Zovirax Topical

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.

Common side effects may include:

• dry, cracked, or peeling lips;
• dryness or flaking of treated skin;
• burning, stinging, or itching when the medicine is applied.

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.

Dosing Strengths & Forms

topical cream

• 5%

topical ointment

• 5%

mucoadhesive buccal tablet

• 50mg (Sitavig)

Herpes Labialis

Cream/ointment

• Limited, non-life-threatening mucocutaneous Herpes simplex virus infections in immunocompromised patients
• Apply topically to lips and around mouth 5 times per day for 4 days; initiate as soon as possible after first signs and symptoms

Mucoadhesive buccal tablet

• Recurrent herpes labialis (cold sores) in immunocompetent adults
• Apply one 50 mg buccal tablet as a single dose to the upper gum (canine fossa) region
• Should be applied within 1 hr after the onset of prodromal symptoms and before the appearance of any signs of Herpes labialis

Genital Herpes

Initial genital herpes

Apply sufficient quantity to adequately cover all lesions q3hr, 6 times/day for 7 days

Herpetic Keratitis (Orphan)

Acute herpetic keratitis caused by Herpes simplex virus types 1 and 2

Orphan indication sponsors

• GlaxoSmithKline, One Franklin Plaza, Philadelphia, PA 19101
• Fera Pharmaceuticals, 134 Birch Hill Road, Locust Valley, NY 11560

Administration

Cream/ointment

• The dose size per application will vary depending on the total lesion area but should approximate a one-half-inch ribbon of ointment per 4 square inches of surface area
• A finger cot or rubber glove should be used when applying, to prevent autoinoculation of other body sites and transmission of infection to other persons

Mucoadhesive buccal tablet

• Do not crush, chew, suck, or swallow tablets

Dosing Strengths & Forms

topical cream

• 5%

topical ointment

• 5%

Herpes Labialis

Recurrent herpes labialis (cold sores) in adults and adolescents

<12 years: Safety and efficacy not established

≥12 years: As adults, apply cream/ointment topically to lips and around mouth 5 times per day for 4 days; initiate as soon as possible after first signs and symptoms

Contraindications

• Hypersensitivity to acyclovir, valacyclovir, or any ingredient in the formulations.101 112

Warnings/Precautions

Sensitivity Reactions

Potential for irritation and contact sensitization with 5% cream; contact dermatitis reported.112

General Precautions

Efficacy of 5% cream not established in immunocompromised patients.112

Clinically important viral resistance associated with use of topical acyclovir not reported to date.101 The possibility of such resistance should be considered, especially in those with poor clinical response.101

Specific Populations

Category B.101 112

Not known whether distributed into human milk after topical application, but systemic exposure after topical administration is minimal.101 112 Distributed into human milk following oral or IV administration.101 112 117

Women with active herpetic lesions near or on the breast should refrain from breast-feeding.101 112 113

Safety and efficacy of 5% cream not established in children <12 years of age.112

Safety and efficacy of 5% ointment not established in children.101

Insufficient experience in patients ≥65 years of age to determine whether geriatric patients respond differently than younger adults.101 112 Clinical experience has not revealed age-related differences.101 112

Common Adverse Effects

Local effects such as mild pain,101 transient burning or stinging,101 112 pruritus,101 112 cracked or dry lips,112 desquamation,112 dry or flaking skin.112

No interactions identified to date when topical acyclovir used concomitantly with other topical or systemic drugs.101 112 Because systemic absorption appears to be minimal following topical application to intact skin,101 112 drug interactions between topical acyclovir and systemically administered drugs are unlikely.a

Absorption

Bioavailability

Not appreciably absorbed into systemic circulation following topical application to intact skin.101 112

Not detected in blood or urine of immunocompromised adults following application of 5% ointment to intact skin (4.5 inch2) at a dosage of 25 mg (1-cm ribbon) 4 times daily for 7 days.101 112

Following topical application of 5% ointment in patients with localized varicella-zoster virus (VZV) infections, plasma acyclovir concentrations were ≤0.28 mcg/mL or ≤0.78 mcg/mL in those with normal or impaired renal function, respectively.101

Following repeated (5 times daily for 4 days) topical application of 5% cream to intact skin (710 cm2) in adult males, plasma acyclovir concentrations measured 1 hour after the final application were undetectable or just above the limits of detection.112

Systemic absorption of 5% cream not evaluated in children <18 years of age.112

Distribution

Not fully characterized following topical application.a

Crosses placenta following oral or IV administration.105 117

Not known if drug or its metabolites distributed into human milk following topical application.101 Following oral or IV administration, distributed into human milk in concentrations greater than concurrent maternal plasma concentrations.100 101 117

Elimination

Metabolism

Not fully characterized following topical application.a

Converted in vivo to the pharmacologically active triphosphate metabolite.101

Elimination Route

Following systemic absorption, excreted principally in urine.101

Following topical application of 5% ointment in immunocompromised patients with localized VZV infections, ≤9.4% of total daily dose excreted in urine.101

Following repeated (5 times daily for 4 days) topical application of 5% cream to intact skin (710 cm2) in adult males, 0.04% of the daily dose was detected in urine within 24 hours.112

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Mild pain, burning, or stinging

• Itching

• Itching, stinging, or redness of the genital area
• skin rash

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

You should not use this medicine if you are allergic to acyclovir or valacyclovir (Valtrex).

To make sure acyclovir topical is safe for you, tell your doctor if you have:

• weak immune system (caused by disease or by using certain medicine).

FDA pregnancy category B. Acyclovir topical is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Herpes virus can be passed from an infected mother to her baby during childbirth. If you have genital herpes, it is very important to prevent herpes lesions during your pregnancy so that you do not have a genital lesion when your baby is born.

It is not known whether acyclovir topical passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby. You should not breast-feed if you have a herpes lesion on or near your breast.

Acyclovir topical should not be used on a child younger than 12 years old.

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

Since this medication is applied to the skin, an overdose is unlikely to occur.

This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. 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. Doing so may spread the infection.

Cold sore outbreaks can be caused by many factors such as stress, hormonal changes (such as pregnancy, menstrual period), injury/surgery on the mouth (such as dental work), tiredness, sunlight, cold weather, or fever/cold/flu.

If you have genital herpes sores, wear loose-fitting clothing to keep from irritating them.

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. Firmly screw the cap back on the tube of medication after each use. 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.Information last revised July 2016. Copyright(c) 2016 First Databank, Inc.