Flector patch 1.3

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.

It is also supplied in boxes of 30 patches NDC Manufacturer: Teikoku Seiyaku Co. NSAID medicines are used to treat pain and redness, swelling, and heat inflammation from medical conditions such as:. NSAID medicines that need a prescription. This Medication Guide has been approved by the U. Food and Drug Administration.

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. Nursing Mothers It is not known whether this drug is excreted in human milk.

Pediatric Use Safety and effectiveness in pediatric patients have not been established. Adverse events in the placebo group may therefore reflect effects of the non-active ingredients. NSAID medicines may increase the chance of a heart attack or stroke that can lead to death. Get emergency help right away if you have any of the following symptoms:.

Principal Display Panel. Application Site Conditions. Gastrointestinal Disorders. If the medication or patch does come in contact with those areas, flush with plenty of water.

Contact your doctor right away if irritation persists. Dosage is based on your medical condition and response to treatment. To reduce side effect risks such as stomach bleeding , use this medication at the lowest effective dose for the shortest possible length of time. Do not increase your dose or use it more often than prescribed. Discuss the risks and benefits with your doctor or pharmacist. If you are using this drug "as needed" not on a regular schedule , remember that pain medications work best if they are used as the first signs of pain occur.

If you wait until the pain has worsened, the medicine may not work as well. Itching, burning, irritation, redness, or dry skin may occur at the application site. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects.

Many people using this medication do not have serious side effects. This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high.

This drug may rarely cause serious possibly fatal liver problems. Get medical help right away if you have any symptoms of liver damage, including:.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. Call your doctor for medical advice about side effects.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at Before using diclofenac, tell your doctor or pharmacist if you are allergic to it; or to aspirin; or to other NSAIDs such as ibuprofen, naproxen, celecoxib ; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:. Problems are more likely to occur if you are dehydrated, have heart failure or kidney disease, are an older adult, or if you take certain medications see also Drug Interactions section.

Drink plenty of fluids as directed by your doctor to prevent dehydration and tell your doctor right away if you have a change in the amount of urine. If you are going to have an MRI test, tell testing personnel that you are using this patch. Some patches may contain metals that can cause serious burns during an MRI.

Ask your doctor whether you will need to remove your patch before the test and apply a new patch afterward, and how to do so properly. This medicine may cause stomach bleeding. Daily use of alcohol and tobacco may increase your risk for stomach bleeding, especially when combined with this medicine. Limit alcohol and stop smoking. Consult your doctor or pharmacist for more information. This medication may make you more sensitive to the sun. Limit your time in the sun. Avoid tanning booths and sunlamps.

Use sunscreen and wear protective clothing when outdoors. Before using this medication, women of childbearing age should talk with their doctor s about the benefits and risks. Tell your doctor if you are pregnant or if you plan to become pregnant. It also contains the following inactive ingredients: 1,3-butylene glycol, dihydroxyaluminum aminoacetate, disodium edetate, D-sorbitol, fragrance Dalin PH , gelatin, kaolin, methylparaben, polysorbate 80, povidone, propylene glycol, propylparaben, sodium carboxymethylcellulose, sodium polyacrylate, tartaric acid, titanium dioxide, and purified water.

In pharmacologic studies, diclofenac has shown anti-inflammatory, analgesic, and antipyretic activity. As with other NSAIDs, its mode of action is not known; its ability to inhibit prostaglandin synthesis, however, may be involved in its anti-inflammatory activity, as well as contribute to its efficacy in relieving pain associated with inflammation.

Following a single application of the Flector Patch on the upper inner arm, peak plasma concentrations of diclofenac range 0. Plasma concentrations of diclofenac in the range of 1.

No clinically relevant differences in systemic absorption were observed, with peak plasma concentrations in the range of 2. The plasma elimination half-life of diclofenac after application of Flector Patch is approximately 12 hours. Diclofenac is eliminated through metabolism and subsequent urinary and biliary excretion of the glucuronide and the sulfate conjugates of the metabolites. 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. Clinical trials of several COX-2 selective and nonselective NSAIDs of up to three years duration have shown an increased risk of serious cardiovascular CV thrombotic events, myocardial infarction, and stroke, which can be fatal. Patients with known CV disease or risk factors for CV disease may be at greater risk.

To minimize the potential risk for an adverse CV event in patients treated with an NSAID, the lowest effective dose should be used for the shortest duration possible.

Physicians and patients should remain alert for the development of such events, even in the absence of previous CV symptoms. There is no consistent evidence that concurrent use of aspirin mitigates the increased risk of serious CV thrombotic events associated with NSAID use. Patients taking thiazides or loop diuretics may have impaired response to these therapies when taking NSAIDs.

These serious adverse events can occur at any time, with or without warning symptoms, in patients treated with NSAIDs. These trends continue with longer duration of use, increasing the likelihood of developing a serious GI event at some time during the course of therapy. However, even short-term therapy is not without risk. NSAIDs should be prescribed with extreme caution in those with a prior history of ulcer disease or gastrointestinal bleeding.

Other factors that increase the risk for GI bleeding in patients treated with NSAIDs include concomitant use of oral corticosteroids or anticoagulants, longer duration of NSAID therapy, smoking, use of alcohol, older age, and poor general health status.

Most spontaneous reports of fatal GI events are in elderly or debilitated patients and therefore, special care should be taken in treating this population. To minimize the potential risk for an adverse GI event in patients treated with an NSAID, the lowest effective dose should be used for the shortest possible duration. Patients and physicians should remain alert for signs and symptoms of GI ulceration and bleeding during NSAID therapy and promptly initiate additional evaluation and treatment if a serious GI adverse event is suspected.

Renal toxicity has also been seen in patients in whom renal prostaglandins have a compensatory role in the maintenance of renal perfusion. In these patients, administration of a nonsteroidal anti-inflammatory drug may cause a dose-dependent reduction in prostaglandin formation and, secondarily, in renal blood flow, which may precipitate overt renal decompensation. Patients at greatest risk of this reaction are those with impaired renal function, heart failure, liver dysfunction, those taking diuretics and ACE inhibitors, and the elderly.

Emergency help should be sought in cases where an anaphylactoid reaction occurs. These serious events may occur without warning. Patients should be informed about the signs and symptoms of serious skin manifestations and use of the drug should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity. Abrupt discontinuation of corticosteroids may lead to disease exacerbation.

Patients on prolonged corticosteroid therapy should have their therapy tapered slowly if a decision is made to discontinue corticosteroids. These laboratory abnormalities may progress, may remain unchanged, or may be transient with continuing therapy.

In addition, rare cases of severe hepatic reactions, including jaundice and fatal fulminant hepatitis, liver necrosis and hepatic failure, some of them with fatal outcomes have been reported. If clinical signs and symptoms consistent with liver disease develop, or if systemic manifestations occur e. This may be due to fluid retention, occult or gross GI blood loss, or an incompletely described effect upon erythropoiesis. NSAIDs inhibit platelet aggregation and have been shown to prolong bleeding time in some patients.

Unlike aspirin, their effect on platelet function is quantitatively less, of shorter duration, and reversible. Patients with asthma may have aspirin-sensitive asthma. The use of aspirin in patients with aspirin-sensitive asthma has been associated with severe bronchospasm which can be fatal. If eye contact occurs, immediately wash out the eye with water or saline.