Atropine Ophthalmic

What is Atropine Ophthalmic?

• Atropine Ophthalmic (Atropine Care 1%; Atropisol; Isopto Atropine; Ocu-Tropine) is an anti-muscarinic agent used before eye examinations to dilate the pupil.
• It is also used to relieve pain caused by swelling and inflammation of the eye.

Atropine

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What are the uses of this medicine?

Atropine Ophthalmic (Atropine Care 1%; Atropisol; Isopto Atropine; Ocu-Tropine) is used for:

• cycloplegia
• mydriasis
• penalization of the healthy eye in the treatment of amblyopia

How does this medicine work?

• Atropine is a reversible antagonist of muscarine-like actions of acetyl-choline and is therefore classified as an antimuscarinic agent.
• Atropine is relatively selective for muscarinic receptors.
• Its potency at nicotinic receptors is much lower, and actions at non-muscarinic receptors are generally undetectable clinically.
• Atropine does not distinguish among the M1, M2, and M3 subgroups of muscarinic receptors.
• The pupillary constrictor muscle depends on muscarinic cholinoceptor activation.
• This activation is blocked by topical atropine resulting in unopposed sympathetic dilator activity and mydriasis.
• Atropine also weakens the contraction of the ciliary muscle, or cycloplegia.
• Cycloplegia results in loss of the ability to accommodate such that the eye cannot focus for near vision.

Who Should Not Use this medicine ?

This medicine cannot be used in patients:

• who has demonstrated a previous hypersensitivity or known allergic reaction to any ingredient of the formulation.

What drug interactions can this medicine cause?

• Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.

Especially tell your doctor if you take:

• antihistamines, cough and cold medicines, and vitamins.

Is this medicine FDA approved?

• Atropine has been in use in medicine for decades, but has not been formally approved for many of its broadly accepted indications.
• Atropine is used in low doses (1 mg or less) and usually for short periods of time.
• Homatropine (hoe mat' roe peen) is a synthetic derivative of Atropine and is less potent and has a shorter half-life, which makes it appropriate as a cycloplegic eye drops to dilate the pupils.
• It is also used in combination with opiate drugs for its aversive side effects to prevent abuse of high doses.

How should this medicine be used?

Recommended dosage:

• In individuals from three months of age or greater, 1 drop topically to the cul-de-sac of the conjunctiva, forty minutes prior to the intended maximal dilation time.
• In individuals 3 years of age or greater, doses may be repeated up to twice daily as needed.

Administration:

• Atropine comes as a solution to instill in the eyes and an eye ointment to apply to the eyes.
• The drops are usually instilled two to four times a day.
• The ointment is usually applied one to three times a day.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As a solution and an eye ointment

This medicine is available in fallowing brand namesː

• Atropine Care 1%; Atropisol; Isopto Atropine; Ocu-Tropine

What side effects can this medication cause?

The most common side effects of this medicine include: Ocular Adverse Reactions:

• Eye pain
• stinging
• blurred vision
• photophobia
• superficial keratitis
• decreased lacrimation
• papillary conjunctivitis
• contact dermatitis
• lid edema

Systemic Adverse Reactions:

• dryness of skin, mouth, and throat from decreased secretions from mucus membranes; restlessness, irritability or delirium from stimulation of the central nervous system; tachycardia; flushed skin of the face and neck

Less common side effects may include:

• Photophobia and Blurred Vision
• Elevation in Blood Pressure

What special precautions should I follow?

• Photophobia and blurred vision due to pupil unresponsiveness and cycloplegia may last up to 2 weeks.
• You should know that your vision may be blurred during your treatment with atropine ophthalmic ointment. Avoid rubbing your eyes even if your vision is blurred. Do not drive a car or operate machinery if you are unable to see clearly.
• Elevation in blood pressure from systemic absorption has been reported following conjunctival instillation of recommended doses of atropine sulfate ophthalmic solution 1%.
• Advise patients not to touch the dropper tip to any surface as this may contaminate the solution.
• Advise patients that drops will sting upon instillation and advise patients that they will experience sensitivity to light and blurred vision which may last for a couple of weeks.
• Traces of atropine have been found in human milk following administration of atropine solution for injection. Because some systemic absorption occurs from topical administration, caution should be exercised when Atropine Sulfate Ophthalmic Solution 1% is administered to a nursing woman.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.
• In the event of accidental ingestion or toxic overdosage with atropine sulfate ophthalmic solution, supportive care may include a short acting barbiturate or diazepam as needed to control marked excitement and convulsions.
• Large doses for sedation should be avoided because central depressant action may coincide with the depression occurring late in atropine poisoning.
• Central stimulants are not recommended.
• Physostigmine, given by slow intravenous injection of 1 to 4 mg (0.5 to 1 mg in pediatric populations), rapidly abolishes delirium and coma caused by large doses of atropine.
• Since physostigmine is rapidly destroyed, the patient may again lapse into coma after one to two hours, and repeated doses may be required.
• Artificial respiration with oxygen may be necessary.
• Cooling measures may be needed to help to reduce fever, especially in pediatric populations.

Can this medicine be used in pregnancy?

• Pregnancy Category C.
• There are no adequate and well-controlled studies of atropine sulfate in pregnant women.
• Atropine sulfate ophthalmic solution 1% should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus.

Can this medicine be used in children?

• Due to the potential for systemic absorption of atropine sulfate ophthalmic solution, the use of atropine sulfate ophthalmic solution 1% in children under the age of 3 months is not recommended.
• The use in children under 3 years of age should be limited to no more than one drop per eye per day.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• atropine sulfate

Inactive ingredients:

• benzalkonium chloride 0.1 mg (0.01%), dibasic sodium phosphate, edetate disodium, hypromellose (2910), monobasic sodium phosphate, hydrochloric acid and/or sodium hydroxide may be added to adjust pH (3.5 to 6. 0), and water for injection USP.

Who manufactures and distributes this medicine?

Distributed by:

• Akorn Operating Company LLC
• Gurnee, IL Lake forest, IL

What should I know about storage and disposal of this medication?

• Store at 20°C to 25°C (68°F to 77°F).
• Keep tightly closed.

• Dailymed label info on Atropine Ophthalmic
• FDA Atropine Ophthalmic

Atropine Ophthalmic Resources
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