Class: Other Nonsteroidal Anti-inflammatory Agents
VA Class: MS120
Chemical Name: Sodium 1-methyl-5-(4-methylbenzoyl)-1H-pyrrole-2-acetate dihydrate
CAS Number: 64490-92-2
Brands: Tolectin
- Cardiovascular Risk
Possible increased risk of serious (sometimes fatal) cardiovascular thrombotic events (e.g., MI, stroke).240 Risk may increase with duration of use.240 Individuals with cardiovascular disease or risk factors for cardiovascular disease may be at increased risk.240 (See Cardiovascular Effects under Cautions.)
Contraindicated for the treatment of pain in the setting of CABG surgery.240
- GI Risk
Increased risk of serious (sometimes fatal) GI events (e.g., bleeding, ulceration, perforation of the stomach or intestine).240 Serious GI events can occur at any time and may not be preceded by warning signs and symptoms.240 Geriatric individuals are at greater risk for serious GI events.240 (See GI Effects under Cautions.)
Introduction
Prototypical NSAIA; pyrrole acetic acid derivative. a
Uses for Tolmetin Sodium
Consider potential benefits and risks of tolmetin therapy as well as alternative therapies before initiating therapy with the drug.240 Use lowest possible effective dosage and shortest duration of therapy consistent with patient's treatment goals.240
Inflammatory Diseases
Symptomatic treatment of osteoarthritis and rheumatoid arthritis.240
Management of juvenile rheumatoid arthritis in children ≥2 years of age.240
Has been reported to be effective in the management of ankylosing spondylitis† (late stages did not respond as well as early stages); has also been used with some success in the treatment of adhesive capsulitis shoulder† (frozen shoulder), radiohumeral bursitis† (tennis elbow), and local trauma† (e.g., recent sprains).a
Tolmetin Sodium Dosage and Administration
General
Administration
Oral Administration
Administer orally 3 or 4 times daily.240
Administration with antacids (i.e., antacid containing aluminum and magnesium hydroxides) may minimize adverse GI effects.240
Dosage
Available as tolmetin sodium; dosage expressed in terms of tolmetin.240
To minimize the potential risk of adverse cardiovascular and/or GI events, use lowest effective dosage and shortest duration of therapy consistent with the patient's treatment goals.240 Adjust dosage based on individual requirements and response; attempt to titrate to the lowest effective dosage.240
Pediatric Patients
Inflammatory Diseases
Juvenile Rheumatoid Arthritis
Oral
Children ≥2 years of age: Initially, 20 mg/kg daily in 3 or 4 divided doses.240 Adjust dosage based on response and tolerance.240
Usual effective dosage: 15–30 mg/kg daily.240
Adults
Inflammatory Diseases
Osteoarthritis or Rheumatoid Arthritis
Oral
Initially, 400 mg 3 times daily, preferably including a dose on arising and at bedtime.240 Adjust dosage based on response (after 1 or 2 weeks) and tolerance.a
Usual effective dosage: 600 mg to 1.8 g daily in 3 divided doses.240
Ankylosing Spondylitis†
Oral
600 mg to 1.6 g daily in divided dose has been used.a
Adhesive Capsulitis Shoulder† (frozen shoulder), Radiohumeral Bursitis† (tennis elbow), Local Trauma† (e.g., recent sprains)
Oral
>600 mg or 1.2 g daily in divided doses has been used.a
Prescribing Limits
Pediatric Patients
Inflammatory Diseases
Juvenile Rheumatoid Arthritis
Oral
Dosages >30 mg/kg daily have not been studied and are not recommended.240
Adults
Inflammatory Diseases
Osteoarthritis or Rheumatoid Arthritis
Oral
Dosages >1.8 g daily have not been studied and are not recommended.240
Special Populations
Renal Impairment
Reduce dosage if necessary.240
Geriatric Patients
Select dosage with caution (potential for age-related renal function decline).247
Cautions for Tolmetin Sodium
Contraindications
Known hypersensitivity to tolmetin or any ingredient in the formulation.240
History of asthma, urticaria, or other sensitivity reaction precipitated by aspirin or other NSAIAs.240
Treatment of perioperative pain in the setting of CABG surgery.240
Warnings/Precautions
Warnings
Cardiovascular Effects
Selective COX-2 inhibitors have been associated with increased risk of cardiovascular events (e.g., MI, stroke) in certain situations.241 Several prototypical NSAIAs also have been associated with increased risk of cardiovascular events.244 245 246 Current data insufficient to assess risk associated with tolmetin.244 245 246
Use NSAIAs with caution and careful monitoring (e.g., monitor for development of cardiovascular events), and at the lowest effective dose for the shortest duration necessary.240
Short-term use to relieve acute pain, especially at low dosages, does not appear to be associated with increased risk of serious cardiovascular events (except immediately following CABG surgery).241
No consistent evidence that concomitant use of low-dose aspirin mitigates the increased risk of serious adverse cardiovascular events associated with NSAIAs.240 (See Specific Drugs and Laboratory Tests under Interactions.)
Hypertension and worsening of preexisting hypertension reported; either event may contribute to the increased incidence of cardiovascular events.240 Use with caution in patients with hypertension; monitor BP.240 Impaired response to certain diuretics may occur.240 (See Specific Drugs and Laboratory Tests under Interactions.)
Fluid retention and edema reported.240 Caution in patients with fluid retention or heart failure.240
GI Effects
Serious GI toxicity (e.g., bleeding, ulceration, perforation) can occur with or without warning symptoms; increased risk in those with a history of GI bleeding or ulceration, geriatric patients, smokers, those with alcohol dependence, and those in poor general health.200 201 212 240 227 230 237
For patients at high risk for complications from NSAIA-induced GI ulceration (e.g., bleeding, perforation), consider concomitant use of misoprostol;203 227 228 229 alternatively, consider concomitant use of a proton-pump inhibitor (e.g., omeprazole)203 227 228 or use of an NSAIA that is a selective inhibitor of COX-2 (e.g., celecoxib).228
Renal Effects
Direct renal injury, including renal papillary necrosis, reported in patients receiving long-term NSAIA therapy.240
Potential for overt renal decompensation.204 240 Increased risk of renal toxicity in patients with renal or hepatic impairment or heart failure, in geriatric patients, in patients with volume depletion, and in those receiving a diuretic, ACE inhibitor, or angiotensin II receptor antagonist.204 240 243 247 (See Renal Impairment under Cautions.)
Sensitivity Reactions
Hypersensitivity Reactions
Anaphylactoid reactions reported. 240
Immediate medical intervention and discontinuance for anaphylaxis.240
Avoid in patients with aspirin triad (aspirin sensitivity, asthma, nasal polyps); caution in patients with asthma.240
Dermatologic Reactions
Serious skin reactions (e.g., exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis) reported; can occur without warning.240 Discontinue at first appearance of rash or any other sign of hypersensitivity (e.g., blisters, fever, pruritus).240
General Precautions
Ocular and Otic Effects
Visual disturbances reported; ophthalmic evaluation recommended if visual changes occur.240
Tinnitus reported; deterioration in hearing reported rarely.a
Hepatic Effects
Severe reactions including jaundice, fatal fulminant hepatitis, liver necrosis, and hepatic failure (sometimes fatal) reported rarely with NSAIAs. 240
Elevations of serum ALT or AST reported.240 Elevations of serum alkaline phosphatase also reported.a
Monitor for symptoms and/or signs suggesting liver dysfunction; monitor abnormal liver function test results.240 Discontinue if signs or symptoms of liver disease or systemic manifestations (e.g., eosinophilia, rash) occur or if liver function test abnormalities persist or worsen.240
Hematologic Effects
Anemia reported rarely.240 Determine hemoglobin concentration or hematocrit in patients receiving long-term therapy if signs or symptoms of anemia occur.240
Small and transient decreases in hemoglobin concentration or hematocrit (not associated with GI bleeding), leukopenia (including granulocytopenia), thrombocytopenia, and hemolytic anemia reported.a One case of fatal agranulocytosis reported. a
May inhibit platelet aggregation and prolong bleeding time.240
Other Precautions
Not a substitute for corticosteroid therapy; not effective in the management of adrenal insufficiency.240
May mask certain signs of infection.240
Obtain CBC and chemistry profile periodically during long-term use.240
Specific Populations
Pregnancy
Category C.240 Avoid use in third trimester because of possible premature closure of the ductus arteriosus.240
Lactation
Distributed into milk in humans.240 Discontinue nursing or the drug.240
Pediatric Use
Safety and efficacy not established in children <2 years of age.240
Geriatric Use
Caution advised.240 Geriatric adults appear to tolerate NSAIA-induced adverse effects less well than younger individuals.247 Fatal adverse GI effects reported more frequently in geriatric patients than younger adults.240
Hepatic Impairment
Monitor closely.240
Renal Impairment
Use not recommended in patients with advanced renal disease; close monitoring of renal function advised if used.240
Common Adverse Effects
Nausea, dyspepsia, GI distress, diarrhea, abdominal pain, flatulence, vomiting, dizziness, headache, asthenia, elevated BP, edema, weight change.240
Interactions for Tolmetin Sodium
Protein-bound Drugs
Potential for tolmetin to be displaced from binding sites by, or to displace from binding sites, other protein-bound drugs.a Observe for adverse effects.a
Specific Drugs and Laboratory Tests
Drug
|
Interaction
|
Comments
|
|---|
ACE inhibitors
|
Reduced BP response to the ACE inhibitor240
|
Monitor BP240
|
Angiotensin II receptor antagonists
|
Reduced BP response to angiotensin II receptor antagonist247
|
Monitor BP247
|
Anticoagulants (warfarin)
|
Possible bleeding complications240
Increased PT and bleeding reported rarelya
|
Caution advised 240
|
Antidiabetic agents
|
Administration with insulin or sulfonylureas does not appear to alter the clinical effects of the NSAIA or the antidiabetic agenta 240
|
|
Diuretics (furosemide, thiazides)
|
Reduced natriuretic effects 240
|
Monitor for diuretic efficacy and renal failure240
|
Lithium
|
Increase plasma lithium concentrations240
|
Monitor for lithium toxicity240
|
Methotrexate
|
Possible increased and prolonged blood concentrations of methotrexate205 206 207 208 209 210 211
|
Use with caution240
|
NSAIAs
|
NSAIAs including aspirin: Increased risk of GI ulceration or other complications 240
Aspirin: No consistent evidence that low-dose aspirin mitigates the increased risk of serious cardiovascular events associated with NSAIAs240
|
Concomitant use not recommended240
|
Tests for urinary protein
|
False-positive results with tests that use sulfosalicylic acid reagent240
|
Use dye-impregnated reagent strips (e.g., Albustix, Uristix)240
|
Tolmetin Sodium Pharmacokinetics
Absorption
Bioavailability
Well absorbed following oral administration.a
Food
Bioavailability reduced 16% when administered immediately after food or with milk. a 240 Peak plasma concentrations reduced 50% when administered immediately after food.a 240
Distribution
Extent
Distributed into human milk.240
Crosses the blood-brain barrier and placenta in animals.a
Plasma Protein Binding
99%.a
Elimination
Metabolism
Oxidized in liver to an inactive dicarboxylic acid metabolite.a
Elimination Route
Excreted in the urine within 24 hours as the dicarboxylic acid metabolite (60%), unchanged tolmetin (20%), and tolmetin conjugates (20%).a
Half-life
Approximately 1 hour in healthy males.a
Special Populations
Patients with rheumatoid arthritis: Pharmacokinetic values generally similar to values in healthy individuals; however, increase in renal clearance of tolmetin and its metabolites reported in one study.a
Stability
Storage
Oral
Capsules and Tablets
Tight, light-resistant containers at 15–30°C.240
ActionsActions
Inhibits cyclooxygenase-1 (COX-1) and COX-2.221 222 223 224 225 226
Pharmacologic actions similar to those of other prototypical NSAIAs; exhibits anti-inflammatory, analgesic, and antipyretic activity.a
Advice to Patients
Importance of reading the medication guide for NSAIAs that is provided to the patient each time the drug is dispensed.240
Risk of serious cardiovascular events with long-term use.240
Risk of GI bleeding and ulceration.240
Risk of serious skin reactions.240 Risk of anaphylactoid and other sensitivity reactions.240
Risk of hepatotoxicity.240
Importance of notifying clinician if signs and symptoms of a cardiovascular event (chest pain, dyspnea, weakness, slurred speech) occur.240
Importance of notifying clinician if signs and symptoms of GI ulceration or bleeding, unexplained weight gain, or edema develops.240
Importance of discontinuing tolmetin and contacting clinician if rash or other signs of hypersensitivity (blisters, fever, pruritus) develop.240 Importance of seeking immediate medical attention if an anaphylactic reaction occurs.240
Importance of discontinuing therapy and contacting clinician immediately if signs and symptoms of hepatotoxicity (nausea, fatigue, lethargy, pruritus, jaundice, upper right quadrant tenderness, flu-like symptoms) occur.240
Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.240 Importance of avoiding tolmetin in late pregnancy (third trimester).240
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant diseases.240
Importance of informing patients of other important precautionary information.240 (See Cautions.)
Preparations
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
Tolmetin Sodium
Routes
|
Dosage Forms
|
Strengths
|
Brand Names
|
Manufacturer
|
|---|
Oral
|
Capsules
|
400 mg (of tolmetin)*
|
Tolectin DS
|
Ortho-McNeil
|
|
|
|
Tolmetin Sodium Capsules
|
Actavis, Mutual, Mylan, Sandoz, Teva
|
|
Tablets
|
200 mg (of tolmetin)*
|
Tolectin (scored)
|
Ortho-McNeil
|
|
|
|
Tolmetin Sodium Tablets
|
Mutual, Sandoz
|
|
Tablets, film-coated
|
600 mg (of tolmetin)*
|
Tolectin
|
Ortho-McNeil
|
|
|
|
Tolmetin Sodium Tablets
|
Actavis, Mylan, Sandoz, Teva
|
Comparative Pricing
This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.
Tolmetin Sodium 200MG Tablets (MUTUAL PHARMACEUTICAL): 100/$75.99 or 300/$209.97
Tolmetin Sodium 400MG Capsules (TEVA PHARMACEUTICALS USA): 90/$89.99 or 100/$99.97
Tolmetin Sodium 600MG Tablets (MYLAN): 100/$200.99 or 300/$579.97
Disclaimer
This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.
The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.
AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions November 2007. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.
† Use is not currently included in the labeling approved by the US Food and Drug Administration.
References
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237. Pharmacia. Daypro (oxaprozin) caplets prescribing information. Chicago, IL; 2002 May.
238. Chan FKL, Hung LCT, Suen BY et al. Celecoxib versus diclofenac and omeprazole in reducing the risk of recurrent ulcer bleeding in patients with arthritis. N Engl J Med. 2002; 347:2104-10. [IDIS 490812] [PubMed 12501222]
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240. Ortho-McNeil Pharmaceuticals. Tolectin DS (tolmetin sodium) capsules and Tolectin 600 (tolmetin sodium) tablets prescribing information. Raritan, NJ; 2006 Feb.
241. Food and Drug Administration. Analysis and recommendations for agency action regarding non-steroidal anti-inflammatory drugs and cardiovascular risk. 2005 Apr 6.
242. Cush JJ. The safety of COX-2 inhibitors: deliberations from the February 16-18, 2005, FDA meeting. From the American College of Rheumatology website (). Accessed 2005 Oct 12.
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245. Kearney PM, Baigent C, Godwin J et al. Do selective cyclo-oxygenase-2 inhibitors and traditional non-steroidal anti-inflammatory drugs increase the risk of atherothrombosis? Meta-analysis of randomised trials. BMJ. 2006; 332: 1302-5. [PubMed 16740558]
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247. Merck & Co. Clinoril (sulindac) tablets prescribing information. Whitehouse Station, NJ; 2006 Feb.
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a. AHFS Drug Information 2007. McEvoy GK, ed. Tolmetin. Bethesda, MD: American Society of Health-System Pharmacists; 2007: 2118-2122.
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