RX ITEM-Isopto Atropine 1% Drops 5Ml By Alcon Labs

ISOPTO ATROPINE - atropine sulfate solution
Alcon Laboratories, Inc.

Chemical Structure5 mL Carton5 mL Label15 mL Carton15 mL Label
1 INDICATIONS AND USAGE

ISOPTO� Atropine 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.

RX ITEM-Isopto Atropine 1% Drops 5Ml By
NDC 00998-0303-05 UPC/GTIN No.3-09980-30305-8 Mfg.Part No.30305

Isopto Atropine 1% Drops 5Ml By Alcon La
BRAND: ISOPTO-ATROPINE NDC: 00998-0303-05,998030305 UPC: 3-00650-30355-2,300650303552 Alcon Labs

ATROPINE SULFATE OPHTHALM
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