Sprix

Sprix is a prescription nonsteroidal anti-inflammatory drug (NSAID) medicine used to treat the symptoms of pain. Sprix may be used alone or with other medications. It is not known if Sprix is safe and effective in children.

• Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) has been reported in patients taking NSAIDs such as Sprix. Some of these events have been fatal or life-threatening.
  • DRESS typically, although not exclusively, presents with fever, rash, lymphadenopathy, and/or facial swelling. Other clinical manifestations may include hepatitis, nephritis, hematological abnormalities, myocarditis, or myositis. Sometimes symptoms of DRESS may resemble an acute viral infection. Eosinophilia is often present. Because this disorder is variable in its presentation, other organ systems not noted here may be involved. It is important to note that early manifestations of hypersensitivity, such as fever or lymphadenopathy, may be present even though rash is not evident. If such signs or symptoms are present, discontinue Sprix and evaluate the patient immediately.
• Nonsteroidal anti-inflammatory drugs (NSAIDS) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use.
• Sprix is contraindicated in the setting of coronary artery bypass graft (CABG) surgery.
• NSAIDS cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events.

Sprix may cause serious side effects including:

• hives,
• difficulty breathing,
• swelling of your face, lips, tongue, or throat,
• fever,
• sore throat,
• burning in your eyes,
• skin pain,
• red or purple skin rash that spreads and causes blistering and peeling,
• chest pain spreading to your jaw or shoulder,
• shoulder numbness,
• weakness on one side of the body,
• slurred speech,
• leg swelling,
• shortness of breath,
• skin rash (no matter how mild),
• severe headache,
• blurred vision,
• pounding in your neck or ears,
• swelling,
• rapid weight gain,
• little or no urination,
• swelling in your feet or ankles,
• tiredness,
• nausea,
• upper stomach pain,
• itching,
• tiredness,
• flu-like symptoms,
• dark urine,
• yellowing of the skin or eyes (jaundice),
• pale skin,
• unusual tiredness,
• lightheadedness,
• cold hands and feet,
• bloody or tarry stools,
• coughing up blood, and
• vomit that looks like coffee grounds

Get medical help right away, if you have any of the symptoms listed above.

The most common side effects of Sprix include:

• heartburn,
• stomach pain,
• gas,
• nausea,
• vomiting,
• diarrhea,
• constipation,
• slow heartbeats,
• decreased urination,
• abnormal liver function tests,
• increased blood pressure,
• pain or irritation in your nose,
• runny nose,
• watery eyes,
• throat irritation, and
• rash

Tell the doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Sprix. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General Dosing Instructions

• Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals.
• 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.
• Do not use Sprix concomitantly with other formulations of ketorolac or other NSAIDs.

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.

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).

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.

See Table 2 for clinically significant drug interactions with ketorolac.

Table 2: Clinically Significant Drug Interactions with Ketorolac

• Use of NSAIDs, including Sprix, during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus.
• Avoid use of NSAIDs, including Sprix, in pregnant women starting at 30 weeks of gestation (third trimester).
• There are no adequate and well-controlled studies of Sprix in pregnant women.
• Ketorolac is excreted in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Sprix and any potential adverse effects on the breastfed infant from the Sprix or from the underlying maternal condition.