Drugs Details

Drugs Info of Zirgan
Drugs Details
  • Drugs Type  : FDA
  • Date : 26th Jan 2015 11:12 pm
  • Brand Name : Zirgan
  • Generic Name : ganciclovir) Ophthalmic Gel 0.15%
Descriptions

ZIRGAN (ganciclovir ophthalmic gel) 0.15% contains a sterile, topical antiviral for ophthalmic use. The chemical name is 9-[[(2-hydroxy-1 -(hydroxymethyl) ethoxy] methyl] guanine (CAS number 82410-32-0). Ganciclovir is represented by the following structural formula:

 

ZIRGAN
  (ganciclovir) Structural Formula Illustration

Ganciclovir has a molecular weight of 255.23, and the empirical formula is C9H13N5O4. Each gram of gel contains: ACTIVE: ganciclovir 1.5 mg (0.15%). INACTIVES: carbopol, water for injection, sodium hydroxide (to adjust the pH to 7.4), mannitol. PRESERVATIVE: benzalkonium chloride 0.075 mg.

What are the possible side effects of ganciclovir (Vitrasert, Zirgan)?

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

Call your doctor at once if you have a serious side effect such as:

  • eye pain, swelling, redness, or watering;
  • severe burning or itching of your eyes;
  • vision changes, increased sensitivity to light;
  • tunnel vision, problems with peripheral (side) vision;
  • seeing flashes of light, halos around lights, or "floaters" in your vision;
  • white patches on your...

Read All Potential Side Effects and See Pictures of Zirgan »

What are the precautions when taking ganciclovir ophthalmic gel (Zirgan)?

Before using ganciclovir, tell your doctor or pharmacist if you are allergic to it; or to valganciclovir; 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.

This drug may cause temporary blurred vision after each application. Do not drive, use machinery, or do any activity that requires clear vision until you are sure you can perform such activities safely.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should...

Read All Potential Precautions of Zirgan »


This monograph has been modified to include the generic and brand name in many instances.

Indications

ZIRGAN (ganciclovir) Ophthalmic Gel 0.15% is indicated for the treatment of acute herpetic keratitis (dendritic ulcers).

Dosage Administration

The recommended dosing regimen for ZIRGAN (ganciclovir ophthalmic gel) is 1 drop in the affected eye 5 times per day (approximately every 3 hours while awake) until the corneal ulcer heals, and then 1 drop 3 times per day for 7 days.

How Supplied

Dosage Forms And Strengths

ZIRGAN contains 0.15% of ganciclovir in a sterile preserved topical ophthalmic gel.

ZIRGAN (ganciclovir ophthalmic gel) is supplied as 5 grams of a sterile, preserved, clear, colorless, topical ophthalmic gel containing 0.15% of ganciclovir in a polycoated aluminum tube with a white polyethylene tip and cap and protective band (NDC 42826-605-50).

Storage

Store at 15°C-25°C (59°F-77°F). Do not freeze.

Manufactured for: Sirion Therapeutics, Inc., Tampa, FL 33619. Manufactured By: Alliance Medical Products, Inc., Irvine, CA 92688.


This monograph has been modified to include the generic and brand name in many instances.

Side Effects

Most common adverse reactions reported in patients were blurred vision (60%), eye irritation (20%), punctate keratitis (5%), and conjunctival hyperemia (5%).

Read the Zirgan (ganciclovir ophthalmic gel) Side Effects Center for a complete guide to possible side effects

Interactions

No information provided.

Read the Zirgan Drug Interactions Center for a complete guide to possible interactions

Learn More »


This monograph has been modified to include the generic and brand name in many instances.

Warnings

Included as part of the PRECAUTIONS section.

Precautions

Topical Ophthalmic Use Only

ZIRGAN (ganciclovir ophthalmic gel) is indicated for topical ophthalmic use only.

Avoidance Of Contact Lenses

Patients should not wear contact lenses if they have signs or symptoms of herpetic keratitis or during the course of therapy with ZIRGAN (ganciclovir ophthalmic gel) .

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, and Impairment of Fertility

Ganciclovir was carcinogenic in the mouse at oral doses of 20 and 1,000 mg/kg/day (approximately 3,000x and 160,000x the human ocular dose of 6.25 mcg/kg/day, assuming complete absorption). At the dose of 1,000 mg/kg/day there was a significant increase in the incidence of tumors of the preputial gland in males, fore stomach (nonglandular mucosa) in males and females, and reproductive tissues (ovaries, uterus, mammary gland, clitoral gland, and vagina) and liver in females. At the dose of 20 mg/kg/day, a slightly increased incidence of tumors was noted in the preputial and harderian glands in males, fore stomach in males and females, and liver in females. No carcinogenic effect was observed in mice administered ganciclovir at 1 mg/kg/day (160x the human ocular dose). Except for histocytic sarcoma of the liver, ganciclovir-induced tumors were generally of epithelial or vascular origin. Although the preputial and clitoral glands, fore stomach and harderian glands of mice do not have human counterparts, ganciclovir should be considered a potential carcinogen in humans. Ganciclovir increased mutations in mouse lymphoma cells and DNA damage in human lymphocytes in vitro at concentrations between 50 to 500 and 250 to 2,000 mcg/mL, respectively. In the mouse micronucleus assay, ganciclovir was clastogenic at doses of 150 and 500 mg/kg (IV) (24,000x to 80,000x human ocular dose) but not 50 mg/kg (8,000x human ocular dose). Ganciclovir was not mutagenic in the Ames Salmonella assay at concentrations of 500 to 5,000 mcg/mL. Ganciclovir caused decreased mating behavior, decreased fertility, and an increased incidence of embryolethality in female mice following intravenous doses of 90 mg/kg/day (approximately 14,000x the human ocular dose of 6.25 mcg/kg/day). Ganciclovir caused decreased fertility in male mice and hypospermatogenesis in mice and dogs following daily oral or intravenous administration of doses ranging from 0.2 to 10 mg/kg (30x to l,600x the human ocular dose).

Use In Specific Populations

Pregnancy: Teratogenic Effects

Pregnancy Category C: Ganciclovir has been shown to be embryotoxic in rabbits and mice following intravenous administration and teratogenic in rabbits. Fetal resorptions were present in at least 85% of rabbits and mice administered 60 mg/kg/day and 108 mg/kg/day (approximately 10,000x and 17,000x the human ocular dose of 6.25 mcg/kg/day), respectively, assuming complete absorption. Effects observed in rabbits included: fetal growth retardation, embryolethality, teratogenicity, and/or maternal toxicity. Teratogenic changes included cleft palate, anophthalmia/microphthalmia, aplastic organs (kidney and pancreas), hydrocephaly, and brachygnathia. In mice, effects observed were maternal/fetal toxicity and embryolethality. Daily intravenous doses of 90 mg/kg/day (14,000x the human ocular dose) administered to female mice prior to mating, during gestation, and during lactation caused hypoplasia of the testes and seminal vesicles in the month-old male offspring, as well as pathologic changes in the nonglandular region of the stomach (see Carcinogenesis, Mutagenesis, Impairment of Fertility).

There are no adequate and well-controlled studies in pregnant women. ZIRGAN (ganciclovir ophthalmic gel) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

It is not known whether topical ophthalmic ganciclovir administration could result in sufficient systemic absorption to produce detectable quantities in breast milk. Caution should be exercised when ZIRGAN (ganciclovir ophthalmic gel) is administered to nursing mothers.

Pediatric Use

Safety and efficacy in pediatric patients below the age of 2 years have not been established.

Geriatric Use

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


This monograph has been modified to include the generic and brand name in many instances.

OverDose

No information provided.

ContrainDications

None.


This monograph has been modified to include the generic and brand name in many instances.

Clinical Pharamacology

Mechanism of Action

ZIRGAN (ganciclovir) ophthalmic gel 0.15% contains the active ingredient, ganciclovir, which is a guanosine derivative that, upon phosphorylation, inhibits DNA replication by herpes simplex viruses (HSV). Ganciclovir is transformed by viral and cellular thymidine kinases (TK) to ganciclovir triphosphate, which works as an antiviral agent by inhibiting the synthesis of viral DNA in 2 ways: competitive inhibition of viral DNA-polymerase and direct incorporation into viral primer strand DNA, resulting in DNA chain termination and prevention of replication.

Pharmacokinetics

The estimated maximum daily dose of ganciclovir administered as 1 drop, 5 times per day is 0.375 mg. Compared to maintenance doses of systemically administered ganciclovir of 900 mg (oral valganciclovir) and 5 mg/kg (IV ganciclovir), the ophthalmically administered daily dose is approximately 0.04% and 0.1% of the oral dose and IV doses, respectively, thus minimal systemic exposure is expected.

Clinical Studies

In one open-label, randomized, controlled, multicenter clinical trial which enrolled 164 patients with herpetic keratitis, ZIRGAN (ganciclovir ophthalmic gel) was non-inferior to acyclovir ophthalmic ointment, 3% in patients with dendritic ulcers Clinical resolution (healed ulcers) at Day 7 was achieved in 77% (55/71) for ZIRGAN (ganciclovir ophthalmic gel) versus 72% (48/67) for acyclovir 3% (difference 5.8%, 95% CI -9.6%-18.3%).

In three randomized, single-masked, controlled, multicenter clinical trials which enrolled 213 total patients, ZIRGAN (ganciclovir ophthalmic gel) was non-inferior to acyclovir ophthalmic ointment 3% in patients with dendritic ulcers. Clinical resolution at Day 7 was achieved in 72% (41/57) for ZIRGAN (ganciclovir ophthalmic gel) versus 69% (34/49) for acyclovir (difference 2.5%, 95%CI-15.6%-20.9%).


This monograph has been modified to include the generic and brand name in many instances.

Patient Information

This product is sterile when packaged. Patients should be advised not to allow the dropper tip to touch any surface, as this may contaminate the gel. If pain develops, or if redness, itching, or inflammation becomes aggravated, the patient should be advised to consult a physician. Patients should be advised not to wear contact lenses when using ZIRGAN (ganciclovir ophthalmic gel) .


This monograph has been modified to include the generic and brand name in many instances.

Consumer Overview Uses

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.

 

GANCICLOVIR - OPHTHALMIC

 

(gan-SYE-klo-veer)

 

COMMON BRAND NAME(S): Zirgan

 

USES: Ganciclovir is used to treat herpes infection of the eye. Although ganciclovir stops the growth of the virus, it is not a cure for the herpes infection. Herpes virus continues to live in the body even between outbreaks of infection. However, treating an outbreak may help the sores in the eye to heal faster and lower the risk of complications (such as decreased vision, blindness).

Ganciclovir is an anti-viral drug. This medication treats only herpes eye infections. It will not work for other types of eye infections, such as those caused by bacteria. Unnecessary use or misuse of any anti-infective drug can lead to its decreased effectiveness.

 

HOW TO USE: Apply this medication to the affected eye as directed by your doctor, usually 5 times a day (about every 3 hours while awake) until the eye has healed, and then 3 times a day for 7 more days.

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

Do not wear contact lenses while you have an eye infection or while using this medication. Sterilize contact lenses according to the manufacturer's directions, and check with your doctor before you begin using them again.

Tilt your head back, look upward, and pull down the lower eyelid to make a pouch. Hold the dropper directly over your eye and place one drop into the pouch. Look downward, gently close your eyes, and place one finger at the corner of your eye (near the nose). Apply gentle pressure for 1 to 2 minutes before opening your eyes. This will prevent the medication from draining out. Try not to blink or rub your eye. Repeat these steps for your other eye if so directed. Wait several minutes for your vision to clear before driving or operating machinery.

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

If you are using another kind of eye medication (such as drops or ointments), wait at least 5 minutes between applying each medication. Use eye drops before eye ointments to allow the drops to enter the eye.

Use this medication regularly 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 allow the virus to continue to grow.

Tell your doctor if your condition persists or if it worsens (for example, you develop eye pain/itching/swelling).

Consumer Overview Side Effect

SIDE EFFECTS: Temporary blurred vision after you apply this medication and mild eye irritation/redness 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.

A very serious allergic reaction to this drug is rare. However, get medical help right away 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 Zirgan (ganciclovir ophthalmic gel) Side Effects Center for a complete guide to possible side effects

Learn More »

PRECAUTIONS: Before using ganciclovir, tell your doctor or pharmacist if you are allergic to it; or to valganciclovir; 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.

This drug may cause temporary blurred vision after each application. Do not drive, use machinery, or do any activity that requires clear vision until you are sure you can perform such activities safely.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

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

It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.

Consumer Overview Missed Dose

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

 

OVERDOSE: This medicine may be harmful if swallowed. If swallowing or overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center 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 (such as eye exams) 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 at room temperature between 59-77 degrees F (15-25 degrees C). Protect from freezing. Keep all medications 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 March 2014. Copyright(c) 2014 First Databank, Inc.

Patient Detailed Side Effect

Brand Names: Vitrasert, Zirgan

Generic Name: ganciclovir ophthalmic (Pronunciation: gan SYE klo veer off THAL mik)

  • What is ganciclovir (Zirgan)?
  • What are the possible side effects of ganciclovir (Zirgan)?
  • What is the most important information I should know about ganciclovir (Zirgan)?
  • What should I discuss with my health care provider before using ganciclovir (Zirgan)?
  • How should I use ganciclovir (Zirgan)?
  • What happens if I miss a dose (Zirgan)?
  • What happens if I overdose (Zirgan)?
  • What should I avoid while taking ganciclovir (Zirgan)?
  • What other drugs will affect ganciclovir (Zirgan)?
  • Where can I get more information?

What is ganciclovir (Zirgan)?

Ganciclovir is an antiviral drug. It slows the growth and spread of the cytomegalovirus.

Ganciclovir ophthalmic (for the eyes) is used to treat certain viral infections affecting the eyes.

Ganciclovir implant (Vitrasert) is used to treat cytomegalovirus (CMV) infection of the eye. This infection usually occurs in patients who have suppressed immune systems such as patients with AIDS and organ transplant patients.

Ganciclovir gel (Zirgan) is used to treat eye ulcers caused by the herpes simplex virus.

Ganciclovir is not a cure for CMV or herpes. This medication will not treat symptoms of these infections in any other part of the body.

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

What are the possible side effects of ganciclovir (Zirgan)?

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

Call your doctor at once if you have a serious side effect such as:

  • eye pain, swelling, redness, or watering;
  • severe burning or itching of your eyes;
  • vision changes, increased sensitivity to light;
  • tunnel vision, problems with peripheral (side) vision;
  • seeing flashes of light, halos around lights, or "floaters" in your vision;
  • white patches on your eyes;
  • cloudiness in the pupils or iris of your eyes;
  • bleeding, oozing, or crusting of your eyes; or
  • sudden vision loss.

Less serious side effects may include:

  • blurred vision (may last up to 4 weeks after Vitrasert implant surgery);
  • mild eye irritation; or
  • increased tearing.

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 Zirgan (ganciclovir ophthalmic gel) Side Effects Center for a complete guide to possible side effects

Learn More »

What is the most important information I should know about ganciclovir (Zirgan)?

You should not use this medication if you are allergic to ganciclovir or acyclovir (Zovirax).

Ganciclovir implant (Vitrasert) is used to treat cytomegalovirus (CMV) infection of the eye. Ganciclovir gel (Zirgan) is used to treat eye ulcers caused by the herpes simplex virus.

Ganciclovir is not a cure for cytomegalovirus or herpes. This medication will not treat symptoms of these infections in any other part of the body.

To make sure you can safely use ganciclovir, tell your doctor if you have low levels of platelets in your blood (easy bruising or bleeding), or an infection in any part of your body (other than your eyes).

Do not wear contact lenses while you are using this medication. You should not wear contact lenses at any time you have an active eye ulcer or infection.

Side Effects Centers
  • Zirgan

Patient Detailed How Take

What should I discuss with my health care provider before using ganciclovir (Zirgan)?

You should not use this medication if you are allergic to ganciclovir or acyclovir (Zovirax).

To make sure you can safely use ganciclovir, tell your doctor if you have any of these other conditions:

  • an infection in any part of your body (other than your eyes); or
  • low levels of platelets in your blood (easy bruising or bleeding).

Do not wear contact lenses while you are using this medication. You should not wear contact lenses at any time you have an active eye ulcer or infection.

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

This medication can decrease sperm count and may affect a man's fertility (ability to have children).

It is not known whether ganciclovir passes into breast milk or if it could harm a nursing baby. Do not use Zirgan without telling your doctor if you are breast-feeding a baby. You should not breast-feed after you have received a Vitrasert implant.

Ganciclovir gel (Zirgan) should not be given to a child younger than 2 years old.

How should I use ganciclovir (Zirgan)?

The Vitrasert implant is surgically placed into the eye. The implant will slowly release ganciclovir into the affected eye over a period of 5 to 8 months.

Use Zirgan gel 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.

Zirgan is usually applied 5 times each day until your eye ulcer heals. Then the gel is applied 3 times per day for 7 days. Follow your doctor's instructions.

Wash your hands before using the eye drops.

To apply Zirgan:

  • 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.

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.

Ganciclovir does not cure herpes or CMV. Your disease may continue to progress even after you are treated with this medication. Your doctor will need to check your progress on a regular basis, and you will need routine eye exams.

Store Zirgan at room temperature away from moisture and heat. Do not freeze. Keep the bottle tightly closed when not in use.

Side Effects Centers
  • Zirgan

Patient Detailed Avoid Taking

What happens if I miss a dose (Zirgan)?

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

Since the Vitrasert implant is surgically put into place, you will not be on a dosing schedule for this medication. The implant may be removed and replaced after 5 to 8 months.

What happens if I overdose (Zirgan)?

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

What should I avoid while taking ganciclovir (Zirgan)?

Do not use any eye medications that your doctor has not prescribed.

Ganciclovir may cause blurred vision, which may last up to 4 weeks after Vitrasert implant surgery. Be careful if you drive or do anything that requires you to be able to see clearly.

What other drugs will affect ganciclovir (Zirgan)?

It is not likely that other drugs you take orally or inject will have an effect on ganciclovir used in the eyes. But many drugs can interact with each other. 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 ganciclovir.


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 1996-2013 Cerner Multum, Inc. Version: 1.02. Revision date: 12/15/2010.

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Side Effects Centers
  • Zirgan

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