RiteMED Diclofenac Special Precautions

General: Frail or debilitated patients may tolerate side effects less well and therefore special care should be taken in treating this population. As with other NSAIDs, caution should be used in the treatment of elderly patients who are more likely to be suffering from impaired renal, hepatic or cardiac function. For high risk patients, alternate therapies that do not involve NSAIDs should be considered.
Diclofenac is not recommended for use with other NSAIDs, with the exception of low-dose aspirin for cardiovascular prophylaxis, because of the absence of any evidence demonstrating synergistic benefits and the potential for additive adverse reactions (see Interactions).
Multiple diclofenac-containing preparations (including diclofenac potassium) should not be used concomitantly.
Cardiovascular Effects: (see Warnings).
Cardiovascular Thrombotic Events: Patients should remain alert for the signs and symptoms of serious arteriothrombotic events (e.g. chest pain, shortness of breath, weakness, slurring of speech), which can occur without warnings. Patients should be instructed to see a physician immediately in case of such an event.
There is no consistent evidence that concurrent use of aspirin mitigates the increased risk of serious cardiovascular thrombotic events associated with NSAID use. The concurrent use of aspirin and an NSAID does increase the risk of serious GI events.
Hypertension: NSAIDs can lead to the onset of new hypertension or worsening of pre-existing hypertension, either of which may contribute to the increased incidence of cardiovascular events. Patients taking thiazides or loop diuretics may have impaired response to these therapies when taking NSAIDs. NSAIDs, including diclofenac, should be used with caution in patients with hypertension. Blood pressure should be monitored closely during the initiation of NSAID treatment and throughout the course of therapy.
Congestive Heart Failure and Edema: Fluid retention and edema have been observed in some patients taking NSAIDs. Diclofenac should be used with caution in patients with fluid retention or heart failure.
Endocrine/Metabolic Effects: Diclofenac is not a substitute for corticosteroids. They do not treat corticosteroid insufficiency. Abrupt discontinuation of corticosteroids may lead to exacerbation of corticosteroid-responsive illness. Patients on prolonged corticosteroid therapy should have their therapy tapered slowly if a decision is made to discontinue corticosteroids (see Interactions).
Gastrointestinal (GI) Effects (see Warnings): NSAIDs, including diclofenac, can increase the risk of serious GI adverse events including inflammation, bleeding, ulceration, and perforation of the stomach, small or large intestines, which can be fatal. These serious adverse events can occur at any time, with or without warning symptoms, in patients treated with NSAIDs.
NSAIDs should be prescribed with extreme caution in those with a history of ulcer disease or GI bleeding since these patients have a greater than 10-fold increased risk for developing a GI bleed compared with patients with neither of these risk factors. Other factors that increase the risk for GI bleeding in patients treated with NSAIDs include concomitant use of oral corticosteroids or anticoagulants, longer duration of NSAID therapy, smoking, use of alcohol, older age, and poor general health status.
Physicians and patients should remain alert for signs and symptoms of GI ulceration and bleeding during NSAID therapy and promptly initiate additional evaluation and treatment if a serious GI adverse event is suspected. This should include discontinuation of the NSAID until a serious GI adverse event is ruled out. Alternate therapies that do not involve NSAIDs should be considered especially for high-risk patients.
Close medical surveillance and caution should be exercised in patients with ulcerative colitis or with Crohn's disease as these conditions may be exacerbated.
Genitourinary Effects: Some NSAIDs are associated with persistent urinary symptoms (bladder pain, dysuria, urinary frequency), hematuria or cystitis. The onset of these symptoms may occur at any time after the initiation of therapy with an NSAID. Should urinary symptoms occur, in the absence of an alternate explanation, treatment with diclofenac should be stopped to ascertain if symptoms disappear. This should be done before urological investigations or treatments are carried out.
Caution should be exercised when initiating treatment with diclofenac in patients with considerable dehydration.
Long-term administration of NSAIDs has resulted in renal papillary necrosis and other renal injury. Renal toxicity has also been seen in patients in whom renal prostaglandins have a compensatory role in the maintenance of renal perfusion. In these patients, administration of an NSAID may cause a dose-dependent reduction in prostaglandin formation and secondarily, in renal blood flow, which may precipitate overt renal decompensation. Patients at greatest risk of this reaction are those with impaired renal function, heart failure, liver dysfunction, those taking diuretics and angiotensin-converting enzyme (ACE) inhibitors, and the elderly. Discontinuation of NSAID therapy is usually followed by recovery to the pretreatment state.
Advanced Renal Disease: There are no controlled studies on the use of diclofenac in patients with advanced renal disease. Therefore, treatment with diclofenac is not recommended in these patients. If diclofenac therapy must be initiated, close monitoring of the patient's renal function is advised.
Anaphylactoid Reactions (see Contraindications): Anaphylactoid reactions may occur in patients without known prior exposure to NSAIDs. Diclofenac should not be given to patients with the aspirin triad. This symptom complex typically occurs in asthmatic patients who experience rhinitis with or without nasal polyps, or who exhibit severe, potentially fatal bronchospasm after taking aspirin or other NSAIDs. Diclofenac should be administered with caution in patients with pre-existing asthma and emergency help should be sought in cases where an anaphylactoid reaction occurs.
Skin Reactions: As with other NSAIDs, diclofenac, can cause serious skin adverse events such as exfoliative dermatitis, Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN or Lyell's syndrome), which can be fatal. These serious events may occur without warning. Patients should be informed about the signs and symptoms of serious skin manifestations and use of the drug should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity.
Use of diclofenac may cause photosensitivity upon exposure to sunlight or ultraviolet light causing symptoms such as sunburn, skin rash, skin blisters, pruritus, erythema and discolouration.
Hepatic Effects: Borderline elevations of one or more liver tests may occur in up to 15% of patients taking NSAIDs including diclofenac. These laboratory abnormalities may progress, may remain unchanged, or may be transient with continuing therapy. In patients with chronic treatment with diclofenac, periodic monitoring of transaminases is recommended. Notable elevations of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) (approximately three or more times the upper limit of normal) have been reported in approximately 2 to 4% of patients, including marked elevations (eight or more times the upper limit of normal) in about 1% of patients. Rare cases of severe hepatic reactions, including jaundice and fatal fulminant hepatitis, liver necrosis and hepatic failure, some with fatal outcomes have been reported.
Patients 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 NSAIDs including diclofenac. Discontinue diclofenac if clinical signs and symptoms consistent with liver disease develop or if systemic manifestations occur (e.g., eosinophilia, rash).
Caution is called for when using diclofenac in patients with hepatic porphyria, since it may trigger an attack.
Hematologic Effects: Anemia is sometimes seen in patients receiving NSAIDS including diclofenac. 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, should have their hemoglobin or hematocrit checked if they exhibit any signs or symptoms of anemia.
In some patients, NSAIDs inhibit platelet aggregation and have been shown to prolong bleeding time. Unlike aspirin, their effect on platelet function is quantitatively less, of short duration, and reversible. Patients receiving diclofenac who may be adversely affected by alterations in platelet function, such as those with coagulation disorders or patients receiving anticoagulants, should be carefully monitored.
Aseptic Meningitis: Rarely, with some NSAIDs, the symptoms of aseptic meningitis (stiff neck, severe headaches, nausea and vomiting, fever or clouding of consciousness) have been observed. Patients with autoimmune disorders (systemic lupus erythematosus, mixed connective tissue diseases, etc.) seem to be pre-disposed. Therefore, in such patients, the doctor must be vigilant to the development of this complication.
Effects on the Ability to Drive and Use Machines: Some patients may experience drowsiness, dizziness, blurred vision, vertigo, insomnia, depression, tinnitus or hearing loss with the use of NSAIDs, such as diclofenac. If patients experience such adverse reaction(s) they should refrain from driving, operating machinery, or carrying out activities that require alertness.
Use in Children: Children (<16 years old): Safety and effectiveness in pediatric patients have not been established (see Contraindications).
Use in the Elderly: Elderly (≥65 years old): Elderly and frail or debilitated patients are more susceptible to a variety of adverse reactions from NSAIDs; the incidence of these adverse reactions increases with dose and duration of treatment. In addition, these patients are less tolerant to ulceration and bleeding. Most reports of fatal GI events are in this population. Older patients are also at risk of lower esophageal injury including ulceration and bleeding.
For such patients, consideration should be given to a starting dose lower than the one usually recommended, with individual adjustment when necessary and under close supervision.