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Sprix

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Sprix

INDICATIONS

SPRIX 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.

DOSAGE AND ADMINISTRATION

Limitations of Use

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]. 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.

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 (four doses).

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].

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.

HOW SUPPLIED

Dosage Forms And Strengths

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

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 of 126 mg of ketorolac tromethamine. Each spray delivers 15.75 mg of ketorolac tromethamine. The delivery system is designed to administer precisely metered doses of 100 μL per spray.

Storage

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

Last reviewed on RxList: 10/21/2011
This monograph has been modified to include the generic and brand name in many instances.

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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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