Track topics on Twitter Track topics that are important to you
Atropine sulfate ophthalmic solution, 1% is an anticholinergic prepared as a sterile topical ophthalmic solution. The active ingredient is represented by the chemical structure:
Established name: atropine sulfateChemical name: benzeneacetic acid, α-(hydroxymethyl)-, 8-methyl-8-aza-bicyclo-[3.2.1]oct-3-yl ester, endo-(±)-, sulfate (2:1) (salt), monohydrate.
Each mL contains: Active: atropine sulfate 1.0%. Preservative: ben zalkonium chloride 0.01%. Vehicle: 0.5% hypromellose 2910. Inactives: boric acid, sodium hydroxide and/or hydrochloric acid (to adjust pH), purified water.
This anticholinergic preparation blocks the responses of the sphincter muscle of the iris and the accommodative muscle of the ciliary body to cholinergic stimulation, producing pupillary dilation (mydriasis) and paralysis of accommodation (cycloplegia).
For mydriasis and/or cycloplegia. For cycloplegic refraction, for papillary dilation desired in inflammatory conditions of the iris and uveal tract.
Contraindicated in persons with primary glaucoma or a tendency toward glaucoma, e.g., narrow anterior chamber angle, and in those persons showing hypersensitivity to any component of this preparation.
FOR TOPICAL OPHTHALMIC USE ONLY – NOT FOR INJECTION. Excessive use in certain individuals with a previous history of susceptibility to belladonna alkaloids may produce systemic symptoms of atropine poisoning.
To avoid excessive systemic absorption, the lacrimal sac should be compressed by digital pressure for two to three minutes after instillation. To avoid inducing angle closure glaucoma, an estimation of the depth of the angle of the anterior chamber should be made. Administration of atropine in infants requires great caution.
Do not touch dropper tip to any surface, as this may contaminate the solution.
No studies have been conducted in animals or in humans to evaluate the potential of these effects.
Animal reproduction studies have not been performed with atropine. It is also not known whether atropine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Atropine should be given to pregnant women only if clearly needed.
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when atropine is administered to a nursing woman.
Safety and effectiveness in pediatric patients have not been established.
No overall differences in safety or effectiveness have been observed between elderly and younger patients.
Patient should be advised not to drive or engage in other hazardous activities while pupils are dilated. Patient may experience sensitivity to light and should protect eyes in bright illumination during dilation. Parents should be warned not to get this preparation in their child’s mouth and to wash their hands following administration.
Prolonged use may produce local irritation character ized by follicular conjunctivitis, vascular congestion, edema, exudate, and an eczematoid dermatitis. Severe reactions are manifested by hypotension with progressive respiratory depression. Coma and death have been reported in the very young.
Systemic atropine toxicity is manifested by flushing and dryness of the skin (a rash may be present in children), blurred vision, a rapid and irregular pulse, fever, abdominal distention in infants, mental aberration (hallucinosis) and loss of neuromuscular coordination. Atropine poisoning, although distressing, is rarely fatal even with large doses of atropine, and is self-limited if the cause is recognized and the atropine medication discontinued. Treatment includes supportive measures including maintaining a patent airway and assisting respiration if needed. Treat hyperthermia, coma and seizures if they occur (1). In infants and children, the body surface must be kept moist. Excitement may be controlled by diazepam or a short acting barbiturate. For ingestion, activated charcoal can be used to prevent drug absorption. If necessary, ipecac or another cathartic may be useful for drug removal during initial treatment (1,2). Physostigmine is used as an antidote to the systemic effects of atropine and may be administered parenterally to provide more prompt relief of intoxication. Parenteral physostigmine may be particularly useful in cases of pronounced hallucinations, agitation in which a patient may be dangerous to himself or others, arrhythmias resulting in uncontrolled hemodynamic instability, and intractable seizures.
Adults: For uveitis, administer one or two drops topically to the eye(s) up to four times daily.
The lacrimal sac should be compressed by digital pressure for two to three minutes after instillation. Heavily pigmented irides may require larger doses.
Supplied in 5 mL and 15 mL in plastic DROP-TAINER* dispensers.5 mL: NDC 61314-303-0115 mL: NDC 61314-303-02
Store at 8° - 27°C (46° - 80°F).
1. Kirk M, Kulig K, Rumack BH. Anticholinergics. In: Clinical Management of Poisoning and Drug Overdose, Second Edition. Edited by Haddad LM, Winchester JF. Philadelphia, W.B. Sauders Company, 1990, p 861-867.
2. Tani SA. Anticholinergics. In: Poisoning and Drug Overdose, Second Edition. Olson KR. Norwalk, CT, Appleton & Lange, 1994, p 75-76.
Revised: August 2003*DROP-TAINER is a registered trademark of Alcon Manufacturing, Ltd. 340909-0803
Dist. by: FALCON Pharmaceuticals, Ltd. Fort Worth, Texas 76134 USA
Mfd. by: ALCON LABORATORIES, INC. Fort Worth, Texas 76134 USAPrinted in USA
NDC 61314-303-01 Rx Only
Atropine Sulfate Ophthalmic Solution
5 mL STERILE
AFFILIATE OFALCON LABORATORIES, INC.
FALCON LABORATORY LTD
ATROPINE SULFATE INJECTION, USP
Atropine Sulfate 0.4 mg/mL Injection, USP Vial
ATROPINE CARE™(Atropine Sulfate Ophthalmic Solution, 1%)
This study was designed to compare the difference of using atropine eyedrops alone from atropine combined with the stimulation of auricular acupoints therapy in reducing myopia progression...
The goals of this study are: - To compare the visual acuity outcome in the amblyopic eye after 17 weeks of daily use of atropine versus weekend-only use of atropine. - T...
The investigators hypothesize that the use of a combination of Atropine and Remifentanil will safely facilitate non emergent intubation procedure as effectively as the protocol of Atropine...
This study is designed to evaluate the effectiveness of adding a plano lens to weekend atropine after visual acuity has stabilized with weekend atropine but amblyopia is still present. Ch...
The aim of this study is to assess the efficacy of atropine in preventing nausea and vomiting after spinal anesthesia with local anesthetic and morphine for elective Caesarean section. ...
To analyze changes in refraction and associated biometric changes in atropine- and placebo-treated eyes in the Atropine for Treatment of Myopia study (ATOM1).
An effective approach to sulfate separation from aqueous solutions is based on the crystallization of extended [SO4 (H2 O)5 (2-) ]n sulfate-water clusters with a bis(guanidinium) ligand. The ligand wa...
Atropine 0.01% eyedrops have been shown to slow childhood myopic progression in primarily Asian populations. We studied its effects on an ethnically diverse population over a broad range of myopia.
Sulfate is an essential nutrient with pronounced regulatory effects on cellular metabolism and proliferation. Little is known, however, about how sulfate is sensed by cells. Sul1 and Sul2 are sulfate ...
The most effective strategy to reduce myopia-related complications is to prevent myopia progression during childhood. This review article examines the latest published evidence on the use of atropine ...
Latest News Clinical Trials Research Drugs Reports Corporate
Within medicine, nutrition (the study of food and the effect of its components on the body) has many different roles. Appropriate nutrition can help prevent certain diseases, or treat others. In critically ill patients, artificial feeding by tubes need t...
Latest News Clinical Trials Research Drugs Reports Corporate
Arthritis Fibromyalgia Gout Lupus Rheumatic Rheumatology is the medical specialty concerned with the diagnosis and management of disease involving joints, tendons, muscles, ligaments and associated structures (Oxford Medical Diction...