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apraclonidine hydrochloride solution
|aN = Number Spikes/Number Eyes.|
Magnitude of Postsurgical Intraocular Pressure in Trabeculoplasty, Iridotomy and Nd:YAG Capsulotomy Patients With Severe Pressure Spikes≥10 mmHg
Maximum Postsurgical Intraocular Pressure (mmHg)
|Treatment||Total Spikes||20-29 mmHg||30-39 mmHg||40-49 mmHg||>50 mmHg
IOPIDINE (apraclonidine hydrochloride ophthalmic solution) is indicated to control or prevent postsurgical elevations in intraocular pressure that occur in patients after argon laser trabeculoplasty, argon laser iridotomy or Nd:YAG posterior capsulotomy.
IOPIDINE Ophthalmic Solution is contraindicated for patients receiving monoamine oxidase inhibitor therapy and for patients with hypersensitivity to any component of this medication or to clonidine.
Since IOPIDINE® Ophthalmic Solution is a potent depressor of intraocular pressure, patients who develop exaggerated reductions in intraocular pressure should be closely monitored.
Although the acute administration of two drops of IOPIDINE Ophthalmic Solution has minimal effect on heart rate or blood pressure in clinical studies evaluating patients undergoing anterior segment laser surgery, the preclinical pharmacologic profile of this drug suggests that caution should be observed in treating patients with severe cardiovascular disease including hypertension.
The possibility of a vasovagal attack occurring during laser surgery should be considered and caution used in patients with history of such episodes.
Topical ocular administration of two drops of 0.5%, 1% and 1.5% IOPIDINE Ophthalmic Solution to New Zealand Albino rabbits three times daily for one month resulted in sporadic and transient instances of minimal corneal cloudiness in the 1.5% group only. No histopathological changes were noted in those eyes. No adverse ocular effects were observed in cynomolgus monkeys treated with two drops of 1.5% IOPIDINE Ophthalmic Solution applied three times daily for three months. No corneal changes were observed in 320 humans given at least one dose of 1% IOPIDINE Ophthalmic Solution.
No significant change in tumor incidence or type was observed following two years of oral administration of apraclonidine HCl to rats and mice at dosages of 1 and 0.6 mg/kg/day, up to 50 and 30 times, respectively, the maximum dose recommended for human topical ocular use. Apraclonidine HCl was not mutagenic in a series of in vitro mutagenicity tests, including the Ames test, a mouse lymphoma forward mutation assay, a chromosome aberration assay in cultured Chinese hamster ovary (CHO) cells, a sister chromatid exchange assay in CHO cells, and a cell transformation assay. An in vivo mouse micronucleus assay conducted with apraclonidine HCl also provided no evidence of mutagenicity. Reproduction and fertility studies in rats showed no adverse effect on male or female fertility at a dose of 0.5 mg/kg/day (25 times the maximum recommended human dose).
Apraclonidine HCl has been shown to have an embryocidal effect in rabbits when given in an oral dose of 3 mg/kg/day (150 times the maximum recommended human dose). Dose related maternal toxicity was observed in pregnant rats at 0.3 mg/kg/day (15 times the maximum recommended human dose). There are no adequate and well controlled studies in pregnant women. IOPIDINE 1% Ophthalmic Solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
It is not known if topically applied IOPIDINE Ophthalmic Solution is excreted in human milk. Decision should be made to discontinue nursing temporarily for the one day on which IOPIDINE Ophthalmic Solution is used.
The following adverse events, occurring in less than 2% of patients, were reported in association with the use of IOPIDINE® Ophthalmic Solution in laser surgery: ocular injection, upper lid elevation, irregular heart rate, nasal decongestion, ocular inflammation, conjunctival blanching, and mydriasis. The following adverse events were observed in investigational studies dosing IOPIDINE Ophthalmic Solution once or twice daily for up to 28 days in nonlaser studies:
Conjunctival blanching, upper lid elevation, mydriasis, burning, discomfort, foreign body sensation, dryness, itching, hypotony, blurred or dimmed vision, allergic response, conjunctival microhemorrhage.
Taste abnormalities, dry mouth, nasal burning or dryness, headache, head cold sensation, chest heaviness or burning, clammy or sweaty palms, body heat sensation, shortness of breath, increased pharyngeal secretion, extremity pain or numbness, fatigue, paresthesia, pruritus not associated with rash.
Ingestion of IOPIDINE 0.5% Ophthalmic Solution has been reported to cause bradycardia, drowsiness, and hypothermia. Accidental or intentional ingestion of oral clonidine has been reported to cause apnea, arrhythmias, asthenia, bradycardia, conduction defects, diminished or absent reflexes, dryness of the mouth, hypotension, hypothermia, hypoventilation, irritability, lethargy, miosis, pallor, respiratory depression, sedation or coma, seizure, somnolence, transient hypertension, and vomiting. Treatment of an oral overdose includes supportive and symptomatic therapy; a patent airway should be maintained. Hemodialysis is of limited value since a maximum of 5% of circulating drug is removed.
One drop of IOPIDINE Ophthalmic Solution should be instilled in the scheduled operative eye one hour before initiating anterior segment laser surgery and a second drop should be instilled to the same eye immediately upon completion of the laser surgical procedure. Use a separate container for each single-drop dose and discard each container after use.
IOPIDINE (apraclonidine hydrochloride ophthalmic solution), 1% as base is a sterile, isotonic, aqueous solution containing apraclonidine hydrochloride. Supplied as follows: 0.1 mL in plastic ophthalmic dispensers, packaged two per pouch. These dispensers are enclosed in a foil overwrap as an added barrier to evaporation.
0.1 mL: NDC 0065-0660-10
Store at 2°- 25°C (36°- 77°F).
Protect from light.
U.S. Patent No. 5,212,196
©2001, 2004 Alcon, Inc.
Made in France
ALCON LABORATORIES, INC.
Fort Worth, Texas 76134 USA
Laboratoires Alcon, S.A.
F-68240 Kaysersberg, France
Revised: December 2004
apraclonidine hydrochloride solution
Revised: 11/2006 ALCON LABORATORIES, INC.
Reproduced with permission of U.S. National Library of Medicine
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