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 |
|---|---|---|---|
| Zovirax topical - | 5 % ointment |  | |
| Zovirax topical - | 5 % cream |  | |
| 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 % 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 % ointment |  | |
| acyclovir topical - | 5 % cream |  | |
| acyclovir topical - | 5 % ointment |  | |
| acyclovir topical - | 5 % ointment |  | |
| acyclovir topical - | 5 % ointment |  | |
| acyclovir oral - | 200 mg capsule |  | |
| acyclovir oral - | 800 mg tablet |  | |
| acyclovir oral - | 200 mg capsule |  | |
| acyclovir oral - | 200 mg capsule |  | |
| acyclovir oral - | 400 mg tablet |  | |
| acyclovir oral - | 400 mg tablet |  | |
| acyclovir oral - | 400 mg tablet |  | |
| acyclovir oral - | 800 mg tablet |  | |
| acyclovir oral - | 200 mg capsule |  | |
| acyclovir oral - | 800 mg tablet |  | |
| acyclovir oral - | 400 mg tablet |  | |
| acyclovir oral - | 200 mg capsule |  | |
| acyclovir oral - | 200 mg capsule |  | |
| acyclovir oral - | 800 mg tablet |  | |
| acyclovir oral - | 400 mg tablet |  | |
| acyclovir oral - | 800 mg tablet |  | |
| acyclovir oral - | 400 mg tablet |  | |
| acyclovir oral - | 200 mg capsule |  | |
| acyclovir oral - | 200 mg capsule |  | |
| acyclovir oral - | 200 mg/5 mL suspension |  | |
| acyclovir oral - | 400 mg tablet |  | |
| acyclovir oral - | 200 mg/5 mL suspension |  | |
| acyclovir oral - | 200 mg/5 mL suspension |  | |
| acyclovir oral - | 400 mg tablet |  | |
| acyclovir oral - | 800 mg tablet |  | |
| acyclovir oral - | 800 mg tablet |  | |
| acyclovir oral - | 800 mg tablet |  | |
| acyclovir oral - | 800 mg tablet |  | |
| acyclovir oral - | 200 mg/5 mL suspension |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
acyclovir oral
ACYCLOVIR - ORAL
(ay-SYE-kloe-vir)
COMMON BRAND NAME(S): Zovirax
USES: Acyclovir is used to treat infections caused by certain types of viruses. It treats cold sores around the mouth (caused by herpes simplex), shingles (caused by herpes zoster), and chickenpox.This medication is also used to treat outbreaks of genital herpes. In people with frequent outbreaks, acyclovir is used to help reduce the number of future episodes.Acyclovir is an antiviral drug. However, it is not a cure for these infections. The viruses that cause these infections continue to live in the body even between outbreaks. Acyclovir decreases the severity and length of these outbreaks. It helps the sores heal faster, keeps new sores from forming, and decreases pain/itching. This medication may also help reduce how long pain remains after the sores heal. In addition, in people with a weakened immune system, acyclovir can decrease the risk of the virus spreading to other parts of the body and causing serious infections.
HOW TO USE: Take this medication by mouth with or without food as directed by your doctor, usually 2 to 5 times a day. Drink plenty of fluids while taking this medication unless your doctor directs you otherwise.If you are using the liquid form of this medication, shake the bottle well before each dose. Carefully measure the dose using a special measuring device/spoon. Do not use a household spoon because you may not get the correct dose.This medication works best when started at the first sign of an outbreak, as directed by your doctor. It may not work as well if you delay treatment.Dosage is based on your medical condition and response to treatment. In children, dosage is also based on weight.This medication works best when the amount of drug in your body is kept at a constant level. Take this drug at evenly spaced intervals. To help you remember, take it at the same times each day.Continue to take this medication until the full prescribed amount is finished. Do not change your dose, skip any doses, or stop this medication early without your doctor's approval.Tell your doctor if your condition lasts or gets worse.
SIDE EFFECTS: Nausea, diarrhea, headache, or vomiting may occur. If any of these effects last or get 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.Tell your doctor right away if you have any serious side effects, including: dizziness, drowsiness, signs of kidney problems (such as a change in the amount of urine, unusual back/side pain), mental/mood changes (such as agitation, confusion, hallucinations), shaky/unsteady movement, trouble speaking.This medication may rarely cause a life-threatening disorder that affects the blood cells, kidneys, and other parts of the body. This disorder is more likely to occur if you have conditions related to a weakened immune system (such as HIV disease, bone marrow transplant, kidney transplant). Get medical help right away if any of these very serious side effects occur: extreme tiredness, slow/fast/irregular heartbeat, easy bruising/bleeding, new fever, bloody/dark urine, severe stomach/abdominal pain, yellowing eyes/skin, sudden vision changes, loss of consciousness, seizures.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 taking 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, 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: kidney problems, conditions related to a weakened immune system (such as HIV disease, bone marrow transplant, kidney transplant).This drug may rarely make you dizzy or drowsy. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).Do not have certain immunizations/vaccinations (such as vaccines against the varicella virus) without the consent of your doctor.Older adults may be more sensitive to the side effects of the drug, especially kidney problems (change in the amount of urine, back/side pain), dizziness, drowsiness, and mental/mood changes (such as confusion, hallucinations, loss of consciousness).Acyclovir does not protect against the spread of genital herpes. To lower the chance of giving 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.During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.This medication passes into breast milk. However, this drug is unlikely to harm a nursing infant. Consult your doctor before breast-feeding.
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.Some products that may interact with this drug include: other drugs that may cause kidney problems (including nonsteroidal anti-inflammatory drugs-NSAIDs such as ibuprofen, naproxen).Acyclovir is very similar to valacyclovir. Do not use medications containing valacyclovir while using acyclovir.
OVERDOSE: 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. Symptoms of overdose may include: change in the amount of urine, extreme tiredness, agitation, loss of consciousness, seizures.
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 your doctor tells you to.
MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.
STORAGE: Store at room temperature away from light and 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 April 2022. Copyright(c) 2023 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
Adding plans allows you to compare formulary status to other drugs in the same class.
To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.
Adding plans allows you to:
- View the formulary and any restrictions for each plan.
- Manage and view all your plans together – even plans in different states.
- Compare formulary status to other drugs in the same class.
- Access your plan list on any device – mobile or desktop.
