Ketorolac Tromethamine Tablets

Ketorolac tromethamine is a nonsteroidal anti-inflammatory drug that inhibits the biosynthesis of prostaglandins, and its biological activity is related to its S-form. Animal studies have shown that ketorolac tromethamine has analgesic effects but no sedative or anxiolytic effects.

The main ingredient is ketorolac tromethamine.

This product is a white film-coated tablet, which is white or off-white after removing the coating.

This product is suitable for short-term treatment of acute and severe pain that requires opioid-level analgesics, usually for postoperative analgesia, and is not suitable for the treatment of mild or chronic pain.

Adults: Regular dose: Oral administration: 10 mg once, twice a day. In case of severe pain, it can be increased to 20 mg once. The duration of medication should not exceed 2 days. Intramuscular injection once 30-60 mg, the maximum daily dose is 90 mg. After the first injection, 20-30 mg can be injected every 6 hours. The duration of medication should not exceed 3 days. Intravenous injection: For severe pain, 10-30 mg once. Ocular administration: 1-2 drops once, 3 times a day. Dosage for renal insufficiency: Low dose is recommended. Dosage for the elderly: Low dose is recommended for people over 65 years old.

1. The complications that may occur during the clinical treatment of this product include: gastrointestinal ulcers, bleeding, perforation, postoperative bleeding, renal failure, allergic and allergic-like reactions and liver failure. 2. The adverse reactions that may be related to ketorolac tromethamine reported in clinical reports are as follows: Incidence rate of more than 1%: Systemic: Edema (4%) Cardiovascular: Hypertension Skin disease: Itching, rash Gastrointestinal: Nausea (12%), indigestion (12%), gastrointestinal pain (13%), diarrhea (7%), constipation, flatulence, gastrointestinal pain, vomiting, stomatitis Blood and lymphatic system: purpura Nervous system: Headache (17%), drowsiness (6%), dizziness (7%), sweating Injection site pain: In multiple-dose studies, about 2% of patients experienced this adverse reaction, incidence rate of 1% or less, systemic, weight gain, fever, infection , weakness Cardiovascular: palpitations, pallor, syncope, vasodilation Skin diseases: urticaria; Gastrointestinal: gastritis, rectal bleeding, belching, anorexia, increased appetite Blood and lymphatic system: epistaxis, anemia, eosinophilia Nervous system: tremor, nightmares, hallucinations, euphoria, extrapyramidal system symptoms, dizziness, paresthesia, depression, insomnia, nervousness, dry mouth, abnormal thinking, inability to concentrate, hyperkinesia, paralysis Respiratory system: dyspnea, pulmonary edema, rhinitis, cough Special senses: abnormal taste, abnormal vision, blurred vision, tinnitus, loss of hearing Urogenital system: hematuria, proteinuria, oliguria, urinary retention, polyuria, frequent urination. 3. Improper use of medication or increasing the dose will increase the incidence of adverse reactions. 4. Post-marketing adverse reaction monitoring: Systemic: allergic reaction, laryngeal edema, tongue edema, angioedema, myalgia Cardiovascular system: hypotension, flushing Skin diseases: Lyell’s syndrome, Stevens-Johnson syndrome, exfoliative dermatitis, maculopapular rash, urticaria Gastrointestinal: peptic ulcer, gastrointestinal bleeding, gastrointestinal perforation, melena, acute pancreatitis, hematemesis, esophagitis Blood and lymphatic system: postoperative wound bleeding, thrombocytopenia, leukopenia Liver: hepatitis, liver failure, cholestatic jaundice Nervous system: convulsions, psychosis, aseptic meningitis Respiratory system: asthma, bronchospasm Urogenital system: acute renal failure, rib pain (with or without hematuria or azotemia), interstitial nephritis, hyponatremia, hyperkalemia, hemolytic uremic syndrome. 5. According to a post-marketing non-randomized follow-up study of approximately 10,000 patients using ketorolac tromethamine, the results showed that there is a risk of severe gastrointestinal bleeding, the degree of which is related to the dose (see the table below). This phenomenon is more common in elderly patients with an average daily dose of more than 60 mg/day.

1. This product is contraindicated in patients with active peptic ulcers, recent gastrointestinal bleeding or perforation, or patients with a history of peptic ulcers or gastrointestinal bleeding. 2. This product is contraindicated in patients with renal failure caused by renal damage and insufficient blood volume. 3. This product is contraindicated in women in labor, delivery, and breastfeeding. 4. This product is contraindicated in patients with a history of allergy to ketorolac tromethamine and allergies to aspirin or other non-steroidal anti-inflammatory drugs. 5. This product is contraindicated for analgesic prevention before major surgery or intraoperative analgesia, and during surgery when emergency hemostasis is required; because of the increased risk of bleeding due to the limitations of intraoperative hemostasis. 6. This product inhibits platelet function, and is contraindicated in patients with suspected or confirmed cerebral hemorrhage, bleeding tendency, incomplete hemostasis, and high-risk bleeding. 7. Because this product contains ethanol, it is contraindicated.

Precautions for children: Not yet clear. Precautions for pregnancy and lactation: Not yet clear. Precautions for the elderly: Not yet clear.

1. There is no research data to clearly confirm the interaction between this product and warfarin, digoxin, salicylates and heparin, but it is necessary to be extremely cautious when giving this product to patients using anticoagulants, and the patients need to be closely observed. 2. The oral preparation of this product and prosoprolol combined can reduce the clearance rate of ketorolac and significantly increase the plasma concentration level of ketorolac (total AUC increased from 5.4 micro; g/h/ml to 17.8 micro; g/h/ml, about three times higher), and the half-life is extended by about 2 times, from 6.6 hours to 15.1 hours. Therefore, this product is forbidden to be used in combination with prosoprolol. 3. When this product is injected intravenously/intramuscularly into healthy subjects with normal blood volume, the diuretic effect of furosemide is reduced by about 20%. 4. There are reports that the simultaneous administration of methotrexate and some non-steroidal anti-inflammatory drugs will reduce the clearance rate of methotrexate and increase its toxicity. However, the effect of this product on the clearance rate of methotrexate has not been studied. 5. There are reports that prostaglandin synthesis inhibitors inhibit the clearance of lithium in the kidneys, leading to an increase in plasma lithium concentration. At present, there is no research data on the effect of this product on plasma lithium, but there have been reports of increased plasma lithium concentration when using ketorolac tromethamine. 6. This product may interact with non-depolarizing muscle relaxants and cause apnea, but there is still a lack of formal research data in this regard. 7. The combined use of this product and ACE inhibitors may increase the possibility of renal damage, especially for patients with blood volume failure. This risk is greater. 8. Epilepsy may occur when this product is used in combination with anti-epileptic drugs (phenytoin, carbamazepine), but this possibility is extremely small. 9. When this product is used in combination with nervous system drugs (fluoxetine, thiothixene, alprazolam), there is a possibility that the patient will have hallucinations. 10. No adverse interactions have been observed when this product is used in combination with morphine to treat postoperative pain; but do not mix this product and morphine in the same syringe for injection. 11. There are no animal or human studies to demonstrate whether this product induces or inhibits liver enzymes that affect the metabolism of ketorolac tromethamine or other drugs.

Store in airtight container away from light.

10mg

24 months

TC Pharmaceuticals (Jiangsu) Co., Ltd.

• Founded in:

  1994-12-12

• Address:

  No. 191, Jinyang West Road, Lujia Town, Kunshan City, Jiangsu Province

• Tax NO.:

  91320583608280290E

• Registered Funds:

  126.271311 yuan

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