Tolectin

Generic Name: Tolmetin Sodium
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

• 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 Tolectin

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

Tolectin Dosage and Administration

General

• 
  

  Consider potential benefits and risks of tolmetin therapy as well as alternative therapies before initiating therapy with the drug.²⁴⁰

  
  

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 Tolectin

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 Tolectin

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

Tolectin 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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229. Lanza FL, and the members of the Ad Hoc Committee on Practice Parameters of the American College of Gastroenterology. A guideline for the treatment and prevention of NSAID-induced ulcers. Am J Gastroenterol. 1998; 93:2037-46. [IDIS 417402] [PubMed 9820370]

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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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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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248. Chou R, Helfand M, Peterson K et al. Comparative effectiveness and safety of analgesics for osteoarthritis. Comparative effectiveness review no. 4. (Prepared by the Oregon evidence-based practice center under contract no. 290-02-0024.) . Rockville, MD: Agency for Healthcare Research and Quality. 2006 Sep. Available at: .

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