- Approval Id
- abce86efa9db10bf
- Drug Name
- KETOROLAC TROMETHAMINE INJECTION 30 mg/ml
- Product Name
- KETOROLAC TROMETHAMINE INJECTION 30 mg/ml
- Approval Number
- SIN11340P
- Approval Date
- 2000-06-16
- Registrant
- PFIZER PRIVATE LIMITED
- Licence Holder
- PFIZER PRIVATE LIMITED
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- INJECTION
- Dosage
- <p><strong>DOSAGE AND ADMINISTRATION</strong><br>
<strong>Carefully consider the potential benefits and risks of ketorolac tromethamine and other treatment options before deciding to use ketorolac tromethamine. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals. In adults, the combined duration of use of intravenous or intramuscular dosing of ketorolac tromethamine and oral ketorolac tromethamine is not to exceed 5 days. In adults, the use of oral ketorolac tromethamine is only indicated as continuation therapy to intravenous or intramuscular dosing of ketorolac tromethamine. See package insert for ketorolac tromethamine tablets for transition from intravenous or intramuscular dosing of ketorolac tromethamine (single- or multiple-dose) to multiple-dose oral ketorolac tromethamine.</strong></p>
<p><strong>Note: Oral formulation</strong> should <strong>not</strong> be given <strong>as an initial dose.</strong></p>
<p><strong>Use minimum effective dose</strong> for the individual patient.</p>
<p><strong>Total duration of treatment in adult patients:</strong> the combined duration of use of intravenous or intramuscular dosing of ketorolac tromethamine and oral ketorolac tromethamine is not to exceed 5 days.</p>
<p><strong>KETOROLAC TROMETHAMINE INJECTION</strong><br>
Ketorolac tromethamine injection may be used as a single or multiple dose on a regular or “as needed” schedule for the management of moderately severe, acute pain that requires analgesia at the opioid level, usually in a postoperative setting. Hypovolemia should be corrected prior to the administration of ketorolac tromethamine (see <strong>WARNINGS – Renal Effects</strong> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>). Patients should be switched to alternative analgesics as soon as possible, but ketorolac tromethamine therapy is not to exceed 5 days.</p>
<p>When administering ketorolac tromethamine injection, the intravenous bolus must be given over no less than 15 seconds. The intramuscular administration should be given slowly and deeply into the muscle. The analgesic effect begins in ~30 minutes with maximum effect in 1 to 2 hours after dosing intravenous or intramuscular. Duration of analgesic effect is usually 4 to 6 hours.</p>
<p><strong>Single-Dose Treatment: The following regimen should be limited to single administration use only</strong></p>
<p><strong>Intramuscular Dosing</strong></p>
<ul>
<li>Patients <65 years of age: One dose of 60 mg.</li>
<li>Patients ≥65 years of age, renally impaired and/or less than 50 kg (110 lbs) of body weight: One dose of 30 mg.</li>
</ul>
<p><strong>Intravenous Dosing</strong></p>
<ul>
<li>Patients <65 years of age: One dose of 30 mg.</li>
<li>Patients ≥65 years of age, renally impaired and/or less than 50 kg (110 lbs) of body weight: One dose of 15 mg.</li>
</ul>
<p><strong>Multiple-Dose Treatment (Intravenous or Intramuscular)</strong></p>
<ul>
<li>Patients <65 years of age: The recommended dose is 30 mg ketorolac tromethamine injection every 6 hours. The maximum daily dose for these populations should not exceed 120 mg.</li>
<li>For patients ≥65 years of age, renally impaired patients (see <strong>WARNINGS</strong> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>), and patients less than 50 kg (110 lbs): The recommended dose is 15 mg ketorolac tromethamine injection every 6 hours. The maximum daily dose for these populations should not exceed 60 mg.</li>
</ul>
<p>For breakthrough pain, do not increase the dose or the frequency of ketorolac tromethamine. Consideration should be given to supplementing these regimens with low doses of opioids “as needed” unless otherwise contraindicated.</p>
<p><strong>Pharmaceutical Information for Ketorolac Tromethamine Injection</strong><br>
Ketorolac tromethamine injection should not be mixed in a small volume (e.g., in a syringe) with morphine sulfate, meperidine hydrochloride, promethazine hydrochloride or hydroxyzine hydrochloride; this will result in precipitation of ketorolac from solution.</p>
<p><strong>NOTE:</strong> Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.</p>
- Route Of Administration
- INTRAVENOUS, INTRAMUSCULAR
- Indication Info
- <p><strong>INDICATIONS AND USAGE</strong><br>
Carefully consider the potential benefits and risks of ketorolac tromethamine and other treatment options before deciding to use ketorolac. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see <strong>WARNINGS</strong> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p><strong>Acute Pain in Adult Patients</strong><br>
Ketorolac tromethamine is indicated for the short-term (≤5 days) management of moderately severe acute pain that requires analgesia at the opioid level, usually in a postoperative setting. Therapy should always be initiated with intravenous or intramuscular dosing of ketorolac tromethamine, and oral ketorolac tromethamine is to be used only as continuation treatment, if necessary.</p>
<p>The total combined duration of use of ketorolac tromethamine injection and oral ketorolac tromethamine is not to exceed 5 days of use because of the potential of increasing the frequency and severity of adverse reactions associated with the recommended doses (see <strong>WARNINGS, PRECAUTIONS, DOSAGE AND ADMINISTRATION</strong>, and <strong>ADVERSE REACTIONS</strong> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>). Patients should be switched to alternative analgesics as soon as possible, but ketorolac tromethamine therapy is not to exceed 5 days.</p>
- Contraindications
- <p><strong>CONTRAINDICATIONS</strong><br>
(see also <strong>Boxed WARNING</strong> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>)<br>
Ketorolac Tromethamine is contraindicated in patients with previously demonstrated hypersensitivity to ketorolac tromethamine.</p>
<p>Ketorolac tromethamine is contraindicated in patients with active peptic ulcer disease, in patients with recent gastrointestinal bleeding or perforation and in patients with a history of peptic ulcer disease or gastrointestinal bleeding.</p>
<p>Ketorolac tromethamine should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients (see <strong>WARNINGS – Anaphylactoid Reactions,</strong> and <strong>PRECAUTIONS – Pre-existing Asthma</strong> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p>Ketorolac tromethamine is contraindicated as prophylactic analgesic before any major surgery.</p>
<p>Ketorolac tromethamine is contraindicated in the setting of coronary artery bypass graft (CABG) surgery (see <strong>WARNINGS</strong> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p>Ketorolac tromethamine is contraindicated in patients with advanced renal impairment or in patients at risk for renal failure due to volume depletion (see <strong>WARNINGS</strong> for correction of volume depletion – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p>Ketorolac tromethamine is contraindicated in labor and delivery because, through its prostaglandin synthesis inhibitory effect, it may adversely affect fetal circulation and inhibit uterine musculature, thus increasing the risk of uterine hemorrhage.</p>
<p>The use of ketorolac tromethamine is contraindicated in nursing mothers because of the potential adverse effects of prostaglandin-inhibiting drugs on neonates.</p>
<p>Ketorolac tromethamine is CONTRAINDICATED intra-operatively when hemostasis is critical because of the increased risk of bleeding.</p>
<p>Ketorolac tromethamine inhibits platelet function and is, therefore, contraindicated in patients with suspected or confirmed cerebrovascular bleeding, hemorrhagic diathesis, incomplete hemostasis and those at high risk of bleeding (see <strong>WARNINGS</strong> and <strong>PRECAUTIONS</strong> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p>Ketorolac tromethamine is contraindicated in patients currently receiving aspirin or NSAIDs because of the cumulative risks of inducing serious NSAID-related adverse events.</p>
<p>The concomitant use of ketorolac tromethamine and probenecid is contraindicated.</p>
<p>The concomitant use of ketorolac tromethamine and pentoxifylline is contraindicated.</p>
<p>Ketorolac tromethamine injection is contraindicated for neuraxial (epidural or intrathecal) administration due to its alcohol content.</p>
- Atc Code
- M01AB15
- Atc Item Name
- ketorolac
- Pharma Manufacturer Name
- PFIZER PRIVATE LIMITED
