Atropine Sulfate

ATROPINE SULFATE- atropine sulfate solution
Alcon Laboratories, Inc.

Chemical StructureCarton LabelCarton Label

1 INDICATIONS AND USAGE

Atropine Sulfate Ophthalmic Solution, 1% is indicated for:

1.1 Mydriasis

1.2 Cycloplegia

1.3 Penalization of the healthy eye in the treatment of amblyopia

2 DOSAGE AND ADMINISTRATION

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.

3 DOSAGE FORMS AND STRENGTHS

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

4 CONTRAINDICATIONS

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.

5 WARNINGS AND PRECAUTIONS

5.1 Photophobia and Blurred Vision

Photophobia and blurred vision due to pupil unresponsiveness and cycloplegia may last up to 2 weeks.

5.2 Elevation of Blood Pressure

Elevation in blood pressure from systemic absorption has been reported following conjunctival instillation of recommended doses of atropine sulfate ophthalmic solution, 1%.

5.3 Increased Adverse Drug Reaction Susceptibility with Certain Central Nervous System Conditions

Individuals with Down syndrome, spastic paralysis, or brain damage are particularly susceptible to central nervous system disturbances, cardiopulmonary, and gastrointestinal toxicity from systemic absorption of atropine.

6 ADVERSE REACTIONS

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.

6.1 Ocular Adverse Reactions

Eye pain and stinging occurs upon instillation of atropine sulfate ophthalmic solution.

Other commonly occurring adverse reactions include blurred vision, photophobia, superficial keratitis and decreased lacrimation. Allergic reactions such as papillary conjunctivitis, contact dermatitis, and eyelid edema may also occur less commonly.

6.2 Systemic Adverse Reactions

Systemic effects of atropine are related to its anti-muscarinic activity. Systemic adverse events reported include dryness of skin, mouth, and throat from decreased secretions from mucus membranes; drowsiness; restlessness, irritability or delirium from stimulation of the central nervous system; tachycardia; flushed skin of the face and neck.

7 DRUG INTERACTIONS

7.1 Monoamine Oxidase Inhibitors

The use of atropine and monoamine oxidase inhibitors (MAOI) is generaly not recommended because of the potential to precipitate hypertensive crisis.

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk SummaryThere are no adequate and self-controlled studies with Atropine Sulfate Ophthalmic Solution, 1% administration in pregnant women to inform a drug-associated risk. Adequate animal development and reproduction studies have not been conducted with atropine sulfate. In humans, 1% atropine sulfate is systemically bioavailable following topical ocular administration [see Clinical Pharmacology (12.3)]. Atropine Sulfate Ophthalmic Solution, 1% should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus.

8.3 Lactation

There is no information to inform risk regarding the presence of atropine in human milk folowing ocular administration of Atropine Sulfate Ophthalmic Solution, 1% to the mother. The effects on breastfed infants and the effects on milk production are also unknown. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Atropine Sulfate Ophthalmic Solution, 1% and any potential adverse effects on the breastfed child from Atropine Sulfate Ophthalmic Solution, 1%.

8.4 Pediatric Use

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 and the use in children under 3 years of age should be limited to no more than one drop per eye per day. Safety and efficacy in children above the age of 3 months has been established in adequate and well-controlled trials.

8.5 Geriatric Use

No overall differences in safety or effectiveness have been observed between elderly and adult patients.

10 OVERDOSAGE

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.

11 DESCRIPTION

Atropine Sulfate Ophthalmic Solution, 1% is a sterile topical ophthalmic solution. Each mL of Atropine Sulfate Ophthalmic, 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 benzene acetic 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 (C17 H23 NO3 )2 • H2 SO4 • H2 O and it is represented by the chemical structure:

Chemical Structure
(click image for full-size original)

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

Atropine Sulfate Ophthalmic Sulfate, 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.

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