A non-steroidal anti-inflammatory medication called Sprix (Ketorolac Nasal Spray) is used to relieve moderately severe pain. Like opioid analgesics, it relieves pain. Use of ketorolac nasal spray for pain alleviation should only be temporary (treatment should not exceed five days). Further Read: Tablets and Injections of Ketorolac (Toradol)

Sprix (Ketorolac Nasal Spray) Uses:

• Moderate to moderately severe Pain:

  • It is indicated for the management of  moderate or severe pain for short term duration i.e up to 5 days in adults that requires opioid level analgesia

• Off Label Use of Ketorolac in Adults:

  • Migraine

Sprix (Ketorolac Nasal Spray) Dose in Adults:

Sprix (Ketorolac Nasal Spray) Dose in the treatment of moderate to moderately severe pain:

Note: For both nasal spray and other ketorolac formulations, the maximum total treatment time is five days. Intranasal:

• Adults <65 years and ≥50 kg:

  • Every six to eight hours, administer one spray (15.75 mg each nostril; total dose: 31.5 mg).
  • Maximum dosage: 126 mg per day in 4 doses.
• Dosage adjustments in adults with low body weight (<50 kg):
  • Every six to eight sprays, giving only one nostril (15.75 mg total)
  • Maximum dosage: 63 mg/day in 4 doses.

Sprix (Ketorolac Nasal Spray) Dose in the treatment of Migraine, acute abortive treatment (off-label):

• Intranasal: One spray (15.75 mg) in each nostril (total dose: 31.5 mg)
• Given as a single dose

Use in Children:

Not indicated.

Pregnancy Risk Factor C (D ≥30 weeks gestation)

• Contraindicated during labor or delivery
• Animal reproduction studies show no adverse effects
• Premature use of ketorolac should be avoided. The ductus arteriosus may prematurely close as a result of NSAID use.

Ketorolac use during breastfeeding:

• After oral administration, Ketorolac excretes from breast milk.
• According to the manufacturer, a decision to give ketorolac to a lactating mom should be made after considering the risks to infant exposure, the benefits to breastfeeding and the benefits to the mother.

Sprix (Ketorolac Nasal Spray) Dose in Kidney Disease:

• Renal insufficiency:
  • Intranasal:Every six to eight hours, one spray (15.75 mg total dose) is administered into one nostril.
  • Maximum dose: 4 doses: 63 mg/day
• Advanced renal impairment (or at risk for renal failure due to volume depletion):
  • Contraindicated

Sprix (Ketorolac Nasal Spray) Dose in Liver disease:

• Those with hepatic impairment or a history of hepatic disease are recommended to use caution since it could increase their liver enzyme levels.
• Discontinue the medication if clinical indicators and symptoms of liver damage appear.

• Events documented with intranasal usage; for information on additional possible adverse effects linked to ketorolac, consult the Ketorolac (Systemic) monograph.

Common Side Effects of Sprix (Ketorolac Nasal Spray):

• Respiratory:

  • Nasal discomfort
  • Sore nose

Less Common Side Effects of Sprix (Ketorolac Nasal Spray):

• Cardiovascular:

  • Bradycardia
  • Hypertension

• Dermatologic:

  • Skin Rash

• Genitourinary:

  • Oliguria
  • Decreased Urine Output

• Hepatic:

  • Increased Serum ALT
  • Increased Serum AST

• Ophthalmic:

  • Increased Lacrimation

• Respiratory:

  • Throat Irritation
  • Rhinitis

Contraindications to Sprix (Ketorolac Nasal Spray):

• Hypersensitivity to any ingredient of the ketorolac formulation
• Active acid peptic illness
• Recent gastrointestinal bleeding, or perforation
• Due to volume depletion, advanced kidney disease or risk of kidney failure
• History of asthma, urticaria or other allergic-type reactions following aspirin use or any other NSAIDs
• Analgesia prophylactic before major surgery
• Surgery to place coronary artery bypass (CABG),
• Delivery and labor
• Hemostasis critical for those with hemostasis essential, hemorhagic diathesis or suspected cerebrovascular bleeding
• Use pentoxifylline or probenecid in conjunction

Warnings and precautions

• Bleeding

  • It blocks platelet function.
  • Individuals with hemorrhagic diathesis, suspected or proven cerebrovascular bleeding, and insufficient hemostasis should not get this medication.
  • It causes platelet adhesion to be impaired and aggregation to increase bleeding time.
  • Anemia can be caused by long-term NSAID usage.
  • NSAIDs can sporadically result in serious blood dyscrasias (eg agranulocytosis or thrombocytopenia and aplasticanemia).

• Cardiovascular events: [US Boxed Warn]

  • The use of NSAIDs increases the risk of serious (and potentially deadly) adverse cardiovascular thrombotic responses, such as MI and stroke.
  • This risk can occur during treatment, and it may increase as the use continues.
  • Exacerbation or new-onset hypertension can occur. NSAIDs could also affect the response to ACE inhibitors or thiazide diuretics or loop diuretics.
  • May be associated with cardiovascular events
  • BP should always be monitored.
  • Hypertensive patients should be cautious.
  • Patients with edema may experience sodium and fluid retention.
  • Patients with heart failure should be avoided
  • Patients with MI should not be treated unless the benefits are greater than the risk of developing cardiovascular thrombotic complications.
  • To reduce cardiovascular events, the lowest effective dose should only be used for the short time. Patients at high risk should consider alternative therapies.

• Gastrointestinal events [US Boxed Warning]

  • The risk of severe gastrointestinal bleeding, ulceration, and perforation is increased by NSAID use (may even be fatal).
  • Individuals who have a history of gastrointestinal bleeding or peptic ulcer disease are more likely to experience major GI problems.
  • These occurrences might happen at any point throughout therapy and without prior notice.
  • Patients with active GI bleeding should be avoided
  • Smoking should not be permitted in patients who are elderly, using concomitant medications that enhance the risk of GI bleeding, such as anticoagulants and/or steroids, selective serotonin reuptake inhibitors, smoking, or alcohol usage.
  • You should consider alternative therapies for patients at high-risk.
  • The lowest effective dose should not be used for longer periods of time.
  • Ketorolac and aspirin together significantly increase the risk of gastrointestinal problems, such as ulcers.
  • It is advised to use gastroprotective therapy, such as proton pump inhibitors.

• Hepatic effects

  • Rare but sometimes fatal hepatic reactions have been linked to NSAIDs.
  • If the patient has signs or symptoms that indicate liver disease or persisting or worsening abnormal hepatic functions, discontinue treatment
  • If the patient has any systemic manifestations, e.g. Eosinophilia or a rash.

• Hyperkalemia:

  • NSAIDs can increase hyperkalemia risk, especially in elderly people, diabetics, and those who use concomitantly with other agents that may cause hyperkalemia e.g. ACE inhibitors.
  • Pay attention to potassium.

• Hypersensitivity

  • Even patients who have never been exposed to the substance before may be at risk of developing hypersensitivity.
  • Anaphylactic shock and hypersensitivity, including bronchospasm, can happen. Individuals with the bronchial asthma "aspirin triad" intolerance to aspirin. Rhinitis.
  • Patients who have had a history of rhinitis or NSAID therapy such as bronchospasm or asthma should not be used.
  • Those who have previously experienced aspirin or NSAID hypersensitivity responses should not use ketorolac nasal spray.

• Effects on the renal system:

  • There have been cases of ARF, interstitial nephritis, and nephrotic syndrome after using ketorolac.
  • NSAIDs have been linked to renal injury and papillary necrosis.

• Reactions to skin:

  • Negative effects of NSAIDs on the skin can be severe and potentially life-threatening.
    • exfoliative dermatitis
    • Stevens-Johnson syndrome (SJS)
    • Toxic epidermal Necrolysis (TEN).
  • If you notice any signs of skin rash, hypersensitivity or other symptoms, discontinue use.

• Asthma

  • Patients with asthma that is aspirin-sensitive should not be given this medication. Bronchospasm can become severe and even fatal.
  • Patients with other forms of asthma should be cautious.

• Coronary artery bypass surgery/major surgery: [US-Boxed Warning]

  • Unsuitable for the implantation of a coronary bypass graft (CABG).
  • There is an elevated risk of stroke and MI following CABG surgery.
  • As a preventative analgesic before major surgery, not advised.
  • Ketorolac has been shown to reduce postoperative bleeding and hematomas in perioperative care

• Hepatic impairment

  • In the event of hepatic impairment and a history of liver illness, caution is suggested.
  • Individuals who have aberrant LFT results need to be watched carefully.

• Hypertension:

  • Exercise caution because hypertension can cause it to worsen or develop.

• Renal impairment

  • Those with advanced renal impairment or those at high risk of renal failure due to fluid depletion should not use it.
  • NSAIDs can cause kidney dysfunction.
  • Risk factors for renal toxicities:
    • Patients with impaired renal function are more at risk
    • Dehydration
    • hypovolemia,
    • heart failure,
    • liver dysfunction,
    • Seniors who are taking diuretics and ACE inhibitors.
  • To avoid dangerous complications from renal derangement, it is important to hydrate the patient before you start therapy
  • Pay attention to your renal function.
  • Modifying the dose may be necessary in cases of moderate serum creatinine elevation

Monitoring parameters:

• Monitor for weight gain/edema
• renal function (serum creatinine, BUN, urine output)
• Observe for bleeding, bruising
• Look for gastrointestinal effects e.g. abdominal pain, bleeding, and dyspepsia.
• CBC and platelets
• Liver function tests

How to administer Sprix (Ketorolac Nasal Spray)?

Intranasal:

• Never breathe in ketorolac nasal spray.
• Each nasal spray bottle provides enough medication for one day of treatment. Before using the nasal spray, prime the bottle by holding it upright and pressing the pump five times.
• If the same bottle is used for the rest of the day/doses, no need to prime again.
• Each new nasal spray bottle should be primed before use.
• Before using the nasal spray, blow your nose to clear your nostrils.

Method to use

• Position: Stand or sit up straight; incline your head forward.
• Keep the bottle upright and insert the tip into the nostril, aiming it away from the centre of the nose and towards the rear.
• Holding your breath, spray once while evenly applying pressure to both sides of the container.
• Following administration, start breathing through your mouth again to expel the medication. If you notice dripping, squeeze your nose to help hold the spray in.
• If not, repeat in the other nostril.

Discard bottle within 24 hours of priming even if there is unused medication.

Mechanism of action of Sprix (Ketorolac Nasal Spray):

• Ketorolac inhibits COX-1 and 2 enzymes reversibly.
• This results in decreased protaglandin precursor production. It has antipyretic and analgesic effects.
• Other suggested approaches, such as reducing pro-inflammatory cytokine levels, blocking neutrophil aggregation/activation, changing lymphocyte activity, and inhibiting chemotaxis are not completely understood or recognised.

Onset of analgesia:

• Within 20 minutes

Absorption:

• Rapid and well absorbed.

Distribution:

• ~13 L following complete distribution
• ketorolac is deposited mainly in the nasal cavity and pharynx;
• In esophagus  and <20% and  <0.5% in the lungs

Protein binding:

• 99%

Metabolism:

• Hepatic to hydroxylated and conjugated forms

Bioavailability:

• ~60% relative to intramuscular administration

Half-life elimination:

• ~5 to 6 hours (similar to IM administration)

Time to peak:

• 0.75 hours

Excretion:

• Urine (~92%, ~60% as unchanged drug)
• feces ~6%

International Brand Names of Ketorolac Nasal Spray:

• Sprix
• Aspriks

Ketorolac Nasal Spray Brand Names in Pakistan:

No Brands Available in Pakistan.