Flector

Name: Flector

Flector Food Interactions

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Flector there are no specific foods that you must exclude from your diet when receiving Flector.

 

Flector and Lactation

Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known if the medication in Flector patch is excreted in human breast milk or if it will harm your nursing baby.

Flector FDA Warning

Cardiovascular Risk

  • Nonsteroidal anti-inflammatory drugs (NSAIDs) may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk.
  • Flector is contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery.

Gastrointestinal Risk

  • NSAIDs cause an increased risk of serious gastrointestinal 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 are at greater risk for serious gastrointestinal events.

What do I need to tell my doctor BEFORE I take Flector?

  • If you have an allergy to diclofenac or any other part of Flector.
  • If you have an allergy to aspirin or NSAIDs.
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you have any of these health problems: GI (gastrointestinal) bleeding or kidney problems.
  • If you are having trouble getting pregnant or you are having your fertility checked.
  • If you are pregnant or may be pregnant. Do not take this medicine if you are in the third trimester of pregnancy. You may also need to avoid Flector at other times during pregnancy. Talk with your doctor to see when you need to avoid taking this medicine during pregnancy.
  • If you are taking any other NSAID.
  • If you are taking a salicylate drug like aspirin.
  • If you are taking pemetrexed.

This is not a list of all drugs or health problems that interact with Flector.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

How is this medicine (Flector) best taken?

Use Flector as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • Do not take this medicine by mouth. Use on your skin only. Keep out of your mouth, nose, and eyes (may burn).
  • Wash your hands before and after use.
  • Clean affected part before use. Make sure to dry well.
  • Put patch on clean, dry, healthy skin.
  • Do not put on cuts, scrapes, eczema, or damaged skin.
  • Do not bathe, shower, or swim after putting on.
  • If the patch falls off, put a new one on.
  • If the patch loosens, put tape over it to hold it in place.

What do I do if I miss a dose?

  • Put on a missed dose as soon as you think about it.
  • If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
  • Do not put on 2 doses or extra doses.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Chest pain or pressure.
  • Shortness of breath, a big weight gain, or swelling in the arms or legs.
  • Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
  • A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.
  • Signs of bleeding like throwing up blood or throw up that looks like coffee grounds; coughing up blood; blood in the urine; black, red, or tarry stools; bleeding from the gums; vaginal bleeding that is not normal; bruises without a reason or that get bigger; or any bleeding that is very bad or that you cannot stop.
  • Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
  • Signs of high potassium levels like a heartbeat that does not feel normal; feeling confused; feeling weak, lightheaded, or dizzy; feeling like passing out; numbness or tingling; or shortness of breath.
  • Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
  • A fast heartbeat.
  • Very bad belly pain.
  • Very bad back pain.
  • Feeling very tired or weak.
  • Flu-like signs.
  • Liver problems have happened with drugs like this one. Sometimes, this has been deadly. Call your doctor right away if you have signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.

What are some other side effects of Flector?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Skin irritation.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Adverse Reactions

The following adverse reactions are discussed in greater detail in other sections of the labeling:

  • Cardiovascular Thrombotic Events [see Warnings and Precautions (5.1)]
  • GI Bleeding, Ulceration and Perforation [see Warnings and Precautions (5.2)]
  • Hepatotoxicity [see Warnings and Precautions (5.3)]
  • Hypertension [see Warnings and Precautions (5.4)]
  • Heart Failure and Edema [see Warnings and Precautions (5.5)]
  • Renal Toxicity and Hyperkalemia [see Warnings and Precautions (5.6)]
  • Anaphylactic Reactions [see Warnings and Precautions (5.7)]
  • Serious Skin Reactions [see Warnings and Precautions (5.9)]
  • Hematologic Toxicity [see Warnings and Precautions (5.11)]

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.

In controlled trials during the premarketing development of Flector PATCH, approximately 600 patients with minor sprains, strains, and contusions were treated with Flector PATCH for up to two weeks.

Adverse Events Leading to Discontinuation of Treatment

In the controlled trials, 3% of patients in both the Flector PATCH and placebo patch groups discontinued treatment due to an adverse event. The most common adverse events leading to discontinuation were application site reactions, occurring in 2% of both the Flector PATCH and placebo patch groups. Application site reactions leading to dropout included pruritus, dermatitis, and burning.

Common Adverse Events

Localized Reactions

Overall, the most common adverse events associated with Flector PATCH treatment were skin reactions at the site of treatment. Table 1 lists all adverse events, regardless of causality, occurring in ≥ 1% of patients in controlled trials of Flector PATCH. A majority of patients treated with Flector PATCH had adverse events with a maximum intensity of "mild" or "moderate."

Table 1. Common Adverse Events (by body system and preferred term) in ≥ 1% of Patients treated with Flector PATCH or Placebo Patch *
Category Diclofenac
N=572		 Placebo
N=564
N Percent N Percent
* The table lists adverse events occurring in placebo-treated patients because the placebo-patch was comprised of the same ingredients as Flector PATCH except for diclofenac. Adverse events in the placebo group may therefore reflect effects of the non-active ingredients. † Includes: application site dryness, irritation, erythema, atrophy, discoloration, hyperhidriosis, and vesicles. ‡ Includes: gastritis, vomiting, diarrhea, constipation, upper abdominal pain, and dry mouth. § Includes: hypoesthesia, dizziness, and hyperkinesias.
Application Site Conditions 64 11 70 12
  Pruritus 31 5 44 8
  Dermatitis 9 2 3 <1
  Burning 2 <1 8 1
  Other† 22 4 15 3
Gastrointestinal Disorders 49 9 33 6
  Nausea 17 3 11 2
  Dysgeusia 10 2 3 <1
  Dyspepsia 7 1 8 1
  Other‡ 15 3 11 2
Nervous System Disorders 13 2 18 3
  Headache 7 1 10 2
  Paresthesia 6 1 8 1
  Somnolence 4 1 6 1
  Other § 4 1 3 <1

Foreign labeling describes that dermal allergic reactions may occur with Flector PATCH treatment. Additionally, the treated area may become irritated or develop itching, erythema, edema, vesicles, or abnormal sensation.

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 Flector PATCH 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 Flector PATCH and analgesic doses of aspirin is not generally recommended because of the increased risk of bleeding [see Warnings and Precautions (5.11)].

Flector PATCH 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 Flector PATCH and ACE-inhibitors, ARBs, or beta-blockers, monitor blood pressure to ensure that the desired blood pressure is obtained.
  • During concomitant use of Flector PATCH 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 Flector PATCH 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 Flector PATCH 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 Flector PATCH 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 Flector PATCH and methotrexate, monitor patients for methotrexate toxicity.
Cyclosporine
Clinical Impact: Concomitant use of Flector PATCH and cyclosporine may increase cyclosporine's nephrotoxicity.
Intervention: During concomitant use of Flector PATCH 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 Flector PATCH and pemetrexed may increase the risk of pemetrexed-associated myelosuppression, renal, and GI toxicity (see the pemetrexed prescribing information).
Intervention: During concomitant use of Flector PATCH 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.

Clinical Studies

Ankle Sprains

Efficacy of Flector PATCH was demonstrated in two of four studies of patients with minor sprains, strains, and contusions. Patients were randomly assigned to treatment with the Flector PATCH, or a placebo patch identical to the Flector PATCH minus the active ingredient. In the first of these two studies, patients with ankle sprains were treated once daily for a week. In the second study, patients with sprains, strains and contusions were treated twice daily for up to two weeks. Pain was assessed over the period of treatment. Patients treated with the Flector PATCH experienced a greater reduction in pain as compared to patients randomized to placebo patch as evidenced by the responder curves presented below (Figures 1-4).

Figure 1: Patients Achieving Various Levels of Pain Relief at Day 3; 14-Day Study

Figure 2: Patients Achieving Various Levels of Pain Relief at End of Study; 14-Day Study

Figure 3: Patients Achieving Various Levels of Pain Relief at Day 3; 7-Day Study

Figure 4: Patients Achieving Various Levels of Pain Relief at End of Study; 7-Day Study

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