Ketorolac Trometamol (Ketorobas) 30mg/ml Solution for Injection I.M/I.V 1ml x Ampoule 10's

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Product Description:

Ketorolac Trometamol (Ketorobas) is a nonsteroidal anti-inflammatory drug (NSAID) used for the short-term management of moderate to severe pain, such as after surgery or injury. It works by inhibiting the production of substances in the body (prostaglandins) that cause pain, inflammation, and fever.

Ketorobas contains 30 mg of Ketorolac Trometamol per 1 ml of solution and is provided in 1 ml ampoules. This injectable form is typically used for intramuscular (I.M.) or intravenous (I.V.) administration. It is designed for short-term use (up to 5 days) and is typically prescribed when oral NSAIDs are not suitable or effective.

Indications:

Ketorolac Trometamol (Ketorobas) is indicated for the short-term treatment of moderate to severe pain. Specific uses include:

1. Postoperative Pain:

   • For the management of moderate to severe pain after surgeries, including dental, orthopedic, and soft tissue procedures.

2. Acute Pain:

   • For the management of acute pain in conditions like musculoskeletal injury, trauma, and severe headaches.

3. Pain Management in Medical Procedures:

   • When rapid pain relief is required and other oral or systemic analgesics are not suitable.

Note: Ketorolac is typically used for short-term pain management, not exceeding 5 days due to potential risks of prolonged NSAID use.

Dosages:

The dosage of Ketorolac Trometamol (Ketorobas) depends on the severity of pain, the patient’s condition, and how the medication is administered (I.M. or I.V.). The usual dosages are as follows:

• Adults:

  • Initial Dose: Typically, 30 mg via I.V. or 60 mg via I.M. (the I.M. dose can be doubled to 60 mg for the first dose).

  • Maintenance Dose: The recommended dose is 10-30 mg every 4-6 hours as needed for pain relief.

  • Maximum Dose: Do not exceed 120 mg per day in the first 2 days of treatment. After the initial 2 days, use should be limited to 90 mg per day.

• Elderly (over 65 years old):

  • For elderly patients, the dosage should be reduced, typically starting with 15 mg I.V. or I.M. for the initial dose and adjusting based on response.

• Renal Impairment:

  • In patients with mild to moderate renal impairment, the dose may need to be adjusted. Severe renal impairment (creatinine clearance < 30 mL/min) generally requires avoiding the use of Ketorolac.

Note: Ketorolac is intended for short-term use only, typically no more than 5 days, due to its potential for side effects and complications with prolonged use.

Side Effects:

While Ketorolac Trometamol (Ketorobas) is effective for pain management, it may cause a range of side effects. Some common and serious side effects include:

1. Common Side Effects:

   • Gastrointestinal issues: Nausea, dyspepsia (indigestion), stomach pain, constipation, diarrhea.

   • Drowsiness or dizziness.

   • Headache.

   • Injection site reactions: Pain, swelling, or irritation at the site of injection.

2. Serious Side Effects:

   • Gastrointestinal Bleeding: Prolonged use of Ketorolac can cause bleeding, ulcers, or perforation of the stomach or intestines. Signs of gastrointestinal bleeding include black or tarry stools, or vomit that looks like coffee grounds.

   • Renal Damage: Ketorolac can affect kidney function, causing acute renal failure. Symptoms include reduced urine output, fluid retention, or swelling.

   • Cardiovascular Risks: Prolonged use may increase the risk of heart attack or stroke, particularly in individuals with preexisting heart conditions.

   • Severe Allergic Reactions: Symptoms include swelling of the face, lips, tongue, or throat, difficulty breathing, or severe skin reactions such as rash, blistering, or peeling (anaphylaxis).

   • Liver Dysfunction: Liver enzyme abnormalities, jaundice, or severe abdominal pain may indicate liver problems.

   • Hemorrhagic Complications: Increased risk of bleeding, especially if taken with other anticoagulants.

3. Rare but Serious Side Effects:

   • CNS Effects: Confusion, hallucinations, and mood changes (especially in elderly patients).

   • Severe Skin Reactions: Such as toxic epidermal necrolysis (TEN) or Stevens-Johnson syndrome (SJS).

Contraindications:

Ketorolac Trometamol (Ketorobas) should not be used in the following situations:

1. Hypersensitivity: If the patient has a known allergy to Ketorolac, other NSAIDs, or any components of the formulation.

2. Active Bleeding or Bleeding Disorders: Ketorolac should not be used in patients with active bleeding, peptic ulcers, or a history of gastrointestinal bleeding.

3. Severe Renal Impairment: Patients with severe renal dysfunction or those with impaired kidney function (creatinine clearance < 30 mL/min) should avoid using Ketorolac.

4. Severe Liver Impairment: Should not be used in patients with severe liver dysfunction or cirrhosis.

5. Pregnancy: Ketorolac is contraindicated during pregnancy, particularly in the third trimester, as it can cause premature closure of the ductus arteriosus in the fetus.

6. Breastfeeding: The use of Ketorolac should be avoided during breastfeeding as it may pass into breast milk and harm the infant.

7. Concurrent Use with Other NSAIDs or Anticoagulants: Avoid concurrent use with other NSAIDs, corticosteroids, or blood thinners (like warfarin), as it increases the risk of gastrointestinal bleeding and renal damage.

8. History of Asthma or Respiratory Problems: Caution should be used in patients with asthma, especially those with a history of aspirin-induced asthma.

Warnings and Precautions:

• Gastrointestinal Risk: Use with caution in patients with a history of ulcers or gastrointestinal disorders. Monitor for signs of bleeding, especially if treatment lasts more than 5 days.

• Kidney Function: Renal function should be closely monitored, particularly in patients with pre-existing kidney disease or those taking other nephrotoxic medications.

• Cardiovascular Risk: Due to the potential for cardiovascular events, use the lowest effective dose for the shortest period necessary, especially in patients with heart disease or risk factors for cardiovascular problems.

• Elderly Patients: Older adults may be more susceptible to side effects, especially related to the gastrointestinal system and kidney function.

• Dehydration: Dehydrated patients may be more prone to renal problems when using Ketorolac. Ensure adequate hydration.

• Avoid in the First and Third Trimesters of Pregnancy: Ketorolac should be avoided, especially in the third trimester, as it can cause significant harm to the fetus (premature closure of the ductus arteriosus).

Storage:

• Store Ketorolac Trometamol (Ketorobas) at room temperature, away from moisture and direct sunlight.

• Keep it in a secure place out of the reach of children.

• Do not use if the solution appears discolored or contains particulate matter.

Important Note: Ketorolac Trometamol (Ketorobas) is intended for short-term use only (typically no more than 5 days) due to the risk of serious side effects with prolonged use. Always follow the prescribed dosage and consult a healthcare provider if any unusual or severe symptoms occur.