ISOPTO ATROPINE Ophthalmic solution (2020)
Βιβλιογραφική αναφορά
Συγγραφείς
Alcon Laboratories, Inc.
Λέξεις κλειδιά
0065-0303
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1. Indications and Usage
ISOPTO Atropine 1% is indicated for: Mydriasis Cycloplegia Penalization of the healthy eye in the treatment of amblyopia
2. Dosage and Administration
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. In individuals 3 years of age or ...
3. Dosage Forms and Strengths
<u>Ophthalmic solution:</u> 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 ...
6. Adverse Reactions
The following adverse reactions are described below and elsewhere in the labeling: Photophobia and Blurred Vision <em>[see Warnings and Precautions (5.1)]</em> Elevation in Blood Pressure <em>[see Warnings ...
7. Drug Interactions
7.1 Monoamine Oxidase Inhibitors The use of atropine and monoamine oxidase inhibitors (MAOI) is generally not recommended because of the potential to precipitate hypertensive crisis.
8.1. Pregnancy
Risk Summary There are no adequate and well-controlled studies with ISOPTO Atropine 1% administration in pregnant women to inform a drug-associated risk. Adequate animal development and reproduction studies ...
8.2. Lactation
There is no information to inform risk regarding the presence of atropine in human milk following ocular administration of ISOPTO Atropine 1% to the mother. The effects on breastfed infants and the effects ...
8.4. Pediatric Use
Due to the potential for systemic absorption of atropine sulfate ophthalmic solution the use of ISOPTO Atropine 1% in children under the age of 3 months is not recommended and the use in children under ...
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 ...
11. Description
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. ...
12.1. Mechanism of Action
Atropine acts as a competitive antagonist of the parasympathetic (and sympathetic) acetylcholine muscarinic receptors. Topical atropine on the eye induces mydriasis by inhibiting contraction of the circular ...
12.2. Pharmacodynamics
The onset of action after administration of ISOPTO Atropine 1% generally occurs in minutes with maximal effect seen in hours and the effect can last multiple days <em>[see Clinical Studies (14)]</em>. ...
12.3. Pharmacokinetics
In a study of healthy subjects, after topical ocular administration of 30 µL of atropine sulfate ophthalmic solution, 1%, the mean (± SD) systemic bioavailability of l-hyoscyamine was reported to be approximately ...
13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility
Atropine sulfate was negative in the Salmonella/microsome mutagenicity test. Studies to evaluate carcinogenicity and impairment of fertility have not been conducted.
14. Clinical Studies
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 ...
16.1. How Supplied
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 ...
16.2. Storage and Handling
Store ISOPTO Atropine 1% at 2–25°C (36–77°F).
17. Patient Counseling Information
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 ...