Cyclogyl
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Questions & Answers
Side Effects & Adverse Reactions
FOR TOPICAL OPHTHALMIC USE ONLY. NOT FOR INJECTION. This preparation may cause 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.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Cyclopentolate hydrochloride is used to produce mydriasis and cycloplegia.
History
There is currently no drug history available for this drug.
Other Information
CYCLOGYL® (cyclopentolate hydrochloride ophthalmic solution, USP) is an anticholinergic prepared as a sterile, borate buffered, solution for topical ocular use. It is supplied in three strengths. The active ingredient is represented by the structural formula:
Molecular Weight=327.85
Molecular Formula: C17H25NO3•HCl
Established name: Cyclopentolate Hydrochloride
Chemical name: 2-(Dimethylamino)ethyl 1-hydroxy-α-phenylcyclopentaneacetate hydrochloride
Each mL contains: Active: cyclopentolate hydrochloride 0.5%, 1% or 2%. Preservative: benzalkonium chloride 0.01%. Inactives: boric acid, edetate disodium, potassium chloride (except 2% strength), sodium carbonate and/or hydrochloric acid (to adjust pH), purified water. The pH range is between 3.0 and 5.5.
Sources
Cyclogyl Manufacturers
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Alcon Laboratories, Inc.
![Cyclogyl (Cyclopentolate Hydrochloride) Solution [Alcon Laboratories, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Cyclogyl | Accord Healthcare, Inc.
Verify dose using body surface area prior to dispensing. Recommended dosage should generally not exceed 4 mg intravenously [see Overdosage (10)] .
2.1 Ovarian CancerRecommended Dose and Schedule
The recommended dose of topotecan for injection is 1.5 mg/m 2 by intravenous infusion over 30 minutes daily for 5 consecutive days, starting on Day 1 of a 21‑day course.
2.2 Small Cell Lung CancerRecommended Dose and Schedule
The recommended dose of topotecan for injection is 1.5 mg/m 2 by intravenous infusion over 30 minutes daily for 5 consecutive days, starting on Day 1 of a 21-day course.
2.3 Cervical CancerRecommended Dose and Schedule
The recommended dose of topotecan for injection is 0.75 mg/m 2 by intravenous infusion over 30 minutes daily on Days 1, 2, and 3 in combination with cisplatin 50 mg/m 2 on Day 1, repeated every 21 days.
2.4 Dose ModificationsHematologic Toxicities
For single-agent use, dose reduce topotecan for injection to 1.25 mg/m 2 for:
neutrophil counts of less than 500 cells/mm 3, or administer granulocyte-colony stimulating factor (G-CSF) starting no sooner than 24 hours following the last dose of topotecan for injection. platelet counts less than 25,000 cells/mm 3 during previous cycle.For combination use with cisplatin, dose reduce topotecan for injection to 0.60 mg/m 2 (and further to 0.45 mg/m 2 if necessary) for :
febrile neutropenia (defined as neutrophil counts less than 1,000 cells/mm 3 with temperature of greater than or equal to 38.0°C (100.4°F), or administer G‑CSF starting no sooner than 24 hours following the last dose of topotecan for injection. platelet counts less than 25,000 cells/mm 3 during previous cycle.Renal Impairment
For single-agent use, dose reduce topotecan for injection to 0.75 mg/m 2 in patients with moderate renal impairment (creatinine clearance [Clcr] = 20 to 39 mL/min). Insufficient data are available in patients with severe renal impairment (Clcr less than 20 mL/min) to provide a dosage recommendation for topotecan for injection [see Use in Specific Populations (8.6), Clinical Pharmacology (12.3)].
2.5 Preparation and Intravenous AdministrationTopotecan for injection is a cytotoxic drug. Follow applicable special handling and disposable procedures. 1
Preparation and Administration
Reconstitute each 4-mg vial of topotecan for injection with 4 mL Sterile Water for Injection, USP. Dilute the appropriate volume of the reconstituted solution in either 0.9% Sodium Chloride Intravenous Infusion, USP or 5% Dextrose in Water for Injection, USP prior to administration.
Stability
Unopened vials of topotecan for injection are stable until the date indicated on the package when stored between 20°C and 25°C (68°F and 77°F) [see USP] and protected from light in the original carton. Because the vials contain no preservative, contents should be used immediately after reconstitution.
Reconstituted vials of topotecan for injection diluted for infusion are stable at approximately 20°C to 25°C (68°F to 77°F) and ambient lighting conditions for 24 hours.
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