pharmacopeia
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/api/v1/drug/cyclopentolate

Mechanism of action

Sourced from openFDA

Mechanism-of-action class: Cholinergic Muscarinic Antagonists.

Cholinergic Muscarinic

Indications

Sourced from openFDA
  • Cyclopentolate hydrochloride is used to produce mydriasis and cycloplegia.

Contraindications

Sourced from openFDA
  • Should not be used if the patient is hypersensitive to any component of this preparation.contraindicated

Dosage & administration

Sourced from openFDA

Adults: Instill one or two drops of 0.5%, 1% or 2% solution in the eye which may be repeated in five to ten minutes if necessary. Complete recovery usually occurs in 24 hours. Complete recovery from mydriasis in some individuals may require several days. Children: Instill one or two drops of 0.5%, 1% or 2% solution in the eye which may be repeated five to ten minutes later by a second application of 0.5% or 1% solution if necessary. Small Infants: A single instillation of one drop of 0.5% in the eye. To minimize absorption, apply pressure over the nasolacrimal sac for two to three minutes. Observe infant closely for at least 30 minutes following instillation. Individuals with heavily pigmented irides may require higher strengths.

Warnings & precautions

Sourced from openFDA

FOR TOPICAL OPHTHALMIC USE ONLY . NOT FOR INJECTION. This preparation may cause Central Nervous System (CNS) disturbances. This is especially true in younger age groups, but may occur at any age, especially with the stronger solutions. Infants are especially prone to CNS and cardiopulmonary side effects from cyclopentolate. To minimize absorption, use only 1 drop of 0.5% CYCLOGYL solution per eye, followed by pressure applied over the nasolacrimal sac for two to three minutes. Observe infants closely for at least 30 minutes following instillation. Mydriatics may produce a transient elevation of intraocular pressure. Therefore, patients with untreated narrow angle glaucoma or anatomically narrow angles may be susceptible to angle closure following administration.

Adverse reactions

Sourced from openFDA

Ocular: Increased intraocular pressure, burning, photophobia, blurred vision, irritation, hyperemia, conjunctivitis, blepharoconjunctivitis, punctate keratitis, synechiae have been reported. Non-ocular: Use of cyclopentolate has been associated with psychotic reactions and behavioral disturbances, usually in children, especially with 2% concentration. These disturbances include ataxia, incoherent speech, restlessness, hallucinations, hyperactivity, seizures, disorientation as to time and place, and failure to recognize people. This drug produces reactions similar to those of other anticholinergic drugs, but the central nervous system manifestations as noted above are more common. 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 manifestations of toxicity include coma, medullary paralysis and death.

Use in specific populations

Sourced from openFDA

Pregnancy: Animal reproduction studies have not been conducted with cyclopentolate. It is also not known whether cyclopentolate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Cyclopentolate should be administered to a pregnant woman only if clearly needed.

Overdosage

Sourced from openFDA

Excessive dosage may produce behavioral disturbances, tachycardia, hyperpyrexia, hypertension, elevated intraocular pressure, vasodilation, urinary retention, diminished gastrointestinal motility and decreased secretion in salivary and sweat glands, pharynx, bronchi and nasal passages. Patients exhibiting signs of overdosage should receive supportive care and monitoring.

Approval history

Sourced from openFDA
  • Jul 31, 1974ANDAANDA084109Alcon Labs Inc
  • Jul 31, 1974ANDAANDA084108Alcon Labs Inc
  • Jul 31, 1974ANDAANDA084110Alcon Labs Inc
  • Sep 12, 1975ANDAANDA084300Alcon Labs Inc
  • Apr 29, 1994ANDAANDA040075Bausch And Lomb Inc

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
708 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Eye Pain598.3%
  2. 2Headache496.9%
  3. 3Dizziness425.9%
  4. 4Vision Blurred425.9%
  5. 5Off Label Use415.8%
  6. 6Apnoea365.1%
  7. 7Nausea365.1%
  8. 8Ocular Hyperaemia354.9%
  9. 9Toxic Anterior Segment Syndrome334.7%
  10. 10Visual Impairment334.7%
  11. 11Eye Irritation304.2%
  12. 12Vomiting294.1%
  13. 13Diarrhoea284.0%
  14. 14Drug Ineffective284.0%
  15. 15Dyspnoea284.0%

Literature

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Recent PubMed references pinned to Cyclopentolate as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 23 ClinicalTrials.gov registrations naming Cyclopentolate as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Cyclopentolate work?
Mechanism-of-action class: Cholinergic Muscarinic Antagonists.
What is Cyclopentolate used for?
According to FDA labeling, Cyclopentolate carries indications including: Cyclopentolate hydrochloride is used to produce mydriasis and cycloplegia.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Cyclopentolate?
Cyclopentolate is classified as Anticholinergics, Cholinergic Muscarinic Antagonists, Decreased Parasympathetic Acetylcholine Activity, Pupillary Dilation.
What are the brand names for Cyclopentolate?
Cyclopentolate is marketed under brand names including Cyclogyl, Cyclomydril, Cylate.
What are the contraindications for Cyclopentolate?
Cyclopentolate labeling lists contraindications including: Should not be used if the patient is hypersensitive to any component of this preparation.. Always consult the full prescribing information and a clinician.
Note. Data for cyclopentolate is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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