Ketorolac

Selected oral and injection labels cover short-term, moderately severe acute pain requiring opioid-level analgesia, often postoperative; combined treatment is limited to 5 days. Oral tablets are continuation treatment after IV or IM ketorolac, never initial therapy. SPRIX is labeled for adults with moderate to moderately severe acute pain requiring opioid-level analgesia, up to 5 days. These products are not chronic or minor-pain treatments.

ACULAR 0.5% treats seasonal allergic-conjunctivitis itching and postoperative inflammation after cataract extraction. ACULAR LS 0.4% treats pain and burning / stinging following corneal refractive surgery. ACUVAIL 0.45% treats pain and inflammation associated with cataract surgery. These indications and regimens are not interchangeable.

All selected products are prescription U.S. products in current public labeling. Current SPL publication does not prove local stock or a newly approved indication. Other manufacturers, foreign products, compounded routes and off-label pediatric systemic protocols need separate review; no class-derived regimen is supplied.

Correct hypovolemia before treatment. Give IV boluses over at least 15 seconds and IM injections slowly / deeply. The selected 60 mg /2 mL presentation is IM ONLY. Do not use epidurally or intrathecally; the formulation contains alcohol. Do not mix in a small volume / syringe with morphine sulfate, meperidine hydrochloride, promethazine hydrochloride or hydroxyzine hydrochloride because precipitation occurs. Breakthrough pain requires reassessment, not extra ketorolac or shortened intervals.

Adults<65:31.5 mg (one 15.75 mg spray in EACH nostril) every 6–8 hours; maximum 126 mg / day, four doses. Adults≥65, renal impairment or weight<50 kg:15.75 mg (one spray in ONE nostril) every 6–8 hours; maximum 63 mg / day, four doses. Do not use concurrently with other ketorolac or NSAIDs; total systemic duration including sequential oral / IV / IM treatment≤5 days. Prime five times before first use; do not reprime. Tilt head slightly forward, direct away from the septum and hold breath while spraying, then resume mouth breathing. This is not an inhalation or eye product.

Separate other topical eye medicines by at least 5 minutes; do not administer while wearing contact lenses. Keep tips free of contact with eyes or surfaces. Use ACUVAIL immediately after opening a single-use vial and discard the remainder. The systemic 5 day cap is not the labeled eye-drop duration.

Selected oral / IV / IM labels contraindicate active ulcers, recent GI bleeding / perforation or a history of ulcer / GI bleeding; advanced renal impairment or renal-failure risk from volume depletion; ketorolac / NSAID hypersensitivity including aspirin-associated asthma / urticaria; CABG surgery; prophylactic analgesia before major surgery; labor / delivery; cerebrovascular bleeding, hemorrhagic diathesis, incomplete hemostasis or high bleeding risk; concurrent aspirin / other NSAIDs, probenecid or pentoxifylline. Prior serious NSAID skin reactions are also contraindicated in warning text; neuraxial injection is prohibited.

SPRIX formal contraindications similarly include active / recent GI injury, advanced renal disease / volume-depletion risk, allergy / NSAID reactions, CABG, pre-major-surgery prophylaxis, labor / delivery, impaired hemostasis, probenecid and pentoxifylline. Prior ulcer / GI-bleed history is a major warning risk rather than identically listed in its§4. Despite less restrictive aspirin language elsewhere in its label,§2 prohibits concurrent NSAIDs: no aspirin co-use regimen is endorsed here. Eye products formally contraindicate ingredient hypersensitivity; do not mechanically apply every systemic contraindication to eye drops.

Selected oral / IV / IM labels carry boxed warnings covering the 5 day limit and oral-continuation restriction, GI / CV / renal / bleeding risks and important contraindications and special-population dose limits. SPRIX carries a boxed warning for serious CV / GI risks; its 5 day limit is stated in indications / dosing rather than the box itself. The selected ophthalmic labels have no boxed warning; their corneal / healing warnings remain clinically serious.

Systemic reports include nausea, dyspepsia, abdominal symptoms, headache, dizziness, edema, renal abnormalities and injection-site pain; serious bleeding, renal failure and hypersensitivity can occur. SPRIX commonly causes nasal discomfort / pain, tearing or throat irritation. Eye-drop reactions include transient burning / stinging, ocular pain / redness, edema, blurred vision and allergy; corneal injury is reported after marketing. Rates differ by product, trial and surgery and are not directly compared here.

For systemic treatment, do not add aspirin, other NSAIDs, another ketorolac product, probenecid or pentoxifylline. Anticoagulants, antiplatelet agents, SSRIs / SNRIs and corticosteroids increase bleeding risk; review the combination and monitor closely. Small volunteer interaction studies do not establish safety of anticoagulant co-use. Do not stop prescribed cardioprotective aspirin without a clinician’s alternative pain plan.

Systemic ketorolac can impair ACE-inhibitor / ARB / beta-blocker and diuretic response, and increase renal injury risk, particularly during dehydration. Review lithium, methotrexate and cyclosporine toxicity risk. SPRIX§7 specifically calls for digoxin-level monitoring and renal / pemetrexed safety review, including its treatment-window instructions; no generalized chemotherapy interruption schedule is invented here. Reports with antiepileptics, psychoactive medicines and nondepolarizing muscle relaxants include seizures, hallucinations or apnea; verify the full interaction list.

Topical corticosteroids may compound delayed corneal healing. Medicines affecting bleeding and an ocular-bleeding history require caution. Separate eye products by≥5 minutes; spacing does not remove systemic or healing interactions. No ophthalmic interaction study establishes a universal safe systemic combination.

For systemic forms, limit use between about 20 and 30 weeks to the lowest effective dose / shortest duration if necessary; avoid at about 30 weeks onward because of ductal-closure risk. Fetal renal injury / oligohydramnios can begin around 20 weeks; consider ultrasound if treatment extends beyond 48 hours and stop if oligohydramnios occurs. Labor / delivery is contraindicated. Limited oral 10 mg milk data show low transfer but do not prove all-route infant safety; use caution and assess infant symptoms. Eye labels report inadequate pregnancy data; ACULAR specifically advises avoiding late pregnancy. Topical milk transfer is unknown and nursing use requires caution.

Selected systemic oral / injection labels do not establish pediatric use; oral dosing begins with its 17–64 age band. SPRIX is adult-labeled: its statement not to use below 2 years is not approval for ages 2–17, whose safety / effectiveness are unestablished. Ophthalmic safety / effectiveness are unestablished below 2 years for ACULAR / ACUVAIL and below 3 for ACULAR LS. Older adults have greater systemic GI / renal risk and reduced systemic dose ceilings as shown; eye studies found no overall age-related difference.

Advanced renal impairment or dehydration-related renal-failure risk contraindicates systemic treatment. Lesser renal impairment requires reduced doses and close follow-up; labels do not provide a universally applicable numeric CrCl threshold. Liver disease needs caution and evaluation of liver symptoms / labs; small PK studies do not establish universal hepatic safety or a numeric adjustment. Eye labels do not supply renal / hepatic adjustment tables. Do not extrapolate systemic dosing to ophthalmic products.

Ketorolac is an NSAID; prostaglandin-synthesis inhibition is thought to contribute to its activity. Systemic analgesia is not opioid-receptor activity and has no inherent sedative / anxiolytic effect, though dizziness can occur. Ocular treatment acts locally to control the selected inflammatory / itching symptoms.

Oral ketorolac is well absorbed; a fatty meal delays / reduces peak concentration without establishing a new dose. It is highly protein bound, metabolized to hydroxylated / conjugated products and eliminated mainly through urine. Systemic racemate half-life is often around 5–6 hours, prolonged in older adults and renal impairment; nasal PK is product / study specific. Ophthalmic labels describe low but sometimes detectable plasma levels in 0.5% studies; these data do not show zero systemic exposure or establish interchangeable 0.4%/0.45% kinetics.

Before systemic use review ulcer / bleeding history, renal function, volume status, CV disease / BP, pregnancy timing and all medicines. Follow pain benefit, BP / edema, renal function / potassium where at risk, bleeding / anemia and liver symptoms; use CBC / chemistry tests when clinically indicated. Labels’ long-term NSAID monitoring language does not authorize long-term ketorolac. Ophthalmic monitoring focuses on healing, corneal integrity, inflammation and vision; no universal lab schedule is asserted.

Follow the prescribed route, exact interval and cap; tablets cannot start a course and no systemic route resets total duration. Seek urgent care for black / bloody stools, chest pain, stroke symptoms, reduced urine, severe rash, facial swelling or breathing trouble. Report eye pain, vision changes or worsening irritation. Avoid contaminated tips / contact-lens administration. SPRIX must not touch eyes: rinse accidental exposure with water / saline and obtain care if irritation lasts>1 hour. Verify missed or uncertain doses with a clinician / pharmacist rather than doubling.

Seek immediate medical / Poison Control advice for overdose, child exposure or the wrong route. Systemic overdose can cause GI bleeding, kidney injury, respiratory depression or coma; care is supportive and there is no specific antidote. Dialysis is unlikely to help substantially because of high protein binding. Do not induce vomiting or attempt home charcoal. Never inject nasal / eye products or put SPRIX into an eye.

Product

Mylan ketorolac tromethamine 10 mg tablet

Route

Oral; prescription continuation after IV / IM

Appearance

White round unscored; M /134 imprint

Example package

Bottle 100 · NDC 0378-1134-01

Selected Hospira injection:15 mg /1 mL and 30 mg /1 mL for IV / IM;60 mg /2 mL (30 mg /mL) is IM ONLY. SPRIX supplies 15.75 mg per 100 microliter spray, eight sprays per 1.7 g bottle (126 mg total). Eye solutions: ACULAR 0.5% (5 mg /mL), ACULAR LS 0.4% (4 mg /mL), ACUVAIL 0.45% (4.5 mg /mL). ACULAR / LS selected 5 mL bottles have gray caps; ACUVAIL has 0.4 mL single-use vials,30 per carton. Tablet / injection strengths express tromethamine salt; no mg-for-mg route conversion is asserted.

Selected tablets:20–25°C, protected from light / excess humidity in tight light-resistant packaging. Hospira injection:20–25°C, protected from light in carton. Unopened SPRIX:2–8°C, protect from light / freezing; in-use 15–30°C away from sunlight. SPRIX§2 says discard within 24 hours after first dose, while§16 says 24 hours after priming; use the earlier priming-based limit if primed before dosing. ACULAR / LS:15–25°C, protect from light; LS explicitly allows opened-bottle use until labeled expiry, without a universal 28 day rule. ACUVAIL:15–30°C in light-protective pouch (fold closed); use an opened vial immediately and discard unused contents.