Generic drug: ketorolac tromethamine
Brand name: Sprix
What is Sprix (ketorolac tromethamine), and how does it work?
It is not known if Sprix is safe and effective in children.
What are the side effects of Sprix?
RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS
Cardiovascular Thrombotic Events
- 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.
Gastrointestinal Bleeding, Ulceration, and Perforation
- 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:
- difficulty breathing,
- swelling of your face, lips, tongue, or throat,
- 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,
- rapid weight gain,
- little or no urination,
- swelling in your feet or ankles,
- upper stomach pain,
- flu-like symptoms,
- dark urine,
- yellowing of the skin or eyes (jaundice),
- pale skin,
- unusual tiredness,
- 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:
- stomach pain,
- slow heartbeats,
- decreased urination,
- abnormal liver function tests,
- increased blood pressure,
- pain or irritation in your nose,
- runny nose,
- watery eyes,
- throat irritation, and
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.
What is the dosage for Sprix?
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.
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 armâ€™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.
What drugs interact with Sprix?
See Table 2 for clinically significant drug interactions with ketorolac.
Table 2: Clinically Significant Drug Interactions with Ketorolac
|Drugs that Interfere with Hemostasis|
|Intervention:||Monitor patients with concomitant use of Sprix with anticoagulants (e.g., warfarin), antiplatelet agents (e.g., aspirin), selective serotonin reuptake inhibitors (SSRIs), and serotonin norepinephrine reuptake inhibitors (SNRIs) for signs of bleeding. Concomitant use of Sprix and pentoxifylline is contraindicated.|
|Clinical Impact:||Controlled clinical studies showed that the concomitant use of NSAIDs and analgesic doses of aspirin does not produce any greater therapeutic effect than the use of NSAIDs alone. In a clinical study, the concomitant use of an NSAID and aspirin was associated with a significantly increased incidence of GI adverse reactions as compared to use of the NSAID alone.|
|Intervention:||Concomitant use of Sprix and analgesic doses of aspirin is not generally recommended because of the increased risk of bleeding. Sprix is not a substitute for low dose aspirin for cardiovascular protection.|
|ACE Inhibitors, Angiotensin Receptor Blockers, and Beta-blockers|
|Clinical Impact:||Clinical studies, as well as post-marketing observations, showed that NSAIDs reduced the natriuretic effect of loop diuretics (e.g., furosemide) and thiazide diuretics in some patients. This effect has been attributed to the NSAID inhibition of renal prostaglandin synthesis|
|Intervention:||During concomitant use of Sprix with diuretics, observe patients for signs of worsening renal function, in addition to assuring diuretic efficacy including antihypertensive effects.|
|Clinical Impact:||The concomitant use of ketorolac with digoxin has been reported to increase the serum concentration and prolong the half-life of digoxin.|
|Intervention:||During concomitant use of Sprix and digoxin, monitor serum digoxin levels.|
|Clinical Impact:||NSAIDs have produced elevations in plasma lithium levels and reductions in renal lithium clearance. The mean minimum lithium concentration increased 15%, and the renal clearance decreased by approximately 20%. This effect has been attributed to NSAID inhibition of renal prostaglandin synthesis.|
|Intervention:||During concomitant use of Sprix and lithium, monitor patients for signs of lithium toxicity.|
|Clinical Impact:||Concomitant use of NSAIDs and methotrexate may increase the risk for methotrexate toxicity (e.g., neutropenia, thrombocytopenia, renal dysfunction).|
|Intervention:||During concomitant use of Sprix and methotrexate, monitor patients for methotrexate toxicity.|
|Clinical Impact:||Concomitant use of Sprix and cyclosporine may increase cyclosporine’s nephrotoxicity.|
|Intervention:||During concomitant use of Sprix and cyclosporine, monitor patients for signs of worsening renal function.|
|NSAIDs and Salicylates|
|Clinical Impact:||Concomitant use of ketorolac with other NSAIDs or salicylates (e.g., diflunisal, salsalate) increases the risk of GI toxicity, with little or no increase in efficacy.|
|Intervention:||The concomitant use of ketorolac with other NSAIDs or salicylates is not recommended.|
|Clinical Impact:||Concomitant use of Sprix and pemetrexed may increase the risk of pemetrexed-associated myelosuppression, renal, and GI toxicity (see the pemetrexed prescribing information).|
|Intervention:||During concomitant use of Sprix and pemetrexed, in patients with renal impairment whose creatinine clearance ranges from 45 to 79 mL/min, monitor for myelosuppression, renal and GI toxicity. NSAIDs with short elimination half-lives (e.g., diclofenac, indomethacin) should be avoided for a period of two days before, the day of, and two days following administration of pemetrexed. In the absence of data regarding potential interaction between pemetrexed and NSAIDs with longer half-lives (e.g., meloxicam, nabumetone), patients taking these NSAIDs should interrupt dosing for at least five days before, the day of, and two days following pemetrexed administration.|
|Clinical Impact:||Concomitant administration of oral ketorolac and probenecid results in increased half-life and systemic exposure.|
|Intervention:||Concomitant use of Sprix and probenecid is contraindicated.|
|Clinical Impact:||Sporadic cases of seizures have been reported during concomitant use of ketorolac and antiepileptic drugs (phenytoin, carbamazepine).|
|Intervention:||During concomitant use of Sprix and antiepileptic drugs, monitor patients for seizures.|
|Clinical Impact:||Hallucinations have been reported when ketorolac was used in patients taking psychoactive drugs (fluoxetine, thiothixene, alprazolam).|
|Intervention:||During concomitant use of Sprix and psychoactive drugs, monitor patients for hallucinations.|
|Nondepolarizing Muscle Relaxants|
|Clinical Impact:||In postmarketing experience there have been reports of a possible interaction between ketorolac and nondepolarizing muscle relaxants that resulted in apnea. The concurrent use of ketorolac with muscle relaxants has not been formally studied.|
|Intervention:||During concomitant use of Sprix and nondepolarizing muscle relaxants, monitor patients for apnea.|
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Is Sprix safe to use while pregnant or breastfeeding?
- 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.
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