administered as 25 mg, 50 mg, or 75 mg delayed-release tablets. Regardless of the indication, the dosage of diclofenac should be individualized to the lowest effective dose to minimize adverse effects (see CLINICAL PHARMACOLOGY: Individualization of Dosage)
displayName: How Supplied section
FDA Article Code: 34069-5
Diclofenac Sodium Delayed-Release Tablets USP25 mg white, round, enteric-coated tabletsTablets Identified 54 140NDC 0054-8223-25: Unit dose, 10 tablets per strip, 10 strips per shelf pack, ten shelf packs per shipper.NDC 0054-4223-25: Bottles of 100 tablets.50 mg white, round, enteric-coated tabletsTablets Identified 54 592NDC 0054-8221-25: Unit dose, 10 tablets per strip, 10 strips per shelf pack, ten shelf packs per shipper.NDC 0054-4221-25: Bottles of 100 tablets.NDC 0054-4221-31: Bottles of 1000 tablets.75 mg white, round, enteric-coated tabletsTablets Identiied 54 839NDC 0054-8222-25: Unit dose, 10 tablets per strip, 10 strips per shelf pack, ten shelf packs per shipper.NDC 0054-4222-25: Bottles of 100 tablets.NDC 0054-4222-31: Bottles of 1000 tablets.Do not store above 30°C (86°F). Protect from moisture.Dispense in a tight, light-resistant container as defined in the USP/NF.4048700//03© RLI, 2005