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02.04.2014
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Voltaren Plus is a brand name for a pain reliever that combines two major ingredients: paracetamol and codeine phosphate. Some side effects of Voltaren Plus may include dizziness, light-headedness, feeling, faint, sleepiness, nausea or vomiting, vision disturbance, unusual tiredness or weakness, insomnia, constipation, stomach cramps, painful urination, redness or swelling at the place of injection, nightmares, a false sense of well-being, dry mouth, headache, or malaise. There have been no conclusive studies done on whether or not analgesics such as Voltaren Plus are harmful to a pregnancy or to a developing fetus. Non-steroidal anti-inflammatory drugs (NSAIDs) may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. VOLTAREN® GEL is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery[see Contraindications (4)][see Contraindications (4)]. NSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal.
The proper amount of VOLTAREN® GEL should be measured using the dosing card supplied in the drug product carton.
Wearing of clothing or gloves should be avoided for at least 10 minutes after applying VOLTAREN® GEL. The use of VOLTAREN® GEL is contraindicated in patients with a known hypersensitivity to diclofenac. Clinical trials of several COX-2 selective and nonselective NSAIDs of up to three years duration have shown an increased risk of serious cardiovascular (CV) thrombotic events, myocardial infarction, and stroke, which can be fatal. There is no consistent evidence that concurrent use of aspirin mitigates the increased risk of serious CV thrombotic events associated with NSAIDs use. Two large, controlled, clinical trials of a COX-2 selective NSAID for the treatment of pain in the first 10-14 days following CABG surgery found an increased incidence of myocardial infarction and stroke [see Contraindications (4)]. NSAIDs, including diclofenac, can cause serious gastrointestinal (GI) events including bleeding, ulceration, and perforation of the stomach, small intestine or large intestine, which can be fatal.
NSAIDs should be prescribed with extreme caution in patients with a prior history of ulcer disease or gastrointestinal bleeding.
To minimize the potential risk for an adverse GI event, the lowest effective dose should be used for the shortest possible duration. Almost all meaningful elevations in transaminases were detected before patients became symptomatic.
In postmarketing reports, cases of drug-induced hepatotoxicity have been reported in the first month, and in some cases, the first 2 months of therapy, but can occur at any time during treatment with diclofenac.
Physicians should measure transaminases periodically in patients receiving long-term therapy with diclofenac, because severe hepatotoxicity may develop without a prodrome of distinguishing symptoms. To minimize the potential risk for an adverse liver related event in patients treated with diclofenac sodium, the lowest effective dose should be used for the shortest duration possible.
Long-term administration of NSAIDs has resulted in renal papillary necrosis and other renal injury.
No information is available from controlled clinical studies regarding the use of VOLTAREN® GEL in patients with advanced renal disease.
NSAIDs, including VOLTAREN® GEL, can cause serious skin adverse events such as exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. VOLTAREN® GEL should not be applied to open skin wounds, infections, inflammations, or exfoliative dermatitis, as it may affect absorption and tolerability of the drug. The effect of VOLTAREN® GEL under occlusive dressings has not been evaluated, and should be avoided. Contact of VOLTAREN® GEL with eyes and mucosa, although not studied, should be avoided. Because serious GI tract ulcerations and bleeding can occur without warning symptoms, physicians should monitor for signs or symptoms of GI bleeding. In the open-label, long-term safety study, distribution of adverse reactions was similar to that in the placebo-controlled studies.
When diclofenac is administered with aspirin, the binding of diclofenac to protein is reduced, although the clearance of free diclofenac is not altered. Clinical studies, as well as post-marketing observations, have shown that NSAIDs can reduce the natriuretic effect of furosemide and thiazides in some patients. NSAIDs have produced an elevation of plasma lithium levels and a reduction in renal lithium clearance. NSAIDs have been reported to competitively inhibit methotrexate accumulation in rabbit kidney slices. Diclofenac, like other NSAIDs, may affect renal prostaglandins and increase the toxicity of certain drugs. Concomitant use of VOLTAREN® GEL with other topical products, including topical medications, sunscreens, lotions, moisturizers, and cosmetics, on the same skin site has not been tested and should be avoided because of the potential to alter local tolerability and absorption. The use of diclofenac, as with other NSAIDs, is associated with the adverse fetal cardiovascular effect of premature closure of the ductus arteriosus. In rat studies with oral NSAIDs, including diclofenac, as with other drugs known to inhibit prostaglandin synthesis, there is an increased incidence of dystocia and delayed parturition corresponding to a human equivalent dose approximately similar to the maximum recommended clinical dose (based on bioavailability and body surface area comparison). It is not known whether diclofenac is excreted in human milk; however, studies in animals detected diclofenac in the milk after oral administration.
Of the total number of subjects treated with VOLTAREN® GEL in clinical studies, 498 were 65 years of age and over. Diclofenac, as with any NSAID, is known to be substantially excreted by the kidney, and the risk of toxic reactions to VOLTAREN® GEL may be greater in patients with impaired renal function. In the event of oral ingestion resulting in significant systemic side effects, it is recommended that the stomach be emptied by vomiting or lavage. For additional information about overdose treatment, call a Poison Control Center (1-800-222-1222). The mechanism of action of diclofenac is similar to that of other non-steroidal anti-inflammatory drugs. Study 1 evaluated the efficacy of VOLTAREN® GEL for the treatment of osteoarthritis of the knee in a 12-week, randomized, double-blind, multicenter, placebo-controlled, parallel-group trial.


Study 2 evaluated the efficacy of VOLTAREN® GEL for the treatment of osteoarthritis in subjects with osteoarthritis of the hand in an 8-week, randomized, double-blind, multicenter, placebo-controlled, parallel-group study.
Advise the patient to read the FDA-approved patient labeling (NSAIDs Medication Guide and Instructions for Use) prior to using VOLTAREN® GEL.
VOLTAREN® GEL, like other NSAIDs, can cause GI discomfort and, rarely, more serious GI side effects, such as ulcers and bleeding, which may result in hospitalization and even death. VOLTAREN® GEL, like other NSAIDs, can cause serious skin side effects such as exfoliative dermatitis, SJS, and TEN, which may result in hospitalization and even death. Advise patients to stop VOLTAREN® GEL immediately if they develop any type of rash and contact their physicians as soon as possible. Instruct patients not to apply VOLTAREN® GEL to open skin wounds, infections, inflammations, or exfoliative dermatitis, as it may affect absorption and tolerability of the drug. Instruct patients to avoid concomitant use of VOLTAREN® GEL with other topical products, including sunscreens, cosmetics, lotions, moisturizers, and insect repellants.
Instruct patients to minimize or avoid exposure of treated areas to natural or artificial sunlight. Instruct patients to avoid contact of VOLTAREN® GEL with the eyes and mucosa, although not studied, should be avoided. Instruct patients how to use the dosing card to measure the proper dose of VOLTAREN® GEL to apply. If the patient loses their dosing card, instruct them that they can call 1-800-398-5876to request a replacement dosing card or ask their pharmacist for a new dosing card.
What is the most important information I should know about medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?
NSAID medicines may increase the chance of a heart attack or stroke that can lead to death. NSAID medicines can cause ulcers and bleeding in the stomach and intestines at any time during treatment. The concurrent use of aspirin and NSAIDs such as diclofenac, does increase the risk of serious GI events [see Warnings and Precautions (5.2)].
These serious adverse events can occur at any time, with or without warning symptoms, in patients treated with NSAIDs. Physicians and patients should remain alert for signs and symptoms of GI ulceration and bleeding during diclofenac therapy and promptly initiate additional evaluation and treatment if a serious GI adverse event is suspected. These laboratory abnormalities may progress, may remain unchanged, or may be transient with continued therapy. In a large, open-label, controlled trial of 3,700 patients treated for 2-6 months, patients were monitored first at 8 weeks and 1,200 patients were monitored again at 24 weeks. Abnormal tests occurred during the first 2 months of therapy with diclofenac in 42 of the 51 patients in all trials who developed marked transaminase elevations. Postmarketing surveillance has reported cases of severe hepatic reactions, including liver necrosis, jaundice, fulminant hepatitis with and without jaundice, and liver failure. The optimum times for making the first and subsequent transaminase measurements are not known. Patients taking thiazides or loop diuretics may have impaired response to these therapies when taking NSAIDs.
Renal toxicity has also been seen in patients in whom renal prostaglandins have a compensatory role in the maintenance of renal perfusion.
Therefore, treatment with VOLTAREN® GEL is not recommended in patients with advanced renal disease. VOLTAREN® GEL should not be allowed to come into contact with the eyes or with mucous membranes.
Abrupt discontinuation of corticosteroids may lead to exacerbation of corticosteroid-responsive illness. This may be due to fluid retention, occult or gross GI blood loss, or an incompletely described effect upon erythropoeisis. The use of aspirin in patients with aspirin-sensitive asthma has been associated with severe bronchospasm, which can be fatal. Patients on long-term treatment with NSAIDs, should have a CBC and a chemistry profile checked periodically.
In this study, where patients were treated for up to 1 year with VOLTAREN® GEL up to 32 g per day, application site dermatitis was observed in 11% of patients. The mean minimum lithium concentration increased 15% and the renal clearance was decreased by approximately 20%. Therefore concomitant therapy with diclofenac may increase cyclosporine’s nephrotoxicity. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from VOLTAREN® GEL a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. No overall differences in effectiveness or safety were observed between these subjects and younger subjects, but greater sensitivity to the effect of NSAIDs in some older individuals cannot be ruled out.
Because elderly patients are more likely to have decreased renal function, care should be taken when using VOLTAREN® GEL in the elderly, and it may be useful to monitor renal function.
Effects similar to those observed after an overdose of diclofenac tablets can be expected if substantial amounts of VOLTAREN® GEL are ingested. Diclofenac inhibits the enzyme, cyclooxygenase (COX), an early component of the arachidonic acid cascade, resulting in the reduced formation of prostaglandins, thromboxanes and prostacylin. VOLTAREN® GEL was administered at a dose of 4 g, 4 times daily, on 1 knee (16 g per day).
VOLTAREN® GEL was administered at a dose of 2 g per hand, 4 times daily, on both hands (16 g per day). Each tube contains diclofenac sodium in a gel base (10 mg of diclofenac sodium per gram of gel or 1%). Although serious GI tract ulcerations and bleeding can occur without warning symptoms, patients should be alert for the signs and symptoms of ulcerations and bleeding. Although serious skin reactions may occur without warning, patients should be alert for the signs and symptoms of skin rash and blisters, fever, or other signs of hypersensitivity such as itching.


Concomitant use may result in skin reactions or change the absorption of VOLTAREN® GEL. If these occur, patients should be instructed to seek immediate emergency help [see Warnings and Precautions (5.7)]. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk [see Warnings and Precautions (5.1)]. Elderly patients are at greater risk for serious gastrointestinal events [see Warnings and Precautions (5.2)]. Only one in five patients who develop a serious upper GI adverse event on NSAID therapy is symptomatic. Other factors that increase the risk of GI bleeding in patients treated with NSAIDs include concomitant use of oral corticosteroids or anticoagulants, longer duration of NSAIDs therapy, smoking, use of alcohol, older age, and poor general health status.
For high-risk patients, alternate therapies that do not involve NSAIDs should be considered. Based on clinical trial data and postmarketing experiences, transaminases should be monitored within 4 to 8 weeks after initiating treatment with diclofenac. 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. If VOLTAREN® GEL therapy is initiated, close monitoring of the patient's renal function is advisable. Patients should be informed about the signs and symptoms of serious skin manifestations, and the use of the drug should be discontinued at the first appearance of skin rash or any other signs of hypersensitivity. Patients on prolonged corticosteroid therapy should have their therapy tapered slowly if a decision is made to discontinue corticosteroids.
Adverse reactions that led to the discontinuation of the study drug were experienced in 12% of patients. These effects have been attributed to inhibition of renal prostaglandin synthesis by the NSAID. Caution should be used when NSAIDs, including diclofenac, are administered concomitantly with methotrexate.
Symptoms following acute oral NSAID overdoses are usually limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which are generally reversible with supportive care. The effect of dialysis or hemoperfusion in the elimination of diclofenac (99% protein-bound) remains unproven. It is not completely understood how reduced synthesis of these compounds results in therapeutic efficacy. Pain as assessed by the patients at Week 12 using the WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) Pain Subindex was lower in the VOLTAREN® GEL group than the placebo group.
Pain in the target hand as assessed by the patients at Weeks 4 and 6 on a visual analog scale from 0 to 100 was lower in the VOLTAREN® GEL group than the placebo group. Instruct patients to ask for medical advice when observing any indicative sign or symptoms including epigastric pain, dyspepsia, melena, and hematemesis.
Instruct patients to ask for medical advice when observing any indicative signs or symptoms [see Warnings and Precautions (5.8)].
The gel should be applied within the oblong area of the dosing card up to the 2 gram or 4 gram line (2 g for each elbow, wrist, or hand, and 4 g for each knee, ankle, or foot). To minimize the potential risk for an adverse CV event in patients treated with NSAIDs, the lowest effective dose should be used for the shortest duration possible. Upper GI ulcers, gross bleeding, or perforation caused by NSAIDs occur in approximately 1% of patients treated for 3-6 months, and in about 2-4% of patients treated for one year. Most spontaneous reports of fatal GI events are in elderly or debilitated patients and therefore special care should be taken in treating this population. In that open-label study, a higher incidence of borderline (less than 3 times the ULN), moderate (3-8 times the ULN), and marked (>8 times the ULN) elevations of ALT or AST was observed in patients receiving diclofenac when compared to other NSAIDs. Patients at greatest risk of this reaction are those with impaired renal function, heart failure, liver dysfunction, those taking diuretics and ACE-inhibitors, and the elderly. Of these, 355 patients were treated for osteoarthritis of 1 knee and 228 were treated for osteoarthritis of both knees. Thus, when NSAIDs, including diclofenac, and lithium are administered concurrently, patients should be observed carefully for signs of lithium toxicity. In addition to supportive measures, the use of oral activated charcoal may help to reduce the absorption of diclofenac. Physicians and patients should remain alert for the development of such events, even in the absence of previous CV symptoms. These trends continue with longer duration of use, increasing the likelihood of developing a serious GI event at some time during the course of therapy. Of the markers of hepatic function, ALT (SGPT) is recommended for the monitoring of liver injury. Elevations in transaminases were seen more frequently in patients with osteoarthritis than in those with rheumatoid arthritis.
Discontinuation of NSAID therapy is usually followed by recovery to the pretreatment state. Supportive and symptomatic treatment should be given for complications such as renal failure, convulsions, gastrointestinal irritation, and respiratory depression.
Anaphylactoid reactions have been reported with therapeutic ingestion of NSAIDs, and may occur after an overdose. If treatment site is the hands, patients should wait at least one (1) hour to wash their hands.



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