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 SPRIX 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 SPRIX concomitantly with other formulations of ketorolac or other NSAIDs [see Warnings and Precautions (5.15)].
Administration
SPRIX 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.
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 SPRIX (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)].
Discard Used SPRIX Bottle after 24 Hours
Do not use any single SPRIX 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.
