Flextor pain patch

If eye contact occurs, immediately wash out the eye with water or saline. Consult a physician if irritation persists for more than an hour. Patients should be informed of the following information before initiating therapy with an NSAID and periodically during the course of ongoing therapy.

Although serious CV events can occur without warning symptoms, patients should be alert for the signs and symptoms of chest pain, shortness of breath, weakness, slurring of speech, and should ask for medical advice when observing any indicative sign or symptoms. Although serious GI tract ulcerations and bleeding can occur without warning symptoms, patients should be alert for the signs and symptoms of ulcerations and bleeding, and should ask for medical advice when observing any indicative sign or symptoms including epigastric pain, dyspepsia, melena, and hematemesis.

Although serious skin reactions may occur without warning, patients should be alert for the signs and symptoms of skin rash and blisters, fever, or other signs of hypersensitivity such as itching, and should ask for medical advice when observing any indicative signs or symptoms. Patients should be advised to stop the drug immediately if they develop any type of rash and contact their physicians as soon as possible.

Patients should be informed of the warning signs and symptoms of hepatotoxicity e. If these occur, patients should be instructed to stop therapy and seek immediate medical therapy. Patients should be informed of the signs of an anaphylactoid reaction e. Patients should be instructed that if eye contact occurs, they should immediately wash out the eye with water or saline, and consult a physician if irritation persists for more than an hour.

Patients and caregivers should be instructed to wash their hands after applying, handling or removing the patch. Because serious GI tract ulcerations and bleeding can occur without warning symptoms, physicians should monitor for signs or symptoms of GI bleeding. If clinical signs and symptoms consistent with liver or renal disease develop, systemic manifestations occur e. The clinical significance of this interaction is not known; however, as with other NSAIDs, concomitant administration of diclofenac and aspirin is not generally recommended because of the potential of increased adverse effects.

This response has been attributed to inhibition of renal prostaglandin synthesis. NSAIDs have produced an elevation of plasma lithium levels and a reduction in renal lithium clearance.

Thus, when NSAIDs and lithium are administered concurrently, subjects should be observed carefully for signs of lithium toxicity. NSAIDs have been reported to competitively inhibit methotrexate accumulation in rabbit kidney slices. This may indicate that they could enhance the toxicity of methotrexate. The effects of warfarin and NSAIDs on GI bleeding are synergistic, such that users of both drugs together have a risk of serious GI bleeding higher than users of either drug alone.

Long-term studies in animals have not been performed to evaluate the carcinogenic potential of either diclofenac epolamine or Flector Patch. Diclofenac epolamine is not mutagenic in Salmonella Typhimurium strains, nor does it induce an increase in metabolic aberrations in cultured human lymphocytes, or the frequency of micronucleated cells in the bone marrow micronucleus test performed in rats. There are no adequate and well-controlled studies in pregnant women.

Flector Patch should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Because of the known effects of nonsteroidal anti-inflammatory drugs on the fetal cardiovascular system closure of ductus arteriosus , use during pregnancy particularly late pregnancy should be avoided.

The number of live born and total born were also reduced as was F1 postnatal survival, but the physical and behavioral development of surviving F1 pups in all groups was the same as the deionized water control, nor was reproductive performance adversely affected despite a slight treatment-related reduction in body weight.

In rat studies with NSAIDs, as with other drugs known to inhibit prostaglandin synthesis, an increased incidence of dystocia, delayed parturition, and decreased pup survival occurred.

It is not known whether this drug is excreted in human milk. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. Application site reactions leading to dropout included pruritus, dermatitis, and burning. Additionally, the treated area may become irritated or develop itching, erythema, edema, vesicles, or abnormal sensation. There were no serious adverse events. Should systemic side effects occur due to incorrect use or accidental overdose of this product, the general measures recommended for intoxication with non-steroidal anti-inflammatory drugs should be taken.

Patients and caregivers should wash their hands after applying, handling or removing the patch. Eye contact should be avoided. Each patch contains mg of diclofenac epolamine in an aqueous base 13 mg of active per gram of adhesive or 1. Manufacturer: Teikoku Seiyaku Co. NSAID medicines are used to treat pain and redness, swelling, and heat inflammation from medical conditions such as:. NSAIDs and some other medicines can interact with each other and cause serious side effects.

Keep a list of your medicines to show to your healthcare provider and pharmacist. NSAID medicines should not be used by pregnant women late in their pregnancy. Get emergency help right away if you have any of the following symptoms:.

Stop your NSAID medicine and call your healthcare provider right away if you have any of the following symptoms:. Aspirin can cause bleeding in the brain, stomach, and intestines. Aspirin can also cause ulcers in the stomach and intestines. This Medication Guide has been approved by the U. Food and Drug Administration. NDC Flector Patch 1. Cardiovascular Risk NSAIDs 1 may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal.

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. Pharmacokinetics Absorption Following a single application of the Flector Patch on the upper inner arm, peak plasma concentrations of diclofenac range 0. Metabolism and Excretion The plasma elimination half-life of diclofenac after application of Flector Patch is approximately 12 hours. Preexisting Asthma Patients with asthma may have aspirin-sensitive asthma.

Information for Patients Patients should be informed of the following information before initiating therapy with an NSAID and periodically during the course of ongoing therapy. Laboratory Tests Because serious GI tract ulcerations and bleeding can occur without warning symptoms, physicians should monitor for signs or symptoms of GI bleeding.

Lithium NSAIDs have produced an elevation of plasma lithium levels and a reduction in renal lithium clearance. Methotrexate NSAIDs have been reported to competitively inhibit methotrexate accumulation in rabbit kidney slices.

Warfarin The effects of warfarin and NSAIDs on GI bleeding are synergistic, such that users of both drugs together have a risk of serious GI bleeding higher than users of either drug alone. Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Long-term studies in animals have not been performed to evaluate the carcinogenic potential of either diclofenac epolamine or Flector Patch.

Mutagenesis Diclofenac epolamine is not mutagenic in Salmonella Typhimurium strains, nor does it induce an increase in metabolic aberrations in cultured human lymphocytes, or the frequency of micronucleated cells in the bone marrow micronucleus test performed in rats. Nonteratogenic Effects Because of the known effects of nonsteroidal anti-inflammatory drugs on the fetal cardiovascular system closure of ductus arteriosus , use during pregnancy particularly late pregnancy should be avoided.

Labor and Delivery In rat studies with NSAIDs, as with other drugs known to inhibit prostaglandin synthesis, an increased incidence of dystocia, delayed parturition, and decreased pup survival occurred. Flector Direct Program With Flector Direct, you can get the lowest out-of-pocket price available for your prescription and have it delivered directly to your home by ordering from a network of participating mail-order pharmacies.

Flector vs. What is Acute Pain. What is acute pain? Acute pain is short-term pain lasting less than 6 months that's often described as a physical sensation such as stabbing, burning, twisting, tearing, or squeezing.

Why do people experience acute pain? Acute short-term pain may be a signal that your body is experiencing—or has experienced—some type of tissue damage. What types of minor injuries can cause acute pain? Acute pain may result from minor injuries, including strains, sprains, and contusions. If you're experiencing pain from any of these injuries, talk to your doctor about your treatment options. Take the Self-Assessment to find out if Flector is right for you Getting the right relief for your pain starts with knowing how to talk with your physician about your condition.

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