Tolmetin Sodium

A to Z Drug Facts

(TOLE-mee-tin SO-dee-uhm)

Tolectin 200, Tolectin 600, Tolectin DS,  Novo-Tolemtin

Class: Analgesic/NSAID

 Action Decreases inflammation, pain and fever, probably through inhibition of cyclooxygenase activity and prostaglandin synthesis.

 Indications Treatment of chronic and acute rheumatoid arthritis and osteoarthritis and juvenile rheumatoid arthritis.

 Contraindications Hypersensitivity to aspirin, iodides or any NSAID.

 Route/Dosage

Osteoarthritis/Rheumatoid Arthritis

ADULTS: PO 400 mg tid initially; titrate to 600 to 1600 mg/day for osteoarthritic patients or 600 to 1800 mg/day in divided doses for rheumatoid arthritis patients. Daily doses exceeding 1800 mg/day are not recommended.

Juvenile Rheumatoid Arthritis

CHILDREN ³ 2 YR: PO 20 mg/kg/day in 3–4 divided doses initially; titrate to 15–30 mg/kg/day (aximum 30 mg/kg/day).

 Interactions

Anticoagulants: May increase effect of anticoagulants due to decreased plasma protein binding. May increase risk of gastric erosion and bleeding. Cyclosporine: May potentiate nephrotoxicity of both agents. Methotrexate: May increase methotrexate levels.

 Lab Test Interferences May prolong bleeding time. May produce false-positive test result for proteinuria using sulfosalicylic acid. Increases in serum uric acid, liver function tests, serum creatinine, BUN.

 Adverse Reactions

CV: Edema; sodium retention; hypertension; CHF. CNS: Dizziness; drowsiness; lightheadedness; confusion; increased sweating; ertigo; headache; nervousness; migraine; anxiety; aggravated Parkinson's disease or epilepsy; paresthesia; peripheral neuropathy; myalgia; fatigue; sthenia; depression. DERM: Rash; pruritus; urticaria; purpura; erythema multiforme; skin irritation; sweating. EENT: Blurred vision; tinnitus; visual disturbances. GI: Nausea; dyspepsia; abdominal pain or discomfort; flatulence; diarrhea; onstipation; vomiting; gastritis; anorexia; glossitis; stomatitis; mouth ulcers; peptic ulcer; GI distress. GU: Hematuria; proteinuria; dysuria; elevations in BUN; acute renal insufficiency; nterstitial nephritis; hyperkalemia; hyponatremia; renal papillary necrosis; TIs. HEMA: Increased bleeding time; anemia; decreases in Hgb or Hct; leukopenia; hrombocytopenia; hemolytic anemia. HEPA: Hepatitis; increased LFT results; elevated liver enzymes. META: Weight decrease or increase. RESP: Bronchospasm; laryngeal edema; rhinitis; dyspnea; pharyngitis; emoptysis; shortness of breath.

 Precautions

Pregnancy: Category C. Lactation: Excreted in breast milk. Children: Safety and efficacy not established in children < 2 yr. Elderly patients: Increased risk of adverse reactions. GI effects: Serious GI toxicity (eg, bleeding, ulceration, perforation) can occur at any time with or without warning symptoms. Anaphylactoid reactions: Have occurred in patients with aspirin hypersensitivity and in patients who discontinued tolmetin, then restarted it. Renal impairment: Use drug with caution in patients with compromised cardiac function, hypertension or other conditions predisposing to fluid retention.

 Administration/Storage

• Administer capsules or tablets orally tid with schedule including morning dose and evening dose.
• Do not administer with food, milk or sodium bicarbonate.
• If GI distress occurs, give with antacids that do not contain sodium bicarbonate.
• Store at room temperature. Do not expose to sunlight or moisture.

 Assessment/Interventions

• Obtain patient history, including drug history and any known allergies.
• Assess renal function before and during therapy, especially in patients with renal impairment.
• Monitor serum uric acid, serum creatinine and BUN and report if increased.
• Monitor periodic urine tests for blood and protein and report positive results to physician. Be aware when testing for proteinuria that using sulfosalicylic acid may cause false-positive results. Use dye-impregnated reagent strips.
• Monitor results of LFTs and report dyscrasias to physician.
• Monitor serum potassium (report hyperkalemia) and sodium (eport hyponatremia).
• Monitor Hgb and Hct and notify physician of decrease.
• Obtain periodic occult blood test in stool if patient is receiving long-term therapy.
• Monitor BP and I&O throughout therapy.
• Notify physician of any shortness of breath or other signs of edema.
• Assess visual acuity and hearing with periodic exams for patients on prolonged therapy, especially if patient experiences blurred vision or changes in color vision.

 Patient/Family Education

• Explain that product should not be taken with aspirin or other NSAIDs without consulting physician.
• Explain that full antirheumatic action may not occur for up to 7 days and may not reach maximum effect for up to 1 mo after starting therapy.
• Tell patient to avoid taking with food or milk or immediately after meal. If medication causes stomach upset tell patient to take with antacids that do not contain sodium bicarbonate. Instruct patient to call physician if pain continues.
• Tell patient to avoid smoking or drinking alcohol while taking this drug.
• Explain that dizziness or black stools should be reported to physician immediately.
• Explain that if drowsiness, dizziness or blurred vision occur, patient should observe caution while driving or performing other tasks requiring alertness.
• Explain that photosensitivity may occur and to use sunscreens and protective clothing when exposed to ultraviolet or sunlight until tolerance is determined.
• Identify potential clinically important adverse reactions: Drowsiness, blurred vision, edema, headache, lightheadedness, confusion, fatigue, swelling feet, ringing of ears, nausea, vomiting, mouth ulcers, unusual bleeding or bruising, rash, itching or skin irritation. Tell patient to notify physician if persistent or severe.
• Tell patient not to store drug in bathroom but in cool, dry place.

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Copyright © 2003 Facts and Comparisons
David S. Tatro
A to Z Drug Facts