SPRIX (Page 7 of 7)

17.5 Adverse Skin Reactions

Ketorolac, like other NSAIDs, can cause serious skin side effects such as exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which may result in hospitalization and even death. Although serious skin reactions may occur without warning, instruct patients to be alert for the signs and symptoms of skin rash and blisters, fever, or other signs of hypersensitivity such as itching, and should ask for medical advice when observing any indicative signs or symptoms. Advise patients to stop the drug immediately if they develop any type of rash, and contact their physicians as soon as possible [see Warnings and Precautions (5.7)].

17.6 Weight Gain and Edema

Instruct patients to promptly report signs or symptoms of unexplained weight gain or edema to their physicians [see Warnings and Precautions (5.4, 5.6)].

17.7 Hepatotoxicity

Inform patients of the warning signs and symptoms of hepatotoxicity (e.g., nausea, fatigue, lethargy, pruritus, jaundice, right upper quadrant tenderness, and “flu-like” symptoms). If these occur, instruct patients to stop therapy and seek immediate medical therapy [see Warnings and Precautions (5.9)].

17.8 Anaphylactoid Reactions

Inform patients of the signs of an anaphylactoid reaction (e.g., difficulty breathing, swelling of the face or throat). If these occur, instruct patients to seek immediate emergency help [see Contraindications (4), Warnings and Precautions (5.5, 5.11)].

17.9 Effects During Pregnancy

Avoid the use of SPRIX at or beyond 30 weeks gestation as ketorolac can cause premature closure of the ductus arteriosus [see, Warnings and Precautions (5.8), Use in Specific Populations (8.1)].

17.10 Single Day Container

Instruct patients not to use any single bottle of SPRIX for more than one day [see Dosage and Administration (2.4)].

17.11 Nasal Discomfort

Advise patients that they may experience transient, mild to moderate nasal irritation or discomfort upon dosing.

Distributed by:

American Regent, Inc.
Shirley, NY 11967

Relabeling and Repackaging by:
Physicians Total Care, Inc.
Tulsa, OK 74146

Medication Guide

For

Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)

(See the end of this Medication Guide for a list of prescription NSAID medicines.)

What is the most important information I should know about medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?

NSAID medicines may increase the chance of a heart attack or stroke that can lead to death. This chance increases:

  • with longer use of NSAID medicines
  • in people who have heart disease

NSAID medicines should never be used right before or after a heart surgery called a “coronary artery bypass graft (CABG).”

NSAID medicines can cause ulcers and bleeding in the stomach and intestines at any time during treatment. Ulcers and bleeding:

  • can happen without warning symptoms
  • may cause death

The chance of a person getting an ulcer or bleeding increases with:

  • taking medicines called “corticosteroids” and “anticoagulants”
  • longer use
  • smoking
  • drinking alcohol
  • older age
  • having poor health

NSAID medicines should only be used:

  • exactly as prescribed
  • at the lowest dose possible for your treatment
  • for the shortest time needed

What are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?

NSAID medicines are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as:

  • different types of arthritis
  • menstrual cramps and other types of short-term pain

Who should not take a Non-Steroidal Anti-Inflammatory Drug (NSAID)?

Do not take an NSAID medicine:

  • if you had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAID medicine
  • for pain right before or after heart bypass surgery

Tell your healthcare provider:

  • about all of your medical conditions.
  • about all of the medicines you take. NSAIDs and some other medicines can interact with each other and cause serious side effects. Keep a list of your medicines to show to your healthcare provider and pharmacist.
  • if you are pregnant. Use of NSAID medicines (at or after 30 weeks of pregnancy) can harm your baby.
  • if you are breastfeeding. Some SPRIX® (ketorolac tromethamine) Nasal Spray may pass into your breast milk.

What are the possible side effects of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?

Serious side effects include:
  • heart attack
  • stroke
  • high blood pressure
  • heart failure from body swelling (fluid retention)
  • kidney problems including kidney failure
  • bleeding and ulcers in the stomach and intestine
  • low red blood cells (anemia)
  • life-threatening skin reactions
  • life-threatening allergic reactions
  • liver problems including liver failure
  • asthma attacks in people who have asthma
Other side effects include:
  • stomach pain
  • constipation
  • diarrhea
  • gas
  • heartburn
  • nausea
  • vomiting
  • dizziness

Get emergency help right away if you have any of the following symptoms:

  • shortness of breath or trouble breathing
  • chest pain
  • weakness in one part or side of your body
  • slurred speech
  • swelling of the face or throat

Stop your NSAID medicine and call your healthcare provider right away if you have any of the following symptoms:

  • nausea
  • more tired or weaker than usual
  • itching
  • your skin or eyes look yellow
  • stomach pain
  • flu-like symptoms
  • vomit blood
  • there is blood in your bowel movement or it is black and sticky like tar
  • unusual weight gain
  • skin rash or blisters with fever
  • swelling of the arms and legs, hands and feet

These are not all the side effects with NSAID medicines. Talk to your healthcare provider or pharmacist for more information about NSAID medicines.

Other information about Non-Steroidal Anti-Inflammatory Drugs (NSAIDs):

  • Aspirin is an NSAID medicine but it does not increase the chance of a heart attack. Aspirin can cause bleeding in the brain, stomach, and intestines. Aspirin can also cause ulcers in the stomach and intestines.
  • Some of these NSAID medicines are sold in lower doses without a prescription (over-the-counter). Talk to your healthcare provider before using over-the-counter NSAIDs for more than 10 days.

NSAID medicines that need a prescription:

Generic Name Tradename
Celecoxib Celebrex
Diclofenac Flector, Cataflam, Voltaren, Arthrotec (combined with misoprostol)
Diflunisal Dolobid
Etodolac Lodine, Lodine XL
Fenoprofen Nalfon, Nalfon 200
Flurbirofen Ansaid
Ibuprofen Motrin, Tab-Profen, Vicoprofen (combined with hydrocodone), Combunox (combined with oxycodone)
Indomethacin Indocin, Indocin SR, Indo-Lemmon, Indomethagan
Ketoprofen Oruvail
Ketorolac SPRIX®
Mefenamic Acid Ponstel
Meloxicam Mobic
Nabumetone Relafen
Naproxen Naprosyn, Anaprox, Anaprox DS, EC-Naproxyn, Naprelan, Naprapac (copackaged with lansoprazole)
Oxaprozin Daypro
Piroxicam Feldene
Sulindac Clinoril
Tolmetin Tolectin, Tolectin DS, Tolectin 600

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Patient Instructions

Guide to Proper Use of SPRIX ® (ketorolac tromethamine) Nasal Spray

Each Nasal Spray Bottle Contains 1 Day’s Supply of Pain Medication

Discard each nasal spray bottle within 24 hours of taking your first dose, even if the bottle still contains some unused medication.

Please read this leaflet carefully before you start to take your medicine. It is important that you use SPRIX properly to achieve the desired results.

For further information ask your doctor or pharmacist.

USE OF SPRIX FOR ACUTE MODERATE TO MODERATELY SEVERE PAIN

Your doctor has prescribed SPRIX to treat pain. It is important that you use SPRIX only as prescribed by your doctor. Do not use SPRIX for more than 5 days in a row. If you are still experiencing pain after 5 days, please contact your doctor or healthcare provider.

SPRIX contains ketorolac, a potent non-steroidal anti-inflammatory drug (NSAID) that reduces inflammation and pain. For more information about NSAID products, please see the separate NSAID Medication Guide.

As with all pain medications, it is important that you drink plenty of fluids while you are taking SPRIX.

USING YOUR NASAL SPRAY

Always follow your doctor’s instructions about how often to use SPRIX. The doctor will tell you how many sprays you should use each time you take SPRIX. These instructions will provide you with information on how to use the spray bottle.

Some patients experience discomfort or irritation in the nose when using SPRIX. Generally, this lasts only a few minutes and does not worsen when you use SPRIX again. Some people experience a brief sensation in the throat. If this happens, you may want to take a sip of water after using SPRIX.

Components of SPRIX Bottle

Figure
(click image for full-size original)

FOLLOW THESE SIMPLE INSTRUCTIONS

  1. First hold the finger flange with your fingers (See Figure 1), and remove the clear plastic cover with your opposite hand; then remove the blue plastic safety clip. Keep the clear plastic cover; you may throw away the blue plastic safety clip.


    Figure 1

    Figure 1
  2. Before using the bottle for the FIRST time, you must activate the pump. To activate the pump, hold the bottle at arm’s length away from you with your index finger and middle finger resting on the top of the finger flange and your thumb supporting the base (see Figure 2).
    Press down evenly and release the pump 5 times. Note: you may not see a spray the first few times you press down.
    The bottle is now ready to use. There is no need to activate the pump again if you use more doses from this bottle.


    Figure 2

    Figure 2
  3. It’s important to get the medication to the correct place in your nose so it will be most effective. Here’s the simple way to do this.
    Blow your nose gently to clear your nostrils.
    Sit up straight or stand. Tilt your head slightly forward.
    Insert the tip of the container into your right nostril.
    Point the container away from the center of your nose (see Figure 3).


    Figure 3

    Figure 3

    Spray once into your right nostril, pressing down evenly on both sides, as shown in Figure 3.
    If your doctor has prescribed only one spray per dose for you, you have now completed administration; skip to Step 5 below.

  4. If your doctor has prescribed a dose of 2 sprays for you, repeat the process for your left nostril. Again, be sure to point the spray away from the center of your nose. Spray once into your 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.

DOSING AND ADMINISTRATION

For adults under 65 years of age, the usual recommended dose is one dose every 6-8 hours, as needed for relief of pain. One dose consists of one spray into each nostril (two sprays in total).
For adults 65 years of age or older, the usual recommended dose is one dose every 6-8 hours, as needed. One dose consists of one spray into either nostril (one spray in total).
Do not use more than the prescribed amount, and do not use more frequently than once every 6 hours.

STORING AND DISCARDING YOUR CONTAINERS

Keep SPRIX upright in a cool, dry location out of direct sunlight.
SPRIX does not contain a preservative. It is important that you throw away each bottle of SPRIX within 24 hours of administering the first dose. Once a bottle has been used, do not keep it for more than 24 hours.
Always keep SPRIX out of the reach of children.
Do not allow SPRIX to become frozen.
Discard in the trash (non-recyclable).

ASSEMBLY INSTRUCTIONS

If the clear plastic cover is improperly removed, the top portion of the nasal spray may be pulled off of the glass vial. If this happens, reinsert the top portion back onto the glass vial by lining it up carefully and softly pushing it back on until it is back in the correct position (See Figure 4). The nasal spray bottle will now work properly again.


Figure 4

Figure 4

FOR MORE INFORMATION

If you have any questions about SPRIX, or are unsure about something, you should ask your doctor or pharmacist.

Do not throw this leaflet away, so you may read it again when you administer additional doses or begin using a new bottle of SPRIX Nasal Spray.

Distributed by:

American Regent, Inc.Shirley, NY 11967

Rev. 1/11

Principal Display Panel – 5 Day Carton Label

NDC 54868-6284-0

Principal Display Panel – image of Label
(click image for full-size original)

SPRIX®

(ketorolac tromethamine)

Nasal Spray

15.75 mg per spray

For Intranasal Use Only

Dispense the accompanying Medication Guide to each patient.

Discard each bottle 24 hours after first dose, even if drug product remains.

Rx Only

SPRIX ketorolac tromethamine spray, metered
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-6284(NDC:0517-8880)
Route of Administration NASAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ketorolac tromethamine (ketorolac) ketorolac tromethamine 15.75 mg
Inactive Ingredients
Ingredient Name Strength
edetate disodium
potassium phosphate, monobasic
sodium hydroxide
water
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-6284-0 5 BOTTLE, SPRAY (5 BOTTLE) in 1 CARTON contains a BOTTLE, SPRAY
1 8 SPRAY, METERED (8 SPRAY) in 1 BOTTLE, SPRAY This package is contained within the CARTON (54868-6284-0)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022382 07/20/2011
Labeler — Physicians Total Care, Inc. (194123980)
Establishment
Name Address ID/FEI Operations
Physicians Total Care, Inc. 194123980 relabel, repack

Revised: 01/2011 Physicians Total Care, Inc.

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