Ketorolac Tromethamine

KETOROLAC TROMETHAMINE- ketorolac tromethamine spray, metered
Prasco Laboratories

WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS

Cardiovascular Thrombotic Events

  • Nonsteroidal anti-inflammatory drugs (NSAIDS) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use [see Warnings and Precautions (5.1) ].
  • Ketorolac Tromethamine is contraindicated in the setting of coronary artery bypass graft (CABG) surgery [see Contraindications (4) and Warnings and Precautions (5.1)].

Gastrointestinal Bleeding, Ulceration, and Perforation

  • NSAIDS cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events [see Warnings and Precautions (5.2) ].

1 INDICATIONS AND USAGE

Ketorolac Tromethamine nasal spray is indicated in adult patients for the short term (up to 5 days) management of moderate to moderately severe pain that requires analgesia at the opioid level.

Limitations of Use

  • Ketorolac Tromethamine nasal spray is not for use in pediatric patients less than 2 years of age.

2 DOSAGE AND ADMINISTRATION

2.1 General Dosing Instructions

Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [see Warnings and Precautions (5) ].

The total duration of use of Ketorolac Tromethamine alone or sequentially with other formulations of ketorolac (IM/IV or oral) must not exceed 5 days because of the potential for increasing the frequency and severity of adverse reactions associated with the recommended doses [see Warnings and Precautions (5.15) ].

Do not use Ketorolac Tromethamine nasal spray concomitantly with other formulations of ketorolac or other NSAIDs [see Warnings and Precautions (5.15) ].

2.2 Administration

Ketorolac Tromethamine is not an inhaled product. Do not inhale when administering this product.

Instruct patients to administer as follows:

1. First hold the finger flange with fingers, and remove the clear plastic cover with opposite hand; then remove the blue plastic safety clip. Keep the clear plastic cover; and throw away the blue plastic safety clip.

2. Before using the bottle for the FIRST time, activate the pump. To activate the pump, hold the bottle at arm’s length away from the body with index finger and middle finger resting on the top of the finger flange and thumb supporting the base.

Press down evenly and release the pump 5 times. Patient may not see a spray the first few times he/she presses down.

The bottle is now ready to use. There is no need to activate the pump again if more doses are used from the bottle.

3. It’s important to get the medication to the correct place in the nose so it will be most effective.

— Blow nose gently to clear nostrils.
— Sit up straight or stand. Tilt head slightly forward.
— Insert the tip of the container into your right nostril.
— Point the container away from the center of your nose.
— Hold your breath and spray once into your right nostril, pressing down evenly on both sides.
— Immediately after administration, resume breathing through mouth to reduce expelling the product. Also pinch the nose to help retain the spray if it starts to drip.

If only one spray per dose is prescribed, administration is complete; skip to Step 5 below.

4. If a dose of 2 sprays is prescribed, repeat the process in Step 3 for the left nostril. Again, be sure to point the spray away from the center of nose. Spray once into the left nostril.

5. Replace the clear plastic cover and place the bottle in a cool, dry location out of direct sunlight, such as inside a medication cabinet. Keep out of reach of children.

2.3 Adult Patients < 65 Years of Age

The recommended dose is 31.5 mg Ketorolac Tromethamine nasal spray (one 15.75 mg spray in each nostril) every 6 to 8 hours. The maximum daily dose is 126 mg (four doses).

2.4 Reduced Doses for Special Populations

For patients ≥ 65 years of age, renally impaired patients, and adult patients less than 50 kg (110 lbs), the recommended dose is 15.75 mg Ketorolac Tromethamine nasal spray (one 15.75 mg spray in only one nostril) every 6 to 8 hours. The maximum daily dose is 63 mg (four doses) [see Warnings and Precautions (5.2, 5.6)].

2.5 Discard Used Ketorolac Tromethamine nasal spray bottle after 24 Hours

Do not use any single Ketorolac Tromethamine nasal spray bottle for more than one day as it will not deliver the intended dose after 24 hours. Therefore, the bottle must be discarded no more than 24 hours after taking the first dose, even if the bottle still contains some liquid.

3 DOSAGE FORMS AND STRENGTHS

Ketorolac Tromethamine nasal spray: 15.75 mg of ketorolac tromethamine in each 100 μL spray. Each 1.7 g bottle contains 8 sprays.

4 CONTRAINDICATIONS

Ketorolac Tromethamine nasal spray is contraindicated in the following patients:

  • Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to ketorolac or any components of the drug product [see Warning and Precautions (5.7, 5.9)]
  • History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients [see Warnings and Precautions (5.7, 5.8)]
  • In the setting of coronary artery bypass graft (CABG) surgery [see Warnings and Precautions (5.1) ]
  • Use in patients with active peptic ulcer disease and in patients with recent gastrointestinal bleeding or perforation [see Warnings and Precautions (5.2) ]
  • Use as a prophylactic analgesic before any major surgery [see Warnings and Precautions (5.11) ]
  • Use in patients with advanced renal disease or patients at risk for renal failure due to volume depletion [see Warnings and Precautions (5.6) ]
  • Use in labor and delivery. Through its prostaglandin synthesis inhibitory effect, ketorolac may adversely affect fetal circulation and inhibit uterine contractions, thus increasing the risk of uterine hemorrhage [see Use in Specific Populations (8.1) ]
  • Use in patients with suspected or confirmed cerebrovascular bleeding, hemorrhagic diathesis, incomplete hemostasis, or those for whom hemostasis is critical [see Warnings and Precautions (5.11), Drug Interactions (7)]
  • Concomitant use with probenecid [see Drug Interactions (7)]
  • Concomitant use with pentoxifylline [see Drug Interactions (7)]

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