"Nov. 2, 2012 -- Safety steps taken in the wake of the fungal meningitis outbreak have worsened drug shortages, raising questions about whether the U.S. must choose between the safety and the availability of crucial medicines.
DOSAGE AND ADMINISTRATION
Limitations Of Use
The total duration of use of SPRIX alone or sequentiallywith other formulations of ketorolac (IM/IV or oral) must not exceed 5 daysbecause of the potential for increasing the frequency and severity of adverse reactions associated with the recommended doses [see WARNINGS AND PRECAUTIONS]. Treat patients for the shortest duration possible, and do not exceed 5 days of therapy with SPRIX.
Do not use SPRIX concomitantly with other formulations of ketorolac or other NSAIDs [see WARNINGS AND PRECAUTIONS].
SPRIX has not been shown to be safe and effective in pediatric patients 17 years of age and younger.
SPRIX is not an inhaled product. Do not inhale when administering this product.
Instruct patients to administer as follows:
- 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.
- Before using the bottle for the FIRST time, activate the pump. To activate the pump, hold the bottle at arm's length away from thebody 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 toactivate the pump again if more doses are used from the bottle.
- 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.
- 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.
- Replace the clear plastic cover and place the bottl ein a cool, dry location out of direct sunlight, such as inside a medication cabinet. Keep out of reach of children.
Adult Patients < 65 Years Of Age
The recommended dose is 31.5 mg SPRIX (one 15.75 mg spray in each nostril) every 6 to 8 hours. The maximum daily dose is 126 mg (fourdoses).
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 is15.75 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].
Discard Used SPRIX Bottle After 24 Hours
Do not use any single SPRIX bottle for more than one dayas 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.
Dosage Forms And Strengths
Nasal spray: 15.75 mg of ketorolac tromethamine in each100 μL spray. Each 1.7 g bottle contains 8 sprays.
Storage And Handling
Preservative-free SPRIX Nasal Spray is supplied in boxes containing 5 single-day nasal spray bottles (NDC 0517-8880-05) or 1 single-day nasal spray bottle (NDC 0517-8880-01). Each single-day nasal spray bottle contains a sufficient quantity of solution to deliver 8 sprays for a total of126 mg of ketorolac tromethamine. Each spray delivers 15.75 mg of ketorolac tromethamine.The delivery system is designed to administer precisely metered doses of 100μL per spray.
Protect from light and freezing. Store unopened SPRIX between 36°F and 46°F (2°C and 8°C). During use, keep containers of SPRIX Nasal Spray at controlled room temperature, between 59°F and 86°F (15°C and 30°C),out of direct sunlight. Bottles of SPRIX should be discarded within 24 hours of priming.
Distributed by: American Regent, Inc. Shirley, NY 11967 IN8880This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 5/12/2014
Additional Sprix Information
- Sprix Drug Interactions Center: ketorolac nasl
- Sprix Side Effects Center
- Sprix FDA Approved Prescribing Information including Dosage
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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