Prefrin Liquifilm (Ophthalmic)

Ophthalmic phenylephrine comes in strengths of 2.5% and 10%. It is used to make the pupil bigger (dilate). This is done before eye exams, before and after eye surgery, and to treat some eye conditions. In the U.S., you can only get these products with a prescription from your doctor.

If you experience eye pain or changes in your vision, or if redness or irritation in your eye continues, worsens, or lasts more than 72 hours, stop using the medicine and consult your doctor.

For patients using the 2.5 or 10% eye drops:

• After applying this medicine to your eyes, your pupils will become unusually large. This will make your eyes more sensitive to light than usual. When you go outside during the day, even if it’s cloudy, wear sunglasses that block ultraviolet (UV) light to protect your eyes from sunlight and other bright lights. Regular sunglasses may not be sufficient protection. If you have questions about what type of sunglasses to wear, consult your doctor. Additionally, if this sensitivity lasts more than 12 hours after stopping the medicine, check with your doctor.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the benefits. This is a decision you will make with your doctor. For this medicine, please consider the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

Children may be particularly sensitive to the effects of phenylephrine, which may increase the chance of side effects during treatment. Additionally, the 10% strength is not recommended for infants. The 2.5 and 10% strengths are also not recommended for low birth weight infants.

Geriatric

Using 2.5 or 10% phenylephrine repeatedly may increase the chance of complications during treatment. Heart and blood vessel problems have occurred more frequently in elderly patients than in younger adults.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication while breastfeeding. Carefully weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction might occur. In such cases, your doctor may want to adjust the dose or take other precautions. When taking this medicine, it is especially important that your healthcare professional knows if you are taking any of the following medicines. The following interactions have been selected based on their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you are taking.

• Clorgyline
• Dihydroergotamine
• Iproniazid
• Isocarboxazid
• Linezolid
• Nialamide
• Phenelzine
• Procarbazine
• Rasagiline
• Selegiline
• Tranylcypromine

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may adjust the dose or the frequency of use for one or both of the medicines.

• Ergonovine
• Furazolidone
• Iobenguane I 123
• Iobenguane I 131
• Methylergonovine
• Midodrine
• Pargyline
• Zavegepant

Using this medicine with any of the following medicines may increase the risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or the frequency of use for one or both of the medicines.

• Guanethidine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken around the time of eating food or certain types of food, as interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions. The following interactions have been selected based on their potential significance and are not necessarily all-inclusive.

Other Medical Problems

Other medical problems may affect the use of this medicine. Be sure to inform your doctor if you have any other medical conditions, especially:

• Type 2 diabetes mellitus
• Heart or blood vessel disease
• High blood pressure—The 2.5 and 10% strengths of phenylephrine may worsen this condition
• Idiopathic orthostatic hypotension (a specific type of low blood pressure)—Using this medicine may cause a significant increase in blood pressure.

Along with its necessary effects, a medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

Symptoms of too much medicine being absorbed into the body

Less common with 10% solution; rare with 2.5% or weaker solution

• Dizziness
• fast, irregular, or pounding heartbeat
• increased sweating
• increase in blood pressure
• paleness
• trembling

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common with 2.5 or 10% solution

• Burning or stinging of eyes
• headache or browache
• sensitivity of eyes to light
• watering of eyes

Less common

• Eye irritation not present before use of this medicine

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• AK-Dilate
• Altafrin
• Eye Cool
• Mydfrin
• Neofrin
• Neo-Synephrine
• Ocu-Phrin
• Prefrin Liquifilm

Available Dosage Forms:

• Solution

Therapeutic Class: Mydriatic-Cycloplegic

Pharmacologic Class: Adrenergic System

Chemical Class: Alkylarylamine

Do not use if the solution turns brown or becomes cloudy.

To use:

• First, wash your hands. Tilt the head back and, pressing your finger gently on the skin just beneath the lower eyelid, pull the lower eyelid away from the eye to make a space. Drop the medicine into this space. Let go of the eyelid and gently close the eyes. Do not blink. Keep the eyes closed and apply pressure to the inner corner of the eye with your finger for 2 or 3 minutes to allow the medicine to be absorbed by the eye.
• Immediately after using the eye drops, wash your hands to remove any medicine that may be on them.
• To keep the medicine as germ-free as possible, do not touch the applicator tip to any surface (including the eye). Also, keep the container tightly closed.

For patients using the 2.5 or 10% eye drops:

• It is very important that you use this medicine only as directed. Do not use more of it and do not use it more often than your doctor ordered. To do so may increase the chance of too much medicine being absorbed into the body and the chance of side effects. This is especially important when this medicine is used in children or in patients with heart disease or high blood pressure, since high doses of this medicine may cause an irregular heartbeat and an increase in blood pressure.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For ophthalmic solution (eye drops) dosage form: For eye redness: Adults and children—Use one drop of 0.12% solution every three or four hours as needed. For eye exams: Adults and children—Use one drop of 2.5% solution. Depending on the eye test to be done, it will take from fifteen minutes to one or two hours for the medicine to work before you can have the eye test. For use before eye surgery: Adults and teenagers—Use one drop of 2.5 or 10% solution thirty to sixty minutes before the start of eye surgery. Children—Use one drop of 2.5% solution thirty to sixty minutes before the start of eye surgery. For certain eye conditions: Adults and teenagers—Depending on the eye condition being treated, your doctor may tell you to use one drop of 2.5 or 10% solution in the eye from once a day to three times a day. Children—Depending on the eye condition being treated, your doctor may tell you to use one drop of 2.5% solution in the eye from once a day to three times a day.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

For non-prescription strength eye drops, follow the package directions.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.