Scopolamine (ophthalmic)

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Scopolamine (ophthalmic)
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Aparna Vuppala, M.B.B.S. [2]

Disclaimer

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Overview

Scopolamine (ophthalmic) is an anticholinergic agent that is FDA approved for the {{{indicationType}}} of diagnosis of mydriasis and cycloplegia. Common adverse reactions include dry mouth, dizziness, somnolence, urinary retention, agitation, visual impairment, confusion, mydriasis and pharyngitis.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

  • For mydriasis and cycloplegia in diagnostic procedures. For some pre- and postoperative states when a mydriatic and cycloplegic is needed in treatment of iridocyclitis.
Dosing Information
  • For refraction, administer one or two drops in the eye(s) one hour before refracting. For uveitis, administer one or two drops in the eye(s) up to four times daily.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Scopolamine (ophthalmic) in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Scopolamine (ophthalmic) in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding FDA-Labeled Use of Scopolamine (ophthalmic) in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Scopolamine (ophthalmic) in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Scopolamine (ophthalmic) in pediatric patients.

Contraindications

  • Contraindicated in persons with primary glaucoma or a tendency toward glaucoma, e.g., narrow anterior chamber angle; and in those showing hypersensitivity to any component of this preparation.

Warnings

  • Do not touch dropper tip to any surface, as this may contaminate the solution.
  • FOR TOPICAL OPHTHALMIC USE ONLY - NOT FOR INJECTION.

Precautions

  • To avoid excessive 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.
  • Patient Warning
  • Patient should be advised not to drive or engage in other hazardous activities when drowsy or 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 own hands and the child’s hands following administration.

Adverse Reactions

Clinical Trials Experience

  • Prolonged use may produce local irritation, characterized by follicular conjunctivitis, vascular congestion, edema, exudate, and an eczematoid dermatitis. Somnolence, dryness of the mouth, or visual hallucinations may occur.

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Scopolamine (ophthalmic) in the drug label.

Drug Interactions

There is limited information regarding Scopolamine (ophthalmic) Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

  • Pregnancy Category


Pregnancy Category (AUS):

  • Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Scopolamine (ophthalmic) in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Scopolamine (ophthalmic) during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Scopolamine (ophthalmic) with respect to nursing mothers.

Pediatric Use

  • Safety and effectiveness in pediatric patients have not been established.

Geriatic Use

  • No overall differences in safety or effectiveness have been observed between elderly and younger patients.

Gender

There is no FDA guidance on the use of Scopolamine (ophthalmic) with respect to specific gender populations.

Race

There is no FDA guidance on the use of Scopolamine (ophthalmic) with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Scopolamine (ophthalmic) in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Scopolamine (ophthalmic) in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Scopolamine (ophthalmic) in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Scopolamine (ophthalmic) in patients who are immunocompromised.

Administration and Monitoring

Administration

Monitoring

There is limited information regarding Monitoring of Scopolamine (ophthalmic) in the drug label.

IV Compatibility

There is limited information regarding IV Compatibility of Scopolamine (ophthalmic) in the drug label.

Overdosage

There is limited information regarding Chronic Overdose of Scopolamine (ophthalmic) in the drug label.

Pharmacology

Template:Px
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Scopolamine (ophthalmic)
Systematic (IUPAC) name
(–)-(S)-3-Hydroxy-2-phenylpropionic acid (1R,2R,4S,7S,9S)-9-methyl-3-oxa-9-azatricyclo[3.3.1.02,4]non-7-yl ester
Identifiers
CAS number 51-34-3
ATC code A04AD01 N05CM05 (WHO), S01FA02 (WHO)
PubChem 5184
DrugBank DB00747
Chemical data
Formula Template:OrganicBox atomTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox 
Mol. mass 303.353 g/mol
SMILES eMolecules & PubChem
Pharmacokinetic data
Bioavailability 0.13-8% (Oral)
Metabolism Hepatic (liver)
Half life 4.5 hours[1]
Excretion Renal
Therapeutic considerations
Pregnancy cat.

B2(AU) C(US)

Legal status

Prescription Only (S4)(AU) ?(CA) POM(UK) [[Prescription drug|Template:Unicode-only]](US)

Routes transdermal, ocular, oral, subcutaneous, intravenous, sublingual, rectal, buccal transmucousal, intramuscular

Mechanism of Action

  • 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).

Structure

  • ISOPTO® Hyoscine (scopolamine hydrobromide ophthalmic solution) is an anticholinergic prepared as a sterile topical ophthalmic solution. The active ingredient is represented by the chemical structure:
This image is provided by the National Library of Medicine.
  • Established name: scopolamine hydrobromide
  • Chemical name: benzeneacetic acid, α-(hydroxymethyl)-, 9-methyl-3-oxa-9-azatricyclo[3.3.1.02,4]non-7-yl ester, hydrobromide, trihydrate, [7(S)-(1α,2β,4β,5α,7β)]-.
  • Each mL contains: Active: scopolamine hydrobromide 0.25%. Preservative: benzalkonium chloride 0.01%. Vehicle: hypromellose 0.5%. Inactives: sodium chloride, glacial acetic acid, sodium acetate (to adjust pH), purified water.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Scopolamine (ophthalmic) in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Scopolamine (ophthalmic) in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Scopolamine (ophthalmic) in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Scopolamine (ophthalmic) in the drug label.

How Supplied

  • In 5 mL plastic DROP-TAINER® dispensers.
  • 5 mL NDC 0998-0331-05
  • Store at 8°-27°C (46°-80°F). Protect from light.

Storage

There is limited information regarding Scopolamine (ophthalmic) Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of Scopolamine (ophthalmic) in the drug label.

Precautions with Alcohol

  • Alcohol-Scopolamine (ophthalmic) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Scopolamine (ophthalmic) Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Scopolamine (ophthalmic) Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

  1. Putcha, L.; Cintrón, N. M.; Tsui, J.; Vanderploeg, J. M.; Kramer, W. G. (1989). "Pharmacokinetics and Oral Bioavailability of Scopolamine in Normal Subjects". Pharmacology Research. 6 (6): 481–485. doi:10.1023/A:1015916423156. PMID 2762223.



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