Tropicamide-Phenylephrine Ophthalmic

Tropicamide-Phenylephrine Ophthalmic spray is a combination medication used to induce mydriasis for diagnostic procedures and in conditions where short-term pupil dilation is required.

• Tropicamide-Phenylephrine Ophthalmic is available under the following different brand names: MydCombi.

Common side effects of Tropicamide-Phenylephrine Ophthalmic include:

• headache
• dizziness
• blurred vision
• photophobia (sensitivity to light)
• eye pain
• eye irritation
• burning or stinging sensation in the eye
• skin rash
• hypotension (low blood pressure)
• nausea (feeling sick)

Serious side effects of Tropicamide-Phenylephrine Ophthalmic include:

• clumsiness or unsteadiness
• fast heartbeats
• flushing or redness of the face
• hallucinations (seeing, hearing, or feeling things that are not there)
• increased thirst or dryness of the mouth
• skin rash
• slurred speech
• swollen stomach in infants

Rare side effects of Tropicamide-Phenylephrine Ophthalmic include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, light-headedness, or passing out

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Ophthalmic spray

• 1%/2.5%
• Each metered spray delivers 0.008 mL (0.08 mg/0.2 mg)
• 2-mL vial enclosed in a dispenser cartridge for use with the device

Mydriasis for ophthalmic exam

Adult dosage

• Administer 1 metered spray to the cornea of each eye to be dilated; repeat after 5 minutes.

Pediatric dosage

• Children aged 1 year and above: Administer 1 metered spray to the cornea of each eye to be dilated; repeat after 5 minutes.
• Children aged below 1 year
• Administer 1 metered spray to the cornea of each eye to be dilated; repeat after 5 minutes.
• Not to exceed 3 sprays/eye per day
• 2-mL vial enclosed in a dispenser cartridge for use with a device

Dosage Considerations – Should be Given as Follows:

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, healthcare provider, or pharmacist first.

• Tropicamide-Phenylephrine Ophthalmic has severe interactions with no other drugs.
• Tropicamide-Phenylephrine Ophthalmic has serious interactions with the following drugs:
  • glucagon
  • glucagon intranasal
  • macimorelin
• Tropicamide-Phenylephrine Ophthalmic has moderate interactions with the following drugs:
  • amitriptyline
  • amoxapine
  • clomipramine
  • desipramine
  • doxepin
  • imipramine
  • isocarboxazid
  • linezolid
  • lofepramine
  • maprotiline
  • nortriptyline
  • phenelzine
  • procarbazine
  • protriptyline
  • tranylcypromine
  • trazodone
  • trimipramine
• Tropicamide/phenylephrine ophthalmic has minor interactions with no other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• known hypersensitivity

Effects of drug abuse

• none

Short-Term Effects

• See “What Are Side Effects Associated with Using Tropicamide/Phenylephrine Ophthalmic?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Tropicamide/Phenylephrine Ophthalmic?”

Cautions

• For ophthalmic use only (not indicated for injection)
• Blood pressure elevation may occur; caution in children younger than 5 years and patients with hyperthyroidism or cardiovascular disease; monitor the post-treatment blood pressure of patients with cardiac and endocrine diseases and any patients who develop symptoms
• CNS disturbances associated with Tropicamide may be dangerous in pediatric patients; consider the possibility of psychotic reactions and behavioral disturbances due to hypersensitivity to anticholinergics
• Mydriatics may transiently elevate intraocular pressure
• Rebound miosis was reported 1 day after administering the drug; readministration produced a lesser mydriatic effect
• Drug interaction overview
  • Agents that may exaggerate vasopressor responses
    • Caution, monitor
• Phenylephrine may enhance the vasopressor effects of Atropine-like drugs and induce tachycardia in some patients
• Cholinergic agonists and ophthalmic cholinesterase inhibitors
  • Caution, monitor
• Tropicamide may interfere with the antihypertensive action of Carbachol, Pilocarpine, or ophthalmic cholinesterase inhibitors
• Potent inhalation anesthetic agents
  • Caution, monitor
• Phenylephrine may potentiate the cardiovascular depressant effects of some inhalation anesthetic agents

Pregnancy and Lactation

• There are no available data regarding the drug’s use in pregnant women or animals to inform any drug-associated risks
• Lactation
  • Data are unavailable regarding the presence of the drug in human milk, its effects on breastfed infants, or milk production