Tropicamide

Tropicamide may be found in some form under the following brand names:

• Mydral

• Mydriacyl

• Ocu-Tropic

• Opticyl

• Paremyd

• Tropicacyl

Serious side effects have been reported with tropicamide. See the “Tropicamide Precautions” section.

Common side effects of tropicamide include the following:

• increased pressure in the eye
• burning in the eye
• sensitivity to light
• blurred vision
• eye irritation
• redness of the eye and/or eye lashes
• dry mouth
• increased heart rate
• headache
• nausea
• vomiting

This is not a complete list of tropicamide side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

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

If you take too much tropicamide, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If tropicamide is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

Storage

Ophthalmic

Tightly closed containers at 8–27°C.101 Avoid excessive heat.101 Do not refrigerate.101

Tropicamide/hydroxyamphetamine: 20–25°C.102 Protect from light.102

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

• It is used before an eye exam.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Eye pain.
• A fast heartbeat.
• A heartbeat that does not feel normal.
• Shortness of breath.
• Mood changes.
• Change in the way you act.
• Pale skin.
• Muscle stiffness.

Contraindicated in persons showing hypersensitivity to any component of this preparation.

Tropicamide Ophthalmic Solution, USP 1% is supplied in a plastic bottle with a red cap and a controlled drop tip in the following sizes:
2 mL - NDC 24208-585-59
15 mL - NDC 24208-585-64

Tropicamide Ophthalmic Solution, USP 0.5% is supplied in a plastic bottle with a red cap and a controlled drop tip in the following size:
15 mL - NDC 24208-590-64

Storage: Store at 20° to 25C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F)
[See USP Controlled Room Temperature].
Keep container tightly closed.

DO NOT USE IF IMPRINTED "Protective Seal" WITH YELLOW IS NOT INTACT.

KEEP OUT OF REACH OF CHILDREN.

Revised: July 2016

Bausch + Lomb, a division of
Valeant Pharmaceuticals North America LLC
Bridgewater, NJ 08807 USA

©Bausch & Lomb Incorporated

9115805 (folded)

9115905 (flat)

NDC 24208-590-64

Tropicamide
Ophthalmic
Solution, USP
0.5% (Sterile)

FOR TOPICAL
OPHTHALMIC
USE ONLY

Rx only

15 mL

BAUSCH + LOMB

Applies to tropicamide ophthalmic: compounding powder, ophthalmic solution

General

Side effects reported with this drug have included transient stinging, blurred vision, photophobia and superficial punctate keratitis. Some patients have experienced prolonged mydriasis.[Ref]

Ocular

Frequency not reported: Headache, drowsiness, somnolence, fatigue, trouble concentrating, central nervous system disturbances, dysphonia
Postmarketing reports: Dizziness[Ref]

Psychiatric

Frequency not reported: Psychotic reaction, behavioral disturbance[Ref]

Behavioral disturbances or psychotic reactions may be more common in children.[Ref]

Nervous system

Frequency not reported: Headache, drowsiness, somnolence, fatigue, trouble concentrating, central nervous system disturbances, dysphonia
Postmarketing reports: Dizziness[Ref]

Cardiovascular

Transient bradycardia followed by tachycardia with palpitations and arrhythmias have been reported.[Ref]

Frequency not reported: Tachycardia, bradycardia, arrhythmias, palpitations
Postmarketing reports: Hypotension, syncope[Ref]

Hypersensitivity

Frequency not reported: Allergic reaction, anaphylaxis[Ref]

Gastrointestinal

Frequency not reported: Dry mouth, thirst, dysphagia, nausea, vomiting, constipation[Ref]

Respiratory

Frequency not reported: Rhinitis, reduced bronchial secretions, bronchospasm
Postmarketing reports: Dryness of mucous membranes[Ref]

Genitourinary

Frequency not reported: Urinary retention, difficult micturition[Ref]

Dermatologic

Frequency not reported: Erythematous rash, pruritus, pallor, flushing, increased sweating, dry skin[Ref]

Musculoskeletal

Frequency not reported: Muscle rigidity[Ref]

Some side effects of tropicamide ophthalmic may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.