Pronunciation:

hye-drox-ee-am-FET-a-meen hye-droe-BROE-mide, troe-PIK-a-mide

Brand Names:

• Paremyd

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Mydriatic-Cycloplegic

Pharmacologic—

Antimuscarinic

Chemical—

Hydroxyamphetamine

Uses of This Medicine:

Hydroxyamphetamine and Tropicamideis medicine that is put into your eye to make your pupil larger. It also reduces your body's ability to adjust your eye for near vision. These drops are used when you have your eyes examined by the eye doctor.

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

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—

Infants and young children may be especially sensitive to the effects of hydroxyamphetamine and tropicamide. This may increase the chance or severity of some of the side effects during treatment.

Older adults—

This medicine has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults.

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 taking 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.

• Potassium Citrate

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
• Buprenorphine
• Bupropion
• Clozapine
• Codeine
• Donepezil
• Glucagon
• Glycopyrrolate
• Glycopyrronium Tosylate
• Methacholine
• Oxycodone
• Quetiapine
• Revefenacin
• Scopolamine
• Secretin Human
• Tapentadol
• Tiotropium

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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

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:

• Glaucoma—Using this medicine may make this condition worse.

Proper Use of This Medicine:

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.

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. This is especially important in infants.
• Immediately after using the eye drops, wash your hands to remove any medicine that may be on the hand to keep the medicine applicator tip as germ-free as possible. If you are using the eye drops for an infant or child, be sure to wash the infant's or child's hands also, and do not let any of the medicine get in the infant's or child's mouth.
• 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 ophthalmic dosage form (drops):
  • For dilating your eye before an eye exam:
    • Adults—1–2 drops 15 minutes before the exam.
    • Children—Use and dose must be determined by your doctor.

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.

Precautions While Using This Medicine:

After this medicine is put into your eyes:

• Your pupils will become unusually large and you will have blurring of vision, especially for things that are close to you. Make sure your vision is clear before you drive, use machines, or do anything else that could be dangerous if you are not able to see well.
• Your eyes will become more sensitive to light than they are normally. When you go out during the daylight hours, even on cloudy days, wear sunglasses to protect your eyes from sunlight and other bright lights . If you have any questions about the kind of sunglasses to wear, check with your doctor.
• If these effects continue for longer than 24 hours after the medicine is used, check with your doctor.

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 immediately if any of the following side effects occur:

Rare

Blurred vision

chest pain or discomfort

confusion

dizziness

faintness or lightheadedness when getting up from a lying or sitting position

fast, slow, or irregular heartbeat

nausea

pain or discomfort in arms, jaw, back or neck

shortness of breath

sudden sweating

unusual tiredness or weakness

Frequency of side effects not known

Agitation

anxiety

cold, clammy, pale skin

cough

difficulty swallowing

eye pain

failure to recognize people

hives

irritability

itching

hyperactivity or restlessness

loss of consciousness

loss of vision

mood or mental changes

nervousness

nightmares

pounding heartbeat or pulse

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

seeing, hearing, or feeling things that are not there

skin rash

tightness in chest

tremor

unusual behavior such as disorientation to time or place

unusual feeling of excitement

wheezing

Symptoms of Overdose

Get emergency help immediately if any of the following symptoms of overdose occur:

Bloating

blurred vision

chest pain or discomfort

diarrhea

dizziness

enlarged pupils

fainting

fast, slow, or irregular heartbeat

gas

headache

heartburn

indigestion

lightheadedness

loss of appetite

nausea

nervousness

pounding in the ears

pounding or rapid pulse

stomach pain

sweating

vomiting

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:

Frequency of side effects not known

Change in color vision

difficulty seeing at night

dry mouth

headache

increased sensitivity of eyes to sunlight

muscle stiffness or tightness

temporary stinging in the eyes

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.