Apraclonidine 5.75 mg/mL
Apraclonidine · SOLUTION · Sandoz Inc
Apraclonidine is a solution containing apraclonidine at 5.75 mg/mL, taken ophthalmic. Manufactured by Sandoz Inc.
Key Facts
- Brand Name
- Apraclonidine
- Generic Name
- Apraclonidine
- NDC Code (Product)
61314-665- Manufacturer
- Sandoz Inc
- Strength
- 5.75 mg/mL
- Dosage Form
- SOLUTION
- Route
- OPHTHALMIC
- Marketing Status
- Application #
- NDA020258
- Marketing Start
- 07/19/2009
Recall History
Akorn, Inc.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Apraclonidine ophthalmic solution 0.5% is indicated for short-term adjunctive therapy, in patients on maximally tolerated medical therapy, who require additional IOP reduction. Patients on maximally tolerated medical therapy, who are treated with apraclonidine ophthalmic solution 0.5% to delay surgery, should have frequent follow-up examinations and treatment should be discontinued if the IOP rises significantly. The addition of apraclonidine ophthalmic solution 0.5% to patients already using two aqueous suppressing drugs (i.e., beta-blocker plus carbonic anhydrase inhibitor) as part of their maximally tolerated medical therapy may not provide additional benefit. This is because apraclonidine ophthalmic solution 0.5% is an aqueous suppressing drug and the addition of a third aqueous suppressant may not significantly reduce IOP. The IOP lowering efficacy of apraclonidine ophthalmic solution 0.5% diminishes over time in some patients. This loss of effect, or tachyphylaxis, appears to be an individual occurrence with a variable time of onset and should be closely monitored. The benefit for most patients is less than one month.
Dosage & Administration
DOSAGE AND ADMINISTRATION One to two drops of apraclonidine ophthalmic solution 0.5% should be instilled in the affected eye(s) three times daily. Since apraclonidine ophthalmic solution 0.5% will be used with other ocular glaucoma therapies, an approximate 5 minute interval between instillation of each medication should be practiced to prevent washout of the previous dose. NOT FOR INJECTION INTO THE EYE. NOT FOR ORAL INGESTION.
Warnings
WARNINGS Not for injection or oral ingestion. FOR EYE USE ONLY.
Contraindications
CONTRAINDICATIONS Apraclonidine ophthalmic solution 0.5% is contraindicated in patients with hypersensitivity to apraclonidine or any other component of this medication, as well as systemic clonidine. It is also contraindicated in patients receiving monoamine oxidase (MAO) inhibitors.
Drug Interactions
Drug Interactions Apraclonidine should not be used in patients receiving MAO inhibitors (see CONTRAINDICATIONS). Although no specific drug interactions with topical glaucoma drugs or systemic medications were identified in clinical studies of apraclonidine ophthalmic solution 0.5%, the possibility of an additive or potentiating effect with CNS depressants (alcohol, barbiturates, opiates, sedatives, anesthetics) should be considered. Tricyclic antidepressants have been reported to blunt the hypotensive effect of systemic clonidine. It is not known whether the concurrent use of these agents with apraclonidine can lead to a reduction in IOP lowering effect. No data on the level of circulating catecholamines after apraclonidine withdrawal are available. Caution, however, is advised in patients taking tricyclic antidepressants which can affect the metabolism and uptake of circulating amines. An additive hypotensive effect has been reported with the combination of systemic clonidine and neuroleptic therapy. Systemic clonidine may inhibit the production of catecholamines in response to insulin-induced hypoglycemia and mask the signs and symptoms of hypoglycemia. Since apraclonidine may re…
Adverse Reactions
ADVERSE REACTIONS In clinical studies the overall discontinuation rate related to apraclonidine ophthalmic solution 0.5% was 15%. The most commonly reported events leading to discontinuation included (in decreasing order of frequency) hyperemia, pruritus, tearing, discomfort, lid edema, dry mouth, and foreign body sensation. The following adverse reactions (incidences) were reported in clinical studies of apraclonidine ophthalmic solution 0.5% as being possibly, probably, or definitely related to therapy: Ocular The following adverse reactions were reported in 5% to 15% of the patients: discomfort, hyperemia, and pruritus. The following adverse reactions were reported in 1% to 5% of the patients: blanching, blurred vision, conjunctivitis, discharge, dry eye, foreign body sensation, lid edema, and tearing. The following adverse reactions were reported in less than 1% of the patients: abnormal vision, blepharitis, blepharoconjunctivitis, conjunctival edema, conjunctival follicles, corneal erosion, corneal infiltrate, corneal staining, edema, irritation, keratitis, keratopathy, lid disorder, lid erythema, lid margin crusting, lid retraction, lid scales, pain, and photophobia. Nonocula…
Frequently Asked Questions
What is Apraclonidine used for?
Apraclonidine contains Apraclonidine. It is a solution taken ophthalmic. Consult your doctor for specific uses.
Is Apraclonidine a controlled substance?
Apraclonidine is not classified as a controlled substance by the DEA.
What is the generic name for Apraclonidine?
The generic name for Apraclonidine is Apraclonidine. There are 1 other brand versions of Apraclonidine.
What is the NDC code for Apraclonidine 5.75 mg/mL?
The NDC (National Drug Code) for Apraclonidine 5.75 mg/mL is 61314-665, listed by Sandoz Inc.