Important Safety Information
ZIOPTAN® (tafluprost ophthalmic solution) 0.0015%
ZIOPTAN® (tafluprost ophthalmic solution) 0.0015% is a prostaglandin analog indicated for reducing elevated intraocular pressure in patients with
open-angle glaucoma or ocular hypertension.
ZIOPTAN® Important Safety Information
ZIOPTAN® has been reported to cause changes to pigmented tissues. The most frequently reported changes have been increased pigmentation of the iris, periorbital tissue (eyelid), and eyelashes. Pigmentation is expected to increase as long as ZIOPTAN® is administered. After discontinuation of ZIOPTAN®, pigmentation of the iris is likely to be permanent, while pigmentation of the periorbital tissue and eyelash changes have been reported to be reversible in some patients. Patients who receive treatment should be informed of the possibility of increased pigmentation. The long-term effects of increased pigmentation are not known. Iris color change may not be noticeable for several months to years. While treatment with ZIOPTAN® can be continued in patients who develop noticeably increased iris pigmentation, these patients should be examined regularly.
ZIOPTAN® may gradually change eyelashes and vellus hair in the treated eye. These changes include increased length, color, thickness, shape, and number of lashes. Eyelash changes are usually reversible on discontinuation of treatment.
ZIOPTAN® should be used with caution in patients with active intraocular inflammation (e.g., iritis/uveitis) because the inflammation may be exacerbated.
Macular edema, including cystoid macular edema, has been reported during treatment with prostaglandin F2α analogs. ZIOPTAN® should be used with caution in aphakic patients, in pseudophakic patients with a torn posterior lens capsule, or in patients with known risk factors for macular edema.
In clinical trials of patients receiving either preservative-containing or preservative-free ZIOPTAN®, the most common pooled adverse reaction observed was conjunctival hyperemia, which was reported in a range of 4% to 20% of patients.
COSOPT® PF (dorzolamide hydrochloride and timolol maleate ophthalmic solution) 2% / 0.5%
COSOPT® PF Indication
COSOPT® PF is a carbonic anhydrase inhibitor with a beta-adrenergic receptor blocking agent indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to beta-blockers.
COSOPT® PF Important Safety Information
COSOPT® PF is contraindicated in patients with bronchial asthma, a history of bronchial asthma, or severe chronic obstructive pulmonary disease, sinus bradycardia, second or third degree atrioventricular block, overt cardiac failure, and cardiogenic shock or hypersensitivity to any component of this product.
COSOPT® PF contains timolol maleate, a beta-adrenergic blocking agent; and although administered topically, is absorbed systemically. Therefore, the same types of adverse reactions that are attributable to systemic administration of beta-adrenergic blocking agents may occur with topical administration. For example, severe respiratory reactions, including death due to bronchospasm in patients with asthma, and rarely death in association with cardiac failure, have been reported following systemic or ophthalmic administration of timolol maleate.
BETIMOL® (timolol ophthalmic solution) 0.25%, 0.5%
Betimol® is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.
BETIMOL® Important Safety Information
Betimol® is contraindicated in patients with overt heart failure, cardiogenic shock, sinus bradycardia, second- or third-degree atrioventricular block, bronchial asthma or history of bronchial asthma, or severe chronic obstructive pulmonary disease, or hypersensitivity to any component of this product.
The most frequently reported ocular event in clinical trials was burning/stinging on instillation and was comparable between Betimol and timolol maleate (approximately one in eight patients).
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/MedWatch or call 1-800-FDA-1088.
AZASITE® (azithromycin ophthalmic solution) 0.1%
AzaSite is indicated for the treatment of bacterial conjunctivitis caused by susceptible isolates of the following microorganisms: CDC coryneform group G*, Haemophilus influenzae, Staphylococcus aureus, Streptococcus mitis group, Streptococcus pneumoniae.*Efficacy for this organism was studied in fewer than 10 infections.
AZASITE® Important Safety Information
AzaSite is contraindicated in patients with hypersensitivity to any component of this product.
AzaSite is NOT FOR INJECTION. AzaSite is for topical ophthalmic use only and should not be administered systemically, injected subconjunctivally, or introduced directly into the anterior chamber of the eye.
In patients receiving systemically administered azithromycin, serious allergic reactions, including angioedema, anaphylaxis, and dermatologic reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported rarely. Although rare, fatalities have been reported.
As with other anti-infectives, prolonged use may result in overgrowth of nonsusceptible organisms, including fungi. If super-infection occurs, discontinue use and institute alternative therapy.
Patients should be advised not to wear contact lenses if they have signs or symptoms of bacterial conjunctivitis.
The most frequently reported ocular adverse reaction reported in clinical trials was eye irritation, which occurred in 1% to 2% of patients. Other adverse reactions associated with the use of AzaSite were reported in less than 1% of patients and included ocular reactions (blurred vision, burning, stinging and irritation upon instillation, contact dermatitis, corneal erosion, dry eye, eye pain, itching, ocular discharge, punctate keratitis, visual acuity reduction) and nonocular reactions (dysgeusia, facial swelling, hives, nasal congestion, periocular swelling, rash, sinusitis, urticaria).
There are no adequate and well-controlled studies in pregnant women. Azithromycin should be used during pregnancy only if clearly needed.
It is not known whether azithromycin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when azithromycin is administered to a nursing woman.
Safety and effectiveness of AzaSite solution in pediatric patients below 1 year of age have not been established.
No overall differences in safety or effectiveness have been observed between elderly and younger patients.
The recommended dosage regimen for the treatment of bacterial conjunctivitis is: Instill 1 drop in the affected eye(s) twice daily, 8 to 12 hours apart, for the first 2 days and then instill 1 drop in the affected eye(s) once daily for the next 5 days.
Store unopened bottle under refrigeration at 2°C to 8°C (36°F–46°F). Once the bottle is opened, store at 2°C to 25°C (36°F–77°F) for up to 14 days. Discard after the 14 days.
*Valid prescription required. Purchases through EyeRx Direct® at the cash price may not be counted toward patient deductible or out-of-pocket costs. Patients with federal or state-funded prescription plans may not seek reimbursement from their plan for EyeRx Direct purchases and must not use their plan benefits for the remainder of the calendar year for any subsequent purchase of the Akorn product purchased through this program. for EyeRx Direct is not insurance. Patient is responsible for complying with applicable requirements of their plan. Valid only in the United States. Limitations may apply in CA and MA. Void where prohibited by law. Akorn reserves the right to rescind, revoke, or amend this program without notice.