Isopto Atropine

ISOPTO^® Atropine 1% is indicated for:

2.1 In individuals from three (3) 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.

2.2 In individuals 3 years of age or greater, doses may be repeated up to twice daily as needed.

Ophthalmic solution: 1% atropine sulfate (10mg/mL)

Atropine sulfate ophthalmic solution should not be used in anyone who has demonstrated a previous hypersensitivity or known allergic reaction to any ingredient of the formulation because it may recur.

The following adverse reactions are described below and elsewhere in the labeling:

• Photophobia and Blurred Vision [see Warnings and Precautions (5.1)]
• Elevation in Blood Pressure [see Warnings and Precautions (5.2)]
• Increased Adverse Drug Reaction Susceptibility with Certain Central Nervous System Conditions [see Warnings and Precautions (5.3)]

The following adverse reactions have been identified following use of atropine sulfate ophthalmic solution. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

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.

The fatal pediatric and adult doses of atropine are not known.

ISOPTO® Atropine 1% is  a sterile topical ophthalmic solution. Each mL of ISOPTO® Atropine 1% contains 10 mg of atropine sulfate monohydrate equivalent to 9.7 mg/mL of atropine sulfate or 8.3 mg of atropine. Atropine sulfate monohydrate is designated chemically as benzeneacetic acid, α-(hydroxymethyl)-,8-methyl-8-aza-bicyclo-[3.2.1]oct-3-yl ester, endo-(+)-, sulfate(2:1) (salt), monohydrate. Its molecular formula is (C17H23NO3)2 • H2SO4 • H2O and it is represented by the chemical structure:

Atropine sulfate monohydrate is colorless crystals or white crystalline powder and has a molecular weight of 694.83.

ISOPTO® Atropine 1% has a pH of 3.5 to 6.0.
Active ingredient: atropine sulfate monohydrate 1.0%
Preservative: benzalkonium chloride 0.01%

Inactive ingredients: hypromellose, boric acid, sodium hydroxide and/or hydrochloric acid (to adjust pH), purified water.

Topical administration of ISOPTO® Atropine 1% results in mydriasis and/or cycloplegia, with efficacy demonstrated in both adults and children. The maximum effect for mydriasis is achieved in about 30–40 minutes after administration, with recovery after approximately 7–10 days. The maximum effect for cycloplegia is achieved within 60–180 minutes after administration, with recovery after approximately 7–12 days.

ISOPTO® Atropine 1% is supplied sterile in low-density polyethylene plastic DROP-TAINER® dispensers with low-density polyethylene tips and red polypropylene caps as follows:

• 5 mL filled in 8-mL bottles             NDC 0065-0303-55

Storage: Store ISOPTO® Atropine 1% at 2–25°C (36–77°F).

• Advise patients not to drive or engage in other hazardous activities while pupils are dilated.
• Advise patient that they may experience blurry vision and sensitivity to light and should protect their eyes in bright illumination during dilation. These effects may last up to a couple weeks.
• Advise patients that they may experience drowsiness.
• Advise patients not to touch the dispenser tip to any surface, as this may contaminate the solution.

ALCON^®
A Novartis company
Fort Worth, Texas 76134 USA
© 2016, 2018 Novartis

NDC 0065-0303-55

Alcon^®

Isopto^® Atropine
(atropine sulfate ophthalmic solution) 1%

5 mL Sterile

USUAL ADULT DOSAGE: One drop topically in the eye(s) up to twice daily. For other dosage information, read enclosed insert.

PRECAUTION: Do not touch dropper tip to any surface, as this may contaminate the solution.

STORAGE: Store at 2°-25°C (36°-77°F). Read enclosed insert.

Rx Only

INGREDIENTS: Each mL contains: Active: atropine sulfate monohydrate 1.0%.

Preservative: benzalkonium chloride 0.01%.

Inactives: hypromellose 0.5%, boric acid, sodium hydroxide and/or hydrochloric acid (to adjust pH), purified water.

© 2003, 2018 Novartis

Alcon^®
ALCON LABORATORIES, INC.
Fort Worth, Texas 76134 USA
Product of Germany

9016388-0618

SN:
LOT:
EXP.:
GTIN: 00300650303552

NDC 0065-0303-55

Alcon^®

Isopto^® Atropine
(atropine sulfate ophthalmic solution) 1%

Sterile 5mL

Rx Only

INGREDIENTS: Each mL contains:
Active: atropine sulfate monohydrate 1.0%.

Preservative: benzalkonium chloride 0.01%.

Inactives: hypromellose 0.5%, boric acid, sodium hydroxide and/or hydrochloric acid (to adjust pH), purified water.

PRECAUTION: Do not touch dropper tip to any surface, as this may contaminate the solution.

USUAL ADULT DOSAGE: One drop topically in the eye(s) up to twice daily. For other dosage information, read enclosed insert. FOR TOPICAL OPHTHALMIC USE.

STORAGE: Store at 2°-25°C (36°-77°F).

ALCON LABORATORIES, INC.
Fort Worth, Texas 76134 USA
©2018 Novartis

H15250-0318