Mydral Ophthalmic

This medication is used to widen (dilate) the pupil of the eye in preparation for certain eye examinations. It belongs to a class of drugs known as anticholinergics. Tropicamide works by relaxing certain eye muscles.

How to use Mydral Drops

To apply eye drops, wash your hands first. To avoid contamination, do not touch the dropper tip or let it touch your eye or any other surface.

If you are wearing contact lenses, remove them before using this medication. Ask your doctor when you may replace your contact lenses.

Tilt your head back, look upward, and pull down the lower eyelid to make a pouch. Hold the dropper directly over your eye and place 1 or 2 drops into the pouch, usually 15 to 20 minutes before an eye examination or as directed by your doctor. Look downward and gently close your eyes for 1 to 2 minutes. Place one finger at the corner of your eye (near the nose) and apply gentle pressure for 2 to 3 minutes. This will prevent the medication from draining out and being absorbed by your body. Try not to blink and do not rub your eye. Repeat these steps for your other eye if so directed.

Do not rinse the dropper. Replace the dropper cap after each use.

If you are using another kind of eye medication (e.g., drops or ointments), wait at least 5 to 10 minutes before applying other medications. Use eye drops before eye ointments to allow the drops to enter the eye.

Wash your hands after using this medication. If giving this medication to a child, do not let the medication get into the child's mouth. Also wash the child's hands after giving this medication.

Eye stinging, temporary blurred vision, dry mouth, or eye sensitivity to light may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if any of these unlikely but serious side effects occur: feeling as if something is in the eye, fast heartbeat, muscle stiffness, mental/mood changes.

Get medical help right away if you have any very serious side effects, including: eye pain/swelling/redness, vision changes (such as seeing rainbows around lights at night).

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using tropicamide, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: personal or family history of glaucoma (angle-closure type), high blood pressure, overactive thyroid (hyperthyroidism), diabetes, heart disease (e.g., irregular heart rhythm, coronary artery disease), Down's syndrome, brain damage or spastic paralysis (in children).

After you apply this drug, your vision may become temporarily blurred. Do not drive, use machinery, or do any activity that requires clear vision until you are sure you can perform such activities safely.

This medication may make your eyes more sensitive to light. Protect your eyes in bright light. Use dark sunglasses when outdoors.

Caution is advised when using this drug in the elderly because they may be more sensitive to the effects of the drug, especially mental/mood changes (e.g., agitation).

Caution is advised when using this drug in children because they may be more sensitive to the effects of the drug, especially mental/mood changes (e.g., agitation).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

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

No dosage adjustment is recommended.

Administration advice:
-For topical use only, not for injection
-Contact lenses should be removed before use.
-Wash hands after administration to avoid accidental ingestion.
-Systemic absorption may be minimized by applying pressure to the lacrimal duct for 1 minute after instillation.

Storage requirements:
Store at 8C to 27C (46F to 80F); do not refrigerate; protect from light; keep container tightly closed.

General:
-Patients with heavily pigmented irides may require higher strength or more doses.
-Complete recovery from mydriasis may take up to 24 hours.

Patient advice:
-Patients should be advised to apply pressure to the lacrimal sac for 1 to 3 minutes after instillation, to minimize systemic absorption (especially in children).
-Parents should be warned about oral toxicity with accidental ingestion, and advised to wash their hands and the child's hands after use.
-Patients should be advised to protect eyes from bright light during dilation.
-Patients should be advised not to drive or perform potentially hazardous activities while pupils are dilated.

Summary of Use during Lactation

No information is available on the use of tropicamide during breastfeeding. Anticholinergic drugs might interfere with breastfeeding. A single dose of ophthalmic tropicamide is not likely to interfere with breastfeeding; however, during long-term use, observe the infant for signs of decreased lactation (e.g., insatiety, poor weight gain). To substantially diminish the amount of drug that reaches the breastmilk after using eye drops, place pressure over the tear duct by the corner of the eye for 1 minute or more, then remove the excess solution with an absorbent tissue.

Drug Levels

Maternal Levels. Relevant published information was not found as of the revision date.

Infant Levels. Relevant published information was not found as of the revision date.

Effects in Breastfed Infants

Relevant published information was not found as of the revision date.

Effects on Lactation and Breastmilk

Relevant published information in nursing mothers was not found as of the revision date. Anticholinergics can inhibit lactation in animals apparently by inhibiting growth hormone and oxytocin secretion.[1][2][3][4][5] Anticholinergic drugs can also reduce serum prolactin in nonnursing women.[6] The prolactin level in a mother with established lactation may not affect her ability to breastfeed.

References

1. Aaron DK, Ely DG, Deweese WP et al. Reducing milk production in ewes at weaning using restricted feeding and methscopolamine bromide. J Anim Sci. 1997;75:1434-42. PMID: 9250502

2. Powell MR, Keisler DH. A potential strategy for decreasing milk production in the ewe at weaning using a growth hormone release blocker. J Anim Sci. 1995;73:1901-5. PMID: 7592071

3. Daniel JA, Thomas MG, Powell MR, Keisler DH. Methscopolamine bromide blocks hypothalmic-stimulated release of growth hormone in ewes. J Anim Sci. 1997;75:1359-62. PMID: 9159285

4. Bizzarro A, Iannucci F, Tolino A et al. Inhibiting effect of atropine on prolactin blood levels after stimulation with TRH. Clin Exp Obstet Gynecol. 1980;7:108-11. PMID: 6788407

5. Svennersten K, Nelson L, Juvnas-Moberg K. Atropinization decreases oxytocin secretion in dairy cows. Acta Physiol Scand. 1992;145:193-4. PMID: 1636447

6. Masala A, Alagna S, Devilla L et al. Muscarinic receptor blockade by pirenzepine: effect on prolactin secretion in man. J Endocrinol Invest. 1982;5:53-5. PMID: 6808052

Substance Name

Tropicamide

CAS Registry Number

1508-75-4

Drug Class

Mydriatics

Muscarinic Antagonists

Parasympatholytics