Dosing & Uses
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
Adverse Effects
>10%
Burning/stinging (30%)
1-10%
Pruritus (4%)
<1%
Dry lips (<1%)
Rash (0.3%)
Frequency Not Defined
Angioedema
Vulvitis
Warnings
Contraindications
Hypersensitivity
Cautions
Not recommended for recurrent infections
Use caution in immunocompromised patients
Avoid physical contact when lesions are present
For external use only; not for use on the eye or inside mouth
Pregnancy & Lactation
Pregnancy
No available data on use in pregnant women; however, published observational studies over decades of use of acyclovir have not identified a drug- associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes; systemic exposure of acyclovir following buccal administration is minimal
Animal data
- Animal reproduction studies with topical formulation not conducted; animal reproduction studies with systemic exposure of acyclovir have been conducted; refer to oral and parental acyclovir prescribing information for additional details
Lactation
There are no data on presence of drug in human milk following buccal administration; there are no data on effects of drug on breastfed infant or milk production; systemic exposure following buccal administration is minimal; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed child from or from underlying maternal condition
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Exerts its antiviral effect on herpes simplex viruses and varicella zoster virus by interfering with DNA synthesis and inhibiting viral replication
Helps shed herpes virus quicker and reduces pain and duration; used for management of initial episodes of herpes genitalis and in mucocutaneous herpes simplex viral infections in immunocompromised patients
Absorption
Minimal
Metabolism
In cells infected with herpes viruses, principally by intracellular phosphorylation of drug by virus-coded thymidine kinase and several cellular enzymes
Elimination
Excretion: Urine
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| acyclovir topical - | 5 % ointment |  | |
| acyclovir topical - | 5 % ointment |  | |
| acyclovir topical - | 5 % ointment |  | |
| acyclovir topical - | 5 % ointment |  | |
| acyclovir topical - | 5 % ointment |  | |
| acyclovir topical - | 5 % ointment |  | |
| acyclovir topical - | 5 % ointment |  | |
| acyclovir topical - | 5 % ointment |  | |
| acyclovir topical - | 5 % ointment |  | |
| acyclovir topical - | 5 % ointment |  | |
| acyclovir topical - | 5 % ointment |  | |
| acyclovir topical - | 5 % ointment |  | |
| acyclovir topical - | 5 % ointment |  | |
| acyclovir topical - | 5 % ointment |  | |
| acyclovir topical - | 5 % ointment |  | |
| acyclovir topical - | 5 % cream |  | |
| acyclovir topical - | 5 % ointment |  | |
| acyclovir topical - | 5 % ointment |  | |
| acyclovir topical - | 5 % ointment |  | |
| acyclovir topical - | 5 % ointment |  | |
| acyclovir topical - | 5 % cream |  | |
| Zovirax topical - | 5 % ointment |  | |
| Zovirax topical - | 5 % cream |  | |
| Zovirax oral - | 800 mg tablet |  | |
| Zovirax oral - | 200 mg capsule |  | |
| Zovirax oral - | 400 mg tablet |  | |
| acyclovir oral - | 800 mg tablet |  | |
| acyclovir oral - | 200 mg capsule |  | |
| acyclovir oral - | 200 mg capsule |  | |
| acyclovir oral - | 200 mg capsule |  | |
| acyclovir oral - | 400 mg tablet |  | |
| acyclovir oral - | 400 mg tablet |  | |
| acyclovir oral - | 800 mg tablet |  | |
| acyclovir oral - | 800 mg tablet |  | |
| acyclovir oral - | 400 mg tablet |  | |
| acyclovir oral - | 200 mg/5 mL suspension |  | |
| acyclovir oral - | 800 mg tablet |  | |
| acyclovir oral - | 200 mg capsule |  | |
| acyclovir oral - | 200 mg capsule |  | |
| acyclovir oral - | 200 mg capsule |  | |
| acyclovir oral - | 400 mg tablet |  | |
| acyclovir oral - | 400 mg tablet |  | |
| acyclovir oral - | 200 mg capsule |  | |
| acyclovir oral - | 400 mg tablet |  | |
| acyclovir oral - | 200 mg capsule |  | |
| acyclovir oral - | 400 mg tablet |  | |
| acyclovir oral - | 200 mg capsule |  | |
| acyclovir oral - | 200 mg/5 mL suspension |  | |
| acyclovir oral - | 800 mg tablet |  | |
| acyclovir oral - | 800 mg tablet |  | |
| acyclovir oral - | 200 mg capsule |  | |
| acyclovir oral - | 400 mg tablet |  | |
| acyclovir oral - | 800 mg tablet |  | |
| acyclovir oral - | 800 mg tablet |  | |
| acyclovir oral - | 200 mg/5 mL suspension |  | |
| acyclovir oral - | 800 mg tablet |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
acyclovir topical
ACYCLOVIR OINTMENT - TOPICAL
(ay-SYE-kloe-vir)
COMMON BRAND NAME(S): Zovirax
USES: This medication is used to treat the first outbreak of genital herpes infection. It is also used to treat non-life-threatening herpes infections of the skin and around the mouth (cold sores) in people with a weakened immune system. This medication may decrease the length of time you have pain and help the sores heal faster. Acyclovir is an antiviral drug. It stops the growth of certain viruses.This medication does not cure herpes or prevent the infection from coming back. Also, it does not prevent the spread of herpes to others.Other antiviral medications taken by mouth may be more effective in treating these conditions. Discuss your treatment options with your doctor.
HOW TO USE: Apply this medication to skin only. Avoid getting this medication in your eyes. If this happens, wash right away with plenty of water.Begin using acyclovir as soon as symptoms of a herpes infection appear. Wash your hands with soap and water before and after using this medication. Clean and dry the affected areas before applying the medication. Use a finger cot or rubber glove when applying acyclovir to prevent spreading the infection to other parts of your body and to other people. Apply enough ointment to cover all sores, usually every 3 hours, 6 times a day, or as directed by your doctor. Continue to use this medication for the full time prescribed.Tell your doctor if your condition does not improve after 7 days of treatment or if it worsens.
SIDE EFFECTS: This medication may cause mild, temporary burning or stinging when you apply it. If either of these effects lasts or gets worse, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor 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 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before using acyclovir, tell your doctor or pharmacist if you are allergic to it; or to valacyclovir; or if you have any other allergies. This product may contain inactive ingredients (such as polyethylene glycol), 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.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).Cold sores can spread easily. Avoid close physical contact with others (such as kissing) during an outbreak until the cold sores have completely healed. Try not to touch the cold sore. If you do, wash your hands afterward.To lower the chance of giving genital herpes to your partner, do not have sexual contact during an outbreak or if you have symptoms. You can spread genital herpes even if you do not have symptoms. Always use an effective barrier method (latex or polyurethane condoms/dental dams) during all sexual activity. Consult your doctor or pharmacist for more details.Tell your doctor if you are pregnant before using this medication. Discuss the risks and benefits with your doctor.It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding. Avoid breastfeeding if you have herpes sores on or near your breast.
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 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.Wear loose-fitting clothing over your herpes sores to keep from irritating them.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. Talk to your doctor about identifying and managing these triggers.
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. Use your next dose at the regular time. Do not double the dose to catch up.
STORAGE: Store at room temperature away from moisture. Do not store in the bathroom. 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 December 2021. Copyright(c) 2022 First Databank, Inc.
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.
Formulary
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