Voltaren Gel
Name: Voltaren Gel
- Voltaren Gel drug
- Voltaren Gel therapeutic effect
- Voltaren Gel side effects
- Voltaren Gel side effects of voltaren gel
- Voltaren Gel effects of voltaren gel
Drug Interactions
See Table 2 for clinically significant drug interactions with diclofenac.
Table 2: Clinically Significant Drug Interactions with Diclofenac
| Drugs That Interfere with Hemostasis | |||
| Clinical Impact: | • Diclofenac and anticoagulants such as warfarin have a synergistic effect on bleeding. The concomitant use of diclofenac and anticoagulants have an increased risk of serious bleeding compared to the use of either drug alone. • Serotonin release by platelets plays an important role in hemostasis. Case-control and cohort epidemiological studies showed that concomitant use of drugs that interfere with serotonin reuptake and an NSAID may potentiate the risk of bleeding more than an NSAID alone. | ||
| Intervention: | Monitor patients with concomitant use of VOLTAREN® GEL with anticoagulants (e.g., warfarin), antiplatelet agents (e.g., aspirin), selective serotonin reuptake inhibitors (SSRIs), and serotonin norepinephrine reuptake inhibitors (SNRIs) for signs of bleeding [see Warnings and Precautions (5.11)]. | ||
| Aspirin | |||
| Clinical Impact: | Controlled clinical studies showed that the concomitant use of NSAIDs and analgesic doses of aspirin does not produce any greater therapeutic effect than the use of NSAIDs alone. In a clinical study, the concomitant use of an NSAID and aspirin was associated with a significantly increased incidence of GI adverse reactions as compared to use of the NSAID alone [see Warnings and Precautions (5.2)]. | ||
| Intervention: | Concomitant use of VOLTAREN® GEL and analgesic doses of aspirin is not generally recommended because of the increased risk of bleeding [see Warnings and Precautions (5.11)]. VOLTAREN® GEL is not a substitute for low dose aspirin for cardiovascular protection. | ||
| ACE Inhibitors, Angiotensin Receptor Blockers, and Beta-Blockers | |||
| Clinical Impact: | • NSAIDs may diminish the antihypertensive effect of angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), or beta-blockers (including propranolol). • In patients who are elderly, volume-depleted (including those on diuretic therapy), or have renal impairment, co-administration of an NSAID with ACE inhibitors or ARBs may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible. | ||
| Intervention: | • During concomitant use of VOLTAREN® GEL and ACE-inhibitors, ARBs, or beta- blockers, monitor blood pressure to ensure that the desired blood pressure is obtained. • During concomitant use of VOLTAREN® GEL and ACE-inhibitors or ARBs in patients who are elderly, volume-depleted, or have impaired renal function, monitor for signs of worsening renal function [see Warnings and Precautions (5.6)]. • When these drugs are administered concomitantly, patients should be adequately hydrated. Assess renal function at the beginning of the concomitant treatment and periodically thereafter. | ||
| Diuretics | |||
| Clinical Impact: | Clinical studies, as well as post-marketing observations, showed that NSAIDs reduced the natriuretic effect of loop diuretics (e.g., furosemide) and thiazide diuretics in some patients. This effect has been attributed to the NSAID inhibition of renal prostaglandin synthesis. | ||
| Intervention: | During concomitant use of VOLTAREN® GEL with diuretics, observe patients for signs of worsening renal function, in addition to assuring diuretic efficacy including antihypertensive effects [see Warnings and Precautions (5.6)]. | ||
| Digoxin | |||
| Clinical Impact: | The concomitant use of diclofenac with digoxin has been reported to increase the serum concentration and prolong the half-life of digoxin. | ||
| Intervention: | During concomitant use of VOLTAREN® GEL and digoxin, monitor serum digoxin levels. | ||
| Lithium | |||
| Clinical Impact: | NSAIDs have produced elevations in plasma lithium levels and reductions in renal lithium clearance. The mean minimum lithium concentration increased 15%, and the renal clearance decreased by approximately 20%. This effect has been attributed to NSAID inhibition of renal prostaglandin synthesis. | ||
| Intervention: | During concomitant use of VOLTAREN® GEL and lithium, monitor patients for signs of lithium toxicity. | ||
| Methotrexate | |||
| Clinical Impact: | Concomitant use of NSAIDs and methotrexate may increase the risk for methotrexate toxicity (e.g., neutropenia, thrombocytopenia, renal dysfunction). | ||
| Intervention: | During concomitant use of VOLTAREN® GEL and methotrexate, monitor patients for methotrexate toxicity. | ||
| Cyclosporine | |||
| Clinical Impact: | Concomitant use of VOLTAREN® GEL and cyclosporine may increase cyclosporine's nephrotoxicity. | ||
| Intervention: | During concomitant use of VOLTAREN® GEL and cyclosporine, monitor patients for signs of worsening renal function. | ||
| NSAIDs and Salicylates | |||
| Clinical Impact: | Concomitant use of diclofenac with other NSAIDs or salicylates (e.g., diflunisal, salsalate) increases the risk of GI toxicity, with little or no increase in efficacy [see Warnings and Precautions (5.2)]. | ||
| Intervention: | The concomitant use of diclofenac with other NSAIDs or salicylates is not recommended. | ||
| Pemetrexed | |||
| Clinical Impact: | Concomitant use of VOLTAREN® GEL and pemetrexed may increase the risk of pemetrexed-associated myelosuppression, renal, and GI toxicity (see the pemetrexed prescribing information). | ||
| Intervention: | During concomitant use of VOLTAREN® GEL and pemetrexed, in patients with renal impairment whose creatinine clearance ranges from 45 to 79 mL/min, monitor for myelosuppression, renal and Gl toxicity. NSAIDs with short elimination half-lives (e.g., diclofenac, indomethacin) should be avoided for a period of two days before, the day of, and two days following administration of pemetrexed. In the absence of data regarding potential interaction between pemetrexed and NSAIDs with longer half-lives (e.g., meloxicam, nabumetone), patients taking these NSAIDs should interrupt dosing for at least five days before, the day of, and two days following pemetrexed administration. | ||
For Healthcare Professionals
Applies to diclofenac topical: topical cream, topical film extended release, topical gel, topical kit, topical solution
General
The most frequently reported side effects were application site reactions.[Ref]
Local
Very common (10% or more): Dryness (up to 32%)
Common (1% to 10%): Dermatitis, burning sensation, pruritus, exfoliation, erythema, pain, induration, rash, scabbing, contusion, inflammation, irritation, itching, tingling, blistering, localized paresthesia
Frequency not reported: Vesicles, papules, localized hair discoloration, vasodilation, purpuric rash, atrophy[Ref]
Dermatologic
Common (1% to 10%): Contact dermatitis, eczema, dry skin, rash, scaly rash, skin hypertrophy, skin ulcer, vesiculobullous rash, exfoliation, urticaria, acne, alopecia, skin nodule
Uncommon (0.1% to 1%): Face edema, maculopapular rash, photosensitivity reaction, seborrhea
Rare (0.01% to 0.1%): Bullous dermatitis
Very rare (less than 0.01%): Pustular rash
Frequency not reported: Skin hypertrophy[Ref]
Cardiovascular
Common (1% to 10%): Hypertension
Uncommon (0.1% to 1%): Hemorrhage
Postmarketing reports: Palpitation, cardiovascular disorder, blood pressure increased[Ref]
Gastrointestinal
Common (1% to 10%): Abdominal pain, diarrhea, dyspepsia, halitosis, nausea, flatulence, constipation
Very rare (less than 0.01%): Gastrointestinal hemorrhage
Frequency not reported: Upper abdominal pain
Postmarketing reports: Dry mouth, gastroenteritis, mouth ulceration, rectal hemorrhage, ulcerative stomatitis, lip swelling, swollen tongue[Ref]
Nervous system
Common (1% to 10%): Headache, migraine, hypokinesia, dysgeusia, somnolence, hypertonia, hyperesthesia, paresthesia
Postmarketing reports: Dizziness, drowsiness, lethargy, taste perversion[Ref]
Renal
Common (1% to 10%): Creatinine increased
Very rare (less than 0.01%): Renal failure[Ref]
Hepatic
Common (1% to 10%): SGOT increased, SGPT increased[Ref]
Metabolic
Common (1% to 10%): Hypercholesterolemia, hyperglycemia
Postmarketing reports: Appetite decreased[Ref]
Musculoskeletal
Common (1% to 10%): Back pain, neck pain, arthralgia, arthrosis, myalgia
Postmarketing reports: Leg cramps[Ref]
Ocular
Common (1% to 10%): Eye pain, conjunctivitis
Uncommon (0.1% to 1%): Lacrimation disorder
Postmarketing reports: Abnormal vision, blurred vision, cataract, eye disorder[Ref]
Respiratory
Common (1% to 10%): Asthma, dyspnea, pharyngitis, pneumonia, rhinitis, sinusitis, sinus congestion
Postmarketing reports: Laryngismus, laryngitis[Ref]
Other
Common (1% to 10%): Accidental injury, asthenia, chest pain, flu-like syndrome, infection, pain, creatine phosphokinase increased, edema
Postmarketing reports: Lack of drug effect, body odor, ear pain[Ref]
Oncologic
Common (1% to 10%): Skin carcinoma[Ref]
Genitourinary
Common (1% to 10%): Hematuria, urinary tract infection[Ref]
Immunologic
Common (1% to 10%): Allergic reaction[Ref]
Psychiatric
Postmarketing reports: Depression[Ref]
Some side effects of Voltaren Gel may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.