Ketorolac Tromethamine Injection 30 mg/ mL, Preservative Free Single Dose Vials 1 mL x 25/Tray (RX)

Ketorolac Tromethamine Injection 30 mg/mL by Fosun Pharma USA is a powerful, non-steroidal anti-inflammatory drug (NSAID) intended for short-term management of moderate to severe pain requiring analgesia at an opioid-level intensity. Specially packaged in preservative-free, single-dose 1 mL vials, this formulation is designed for maximum safety, sterility, and efficacy in hospital and procedural settings.

What It Is Used For

Ketorolac Tromethamine Injection is indicated for the short-term treatment (up to 5 days in adults) of moderate to severe acute pain that requires analgesia at the opioid level, typically administered postoperatively or when oral analgesics are not suitable. It is NOT indicated for minor or chronic pain conditions.

Product Details & Features

• Strength/Concentration: 30 mg/mL
• Packaging: 1 mL single-dose vials, 25 vials per tray
• Preservative-Free: Reduces risk of hypersensitivity and ensures suitability for sensitive populations
• Sterile, Ready-to-Use: Reduces risks of contamination and dosimetric errors
• Manufacturer: Fosun Pharma USA, known for high-quality hospital pharmaceuticals
• Route: Intravenous (IV) or intramuscular (IM) injection

Features

• Opioid-Sparing Effect: Potent analgesic reduces or eliminates the need for opioids, minimizing addiction risk
• Rapid Onset: Provides quick pain relief post-surgery
• Convenient Dosing: Each vial is single-use, minimizing waste and dosing errors
• Preservative-Free: Safe for neonatal, pediatric, and allergic populations

Directions for Use

• Administration: For intravenous (IV) or intramuscular (IM) use only.
• IV Injection: Inject slowly over no less than 15 seconds.
• IM Injection: Inject deeply into a large muscle mass.

Dosage & Administration

Adults (Under 65 years, normal renal function):

• IM Administration: 60 mg as a single dose, or 30 mg every 6 hours as needed. MAX 120 mg/24 hours.
• IV Administration: 30 mg as a single dose, or 30 mg every 6 hours as needed. MAX 120 mg/24 hours.
• Duration: Not to exceed 5 days in total.

Elderly (≥65 years), Renally Impaired, or <50 kg Body Weight:

• MAX Dose: 15 mg per administration, not to exceed 60 mg/24 hours.

Note: Always follow the specific dosage and administration instructions provided by the prescribing healthcare professional.

Allergies

Contraindicated in Patients With:

• Known hypersensitivity to ketorolac, other NSAIDs, aspirin, or any formulation components
• History of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs.

Drug Interactions

Ketorolac Tromethamine may interact with:

• Other NSAIDs: Increases risk of side effects; avoid concurrent use
• Anticoagulants (Warfarin, Heparin): Increased risk of bleeding
• SSRIs, SNRIs, Corticosteroids: Increased risk of GI bleeding
• ACE Inhibitors, Diuretics: Decreased renal function and efficacy
• Lithium: Possible lithium toxicity due to decreased clearance
• Methotrexate: Increased risk of toxicity

Side Effects & Warnings

Common Side Effects:

• Nausea
• Abdominal pain
• Indigestion
• Headache
• Drowsiness
• Injection site reactions

Serious or Rare Side Effects:

• Gastrointestinal bleeding/ulceration
• Renal impairment/failure
• Severe allergic or anaphylactic reactions
• Liver function disturbances
• Bleeding complications
• Hypertension
• Bronchospasm in susceptible individuals

Warnings:

• Not for Epidural or Spinal Administration
• Not indicated for chronic pain or minor pain
• Risk of serious cardiovascular and gastrointestinal events
• Avoid use in patients with peptic ulcer disease, GI bleeding, or advanced renal impairment
• Caution in elderly, those with bleeding disorders, or on anticoagulants

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