Acyclovir topical

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

In the U.S.

• Zovirax

In Canada

• Acyclovir

Available Dosage Forms:

• Cream
• Ointment

Therapeutic Class: Antiviral

Pharmacologic Class: Viral DNA Polymerase Inhibitor

Chemical Class: Guanosine Nucleoside Analog

Acyclovir belongs to the family of medicines called antivirals. Antivirals are used to treat infections caused by viruses. Usually they work for only one kind or group of virus infections.

Topical acyclovir is used to treat the symptoms of herpes simplex virus infections of the skin, mucous membranes, and genitals (sex organs). Although topical acyclovir will not cure herpes simplex, it may help relieve the pain and discomfort and may help the sores (if any) heal faster. Topical acyclovir may also be used for other conditions as determined by your doctor.

Acyclovir is available only with your doctor's prescription.

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.

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.

Cream: Apply to the affected area 5 times a day for 4 days. Therapy should be started as early as possible following onset of signs and symptoms (i.e., during the prodromal phase or when lesions appear).

Ointment:
Children: Apply to affected area every 3 hours, 6 times a day for 7 days. Therapy should be started as early as possible following onset of signs and symptoms.

Acyclovir topical cream and ointment are intended for cutaneous use only and should not be used in the eye. In addition, the cream should only be used on the affected external aspects of the lips and face and should not be used inside the mouth or nose.

The recommended dosage, application frequency, and treatment duration of acyclovir topical ointment should not be exceeded. The ointment should not be used for the prevention of recurrent herpes simplex virus infections.

The efficacy of acyclovir topical cream has not been established in immunocompromised patients.

Safety and efficacy of the cream and ointment have not been established in pediatric patients less than 12 and 18 years of age, respectively.

Data not available

In a review of 229,101 deliveries to Michigan Medicaid patients, 391 first trimester exposures to acyclovir and 1081 exposures any time during pregnancy were recorded. These exposures include systemic and nonsystemic exposures. A total of 18 birth defects were reported with first trimester exposure (17 expected) and included (observed/expected) 5/4 cardiovascular defects, 1 polydactyly, and limb reductions. (Written communication, Franz Rosa, MD, Food and Drug Administration, 1994.)

Acyclovir topical has been assigned to pregnancy category B by the FDA. Animal studies have failed to reveal evidence of fetotoxicity. There are no controlled data in human pregnancy. Acyclovir topical should only be used during pregnancy when the potential benefits outweigh the potential risks.

LactMed Record Number

331

Last Revision Date

20150310

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