Isopto Atropine

• Alcon Laboratories, Inc.

• Alcon Laboratories, Ophthalmic Div.

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Wash your hands before using eye medication.

To apply the eye drops:

• Tilt your head back slightly and pull down your lower eyelid to create a small pocket. Hold the dropper above the eye with the tip down. Look up and away from the dropper and squeeze out a drop.

• Close your eyes for 2 or 3 minutes with your head tipped down, without blinking or squinting. Gently press your finger to the inside corner of the eye for about 1 minute, to keep the liquid from draining into your tear duct.

• Use only the number of drops your doctor has prescribed. If you use more than one drop, wait about 5 minutes between drops.

• Wait at least 10 minutes before using any other eye drops your doctor has prescribed.

Do not use the eye drops if the liquid has changed colors or has particles in it. Call your pharmacist for new medicine.

To apply the ointment:

• Tilt your head back slightly and pull down your lower eyelid to create a small pocket. Hold the ointment tube with the tip pointing toward this pocket. Look up and away from the tip.

• Squeeze out a ribbon of ointment into the lower eyelid pocket without touching the tip of the tube to your eye. Blink your eye gently and then keep it closed for 1 or 2 minutes.

• Use a tissue to wipe excess ointment from your eyelashes.

• After opening your eyes, you may have blurred vision for a short time. Avoid driving or doing anything that requires you to be able to see clearly.

Do not touch the tip of the eye dropper or ointment tube or place it directly on your eye. A contaminated dropper or tube tip can infect your eye, which could lead to serious vision problems.

Store at room temperature away from moisture and heat. Do not freeze. Keep the bottle or tube tightly closed when not in use.

Apply the missed dose as soon as you remember. However, if it is almost time for your next regularly scheduled dose, skip the missed dose and apply the next one as directed. Do not use a double dose of this medication.

Do not use atropine eye drops while wearing contact lenses. The medicine may contain a preservative that can discolor soft contact lenses. Wait at least 15 minutes after using the eye drops before putting in your contact lenses.

Atropine ophthalmic may make your eyes more sensitive to light. Wear sunglasses to protect your eyes whenever you are outdoors or in bright light.

Do not use other eye medications unless your doctor tells you to.

Tell your doctor about all your current medicines and any you start or stop using, especially:

• an MAO inhibitor--isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.

Although it is not likely that other drugs you take orally or inject will have an effect on atropine used in the eyes, many drugs can interact with each other. Tell each of your healthcare providers about all medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

In the U.S.

• AK-Dilate
• AK-Pentolate
• Altafrin
• Atropine Care
• Cyclogyl
• Cyclomydril
• Eye Cool
• Homatropaire
• Isopto Atropine
• Isopto Homatropine
• Isopto Hyoscine
• Mydfrin
• Mydral
• Mydriacyl
• Neofrin
• Neo-Synephrine
• Omidria
• Paremyd

In Canada

• Ak-Dilate
• Ak-Pentolate
• Atropine
• Atropine-Ak
• Atropine Eye Ointment
• Atropine Ointment
• Atropisol
• Minims Phenylephrine Hydrochloride

Available Dosage Forms:

• Ointment
• Solution

Ophthalmic atropine, homatropine, and scopolamine are used to dilate (enlarge) the pupil of the eye. They are used before eye examinations, before and after eye surgery, and to treat certain eye conditions, such as uveitis or posterior synechiae.

These medicines are available only with your doctor's prescription.

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group 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.

Pediatric

Infants and young children and children with blond hair or blue eyes may be especially sensitive to the effects of atropine, homatropine, or scopolamine. This may increase the chance of side effects during treatment . Children should use a lower strength of this medicine.

Geriatric

Elderly people are especially sensitive to the effects of atropine, homatropine, or scopolamine. This may increase the chance of side effects during treatment.

Pregnancy

Studies on effects in pregnancy have not been done in either humans or animals. However, these medicines may be absorbed into the body.

Breast Feeding

These medicines may be absorbed into the body. Atropine passes into the breast milk in very small amounts and may cause side effects, such as fast pulse, fever, or dry skin, in babies of nursing mothers using ophthalmic atropine. It is not known whether homatropine or scopolamine passes into breast milk. Although most medicines pass into breast milk in small amounts, many of them may be used safely while breast-feeding. Mothers who are using one of these medicines and who wish to breast-feed should discuss this with their doctor.

Interactions with 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 any of these medicines, 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 medicines in this class with any of the following medicines is not recommended. Your doctor may decide not to treat you with a medication in this class or change some of the other medicines you take.

• Aceclofenac
• Acemetacin
• Amtolmetin Guacil
• Aspirin
• Bromfenac
• Bufexamac
• Celecoxib
• Choline Salicylate
• Clonixin
• Clorgyline
• Dexibuprofen
• Dexketoprofen
• Diclofenac
• Diflunisal
• Dipyrone
• Droxicam
• Etodolac
• Etofenamate
• Etoricoxib
• Felbinac
• Fenoprofen
• Fepradinol
• Feprazone
• Floctafenine
• Flufenamic Acid
• Flurbiprofen
• Ibuprofen
• Indomethacin
• Iproniazid
• Isocarboxazid
• Ketoprofen
• Linezolid
• Lornoxicam
• Loxoprofen
• Lumiracoxib
• Meclofenamate
• Mefenamic Acid
• Meloxicam
• Morniflumate
• Nabumetone
• Naproxen
• Nepafenac
• Nialamide
• Niflumic Acid
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Oxaprozin
• Oxyphenbutazone
• Parecoxib
• Pentoxifylline
• Phenelzine
• Phenylbutazone
• Piketoprofen
• Piroxicam
• Probenecid
• Procarbazine
• Proglumetacin
• Propyphenazone
• Proquazone
• Rasagiline
• Rofecoxib
• Salicylic Acid
• Salsalate
• Selegiline
• Sodium Salicylate
• Sulfasalazine
• Sulindac
• Tenoxicam
• Tiaprofenic Acid
• Tolfenamic Acid
• Tolmetin
• Tranylcypromine
• Valdecoxib

Using medicines in this class 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.

• Abciximab
• Acenocoumarol
• Amiloride
• Amineptine
• Amitriptyline
• Amitriptylinoxide
• Amoxapine
• Anagrelide
• Apixaban
• Ardeparin
• Argatroban
• Bemiparin
• Bendroflumethiazide
• Benzthiazide
• Betamethasone
• Betrixaban
• Bivalirudin
• Budesonide
• Bumetanide
• Bupropion
• Cangrelor
• Certoparin
• Chlorothiazide
• Chlorthalidone
• Cilostazol
• Citalopram
• Clomipramine
• Clopamide
• Clopidogrel
• Cortisone
• Cyclopenthiazide
• Cyclosporine
• Dabigatran Etexilate
• Dalteparin
• Danaparoid
• Deflazacort
• Desipramine
• Desirudin
• Desmopressin
• Desvenlafaxine
• Dexamethasone
• Diazoxide
• Dibenzepin
• Digoxin
• Dipyridamole
• Donepezil
• Dothiepin
• Doxepin
• Duloxetine
• Edoxaban
• Enoxaparin
• Eplerenone
• Epoprostenol
• Eptifibatide
• Escitalopram
• Ethacrynic Acid
• Feverfew
• Fluocortolone
• Fluoxetine
• Fluvoxamine
• Fondaparinux
• Furazolidone
• Furosemide
• Ginkgo
• Gossypol
• Heparin
• Hydrochlorothiazide
• Hydrocortisone
• Hydroflumethiazide
• Iloprost
• Imipramine
• Indapamide
• Iobenguane I 123
• Lepirudin
• Levomilnacipran
• Lithium
• Lofepramine
• Meadowsweet
• Melitracen
• Methotrexate
• Methyclothiazide
• Methylprednisolone
• Metolazone
• Midodrine
• Milnacipran
• Nadroparin
• Nefazodone
• Nortriptyline
• Opipramol
• Paramethasone
• Pargyline
• Parnaparin
• Paroxetine
• Pemetrexed
• Pentosan Polysulfate Sodium
• Phenindione
• Phenprocoumon
• Polythiazide
• Pralatrexate
• Prasugrel
• Prednisolone
• Prednisone
• Protein C
• Protriptyline
• Reboxetine
• Reviparin
• Rivaroxaban
• Sertraline
• Sibutramine
• Spironolactone
• Tacrolimus
• Tianeptine
• Ticagrelor
• Ticlopidine
• Tinzaparin
• Tiotropium
• Tirofiban
• Torsemide
• Treprostinil
• Triamterene
• Trichlormethiazide
• Trimipramine
• Venlafaxine
• Vilazodone
• Vorapaxar
• Vortioxetine
• Warfarin
• Xipamide

Interactions with Food/Tobacco/Alcohol

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 medicines in this class. Make sure you tell your doctor if you have any other medical problems, especially:

• Brain damage (in children) or
• Down's syndrome (mongolism) (in children and adults) or
• Glaucoma or
• Other eye diseases or problems or
• Spastic paralysis (in children)—Use of ophthalmic atropine, homatropine, or scopolamine may make the condition worse.

Applies to atropine ophthalmic: ophthalmic ointment, ophthalmic solution

Along with its needed effects, atropine ophthalmic (the active ingredient contained in Isopto Atropine) 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 while taking atropine ophthalmic:

• Blurred vision
• change in color vision
• difficulty seeing at night
• eye pain or stinging
• fast, pounding, or irregular heartbeat or pulse
• increased sensitivity of the eyes to sunlight

Some side effects of atropine ophthalmic 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:

• Confusion as to time, place, or person
• decreased tearing of the eyes
• drowsiness
• dry skin, mouth, or throat
• feeling of warmth
• hallucinations
• holding false beliefs that cannot be changed by fact
• irritability
• redness of the clear part of the eye
• redness of the face, neck, arms, and occasionally, upper chest
• unusual excitement, nervousness, or restlessness

Applies to atropine ophthalmic: ophthalmic ointment, ophthalmic solution

General

The most commonly occurring side effects include blurred vision, photophobia, eye pain and stinging, decreased lacrimation. Systemic effects are more common in infants and elderly.[Ref]

Cardiovascular

Severe reaction to the ointment may include hypotension.[Ref]

Frequency not reported: Transient bradycardia followed by tachycardia, palpitations, and arrhythmia[Ref]

Nervous system

Frequency not reported: Ataxia, restlessness, excitement, irritability, hyperactivity, somnolence, confusion, delirium, hallucinations[Ref]

Ocular

Common (1% to 10%): Eye pain, stinging, blurred vision, photophobia, decreased lacrimation
Frequency not reported: Superficial keratitis (with prolonged use), conjunctivitis, hyperemia, edema[Ref]

Gastrointestinal

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

Hypersensitivity

Frequency not reported: Contact dermatitis, allergic conjunctivitis, eyelid edema[Ref]

Respiratory

Severe reaction to the ointment may include hypotension with progressive respiratory depression. Coma and death have been reported in very young children.[Ref]

Frequency not reported: Decreased bronchial secretions with dry throat and difficulty talking[Ref]

Dermatologic

Frequency not reported: Dry skin, flushing, rash[Ref]

Genitourinary

Frequency not reported: Urinary retention, urinary urgency

Local

Frequency not reported: Local irritation (with prolonged use)

Psychiatric

Frequency not reported: Confusion, delirium, hallucinations

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