Pronunciation:

troe-PIK-a-mide, fen-il-EF-rin hye-droe-KLOR-ide

Brand Names:

• Mydcombi
• Phenyltrope

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Mydriatic-Cycloplegic

Pharmacologic—

Antimuscarinic

Chemical—

Phenylephrine

Uses of This Medicine:

Tropicamide and phenylephrine combination eye spray is used to dilate (enlarge) the pupil of the eye during certain medical procedures.

This medicine is to be given only by or under the direct supervision of your doctor.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional 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.

Children—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of tropicamide and phenylephrine combination eye spray in children younger than 1 year of age. However, this medicine may cause mood or mental changes and lung, heart, or blood vessel problems which may require caution in children.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of tropicamide and phenylephrine combination eye spray in the elderly.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of 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 take.

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

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Amantadine
• Amifampridine
• Amphetamine
• Buprenorphine
• Bupropion
• Clozapine
• Codeine
• Dextroamphetamine
• Donepezil
• Ergonovine
• Furazolidone
• Glucagon
• Glycopyrrolate
• Glycopyrronium Tosylate
• Iobenguane I 123
• Iobenguane I 131
• LetibotulinumtoxinA-wlbg
• Lisdexamfetamine
• Methacholine
• Methylergonovine
• Midodrine
• Oliceridine
• Oxycodone
• Pargyline
• Quetiapine
• Revefenacin
• Scopolamine
• Secretin Human
• Sufentanil
• Tapentadol
• Tiotropium
• Tramadol
• Zavegepant

Using this medicine with any of the following medicines may cause an increased 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.

• Guanethidine

Other interactions—

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

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Heart or blood vessel disease or
• Hyperthyroidism (overactive thyroid)—Use with caution. May make these conditions worse.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine in a medical facility. It is given by spraying into your eye. Your doctor will give another spray after 5 minutes.

If you are wearing contact lenses, remove them at least 10 minutes before you receive the eye spray.

Do not use other eye products (eg, artificial tears) within 10 minutes of receiving this medicine.

Precautions While Using This Medicine:

It is very important that your doctor check your or your child's progress closely while you are receiving this medicine. This is to make sure that the medicine is working properly and that the infection is cleared up completely. Blood tests may be needed to check for unwanted effects.

Check with your doctor right away if you have mood or mental changes or unusual behavior, including disorientation to time or place, failure to recognize people, hyperactivity, or restlessness.

Check with your doctor right away if you have blurred vision, change in vision, or loss of vision. These maybe symptoms of increased pressure in the eye.

This medicine may cause rebound miosis (narrowing of the pupils) a day after receiving this medicine. Talk to your doctor about this concern.

This medicine may cause blurred vision. Do not drive or do anything else that could be dangerous after receiving this medicine until you know how this medicine affects you.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

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

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

Incidence not known

Blurred vision

change in color vision

chest pain or discomfort

cold, clammy, pale skin

difficulty seeing at night

dizziness

eye discomfort

increased sensitivity of the eyes to sunlight

irregular heartbeat

loss of vision

mood or mental changes

muscle stiffness or tightness

painful irritation of the clear front part of the eye

slow heart rate

trouble breathing

unusual behavior, such as disorientation to time or place, failure to recognize people, hyperactivity, or restlessness

weakness

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:

Incidence not known

Dry mouth

headache

nausea

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.