Professional Drug Information > Scopolamine Hydrobromide

Scopolamine (Ophthalmic)

VA CLASSIFICATION
Primary: OP600

Commonly used brand name(s): Isopto Hyoscine.

Another commonly used name is
hyoscine . ^{52}
Note: For a listing of dosage forms and brand names by country availability, see Dosage Forms section(s).

^†Not commercially available in Canada.

Category:


Cycloplegic—

mydriatic—

Indications

Note: Bracketed information in the Indications section refers to uses that are not included in U.S. product labeling.

Accepted

Refraction, cycloplegic—Scopolamine is indicated for measurement of refractive errors. ^{102} Scopolamine is not useful for refraction in adults, because of its long duration of action. ^{{17} {18}}

Uveitis (treatment)—Scopolamine is indicated for pupil dilation ^{91} and ciliary muscle relaxation, which are desirable in acute ^{43} and sub-acute ^{61} inflammatory conditions of the iris and uveal tract. ^{19}

[Synechiae, posterior (prophylaxis)] or
Synechiae, posterior (treatment)—Scopolamine may be indicated for pupil dilation to break posterior synechiae. ^{19} In addition, scopolamine is used in the prophylaxis of posterior synechiae. ^{{18} {20}}

Mydriasis, postoperative—Scopolamine may be indicated for postoperative mydriasis. ^{19}

Iridocyclitis, postoperative (treatment) or
Iridocyclitis, preoperative (treatment)—Scopolamine is indicated in certain preoperative and postoperative conditions when a medication having mydriatic and cycloplegic properties is required in the treatment of iridocyclitis. ^{{17} {20} {102}}

[Iridocyclitis (treatment)]—Scopolamine is also used in the treatment of iridocyclitis at times other than postoperative or preoperative conditions. ^{{18} {20}}

Mydriasis, in diagnostic procedures—Scopolamine is indicated in diagnostic procedures to produce mydriasis. ^{{17} {20} {102}}

Note: Scopolamine may be useful in patients who are allergic to atropine.



Pharmacology/Pharmacokinetics

Mechanism of action/Effect:

Scopolamine (a belladonna alkaloid) is an anticholinergic agent that blocks the responses of the sphincter muscle of the iris and the accommodative muscle of the ciliary body to stimulation by acetylcholine. ^{17} Dilation of the pupil (mydriasis) and paralysis of accommodation (cycloplegia) result. ^{17}

Duration of action:

Has shorter duration of action than atropine.

Residual cycloplegia and mydriasis may persist for approximately 3 to 7 days following instillation of medication. ^{39}


Precautions to Consider

Cross-sensitivity and/or related problems

Patients sensitive to any of the other belladonna alkaloids may be sensitive to scopolamine also.

Pregnancy/Reproduction

Pregnancy—
Problems in humans have not been documented; however, ophthalmic scopolamine may be systemically absorbed.

Breast-feeding

Problems in humans have not been documented; however, ophthalmic scopolamine may be systemically absorbed.

Pediatrics

An increased susceptibility to scopolamine and similar drugs (such as atropine) has been reported in infants ^{59} and young children ^{59} and in children with blond hair, ^{59} blue eyes, ^{59} Down's syndrome, ^{59} spastic paralysis, ^{59} or brain damage; ^{59} therefore, scopolamine should be used with great caution in these patients. ^{17}


Geriatrics


Geriatric patients are more susceptible to the effects of scopolamine ^{59} and similar drugs (such as atropine) ^{59}, thus increasing the potential for systemic side effects. ^{61}

Drug interactions and/or related problems
The following drug interactions and/or related problems have been selected on the basis of their potential clinical significance (possible mechanism in parentheses where appropriate)—not necessarily inclusive (» = major clinical significance):


Note: Combinations containing any of the following medications, depending on the amount present, may also interact with this medication.

Anticholinergics or medications with anticholinergic activity, other (See Appendix II )    (if significant systemic absorption of ophthalmic scopolamine occurs, concurrent use of other anticholinergics or medications with anticholinergic activity may result in potentiated anticholinergic effects ^{76})


Antiglaucoma agents, cholinergic, long-acting, ophthalmic^{{78}{79}{80}{81}}    (concurrent use with scopolamine may antagonize the antiglaucoma and miotic actions of ophthalmic long-acting cholinergic antiglaucoma agents, such as demecarium, echothiophate, and isoflurophate; concurrent use with scopolamine may also antagonize the antiaccommodative convergence effects of these medications when they are used for the treatment of strabismus ^{91})


Antimyasthenics or^{85}
Potassium citrate^{84} or
Potassium supplements^{83}    (if significant systemic absorption of ophthalmic scopolamine occurs, concurrent use may increase the chance of toxicity and/or side effects of these systemic medications because of the anticholinergic-induced slowing of gastrointestinal motility)


Carbachol or^{91}
Physostigmine or^{91}
Pilocarpine^{91}    (concurrent use with scopolamine may interfere with the antiglaucoma action of carbachol, physostigmine, or pilocarpine. Also, concurrent use may counteract the mydriatic effect of scopolamine; ^{91} this counteraction may be used to therapeutic advantage)


CNS depression–producing medications (See Appendix II )    (if significant systemic absorption of ophthalmic scopolamine occurs, concurrent use of medications having CNS effects, such as antiemetic agents, phenothiazines, or barbiturates, may result in opisthotonos, convulsions, coma, and extrapyramidal symptoms ^{82})


Medical considerations/Contraindications
The medical considerations/contraindications included have been selected on the basis of their potential clinical significance (reasons given in parentheses where appropriate)— not necessarily inclusive (» = major clinical significance).


Risk-benefit should be considered when the following medical problems exist
Brain damage, in children^{59}
Down's syndrome (mongolism), in children and adults^{59}
» Glaucoma, primary, or predisposition to angle closure^{17}
Keratoconus    (scopolamine may produce fixed dilated pupil)


Sensitivity to scopolamine^{17}
Spastic paralysis, in children^{59}
Synechiae between the iris and lens^{89}{91}


Side/Adverse Effects

Note: An increased susceptibility to scopolamine and similar drugs (such as atropine) has been reported in infants, ^{59} young children, ^{59} children with blond hair ^{59} or blue eyes, ^{59} adults and children with Down's syndrome, ^{59} children with brain damage ^{59} or spastic paralysis, ^{59} and the elderly. ^{59} This susceptibility increases the potential for systemic side effects. ^{17}
Prolonged use of scopolamine may produce local irritation, resulting in follicular conjunctivitis, vascular congestion, edema, exudate, contact dermatitis, or an eczematoid dermatitis. ^{{17} {102}}

The following side/adverse effects have been selected on the basis of their potential clinical significance (possible signs and symptoms in parentheses where appropriate)—not necessarily inclusive:

Those indicating need for medical attention
Symptoms of systemic absorption
    
Clumsiness or unsteadiness
    
confusion or unusual behavior
    
dryness of skin^{60}
    
fever
    
flushing or redness of face
    
hallucinations^{71}{102}
    
skin rash^{102}
    
slurred speech
    
swollen stomach in infants
    
tachycardia (fast or irregular heartbeat)
    
unusual drowsiness^{17}{102}
    
tiredness or weakness
    
xerostomia^{71}{102} (thirst or dryness of mouth)



Those indicating need for medical attention only if they continue or are bothersome
    
Blurred vision^{17}
    
eye irritation not present before therapy^{17}{102}
    
increased sensitivity of eyes to light^{17}
    
swelling of the eyelids^{56}




Overdose
For specific information on the agents used in the management of ophthalmic scopolamine overdose, see:
   • Atropine in Anticholinergics/Antispasmodics (Systemic) monograph;
   • Diazepam in Benzodiazepines (Systemic) monograph;
   • Physostigmine (Systemic) monograph.
For more information on the management of overdose or unintentional ingestion, contact a Poison Control Center (see Poison Control Center Listing ).

Treatment of overdose
For accidental ingestion, emesis or gastric lavage with 4% tannic acid solution is recommended. ^{{40} {44}}

For systemic effects, 0.2 to 1 mg (0.2 mg in children) physostigmine should be administered intravenously as a dilution containing 1 mg in 5 mL of normal saline. ^{{40} {44}} The solution should be injected over a period of not less than 2 minutes. ^{{40} {44}} Dosage may be repeated every 5 minutes up to a total dose of 2 mg in children and 6 mg in adults in each 30-minute period. ^{{40} {44}}

Physostigmine is contraindicated in hypotensive reactions. ^{{40} {44}}

ECG monitoring is recommended during physostigmine administration. ^{{40} {44}}

Excitement may be controlled by diazepam or a short-acting barbiturate. ^{{40} {44}}

It is recommended that 1 mg of atropine be available for immediate injection if the physostigmine causes bradycardia, convulsion, or bronchoconstriction. ^{{40} {44}}

Supportive therapy may require oxygen and assisted respiration; ^{{40} {44}} cool water baths for fever, especially in children; ^{{40} {44}} and catheterization for urinary retention. ^{{40} {44}} In infants and small children, the body surface should be kept moist. ^{{40} {44}}


Patient Consultation
As an aid to patient consultation, refer to Advice for the Patient, Atropine/Homatropine/Scopolamine (Ophthalmic).

In providing consultation, consider emphasizing the following selected information (» = major clinical significance):

Before using this medication
»   Conditions affecting use, especially:
Sensitivity to atropine, homatropine, or scopolamine





Use in children—Infants and young children and children with blond hair or blue eyes may be especially sensitive to the effects of scopolamine; this may increase the chance of side effects during treatment






Use in the elderly—Geriatric patients are more susceptible to the effects of scopolamine and similar drugs (such as atropine), thus increasing the potential for systemic side effects
Other medical problems, especially primary glaucoma or predisposition to angle closure

Proper use of this medication
Proper administration technique

Washing hands immediately after application to remove any medication that may be on them; if applying medication to infants or children, washing their hands immediately afterwards; also, and not letting any medication get into their mouths; wiping off any medication that may have accidentally gotten on the infant or child, including his or her face and eyelids

Preventing contamination: Not touching applicator tip to any surface; keeping container tightly closed

» Importance of not using more medication than the amount prescribed

» Proper dosing
Missed dose: If dosing schedule is—

• Once a day: Applying as soon as possible if remembered same day; if remembered later, skipping missed dose and going back to regular dosing schedule; not doubling doses


• More than once a day: Applying as soon as possible; if almost time for next dose, skipping missed dose and going back to regular dosing schedule; not doubling doses


» Proper storage

Precautions while using this medication
» Medication causes blurred vision and increased sensitivity of the eyes to light; checking with physician if these effects continue longer than 7 days after discontinuation of scopolamine


Side/adverse effects
Signs of potential side effects, especially symptoms of systemic absorption


General Dosing Information
Scopolamine has a cycloplegic effect comparable to that of atropine.

Although some manufacturers recommend a dose of 2 drops of an ophthalmic solution at appropriate intervals, the conjunctival sac will usually hold only 1 drop. ^{63}

More frequent instillation or use of a stronger concentration may be required to produce adequate cycloplegia in eyes with brown or hazel irides than in eyes with blue irides.

To avoid excessive systemic absorption, patient should press finger to the lacrimal sac during, and for 2 or 3 ^{17} minutes following, instillation of the solution. ^{{17} {102}}


Ophthalmic Dosage Forms

Note: Bracketed uses in the Dosage Forms section refer to categories of use and/or indications that are not included in U.S. product labeling.

SCOPOLAMINE HYDROBROMIDE OPHTHALMIC SOLUTION USP

Usual adult and adolescent dose
Cycloplegic refraction
Topical, to the conjunctiva, 1 drop of a 0.25% solution one hour prior to refraction. ^{{17} {102}}

Uveitis
Topical, to the conjunctiva, 1 drop of a 0.25% solution up to four times a day, depending on the severity of the condition. ^{{17} {44} {61} {102}}

Posterior synechiae (treatment)
Topical, to the conjunctiva, 1 drop of a 0.25% solution ^{61} every ten minutes ^{{89} {91}} for three applications. ^{91}

Note: To enhance the mydriatic effect of scopolamine, 1 drop of a 2.5 or 10% phenylephrine solution may be instilled every ten minutes ^{{89} {91}} for three applications. ^{61} Extreme caution should be used if 10% phenylephrine is administered. ^{61}


[Posterior synechiae (prophylaxis)]
Topical, to the conjunctiva, 1 drop of a 0.25% solution one or two times a day as needed to maintain mydriasis. ^{20}

Postoperative mydriasis
Topical, to the conjunctiva, 1 drop of a 0.25% solution once a day. ^{61} Administration two or three times a day may be necessary for patients with dark brown irides. ^{61}

[Iridocyclitis (other than preoperative or postoperative)] or
Postoperative iridocyclitis or
Preoperative iridocyclitis
Topical, to the conjunctiva, 1 drop of a 0.25% solution one to four times a day as needed to maintain mydriasis, the dose being decreased as the severity of the inflammation decreases. ^{20}

Mydriasis in diagnostic procedures
Topical, to the conjunctiva, 1 drop of a 0.25% solution as needed to maintain mydriasis. ^{20}


Usual pediatric dose
Cycloplegic refraction
Topical, to the conjunctiva, 1 drop of a 0.25% solution two times a day for two days prior to refraction. ^{61}

Uveitis
Topical, to the conjunctiva, 1 drop of a 0.25% solution up to four times a day, depending on the severity of the condition and the size and weight of the child. ^{61}

[Posterior synechiae (prophylaxis)]
See Usual adult and adolescent dose. ^{20}

[Iridocyclitis (other than preoperative or postoperative)] or
Postoperative iridocyclitis or
Preoperative iridocyclitis
See Usual adult and adolescent dose . ^{20}

Note: The pediatric dose should be individualized based on the age and weight of the child as well as the severity of the inflammation. ^{20}


Mydriasis in diagnostic procedures
See Usual adult and adolescent dose . ^{20}


Strength(s) usually available
U.S.—


0.25% (Rx) [Isopto Hyoscine^{102} (benzalkonium chloride 0.01%)]

Canada—
Not commercially available.

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Store in a tight container. Protect from freezing. Protect from light. ^{17}

Auxiliary labeling:
   • For the eye.
   • Keep container tightly closed.

Revised: 06/21/1994

References

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