Licart
- Generic Name: diclofenac epolamine topical system
- Brand Name: Licart
- Drug Class: Topical Skin Products
Licart (Diclofenac Epolamine Topical System) side effects drug center
- Related Drugs
- application site itching,
- redness,
- rash, and
- inflammation
- a skin rash, no matter how mild;
- shortness of breath (even with mild exertion);
- swelling or rapid weight gain;
- signs of stomach bleeding--bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
- liver problems--nausea, upper stomach pain, itching, tired feeling, flu-like symptoms, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
- kidney problems--little or no urination, swelling in your feet or ankles, feeling tired or short of breath; or
- low red blood cells (anemia)--pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet.
- heartburn, gas, stomach pain, nausea, vomiting;
- diarrhea, constipation; or
- mild itching, burning, redness, or other skin irritation where the patch was worn.
- Cardiovascular Thrombotic Events [see WARNINGS AND PRECAUTIONS]
- GI Bleeding, Ulceration and Perforation [see WARNINGS AND PRECAUTIONS]
- Hepatotoxicity [see WARNINGS AND PRECAUTIONS]
- Hypertension [see WARNINGS AND PRECAUTIONS]
- Heart Failure and Edema [see WARNINGS AND PRECAUTIONS]
- Renal Toxicity and Hyperkalemia [see WARNINGS AND PRECAUTIONS]
- Anaphylactic Reactions [see WARNINGS AND PRECAUTIONS]
- Serious Skin Reactions [see WARNINGS AND PRECAUTIONS]
- Hematologic Toxicity [see WARNINGS AND PRECAUTIONS]
- 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.
- During concomitant use of LICART and ACE-inhibitors, ARBs, or betablockers, monitor blood pressure to ensure that the desired blood pressure is obtained.
- During concomitant use of LICART 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]. When these drugs are administered concomitantly, patients should be adequately hydrated. Assess renal function at the beginning of the concomitant treatment and periodically thereafter.
What Is Licart?
Licart (diclofenac epolamine) contains a nonsteroidal anti-inflammatory drug (NSAID), and is indicated for the topical (on the skin) treatment of acute pain due to minor strains, sprains, and bruises (contusions).
What Are Side Effects of Licart?
Common side effects of Licart include:
Dosage for Licart
The recommended dose is one (1) Licart topical system to the most painful area once daily.
What Drugs, Substances, or Supplements Interact with Licart?
Licart may interact with anticoagulants, aspirin, selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), ACE inhibitors, angiotensin receptor blockers (ARB), beta-blockers, diuretics, digoxin, lithium, methotrexate, cyclosporine, other NSAIDs or salicylates, or pemetrexed. Tell your doctor all medications and supplements you use.
Licart During Pregnancy and Breastfeeding
Tell your doctor if you are pregnant or plan to become pregnant before using Licart; use of NSAIDs during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. Pregnant women should avoid use of NSAIDs such as Licart starting at 30 weeks gestation. Consult your doctor before breastfeeding.
Additional Information
Our Licart (diclofenac epolamine) Topical System Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
Get emergency medical help if you have signs of an allergic reaction (runny or stuffy nose, hives, wheezing, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).
Get emergency medical help if you have signs of a heart attack or stroke: chest pain spreading to your jaw or shoulder, sudden numbness or weakness on one side of the body, slurred speech, leg swelling, feeling short of breath.
Stop using diclofenac and call your doctor at once if you have:
Common side effects may include:
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Licart (Diclofenac Epolamine Topical System)
SIDE EFFECTS
The following adverse reactions are discussed in greater detail in other sections of the labeling:
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.
A total of 874 subjects were exposed to one or more doses of LICART in eleven clinical studies, including approximately 500 subjects who were treated with LICART in six controlled multiple-dose trials. Approximately 400 of these were exposed to the once-a-day 24-hour application, for up to one week in 288 subjects and up to two weeks in 121 subjects.
Adverse Reactions Leading To Discontinuation Of Treatment
In the controlled trials, none of the patients given LICART discontinued treatment due to an adverse reaction.
Common Adverse Reactions
Localized Reactions
Overall, the most common adverse reactions associated with LICART treatment were application site skin reactions. Table 1 lists all adverse reactions occurring in ≥ 1% of patients in nine studies (excluding the two dermatologic safety
studies) of LICART. A majority of patients treated with LICART experienced adverse reactions with a maximum intensity of “mild” or “moderate”.
Table 1: Common Adverse Reactions (by System Organ Class) in ≥ 1% of Patients Treated with LICART or Placebo based on Data Pooled from Single-Dose and Multiple-Dose Studies
| LICART N=573 | Placebo N=492 |
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| N | Percent | N | Percent | |
| General Disorders and Administration Site Conditions | 8 | 1.4 | 19 | 3.9 |
| Application Site Pruritus | 5 | 0.9 | 11 | 2.2 |
| Other Application Site Reactions† | 5 | 0.9 | 11 | 2.2 |
| *The placebo was comprised of the same ingredients as LICART except for diclofenac and may inform adverse reactions associated with the non-active ingredients contained in LICART. † Includes application site irritation (6 subjects), application site erythema (3 subjects), application site reaction (4 subjects), application site rash (1 subject), application site inflammation (1 subject), blister (1 subject). |
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Post-Marketing Experience
The following adverse reactions have been identified during post-approval use of diclofenac topical system. Because
these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Cases suggesting dermal allergic reactions and photoallergic reactions have been reported through foreign post-marketing surveillance.
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: |
|
| Intervention: | Monitor patients with concomitant use of LICART 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]. |
| 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]. |
| Intervention: | Concomitant use of LICART and analgesic doses of aspirin is not generally recommended because of the increased risk of bleeding [see WARNINGS AND PRECAUTIONS]. LICART 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: |
|
| 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 LICART with diuretics, observe patients for signs of worsening renal function, in addition to assuring diuretic efficacy including antihypertensive effects [see WARNINGS AND PRECAUTIONS]. |
| 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 LICART 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 LICART 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 LICART and methotrexate, monitor patients for methotrexate toxicity. |
| Cyclosporine | |
| Clinical Impact: | Concomitant use of LICART and cyclosporine may increase cyclosporine's nephrotoxicity. |
| Intervention: | During concomitant use of LICART 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]. |
| Intervention: | The concomitant use of diclofenac with other NSAIDs or salicylates is not recommended. |
| Pemetrexed | |
| Clinical Impact: | Concomitant use of LICART and pemetrexed may increase the risk of pemetrexed-associated myelosuppression, renal, and GI toxicity (see the pemetrexed prescribing information). |
| Intervention: | During concomitant use of LICART and pemetrexed, in patients with renal impairment whose creatinine clearance ranges from 45 to 79 mL/min, monitor for myelosuppression, renal and GI 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. |
Read the entire FDA prescribing information for Licart (Diclofenac Epolamine Topical System)
© Licart Patient Information is supplied by Cerner Multum, Inc. and Licart Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.