Diclofenac Sodium Information
Diclofenac sodium (Diclofenac sodium) Description
Diclofenac sodium (Diclofenac sodium) delayed-release is a benzene-acetic acid derivative. The chemical name is 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid, monosodium salt. The molecular weight is 318.13. Its molecular formula is CHClNNaO, and it has the following structural formula
Each enteric-coated tablet for oral administration contains 50 mg or 75 mg of Diclofenac sodium (Diclofenac sodium) . In addition, each tablet contains the following inactive ingredients: aluminum hydrate, colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, polyvinyl acetate phthalate, propylene glycol, silica, sodium alginate, sodium starch glycolate (Type A), stearic acid, synthetic black iron oxide, talc, and titanium dioxide.
Diclofenac sodium (Diclofenac sodium) Indications And Usage
Carefully consider the potential benefits and risks of Diclofenac sodium (Diclofenac sodium) delayed-release and other treatment options before deciding to use Diclofenac sodium (Diclofenac sodium) delayed-release. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see ).
Diclofenac sodium (Diclofenac sodium) delayed-release tablets are indicated:
• For relief of signs and symptoms of osteoarthritis
• For relief of signs and symptoms of rheumatoid arthritis
• For acute or long-term use in the relief of signs and symptoms of ankylosing spondylitis
Diclofenac sodium (Diclofenac sodium) Contraindications
Diclofenac sodium (Diclofenac sodium) delayed-release tablets are contraindicated in patients with known hypersensitivity to diclofenac. Diclofenac sodium (Diclofenac sodium) delayed-release 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 NSAIDs have been reported in such patients (see , and ).
Diclofenac sodium (Diclofenac sodium) delayed-release is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery (see ).
Diclofenac sodium (Diclofenac sodium) Precautions
Diclofenac sodium (Diclofenac sodium) delayed-release tablets cannot be expected to substitute for corticosteroids or to treat corticosteroid insufficiency. Abrupt discontinuation of corticosteroids may lead to disease exacerbation. Patients on prolonged corticosteroid therapy should have their therapy tapered slowly if a decision is made to discontinue corticosteroids.
The pharmacological activity of Diclofenac sodium (Diclofenac sodium) delayed-release in reducing fever and inflammation may diminish the utility of these diagnostic signs in detecting complications of presumed noninfectious, painful conditions.
Hepatic Effects
Borderline elevations of one or more liver tests may occur in up to 15% of patients taking NSAIDs including Diclofenac sodium (Diclofenac sodium) delayed-release. These laboratory abnormalities may progress, may remain unchanged, or may be transient with continuing therapy. Based on this experience, in patients on chronic treatment with Diclofenac sodium (Diclofenac sodium) delayed-release, periodic monitoring of transaminases is recommende. (see ).Notable elevations of ALT or AST (approximately three or more times the upper limit of normal) have been reported in approximately 2%-4% of patients, including marked elevations (eight or more times the upper limit of normal) in about 1% of patients in clinical trials with diclofenac. In addition, rare cases of severe hepatic reactions, including jaundice and fatal fulminant hepatitis, liver necrosis and hepatic failure, some of them with fatal outcomes have been reported.
A patient with symptoms and/or signs suggesting liver dysfunction, or in whom an abnormal liver test has occurred, should be evaluated for evidence of the development of a more severe hepatic reaction while on therapy with Diclofenac sodium (Diclofenac sodium) delayed-release. If clinical signs and symptoms consistent with liver disease develop, or if systemic manifestations occur (e.g., eosinophilia, rash, etc.), Diclofenac sodium (Diclofenac sodium) delayed-release should be discontinued.
Hematological Effects
Anemia is sometimes seen in patients receiving NSAIDs, including Diclofenac sodium (Diclofenac sodium) delayed-release. This may be due to fluid retention, occult or gross GI blood loss, or an incompletely described effect upon erythropoiesis. Patients on long-term treatment with NSAIDs, including Diclofenac sodium (Diclofenac sodium) delayed-release, should have their hemoglobin or hematocrit checked if they exhibit any signs or symptoms of anemia.
NSAIDs inhibit platelet aggregation and have been shown to prolong bleeding time in some patients. Unlike aspirin, their effect on platelet function is quantitatively less, of shorter duration, and reversible. Patients receiving Diclofenac sodium (Diclofenac sodium) delayed-release who may be adversely affected by alterations in platelet function, such as those with coagulation disorders or patients receiving anticoagulants, should be carefully monitored.
Patients should be informed of the following information before initiating therapy with an NSAID and periodically during the course of ongoing therapy. Patients should also be encouraged to read the NSAID Medication Guide that accompanies each prescription dispensed.
Aspirin:When Diclofenac sodium (Diclofenac sodium) delayed-release is administered with aspirin, its protein binding is reduced. The clinical significance of this interaction is not known; however, as with other NSAIDs, concomitant administration of diclofenac and aspirin is not generally recommended because of the potential of increased adverse effects.
MethotrexateNSAIDs have been reported to competitively inhibit methotrexate accumulation in rabbit kidney slices. This may indicate that they could enhance the toxicity of methotrexate. Caution should be used when NSAIDs are administered concomitantly with methotrexate.
CyclosporineDiclofenac sodium (Diclofenac sodium) delayed-release, like other NSAIDs, may affect renal prostaglandins and increase the toxicity of certain drugs. Therefore, concomitant therapy with Diclofenac sodium (Diclofenac sodium) delayed-release may increase cyclosporine’s nephrotoxicity. Caution should be used when diclofenac is administered concomitantly with cyclosporine.
ACE-inhibitors:Reports suggest that NSAIDs may diminish the antihypertensive effect of ACE inhibitors. This interaction should be given consideration in patients taking NSAIDs concomitantly with ACE inhibitors.
Furosemide:Clinical studies, as well as post-marketing observations, have shown that Diclofenac sodium (Diclofenac sodium) delayed-release can reduce the natriuretic effect of furosemide and thiazides in some patients. This response has been attributed to inhibition of renal prostaglandin synthesis. During concomitant therapy with NSAIDs, the patient should be observed closely for signs of renal failure (see WARNINGS, Renal Effects), as well as to assure diuretic efficacy.
Lithium:NSAIDs have produced an elevation of plasma lithium levels and a reduction in renal lithium clearance. The mean minimum lithium concentration increased 15% and the renal clearance was decreased by approximately 20%. These effects have been attributed to inhibition of renal prostaglandin synthesis by the NSAID. Thus, when NSAIDs and lithium are administered concurrently, subjects should be observed carefully for signs of lithium toxicity.
Warfarin:The effects of warfarin and NSAIDs on GI bleeding are synergistic, such that users of both drugs together have a risk of serious GI bleeding higher than users of either drug alone.
Diclofenac sodium (Diclofenac sodium) Adverse Reactions
In patients taking Diclofenac sodium (Diclofenac sodium) delayed-release tablets, or other NSAIDs, the most frequently reported adverse experiences occurring in approximately 1%-10% of patients are:
Gastrointestinal experiences including: abdominal pain, constipation, diarrhea, dyspepsia, flatulence, gross bleeding/perforation, heartburn, nausea, GI ulcers (gastric/duodenal) and vomiting.
Abnormal renal function, anemia, dizziness, edema, elevated liver enzymes, headaches, increased bleeding time, pruritus, rashes and tinnitus.
Additional adverse experiences reported occasionally include:
Other adverse reactions, which occur rarely are:
Special Senses:conjunctivitis, hearing impairment
Diclofenac sodium (Diclofenac sodium) Overdosage
Symptoms following acute NSAID overdoses are usually limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which are generally reversible with supportive care. Gastrointestinal bleeding can occur. Hypertension, acute renal failure, respiratory depression and coma may occur, but are rare. Anaphylactoid reactions have been reported with therapeutic ingestion of NSAIDs, and may occur following an overdose.
Patients should be managed by symptomatic and supportive care following a NSAID overdose. There are no specific antidotes. Emesis and/or activated charcoal (60 to 100 g in adults, 1 to 2 g/kg in children) and/or osmotic cathartic may be indicated in patients seen within 4 hours of ingestion with symptoms or following a large overdose (5 to 10 times the usual dose). Forced diuresis, alkalinization of urine, hemodialysis, or hemoperfusion may not be useful due to high protein binding.
Diclofenac sodium (Diclofenac sodium) Dosage And Administration
Carefully consider the potential benefits and risks of Diclofenac sodium (Diclofenac sodium) delayed-release tablets and other treatment options before deciding to use Diclofenac sodium (Diclofenac sodium) delayed-release. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see ).
After observing the response to initial therapy with Diclofenac sodium (Diclofenac sodium) delayed-release tablets, the dose and frequency should be adjusted to suit an individual patient’s needs.
For the relief of osteoarthritis, the recommended dosage is 100-150 mg/day in divided doses (50 mg b.i.d. or t.i.d., or 75 mg b.i.d.).
For the relief of rheumatoid arthritis, the recommended dosage is 150-200 mg/day in divided doses (50 mg t.i.d. or q.i.d., or 75 mg b.i.d.).
For the relief of ankylosing spondylitis, the recommended dosage is 100-125 mg/day, administered as 25 mg q.i.d., with an extra 25-mg dose at bedtime if necessary.
Different formulations of diclofenac (Diclofenac sodium (Diclofenac sodium) delayed-release tablets; Diclofenac sodium (Diclofenac sodium) extended-release tablets; diclofenac potassium immediate-release tablets) are not necessarily bioequivalent even if the milligram strength is the same.
Diclofenac sodium (Diclofenac sodium) Medication Guide For Non-steroidal Anti-inflammatory Drugs (nsaids)
(See the end of this Medication Guide for a list of prescription NSAID medicines.)
NSAID medicines are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as:
of the following symptoms:
These are not all the side effects with NSAID medicines. Talk to your healthcare provider or
pharmacist for more information about NSAID medicines.
Call your doctor for medical advice about side effects. You may report side effects to FDA at .
Diclofenac sodium (Diclofenac sodium) How Supplied
Diclofenac sodium (Diclofenac sodium) Delayed-Release Tablets, USP are available as follows:
50 mg — Each white, round, enteric-coated tablet printed with on one side and 550 on the other side with black ink contains 50 mg of Diclofenac sodium (Diclofenac sodium) , USP. Tablets are supplied in blistercards of 30 (NDC 0615-4506-39).
75 mg — Each white, round, enteric-coated tablet printed with on one side and 551 on the other side with black ink contains 75 mg of Diclofenac sodium (Diclofenac sodium) , USP. Tablets are supplied in blistercards of 30 (NDC 0615-4507-39).
Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). Protect from moisture.
Dispense in a tight, light-resistant container as defined in the USP.
Manufactured by: Actavis Elizabeth LLC
200 Elmora Avenue, Elizabeth, NJ 07207 USA
40-8780
Revised — January 2008
Diclofenac sodium (Diclofenac sodium) Principal Display Panel
Diclofenac sodium (Diclofenac sodium) Dealyed-Release EC Tabs, USP 50mg
Diclofenac sodium (Diclofenac sodium) Principal Display Panel
Diclofenac sodium (Diclofenac sodium) Delayed-Release EC Tabs, USP 75mg
