Isopto Atropine

Isopto Atropine

atropine

Manufacturer:

Alcon

Distributor:

Zuellig
Full Prescribing Info
Contents
Atropine sulfate.
Description
Each mL contains: Active ingredient: Atropine sulfate 10.0 mg.
ATROPINE sulfate (ISOPTO ATROPINE) Sterile Ophthalmic Solution is an anti-cholinergic prepared as a sterile topical ophthalmic solution.
Excipients/Inactive Ingredients: Boric Acid, Benzalkonium Chloride Solution, Hypromellose, Sodium Hydroxide, Concentrated Hydrochloric Acid, Purified Water.
Action
Pharmacology: 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).
Indications/Uses
For mydriasis and/or cycloplegia. For cycloplegic refraction, for pupillary dilation desired in inflammatory conditions of the iris and uveal tract.
Dosage/Direction for Use
Adults: For refraction, administer one or two drops topically to the eye(s) one hour before refraction.
NOTE: 1% strength is not recommended for use with children.
Children: For refraction, administer one or two drops of 1/2% solution to each eye twice daily for one to three days prior to examination.
For uveitis: administer one or two drops of 1/2% solution to each eye up to three times daily.
Overdosage
Systemic toxicity may occur following topical use, particularly in children. It 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 distension in infants, convulsions and hallucinations and the loss of neuromuscular coordination. Severe intoxication is characterized by central nervous system depression, coma, circulatory and respiratory failure, and death.
Treatment is symptomatic and supportive. In infants and small children the body surface must be kept moist.
Contraindications
Contraindicated in persons with primary glaucoma or a tendency toward glaucoma, e.g. narrow anterior chamber angle, and in those persons showing hypersensitivity to the active substance or to any of the excipients.
Patients with known or suspected angle-closure glaucoma.
Children below 3 years. Children with Down's syndrome, spastic paralysis or brain damage.
Warnings
FOR EXTERNAL USE ONLY-NOT FOR INJECTION.
In infants and small children use with extreme caution. Excessive use in children or in certain individuals with a previous history of susceptibility to belladonna alkaloids may produce systemic symptoms of atropine poisoning.
ATROPINE sulfate (ISOPTO ATROPINE) Sterile Ophthalmic Solution-induced psychotic reactions and behavioral disturbances may occur in patients with increased susceptibility to anticholinergic drugs.
Use with caution in children and elderly patients, but reactions may occur at any age.
Because of risk of provoking hyperthermia, use with caution in patients, especially children, who may be exposed to elevated environmental temperatures or who are febrile.
Patients may experience sensitivity to light and should protect eyes in bright illumination.
Patient Warning: Patient should be advised not to drive or engage in other hazardous activities while pupils are dilated.
Patients may experience sensitivity to light and should protect eyes in bright illumination. Parents should be warned not to get this preparation in their children's mouth or cheeks and to wash their hands and the child's hands or cheeks following administration.
Special Precautions
Nasolacrimal occlusion or gently closing the eyelid after administration is recommended. This may reduce the systemic absorption of medicinal products administered via the ocular route and result in a decrease in systemic adverse reactions.
ATROPINE sulfate (ISOPTO ATROPINE) Sterile Ophthalmic Solution may cause increased intraocular pressure. The possibility of undiagnosed glaucoma should be considered in some patients, such as elderly patients. Determine the intraocular pressure and an estimation of the depth of the angle of the anterior chamber prior to initiation of therapy to avoid glaucoma attacks.
This product contains benzalkonium chloride which may cause eye irritation and is known to discolour soft contact lenses. Avoid contact with soft contact lenses. Patients must be instructed to remove contact lenses prior to application of ATROPINE sulfate (ISOPTO ATROPINE) Sterile Ophthalmic Solution and wait 15 minutes before reinsertion.
Effects on Ability to Drive and Use Machines: Atropine may cause drowsiness, blurred vision and sensitivity to light. Patients receiving ATROPINE sulfate (ISOPTO ATROPINE) Sterile Ophthalmic Solution should be advised not to drive or engage in other hazardous activities unless vision is clear.
Use in Children: Because of the risk of serious systemic side effects, ATROPINE sulfate (ISOPTO ATROPINE) Sterile Ophthalmic Solution is contraindicated in children below 3 years and caution is advised in older children. The lowest dose necessary to produce the desired effect should always be used Children, especially premature and low birth weight, or patients 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.
Fair-skinned children with blue eyes may exhibit an increased response and / or increased susceptibility to adverse reactions
Use In Pregnancy & Lactation
Fertility: Studies have not been performed to evaluate the effects of topical ocular administration of atropine on fertility.
Use in Pregnancy: There are no or limited amount of data from the use of ATROPINE sulfate (ISOPTO ATROPINE) Sterile Ophthalmic Solution in pregnant women. Animal studies are insufficient with respect to reproductive toxicity. There are documented systemic effects stemming from ophthalmic atropine.
Use in Lactation: It is unknown whether Atropine is excreted in human milk. However, atropine and antimuscarinic agents have been shown to adversely affect lactation in preclinical and in clinical studies.
Adverse Reactions
Prolonged use may produce local irritation characterized by follicular conjunctivitis, vascular congestion, edema, exudates, and an eczematoid dermatitis. Severe reactions are manifested by hypotension with progressive respiratory depression. Coma and death have been reported in the very young.
The following adverse reactions have been identified from post-marketing surveillance following administration of ATROPINE sulfate (ISOPTO ATROPINE) Sterile Ophthalmic Solution. Frequency cannot be estimated from the available data. Within each System Organ Class, adverse reactions are presented in order of decreasing seriousness. (See table.)

Click on icon to see table/diagram/image

Description of selected adverse reactions: This drug produces reactions similar to those of other anticholinergic drugs. The central nervous system manifestations such as ataxia, incoherent speech, restlessness, hallucinations, hyperactivity, seizures, disorientation as to time and place, and failure to recognize people are possible. Other toxic manifestations of anticholinergic drugs are skin rash, abdominal distention in infants, unusual drowsiness, tachycardia, hyperpyrexia, vasodilation, urinary retention, diminished gastrointestinal motility, and decreased secretion in salivary and sweat glands, pharynx, bronchi and nasal passages. Severe reactions are manifested by hypotension with rapid progressive respiratory depression. Symptoms of toxicity are usually transient (lasting a few hours), but may last up to 24 hours.
Mydriatics may increase intraocular pressure and provoke glaucoma attacks in patients predisposed to acute angle closure in particular geriatric patients.
Prolonged use of mydriatics may produce local irritation characterized by conjunctivitis (follicular), ocular hyperaemia, eye oedema, eye discharge, and eczema.
Pediatric population: Use of ATROPINE sulfate (ISOPTO ATROPINE) Sterile Ophthalmic Solution has been associated with psychotic reactions and behavior changes in pediatric patients. Central nervous system reactions manifest similar to those listed in the previous text. ATROPINE sulfate (ISOPTO ATROPINE) Sterile Ophthalmic Solution can cause hyperpyrexia in children.
Increased risk for systemic toxicity has been observed in children, especially premature and low birth weight, or patients with Down syndrome, spastic paralysis or brain damage with this class of drug. Intestinal obstruction, abdominal distension and bradycardia were reported in premature or low birth weight infants.
Drug Interactions
The effects of ATROPINE sulfate (ISOPTO ATROPINE) Sterile Ophthalmic Solution may be enhanced by concomitant use of other drugs having antimuscarinic properties, such as amantadine, some antihistamines, phenothiazine antipsychotics, and tricyclic antidepressants.
Storage
Store at a temperature not exceeding 25°C. Keep container tightly closed.
MIMS Class
Mydriatic Drugs
ATC Classification
S01FA01 - atropine ; Belongs to the class of anticholinergics used as mydriatics and cycloplegics.
Presentation/Packing
Eye drops 10 mg/mL x 5 mL.
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