- April 12, 2021
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Your list will be saved and can be edited at any time. Diclofenac is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Do not start taking any new medicine without talking to your healthcare provider first. Call your doctor for medical advice about side effects. NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. provider for the most current information. Some observational studies found that this increased risk of serious CV thrombotic events began as early as the first weeks of treatment. Drugs, encoded search term (diclofenac (Voltaren XR%2C Cataflam)) and diclofenac (Voltaren XR, Cataflam), Oral Mosapride Can Provide Additional Antiemetic Efficacy Following Total Joint Arthroplasty Under General Anesthesia, Malpractice Case: When 'Normal' Test Results Get You Into Trouble, Brand-Name Prescription Drug Prices Skyrocketing for Seniors, Medscape Rheumatologist Compensation Report 2018, Fast Five Quiz: Lyme Disease Practice Essentials, Greater Reductions in Knee OA Pain Seen With Supportive Rather Than Flexible Shoes, My Personal Experience With the Pfizer Vaccine, FDA Approves Voclosporin for Lupus Nephritis. 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. Diclofenac sodium extended-release tablets, USP are a benzene-acetic acid derivative. In the setting of concomitant use of low-dose aspirin for cardiac prophylaxis, inform patients of the increased risk for the signs and symptoms of GI bleeding (see WARNINGS: Gastrointestinal Bleeding, Ulceration, and Perforation). When co-administered with voriconazole (inhibitor of CYP2C9, 2C19 and 3A4 enzyme), the Cmax and AUC of diclofenac increased by 114% and 78%, respectively (see PRECAUTIONS: Drug Interactions). Diclofenac sodium: 50 mg PO q8hr or 75 mg PO q12hr, Extended release: 100 mg PO once daily; may be increased to 100 mg PO q12hr, Diclofenac sodium: 25 mg PO 4 or 5 times daily, Immediate-release (Cataflam): 100 mg PO once, then 50 mg PO q8hr PRN, Immediate-release tab (Cataflam): 100 mg PO once, then 50 mg PO q8hr PRN, Indicated for management of mild-to-moderate pain and moderate-to-severe pain alone or in combination with opioid analgesics, Use for the shortest duration consistent with individual patient treatment goals, 37.5 mg IV bolus injection infused over 15 seconds q6hr as needed, not to exceed 150 mg/day, To reduce the risk of renal adverse reactions, patients must be well hydrated prior to IV administration, Oral solution: 50 mg (1 packet) in 30-60 mL of water, mixed well and drunk immediately, Diclofenac potassium: Cambia, Cataflam, Zipsor, Take with food or 8-12 oz of water to avoid GI adverse effects, Zorvolex: Take on empty stomach; food decreases AUC by 11% and peak concentration by 60%, Oral solution: Do not use liquids other than water to reconstitute; foods decrease effectiveness, Safety and efficacy not established; drug has been used safely in limited number of children aged 3-16 years with juvenile rheumatoid arthritis, <3 years: Safety and efficacy not established, ≥3 years: 2-3 mg/kg/day for up to 4 weeks, Blood urea nitrogen (BUN) >40 mg/dL (>14.3 mmol/L), Absolute: Hypersensitivity to diclofenac, history of aspirin triad, treatment of perioperative pain associated with CABG; active gastrointestinal bleeding, IV: Moderate-to severe renal insufficiency in the perioperative period and patients who are at risk for volume depletion, Zipsor capsules are contraindicated in patients with history of hypersensitivity to bovine protein, Use caution in patients with bronchospasm, cardiac disease, CHF, hepatic porphyria, hypertension, fluid retention, severe renal impairment, smoking, systemic lupus erythematosus, Platelet aggregation and adhesion may be decreased; may prolong bleeding time, Use caution in blood dyscrasias or bone marrow depression; also with thrombocytopenia, agranulocytosis, and aplastic anemia, Long-term administration of NSAIDs may result in renal papillary necrosis and other renal injury; patients at greatest risk include elderly individuals, those with impaired renal function, hypovolemia, heart failure, liver dysfunction, or salt depletion, and those taking diuretics, angiotensin-converting enzyme inhibitors, or angiotensin-receptor blockers, Therapy may increase risk of hyperkalemia, especially in renal disease, diabetics, the elderly, and concomitant use of agents that may induce hyperkalemia; monitor potassium closely, May cause dizziness blurred vision and neurologic effects that may impair physical and mental abilities, Risk of serious skin reactions, including Stevens Johnson syndrome and necrotizing enterocolitis, Persistent urinary symptoms, including bladder pain and dysuria, hematuria or cystitis may occur after initiating therapy; discontinue therapy with symptom onset and evaluate cause, Increase in transaminase levels reported within 2 months of therapy; may occur at any time; monitor transaminase levels periodically beginning 4-8 weeks after initiation of therapy, May increase risk of aseptic meningitis (rare), especially in patients with systemic lupus erythrmatosus, and mixed connective tissue disorders, Use caution if patient dehydrated before initiating therapy; rehydrate patient before initiating therapy and monitor renal function closely, Injectable dosage form not recommended for long-term use, Overuse of acute migraine drugs (eg, ergotamine, triptans, opioids, nonsteroidal anti-inflammatory drugs or combination of these drugs for 10 or more days per month) may lead to exacerbation of headache (medication overuse headache); may present as migraine-like daily headaches or as a marked increase in frequency of migraine attacks; detoxification of patients, including withdrawal of overused drugs and treatment of withdrawal symptoms (which often includes a transient worsening of headache) may be necessary, Different formulations not bioequivalent even if milligram strength the same; do not interchange products, Withhold for at least 4-6 half-lives prior to surgical or dental procedures, Published literature reports that use of NSAIDs after 30 weeks’ gestation increases risk of premature closure of fetal ductus arteriosus; data from observational studies regarding potential embryofetal risks of NSAID use, including diclofenac, in women in first or second trimester of pregnancy are inconclusive; avoid use of NSAIDs in pregnant women starting at 30 weeks of gestation (third trimester), Data from published literature reports with oral preparations of diclofenac indicate presence of small amounts of diclofenac in human milk; there are no data on effects on breastfed infant, or on milk production; consider developmental and health benefits of breastfeeding along with mother’s clinical need for therapy and any potential adverse effects on breastfed infant from treatment or from underlying maternal condition. Avoid the use of diclofenac sodium extended-release tablets in patients with a recent MI unless the benefits are expected to outweigh the risk of recurrent CV thrombotic events. Co-administration of diclofenac with CYP2C9 inhibitors (e.g., voriconazole) may enhance the exposure and toxicity of diclofenac whereas co-administration with CYP2C9 inducers (e.g., rifampin) may lead to compromised efficacy of diclofenac. Because diclofenac is an inhibitor of prostaglandin synthesis, its mode of action may be due to a decrease of prostaglandins in peripheral tissues. This risk may occur early in treatment and may increase with duration of use (see, Diclofenac sodium extended-release tablets are contraindicated in the setting of coronary artery bypass graft (CABG) surgery (see, NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. The mechanism of action of diclofenac sodium extended-release tablets, like that of other NSAIDs, is not completely understood but involves inhibition of cyclooxygenase (COX-1 and COX-2). What are the signs of bleeding? Pharmacokinetic differences due to race have not been identified. allergic disorders; cardiac impairment (NSAIDs may impair renal function); coagulation defects; connective-tissue disorders; dehydration (risk of renal impairment); elderly (risk of serious side-effects and fatalities); history of cardiac failure; history of gastro-intestinal disorders (e.g. Monitor renal function in patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia during use of diclofenac sodium extended-release tablets (see PRECAUTIONS: Drug Interactions).Avoid the use of diclofenac sodium extended-release tablets in patients with advanced renal disease unless the benefits are expected to outweigh the risk of worsening renal function. For seniors: Seniors are at higher risk for stomach problems, bleeding, water retention, and other side effects from diclofenac. The following adverse reactions are discussed in greater detail in other sections of the labeling: Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In animal studies, administration of prostaglandin synthesis inhibitors such as diclofenac, resulted in increased pre- and post-implantation loss. Inform patients, families, or their caregivers of the following information before initiating therapy with diclofenac sodium extended-release tablets and periodically during the course of ongoing therapy. voltaren-xr-cataflam-diclofenac-343284 Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). NSAIDs, including diclofenac sodium extended-release tablets, may increase the risk of bleeding events. This effect has been attributed to the NSAID inhibition of renal prostaglandin synthesis. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. By clicking send, you acknowledge that you have permission to email the recipient with this information. The concomitant use of diclofenac with digoxin has been reported to increase the serum concentration and prolong the half-life of digoxin. Five diclofenac metabolites have been identified in human plasma and urine. Diclofenac sodium extended-release tablets are available as film-coated tablets of 100 mg (yellow) for oral administration. Medication Guide to each patient. Almost all meaningful elevations in transaminases were detected before patients became symptomatic. prescription products. container as defined in the USP Diclofenac sodium administered to male and female rats at 4 mg/kg/day (approximately 0.2 times the MRHD based on BSA comparison) did not affect fertility. Gastrointestinal bleeding has occurred. Temperature.]. Diclofenac concentrations reached during therapy have produced in vivo effects. Diclofenac is more than 99% bound to human serum proteins, primarily to albumin.
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