زالاتان
Latanoprost Ophthalmic (Xalatan)
زالاتان

نام ژنریک

Latanoprost

شکل دارویی

اشكال دارويي:


Solution: 50 mcg/ml


Drop: Latanoprost 50 mcg + Timolol (As Maleate) 5 mg

موارد مصرف

موارد و مقدار مصرف


درمان خط اول افزايش فشار داخل چشمي در بيماران با هيپرتانسيون چشمي يا گلوکوم با زاويه باز:


بزرگسالان: يک قطره در ساک ملتحمه در چشم آسيب ديده، يک بار در روز عصرها بچکانيد.


مكانيسم اثر


اثر ضد گلوکوم و ضد افزايش فشار چشمي: مکانيسم دقيق آن مشخص نمي‌باشد. دارو مي‌تواند فشار داخل چشم را با افزايش جريان مايع زلاليه کاهش دهد.


فارماکوکينتيک


جذب: از طريق قرنيه جذب مي‌شود.


پخش: حجم پخش آن L/kg 0.16 مي‌باشد. اسيد لاتانوپروست در مايع زلاليه در مدت 4 ساعت اول و در پلاسما فقط در ساعت اول پس از مصرف موضعي قابل اندازه گيري مي‌باشد.


متابوليسم: بوسيله استرازها در قرنيه هيدروليز شده و به اسيد فعال بيولوژيک تبديل مي‌شود. اسيد فعال دارو که به جريان خون سيستميک مي‌رسد، بوسيله کبد متابوليزه مي‌شود.


دفع: متابوليتها عمدتاً از طريق ادرار دفع مي‌شوند.

موارد منع مصرف

اثر بر آزمايشهاي تشخيصي


مورد خاصي گزارش نشده است.

موارد قابل توجه

-

تداخل دارویی

عوارض جانبي


قلبي ـ عروقي: آنژين صدري، درد قفسه سينه.


چشم، گوش، حلق، بيني: تاري ديد، سوزش، پر خوني ملتحمه، کونژکتيويت، دو بيني، خشکي چشم، افزايش ريزش اشک، درد چشم يا ترشح، کراسته شدن پلک، ادم، اريتم، ناراحتي يا درد، احساس جسم خارجي، کراتيت هرپس سيمپلکس، افزايش پيگمانتاسيون عنبيه، خارش، فتوفوبي، کراتوپاتي نقطه نقطه اپيتليال، تيرگي پوست پلک، افزايش طول، ضخامت و تعداد مژه ها.


عضلاني - اسکلتي: درد پشت، مفصل يا عضله.


تنفسي: آسم، عفونت دستگاه تنفسي فوقاني.


پوست: واکنشهاي حساسيت پوستي، راش.


ساير عوارض: سرماخوردگي، آنفلوانزا.


مسموميت و درمان


تظاهرات باليني: جداي از حساسيت چشمي و پرخوني کونژکتيوا يا اپي اسکلرا، اثرات چشمي لاتانوپروست در دوزهاي بالا شناخته شده نمي‌باشد.


درمان: در صورت مصرف بيش از حد دارو، درمان به صورت علامتي مي‌باشد.

مکانیزم اثر

عوارض جانبي


قلبي ـ عروقي: آنژين صدري، درد قفسه سينه.


چشم، گوش، حلق، بيني: تاري ديد، سوزش، پر خوني ملتحمه، کونژکتيويت، دو بيني، خشکي چشم، افزايش ريزش اشک، درد چشم يا ترشح، کراسته شدن پلک، ادم، اريتم، ناراحتي يا درد، احساس جسم خارجي، کراتيت هرپس سيمپلکس، افزايش پيگمانتاسيون عنبيه، خارش، فتوفوبي، کراتوپاتي نقطه نقطه اپيتليال، تيرگي پوست پلک، افزايش طول، ضخامت و تعداد مژه ها.


عضلاني - اسکلتي: درد پشت، مفصل يا عضله.


تنفسي: آسم، عفونت دستگاه تنفسي فوقاني.


پوست: واکنشهاي حساسيت پوستي، راش.


ساير عوارض: سرماخوردگي، آنفلوانزا.


مسموميت و درمان


تظاهرات باليني: جداي از حساسيت چشمي و پرخوني کونژکتيوا يا اپي اسکلرا، اثرات چشمي لاتانوپروست در دوزهاي بالا شناخته شده نمي‌باشد.


درمان: در صورت مصرف بيش از حد دارو، درمان به صورت علامتي مي‌باشد.

فارماكوكینتیك

تداخل دارويي


وقتي قطره‌هاي چشمي حاوي تيمروسال با لاتانوپروست ترکيب شوند، مي‌توانند رسوب ايجاد کنند. در صورت استفاده همزمان از اين دو دارو، دوزهاي مجزا با حداقل 5 دقيقه فاصله مصرف شود.


بتا بلاکرهاي موضعي مانند بتاکسولول، کارتئولول، لووبونولول، متي پرانولول و تيمولول، مهار کننده خوراکي کربونيک انهيدراز مانند استازولاميد، مهار کننده موضعي کربنيک انهيدراز مانند دورزولاميد، ديپي وفرين موضعي و اپي نفرين موضعي اثر کاهندگي فشار داخل چشم را افزايش مي‌دهند. اين اثر مي‌تواند از لحاظ درماني مفيد باشد. اما در استفاده تو ام با داروهاي موضعي ديگر، بين مصرف دوزها حداقل 5 دقيقه فاصله باشد.

سایر اطلاعات

طبقه‌بندي فارماكولوژيك: آگونيست پروستاگلاندين


طبقه‌بندي درماني: داروي ضد گلوکوم، کاهنده فشار چشمي.


طبقه‌بندي مصرف در بارداري: رده C


نام‌هاي تجاري: Xalatan


ملاحظات اختصاصي


1- لاتانوپروست مي‌تواند به تدريج باعث تغيير رنگ چشم و افزايش مقدار پيگمان قهوه‌اي در عنبيه شود. تغيير در رنگ عنبيه به آهستگي ايجاد شده و براي ماهها تا سالها قابل توجه نمي‌باشد. افزايش پيگمانتاسيون ممکن است دائمي باشد.


2- دارو در معرض نور قرار نگيرد. قطره باز نشده در يخچال نگه داري شود.


نكات قابل توصيه به بيمار


1- به علت خطر افزايش پيگمانتاسيون قهوه‌اي در چشم درمان شده همچنين تنوع رنگ بين چشمها، بيمار تنها از يک چشم درمان شود.


2- دارو مي‌تواند تيرگي پلک يا افزايش طول، ضخامت يا تعداد مژه‌ها را باعث شود. اين تغييرات مي‌تواند دائمي باشد يا نباشد.


3- چکاندن قطره را به بيمار آموزش دهيد. به او توصيه کنيد که قبل و بعد از چکاندن قطره دستها را شسته و نوک قطره چکان را لمس نکرده و به داخل چشم و بافتهاي اطراف برخورد نکند.


4- پس از چکاندن قطره، براي کاهش جذب سيستميک دارو، با انگشت به آرامي به اندازه 1 دقيقه روي ساک اشکي فشار وارد کنيد.


5- واکنشهاي چشمي بويژه کونژکتيويت و واکنشهاي پلک گزارش شود.


6- لنزهاي تماسي قبل از چکاندن قطره خارج شده و تا 15 دقيقه پس از چکاندن قطره دوباره در چشم قرار نگيريد.


7- در صورت استفاده از بيش از يک داروي موضعي چشمي، بين مصرف آنها حداقل 5 دقيقه فاصله باشد.


کمپليانس بيمار براي انجام درمان توصيه شده، بسيار مهم مي‌باشد.


مصرف در کودکان: بي خطري و کارايي دارو در کودکان اثبات نشده است.


مصرف در شيردهي: ترشح دارو در شير نامشخص مي‌باشد. با احتياط مصرف شود.

Latanoprost Ophthalmic (Xalatan)

Xalatan®
(latanoprost) Ophthalmic Solution 0.005% (50 μg/mL)

DRUG DESCRIPTION

Latanoprost is a prostaglandin F2α analogue. Its chemical name is isopropyl-(Z)7[(1R,2R,3R,5S)3,5-dihydroxy-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 yellow oil that is very soluble in acetonitrile and freely soluble in acetone, ethanol, ethyl acetate, isopropanol, methanol, and octanol. It is practically insoluble in water.

XALATAN Sterile Ophthalmic Solution (latanoprost ophthalmic solution) is supplied as 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 50 micrograms 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. One drop contains approximately 1.5 μg of latanoprost.

What are the possible side effects of latanoprost ophthalmic (Xalatan, Xalatan Multi-Pack)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using latanoprost ophthalmic and call your doctor at once if you have any of these serious side effects:

  • redness, swelling, itching, or pain in or around your eye;
  • oozing or discharge from your eye;
  • increased sensitivity to light;
  • vision changes; or
  • chest pain.

Less serious side effects may include:

  • cold symptoms such as...

Read All Potential Side Effects and See Pictures of Xalatan »

What are the precautions when taking latanoprost ophthalmic (Xalatan)?

Before using latanoprost, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as preservatives like benzalkonium chloride), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: an active swelling process within the eye (e.g., iritis, uveitis).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: other eye problems (e.g., macular edema, history of iritis/uveitis, lens extraction/aphakia), contact lens use.

If you develop an eye infection or...

Read All Potential Precautions of Xalatan »

Last reviewed on RxList: 3/26/2012
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

XALATAN Sterile Ophthalmic Solution is indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.

DOSAGE AND ADMINISTRATION

The recommended dosage is one drop (1.5 μg) in the affected eye(s) once daily in the evening. If one dose is missed, treatment should continue with the next dose as normal.

The dosage of XALATAN Sterile Ophthalmic Solution should not exceed once daily; the combined use of two or more prostaglandins, or prostaglandin analogs including XALATAN Sterile Ophthalmic Solution is not recommended. It has been shown that administration of these prostaglandin drug products more than once daily may decrease the intraocular pressure lowering effect or cause paradoxical elevations in IOP.

Reduction of the intraocular pressure starts approximately 3 to 4 hours after administration and the maximum effect is reached after 8 to 12 hours.

XALATAN may be used concomitantly with other topical ophthalmic drug products to lower intraocular pressure. If more than one topical ophthalmic drug is being used, the drugs should be administered at least five (5) minutes apart.

HOW SUPPLIED

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

2.5 mL fill, 0.005% (50 μg/mL)

Package of 1 bottle NDC 0013-8303-04

Storage

Protect from light. Store unopened bottle(s) under 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 not exceeding 8 days. Once a bottle is opened for use, it may be stored at room temperature up to 25°C (77°F) for 6 weeks.

Distributed by: Pharmacia & Upjohn Co., Division of Pfizer Inc, NY, NY 10017. Manufactured By: Catalent Pharma Solutions Woodstock, IL 60098, USA. Pfizer Manufacturing Belgium NV Puurs, Belgium. Revised August 2011

Last reviewed on RxList: 3/26/2012
This monograph has been modified to include the generic and brand name in many instances.

SIDE EFFECTS

Adverse events referred to in other sections of this insert

Eyelash changes (increased length, thickness, pigmentation, and number of lashes); eyelid skin darkening; intraocular inflammation (iritis/uveitis); iris pigmentation changes; and macular edema, including cystoid macular edema (see WARNINGS and PRECAUTIONS).

Controlled Clinical Trials

The ocular adverse events and ocular signs and symptoms reported in 5 to 15% of the patients on XALATAN Sterile Ophthalmic Solution in the three 6-month, multi-center, double-masked, active-controlled trials were blurred vision, burning and stinging, conjunctival hyperemia, foreign body sensation, itching, increased pigmentation of the iris, and punctate epithelial keratopathy.

Local conjunctival hyperemia was observed; however, less than 1% of the patients treated with XALATAN required discontinuation of therapy because of intolerance to conjunctival hyperemia.

In addition to the above listed ocular events/signs and symptoms, the following were reported in 1 to 4% of the patients: dry eye, excessive tearing, eye pain, lid crusting, lid discomfort/pain, lid edema, lid erythema, and photophobia.

The following events were reported in less than 1% of the patients: conjunctivitis, diplopia, and discharge from the eye.

During clinical studies, there were extremely rare reports of the following: retinal artery embolus, retinal detachment, and vitreous hemorrhage from diabetic retinopathy.

The most common systemic adverse events seen with XALATAN were upper respiratory tract infection/cold/flu, which occurred at a rate of approximately 4%. Chest pain/angina pectoris, muscle/joint/back pain, and rash/allergic skin reaction each occurred at a rate of 1 to 2%.

Clinical Practice

The following events have been identified during postmarketing use of XALATAN in clinical practice. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. The events, which have been chosen for inclusion due to either their seriousness, frequency of reporting, possible causal connection to XALATAN, or a combination of these factors, include: asthma and exacerbation of asthma; corneal edema and erosions; dyspnea; eyelash and vellus hair changes (increased length, thickness, pigmentation, and number); eyelid skin darkening; herpes keratitis; intraocular inflammation (iritis/uveitis); keratitis; macular edema, including cystoid macular edema; misdirected eyelashes sometimes resulting in eye irritation; dizziness, headache, and toxic epidermal necrolysis; periorbital and lid changes resulting in deepening of the eyelid sulcus.

Read the Xalatan (latanoprost ophthalmic) Side Effects Center for a complete guide to possible side effects »

DRUG INTERACTIONS

In vitro studies have shown that precipitation occurs when eye drops containing thimerosal are mixed with XALATAN. If such drugs are used, they should be administered at least five (5) minutes apart.

Last reviewed on RxList: 3/26/2012
This monograph has been modified to include the generic and brand name in many instances.

WARNINGS

XALATAN Sterile Ophthalmic Solution 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, and growth of eyelashes. Pigmentation is expected to increase as long as XALATAN is administered. After discontinuation of XALATAN, 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 effects of increased pigmentation beyond 5 years are not known.

PRECAUTIONS

General

XALATAN Sterile Ophthalmic Solution may gradually increase the pigmentation of the iris. The eye color change is due to increased melanin content in the stromal melanocytes of the iris rather than to an increase in the number of melanocytes. This change may not be noticeable for several months to years (see WARNINGS). Typically, the brown pigmentation around the pupil spreads concentrically towards the periphery of the iris and the entire iris or parts of the iris become more brownish. Neither nevi nor freckles of the iris appear to be affected by treatment. While treatment with XALATAN can be continued in patients who develop noticeably increased iris pigmentation, these patients should be examined regularly.

During clinical trials, the increase in brown iris pigment has not been shown to progress further upon discontinuation of treatment, but the resultant color change may be permanent.

Eyelid skin darkening, which may be reversible, has been reported in association with the use of XALATAN (see WARNINGS).

XALATAN may gradually change eyelashes and vellus hair in the treated eye; 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.

XALATAN should be used with caution in patients with a history of intraocular inflammation (iritis/uveitis) and should generally not be used in patients with active intraocular inflammation.

Macular edema, including cystoid macular edema, has been reported during treatment with XALATAN. These reports have mainly occurred in aphakic patients, in pseudophakic patients with a torn posterior lens capsule, or in patients with known risk factors for macular edema. XALATAN should be used with caution in patients who do not have an intact posterior capsule or who have known risk factors for macular edema.

There is limited experience with XALATAN in the treatment of angle closure, inflammatory or neovascular glaucoma.

There have been reports of bacterial keratitis associated with the use 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).

Contact lenses should be removed prior to the administration of XALATAN, and may be reinserted 15 minutes after administration (see PATIENT INFORMATION).

Carcinogenesis, Mutagenesis, Impairment of Fertility

Latanoprost was not mutagenic in bacteria, in mouse lymphoma, or in mouse micronucleus tests.

Chromosome aberrations were observed in vitro with human lymphocytes.

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

Additional in vitro and in vivo studies on unscheduled DNA synthesis in rats were negative. Latanoprost has not been found to have any effect on male or female fertility in animal studies.

Pregnancy

Teratogenic Effects - 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 80 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

It 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 Use

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

No overall differences in safety or effectiveness have been observed between elderly and younger patients.

Last reviewed on RxList: 3/26/2012
This monograph has been modified to include the generic and brand name in many instances.

OVERDOSE

Apart from ocular irritation and conjunctival or episcleral hyperemia, the ocular effects of latanoprost administered at high doses are not known. Intravenous administration of large doses of latanoprost in monkeys has been associated with transient bronchoconstriction; however, in 11 patients with bronchial asthma treated with latanoprost, bronchoconstriction was not induced. Intravenous infusion of up to 3 μg/kg in healthy volunteers produced mean plasma concentrations 200 times higher than during clinical treatment and no adverse reactions were observed. Intravenous dosages of 5.5 to 10 μg/kg caused abdominal pain, dizziness, fatigue, hot flushes, nausea, and sweating.

If overdosage with XALATAN Sterile Ophthalmic Solution occurs, treatment should be symptomatic.

CONTRAINDICATIONS

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

Last reviewed on RxList: 3/26/2012
This monograph has been modified to include the generic and brand name in many instances.

CLINICAL PHARMACOLOGY

Mechanism of Action

Latanoprost is a prostanoid selective FP receptor agonist that is believed to reduce the intraocular pressure (IOP) by increasing the outflow of aqueous humor. Studies in animals and man suggest that the main mechanism of action is increased uveoscleral outflow. Elevated IOP represents a major risk factor for glaucomatous field loss. The higher the level of IOP, the greater the likelihood of optic nerve damage and visual field loss.

Pharmacokinetics/Pharmacodynamics

Absorption

Latanoprost is absorbed through the cornea where the isopropyl ester prodrug is hydrolyzed to the acid form to become biologically active. Studies in man indicate that the peak concentration in the aqueous humor is reached about two hours after topical administration.

Distribution

The distribution volume in humans is 0.16 ± 0.02 L/kg. The acid of latanoprost can be measured in aqueous humor during the first 4 hours, and in plasma only during the first hour after local administration.

Metabolism

Latanoprost, an isopropyl ester prodrug, is hydrolyzed by esterases in the cornea to the biologically active acid. The active acid of latanoprost reaching the systemic circulation is primarily metabolized by the liver to the 1,2-dinor and 1,2,3,4-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 administration. 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 after topical and intravenous dosing, respectively.

Animal Studies

In monkeys, latanoprost has been shown to induce increased pigmentation of the iris. The mechanism of increased pigmentation seems to be stimulation of melanin production in melanocytes of the iris, with no proliferative changes observed. The change in iris color may be permanent.

Ocular administration of latanoprost at a dose of 6 μg/eye/day (4 times the daily human dose) to cynomolgus monkeys has also been shown to induce increased palpebral fissure. This effect was reversible upon discontinuation of the drug.

Clinical Studies

Patients with mean baseline intraocular pressure of 24 – 25 mmHg who were treated for 6 months in multi-center, randomized, controlled trials demonstrated 6 – 8 mmHg reductions in intraocular pressure. This IOP reduction with XALATAN Sterile Ophthalmic Solution 0.005% dosed once daily was equivalent to the effect of timolol 0.5% dosed twice daily.

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

Results showed that the onset of noticeable increased iris pigmentation occurred within the first year of treatment for the majority of the patients who developed noticeable increased iris pigmentation. Patients continued to show signs of increasing iris pigmentation throughout the five years of the study. 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.

Last reviewed on RxList: 3/26/2012
This monograph has been modified to include the generic and brand name in many instances.

PATIENT INFORMATION

Information for Patients (see WARNINGS and PRECAUTIONS): Patients should be advised about the potential for increased brown pigmentation of the iris, which may be permanent. Patients should also be informed about the possibility of eyelid skin darkening, which may be reversible after discontinuation of XALATAN.

Patients should also be informed of the possibility of eyelash and vellus hair changes in the treated eye during treatment with XALATAN. These changes may result in a disparity between eyes in length, thickness, pigmentation, number of eyelashes or vellus hairs, and/or direction of eyelash growth. Eyelash changes are usually reversible upon discontinuation of treatment.

Patients should be instructed to avoid allowing the tip of the dispensing container to contact the eye or surrounding structures because this could cause the tip to become contaminated by common bacteria known to cause ocular infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions.

Patients also should be advised that if they develop an intercurrent ocular condition (e.g., trauma or infection) or have ocular surgery, they should immediately seek their physician's advice concerning the continued use of the multiple-dose container.

Patients should be advised that if they develop any ocular reactions, particularly conjunctivitis and lid reactions, they should immediately seek their physician's advice.

Patients should also be advised that XALATAN contains benzalkonium chloride, which may be absorbed by contact lenses. Contact lenses should be removed prior to administration of the solution. Lenses may be reinserted 15 minutes following administration of XALATAN.

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

Last reviewed on RxList: 3/26/2012
This monograph has been modified to include the generic and brand name in many instances.

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PATIENT INFORMATION

Information for Patients (see WARNINGS and PRECAUTIONS): Patients should be advised about the potential for increased brown pigmentation of the iris, which may be permanent. Patients should also be informed about the possibility of eyelid skin darkening, which may be reversible after discontinuation of XALATAN.

Patients should also be informed of the possibility of eyelash and vellus hair changes in the treated eye during treatment with XALATAN. These changes may result in a disparity between eyes in length, thickness, pigmentation, number of eyelashes or vellus hairs, and/or direction of eyelash growth. Eyelash changes are usually reversible upon discontinuation of treatment.

Patients should be instructed to avoid allowing the tip of the dispensing container to contact the eye or surrounding structures because this could cause the tip to become contaminated by common bacteria known to cause ocular infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions.

Patients also should be advised that if they develop an intercurrent ocular condition (e.g., trauma or infection) or have ocular surgery, they should immediately seek their physician's advice concerning the continued use of the multiple-dose container.

Patients should be advised that if they develop any ocular reactions, particularly conjunctivitis and lid reactions, they should immediately seek their physician's advice.

Patients should also be advised that XALATAN contains benzalkonium chloride, which may be absorbed by contact lenses. Contact lenses should be removed prior to administration of the solution. Lenses may be reinserted 15 minutes following administration of XALATAN.

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

Last reviewed on RxList: 3/26/2012
This monograph has been modified to include the generic and brand name in many instances.

Disclaimer

Xalatan Consumer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

LATANOPROST - OPHTHALMIC SOLUTION

(lay-TAN-oh-prost)

COMMON BRAND NAME(S): Xalatan

USES: Latanoprost is used to treat high pressure inside the eye due to glaucoma (open angle type) or other eye diseases (e.g., ocular hypertension). It is similar to a natural chemical in the body (prostaglandin) and works by regulating the flow of fluid within the eye which results in lower pressure. Lowering high pressure inside the eye helps to prevent blindness.

HOW TO USE: Apply this medication in the affected eye(s) usually once daily in the evening, or as directed by your doctor. Do not use this medication more frequently than prescribed; using more can decrease effectiveness.

To apply eye drops, wash your hands first. To avoid contamination, do not touch the dropper tip or let it touch your eye or any other surface.

The preservative in this product may be absorbed by contact lenses. If you wear contact lenses, remove them before using this medication and keep them out of your eyes for at least 15 minutes after applying latanoprost.

Tilt your head back, look upward and pull down the lower eyelid to make a pouch. Hold the dropper directly over your eye and apply the prescribed number of drops. Look downward and gently close your eye for 1 to 2 minutes. Place one finger at the inside corner of your eye near the nose and apply gentle pressure. This will prevent the medication from draining out. Try not to blink and do not rub your eye.

Do not rinse the dropper. Replace the dropper cap after each use.

Use this medication regularly in order to get the most benefit from it. Remember to use it at the same time each day. It is important to continue using latanoprost even if you feel well. Most people with glaucoma or high pressure in the eye do not feel sick.

If you are using another kind of eye medication (e.g., drops or ointments), wait at least 5 minutes before applying other products. Use eye drops before eye ointments to allow the eye drops to enter the eye.

Disclaimer

Xalatan Consumer (continued)

SIDE EFFECTS: Blurred vision, burning/stinging/itching/redness of the eye, feeling as if something is in the eye, changes in eyelash number/color/length/thickness, eyelid changes/skin darkening, dry eye, lid crusting/discomfort, increased sensitivity to light, flu-like symptoms, or muscle/joint pain may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

This medication may slowly (over months to years) cause brown discoloration of the colored portion of the eye (iris). If you are using latanoprost in only one eye, only that iris may change color. This color change may be permanent but the long-term effects are uncertain. Notify your doctor if this occurs and schedule regular eye exams to monitor it.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: eye pain, suspected eye infection (unusual redness or swelling of eyes), chest pain.

Tell your doctor immediately if any of these highly unlikely but very serious side effects occur: rapid vision changes (e.g., loss of vision).

A serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, severe itching/swelling (especially of the face/tongue/throat), dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the Xalatan (latanoprost ophthalmic) Side Effects Center for a complete guide to possible side effects »

PRECAUTIONS: Before using latanoprost, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as preservatives like benzalkonium chloride), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: an active swelling process within the eye (e.g., iritis, uveitis).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: other eye problems (e.g., macular edema, history of iritis/uveitis, lens extraction/aphakia), contact lens use.

If you develop an eye infection or injury, or have eye surgery, check with your doctor about the continued use of your current bottle of latanoprost. You may be advised to start using a new bottle.

Your vision may be temporarily blurred or unstable after applying this drug. Do not drive, use machinery, or do any activity that requires clear vision until you are sure you can perform such activities safely.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

Disclaimer

Xalatan Consumer (continued)

DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with them first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: eyelash treatment (such as topically applied bimatoprost).

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly. This medicine may be harmful if swallowed.

NOTES: Do not share this medication with others.

Laboratory and/or medical tests (e.g., eye exams) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

MISSED DOSE: If you miss a dose, use it as soon as you remember if it is on the same day. If you do not remember until the next day, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: US Product: Store the unopened bottles in the refrigerator between 36-46 degrees F (2-8 degrees C). Once a bottle is opened for use, it may be stored at room temperature (up to 77 degrees F or 25 degrees C) for 6 weeks. Discard any opened, unused bottles after this time period.

Canadian Product: Store the unopened bottles in the refrigerator between 36-46 degrees F (2-8 degrees C). Once a bottle is opened for use, store it in a cool place (refrigerate if possible) for 6 weeks. Discard any opened, unused bottles after this time period.

Store away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised April 2012. Copyright(c) 2012 First Databank, Inc.

Xalatan Patient Information Including Side Effects

Brand Names: Xalatan, Xalatan Multi-Pack

Generic Name: latanoprost ophthalmic (Pronunciation: la TAN oh prost)

What is latanoprost ophthalmic (Xalatan)?

Latanoprost reduces pressure in the eye by increasing the amount of fluid that drains from the eye.

Latanoprost ophthalmic (for the eyes) is used to treat certain types of glaucoma and other causes of high pressure inside the eye.

Latanoprost ophthalmic may also be used for purposes not listed in this medication guide.

What are the possible side effects of latanoprost ophthalmic (Xalatan)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using latanoprost ophthalmic and call your doctor at once if you have any of these serious side effects:

  • redness, swelling, itching, or pain in or around your eye;
  • oozing or discharge from your eye;
  • increased sensitivity to light;
  • vision changes; or
  • chest pain.

Less serious side effects may include:

  • cold symptoms such as stuffy nose, sneezing, sore throat;
  • headache, dizziness;
  • mild eye discomfort;
  • blurred vision;
  • feeling like something is in your eye;
  • dry or watery eyes; or
  • stinging or burning of the eyes after using the drops.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the Xalatan (latanoprost ophthalmic) Side Effects Center for a complete guide to possible side effects »

What is the most important information I should know about latanoprost ophthalmic (Xalatan)?

Do not use this medication while wearing contact lenses. Latanoprost ophthalmic may contain a preservative that can discolor soft contact lenses. Wait at least 15 minutes after using latanoprost ophthalmic before putting your contact lenses in.

Latanoprost ophthalmic may cause a gradual change in the color of your eyes or eyelids and lashes, as well as increased growth or thickness of your eyelashes. These color changes, usually an increase in brown pigment, occur slowly and you may not notice them for months or years. Color changes may be permanent even after your treatment ends, and may occur only in the eye being treated. This could result in a cosmetic difference in eye or eyelash color from one eye to the other.

Do not allow the tip of the dropper to touch any surface, including your eyes or hands. If the dropper becomes contaminated it could cause an infection in your eye, which can lead to vision loss or serious damage to the eye.

After using this medication, wait at least 5 minutes before using any other eye drops that your doctor has prescribed.

Side Effects Centers

Xalatan Patient Information including How Should I Take

What should I discuss with my health care provider before using latanoprost ophthalmic (Xalatan)?

Do not use this medication if you are allergic to latanoprost.

To make sure you can safely use latanoprost ophthalmic, tell your doctor if you have swelling or infection of your eye.

Latanoprost ophthalmic may cause a gradual change in the color of your eyes or eyelids and lashes, as well as increased growth or thickness of your eyelashes. These color changes, usually an increase in brown pigment, occur slowly and you may not notice them for months or years. Color changes may be permanent even after your treatment ends, and may occur only in the eye being treated. This could result in a cosmetic difference in eye or eyelash color from one eye to the other.

FDA pregnancy category C. It is not known whether latanoprost ophthalmic will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether latanoprost passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I use latanoprost ophthalmic (Xalatan)?

Do not use this medication while wearing contact lenses. Latanoprost ophthalmic may contain a preservative that can discolor soft contact lenses. Wait at least 15 minutes after using latanoprost ophthalmic before putting your contact lenses in.

Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Wash your hands before using the eye drops.

To apply the eye drops:

  • Tilt your head back slightly and pull down your lower eyelid to create a small pocket. Hold the dropper above the eye with the tip down. Look up and away from the dropper as you squeeze out a drop, then close your eye.
  • Use only the number of drops your doctor has prescribed.
  • Gently press your finger to the inside corner of the eye (near your nose) for about 1 minute to keep the liquid from draining into your tear duct.
  • If you use more than one drop in the same eye, wait about 5 minutes before putting in the next drop.
  • Wait at least 10 minutes before using any other eye drops that your doctor has prescribed.

Do not allow the tip of the dropper to touch any surface, including your eyes or hands. If the dropper becomes contaminated it could cause an infection in your eye, which can lead to vision loss or serious damage to the eye.

Tell your doctor right away if you have any eye injury or infection, or if you need to have any type of surgery, especially eye surgery.

Do not use the eye drops if the liquid changes colors or has particles in it.

Store an unopened bottle of latanoprost eye drops in a refrigerator.

Once you have opened and begun using the drops, you may store them at room temperature, away from moisture, heat, and light. Keep the bottle tightly closed when not in use.

Do not use the eye drops if it has been longer than 6 weeks since you first opened the bottle. If you still need to use the medication, call your doctor for a new prescription.

Side Effects Centers

Xalatan Patient Information including If I Miss a Dose

What happens if I miss a dose (Xalatan)?

If you forget to use the eye drops, skip the missed dose and use the medicine at the next regularly scheduled time. Do not use extra medicine to make up the missed dose.

What happens if I overdose (Xalatan)?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while using latanoprost ophthalmic (Xalatan)?

Avoid using too much of this medication, which can actually make it less effective in lowering the pressure inside the eye.

Do not use other eye medications unless your doctor tells you to.

What other drugs will affect latanoprost ophthalmic (Xalatan)?

There may be other drugs that can interact with latanoprost ophthalmic. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about latanoprost ophthalmic.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 8.01. Revision date: 2/1/2011.

Your use of the content provided in this service indicates that you have read,understood and agree to the End-User License Agreement,which can be accessed by clicking on this link.

Healthwise

Side Effects Centers

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