Adult Dosing
Rheumatoid arthritis or osteoarthritis
- Initial: 400 mg PO tid; adjust dose according to the patient's response after 1-2 weeks until therapeutic response is seen
- Maintenance: 600-1800 mg PO divided tid
- Max: 1800 mg/day
Notes:- Individualize therapy as per patient's needs. Use the lowest effective dose for shortest duration possible
- Administer with antacids except sodium bicarbonate, if GI symptoms occur
Pediatric Dosing
Juvenile rheumatoid arthritis
Children >2 yrs
- Initial: 20 mg/kg/day PO divided tid-qid, until therapeutic response is seen
- Maintenance: 15-30 mg/kg/day PO divided tid-qid
- Max: 30 mg/kg/day
Below 2 yrs
- Safety and effectiveness in pediatric patients <2 yrs have not been established
Notes:- Individualize therapy as per patient's needs. Use the smallest effective dose for shortest duration possible
- Administer with antacids except sodium bicarbonate, if GI symptoms occur
[Outline]
- The risk of serious and potentially fatal cardiovascular thrombotic events, MI, and stroke increases with the use of NSAIDs and is proportional to the duration of use. Patients with preexisting cardiovascular disease or risk factors are more prone to these events [US black box warning]
- Using lowest effective dose for shortest duration of time is recommended to reduce the risk of CV events
- Tolmetin should not be used for the treatment of perioperative pain following CABG surgery [US black box warning]
- Therapy may cause onset of new hypertension or worsening of preexisting hypertension, either of which may contribute to the increased incidence of CV events. Use with caution in hypertensive patients
- Use with caution in patients taking thiazides or loop diuretics as it may hamper the therapeutic response of these agents; closely monitor BP during therapy
- Use cautiously in patients with fluid retention and heart failure, as tolmetin may cause fluid retention and edema
- Tolmetin may cause potentially fatal GI adverse events such as inflammation, bleeding, ulceration, and perforation of the stomach, small intestine or large intestine. Use with extreme caution in patients with a prior history of peptic ulcer disease and/or gastrointestinal bleeding
- Factors that increase the risk for GI bleeding in patients receiving NSAID therapy include concomitant use of oral corticosteroids or anticoagulants, longer duration of NSAID therapy, smoking, alcohol use, older age, and poor general health status
- If a serious GI adverse event is suspected, discontinue therapy and promptly institute an alternative therapy
- Long-term use of tolmetin may cause renal toxicity such as renal papillary necrosis, acute interstitial nephritis and nephrotic syndrome, especially in patients with renal impairment, heart failure, liver dysfunction, those taking diuretics and ACE inhibitors and the elderly
- Therapy not recommended in patients with advanced renal disease
- Anaphylactoid reactions may occur in patients previously sensitized to tolmetin. Tolmetin is contraindicated in patients with aspirin triad, which occurs typically in asthmatic patients who experience rhinitis with or without nasal polyps, or who exhibit potentially fatal bronchospasm after taking aspirin or other NSAIDs
- Serious dermatological reactions such as exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis have been reported with tolmetin use. Discontinue therapy if any signs of hypersensitivity are observed
- Do not administer in late pregnancy, as it may cause premature closure of ductus arteriosus in the fetus
- Tolmetin is not a therapeutic substitute for corticosteroids. Abrupt discontinuation of corticosteroids is not recommended as it may lead to disease exacerbation
- Ophthalmologic evaluations are recommended if patients develop any visual disturbances during tolmetin therapy
- Tolmetin may cause abnormal LFTs. Severe jaundice, fulminant hepatitis, liver necrosis, and hepatic failure have also been reported in rare cases, some of which were fatal. Discontinue the drug if signs of liver dysfunction are seen
- Evaluation of hemoglobin and hematocrit values at regular intervals in patients on long-term treatment with NSAIDs is recommended as therapy is associated with anemia in some cases, possibly due to fluid retention, occult or gross GI blood loss
- Tolmetin inhibits platelet aggregation and prolongs bleeding time in some patients; closely monitor patients with coagulation disorders or those receiving anticoagulants
- Tolmetin is contraindicated in patients with aspirin-sensitivity and should be used cautiously in patients with preexisting asthma due to the risk of bronchospasm
- Monitor for signs of GI bleeding; perform CBC and other blood chemistries, liver function and renal function tests periodically
Cautions: Use cautiously in
- Hepatic impairment
- Dehydration
Pregnancy Category:C
Breastfeeding: Due to the low levels of tolmetin excreted in human milk and its short half-life, it is not likely to cause any adverse effects in breastfed infant. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 15 June 2011). As per manufacturer's data, due of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
