Tolmetin (Tolmetin Sodium) - Drug Interactions, Contraindications, Overdosage

DRUG INTERACTIONS

Pregnancy category C

Reproduction studies in rats and rabbits at doses up to 50 mg/kg (1.5 times the maximum clinical dose based on a body weight of 60 kg) revealed no evidence of teratogenesis or impaired fertility due to tolmetin sodium. However, animal reproduction studies are not always predictive of human response. There are no adequate and well-controlled studies in pregnant women. Tolmetin sodium capsules should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus.

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.

CONTRAINDICATIONS

Tolmetin sodium capsules are contraindicated in patients with known hypersensitivity to tolmetin sodium.

Tolmetin sodium capsules 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 capsules are contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS).