Isopto Atropine 1 %/10 mg Solution

For use as long acting mydriatic and cycloplegic.

For ocular use only. After cap is removed, if tamper evident snap collar is loose, remove it before using the product. Care should be taken to avoid contact between the dropper tip and the eye, eyelashes or any other surface. For refraction: Place one drop twice daily in the eye(s) for 1 to 2 days before examination, and 1 drop 1 hour before examination. For uveitis: Place 1 drop in the eye(s) 3 times daily. Systemic absorption may be minimised by compressing the lacrimal sac for a minute or two following instillation. If more than one topical ophthalmic medicinal product is being used, the medicines must be administered at least 5 minutes apart. Eye ointments should be administered last. The cap should be replaced tightly after use.

ISOPTOu00ae ATROPINE is contra indicated in patients with closed angle glaucoma or with a narrow angle between the iris and the cornea. Hypersensitivity to the active ingredient, belladonna alkaloids, or to any of the excipients. Children younger than 3 years.

Use with extreme caution, if at all, in children 12 years and above with Down syndrome, spastic paralysis or brain damage. It may increase intra ocular pressure, therefore mydriatics and cycloplegics should be used with caution in elderly and others where an increase may be encountered. 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. Tonometric examination prior to drop instillation is advisable. Use with caution in children and elderly patients, but reactions may occur at any age. Patients may experience sensitivity to light and should protect their eyes in bright illumination. Because of the risk of provoking hyperthermia ISOPTO ATROPINE should be used with caution in patents, especially children, who may be exposed to elevated environmental temperatures or who are febrile. ISOPTO ATROPINE 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 instillation and to wait at least 15 minutes before reinsertion. As the possibility of adverse effects on the corneal permeability and the danger of disruption of the corneal epithelium with prolonged or repeated usage of benzalkonium chloride preserved preparations cannot be excluded, regular ophthalmological examination is required. Caution should be exercised in the use of benzalkonium chloride preserved topical medication over an extended period in patients with extensive ocular surface disease.

No interaction studies have been performed. The effects of ISOPTO ATROPINE may be enhanced by concomitant use of other medicines having antimuscarinic properties, such as amantadine, some antihistamines, phenothiazine antipsychotics and tricyclic antidepressants.

Fertility
There is no adequate information on whether this medicine may affect fertility in males and females.
Pregnancy
Safety and efficacy has not been established. Since it is not known whether topically administered atropine sulphate can cause foetal harm, ISOPTOu00ae ATROPINE should not be used during pregnancy.
Lactation / Breastfeeding
It is unknown whether atropine is excreted in breast milk. Traces of atropine have been found in human milk following administration of atropine solution for injection. Because some systemic absorption occurs from topical administration, caution should be exercised when ISOPTOu00ae ATROPINE is administered to a nursing woman.

ISOPTO ATROPINE has a major influence on the ability to drive and use machines. ISOPTO ATROPINE may cause drowsiness, blurred vision and sensitivity to light. Patients should be advised not to drive or engage in other hazardous activities unless vision is clear.

The following side effects have been identified from post-marketing surveillance following administration of ISOPTO ATROPINE. Frequency categories are defined according to the following convention: Not known (cannot be estimated from the available data). Within each System Organ Class adverse reactions are presented in order of decreasing seriousness.
System Organ Classification
Frequency Undesirable effects
Immune system disorders Not known hypersensitivity
Psychiatric disorders Not known hallucination, confused state, disorientation
Nervous system disorders Not known dizziness, headache
Eye disorders Not known eyelid oedema, photophobia, vision blurred, drug effect prolonged (mydriasis)
Cardiac Disorders Not known tachycardia, bradycardia
Gastrointestinal Disorders Not known intestinal obstruction, abdominal distention, vomiting
Skin and subcutaneous disorders Not known erythema, rash
General disorders and administration site conditions Not known pyrexia
Hypersensitivity to atropine is not uncommon and occurs as conjunctivitis. Systemic toxicity may be produced by the instillation of anti cholinergic ophthalmic solution. Atropine produces reactions similar to those of other anti cholinergic 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, 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. Prolonged use of mydriatics may produce local irritation characterized by conjunctivitis (follicular), ocular hyperaemia, eye oedema, eye discharge and eczema. Paediatric population Use of ISOPTO ATROPINE has been associated with psychotic reactions and behavioural changes in children. Central nervous system reactions manifest similarly to those listed above. ISOPTO ATROPINE can cause hyperpyrexia in children. Increased risk for systemic toxicity has been observed in children with Down syndrome, spastic paralysis or brain damage with this class of drug.

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, 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. Physostigmine salicylate 1 to 2 mg subcutaneously, I.M. or I.V. will control central and peripheral effects. Excitement may be controlled by small doses of a short acting barbiturate such as thiopentone sodium 100 mg. An ocular overdose can be flushed from the eye(s) with lukewarm water.