Proparacaine

Name: Proparacaine

Proparacaine Overview

Proparacaine is a prescription medication used to induce anesthesia for eye examinations and procedures.

Proparacaine belongs to a group of drugs called rapid-acting topical anesthetics. These work by preventing the initiation and transmission of nerve signals.

This medication comes in solution form for topical use during surgical procedures and examinations of the eye.

Common side effects of proparacaine include burning, stinging, or redness of the eye.

Proparacaine Food Interactions

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of proparacaine, there are no specific foods that you must exclude from your diet when receiving this medication.

Proparacaine and Lactation

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if proparacaine crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using proparacaine.

Proparacaine Overdose

If you take too much proparacaine, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If proparacaine is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

Forms of Medication


Proparacaine FDA Warning


What do I need to tell my doctor BEFORE I take Proparacaine?

  • If you have an allergy to proparacaine or any other part of proparacaine.
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

Consumer Information Use and Disclaimer

  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else's drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take proparacaine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to proparacaine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

Principal display panel

NDC 61314-016-01

Proparacaine Hydrochloride Ophthalmic Solution, USP

0.5%

Rx only

STERILE

15 mL

PRECAUTION: NOT FOR INJECTION. FOR TOPICAL OPHTHALMIC USE ONLY. Do not touch dropper tip to any surface, as this may contaminate the solution.

USUAL DOSAGE: 1 or 2 drops.
Read enclosed insert.
Bottles must be stored in unit
carton to protect from light.

STORAGE: Store between 2°-8°C (36°-46°F). Proparacaine hydrochloride ophthalmic solution should be clear to straw-color. If the solution becomes darker, discard the solution.

INGREDIENTS: Each mL contains:

Active: Proparacaine hydrochloride 5 mg (0.5%).

Preservative: benzalkonium chloride 0.01%.

Inactives: glycerin, hydrochloric acid and/or sodium hydroxide (to adjust pH), purified water.

MANUFACTURED BY ALCON LABORATORIES, INC.

Manufactured by
Alcon Laboratories, Inc.
Fort Worth, Texas 76134 for
Sandoz Inc.
Princeton, NJ 08540

Printed in USA

9012981-0216

Rev. 06/2012

NDC 61314-016-01

Proparacaine Hydrochloride Ophthalmic Solution, USP

0.5%

Rx only

STERILE

15 mL

SANDOZ

INGREDIENTS: Each mL contains:

Active: Proparacaine hydrochloride 5 mg (0.5%).

PRECAUTION: NOT FOR INJECTION. FOR TOPICAL OPHTHALMIC USE ONLY. Do not touch dropper tip to any surface as this may contaminate the solution.

USUAL DOSAGE: 1 or 2 drops.
Read enclosed insert.

STORAGE: Store between 2º-8ºC (36º-46ºF).

Bottles must be stored in unit carton to protect from light.

Proparacaine hydrochloride ophthalmic solution should be clear to straw-color. If the solution becomes darker, discard the solution.

Manufactured by
Alcon Laboratories, Inc.
Fort Worth, Texas 76134 for
Sandoz Inc.
Princeton, NJ 08540
Rev. 04-2012

LOT/EXP.:

H14233-0216

Proparacaine HYDROCHLORIDE  
Proparacaine hydrochloride solution/ drops
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:61314-016
Route of Administration OPHTHALMIC DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Proparacaine HYDROCHLORIDE (Proparacaine) Proparacaine HYDROCHLORIDE 5 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
BENZALKONIUM CHLORIDE  
GLYCERIN  
WATER  
HYDROCHLORIC ACID  
SODIUM HYDROXIDE  
Packaging
# Item Code Package Description
1 NDC:61314-016-01 1 BOTTLE in 1 CARTON
1 15 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA080027 06/05/2000
Labeler - Sandoz Inc. (005387188)
Registrant - Alcon Laboratories, Inc. (008018525)
Establishment
Name Address ID/FEI Operations
Alcon Research Ltd 007672236 manufacture(61314-016)
Revised: 02/2017   Sandoz Inc.
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