Product image of Ketorolac Mylan (Ketorolac Trometamol) supplied by GNH India

Ketorolac Mylan

Active Ingredient:
Ketorolac Trometamol
Origin:
EU

Ketorolac Mylan (Ketorolac Trometamol)

Ketorolac trometamol, the active ingredient in Ketorolac Mylan, is a nonsteroidal anti‑inflammatory drug (NSAID) presented as a sterile injectable solution for intramuscular and intravenous use. It is employed for short‑term management of moderate to severe acute pain, including postoperative pain, in adult patients.

GNH India supplies Ketorolac Mylan as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide. The company adheres to EU quality standards and provides reliable global distribution.

Manufacturer / TM Owner

Mylan S.P.A.

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Indications & Clinical Uses

Ketorolac Mylan is an NSAID indicated for conditions that involve acute pain pathways.

  • Post‑operative pain: provides rapid analgesia after surgical procedures
  • Moderate to severe acute pain: reduces pain intensity when opioid‑sparing therapy is desired
  • Short‑term pain management (≤5 days): used to control pain where NSAIDs are appropriate

How It Works

  • Ketorolac trometamol exerts its analgesic and anti‑inflammatory effects by non‑selectively inhibiting cyclooxygenase‑1 (COX‑1) and cyclooxygenase‑2 (COX‑2) enzymes. This inhibition blocks the conversion of arachidonic acid to prostaglandins, reducing peripheral sensitisation and inflammation, which in turn diminishes pain signalling at the site of injury.

Side Effects

Ketorolac Mylan may cause a range of adverse reactions, varying from mild to severe.

Common Side Effects

  • Nausea or vomiting
  • Headache
  • Dizziness or vertigo
  • Injection‑site pain or erythema
  • Mild gastrointestinal discomfort

Serious or Rare Side Effects

  • Gastrointestinal bleeding or perforation
  • Acute renal impairment or failure
  • Severe hypersensitivity reactions, including anaphylaxis or Stevens‑Johnson syndrome

Precautions & Warnings

When prescribing Ketorolac Mylan, clinicians should observe several safety precautions to minimise risk.

  • Renal function: assess baseline renal status and avoid use in patients with severe renal impairment.
  • Bleeding risk: avoid in individuals with active peptic ulcer disease or concurrent anticoagulant therapy.
  • Cardiovascular disease: use cautiously in patients with coronary artery disease or uncontrolled hypertension.
  • Pregnancy: contraindicated in the third trimester and should be avoided during pregnancy unless benefits outweigh risks.
  • Drug interactions: review concomitant NSAIDs, anticoagulants, and ACE inhibitors before initiating therapy.
  • Store at 2-8°C: keep refrigerated, protect from light, do not freeze.

Avoid Interactions

Ketorolac Mylan can interact with several drug classes, requiring careful management.

Major Interactions (Avoid)

  • Anticoagulants (e.g., warfarin, heparin): additive risk of serious bleeding.
  • Concurrent NSAIDs or COX‑2 inhibitors: increased gastrointestinal toxicity and renal adverse effects.

Moderate Interactions (Monitor Closely)

  • ACE inhibitors or ARBs: may potentiate renal function decline, especially in volume‑depleted patients.
  • Lithium: ketorolac may raise serum lithium concentrations, necessitating monitoring.
  • Methotrexate: reduced clearance can lead to toxicity; monitor levels.

Frequently Asked Questions

Ketorolac Mylan is prescribed for the short‑term management of moderate to severe acute pain, most commonly after surgical procedures. It provides rapid analgesia and is intended for use in adult patients for a limited duration, typically not exceeding five days, to minimise the risk of adverse effects associated with prolonged NSAID therapy.

Ketorolac trometamol works by non‑selectively inhibiting the cyclooxygenase enzymes COX‑1 and COX‑2. This inhibition reduces the synthesis of prostaglandins, which are mediators of inflammation, pain, and fever. Lower prostaglandin levels lead to decreased peripheral sensitisation and a reduction in pain perception at the site of injury.

The specific dose of Ketorolac Mylan is determined by the prescribing clinician based on the patient’s clinical condition, weight, renal function, and overall risk profile. Dosing regimens are individualized and should follow the prescriber’s instructions, adhering to the recommended maximum duration of therapy to avoid toxicity.

Ketorolac Mylan is generally avoided during the third trimester of pregnancy because of the risk of fetal renal impairment and premature closure of the ductus arteriosus. Use in earlier trimesters should only be considered if the potential benefit justifies the risk. Limited data are available for breastfeeding, and caution is advised; consult a healthcare professional before use.

To order Ketorolac Mylan, submit an enquiry on the product page at gnhindia.com, specifying the required quantity. GNH India supplies hospitals, pharmacies and procurement teams across international markets. After the request, the sales team will verify trade or institutional credentials, then provide pricing, availability, shipping details (including cold‑chain if required) and assist with any necessary import documentation.

Ketorolac offers potent analgesia comparable to moderate‑dose opioids but without the risk of respiratory depression or dependence. Compared with other NSAIDs, it has a stronger analgesic effect but a higher risk of gastrointestinal and renal adverse events, especially with prolonged use. It is therefore reserved for short‑term, severe pain where rapid relief is needed.

Ketorolac Mylan should be stored at 2‑8 °C in a refrigerator, protected from light and moisture. The product must not be frozen or shaken vigorously. If the temperature range is temporarily exceeded, discard the vial according to local regulations. Always keep the medication in its original packaging until use.

Ketorolac Mylan is supplied as a sterile injectable solution for intramuscular (IM) or intravenous (IV) administration. The route, injection site and rate of infusion are determined by the prescribing clinician. Proper aseptic technique and appropriate dilution, if required, should be followed according to the product’s prescribing information.

Serious risks include gastrointestinal bleeding or perforation, acute renal failure, and severe hypersensitivity reactions such as anaphylaxis or Stevens‑Johnson syndrome. Patients should be monitored for signs of bleeding, sudden loss of kidney function, or allergic manifestations, and the drug should be discontinued immediately if any of these events occur.

Ketorolac Mylan is contraindicated in patients with known hypersensitivity to ketorolac or other NSAIDs, active peptic ulcer disease, recent gastrointestinal bleeding, severe renal impairment, and in the third trimester of pregnancy. Caution is also advised for individuals with uncontrolled hypertension, coronary artery disease, or those receiving anticoagulants, unless the prescriber determines that benefits outweigh the risks.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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