ویروسید
Trifluridine (Viroptic)
ویروسید

نام ژنریک

Trifluridine

شکل دارویی

اشكال دارويي:


Drop: 1%

موارد مصرف

موارد و مقدار مصرف


درمان التهاب اوليه قرنيه و ملتحمه و التهاب عودكننده بافت اپي‌تليال قرنيه ناشي از ويروس هرپس سيمپلكس نوع 1 و 2


بزرگسالان: در هنگام بيداري، يك قطره هر دو ساعت در چشم مورد نظر، حداكثر 9 قطره در روز تا التيام كامل بافت پوششي قرنيه ؛ بعد از التيام نيز، يك قطره هر چهار ساعت (حداقل پنج قطره در روز)، به مدت هفت روز ديگر استفاده مي‌گردد.


مكانيسم اثر


اثر ضد ويروس:‌ مكانيسم دقيق اثر دارو مشخص نيست، اما به نظر مي‌رسد اين دارو در ساخت DNA تداخل كرده و از تكثير سلولي ويروسها جلوگيري مي‌كند. اين دارو بر ويروس تبخال ساده نوع يك و دو و ويروس واكسينيا مؤثر است.

موارد منع مصرف

عوارض جانبي


چشم:‌ سوزش ، احساس گزش، تحريك، اشك ريزش، ادم پلكها ، پرخوني، كراتوپاتي سطحي نقطه‌دار، كراتوپاتي اپي تليال، ادم استرومايي ، كراتيت سيكا، افزايش فشار داخل چشم.


مسموميت و درمان


تظاهرات باليني: سميت داروي بلعيده شده مشخص نيست.


درمان: در صورت بلع مقادير زياد دارو، انجام اقدامات عمومي، مانند واداشتن بيمار به استفراغ، شستشوي معده با مصرف يك مسهل، از جذب دارو جلوگيري مي‌كند. در صورت تماس دارو با پوست ، موضع بايد با آب و صابون شسته شود. بيمار بايد از نظر بروز علائم و نشانه‌ها به طور دقيق بررسي شود.

موارد قابل توجه

-

مکانیزم اثر

فارماكوكینتیك

موارد منع مصرف و احتياط


موارد منع مصرف: واكنشهاي حساسيت مفرط يا عدم تحمل شيميايي نسبت به اين دارو.


موارد احتياط : ‌درمان طولاني مدت (بعد از چندين مرتبه استعمال دارو، احتمال بروز مقاومت ويروسي وجود دارد).

سایر اطلاعات

طبقه‌بندي فارماكولوژيك: ضد ويروس.


طبقه‌بندي درماني: ضد ويروس چشمي.


طبقه‌بندي مصرف در بارداري: رده C


ملاحظات اختصاصي


1ـ‌در صورتي كه پس از هفت روز درمان بهبودي مشاهده نشود يا پس از 14 روز درمان را التيام كامل نگردد، درمان ديگري بايد در نظر گرفته شود.


2-‌ تري فلوريدين نبايد بيش از 21 روز متوالي مصرف شود، زيرا خطر مسموميت چشمي وجود دارد.


3ـ‌ دارو بايد در يخچال نگهداري شود؛ قبل از مصرف، دارو به تدريج تا حد درجه حرارت اتاق گرم شود.


4ـ تحريك موضعي خفيف ملتحمه و قرنيه بعد از چكاندن دارو معمولاً موقتي است.


5ـ مقدار و دفعات مصرف دارو نبايد بيش از ميزان تجويز شده باشد.


6ـ در صورتي كه پس از هفت روز درمان بهبودي مشاهده نگردد يا وضع بيمار بدتر شود يا هر نوع تحريكي بروز كند، به پزشك اطلاع داده شود.

Trifluridine (Viroptic)

VIROPTIC
(trifluridine) Solution

DRUG DESCRIPTION

VIROPTIC is the brand name for trifluridine (also known as trifluorothymidine, F3TdR,F3T), an antiviral drug for topical treatment of epithelial keratitis caused by herpes simplex virus. The chemical name of trifluridine is αα α -trifluorothymidine; it has the following structural formula:

VIROPTIC (trifluridine) structural formula illustration

VIROPTIC sterile ophthalmic solution contains 1% trifluridine in an aqueous solution with acetic acid and sodium acetate (buffers), sodium chloride, and thimerosal 0.001% (added as a preservative). The pH range is 5.5 to 6.0 and osmolality is approximately 283 mOsm.

What are the possible side effects of trifluridine ophthalmic (Trifluridine, Viroptic)?

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

  • severe swelling around your eyes;
  • tunnel vision; or
  • severe pain, burning, or other irritation of your eyes.

Keep using the medication and talk to your doctor if you have any of these less serious side effects:

  • mild eye pain, burning,...

Read All Potential Side Effects and See Pictures of Viroptic »

What are the precautions when taking trifluridine (Viroptic)?

Before using trifluridine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: other eye problems (e.g., glaucoma).

After you apply this drug, your vision may become temporarily blurred. Do not drive, use machinery, or do any activity that requires clear vision until you are sure you can perform such activities safely.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes...

Read All Potential Precautions of Viroptic »

Last reviewed on RxList: 4/13/2009
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

VIROPTIC (trifluridine) Ophthalmic Solution, 1% (trifluridine ophthalmic solution) is indicated for the treatment of primary keratoconjunctivitis and recurrent epithelial keratitis due to herpes simplex virus, types 1 and 2.

DOSAGE AND ADMINISTRATION

Instill one drop of VIROPTIC (trifluridine) Ophthalmic Solution, 1% onto the cornea of the affected eye every 2 hours while awake for a maximum daily dosage of nine drops until the corneal ulcer has completely re-epithelialized. Following re-epithelialization, treatment for an additional 7 days of one drop every 4 hours while awake for a minimum daily dosage of five drops is recommended. If there are no signs of improvement after 7 days of therapy or complete re-epithelialization has not occurred after 14 days of therapy, other forms of therapy should be considered. Continuous administration of VIROPTIC (trifluridine) for periods exceeding 21 days should be avoided because of potential ocular toxicity.

HOW SUPPLIED

VIROPTIC (trifluridine) Ophthalmic Solution, 1% is supplied as a sterile ophthalmic solution in a plastic Drop Dose® dispenser bottle of 7.5 mL (NDC 61570-037-75).

Store under refrigeration 2° to 8°C (36° to 46°F).

Prescribing Information as of April 2007. Distributed by: Monarch Pharmaceuticals, Inc., Bristol, TN 37620. Manufactured by: DSM Pharmaceuticals, Inc., Greenville, NC 27834

Last reviewed on RxList: 4/13/2009
This monograph has been modified to include the generic and brand name in many instances.

SIDE EFFECTS

The most frequent adverse reactions reported during controlled clinical trials were mild, transient burning or stinging upon instillation (4.6%) and palpebral edema (2.8%). Other adverse reactions in decreasing order of reported frequency were superficial punctate keratopathy, epithelial keratopathy, hypersensitivity reaction, stromal edema, irritation, keratitis sicca, hyperemia, and increased intraocular pressure.

Read the Viroptic (trifluridine) Side Effects Center for a complete guide to possible side effects »

DRUG INTERACTIONS

No information provided.

Last reviewed on RxList: 4/13/2009
This monograph has been modified to include the generic and brand name in many instances.

WARNINGS

The recommended dosage and frequency of administration should not be exceeded (See DOSAGE AND ADMINISTRATION).

PRECAUTIONS

General

VIROPTIC (trifluridine) Ophthalmic Solution, 1% should be prescribed only for patients who have a clinical diagnosis of herpetic keratitis. VIROPTIC (trifluridine) may cause mild local irritation of the conjunctiva and cornea when instilled, but these effects are usually transient. Although documented in vitro viral resistance to trifluridine has not been reported following multiple exposures to VIROPTIC (trifluridine) , the possibility of the development of viral resistance exists.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Mutagenic Potential

Trifluridine has been shown to exert mutagenic, DNA-damaging and cell-transforming activities in various standard in vitro test systems, and clastogenicactivity in Vicia faba cells. It did not induce chromosome aberrations in bone marrow cells of male or female rats following a single subcutaneous dose of 100 mg/kg, but was weakly positive in female, but not in male, rats following daily subcutaneous administration at 700 mg/kg/day for 5 days.

Although the significance of these test results is not clear or fully understood, there exists the possibility that mutagenic agents may cause genetic damage in humans.

Oncogenic Potential

Lifetime carcinogenicity bioassays in rats and mice given daily subcutaneous doses of trifluridine have been performed. Rats tested at 1.5, 7.5, and 15 mg/kg/day had increased incidences of adenocarcinomas of the intestinal tract and mammary glands, hemangiosarcomas of the spleen and liver, carcinosarcomas of the prostate gland, and granulosa-thecal cell tumors of the ovary. Mice were tested at 1, 5, and 10 mg/kg/day; those given 10 mg/kg/day trifluridine had significantly increased incidences of adenocarcinomas of the intestinal tract and uterus. Those given 10 mg/kg/day also had a significantly increased incidence of testicular atrophy as compared to vehicle control mice.

Pregnancy

Teratogenic Effects

Pregnancy Category C. Trifluridine was not teratogenic at doses up to 5 mg/kg/day (23 times the estimated human exposure) when given subcutaneously to rats and rabbits. However, fetal toxicity consisting of delayed ossification of portions of the skeleton occurred at dose levels of 2.5 and 5 mg/kg/day in rats and at 2.5 mg/kg/day in rabbits. In addition, both 2.5 and 5 mg/kg/day produced fetal death and resorption in rabbits. In both rats and rabbits, 1 mg/kg/day (5 times the estimated human exposure) was a no-effect level. There were no teratogenic or fetotoxic effects after topical application of VIROPTIC (trifluridine) Ophthalmic Solution, 1% (approximately 5 times the estimated human exposure) to the eyes of rabbits on the 6th through the 18th days of pregnancy. In a non-standard test, trifluridine solution has been shown to be teratogenic when injected directly into the yolk sac of chicken eggs. There are no adequate and well-controlled studies in pregnant women. VIROPTIC (trifluridine) Ophthalmic Solution, 1% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

It is unlikely that trifluridine is excreted in human milk after ophthalmic instillation of VIROPTIC (trifluridine) because of the relatively small dosage ( < 5 mg/day), its dilution in body fluids and its extremely short half-life (approximately 12 minutes). The drug should not be prescribed for nursing mothers unless the potential benefits outweigh the potential risks.

Pediatric Use

Safety and effectiveness in pediatric patients below six years of age have not been established.

Geriatric Use

No overall clinical differences in safety or effectiveness have been observed between elderly and other adult patients.

Last reviewed on RxList: 4/13/2009
This monograph has been modified to include the generic and brand name in many instances.

OVERDOSE

Overdosage by ocular instillation is unlikely because any excess solution should be quickly expelled from the conjunctival sac. Acute overdosage by accidental oral ingestion of VIROPTIC (trifluridine) has not occurred. However, should such ingestion occur, the 75 mg dosage of trifluridine in a 7.5 mL bottle of VIROPTIC (trifluridine) is not likely to produce adverse effects. Single intravenous doses of 1.5 to 30 mg/kg/day in children and adults with neoplastic disease produce reversible bone marrow depression as the only potentially serious toxic effect and only after three to five courses of therapy. The acute oral LD50 in the mouse and rat was 4379 mg/kg or higher.

CONTRAINDICATIONS

VIROPTIC (trifluridine) Ophthalmic Solution, 1% is contraindicated for patients who develop hypersensitivity reactions or chemical intolerance to trifluridine.

Last reviewed on RxList: 4/13/2009
This monograph has been modified to include the generic and brand name in many instances.

CLINICAL PHARMACOLOGY

Trifluridine is a fluorinated pyrimidine nucleoside with in vitro and in vivo activity against herpes simplex virus, types 1 and 2 and vacciniavirus. Some strains of adenovirus are also inhibited in vitro.

VIROPTIC (trifluridine) is also effective in the treatment of epithelial keratitis that has not responded clinically to the topical adminstration of idoxuridine or when ocular toxicity or hypersensitivity to idoxuridine has occurred. In a smaller number of patients found to be resistant to topical vidarabine, VIROPTIC was also effective.

Trifluridine interferes with DNA synthesis in cultured mammalian cells. However, its antiviral mechanism of action is not completely known.

In vitro perfusion studies on excised rabbit corneas have shown that trifluridine penetrates the intact cornea as evidenced by recovery of parental drug and its major metabolite, 5-carboxy-2'-deoxyuridine, on the endothelial side of the cornea. Absence of the corneal epithelium enhances the penetration of trifluridine approximately two-fold.

Intraocular penetration of trifluridine occurs after topical instillation of VIROPTIC (trifluridine) into human eyes. Decreased corneal integrity or stromal or uveal inflammation may enhance the penetration of trifluridine into the aqueous humor. Unlike the results of ocular penetration of trifluridine in vitro, 5-carboxy-2'-deoxyuridine was not found in detectable concentrations within the aqueous humor of the human eye.

Systemic absorption of trifluridine following therapeutic dosing with VIROPTIC (trifluridine) appears to be negligible. No detectable concentrations of trifluridine or 5-carboxy-2'-deoxyuridine were found in the sera of adult healthy normal subjects who had VIROPTIC (trifluridine) instilled into their eyes seven times daily for 14 consecutive days.

Clinical Studies

During a controlled multicenter clinical trial, 92 of 97 (95%) patients (78 of 81 with dendritic and 14 of 16 with geographic ulcers) responded to therapy with VIROPTIC (trifluridine) as evidenced by complete corneal re-epithelialization within the 14-day therapy period. Fifty-six of 75 (75%) patients (49 of 58 with dendritic and 7 of 17 with geographic ulcers) responded to idoxuridine therapy. The mean time to corneal re-epithelialization for dendritic ulcers (6 days) and geographic ulcers (7 days) was similar for both therapies. In other clinical studies, VIROPTIC (trifluridine) was evaluated in the treatment of herpes simplex virus keratitis in patients who were unresponsive or intolerant to the topical administration of idoxuridine or vidarabine. VIROPTIC (trifluridine) was effective in 138 of 150 (92%) patients (109 of 114 with dendritic and 29 of 36 with geographic ulcers) as evidenced by corneal re-epithelialization. The mean time to corneal re-epithelialization was 6 days for patients with dendritic ulcers and 12 days for patients with geographic ulcers. The clinical efficacy of VIROPTIC (trifluridine) in the treatment of stromal keratitis and uveitis due to herpes simplex virus or ophthalmic infections caused by vacciniavirus and adenovirus has not been established by well-controlled clinical trials. VIROPTIC (trifluridine) has not been shown to be effective in the prophylaxis of herpes simplex virus keratoconjunctivitis and epithelial keratitis by well-controlled clinical trials. VIROPTIC (trifluridine) is not effective against bacterial, fungal, or chlamydial infections of the cornea or nonviral trophic lesions.

Animal Pharmacology And Animal Toxicology

Corneal wound healing studies in rabbits showed that VIROPTIC (trifluridine) did not significantly retard closure of epithelial wounds. However, mild toxic changes such as intracellular edema of the basal cell layer, mild thinning of the overlying epithelium and reduced strength of stromal wounds were observed.

Whereas instillation of VIROPTIC (trifluridine) into rabbit eyes during a subchronic toxicity study produced some degree of corneal epithelial thinning, a 12-month chronic toxicity study in rabbits in which VIROPTIC (trifluridine) was instilled into eyes in intermittent, multiple, full-therapy courses showed no drug-related changes in the cornea.

Last reviewed on RxList: 4/13/2009
This monograph has been modified to include the generic and brand name in many instances.

PATIENT INFORMATION

No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.

Last reviewed on RxList: 4/13/2009
This monograph has been modified to include the generic and brand name in many instances.

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PATIENT INFORMATION

No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.

Last reviewed on RxList: 4/13/2009
This monograph has been modified to include the generic and brand name in many instances.

Disclaimer

Viroptic 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.

TRIFLURIDINE DROPS - OPHTHALMIC

(try-FLEWR-ih-deen)

COMMON BRAND NAME(S): Viroptic

USES: This medication is used to treat herpes infection of the eye. Herpes is a virus that lives in the body quietly until an outbreak is triggered. Trifluridine is not a cure for the infection, but treatment of an outbreak can speed up the healing of the sores/swelling in the eye and lower the risk of complications (e.g., vision loss).

OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

This medication may also be used to treat other eye infections caused by viruses (e.g., vaccinia virus infections).

HOW TO USE: 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.

Tilt your head back, look up, and pull down the lower eyelid to make a pouch. Hold the dropper directly over your eye and place 1 drop into the pouch as directed by your doctor. Look down and gently close your eyes for 1 to 2 minutes. Place one finger at the corner of your eye (near the nose) and press gently. This will prevent the medication from draining out. Try not to blink and do not rub your eye. Repeat these steps for your other eye if so directed.

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

Use this medication usually every 2 hours while awake until the eye has healed. Do not use more than 9 drops into the eye in a 24-hour period. After healing, use this medication for another 7 days, usually every 4 hours while awake (at least 5 drops per day) or as directed by your doctor.

If you are using another kind of eye medication (e.g., drops or ointments), wait at least 5 to 10 minutes before applying other medications. Use eye drops before eye ointments to allow the drops to enter the eye.

Use this medication regularly in order to get the most benefit from it. To help you remember, use it at the same times each day. Continue using it for the full time prescribed. Stopping the medication too early may result in a return of the infection.

Do not use this medication more often or use longer than prescribed because doing so may increase the risk of side effects. This medication should not be used for more than 21 days at a time.

Tell your doctor if your condition worsens, does not improve after 7 days, or does not completely heal after 14 days.

Disclaimer

Viroptic Consumer (continued)

SIDE EFFECTS: Temporary mild burning, stinging, and irritation may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

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: swelling eyelids, eye pain/redness, feeling as if something is in the eye, persistent blurred vision.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe 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 Viroptic (trifluridine) Side Effects Center for a complete guide to possible side effects »

PRECAUTIONS: Before using trifluridine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: other eye problems (e.g., glaucoma).

After you apply this drug, your vision may become temporarily blurred. Do not drive, use machinery, or do any activity that requires clear vision until you are sure you can perform such activities safely.

During pregnancy, this medication should be used only when clearly needed. 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

Viroptic 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.

Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: This medicine may be harmful if swallowed. If swallowing or 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. Canada residents can call a provincial poison control center.

NOTES: Do not share this medication with others.

This medication has been prescribed for your current condition only. Do not use it later for another infection unless told to do so by your doctor. A different medication may be necessary in that case.

Laboratory and/or medical tests (e.g., eye exam) may 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 near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store in the refrigerator between 36-46 degrees F (2-8 degrees C) away from light. 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 May 2010. Copyright(c) 2010 First Databank, Inc.

Viroptic Patient Information Including Side Effects

Brand Names: Trifluridine, Viroptic

Generic Name: trifluridine ophthalmic (Pronunciation: trye FLURE i deen off THAL mik)

What is trifluridine ophthalmic (Viroptic)?

Trifluridine ophthalmic is an antiviral medication. It fights eye infections that are caused by certain viruses.

Trifluridine ophthalmic is used to treat eye infections caused by the herpes simplex virus, which can lead to swelling or ulcers in the eyelids or cornea (surface of the eyeball).

Trifluridine ophthalmic may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of trifluridine ophthalmic (Viroptic)?

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

  • severe swelling around your eyes;
  • tunnel vision; or
  • severe pain, burning, or other irritation of your eyes.

Keep using the medication and talk to your doctor if you have any of these less serious side effects:

  • mild eye pain, burning, stinging, itching, or redness;
  • blurred vision; or
  • feeling of pressure inside the eye.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

Read the Viroptic (trifluridine) Side Effects Center for a complete guide to possible side effects »

What is the most important information I should know about trifluridine ophthalmic (Viroptic)?

Do not use this medication if you are allergic to trifluridine. This medication will not treat an infection that is caused by bacteria or fungus.

The usual dose of trifluridine ophthalmic is one drop into the affected eye every 2 hours while you are awake. Do not use more than 9 drops in the course of one full day.

Once your condition improves, you may need to keep using the medication 4 times daily (up to 5 drops per day) for another 7 days. Your doctor should check your eyes to determine how long you need to use the medicine.

If you wear contact lenses, remove them before applying trifluridine ophthalmic. Ask your doctor if contact lenses can be reinserted after putting in the eye drops.

Avoid using other eye medications while using trifluridine ophthalmic, unless your doctor has told you to.

Trifluridine ophthalmic may cause blurred vision. Be careful if you drive, operate machinery, or do anything else that requires you to be able to see clearly.

Do not allow the dropper tip to touch any surface, including the 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.

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

Contact your doctor if your symptoms do not improve, or if they get worse after using this medication for 7 days.

Side Effects Centers

Viroptic Patient Information including How Should I Take

What should I discuss with my healthcare provider before using trifluridine ophthalmic (Viroptic)?

Do not use this medication if you are allergic to trifluridine. This medication will not treat an infection that is caused by bacteria or fungus.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether trifluridine ophthalmic 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.

Do not use this medication in a child younger than 6 years old.

How should I use trifluridine ophthalmic (Viroptic)?

Use this medication exactly as it was prescribed for you. Do not use the medication in larger amounts, or use it for longer than recommended by your doctor. Follow the instructions on your prescription label.

The usual dose of trifluridine ophthalmic is one drop into the affected eye every 2 hours while you are awake. Do not use more than 9 drops in the course of one full day.

Once your condition improves, you may need to keep using the medication 4 times daily (up to 5 drops per day) for another 7 days. Your doctor should check your eyes to determine how long you need to use the medicine.

Wash your hands before using the eye drops.

If you wear contact lenses, remove them before applying trifluridine ophthalmic. Ask your doctor if contact lenses can be reinserted after putting in the eye drops.

To apply the eye drops:

  • Tilt your head back slightly and pull down your lower eyelid. Hold the dropper above the eye with the dropper tip down. Look up and away from the dropper as you squeeze out a drop, then close your eye. 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.
  • Do not allow the dropper tip to touch any surface, including the 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.

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

Contact your doctor if your symptoms do not improve, or if they get worse after using this medication for 7 days.

Store the eye drops at room temperature away from heat and moisture. Keep the bottle tightly closed when not in use.

Side Effects Centers

Viroptic Patient Information including If I Miss a Dose

What happens if I miss a dose (Viroptic)?

Use the medication as soon as you remember the missed dose. If it is almost time for your next dose, skip the missed dose and use the medicine at your next regularly scheduled time. Do not use extra medicine to make up the missed dose.

What happens if I overdose (Viroptic)?

Rinse the eye with water and seek emergency medical attention if you think you have used too much of this medicine.

An overdose of trifluridine ophthalmic is not expected to produce life-threatening symptoms.

What should I avoid while taking trifluridine ophthalmic (Viroptic)?

This medication may cause blurred vision. Be careful if you drive, operate machinery, or do anything else that requires you to be able to see clearly.

Avoid using other eye medications while using trifluridine ophthalmic, unless your doctor has told you to.

What other drugs will affect trifluridine ophthalmic (Viroptic)?

There may be other drugs that can affect trifluridine ophthalmic. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

Your pharmacist has information about trifluridine ophthalmic written for health professionals that you may read.


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.

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