Licart (diclofenac epolamine): NSAID Side Effects & Warnings

Generic drug: diclofenac epolamine

Brand name: Licart

What is Licart (diclofenac epolamine), and how does it work?

Licart (diclofenac epolamine) is a topical NSAID (non-steroidal anti-inflammatory drug) used on the skin to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as different types of arthritis, menstrual cramps, and other types of short-term pain.

What are the side effects of Licart?

WARNING

RISK OF SERIOUS CARDIOVASCULAR and GASTROINTESTINAL EVENTS

Cardiovascular Thrombotic Events

• Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use.
• Licart is contraindicated in the setting of coronary artery bypass graft (CABG) surgery.

Gastrointestinal Bleeding, Ulceration, and Perforation

• NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events.

Licasrt can cause serious side effects, including:

• new or worse high blood pressure
• heart failure
• liver problems including liver failure
• kidney problems including kidney failure
• low red blood cells (anemia)
• life-threatening skin reactions
• life-threatening allergic reactions

Other side effects of NSAIDs include:

• stomach pain,
• constipation,
• diarrhea,
• gas,
• heartburn,
• nausea,
• vomiting, and
• dizziness.

Get emergency help right away if you get any of the following symptoms:

• shortness of breath or trouble breathing
• chest pain
• weakness in one part or side of your body
• slurred speech
• swelling of the face or throat

Stop taking your NSAID and call your healthcare provider right away if you get any of the following symptoms:

• nausea
• more tired or weaker than usual
• diarrhea
• itching
• your skin or eyes look yellow
• indigestion or stomach pain
• flu-like symptoms
• vomit blood
• there is blood in your bowel movement or it is black and sticky like tar
• unusual weight gain
• skin rash or blisters with fever
• swelling of the arms, legs, hands and feet

If you take too much of your NSAID, call your healthcare provider or get medical help right away.

These are not all the possible side effects of NSAIDs. For more information, ask your healthcare provider or pharmacist about NSAIDs.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the dosage for Licart?

Important Dosage And Administration Information

Use the lowest effective dosage for the shortest duration consistent with
individual patient treatment goals.

Licart is intended for topical use only.

Convey the following important administration instructions to the patient:

• If Licart begins to peel-off, the edges of the topical system may be taped down. If problems with adhesion persist, patients may overlay the topical system with a mesh netting sleeve, where appropriate (e.g., to secure topical systems applied to ankles, knees, or elbows). The mesh netting sleeve (e.g., Curad Hold Tite, Surgilast Tubular Elastic Dressing) must allow air to pass through and not be occlusive (i.e., non-breathable) .
• Do not apply Licart to non-intact or damaged skin resulting from any etiology, e.g., exudative dermatitis, eczema, infected lesion, burns or wounds.
• Do not wear a Licart topical system when bathing or showering.
• Wash your hands after applying, handling, or removing the topical system.
• Avoid contact with eyes.
• Do not use Licart in combination with an oral NSAID unless the benefit outweighs the risk and periodic laboratory evaluations are conducted.

Recommended Dose

The recommended dose is one (1) Licart topical system to the most painful area once daily.

Medically speaking, the term “myalgia” refers to what type of pain?
See Answer

What drugs interact with Licart?

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 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.

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.

Intervention:
Concomitant use of Licart and analgesic doses of aspirin is not
generally recommended because of the increased risk of bleeding.
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:

• 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. 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 Licart with diuretics, observe
patients for signs of worsening renal function, in addition to
assuring diuretic efficacy including antihypertensive effects.

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.

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.

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Is Licart safe to use while pregnant or breastfeeding?

• Published literature reports that use of NSAIDs, including Licart, after 30 weeks’ gestation increases the risk of premature closure of the fetal ductus arteriosus.
• Data from observational studies regarding potential embryofetal risks of NSAID use, including diclofenac, in women in the first or second trimester of pregnancy are inconclusive.
• Avoid use of NSAIDs, including Licart, in pregnant women starting at 30 weeks of gestation (third trimester).
• Data from published literature reports with oral preparations of diclofenac indicate the presence of small amounts of diclofenac in human milk.
• There are no data on the effects on the breastfed infant or the effects on milk production.
• The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for
  Licart and any potential adverse effects on the breastfed infant from Licart or from the underlying maternal condition.