Tolmetin

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Tolmetin
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Rabin Bista, M.B.B.S. [2]

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Black Box Warning

Cardiovascular Risk:
See full prescribing information for complete Boxed Warning.
Cardiovascular Risk:
  • NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk (See WARNINGS).

Tolmetin sodium is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery

Gastrointestinal Risk:

  • NSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at anytime during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events

Overview

Tolmetin is a Antirheumatic that is FDA approved for the treatment of rheumatoid arthritis, osteoarthritis and juvenile rheumatoid arthritis. There is a Black Box Warning for this drug as shown here. Common adverse reactions include Nausea, dyspepsia, gastrointestinal distress, abdominal pain, diarrhea, flatulence, vomiting.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

Carefully consider the potential benefits and risks of tolmetin sodium and other treatment options before deciding to use tolmetin sodium. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).

Tolmetin sodium is indicated for the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis. Tolmetin sodium is indicated in the treatment of acute flares and the long-term management of the chronic disease.

Tolmetin sodium is also indicated for treatment of juvenile rheumatoid arthritis. The safety and effectiveness of tolmetin sodium have not been established in pediatric patients under 2 years of age

Dosage

Carefully consider the potential benefits and risks of tolmetin sodium and other treatment options before deciding to use tolmetin sodium. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).

After observing the response to initial therapy with tolmetin sodium, the dose and frequency should be adjusted to suit an individual patient's needs.

For the relief of rheumatoid arthritis or osteoarthritis, the recommended starting dose for adults is 400 mg three times daily (1200 mg daily), preferably including a dose on arising and a dose at bedtime. To achieve optimal therapeutic effect the dose should be adjusted according to the patient's response after one or two weeks. Control is usually achieved at doses of 600–1800 mg daily in divided doses (generally t.i.d.). Doses larger than 1800 mg/day have not been studied and are not recommended.

For the relief of juvenile rheumatoid arthritis, the recommended starting dose for pediatric patients (2 years and older) is 20 mg/kg/day in divided doses (t.i.d. or q.i.d.). When control has been achieved, the usual dose ranges from 15 to 30 mg/kg/day. Doses higher than 30 mg/kg/day have not been studied, and, therefore, are not recommended.

A therapeutic response to tolmetin sodium can be expected in a few days to a week. Progressive improvement can be anticipated during succeeding weeks of therapy. If gastrointestinal symptoms occur, tolmetin sodium can be administered with antacids other than sodium bicarbonate. Tolmetin sodium bioavailability and pharmacokinetics are not significantly affected by acute or chronic administration of magnesium and aluminum hydroxides; however, bioavailability is affected by food or milk

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Tolmetin in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Tolmetin in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Indications

  • Tolmetin sodium is also indicated for treatment of juvenile rheumatoid arthritis. The safety and effectiveness of tolmetin sodium have not been established in pediatric patients under 2 years of age

Dosage

For the relief of juvenile rheumatoid arthritis, the recommended starting dose for pediatric patients (2 years and older) is 20 mg/kg/day in divided doses (t.i.d. or q.i.d.). When control has been achieved, the usual dose ranges from 15 to 30 mg/kg/day. Doses higher than 30 mg/kg/day have not been studied, and, therefore, are not recommended.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Tolmetin in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Tolmetin in pediatric patients.

Contraindications

  • Tolmetin sodium is contraindicated in patients with known hypersensitivity to tolmetin sodium.

Tolmetin sodium should not be given to patients who have experienced asthma, urticaria or allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients (see WARNINGS: ANAPHYLACTOID REACTIONS and PRECAUTIONS: PREEXISTING ASTHMA).

Tolmetin sodium is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery

Warnings

Cardiovascular Risk:
See full prescribing information for complete Boxed Warning.
Cardiovascular Risk:
  • NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk (See WARNINGS).

Tolmetin sodium is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery

Gastrointestinal Risk:

  • NSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at anytime during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events
  • Description

Precautions

  • Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Tolmetin in the drug label.

Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Tolmetin in the drug label.

Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous

Drug Interactions

  • Drug
  • Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

  • Pregnancy Category


Pregnancy Category (AUS):

  • Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Tolmetin in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Tolmetin during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Tolmetin with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Tolmetin with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Tolmetin with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Tolmetin with respect to specific gender populations.

Race

There is no FDA guidance on the use of Tolmetin with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Tolmetin in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Tolmetin in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Tolmetin in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Tolmetin in patients who are immunocompromised.

Administration and Monitoring

Administration

  • Oral
  • Intravenous

Monitoring

There is limited information regarding Monitoring of Tolmetin in the drug label.

  • Description

IV Compatibility

There is limited information regarding IV Compatibility of Tolmetin in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

  • Description

Management

  • Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Tolmetin in the drug label.

Pharmacology

There is limited information regarding Tolmetin Pharmacology in the drug label.

Mechanism of Action

Structure

File:Tolmetin01.png
This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Tolmetin in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Tolmetin in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Tolmetin in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Tolmetin in the drug label.

How Supplied

Storage

There is limited information regarding Tolmetin Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

{{#ask: Label Page::Tolmetin |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

Patient Counseling Information

There is limited information regarding Patient Counseling Information of Tolmetin in the drug label.

Precautions with Alcohol

  • Alcohol-Tolmetin interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

Look-Alike Drug Names

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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  2. ↑ "http://www.ismp.org". External link in |title= (help)

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