Abridged Prescribing Information

Ketorolac 10mg Oral disintegrating tablet

Composition: Each uncoated orally disintegrating tablets contains: Ketorolac Tromethamine USP 10 mg. Indications: Short-term management of moderate postoperative pain. The maximum duration of treatment is seven days. Dosage & administration Ketorolac tablets are recommended for short-term use only (up to 7 days) and are not recommended for chronic use. Adults: 10 mg every 4 to 6 hours as required. Doses exceeding 40 mg per day are not recommended. For patients receiving parenteral ketorolac, and who are converted to ketorolac oral tablets, the total combined daily dose should not exceed 90 mg and the oral component should not exceed 40 mg on the day the change of formulation is made. Elderly: A longer dosing interval, e.g. 6-8 hourly, is advisable in the elderly. Use in Children Safety and efficacy of ketorolac has not been studied in children less than 18 years of age. Contraindications: Ketorolac is contraindicated in patients with previously demonstrated hypersensitivity to Ketorolac, any of its excipients; with a history of asthma; Children and adolescents aged less than 18 years; active peptic ulcer, or any history of gastrointestinal bleeding, ulceration or perforation; severe heart failure, hepatic failure and renal failure; moderate or severe renal impairment (serum creatinine >160 μmol/l); pregnancy, labour, delivery and lactation; intraoperatively because of the increased risk of bleeding; suspected or confirmed cerebrovascular bleeding, high risk of haemorrhage or bleeding, including coagulation disorders, patients on anticoagulants, including warfarin and low dose heparin; patients currently receiving ASA or other NSAIDs, oxpentifylline, probenecid or lithium salts. Ketorolac is contraindicated in patients with the complete or partial syndrome of nasal polyps, angioedema or bronchospasm. Special Warnings and Precautions for use: The long-term administration of ketorolac tromethamine is not recommended as the incidence of side-effects increases with the duration of treatment. Use in specific populations:  Use in Pregnancy and Lactation: Not recommended during pregnancy or lactation. Use in Children - Not recommended for use in children under age 16. Use in the Elderly: Extra caution and the lowest effective dose should be used. Adverse Reactions: Renal Events: acute renal failure, flank pain with or without hematuria and/or azotemia, nephritis, hyponatremia, hyperkalemia, hemolytic uremic syndrome, urinary retention. Hypersensitivity reactions: bronchospasm, laryngeal edema, asthma, hypotension, flushing, rash, anaphylaxis, and anaphylactoid reactions. Gastrointestinal Events: gastrointestinal hemorrhage, peptic ulceration, gastrointestinal perforation, pancreatitis, melena. Hematologic Events: postoperative wound hemorrhage, rarely requiring blood transfusion, thrombocytopenia, epistaxis, leukopenia. Central Nervous System: Convulsions, hallucinations, hyperkinesia, hearing loss, aseptic meningitis, extrapyramidal symptoms. Hepatic Events: hepatitis, liver failure, cholestatic jaundice Cardiovascular: pulmonary edema, hypotension, flushing. Dermatology: Lyell's syndrome, Stevens-Johnson syndrome, exfoliative dermatitis, maculopapular rash, urticarial. Over dosage: Overdose is associated with abdominal pain, nausea, vomiting, hyperventilation, peptic ulcers and/or erosive gastritis, gastrointestinal bleeding, and renal dysfunction which have generally resolved after discontinuation of dosing.

Dated: 13th July, 2021

Further information is available on request.

LMRC: GGI-CO-RE-RAE-300023454-300023454-WM-B22-107