Tolectin

What Is Tolmetin?

 

Tolmetin is a nonsteroidal anti-inflammatory drug (NSAID) used to relieve signs and symptoms of rheumatoid arthritis and osteoarthritis and to treat acute flares and for the long-term management of the chronic disease. Tolmetin is also used to treat juvenile rheumatoid arthritis. 

 

What Are Side Effects of Tolmetin?

Side effects of tolmetin include:

• nausea, 
• indigestion, 
• stomach upset,
• abdominal pain,
• diarrhea,
• gas (flatulence), 
• vomiting, 
• constipation, 
• peptic ulcer,
• headache, 
• weakness,
• chest pain,
• elevated blood pressure, 
• fluid retention (edema), 
• dizziness, 
• drowsiness, 
• depression
• weight changes, 
• skin irritation,
• ringing in the ears (tinnitus), 
• visual disturbance, and 
• urinary tract infection (UTI).

Dosage for Tolmetin

For the relief of rheumatoid arthritis or osteoarthritis, the recommended starting dose of tolmetin for adults is 400 mg three times daily (1200 mg daily), preferably including a dose on arising and a dose at bedtime. Control is usually achieved at doses of 600 mg to 1800 mg daily in divided doses (generally three times daily). 

 

For the relief of juvenile rheumatoid arthritis, the recommended starting dose of tolmetin for pediatric patients (2 years and older) is 20 mg/kg/day in divided doses (three or four times daily). When control has been achieved, the usual dose of tolmetin ranges from 15 to 30 mg/kg/day. 

Tolmetin In Children

The safety and effectiveness of tolmetin have not been established in pediatric patients under 2 years of age.

 

What Drugs, Substances, or Supplements Interact with Tolmetin?
 

Tolmetin may interact with other medicines such as:

• ACE inhibitors,
• aspirin,
• diuretics,
• lithium,
• methotrexate,
• warfarin, and
• hypoglycemic agents.

 

Tell your doctor all medications and supplements you use.

Tolmetin During Pregnancy and Breastfeeding

 

Tolmetin is not recommended for use during pregnancy. Because of the known effects of NSAIDs on the fetal cardiovascular system (closure of the ductus arteriosus), use during pregnancy (particularly late pregnancy) should be avoided. Tolmetin passes into breast milk. Because of the potential for serious adverse reactions in nursing infants, breastfeeding is not recommended while using tolmetin.

 

Additional Information

 

Our Tolmetin Sodium Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication. 

 

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

 

Tolectin Consumer Information

Get emergency medical help if you have signs of an allergic reaction (hives, sneezing, runny nose, wheezing, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Get emergency medical help if you have signs of a heart attack or stroke: chest pain spreading to your jaw or shoulder, sudden numbness or weakness on one side of the body, slurred speech, feeling short of breath.

Stop using tolmetin and call your doctor at once if you have:

• changes in your vision;
• shortness of breath (even with mild exertion);
• swelling or rapid weight gain;
• any skin rash, no matter how mild;
• signs of stomach bleeding--bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
• liver problems--nausea, upper stomach pain, itching, tired feeling, flu-like symptoms, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• kidney problems--little or no urinating, painful or difficult urination, swelling in your feet or ankles, feeling tired or short of breath; or
• low red blood cells (anemia)--pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet.

Common side effects may include:

• indigestion, stomach pain, nausea, vomiting;
• diarrhea, gas;
• headache, dizziness;
• weakness; or
• changes in weight.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Tolectin (Tolmetin Sodium)

 

Tolectin Professional Information

SIDE EFFECTS

The adverse reactions which have been observed in clinical trials encompass observations in about 4,370 patients treated with tolmetin sodium, over 800 of whom have undergone at least one year of therapy. These adverse reactions, reported below by body system, are among those typical of non-steroidal anti-inflammatory drugs and, as expected, gastrointestinal complaints were most frequent. In clinical trials with tolmetin, about 10% of patients dropped out because of adverse reactions, mostly gastrointestinal in nature.

Incidence Greater Than 1%

The following adverse reactions which occurred more frequently than 1 in 100 were reported in controlled clinical trials

Gastrointestinal: nausea (11%), dyspepsia¹, gastrointestinal distress¹, abdominal pain¹ , diarrhea¹, flatulence¹,vomiting¹, constipation,gastritis, and peptic ulcer. Forty percent of the ulcer patients had a prior history of peptic ulcer disease and/or were receiving concomitant anti-inflammatory drugs including corticosteroids, which are known to produce peptic ulceration.

Body as a Whole: headache¹,asthenia¹,chest pain

Cardiovascular: elevated blood pressure¹,edema¹

Central Nervous System: dizziness¹,drowsiness depression

Metabolic/Nutritional: weight gain¹,weight loss¹

Dermatologic: skin irritation

Special Senses: tinnitus, visual disturbance

Hematologic: Small and transient decreases in hemoglobin and hematocrit not associated with gastrointestinal bleeding have occurred. These are similar to changes reported with other non-steroidal anti-inflammatory drugs.

Urogenital: elevated BUN, urinary tract infection

¹ Reactions occurring in 3% to 9% of patients treated with tolmetin sodium.

Reactions occurring in fewer than 3% of the patients are unmarked.

Incidence Less Than 1%

(Causal Relationship Probable) The following adverse reactions were reported less frequently than 1 in 100 in controlled clinical trials or were reported since marketing. The probability exists that there is a causal relationship between tolmetin and these adverse reactions.

Gastrointestinal: gastrointestinal bleeding with or without evidence of peptic ulcer, perforation, glossitis, stomatitis, hepatitis, liver function abnormalities.

Body as a Whole: anaphylactoid reactions, fever, lymphadenopathy, serum sickness

Hematologic: hemolytic anemia, thrombocytopenia, granulocytopenia, agranulocytosis

Cardiovascular: congestive heart failure in patients with marginal cardiac function

Dermatologic: urticaria, purpura, erythema multiforme, toxic epidermal necrolysis

Urogenital: hematuria, proteinuria, dysuria, renal failure

Incidence Less Than 1%

(Causal Relationship Unknown) Other adverse reactions were reported less frequently than 1 in 100 in controlled clinical trials or were reported since marketing, but a causal relationship between tolmetin and the reaction could not be determined. These rarely reported reactions are being listed as alerting information for the physician since the possibility of a causal relationship cannot be excluded.

Body as a Whole: epistaxis

Special Senses: optic neuropathy, retinal and macular changes

Management Of Overdosage

In the event of overdosage, the stomach should be emptied by inducing vomiting or by gastric lavage followed by the administration of activated charcoal.

DRUG INTERACTIONS

ACE Inhibitors

Reports suggest that NSAIDs may diminish the antihypertensive effect of ACE Inhibitors. This interaction should be given consideration in patients taking NSAIDs concomitantly with ACE Inhibitors.

Aspirin

As with other NSAIDs, concomitant administration of tolmetin sodium and aspirin is not generally recommended because of the potential of increased adverse effects.

Diuretics

Clinical studies, as well as post-marketing observations have shown that NSAIDs can reduce the natriuretic effect of furosemide and thiazides in some patients. This response has been attributed to inhibition of renal prostaglandin synthesis. During concomitant therapy with NSAIDs, the patient should be observed closely for signs of renal failure, as well as to assure diuretic efficacy.

Lithium

NSAIDs have produced an elevation of plasma lithium levels and a reduction in renal lithium clearance. The mean minimum lithium concentration increased 15% and the renal clearance was decreased by approximately 20%. These effects have been attributed to inhibition of renal prostaglandin synthesis by the NSAID. Thus, when NSAIDs and lithium are administered concurrently, subjects should be observed carefully for signs of lithium toxicity.

Methotrexate

NSAIDs have been reported to competitively inhibit methotrexate accumulation in rabbit kidney slices. This may indicate that they could enhance the toxicity of methotrexate. Caution should be used when NSAIDs are administered concomitantly with methotrexate.

Warfarin

The effects of warfarin and NSAIDs on GI bleeding are synergistic, such that users of both drugs together have a risk of serious GI bleeding higher than users of either drug alone.

The in vitro binding of warfarin to human plasma proteins is unaffected by tolmetin, and tolmetin does not alter the prothrombin time of normal volunteers. However, increased prothrombin time and bleeding have been reported in patients on concomitant tolmetin and warfarin therapy. Therefore, caution should be exercised when administering tolmetin to patients on anticoagulants.

Hypoglycemic Agents

In adult diabetic patients under treatment with either sulfonylureas or insulin there is no change in the clinical effects of either tolmetin or the hypoglycemic agents.

Read the entire FDA prescribing information for Tolectin (Tolmetin Sodium)