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Proparacaine: Pediatric drug information

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

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Alcaine
Therapeutic Category
  • Local Anesthetic, Ophthalmic
Dosing: Neonatal
Short corneal or conjunctival procedures, ophthalmic anesthesia

Short corneal or conjunctival procedures, ophthalmic anesthesia: Ophthalmic: Instill 2 drops of 0.5% solution 30 seconds prior to procedure; a crossover study in 22 premature neonates (GA: <30 weeks) undergoing examination for retinopathy of prematurity showed decreased pain scores compared to placebo (Ref).

Dosing: Pediatric
Short corneal or conjunctival procedures

Short corneal or conjunctival procedures: Infants, Children, and Adolescents: Ophthalmic: Instill 1 drop of 0.5% solution in eye every 5 to 10 minutes for 5 to 7 doses

Tonometry, gonioscopy, suture removal

Tonometry, gonioscopy, suture removal: Infants, Children, and Adolescents: Ophthalmic: Instill 1 to 2 drops of 0.5% solution in eye just prior to procedure

Dosing: Kidney Impairment: Pediatric

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

Dosing: Hepatic Impairment: Pediatric

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

Dosing: Adult

(For additional information see "Proparacaine: Drug information")

Anesthesia, ocular

Anesthesia, ocular:

Short corneal and conjunctival procedures: Ophthalmic: Instill 1 drop in eye(s) every 5 to 10 minutes for 5 to 7 doses.

Tonometry, gonioscopy, suture removal: Ophthalmic: Instill 1 to 2 drops in eye(s) just prior to procedure.

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.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Frequency not defined.

Dermatologic: Allergic contact dermatitis

Hypersensitivity: Hypersensitivity reaction (corneal; characterized by acute, intense, and diffuse epithelial keratitis; gray, ground glass appearance; exfoliation of skin; corneal filaments; and can include iritis with descemetitis)

Ophthalmic: Burning sensation of eyes, conjunctival hemorrhage, conjunctival hyperemia, corneal erosion, cycloplegia, eye redness, mydriasis, stinging of eyes

Contraindications

Hypersensitivity to proparacaine or any component of the formulation

Warnings/Precautions

Other warnings/precautions:

• Appropriate use: For topical ophthalmic use only; prolonged use may result in permanent corneal opacification and visual loss and is not recommended.

Dosage Forms: US

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

Solution, Ophthalmic, as hydrochloride:

Alcaine: 0.5% (15 mL) [contains benzalkonium chloride]

Generic: 0.5% (15 mL)

Generic Equivalent Available: US

Yes

Pricing: US

Solution (Alcaine Ophthalmic)

0.5% (per mL): $3.27

Solution (Proparacaine HCl Ophthalmic)

0.5% (per mL): $2.81 - $2.93

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.

Administration: Pediatric

For ophthalmic use only. Do not use if discolored; protect eye from irritating chemicals, foreign bodies, and blink reflex; use eye patch if necessary.

Ophthalmic: Instill drops into affected eye(s); avoid contact of bottle tip with skin or eye

Administration: Adult

Ophthalmic: For topical ophthalmic use only. To be administered by health care provider; not for patient self-administration. Do not use if discolored (darker than clear to straw color); protect eye from irritating chemicals, foreign bodies, and blink reflex; use eye patch if necessary. To avoid contamination, do not touch dropper tip to eyelids or any surface.

Storage/Stability

Store under refrigeration at 2°C to 8°C (36°F to 46°F). Protect from light.

Use

Local anesthesia for tonometry, gonioscopy; suture removal from cornea; removal of corneal foreign body; cataract extraction, glaucoma surgery; short operative procedure involving the cornea and conjunctiva (FDA approved in all ages)

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.

Methemoglobinemia Associated Agents: May enhance the adverse/toxic effect of Local Anesthetics. Specifically, the risk for methemoglobinemia may be increased. Risk C: Monitor therapy

Pregnancy Considerations

Animal reproduction studies have not been conducted.

Mechanism of Action

Prevents initiation and transmission of impulse at the nerve cell membrane by decreasing ion permeability through stabilizing

Pharmacokinetics (Adult Data Unless Noted)

Onset of action: Within 20 seconds of instillation

Duration: ~10 to 20 minutes

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

  • (AE) United Arab Emirates: Alcain | Minims proxymetacaine;
  • (AR) Argentina: Anestalcon | Poen caina | Proparacaina Phoenix;
  • (AU) Australia: Alcaine | Ophthetic;
  • (BD) Bangladesh: P Caine | Procain;
  • (BG) Bulgaria: Alcaine;
  • (BR) Brazil: Anestalcon | Visonest;
  • (CL) Chile: Anestalcon | Poen caina;
  • (CN) China: Alcaine | Proparacaine hydrochloride;
  • (CO) Colombia: Alcaine | Bioglokaina | Miraxil | Syndap;
  • (CZ) Czech Republic: Alcaine;
  • (DE) Germany: Proparakain-pos;
  • (DO) Dominican Republic: Anestears;
  • (EC) Ecuador: Alcaine | Anestears | Poen caina;
  • (EE) Estonia: Alcaine | Proparakain-pos;
  • (FI) Finland: Ophtetic;
  • (GB) United Kingdom: Ophthaine;
  • (GR) Greece: Alcaine;
  • (HK) Hong Kong: Alcaine | Provain pos;
  • (IE) Ireland: Minims proxymetacaine;
  • (IN) India: Aurocaine | Cainpro | Idope | P Caine | Paracain | Propcaine | Sensochek | Topicaine;
  • (JP) Japan: Op.copalon;
  • (KR) Korea, Republic of: Alcaine | Proparacaine;
  • (LT) Lithuania: Alcain | P Caine | Proparakain-pos;
  • (LV) Latvia: Alcaine | Proparakain-pos;
  • (MX) Mexico: Alcaine;
  • (MY) Malaysia: Alcaine;
  • (NO) Norway: Alcaine;
  • (NZ) New Zealand: Alcaine | Ophthetic;
  • (PE) Peru: Alcaine | Anestears | Proparacaina | Unigese;
  • (PH) Philippines: Alcaine;
  • (PK) Pakistan: Alcaine | Cainzex;
  • (PL) Poland: Alcaine | Proparakain-pos;
  • (PR) Puerto Rico: Ak-taine | Alcaine | Ophthetic | Proparacaine HCL | Proparacaine hydrochloride;
  • (PY) Paraguay: Anestalcon;
  • (RO) Romania: Alcaine;
  • (RU) Russian Federation: Alcaine;
  • (SG) Singapore: Alcaine;
  • (SI) Slovenia: Alcaine;
  • (TH) Thailand: Ophthetic;
  • (TR) Turkey: Alcaine;
  • (TW) Taiwan: Alcaine | Proparacaine hydrochloride;
  • (UA) Ukraine: Alcain;
  • (UY) Uruguay: Anestalcon | Poen caina;
  • (VE) Venezuela, Bolivarian Republic of: Alcaine | Poen caina;
  • (ZA) South Africa: Ophthetic
  1. Alcaine (proparacaine hydrochloride) [prescribing information]. Fort Worth, TX: Alcon Laboratories Inc; September 2022. [PubMed 17687059]
  2. Cohen V, Jellinek SP, Teperikidis L, et al. Room-temperature storage of medications labeled for refrigeration. Am J Health-Syst Pharm. 2007;64(16):1711-1715.
  3. Marsh VA, Young WO, Dunaway KK, et al, "Efficacy of Topical Anesthetics to Reduce Pain in Premature Infants During Eye Examinations for Retinopathy of Prematurity," Ann Pharmacother, 2005, 39(5):829-33. [PubMed 15797982]
  4. Proparacaine hydrochloride ophthalmic solution [prescribing information]. Gurnee, IL: Akorn Inc; June 2022.
Topic 12740 Version 170.0

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