TM Owner IBSA Pharma Inc.
Licart 1.30% Topical System
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Indications & Clinical Uses
- Licart 1.30% is a diclofenac epolamine topical system, a medicated patch that delivers the non-steroidal anti-inflammatory drug (NSAID) diclofenac through the skin.
- It is approved in the United States for the topical treatment of acute pain due to minor strains, sprains and contusions in adults and children aged 6 years and older.
- One topical system is applied to the most painful area once daily.
- Licart is manufactured for IBSA Institut Biochimique SA in Switzerland and distributed by IBSA Pharma Inc. in the United States, and it is closely related to Flector, the diclofenac epolamine patch from the same company; the two products differ in strength and application schedule and are not interchangeable.
- Licart is a prescription topical NSAID and is not the same as over-the-counter diclofenac gel.
- Use the lowest effective dose for the shortest duration that treats your symptoms.
Side Effects
- Because Licart is applied to the skin, side effects are mostly local and uncommon: in clinical trials application site itching occurred in 0.9% of people and other application site reactions such as irritation, redness, rash or dryness in about 0.9%.
- Licart carries a BOXED WARNING.
- 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.
- NSAIDs also cause an increased risk of serious gastrointestinal bleeding, ulceration and perforation of the stomach or intestines, which can be fatal and can occur at any time without warning symptoms.
- Licart is contraindicated in the setting of coronary artery bypass graft surgery.
- Remove the system and seek urgent help for chest pain, one-sided weakness, slurred speech, black or bloody stools, vomiting blood, or a spreading rash with blistering.
Precautions & Warnings
- Apply Licart to intact skin only.
- It must not be applied to non-intact or damaged skin such as exudative dermatitis, eczema, infected lesions, burns or wounds, and it should not be worn while bathing or showering.
- Do not use Licart if aspirin or another NSAID has ever caused asthma, hives or an allergic-type reaction, or after coronary artery bypass graft surgery.
- Use the lowest effective dose for the shortest time in people with high blood pressure, heart failure, fluid retention, kidney impairment, liver disease or a history of ulcers or bleeding; liver tests should be checked at baseline and periodically and treatment stopped if liver disease develops.
- Serious skin reactions including Stevens-Johnson syndrome, toxic epidermal necrolysis and DRESS have been reported with NSAIDs.
- Avoid use from about 20 weeks of pregnancy because of fetal kidney problems and low amniotic fluid, and avoid it altogether from 30 weeks because of premature closure of the ductus arteriosus.
Avoid Interactions
- Toxicity increases when Licart is combined with other NSAIDs or salicylates, including analgesic doses of aspirin, so these should not be used together; with anticoagulants such as warfarin, with antiplatelet drugs and with SSRIs or SNRIs, all of which raise the risk of serious gastrointestinal bleeding; with corticosteroids, which add to ulcer risk; and with digoxin, lithium, methotrexate and ciclosporin, whose blood levels or toxicity can rise.
- Alcohol and smoking further increase bleeding risk.
- Licart can reduce the efficacy of ACE inhibitors, angiotensin receptor blockers, beta-blockers and diuretics, and kidney function should be monitored when these are combined, particularly in older people, those who are dehydrated and those already on an ACE inhibitor plus a diuretic.
- Tell your healthcare provider about every prescription medicine, over-the-counter painkiller, herbal remedy and supplement you take, and do not apply other topical products to the same patch of skin.
References
Frequently Asked Questions
Licart (diclofenac epolamine) is a 1.3% medicated patch that treats acute pain from minor strains, sprains and bruises in adults and children aged 6 and over. It delivers a non-steroidal anti-inflammatory drug through the skin into the painful area. It is meant for short-term use.
Apply one Licart topical system to the most painful area once a day, on clean intact skin only. Never place it on broken, damaged, infected or irritated skin, and do not wear it while bathing or showering. Wash your hands after handling the patch.
Side effects of Licart (diclofenac epolamine) are mostly local: itching, irritation, redness, rash or dryness where the patch sits, each in about 1% of people. As an NSAID it also carries a boxed warning for heart attack, stroke and stomach bleeding. Get urgent help for chest pain or black stools.
Avoid other NSAIDs, including ibuprofen and painkilling doses of aspirin, while using Licart. Do not use it after coronary artery bypass surgery, or if aspirin or NSAIDs have ever caused asthma or hives. Limit alcohol, and tell your provider about warfarin, SSRIs, steroids, lithium and methotrexate.
Store Licart at 20°C to 25°C, with short excursions allowed between 15°C and 30°C. Keep the systems in the re-sealable envelope and close it after each use; once opened, the envelope contents stay stable for up to 6 months at room temperature. Each box holds 3 envelopes of 5 systems.
Not in later pregnancy. Avoid Licart (diclofenac epolamine) from about 20 weeks because it can damage the unborn baby's kidneys and lower amniotic fluid, and avoid it completely from 30 weeks because it can close a fetal heart vessel early. Tell your provider if you are pregnant.
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