Sprix

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Side Effects & Adverse Reactions

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Legal Issues

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FDA Safety Alerts

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Manufacturer Warnings

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FDA Labeling Changes

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Uses

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.

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History

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Other Information

Ketorolac tromethamine is a member of the pyrrolo-pyrrole group of nonsteroidal anti-inflammatory drugs (NSAIDs). The chemical name for ketorolac tromethamine is (±)-5-benzoyl-2,3-dihydro-1H-pyrrolizine-1-carboxylic acid, compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1), and the structural formula is:

The molecular weight of ketorolac tromethamine is 376.41. Ketorolac tromethamine is highly water-soluble, allowing its formulation in an aqueous nasal spray product at pH 7.2.

SPRIX is a clear, colorless to yellow solution packaged in a glass vial with a snap on spray pump for use as an intranasal spray product. It contains the active ingredient (ketorolac tromethamine) and the excipients edetate disodium (EDTA), monobasic potassium phosphate, sodium hydroxide, and water for injection.

Sources

Sprix Manufacturers

Egalet Us Inc.

Sprix | Egalet Us Inc.

2.1 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 (5.1)]. 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 (5.1)].

SPRIX has not been shown to be safe and effective in pediatric patients 17 years of age and younger.
2.2 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.
2.3 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).
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 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, 5.4)].
2.5 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.

No Recall
Physicians Total Care, Inc.

Sprix | Physicians Total Care, Inc.

2.1 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 (5.1)]. 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 (5.1)].

SPRIX has not been shown to be safe and effective in pediatric patients 17 years of age and younger.
2.2 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).
2.3 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, 5.4)].
2.4 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.

No Recall
H.j. Harkins Company, Inc.

Sprix | H.j. Harkins Company, Inc.

2.1 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 (5.1)]. 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 (5.1)].

SPRIX has not been shown to be safe and effective in pediatric patients 17 years of age and younger.
2.2 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).
2.3 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, 5.4)].
2.4 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.

No Recall
American Regent, Inc.

Sprix | American Regent, Inc.

2.1 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 (5.1)]. 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 (5.1)].

SPRIX has not been shown to be safe and effective in pediatric patients 17 years of age and younger.
2.2 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.
2.3 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).
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 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, 5.4)].
2.5 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.

No Recall
Medsource Pharmaceuticals

Sprix | Medsource Pharmaceuticals

2.1 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 ( 5.1)]. 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 ( 5.1)].

SPRIX has not been shown to be safe and effective in pediatric patients 17 years of age and younger.
2.2 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.
2.3 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).
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 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, 5.4)].
2.5 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.

No Recall