Ketorolac Trometamol (Ketopane) 30mg/ml Solution for Injection (I.M/I.V) Non Steroidal Anti Inflamatory Drugs 10 x 1ml Ampoules

Certainly! Here's the detailed information for Ketorolac Trometamol (Ketopane) 30mg/ml Solution for Injection (I.M/I.V) Non-Steroidal Anti-Inflammatory Drug (NSAID) in 10 x 1ml Ampoules:

Product Description:

Ketorolac Trometamol (Ketopane) is a non-steroidal anti-inflammatory drug (NSAID) that is used for the management of moderate to severe pain, particularly in the short-term. It is available as a solution for injection, providing a concentration of 30 mg per 1 ml. The solution is intended for intramuscular (I.M.) or intravenous (I.V.) injection, and comes in 10 x 1 ml ampoules.

Ketopane is a potent analgesic and anti-inflammatory agent. It works by inhibiting the enzymes COX-1 and COX-2, which are involved in the production of prostaglandins—chemicals in the body that mediate inflammation, pain, and fever.

Indications:

Ketorolac Trometamol (Ketopane) is primarily used for the short-term management of moderate to severe pain, including:

1. Postoperative Pain:

   • For the relief of mild to moderate pain following surgery (such as dental or orthopedic procedures).

2. Acute Pain:

   • Musculoskeletal pain (pain in muscles and joints).

   • Back pain, including pain from sprains and strains.

3. Renal Colic:

   • To manage pain associated with kidney stones.

4. Other Pain:

   • Short-term relief of pain following trauma or injury.

Note: It is typically used for a short duration (not exceeding 5 days) due to the risk of serious side effects such as gastrointestinal bleeding and renal impairment when used long-term.

Dosages:

The dosage of Ketorolac Trometamol (Ketopane) varies depending on the severity of pain, the patient's age, and overall health condition. The usual dosages are:

• Adults:

  • Initial Dose: 30 mg (1 ml) I.M. or I.V., followed by 15–30 mg every 6 hours as needed.

  • Maximum Dose: The total daily dose should not exceed 90 mg for a short duration (no more than 5 days).

  • If the pain persists or more extended treatment is necessary, switch to an oral form of ketorolac or another analgesic.

• Elderly Patients:

  • Lower doses may be required in elderly patients due to the increased risk of side effects, particularly renal toxicity.

  • Recommended starting dose is 15 mg I.M. or I.V., with a maximum daily dose of 60 mg.

• Renal Impairment:

  • Severe renal impairment (creatinine clearance < 30 mL/min): Ketorolac Trometamol is contraindicated due to the increased risk of adverse effects.

  • Moderate renal impairment: The dose should be reduced, and therapy should be closely monitored.

Administration:

• I.M. (Intramuscular) Injection: Inject into the large muscle mass (such as the gluteal muscle) for slow absorption.

• I.V. (Intravenous) Injection: Administer as a slow intravenous injection, typically over 15 seconds, to avoid irritation at the injection site.

Side Effects:

While Ketorolac Trometamol (Ketopane) is an effective analgesic, it can cause various side effects, some of which can be serious. The common and severe side effects include:

1. Common Side Effects:

   • Gastrointestinal issues: Nausea, dyspepsia (indigestion), abdominal pain, and diarrhea.

   • Headache, dizziness, or lightheadedness.

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

2. Serious Side Effects:

   • Gastrointestinal bleeding or ulcers: Ketorolac increases the risk of bleeding, ulceration, and perforation of the gastrointestinal tract, which can be life-threatening.

   • Kidney damage: Ketorolac can lead to acute kidney failure or renal impairment, particularly in individuals with pre-existing kidney conditions.

   • Severe allergic reactions: Symptoms such as swelling of the face, lips, tongue, or throat, difficulty breathing, or severe rash (anaphylaxis).

   • Liver damage: Symptoms of liver dysfunction include jaundice (yellowing of the skin or eyes), dark urine, and upper abdominal pain.

   • Hypertension: Long-term use of NSAIDs like ketorolac can increase blood pressure and worsen existing hypertension.

   • Bleeding: Prolonged use can cause an increased risk of bleeding, including bleeding from cuts, surgery, or internal bleeding.

3. Rare but Severe Side Effects:

   • Respiratory issues: Bronchospasm or difficulty breathing, particularly in patients with asthma or other respiratory conditions.

   • Severe skin reactions: Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN), which can lead to life-threatening skin rashes.

Contraindications:

Ketorolac Trometamol (Ketopane) should not be used in certain populations or conditions due to the risk of serious side effects. It is contraindicated in:

1. Hypersensitivity:

   • Known hypersensitivity to Ketorolac or other NSAIDs, including aspirin or other nonsteroidal anti-inflammatory drugs.

   • History of severe allergic reactions such as anaphylaxis, angioedema, or bronchospasm.

2. Active or History of Gastrointestinal Bleeding:

   • Peptic ulcer disease, gastritis, or history of gastrointestinal bleeding or perforation.

3. Severe Renal Impairment:

   • Severe renal impairment or conditions that significantly reduce renal function (creatinine clearance < 30 mL/min).

4. Active or History of Bleeding Disorders:

   • Conditions like hemophilia, thrombocytopenia, or other disorders where there is a risk of bleeding or hemorrhage.

5. Pregnancy:

   • Third trimester: Ketorolac should be avoided in pregnancy, especially in the third trimester, as it can cause premature closure of the ductus arteriosus in the fetus, leading to complications.

   • It should be avoided during labor and delivery due to its potential effects on uterine contractions.

6. Breastfeeding:

   • Avoid using Ketorolac during breastfeeding, as it can pass into breast milk and may harm the infant.

7. Elderly Patients:

   • Use with caution in elderly patients due to the increased risk of renal toxicity, gastrointestinal bleeding, and cardiovascular complications.

Warnings and Precautions:

• Gastrointestinal Risk: Ketorolac can cause gastritis, ulcers, and GI bleeding, particularly with prolonged use or in those with a history of peptic ulcer disease. It is recommended to use the lowest effective dose for the shortest possible duration.

• Cardiovascular Risk: Long-term use of NSAIDs can increase the risk of heart attack and stroke, particularly in patients with pre-existing cardiovascular conditions.

• Renal Function: Ketorolac can cause kidney damage, particularly in patients with pre-existing kidney disease, dehydration, or those on other nephrotoxic drugs. Kidney function should be monitored during treatment.

• Fluid Retention: NSAIDs like Ketorolac can lead to fluid retention and worsen conditions like heart failure and hypertension.

• Discontinue If Symptoms Worsen: Ketorolac should be discontinued if signs of gastrointestinal bleeding, severe allergic reactions, or signs of kidney damage (such as reduced urine output) occur.

Storage:

• Store Ketorolac Trometamol (Ketopane) at room temperature, away from moisture, light, and heat.

• Keep out of reach of children.

Important Note: Ketorolac Trometamol (Ketopane) is generally used for short-term management of pain due to the risk of side effects, especially with prolonged use. Always follow your healthcare provider’s instructions for proper dosage and duration of treatment.