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تعداد آیتم قابل مشاهده باقیمانده : 3 مورد
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Ketorolac (ophthalmic): Drug information

Ketorolac (ophthalmic): Drug information
(For additional information see "Ketorolac (ophthalmic): Patient drug information" and see "Ketorolac (ophthalmic): Pediatric drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Acular;
  • Acular LS;
  • Acuvail
Brand Names: Canada
  • Acular;
  • Acular LS;
  • Acuvail
Pharmacologic Category
  • Nonsteroidal Anti-inflammatory Drug (NSAID), Ophthalmic
Dosing: Adult
Cataract surgery, postoperative ocular inflammation

Cataract surgery, postoperative ocular inflammation:

0.5% solution (Acular): Ophthalmic: Instill 1 drop into affected eye(s) 4 times daily beginning 24 hours after surgery; continue for 2 weeks.

Cataract surgery, postoperative ocular pain/inflammation

Cataract surgery, postoperative ocular pain/inflammation:

0.45% solution (Acuvail): Ophthalmic: Instill 1 drop into affected eye(s) 2 times daily beginning 24 hours before surgery and continuing on the day of surgery; continue for 2 weeks after surgery.

Corneal refractive surgery, postoperative ocular pain

Corneal refractive surgery, postoperative ocular pain:

0.4% solution (Acular LS): Ophthalmic: Instill 1 drop into affected eye(s) 4 times daily as needed for up to 4 days after surgery.

Seasonal allergic conjunctivitis

Seasonal allergic conjunctivitis (ocular itching):

0.5% solution (Acular): Ophthalmic: Instill 1 drop into affected eye(s) 4 times daily.

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Older Adult

Refer to adult dosing.

Dosing: Pediatric

(For additional information see "Ketorolac (ophthalmic): Pediatric drug information")

Postoperative inflammation following cataract extraction

Postoperative inflammation following cataract extraction (0.5% solution): Children ≥2 years and Adolescents: Ophthalmic: Instill 1 drop into affected eye(s) 4 times daily starting 24 hours after cataract surgery and through 14 days after surgery

Postoperative pain, burning, and stinging following corneal refractive surgery

Postoperative pain, burning, and stinging following corneal refractive surgery (0.4% solution): Children ≥3 years and Adolescents: Ophthalmic: Instill 1 drop into affected eye 4 times daily as needed for up to 4 days after corneal refractive surgery

Seasonal allergic conjunctivitis

Seasonal allergic conjunctivitis ( 0.5% solution): Children ≥2 years and Adolescents: Ophthalmic: Instill 1 drop into affected eye(s) 4 times daily

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer’s labeling.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer’s labeling.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

>10%: Ophthalmic: Burning sensation of eyes (transient: ≤40%), stinging of eyes (transient: ≤40%)

1% to 10%:

Hypersensitivity: Hypersensitivity reaction

Nervous system: Headache (1% to 6%)

Ophthalmic: Blurred vision (1% to 6%), conjunctival hyperemia (1% to 6%), corneal edema, corneal infiltrates (1% to 5%), eye irritation, eye pain (1% to 6%), eyelid edema, increased intraocular pressure (1% to 6%), iritis, lacrimation (1% to 6%), ocular edema (1% to 5%), ocular hyperemia, ophthalmic inflammation, superficial eye infection, superficial keratitis, swelling of eye

<1%: Ophthalmic: Corneal ulcer, dry eye syndrome

Postmarketing:

Ophthalmic: Corneal erosion, corneal perforation, corneal thinning (including corneal melt), epithelial keratopathy (breakdown), keratitis (ulcerative)

Respiratory: Bronchospasm, exacerbation of asthma

Contraindications

Hypersensitivity to ketorolac or any component of the formulation.

Warnings/Precautions

Concerns related to adverse effects:

• Aspirin/NSAID sensitivity: Use with caution in patients with previous sensitivity to acetylsalicylic acid, phenylacetic acid derivatives, and other NSAIDs including patients who experience bronchospasm, asthma, rhinitis, or urticaria following NSAID or aspirin therapy.

• Corneal effects: May cause keratitis; continued use may cause severe corneal adverse effects, including corneal thinning, erosion, perforation, or ulceration; may result in loss of vision. Discontinue use in patients with evidence of corneal epithelial damage.

• Delayed healing: Healing time may be slowed or delayed. Use with caution in patients receiving concomitant topical steroid therapy due to an increased risk for healing problems.

Disease-related concerns:

• Bleeding disorders: Use with caution in patients with a predisposition to bleeding (bleeding tendencies or medications which interfere with coagulation). Increased intraocular bleeding (including hyphema) has been reported following surgery.

• Diabetes: Use with caution in patients with diabetes mellitus; may be at risk of corneal adverse events, potentially resulting in loss of vision.

• Ocular disease: Use with caution in patients with complicated ocular surgeries, corneal denervation, corneal epithelial defects, ocular surface disease, or repeat ocular surgeries (within a short timeframe); may be at risk of corneal adverse events, potentially resulting in loss of vision.

• Rheumatoid arthritis: Use with caution in patients with rheumatoid arthritis; may be at risk of corneal adverse events, potentially resulting in loss of vision.

Special populations:

• Postsurgical patients: To minimize the risk of infection following surgery of both eyes, two separate bottles of eye drops (one for each eye) should be used; instruct patients not to use the same bottle for both eyes.

Dosage form specific issues:

• Benzalkonium chloride: May contain benzalkonium chloride as a preservative.

Other warnings/precautions:

• Appropriate use: The safety and efficacy of Acular LS (0.4% solution) has not been established in postcataract surgery patients.

• Contact lenses: Contact lenses should be removed prior to instillation (contains benzalkonium chloride, which may be adsorbed by contact lens); may be reinserted after 15 minutes (Acular Canadian product monograph).

• Duration of therapy: Use for more than 1 day prior to surgery or for 14 days beyond surgery may increase risk and severity of corneal adverse events.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Solution, Ophthalmic, as tromethamine:

Acular: 0.5% (5 mL) [contains benzalkonium chloride, edetate (edta) disodium]

Acular LS: 0.4% (5 mL) [contains benzalkonium chloride, edetate (edta) disodium]

Generic: 0.4% (5 mL); 0.5% (3 mL [DSC], 5 mL, 10 mL)

Solution, Ophthalmic, as tromethamine [preservative free]:

Acuvail: 0.45% (10 ea, 30 ea [DSC])

Generic Equivalent Available: US

Yes

Pricing: US

Solution (Acular LS Ophthalmic)

0.4% (per mL): $67.96

Solution (Acular Ophthalmic)

0.5% (per mL): $66.10

Solution (Acuvail Ophthalmic)

0.45% (per each): $13.37

Solution (Ketorolac Tromethamine Ophthalmic)

0.4% (per mL): $14.58

0.5% (per mL): $21.10 - $21.37

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Ophthalmic, as tromethamine:

Acular: 0.5% (5 mL, 10 mL) [contains benzalkonium chloride, edetate (edta) disodium]

Acular LS: 0.4% (5 mL) [contains benzalkonium chloride, edetate (edta) disodium]

Acuvail: 0.45% (0.4 mL)

Generic: 0.5% (5 mL, 10 mL)

Administration: Adult

Ophthalmic: For topical ophthalmic use only. Remove contact lenses prior to administration and wait 15 minutes before reinserting. May be used with other eye drops. If using more than 1 ophthalmic product, wait at least 5 minutes between application of each medication. Minimize contamination by not touching the eyelids or surrounding areas with the dropper tip; keep bottle tightly closed when not in use. Also, to minimize the risk of infection following surgery of both eyes, two separate bottles of eye drops (one for each eye) should be used; instruct patients not to use the same bottle for both eyes.

Administration: Pediatric

For ophthalmic use only. May contain benzalkonium chloride which may be absorbed by contact lenses; contact lenses should not be worn during treatment. Instill drops into affected eye(s); avoid contact of container tip with skin or eyes; wait at least 5 minutes before administering other ophthalmic drops. Apply gentle pressure to lacrimal sac during and immediately following instillation (1 minute) or instruct patient to gently close eyelid after administration, to decrease systemic absorption of ophthalmic drops (Ref). To minimize the risk of infection following surgery of both eyes, two separate bottles of eye drops (one for each eye) should be used; instruct patients not to use the same bottle for both eyes.

Use: Labeled Indications

Cataract surgery:

Postoperative ocular inflammation following cataract surgery (0.5% solution [Acular]): Treatment of postoperative inflammation following cataract surgery.

Postoperative ocular pain/inflammation following cataract surgery (0.45% solution [Acuvail]): Treatment of pain and inflammation following cataract surgery.

Corneal refractive surgery:

Postoperative ocular pain following corneal refractive surgery (0.4% solution): Reduction of ocular pain and burning/stinging following corneal refractive surgery.

Seasonal allergic conjunctivitis (ocular itching) (0.5% solution): Temporary relief of ocular itching caused by seasonal allergic conjunctivitis.

Medication Safety Issues
Sound-alike/look-alike issues:

Acular may be confused with Acthar, Ocular

Ketorolac may be confused with Ketalar

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Anticoagulants: Nonsteroidal Anti-Inflammatory Agents (Ophthalmic) may enhance the anticoagulant effect of Anticoagulants. Risk C: Monitor therapy

Corticosteroids (Ophthalmic): Nonsteroidal Anti-Inflammatory Agents (Ophthalmic) may enhance the adverse/toxic effect of Corticosteroids (Ophthalmic). Healing of ophthalmic tissue during concomitant administration of ophthalmic products may be delayed. Risk C: Monitor therapy

Prostaglandins (Ophthalmic): Nonsteroidal Anti-Inflammatory Agents (Ophthalmic) may diminish the therapeutic effect of Prostaglandins (Ophthalmic). Nonsteroidal Anti-Inflammatory Agents (Ophthalmic) may enhance the therapeutic effect of Prostaglandins (Ophthalmic). Risk C: Monitor therapy

Pregnancy Considerations

Adverse events have been observed in animal reproduction studies. Systemic exposure is decreased with ophthalmic administration (concentrations are ~4% to 8% of the minimum plasma concentration following an oral dose). If ophthalmic agents are needed during pregnancy, the minimum effective dose should be used in combination with punctal occlusion to decrease potential exposure to the fetus (Samples 1988). However, because it may cause prenatal constriction of the ductus arteriosus, the manufacturer recommends that the use of ketorolac ophthalmic drops late in pregnancy be avoided.

Breastfeeding Considerations

When administered orally, ketorolac enters breast milk; systemic exposure is decreased with ophthalmic administration (concentrations are ~4% to 8% of the minimum plasma concentration following an oral dose). The manufacturer recommends that caution be used when administering ketorolac ophthalmic to breast-feeding women.

Mechanism of Action

Inhibits prostaglandin synthesis by decreasing the activity of the enzyme, cyclooxygenase 1 and 2, which results in decreased formation of prostaglandin precursors.

Pharmacokinetics (Adult Data Unless Noted)

Absorption: Following instillation of ketorolac 0.5% ophthalmic drops 3 times/day, the mean plasma concentrations of ketorolac are ~4% to 8% of the minimum concentration observed following oral doses of 10 mg 4 times/day.

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AE) United Arab Emirates: Acular | Acular ls | Acuvail | Torolac;
  • (AR) Argentina: Acular | Acuvail | Ketopharm | Klenac | Poenkerat | Sinalgico;
  • (AT) Austria: Acular | Ketorolac medicopharm;
  • (AU) Australia: Acular;
  • (BD) Bangladesh: Emodol | Etorac | Kelorac | Recular | Todol | Toroaid | Winop | Xidolac;
  • (BE) Belgium: Aculare;
  • (BG) Bulgaria: Ketorolac vision;
  • (BR) Brazil: Acular | Acular cmc | Acular ls | Cetorolaco de trometamina | Cetorolaco de trometamol | Cetorolaco Trometamol | Cetrolac | Cetrolac md | Clilon | Neocular | Optilar | Softalm | Terolac | Teroquatro | Toragesic ofta;
  • (CH) Switzerland: Acular | Ketorolac medano | Ketovision;
  • (CL) Chile: Acular | Poenkerat;
  • (CN) China: Acular | Acular pf;
  • (CO) Colombia: Acular ls | Acuvail | Expodol k | Kenalgesic | Oftalmotrilac;
  • (DE) Germany: Acular | Ketorolac micro labs | Ketovision;
  • (DO) Dominican Republic: Acular | Acular ls | Coral | Dustalox | Godekan | Oftalgesic | Rapiblok;
  • (EC) Ecuador: Acular | Acular ls | Dustalox | Poenkerat;
  • (EE) Estonia: Acular;
  • (EG) Egypt: Acular | Dolomine | Ketorolac | Ketorolin | Samulgin;
  • (ES) Spain: Acular;
  • (ET) Ethiopia: Elipa | Torolac;
  • (FI) Finland: Acular;
  • (FR) France: Acular;
  • (GB) United Kingdom: Acular | Ketorolac trometamol;
  • (GR) Greece: Acular | Errkes;
  • (HK) Hong Kong: Acular | Acular pf;
  • (IE) Ireland: Acular;
  • (IN) India: Acular | Acular ls | Acuvail | Cadolac | Centagesic | Doloket | K-lac | Ked | Ketanov | Ketlur | Ketodrops | Ketolac | Ketostar | Ketromin | Ketzy | Key | Kls | Kt | Lokat | Nsaid-K | Oculac | T lac | Torolac;
  • (IT) Italy: Acular | Girolac | Ketorolac Abc | Ketorolac Actavis | Ketorolac Doc | Ketorolac EG | Ketorolac Epifarma | Ketorolac Fg | Ketorolac Pensa | Ketorolac rk | Ketorolac Sandoz | Kevindol | Komorebi | Lixidol | Rikedol | Tora Dol;
  • (JO) Jordan: Acular ls | Acuvail;
  • (KE) Kenya: Acular;
  • (KR) Korea, Republic of: Acular | Acuvail | Ketlur | Kitolac;
  • (KW) Kuwait: Acular | Acuvail;
  • (LB) Lebanon: Acular | Acular ls | Acuvail;
  • (LT) Lithuania: Acular;
  • (LU) Luxembourg: Aculare;
  • (LV) Latvia: Acular;
  • (MA) Morocco: Acular;
  • (MX) Mexico: Acularen | Acularen pf | Bauket | Dustalox | Godek | Kendol | Mardam | Poenkerat | Trub K;
  • (MY) Malaysia: Acular | Acuvail;
  • (NG) Nigeria: Acuvail | Oradol;
  • (NL) Netherlands: Acular;
  • (NZ) New Zealand: Acular;
  • (PE) Peru: Acular | Acular ls | Dustalox | Godek;
  • (PH) Philippines: Acular | Acuvail;
  • (PK) Pakistan: Dylac | Ketanov | Ketro | Ketrosan | Oculac | Optiket | Trulac;
  • (PL) Poland: Acular;
  • (PR) Puerto Rico: Acular ls | Acular pf | Acuvail;
  • (PT) Portugal: Elipa;
  • (PY) Paraguay: Poenkerat;
  • (RU) Russian Federation: Akyular LS | Ketadrop;
  • (SA) Saudi Arabia: Acular ls | Acuvail;
  • (SG) Singapore: Acular | Acuvail;
  • (TH) Thailand: Acular;
  • (TR) Turkey: Acufix | Acular | Enfluat | Medrolgin;
  • (TW) Taiwan: Acular | Ketoro | Sukerin;
  • (UA) Ukraine: Acuvail | Medrolgin;
  • (VE) Venezuela, Bolivarian Republic of: Acular ls | Dolak | Ocudol | Poenkerat;
  • (ZA) South Africa: Acular | Kelopt
  1. Acular (ketorolac tromethamine) [prescribing information]. Irvine, CA: Allergan; June 2012.
  2. Acular/Acular LS (ketorolac tromethamine) [product monograph]. St-Laurent, Ontario, Canada: AbbVie Corporation; November 2022.
  3. Acular LS (ketorolac tromethamine) [prescribing information]. Madison, NJ: Allergan; March 2021.
  4. Acuvail (ketorolac tromethamine) [prescribing information]. Irvine, CA: Allergan; February 2019.
  5. Acuvail (ketorolac tromethamine) [product monograph]. Markham, Ontario, Canada: Allergan Inc; September 2018.
  6. Samples JR, Meyer SM. Use of ophthalmic medications in pregnant and nursing women. Am J Ophthalmol. 1988;106(5):616-623. [PubMed 2903673]
  7. Urtti A, Salminen L. Minimizing systemic absorption of topically administered ophthalmic drugs. Surv Ophthalmol. 1993;37(6):435-456. [PubMed 8100087]
  8. Zimmerman TJ, Kooner KS, Kandarakis AS, Ziegler LP. Improving the therapeutic index of topically applied ocular drugs. Arch Ophthalmol. 1984;102(4):551-553. [PubMed 6704011]
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