How To Use Latanoprost Eye Drops

XALATAN®
(latanoprost) Ophthalmic Solution

DESCRIPTION

Latanoprost is a prostaglandin F2α analogue. Its chemic proper noun is isopropyl-(Z)-7[(1R,2R,3R,5S)three,5dihydroxy-2-[(3R)-3-hydroxy-5-phenylpentyl]cyclopentyl]-5-heptenoate. Its molecular formula is C₂₆H₄₀O₅ and its chemical structure is:

XALATAN® (latanoprost) Structural Formula Illustration

Latanoprost is a colorless to slightly xanthous oil that is very soluble in acetonitrile and freely soluble in acetone, ethanol, ethyl acetate, isopropanol, methanol, and octanol. It is practically insoluble in h2o.

XALATAN (latanoprost ophthalmic solution) 0.005% is supplied equally a sterile, isotonic, buffered aqueous solution of latanoprost with a pH of approximately 6.7 and an osmolality of approximately 267 mOsmol/kg. Each mL of XALATAN contains fifty mcg of latanoprost. Benzalkonium chloride, 0.02% is added as a preservative. The inactive ingredients are: sodium chloride, sodium dihydrogen phosphate monohydrate, disodium hydrogen phosphate anhydrous, and water for injection. Ane drop contains approximately ane.five mcg of latanoprost.

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INDICATIONS

XALATAN is indicated for the reduction of elevated intraocular force per unit area in patients with open up-angle glaucoma or ocular hypertension.

DOSAGE AND Administration

The recommended dosage is i drop in the affected centre(s) once daily in the evening. If one dose is missed, handling should go on with the next dose as normal.

The dosage of XALATAN should non exceed one time daily; the combined use of 2 or more than prostaglandins, or prostaglandin analogs including XALATAN is not recommended. It has been shown that administration of these prostaglandin drug products more than than in one case daily may subtract the intraocular pressure (IOP) lowering issue or cause paradoxical elevations in IOP.

Reduction of the IOP starts approximately three to 4 hours after assistants and the maximum effect is reached after eight to 12 hours.

XALATAN may be used concomitantly with other topical ophthalmic drug products to lower IOP. If more i topical ophthalmic drug is being used, the drugs should be administered at least v (5) minutes apart. Contact lenses should be removed prior to the administration of XALATAN, and may be reinserted 15 minutes afterward assistants

HOW SUPPLIED

Dosage Forms And Strengths

Sterile ophthalmic solution containing l mcg/mL latanoprost.

Storage And Treatment

XALATAN is a clear, isotonic, buffered, preserved colorless solution of latanoprost 0.005% (50 mcg/mL). Information technology is supplied as a 2.5 mL solution in a 5 mL clear low density polyethylene bottle with a articulate polyethylene dropper tip, a turquoise high density polyethylene screw cap, and a tamper-evident clear depression density polyethylene overcap.

2.5 mL fill up, 0.005% (l mcg/mL): Package of 1 bottle: NDC 0013-8303-04
2.five mL make full, 0.005% (50 mcg/mL): Multi-pack of 3 bottles: NDC 0013-8303-01

Storage

Protect from low-cal. Store unopened bottle(southward) nether refrigeration at 2° to 8°C (36° to 46°F). During shipment to the patient, the bottle may be maintained at temperatures up to 40°C (104°F) for a period non exceeding 8 days. One time a bottle is opened for apply, it may be stored at room temperature upward to 25°C (77°F) for 6 weeks.

Distributed past: Pharmacia & Upjohn Co., Division of Pfizer Inc., NY, NY 10017. Pfizer Manufacturing Belgium NV Puurs, Belgium. Revised: north/a

SLIDESHOW

Pink Heart (Conjunctivitis) Symptoms, Causes, Treatments See Slideshow

Side Effects & Drug Interactions

SIDE EFFECTS

The following adverse reactions were reported in postmarketing feel and are discussed in greater particular in other sections of the label:

Iris pigmentation changes [see WARNINGS AND PRECAUTIONS]
Eyelid skin darkening [see WARNINGS AND PRECAUTIONS]
Eyelash changes (increased length, thickness, pigmentation, and number of lashes) [see WARNINGS AND PRECAUTIONS]
Intraocular inflammation (iritis/uveitis) [come across WARNINGS AND PRECAUTIONS]
Macular edema, including cystoid macular edema [come across WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Considering clinical trials are conducted under widely varying conditions, the agin reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical exercise.

XALATAN was studied in three multicenter, randomized, controlled clinical trials. Patients received l mcg/mL XALATAN once daily or 5 mg/mL active-comparator (timolol) twice daily. The patient population studied had a hateful historic period of 65±ten years. Seven percent of patients withdrew earlier the 6-calendar month endpoint.

Table 1: Ocular Adverse Reactions and Ocular Signs/Symptoms Reported by 5-15% of Patients Receiving Latanoprost

Symptom/Finding	Adverse Reactions (incidence (%))
Symptom/Finding	Latanoprost (n=460)	Timolol (n=369)
Foreign body awareness	xiii	8
Punctate keratitis	10	9
Stinging	9	12
Conjunctival hyperemia	8	3
Blurred vision	8	eight
Itching	8	8
Burning	seven	8
Increased pigmentation of the Iris	7	0

Less than 1% of the patients treated with XALATAN required discontinuation of therapy because of intolerance to conjunctival hyperemia.

Table two: Agin Reactions That Were Reported in 1-5% of Patients Receiving Latanoprost

	Agin Reactions (incidence (%))
	Latanoprost (n=460)	Timolol (n=369)
Ocular Events/Signs and Symptoms
Excessive tearing	4	half dozen
Eyelid discomfort/pain	4	2
Dry out eye	3	3
Eye pain	3	iii
Eyelid margin crusting	3	iii
Erythema of the eyelid	3	ii
Photophobia	2	1
Eyelid edema	1	iii
Systemic Events
Upper respiratory tract infection/nasopharyngitis/influenza	3	iii
Myalgia/arthralgia/back pain	one	0.5
Rash/allergic skin reaction	1	0.3

The ocular upshot/signs and symptoms of blepharitis take been identified as "unremarkably observed" through analysis of clinical trial information.

Postmarketing Experience

The following reactions take been identified during postmarketing use of XALATAN in clinical practice. Considering they are reported voluntarily from a population of unknown size, it is not always possible to reliably guess their frequency or constitute a causal relationship to drug exposure. The reactions, which have been called for inclusion due to either their seriousness, frequency of reporting, possible causal connection to XALATAN, or a combination of these factors, include:

Nervous Arrangement disorders: Dizziness; headache; toxic epidermal necrolysis

Middle Disorders: Eyelash and vellus hair changes of the eyelid (increased length, thickness, pigmentation, and number of eyelashes); keratitis; corneal edema and erosions; intraocular inflammation (iritis/uveitis); macular edema, including cystoid macular edema; trichiasis; periorbital and lid changes resulting in deepening of the eyelid sulcus; iris cyst; eyelid peel darkening; localised skin reaction on the eyelids; conjunctivitis; pseudopemphigoid of the ocular conjunctiva

Respiratory, Thoracic and Mediastinal Disorders: Asthma and exacerbation of asthma; dyspnea

Peel and Subcutaneous Tissue Disorders: Pruritus

Infections and Infestations: Herpes keratitis

Cardiac Disorders: Angina; palpitations; angina unstable

General Disorders and Administration Site Weather: Breast pain

DRUG INTERACTIONS

In vitro studies take shown that atmospheric precipitation occurs when center drops containing thimerosal are mixed with XALATAN. If such drugs are used, they should be administered at least v (5) minutes autonomously.

The combined employ of two or more than prostaglandins, or prostaglandin analogs including XALATAN is not recommended. It has been shown that administration of these prostaglandin drug products more than than once daily may decrease the IOP lowering effect or cause paradoxical elevations in IOP.

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

Pigmentation

XALATAN 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 equally long as latanoprost is administered.

The pigmentation modify is due to increased melanin content in the melanocytes rather than to an increase in the number of melanocytes. Afterward discontinuation of latanoprost, 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. Across 5 years the effects of increased pigmentation are not known [see Clinical Studies].

Iris color change may non be noticeable for several months to years. Typically, the brown pigmentation around the pupil spreads concentrically towards the periphery of the iris and the entire iris or parts of the iris go more brownish. Neither nevi nor freckles of the iris appear to exist affected by handling. While treatment with XALATAN can be continued in patients who develop noticeably increased iris pigmentation, these patients should be examined regularly [see PATIENT Data].

Eyelash Changes

XALATAN may gradually change eyelashes and vellus pilus in the treated center; these changes include increased length, thickness, pigmentation, the number of lashes or hairs, and misdirected growth of eyelashes. Eyelash changes are usually reversible upon discontinuation of treatment [run across PATIENT INFORMATION].

Intraocular Inflammation

XALATAN should be used with caution in patients with a history of intraocular inflammation (iritis/uveitis) and should generally not exist used in patients with agile intraocular inflammation because inflammation may be exacerbated.

Macular Edema

Macular edema, including cystoid macular edema, has been reported during treatment with XALATAN. XALATAN should be used with circumspection in aphakic patients, in pseudophakic patients with a torn posterior lens capsule, or in patients with known risk factors for macular edema.

Herpetic Keratitis

Reactivation of Herpes Simplex keratitis has been reported during treatment with XALATAN. XALATAN should be used with caution in patients with a history of herpetic keratitis. XALATAN should exist avoided in cases of agile herpes simplex keratitis because inflammation may exist exacerbated.

Bacterial Keratitis

There have been reports of bacterial keratitis associated with the utilize of multiple-dose containers of topical ophthalmic products. These containers had been inadvertently contaminated by patients who, in most cases, had a concurrent corneal disease or a disruption of the ocular epithelial surface [see PATIENT Information].

Use With Contact Lenses

Contact lenses should be removed prior to the assistants of XALATAN, and may be reinserted 15 minutes after assistants.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment Of Fertility

Latanoprost was not carcinogenic in either mice or rats when administered by oral gavage at doses of upwardly to 170 mcg/kg/day (approximately 2800 times the recommended maximum human dose) for up to 20 and 24 months, respectively.

Latanoprost was not mutagenic in bacteria, in mouse lymphoma, or in mouse micronucleus tests. Chromosome aberrations were observed in vitro with human lymphocytes. Additional in vitro and in vivo studies on unscheduled DNA synthesis in rats were negative.

Latanoprost has not been plant to have any effect on male or female fertility in creature studies.

Utilise In Specific Populations

Pregnancy

Teratogenic Furnishings

Pregnancy Category C.

Reproduction studies have been performed in rats and rabbits. In rabbits, an incidence of 4 of 16 dams had no viable fetuses at a dose that was approximately eighty times the maximum human dose, and the highest nonembryocidal dose in rabbits was approximately 15 times the maximum human dose.

There are no adequate and well-controlled studies in pregnant women. XALATAN should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

Information technology is not known whether this drug or its metabolites are excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when XALATAN is administered to a nursing woman.

Pediatric Utilize

Safety and effectiveness in pediatric patients accept non been established.

Geriatric Utilize

No overall differences in safety or effectiveness accept been observed betwixt elderly and younger patients.

Overdose & Contraindications

OVERDOSE

Intravenous infusion of upwardly to three mcg/kg in healthy volunteers produced mean plasma concentrations 200 times higher than during clinical treatment and no agin reactions were observed. Intravenous dosages of v.5 to 10 mcg/kg acquired intestinal pain, dizziness, fatigue, hot flushes, nausea, and sweating. If overdosage with XALATAN occurs, handling should exist symptomatic.

CONTRAINDICATIONS

Known hypersensitivity to latanoprost, benzalkonium chloride, or any other ingredients in this production.

CLINICAL PHARMACOLOGY

Mechanism Of Action

Latanoprost is a prostanoid selective FP receptor agonist that is believed to reduce the intraocular force per unit area (IOP) by increasing the outflow of aqueous humour. Studies in animals and homo suggest that the primary machinery of action is increased uveoscleral outflow. Elevated IOP represents a major adventure factor for glaucomatous field loss. The college the level of IOP, the greater the likelihood of optic nervus harm and visual field loss.

Pharmacodynamics

Reduction of the IOP in man starts well-nigh 3-4 hours after administration and maximum event is reached afterwards eight-12 hours. IOP reduction is present for at least 24 hours.

Pharmacokinetics

Absorption

Latanoprost is captivated through the cornea where the isopropyl ester prodrug is hydrolyzed to the acrid form to become biologically active.

Distribution

The distribution volume in humans is 0.16 ± 0.02 L/kg. The acrid of latanoprost can be measured in aqueous humor during the starting time 4 hours, and in plasma only during the first hr after local administration. Studies in human indicate that the summit concentration in the aqueous humor is reached nigh two hours later on topical assistants.

Metabolism

Latanoprost, an isopropyl ester prodrug, is hydrolyzed past esterases in the cornea to the biologically active acid. The active acid of latanoprost reaching the systemic circulation is primarily metabolized past the liver to the 1,2-dinor and one,2,iii,four-tetranor metabolites via fatty acid β-oxidation.

Excretion

The elimination of the acid of latanoprost from human plasma is rapid (t½ = 17 min) after both intravenous and topical assistants. Systemic clearance is approximately 7 mL/min/kg. Following hepatic β-oxidation, the metabolites are mainly eliminated via the kidneys. Approximately 88% and 98% of the administered dose are recovered in the urine later topical and intravenous dosing, respectively.

Clinical Studies

Elevated Baseline IOP

Patients with hateful baseline IOP of 24 - 25 mmHg who were treated for 6 months in multi-heart, randomized, controlled trials demonstrated 6 - viii mmHg reductions in IOP. This IOP reduction with XALATAN 0.005% dosed in one case daily was equivalent to the effect of timolol 0.5% dosed twice daily.

Progression Of Increased Iris Pigmentation

A 3-year open-characterization, prospective safety report with a 2-yr extension phase was conducted to evaluate the progression of increased iris pigmentation with continuous employ of XALATAN once-daily as adjunctive therapy in 519 patients with open up-angle glaucoma. The analysis was based on observed-cases population of the 380 patients who continued in the extension stage.

Results showed that the onset of noticeable increased iris pigmentation occurred within the first twelvemonth of handling for the majority of the patients who developed noticeable increased iris pigmentation. Patients continued to prove signs of increasing iris pigmentation throughout the five years of the report. Observation of increased iris pigmentation did not affect the incidence, nature, or severity of adverse events (other than increased iris pigmentation) recorded in the study. IOP reduction was similar regardless of the development of increased iris pigmentation during the study.

PATIENT INFORMATION

Potential For Pigmentation

Advise patients near the potential for increased brown pigmentation of the iris, which may be permanent. Inform patients about the possibility of eyelid pare darkening, which may be reversible subsequently discontinuation of XALATAN [see WARNINGS AND PRECAUTIONS].

Potential For Eyelash Changes

Inform patients of the possibility of eyelash and vellus hair changes in the treated eye during treatment with XALATAN. These changes may upshot in a disparity between optics in length, thickness, pigmentation, number of eyelashes or vellus hairs, and/or management of eyelash growth. Eyelash changes are ordinarily reversible upon discontinuation of treatment.

Handling The Container

Instruct patients to avert allowing the tip of the dispensing container to contact the centre or surrounding structures considering this could cause the tip to become contaminated by mutual bacteria known to cause ocular infections. Serious harm to the centre and subsequent loss of vision may event from using contaminated solutions [see WARNINGS AND PRECAUTIONS].

When To Seek Physician Advice

Suggest patients that if they develop an intercurrent ocular status (e.g., trauma or infection) or accept ocular surgery, or develop any ocular reactions, particularly conjunctivitis and eyelid reactions, they should immediately seek their md'due south advice concerning the connected utilise of the multiple-dose container.

Apply With Contact Lenses

Advise patients that XALATAN contains benzalkonium chloride, which may exist absorbed by contact lenses. Contact lenses should exist removed prior to administration of the solution. Lenses may be reinserted 15 minutes post-obit administration of XALATAN.

Use With Other Ophthalmic Drugs

If more one topical ophthalmic drug is beingness used, the drugs should exist administered at least five (5) minutes apart.

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