Atropin-Care

For all patients taking Atropin-Care (atropine eye drops):

• If you have an allergy to atropine or any other part of this medicine.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have glaucoma.

Children:

• If your child has had a bad reaction to Atropin-Care in the past.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Atropin-Care with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

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.
• Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
• A fast heartbeat.
• A heartbeat that does not feel normal.
• Flushing.
• Restlessness.
• Feeling irritable.
• Dry mouth.
• Dry skin.
• Change in eyesight, eye pain, or very bad eye irritation.

• Store at room temperature.
• Protect from heat.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

Applies to atropine ophthalmic: ophthalmic ointment, ophthalmic solution

Along with its needed effects, atropine ophthalmic (the active ingredient contained in Atropine-Care) 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

Eye drops:
3 months to 3 years:
-Instill 1 drop into the eye(s) 40 minutes prior to intended maximal dilation
Maximum dose: 1 drop per eye per day

3 years or older:
-Instill 1 drop into eye(s) 40 minutes prior to intended maximal dilation
Maximum dose: 1 drop in each eye twice a day

Ointment:
-Instill a small amount into the conjunctival sac once or twice a day.

Comments:
-Systemic absorption can be minimized by applying pressure to the lacrimal duct for 2 to 3 minutes after instillation.

Use: For pupillary dilation desired in inflammatory conditions of the iris and uveal tract.

No adjustment recommended

This drug should be used during pregnancy only if the benefit outweighs the risk AU TGA pregnancy category: A US FDA pregnancy category: C

Animal studies have not been conducted. There are no adequate controlled data in human pregnancy. AU TGA pregnancy category A: Drugs which have been taken by a large number of pregnant women and women of childbearing age without any proven increase in the frequency of malformations or other direct or indirect harmful effects on the fetus having been observed. US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Following IV administration, trace amounts of this drug have been found in human breast milk. Because some systemic absorption can be expected from eye drop use, the breastfed infant may experience dry skin, fever, or rapid pulse. A single use of this drug is not likely to interfere with breastfeeding. Long-term use may inhibit lactation, producing signs in the nursing infant (e.g., slow weight gain, insatiety). The American Academy of Pediatrics considers atropine to be compatible with breast-feeding.

Benefit to mother should outweigh risk to the infant Excreted into human milk: Yes Comment: Placing pressure over the tear duct for at least 1 minute during and after instillation can minimize systemic absorption.