
Properties
What is it?
MEDROLGIN Ketorolac Composition: Film-coated tablet contains: Active substance: Ketorolac tromethamine 10mg; Excipients: anhydrous lactose, croscarmellose sodium, microcrystalline cellulose, magnesium stearate. Coating composition: Opadry® Y-1-7000 White (hypromellose, titanium dioxide, macrogol). Indications: Short-term (less than or equal to 5 days) treatment of moderate to severe acute pain, when opioid analgesia is needed, usually in the postoperative period. Dosage and Administration: Before deciding to administer MEDROLGIN in tablet form, a proper assessment of the potential benefits and risks of treatment with ketorolac tromethamine, as well as other treatment options, is necessary. The lowest effective dose of the drug should be used for the shortest possible period, taking into account the individual treatment goals of the patient. MEDROLGIN tablets are taken orally, single or repeated dose, depending on the severity of the pain syndrome. Treatment should always be initiated with intravenous or intramuscular administration of ketorolac tromethamine, followed by oral administration of MEDROLGIN tablets (if necessary). The total duration of oral and intravenous-intramuscular administration of ketorolac tromethamine in adults should not exceed 5 days, due to the potential increase in the frequency and severity of adverse reactions associated with recommended doses. Patients should switch to alternative analgesics as soon as possible, but treatment with ketorolac tromethamine should not exceed 5 days. Transition from intravenous or intramuscular to oral administration: Patients aged 17 to 64 years: a single oral dose of 20mg, then 10mg every 4-6 hours as needed, but not exceeding 40mg per day. Patients over 65 years of age, patients with renal dysfunction and/or body weight less than 50kg: a single oral dose of 10mg, then 10mg every 4-6 hours as needed, but not exceeding 40mg per day. Note: Oral preparation should not be used as an initial dose. The minimum effective dose is used for the patient. The dosing interval of 4-6 hours cannot be shortened. Children: MEDROLGIN in tablet form is not intended for use in children. The efficacy and safety of the drug in children under 17 years of age have not been established. Elderly patients: Since ketorolac tromethamine may be eliminated more slowly from the body in elderly patients, and such patients are more sensitive to dose-related adverse reactions to NSAIDs, appropriate clinical monitoring is necessary when treating elderly patients with ketorolac tromethamine. Contraindications: Hypersensitivity to ketorolac tromethamine; patients with active peptic ulcer, recent gastrointestinal bleeding or perforation, as well as a history of peptic ulcer disease or gastrointestinal bleeding; as a prophylactic analgesic before major surgery; for the treatment of perioperative pain during coronary artery bypass grafting; patients with severe renal impairment or patients at risk of developing renal failure due to volume depletion. During labor, as its prostaglandin synthesis inhibitory effect may adversely affect fetal circulation and suppress uterine contractions, thereby increasing the risk of uterine bleeding.