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. 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. Adverse Events Leading to Discontinuation of Treatment.
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. See Table 2 for clinically significant drug interactions with diclofenac.
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. In animal reproduction studies, diclofenac epolamine administered orally to pregnant rats and rabbits during the period of organogenesis produced embryotoxicity at approximately 3 and 7 times, respectively, the topical exposure from the maximum recommended human dose MRHD of FLECTOR PATCH.
In rats, increased incidences of skeletal anomalies and maternal toxicity were also observed at this dose. Diclofenac epolamine administered orally to both male and female rats prior to mating and throughout the mating period, and during gestation and lactation in females produced embryotoxicity at doses approximately 3 and 7 times, respectively, the topical exposure from the MRHD see Data.
Based on animal data, prostaglandins have been shown to have an important role in endometrial vascular permeability, blastocyst implantation, and decidualization. In animal studies, administration of prostaglandin synthesis inhibitors such as diclofenac, resulted in increased pre- and post-implantation loss. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.
All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U. Published literature reports that use of NSAIDS, including diclofenac, after 30 weeks' gestation may cause constriction of the patent ductus arteriosus and premature closure of the fetal ductus arteriosus.
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. Data from published literature reports with oral preparations of diclofenac indicate the presence of small amounts of diclofenac in human milk see Data.
There are no data on the effects on the breastfed infant, or the effects on milk production. Published animal studies have shown that administration of prostaglandin synthesis inhibitors has the potential to disrupt prostaglandin- mediated follicular rupture required for ovulation. If the anticipated benefit for the elderly patient outweighs these potential risks, start dosing at the low end of the dosing range, and monitor patients for adverse effects [ see Warnings and Precautions 5.
Other reported clinical experience has not identified differences in responses between the elderly and younger patients. Symptoms following acute NSAID overdosages have been typically limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which have been generally reversible with supportive care. Gastrointestinal bleeding has occurred. Hypertension, acute renal failure, respiratory depression, and coma have occurred, but were rare [ see Warnings and Precautions 5.
There are no specific antidotes. Forced diuresis, alkalinization of urine, hemodialysis, or hemoperfusion may not be useful due to high protein binding. For additional information about overdosage treatment contact a poison control center The release liner is removed prior to topical application to the skin. The chemical name of diclofenac epolamine is 2-[ 2,6-dichlorophenyl amino]benzeneacetic acid, 2- pyrrolidinyl ethanol salt, with a molecular formula of C 20 H 24 Cl 2 N 2 O 3, and molecular weight Each adhesive patch contains mg of diclofenac epolamine 13 mg per gram adhesive in an aqueous base.
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.
Diclofenac is a potent inhibitor of prostaglandin synthesis in vitro. Diclofenac concentrations reached during therapy have produced in vivo effects. Prostaglandins sensitize afferent nerves and potentiate the action of bradykinin in inducing pain in animal models.
Prostaglandins are mediators of inflammation. Because diclofenac is an inhibitor of prostaglandin synthesis, its mode of action may be due to a decrease of prostaglandins in peripheral tissues. 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. Diclofenac diffuses into and out of the synovial fluid.
Diffusion into the joint occurs when plasma levels are higher than those in the synovial fluid, after which the process reverses and synovial fluid levels are higher than plasma levels.
It is not known whether diffusion into the joint plays a role in the effectiveness of diclofenac. Five diclofenac metabolites have been identified in human plasma and urine.
The metabolites include 4'-hydroxy-, 5-hydroxy-, 3'-hydroxy-, 4',5-dihydroxy- and 3'-hydroxy-4'-methoxy diclofenac. The major diclofenac metabolite, 4'hydroxy-diclofenac, has very weak pharmacologic activity. The formation of 4'-hydroxy diclofenac is primarily mediated by CPY2C9. Both diclofenac and its oxidative metabolites undergo glucuronidation or sulfation followed by biliary excretion. CYP3A4 is responsible for the formation of minor metabolites, 5-hydroxy and 3'-hydroxy- diclofenac.
Diclofenac is eliminated through metabolism and subsequent urinary and biliary excretion of the glucuronide and the sulfate conjugates of the metabolites. Little or no free unchanged diclofenac is excreted in the urine. The clinical significance of this interaction is not known. 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.
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. Advise the patient to read the FDA-approved patient labeling Medication Guide that accompanies each prescription dispensed, as well as the Directions for Use on the product packaging.
Advise patients to be alert for the symptoms of cardiovascular thrombotic events, including chest pain, shortness of breath, weakness, or slurring of speech, and to report any of these symptoms to their health care provider immediately [ see Warnings and Precautions 5. Advise patients to report symptoms of ulcerations and bleeding, including epigastric pain, dyspepsia, melena, and hematemesis to their health care provider.
In the setting of concomitant use of low-dose aspirin for cardiac prophylaxis, inform patients of the increased risk for and the signs and symptoms of GI bleeding [ see Warnings and Precautions 5. Advise patients to be alert for the symptoms of congestive heart failure including shortness of breath, unexplained weight gain, or edema and to contact their healthcare provider if such symptoms occur [ see Warnings and Precautions 5.
Inform patients of the signs of an anaphylactic reaction e. Instruct patients to seek immediate emergency help if these occur [ see Contraindications 4 and Warnings and Precautions 5. Advise females of reproductive potential to contact their healthcare provider with a known or suspected pregnancy [see Warnings and Precautions 5.
Alert patients that NSAIDs may be present in "over the counter" medications for treatment of colds, fever, or insomnia. Instruct patients to avoid contact of Flector Patch with the eyes and mucosa. Advise patients that if eye contact occurs, immediately wash out the eye with water or saline and consult a physician if irritation persists for more than an hour [see Warnings and Precautions 5.
NSAIDs are used 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.
Tell your healthcare provider about all of the medicines you take, including prescription or over-the- counter medicines, vitamins or herbal supplements. NSAIDs and some other medicines can interact with each other and cause serious side effects. Do not start taking any new medicine without talking to your healthcare provider first. Get emergency help right away if you get any of the following symptoms:. 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.
This option works whether or not you have health insurance. Click Here for Important Safety Information. Getting the right relief for your pain starts with knowing how to talk with your physician about your condition.
Fill out this brief questionnaire to receive a report that you can discuss with your doctor to determine if Flector is right for you. Acute Pain? Put Flector on it Flector - the original NSAID topical system - is a topical prescription therapy for acute pain due to minor strains, sprains, and contusions.
Non-opioid A non-opioid topical treatment. Experience Backed up by over 30 years of clinical experience.
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