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 an oral tablet for oral use. It is employed for short‑term management of moderate to severe acute pain, including post‑operative pain, in adult patients when other analgesics are insufficient.
GNH India supplies Ketorolac Mylan as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals and clinics worldwide.

Manufacturer / TM Owner

Mylan S.P.A.

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Indications & Clinical Uses

Ketorolac Mylan is an NSAID that provides analgesia by inhibiting prostaglandin synthesis in acute pain states.

  • Moderate to severe acute pain: delivers short‑term relief when opioid therapy is not required.
  • Post‑operative pain: reduces pain intensity after surgical procedures.
  • Dental pain: controls discomfort following dental extractions or oral surgery.

How It Works

  • Ketorolac Trometamol reversibly inhibits cyclooxygenase‑1 and cyclooxygenase‑2 enzymes, decreasing the conversion of arachidonic acid to prostaglandins. The reduced prostaglandin levels diminish peripheral sensitisation of nociceptors and lower inflammation, resulting in analgesic and antipyretic effects without directly acting on central opioid receptors.

Side Effects

Ketorolac Mylan may cause a range of adverse reactions, most of which are dose‑related and reversible.

Common Side Effects

  • Dyspepsia or stomach upset.
  • Nausea and occasional vomiting.
  • Headache or dizziness.
  • Diarrhoea or constipation.
  • Mild elevation of serum creatinine.

Serious or Rare Side Effects

  • Gastrointestinal bleeding, ulceration or perforation.
  • Severe renal impairment or acute kidney injury.
  • Anaphylactic or severe hypersensitivity reactions.
  • Hepatic dysfunction with elevated transaminases.
  • Thrombotic events such as myocardial infarction or stroke.
  • Skin reactions like Stevens‑Johnson syndrome.

Precautions & Warnings

When prescribing Ketorolac Mylan, clinicians should consider several safety measures.

  • Assess renal function: avoid in patients with severe renal impairment.
  • Evaluate gastrointestinal risk: contraindicated in active peptic ulcer disease.
  • Use caution in the elderly: higher incidence of GI bleeding and renal effects.
  • Do not combine with other NSAIDs, anticoagulants, or antiplatelet agents without supervision.
  • Pregnancy and lactation: safety not established; avoid if possible.
  • Store at room temperature: keep in the original pack, protect from moisture and direct sunlight.

Avoid Interactions

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

Major Interactions (Avoid)

  • Anticoagulants (e.g., warfarin, DOACs): increased risk of serious bleeding.
  • Other NSAIDs or COX‑2 inhibitors: additive gastrointestinal toxicity.
  • Systemic corticosteroids: heightened ulcer risk.

Moderate Interactions (Monitor Closely)

  • ACE inhibitors or ARBs: may reduce renal function, especially in volume‑depleted patients.
  • Loop or thiazide diuretics: potential for renal impairment.
  • Lithium: NSAIDs can raise lithium serum concentrations, risking toxicity.

Frequently Asked Questions

Ketorolac Mylan is an oral NSAID indicated for the short‑term management of moderate to severe acute pain, including pain after surgery or dental procedures. It provides analgesia when other non‑opioid options are insufficient, typically for a limited duration of up to five days.

Ketorolac Trometamol blocks the cyclooxygenase‑1 and cyclooxygenase‑2 enzymes, preventing the formation of prostaglandins that mediate inflammation, pain, and fever. By reducing prostaglandin levels, the drug lessens peripheral sensitisation of pain receptors and diminishes the inflammatory response.

The specific dose and duration of Ketorolac Mylan are determined by the prescribing clinician based on the patient’s condition, age, renal function, and other factors. The medication is intended for short‑term use, and the prescriber will set the appropriate regimen.

Safety data for Ketorolac Trometamol in pregnancy and lactation are limited, and the drug is generally avoided unless the potential benefit outweighs the risk. Women who are pregnant, planning pregnancy, or breastfeeding should discuss alternatives with their healthcare provider.

To request Ketorolac Mylan, submit an enquiry on the product page at gnhindia.com, specifying the required quantity. GNH India works with hospitals, pharmacies, and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details, and any necessary import documentation.

Ketorolac is a potent NSAID with analgesic efficacy comparable to moderate‑dose opioids for short‑term use, whereas many other NSAIDs are primarily used for mild to moderate pain. Its stronger COX inhibition offers rapid pain relief but also carries a higher risk of gastrointestinal and renal adverse effects, requiring careful patient selection.

Ketorolac Mylan tablets should be stored at room temperature, below 25 °C, in the original container to protect them from moisture and light. Keep the product out of reach of children and avoid storing in humid or excessively hot environments.

Ketorolac Mylan is taken orally, usually with a full glass of water. It may be taken with or without food, but patients with a history of stomach upset may benefit from taking it with meals to minimise gastrointestinal irritation.

The most serious risks include gastrointestinal bleeding, ulceration or perforation, severe renal impairment, and hypersensitivity reactions such as anaphylaxis. Patients should be monitored for signs of bleeding, reduced urine output, or allergic symptoms, and the drug should be stopped immediately if these occur.

Ketorolac Mylan is contraindicated in patients with known hypersensitivity to ketorolac or other NSAIDs, active peptic ulcer disease, severe renal impairment, and those who have had recent coronary artery bypass graft surgery. It should also be avoided in pregnancy, especially in the third trimester, unless clearly indicated by a physician.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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