Hydroxyamphetamine and tropicamide (Ophthalmic)

Hydroxyamphetamine and tropicamide is a 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.

After this medicine is put into your eyes:

• Your pupils will become unusually large and you will have blurred 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 daytime, 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 last longer than 24 hours after using the medicine, check with your doctor.

In deciding to use a medicine, you and your doctor must consider the risks and benefits. For this medicine, please keep the following in mind:

Allergies

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

Pediatric

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

Geriatric

This medicine has been tested and has not shown different side effects or issues in older adults compared to younger adults.

Interactions with Medicines

Some medicines should not be used together at all, while others can be used together even if there might be an interaction. In these cases, your doctor may want to adjust the dose, or take other precautions. It is especially important for your healthcare professional to know if you are taking any of the medicines listed below when you are using this medicine. The following interactions have been chosen based on their potential significance and may not include all possibilities.

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 necessary in some cases. If both medicines are prescribed together, your doctor may adjust the dose or frequency of one or both medicines.

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

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken around the time of eating food or certain types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect how this medicine works. Make sure to inform your doctor if you have any other medical issues, especially:

• Glaucoma—Using this medicine may worsen this condition.

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 require medical attention.

Check with your doctor right away 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 happen that usually do not require medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your health care professional may also be able to tell you how to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue, 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 health care 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.

• Paremyd

Available Dosage Forms:

• Solution

Therapeutic Class: Mydriatic-Cycloplegic

Pharmacologic Class: Antimuscarinic

Chemical Class: Hydroxyamphetamine

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.