Drug: Dyloject

Dyloject Injection is a clear, colorless solution for intravenous administration. Each mL of aqueous solution contains 37.5 mg of diclofenac sodium (34.8 mg of diclofenac), 333 mg hydroxypropyl betadex (HPβCD), 5 mg monothioglycerol, sodium hydroxide and/or hydrochloric acid for Ph adjustment, and water for injection. Diclofenac sodium, a nonsteroidal anti-inflammatory drug, is designated chemically as benzeneacetic acid, 2-[(2,6-dichlorophenyl)amino] monosodium salt, with a molecular formula of C14H10Cl2NNaO2. The molecular weight is 318.13. The structural formula of diclofenac sodium is: Last reviewed on RxList: 1/8/2015
This monograph has been modified to include the generic and brand name in many instances.

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The following serious adverse reactions are discussed elsewhere in the labeling:
  • Cardiovascular thrombotic events [see BOXED WARNING and WARNINGS AND PRECAUTIONS]
  • Gastrointestinal effects [see BOXED WARNING and WARNINGS AND PRECAUTIONS]
  • Renal effects [see CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS]
  • Hepatic effects [see WARNINGS AND PRECAUTIONS]
  • Hypertension [see WARNINGS AND PRECAUTIONS]
  • Congestive heart failure and edema [see WARNINGS AND PRECAUTIONS]
  • Anaphylactoid reactions [see WARNINGS AND PRECAUTIONS]
  • Serious skin reactions [see WARNINGS AND PRECAUTIONS]
Adverse reactions from clinical studies of Dyloject Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. During clinical development, 1,156 patients were exposed to Dyloject in multiple-dose, controlled and open-label studies. Dyloject was administered post-surgically every 6 hours for up to 5 days. The incidence rates of adverse reactions listed in the following table are derived from multicenter, controlled clinical studies in post-operative patients comparing Dyloject to placebo in patients who may have also received morphine rescue medication. Table 1: Proportion of Patients Experiencing Common Adverse Reactions in Placebo-Controlled Clinical Studies in Patients with Acute Moderate-to-Severe Postoperative Pain occurring in greater than or equal to 3% in patients treated with Dyloject*
MedDRA Preferred Term Placebo
N=126 Dyloject
N=187 Any Reaction 104 (83%) 146 (78%) Nausea 50 (40%) 45 (24%) Constipation 14 (11%) 25 (13%) Headache 20 (16%) 19 (10%) Infusion Site Pain 10 (8%) 19 (10%) Dizziness 2 (2%) 15 (8%) Flatulence 20 (16%) 15 (8%) Vomiting 23 (18%) 12 (6%) Insomnia 12 (10%) 11 (6%) Pruritus 10 (8%) 9 (5%) Hypotension 6 (5%) 9 (5%) Pyrexia 13 (10%) 8 (4%) Anemia 9 (7%) 8 (4%) Infusion Site Extravasation 1 (1%) 6 (3%) *Intravenous morphine was permitted as rescue medication for pain management. Adverse Reactions From Clinical Studies Or Spontaneous Reports For Other Formulations Of Diclofenac And Other NSAIDs In patients taking diclofenac or other NSAIDs, the most frequently reported adverse reactions occurring in approximately 1%-10% of patients are: Gastrointestinal experiences including abdominal pain, constipation, diarrhea, dyspepsia, flatulence, gross bleeding/perforation, heartburn, nausea, GI ulcers (gastric/duodenal) and vomiting. Abnormal renal function, anemia, dizziness, edema, elevated liver enzymes, headaches, increased bleeding time, pruritus, rashes and tinnitus. Additional adverse reactions reported occasionally include: Body as a Whole: fever, infection, sepsis Cardiovascular System: congestive heart failure, hypertension, tachycardia, syncope Digestive System: esophagitis, gastric/peptic ulcers, gastritis, gastrointestinal bleeding, glossitis, hematemesis, hepatitis, jaundice Hemic and Lymphatic System: ecchymosis, eosinophilia, leukopenia, melena, purpura, rectal bleeding, stomatitis, thrombocytopenia Metabolic and Nutritional: weight changes Nervous System: anxiety, asthenia, confusion, depression, dream abnormalities, drowsiness, insomnia, malaise, nervousness, paresthesia, somnolence, tremors, vertigo Respiratory System: asthma, dyspnea Skin and Appendages: alopecia, photosensitivity, sweating increased Special Senses: blurred vision Urogenital System: cystitis, dysuria, hematuria, interstitial nephritis, oliguria/polyuria, proteinuria, renal failure Other adverse reactions, which occur rarely are: Body as a Whole: anaphylactic reactions, appetite changes, death Cardiovascular System: arrhythmia, hypotension, myocardial infarction, palpitations, vasculitis Digestive System: colitis, eructation, fulminant hepatitis with and without jaundice, liver failure, liver necrosis, pancreatitis Hemic and Lymphatic System: agranulocytosis, hemolytic anemia, aplastic anemia, lymphadenopathy, pancytopenia Metabolic and Nutritional: hyperglycemia Nervous System: convulsions, coma, hallucinations, meningitis Respiratory System: respiratory depression, pneumonia Skin and Appendages: angioedema, toxic epidermal necrolysis, erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome, urticaria Special Senses: conjunctivitis, hearing impairment Adverse Reactions of Special Interest Based on the analysis of the pooled data from the multi-dose, controlled clinical trials, postoperative patients treated with Dyloject had more adverse reactions related to wound healing (7.5%) compared to patients treated with placebo (4%). Read the Dyloject (diclofenac sodium for injection) Side Effects Center for a complete guide to possible side effectsLearn More »

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Use for the shortest duration consistent with individual patient treatment goals [see WARNINGS AND PRECAUTIONS]. For intravenous administration only. For the treatment of acute pain, the recommended dose of Dyloject is 37.5 mg administered by intravenous bolus injection over 15 seconds every 6 hours as needed, not to exceed 150 mg/day. To reduce the risk of renal adverse reactions, patients must be well hydrated prior to administration of Dyloject. Visually inspect parenteral drug products for particulate matter and discoloration prior to administration. If visibly opaque particles, discoloration or other foreign particles are observed, the solution should not be used.

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Aspirin When administered with aspirin, the protein binding of Dyloject is reduced. The clinical significance of this interaction is not known; however, as with other NSAIDs, concomitant administration of Dyloject and aspirin is not generally recommended because of the potential of increased adverse effects. Anticoagulants The effects of anticoagulants (e.g., warfarin) and NSAIDs on GI bleeding are synergistic, such that the users of both drugs together have a higher risk of serious GI bleeding than users of either drug alone [see WARNINGS AND PRECAUTIONS]. ACE Inhibitors NSAIDs may diminish the antihypertensive effect of ACE inhibitors. This interaction should be given consideration in patients taking NSAIDs concomitantly with ACE inhibitors. Cyclosporine NSAIDs, including Dyloject, may affect renal prostaglandins and increase the toxicity of certain drugs. Therefore, concomitant therapy with Dyloject may increase cyclosporine's nephrotoxicity. Use caution when Dyloject is administered concomitantly with cyclosporine. Diuretics Clinical studies and postmarketing observations have shown that Dyloject can reduce the natriuretic effect of furosemide and thiazides in some patients. This response has been attributed to inhibition of renal prostaglandin synthesis. During concomitant therapy with NSAIDs, observe patients closely for signs of renal failure, as well as to assure diuretic efficacy [see WARNINGS AND PRECAUTIONS]. Lithium NSAIDs have produced elevations of plasma lithium levels and a reduction in renal lithium clearance. The mean minimum lithium concentration increased 15% and the renal clearance decreased by 20%. This effect has been attributed to inhibition of renal prostaglandin synthesis by the NSAID. Thus, when NSAIDs and lithium are administered concurrently, observe patients carefully for signs of lithium toxicity. Methotrexate NSAIDs have been reported to competitively inhibit methotrexate accumulation in rabbit kidney slices. This indicates that NSAIDs may enhance the toxicity of methotrexate. Use caution when NSAIDs are administered concomitantly with methotrexate. CYP2C9 Inhibitors Or Inducers Diclofenac is metabolized by cytochrome P450 enzymes, predominantly by CYP2C9. 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. Use caution when dosing Dyloject with CYP2C9 inhibitors or inducers; a dosage adjustment may be warranted. Last reviewed on RxList: 1/8/2015
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

Dyloject is an NSAID indicated in adults for the management of mild to moderate pain and management of moderate to severe pain alone or in combination with opioid analgesics.

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Dyloject is contraindicated in patients with:
  • known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to diclofenac [see WARNINGS AND PRECAUTIONS].
  • a history of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal anaphylactic-like reactions to NSAIDs have been reported in such patients [see WARNINGS AND PRECAUTIONS].
  • perioperative pain in the setting of coronary artery bypass graft (CABG) surgery [see WARNINGS AND PRECAUTIONS].
  • moderate to severe renal insufficiency in the perioperative period and who are at risk for volume depletion [see WARNINGS AND PRECAUTIONS].
Last reviewed on RxList: 1/8/2015
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

Symptoms following acute NSAID overdoses are usually limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which are generally reversible with supportive care. Gastrointestinal bleeding can occur. Hypertension, acute renal failure, respiratory depression and coma may occur, but are rare. Anaphylactoid reactions have been reported with therapeutic ingestion of NSAIDs, and may occur following an overdose. Patients should be managed by symptomatic and supportive care following an NSAID overdose. There are no specific antidotes. Forced diuresis, alkalinization of urine, hemodialysis, or hemoperfusion may be employed but are not likely to be useful due to high protein binding. In case of an overdosage, discontinue Dyloject therapy and consider contacting a regional poison control center at 1-800-222-1222.

Source: http://www.rxlist.com

Dosage Forms And Strengths Dyloject Injection is available as a 37.5 mg/mL single-dose glass vial. Storage And Handling Dyloject (diclofenac sodium) Injection, is a clear, colorless solution that is supplied as a 1 mL fill in a clear 2 mL glass vial with an orange tamper-evident top. NDC No. Strength Fill Container Size 0409-1068-01 37.5 mg/mL 1 mL 2 mL Carton of 25 vials Store at Controlled Room Temperature 20 to 25°C (68 to 77°F) [see USP Controlled Room Temperature]. Do not freeze. Protect from light. Keep Dyloject out of reach and sight of children. Not made with natural rubber latex. Manufactured for: Hospira, Inc., Lake Forest, IL 60045 USA. Revised: Dec 2014 Last reviewed on RxList: 1/8/2015
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

Cardiovascular Thrombotic Events 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. All NSAIDs, both COX-2 selective and nonselective, may have a similar risk. 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, use the lowest effective dose 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. Patients should be informed about the signs and/or symptoms of serious CV events and the steps to take if they occur. Two large, controlled clinical trials of a COX-2 selective NSAID for the treatment of pain in the first 10-14 days following CABG surgery found an increased incidence of myocardial infarction and stroke [see CONTRAINDICATIONS]. There is no consistent evidence that concurrent use of aspirin mitigates the increased risk of serious CV thrombotic events associated with NSAID use. The concurrent use of aspirin and an NSAID does increase the risk of serious gastrointestinal (GI) events [see Gastrointestinal Effects: Risk of Ulceration, Bleeding, and Perforation]. Gastrointestinal Effects: Risk Of Ulceration, Bleeding, And Perforation NSAIDs, including Dyloject, can cause serious GI adverse events including inflammation, bleeding, ulceration, and perforation of the stomach, small intestine, or large intestine, which can be fatal. These serious adverse events can occur at any time, with or without warning symptoms, in patients treated with NSAIDs. Only one in five patients who develop a serious upper GI adverse event on NSAID therapy is symptomatic. Upper GI ulcers, gross bleeding, or perforation caused by NSAIDs occur in approximately 1% of patients treated for 3-6 months and in about 2-4% of patients treated for one year. 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. Dyloject is administered by intravenous injection and is intended for acute short term use. However, even short-term therapy is not without risk. Prescribe NSAIDs, including Dyloject, with extreme caution in those with a prior history of ulcer disease or GI bleeding. Patients with a prior history of peptic ulcer disease and/or GI bleeding who use NSAIDs have a greater than 10-fold increased risk for developing a GI bleed compared to treated patients with neither of these risk factors. 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 reports of spontaneous 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, use the lowest effective dose for the shortest possible duration. Patients and physicians should remain alert for signs and symptoms of GI ulcerations and bleeding during NSAID therapy and promptly initiate additional evaluation and treatment if a serious GI event is suspected. This should include discontinuation of the NSAID until a serious GI adverse event is ruled out. For high risk patients, alternate therapies that do not involve NSAIDs should be considered. Renal Effects Use caution when initiating treatment with Dyloject in patients with considerable dehydration. Dyloject is not recommended in patients with moderate to severe renal insufficiency and is contraindicated in patients with moderate to severe renal insufficiency in the perioperative period and who are at risk for volume depletion. Acute renal decompensation was observed in 4% out of 68 patients enrolled with renal impairment and treated with Dyloject in clinical trials in the perioperative period. Long-term administration of NSAIDs has resulted in renal papillary necrosis and other renal injury. 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 an NSAID 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. Discontinuation of NSAID therapy is usually followed by recovery to the pretreatment state. Hepatic Effects Elevations of one or more liver tests may occur during therapy with Dyloject. These laboratory abnormalities may progress, may remain unchanged, or may be transient with continued therapy. Borderline elevations (i.e., less than 3 times the ULN [ULN = the upper limit of the normal range]) or greater elevations of transaminases occurred in about 15% of diclofenac-treated patients in clinical trials of indications other than acute pain. Of the markers of hepatic function, ALT (SGPT) is recommended for the monitoring of liver injury. In clinical trials of oral diclofenac, meaningful elevations (i.e., more than 3 times the ULN) of AST (SGOT) occurred in about 2% of approximately 5,700 patients at some time during diclofenac treatment (ALT was not measured in all studies). In a large, open-label, controlled trial of 3,700 patients treated for 2-6 months, patients were monitored first at 8 weeks and 1,200 patients were monitored again at 24 weeks. Meaningful elevations of ALT and/or AST occurred in about 4% of the 3,700 patients and included marked elevations (i.e., more than 8 times the ULN) in about 1% of the 3,700 patients. In this open-label study, a higher incidence of borderline (less than 3 times the ULN), moderate (3-8 times the ULN), and marked (greater than 8 times the ULN) elevations of ALT or AST was observed in patients receiving diclofenac when compared to other NSAIDs. Elevations in transaminases were seen more frequently in patients with osteoarthritis than in those with rheumatoid arthritis. Almost all meaningful elevations in transaminases were detected before patients became symptomatic. Abnormal tests occurred during the first 2 months of therapy with diclofenac in 42 of the 51 patients in all trials who developed marked transaminase elevations. In postmarketing reports, cases of drug-induced hepatotoxicity have been reported in the first month, and in some cases, the first 2 months of therapy, but can occur at any time during treatment with diclofenac. Postmarketing surveillance has reported cases of severe hepatic reactions, including liver necrosis, jaundice, fulminant hepatitis with and without jaundice, and liver failure. Some of these reported cases resulted in fatalities or liver transplantation. Measure transaminases (ALT and AST) periodically in patients receiving long-term therapy with diclofenac, because severe hepatotoxicity may develop without a prodrome of distinguishing symptoms. The optimum times for making the first and subsequent transaminase measurements are not known. Based on clinical trial data and postmarketing experiences, transaminases should be monitored within 4 to 8 weeks after initiating treatment with diclofenac. Dyloject is not indicated for long-term treatment. However, severe hepatic reactions can occur at any time during treatment with diclofenac. If abnormal liver tests persist or worsen, if clinical signs and/or symptoms consistent with liver disease develop, or if systemic manifestations occur (e.g. eosinophilia, rash, abdominal pain, diarrhea, dark urine, etc.), discontinue Dyloject immediately. To minimize the possibility that hepatic injury will become severe between transaminase measurements, inform patients of the warning signs and symptoms of hepatotoxicity (e.g., nausea, fatigue, lethargy, diarrhea, pruritus, jaundice, right upper quadrant tenderness, and “flu-like” symptoms), and the appropriate action patients should take if these signs and symptoms appear. To minimize the potential risk for an adverse liver-related event in patients treated with diclofenac, use the lowest effective dose for the shortest duration possible. Exercise caution when prescribing Dyloject with concomitant drugs that are known to be potentially hepatotoxic (e.g., acetaminophen, certain antibiotics, anti-epileptics). Hypertension NSAIDs, including Dyloject, can lead to onset of new hypertension or worsening of pre-existing hypertension, either of which may contribute to the increased incidence of CV events. Use NSAIDs, including Dyloject, with caution in patients with hypertension. Monitor blood pressure closely during the initiation of NSAID treatment and throughout the course of therapy. Patients taking ACE inhibitors, thiazides or loop diuretics may have impaired response to these therapies when taking NSAIDs. Congestive Heart Failure And Edema Fluid retention and edema have been observed in some patients taking NSAIDs. Use Dyloject with caution in patients with fluid retention or heart failure. Anaphylactic Reactions As with other NSAIDs, anaphylactic reactions may occur in patients without known prior exposure to Dyloject. Dyloject is contraindicated in patients with the aspirin triad. This symptom complex typically occurs in asthmatic patients who experience rhinitis with or without nasal polyps, or who exhibit severe, potentially fatal bronchospasm after taking aspirin or other NSAIDs [see CONTRAINDICATIONS]. Serious Skin Reactions NSAIDs, including Dyloject, can cause serious skin adverse reactions such as exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. These serious events may occur without warning. Inform patients about the signs and symptoms of serious skin manifestations, and discontinue Dyloject at the first appearance of skin rash or any other sign of hypersensitivity [see CONTRAINDICATIONS]. Pregnancy Starting at 30 weeks gestation, Dyloject and other NSAIDs, should be avoided by pregnant women as premature closure of the ductus arteriosus in the fetus may occur. If this drug is used during this time period in pregnancy, the patient should be apprised of the potential hazard to a fetus [see Use in Specific Populations]. Corticosteroid Treatment Dyloject cannot be expected to substitute for corticosteroids or to treat corticosteroid insufficiency. Abrupt discontinuation of corticosteroids may lead to exacerbation of corticosteroidresponsive illness. Patients on prolonged corticosteroid therapy should have their therapy tapered slowly if a decision is made to discontinue corticosteroids. Masking Inflammation And Fever The pharmacological activity of Dyloject in reducing inflammation, and possibly fever, may diminish the utility of these diagnostic signs in detecting infectious complications of presumed noninfectious, painful conditions. Hematological Effects Anemia may occur in patients receiving NSAIDs, including Dyloject. This may be due to fluid retention, occult or gross GI blood loss, or an incompletely described effect upon erythropoiesis. In patients on long-term treatment with NSAIDs, including diclofenac, check hemoglobin or hematocrit if they exhibit any signs or symptoms of anemia or blood loss. Dyloject is not indicated for long-term treatment. 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. Carefully monitor patients who may be adversely affected by alterations in platelet function, such as those with coagulation disorders or patients receiving anticoagulants. Pre-existing Asthma 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. Since crossreactivity between aspirin and NSAIDs has been reported in such aspirin-sensitive patients, including bronchospasm, Dyloject is contraindicated in patients with this form of aspirin sensitivity and should be used with caution in all patients with pre-existing asthma [see CONTRAINDICATIONS]. Monitoring Because serious GI tract ulcerations and bleeding can occur without warning symptoms, monitor for signs or symptoms of GI bleeding. For patients on long-term treatment with NSAIDs, periodically check a CBC and chemistry profile, including liver function tests. Discontinue Dyloject if clinical signs and symptoms consistent with liver or renal disease develop, systemic manifestations occur (e.g., eosinophilia, rash), or abnormal liver tests persist or worsen. Dyloject is not indicated for long-term treatment. Nonclinical Toxicology Carcinogenesis, Mutagenesis, Impairment Of Fertility Carcinogenesis Long-term carcinogenicity studies in rats given diclofenac sodium up to 2 mg/kg/day (0.13-fold the maximum recommended human dose [MRHD] of 150 mg/day based on mg/m² body surface area [BSA] comparison) have revealed no significant increase in tumor incidence. A 2-year carcinogenicity study conducted in mice employing diclofenac sodium at doses up to 0.03 mg/kg/day (0.01-fold the MRHD of 150 mg/day based on BSA comparison) in males and 1 mg/kg/day (0.04-fold the MRHD of 150 mg/day based on BSA comparison) in females did not reveal any oncogenic potential. Mutagenesis Diclofenac sodium did not show mutagenic activity in in vitro point mutation assays in mammalian (mouse lymphoma) and microbial (yeast, Ames) test systems and was nonmutagenic in several mammalian in vitro and in vivo tests, including dominant lethal and male germinal epithelial chromosomal aberration studies in Chinese hamsters. Impairment of Fertility Diclofenac sodium administered to male and female rats at 4 mg/kg/day (0.3-fold the MRHD of 150 mg/day based on BSA comparison) did not affect fertility. Use In Specific Populations Pregnancy Teratogenic Effects Pregnancy Category C prior to 30 weeks gestation; Category D starting at 30 weeks gestation. Starting at 30 weeks gestation, Dyloject and other NSAIDs should be avoided by pregnant women as premature closure of the ductus arteriosus in the fetus may occur. Dyloject can cause fetal harm when administered to a pregnant woman starting at 30 weeks gestation. There are no adequate and well-controlled studies in pregnant women. Prior to 30 weeks gestation, Dyloject should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Reproductive studies have been performed in mice given diclofenac sodium (up to 20 mg/kg/day or 60 mg/m²/day) and in rats and rabbits given diclofenac sodium (up to 10 mg/kg/day or 60 mg/m²/day for rats, and 80 mg/m²/day for rabbits, 0.75-fold and 1-fold the maximum recommended human dose [MRHD] of 150 mg/day based on body surface area comparison, respectively), and have revealed no evidence of teratogenicity despite the induction of maternal toxicity and fetal toxicity. In rats maternally toxic doses were associated with dystocia, prolonged gestation, reduced fetal weights and growth, and reduced fetal survival. Diclofenac has been shown to cross the placental barrier in mice, rats, and humans. Labor And Delivery Dyloject should not be used in labor and delivery due to the inhibitory effects on prostaglandin synthesis that may adversely affect fetal circulation, inhibit uterine contractions and increase risk of uterine bleeding. In rat studies, maternal exposure to NSAIDs, as with other drugs known to inhibit prostaglandin synthesis, increased the incidence of dystocia and delayed parturition, and decreased pup survival. Nursing Mothers Based on available data, diclofenac may be present in human milk. One woman treated orally with a diclofenac salt, 150 mg/day, had a milk diclofenac level of 100 mcg/L, equivalent to an infant dose of about 0.03 mg/kg/day. Diclofenac was not detectable in breast milk in 12 women using diclofenac (after either 100 mg/day orally for 7 days or a single 50 mg intramuscular dose administered in the immediate postpartum period). Exercise caution when Dyloject is administered to a nursing woman. Pediatric Use The safety and efficacy of Dyloject have not been established in pediatric patients. Geriatric Use Use caution in elderly patients given the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Diclofenac metabolites are 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. Because elderly patients are more likely to have decreased renal function, use caution in this patient population, and it may be useful to monitor renal function. Elderly patients are at increased risk for serious GI and renal adverse events. Older age increases the risk for GI bleeding. Most spontaneous reports of fatal GI events are in elderly or debilitated patients, and therefore special care should be taken in treating this population [see WARNINGS AND PRECAUTIONS]. The pharmacokinetics of Dyloject are similar in elderly compared to young adults [see CLINICAL PHARMACOLOGY]. Hepatic Impairment Orally administered diclofenac sodium is extensively metabolized. The pharmacokinetics of Dyloject are similar in patients with mild hepatic impairment compared to healthy subjects [see CLINICAL PHARMACOLOGY]. Dosing adjustments in patients with mild hepatic impairment is not necessary. The pharmacokinetics of Dyloject were not studied in patients with moderate to severe hepatic impairment and use in this population is not recommended. Renal Impairment Pharmacokinetics of Dyloject in patients with mild to moderate renal impairment is similar compared to healthy subjects. However, acute renal decompensation was observed in 4% out of 68 patients enrolled with renal impairment and treated with Dyloject in clinical trials in the perioperative period. Dyloject is not recommended in patients with moderate to severe renal insufficiency and is contraindicated in patients with moderate to severe renal insufficiency in the perioperative period and who are at risk for volume depletion [see WARNINGS AND PRECAUTIONS and CLINICAL PHARMACOLOGY]. Body Weight Pharmacokinetics of diclofenac following Dyloject injection appear to be dependent on body weight. The effect of body weight on clinical efficacy and safety of Dyloject has not been fully studied. Therefore, adjusting dose based on body weight is not recommended [see CLINICAL PHARMACOLOGY]. Last reviewed on RxList: 1/8/2015
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

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