Phentolamine (Ophthalmic)

Phentolamine eye drops are used to treat mydriasis (a dilated or enlarged pupil of the eye) caused by specific medicines (for example, phenylephrine or tropicamide).

This medicine is available only with your doctor's prescription.

It is very important that your doctor checks your progress at regular visits to ensure this medicine is working properly and to look for any unwanted effects.

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

Allergies

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

Pediatric

Studies to date have not shown any specific problems in children 3 years of age and older that would limit the use of phentolamine eye drops. Safety and effectiveness have been confirmed.

Geriatric

Studies to date have not shown any specific problems in older adults that would limit the use of phentolamine eye drops.

Breast Feeding

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

Interactions with Medicines

Some medicines should not be used together, while others may be used together even if an interaction might happen. In these cases, your doctor may want to adjust the dose, or other precautions may be needed. When taking this medicine, it is very important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions have been selected based on their potential importance and are not necessarily all-inclusive.

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

• Alfuzosin
• Asenapine
• Melphalan
• Silodosin
• Tadalafil
• Tamsulosin
• Vardenafil

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 how often you use one or both of the medicines.

• Acebutolol
• Alprenolol
• Atenolol
• Betaxolol
• Bevantolol
• Bisoprolol
• Bucindolol
• Carteolol
• Carvedilol
• Celiprolol
• Dilevalol
• Esmolol
• Labetalol
• Levobunolol
• Mepindolol
• Metipranolol
• Metoprolol
• Nadolol
• Nebivolol
• Oxprenolol
• Penbutolol
• Pindolol
• Propranolol
• Sotalol
• Talinolol
• Tertatolol
• Timolol

Interactions with Food/Tobacco/Alcohol

Some medicines should not be used at or around the time of eating food or certain types of food due to potential interactions. Using alcohol or tobacco with certain medicines may also cause interactions. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect the use of this medicine. Be sure to tell your doctor if you have any other medical issues, especially:

• Eye problems (e.g., iritis, uveitis), active—Use is not recommended in patients with these conditions.

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

Check with your doctor immediately if any of the following side effects occur:

More common

• Redness of the white part of the eyes or inside of the eyelids

Some side effects may happen 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

• Burning, discomfort, pain, or stinging where the medicine is applied
• Change or loss of taste

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.

• Ryzumvi

Pharmacologic Class: Alpha-Adrenergic Blocker

Your eye doctor will tell you how much of this medicine to use and how often. Do not use more medicine or use it more often than your doctor tells you to.

To use the eye drops:

• 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 1 or 2 minutes to allow the medicine to be absorbed by the eye.
• Immediately after using the medicine, 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. Serious damage to the eye and possible loss of vision may result from using contaminated eye drops.

If you are wearing contact lenses, remove them before you use the eye drops. Wait for at least 10 minutes before putting the contact lenses back in.

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 dosage form (eye drops):For mydriasis: Adults and children 12 years of age and older—One or 2 drops in the affected eye(s) after the eye examination or procedure. If 2 drops are needed, the second drop should be given 5 minutes after the first drop. Children 3 to 11 years of age—One drop in the affected eye(s) after the eye examination or procedure. Children younger than 3 years of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, apply 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.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store in the refrigerator. Do not freeze.

You may store the opened medicine at room temperature for up to 14 days.