Tolmetin sodium


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult : PO Rheumatoid arthritis; Osteoarthritis Initial: 400 mg tid then adjust dose after 1-2 weeks according to response. Maintenance dose: 600-1,800 mg daily in 3 divided doses.
Dosage Details
Oral
Juvenile idiopathic arthritis
Child: ≥2 years Initially, 20 mg/kg daily in 3 or 4 divided doses. Maintenance: 15-30 mg/kg daily in 3 or 4 divided doses.

Topical/Cutaneous
Osteoarthritis, Rheumatoid arthritis
Adult: Initially, 400 mg tid, then adjust after 1-2 weeks according to response. Maintenance: 600-1,800 mg daily in 3 divided doses.
Administration
Should be taken with food. Take w/ or immediately after meals.
Contraindications
Hypersensitivity to salicylates (e.g. aspirin) or other NSAIDs. Aspirin-sensitive asthma. Treatment of peri-operative pain in CABG surgery. Pregnancy (late stage).
Special Precautions
Patient with CV disease, history of gastrointestinal disease (e.g. bleeding or ulcer), fluid retention, dehydration, pre-existing asthma, coagulation disorders, hypertension. Smokers or alcoholic patient. Hepatic and severe renal impairment. Pregnancy and lactation.
Adverse Reactions
Significant: Hyperkalaemia, elevated ALT/AST levels, hypertension, oedema, peptic ulcer, jaundice, weight changes (gain/loss); renal papillary necrosis, acute interstitial nephritis, nephrotic syndrome (long-term use).
Cardiac disorders: Chest pain.
Ear and labyrinth disorders: Tinnitus.
Eye disorders: Visual disturbance.
Gastrointestinal disorders: Abdominal pain, diarrhoea, dyspepsia, flatulence, gastrointestinal distress, nausea, vomiting, constipation, gastritis.
General disorders and administration site conditions: Asthenia, fever.
Nervous system disorders: Dizziness, headache.
Psychiatric disorders: Depression, drowsiness.
Renal and urinary disorders: UTI, increased BUN.
Skin and subcutaneous tissue disorders: Irritation.
Potentially Fatal: Anaphylactoid reactions (e.g. swelling of the face or throat, breathing difficulty), exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, MI, stroke, gastrointestinal bleeding, ulceration, and perforation, severe blood dyscrasias (e.g. agranulocytosis, thrombocytopenia, aplastic anaemia), hepatic failure, liver necrosis, fulminant hepatitis.
PO: C (Avoid during 3rd trimester or near delivery)
Patient Counseling Information
This drug may cause dizziness, drowsiness, and blurred vision, if affected, do not drive or operate machinery.
MonitoringParameters
Monitor blood pressure and K levels closely during initiation and throughout the course of treatment. Perform CBC, chemistry profile, hepatic and renal function tests regularly, especially for patients with prolonged use. Monitor for signs and symptoms of gastrointestinal bleeding and hepatic dysfunction.
Drug Interactions
Increased risk of bleeding with anticoagulants, corticosteroids, salicylates (e.g. aspirin) and other NSAIDs. May decrease the antihypertensive effect of ACE inhibitors or angiotensin receptor blockers. Increases the plasma concentration of lithium. May reduce the natriuretic effects of furosemide or thiazide diuretics. May enhance methotrexate toxicity.
Food Interaction
Avoid alcohol.
Lab Interference
False-positive result for proteinuria test using acid precipitation method.
Action
Description: Tolmetin, a pyrrole acetic acid derivative blocks prostaglandin synthesis by inhibiting cyclooxygenase isoenzymes COX-1 and COX-2.
Onset: Analgesic: 1-2 hours. Anti-inflammatory: Days to weeks.
Pharmacokinetics:
Absorption: Rapidly and well absorbed from the gastrointestinal tract. Food and milk decreases bioavailability. Time to peak plasma concentration: Approx 30-60 minutes.
Distribution: Penetrates synovial fluid and enters breast milk (very small amounts). Plasma protein binding: >99%, to albumin.
Metabolism: Metabolised in the liver via oxidation and conjugation.
Excretion: Mainly via urine (as inactive metabolites/conjugates and unchanged drug). Elimination half-life: Biphasic 1-2 hours (rapid); approx 5 hours (slow).
Chemical Structure

Chemical Structure Image
Tolmetin sodium

Source: National Center for Biotechnology Information. PubChem Database. Tolmetin sodium, CID=23665411, https://pubchem.ncbi.nlm.nih.gov/compound/Tolmetin-sodium (accessed on Jan. 23, 2020)

Storage
Store between 20-25°C. Protect from light.
ATC Classification
M01AB03 - tolmetin ; Belongs to the class of acetic acid derivatives and related substances of non-steroidal antiinflammatory and antirheumatic products.
References
Anon. Tolmetin. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 08/11/2017.

Buckingham R (ed). Tolmetin Sodium. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 08/11/2017.

McEvoy GK, Snow EK, Miller J et al (eds). Tolmetin Sodium. AHFS Drug Information (AHFS DI) [online]. American Society of Health-System Pharmacists (ASHP). https://www.medicinescomplete.com. Accessed 08/11/2017.

Tolectin DS Capsules/Tolectin 600 Tablets (Ortho-Mcneil Pharmaceutical, Inc.). U.S. FDA. https://www.fda.gov/. Accessed 09/11/2017.

Tolmetin Sodium Tablet, Film Coated (Mylan Pharmaceuticals Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 08/11/2017.

Disclaimer: This information is independently developed by MIMS based on Tolmetin sodium from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 MIMS. All rights reserved. Powered by MIMS.com
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