Dosing & Uses
Dosage Forms & Strengths
cream
- 1%
Herpes Simplex Labialis (Cold Sores)
Apply at first onset of symptoms (tinglint, swelling, etc) apply q2hr while awake for 4 days
Dosage Forms & Strengths
cream
- 1%
Herpes Simplex Labialis (Cold Sores)
< 12 years: Safety & efficacy not established
>12 years: At first onset of symptoms apply q2hr while awake for 4 days
Adverse Effects
> 10%
Milde erythema
1-10%
Application site reaction (1%)
Headache (5%)
<1%
Hypesthesia/local anesthesia
Erythematous rash
Local edema
Oropharyngeal edema
Paresthesia
Parosmia
Skin discoloration
Pain
Urticaria
Taste perversion
Warnings
Contraindications
Hypersensitivity
Cautions
Use gloves to apply because may inoculate other areas
External use only
Effects in immunocompromised patients not established
For use on herpes labialis on the lips and face
NOT for use in mucous membranes not recommended
NOT for use in or near eyes
Lesions that do not improve or that worsen on therapy should be evaluated for secondary bacterial infection
Pregnancy & Lactation
Pregnancy
Drug is not absorbed systemically following topical administration and maternal use is not expected to result in fetal exposure to drug
Lactation
Drug is not absorbed systemically by the mother following topical administration and breastfeeding is not expected to result in exposure of child to drug
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
Penciclovir is converted to the pharmacologically active triphosphate metabolite, which has in vitro and in vivo inhibitory activity against various Herpesviridae, including herpes simplex virus types 1 and 2 (HSV-1 and HSV-2), varicella-zoster virus (VZV), and Epstein-Barr virus (EBV)
Pharmacokinetics
Absorption: Not absorbed
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| Denavir topical - | 1 % cream |  | |
| penciclovir topical - | 1 % cream |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
penciclovir topical
PENCICLOVIR CREAM - TOPICAL
(pen-SYE-kloe-vir)
COMMON BRAND NAME(S): Denavir
USES: This medication is used to treat "cold sores/fever blisters" (herpes labialis). It can speed up healing of the sores and decrease symptoms (such as tingling, pain, burning, itching). Penciclovir belongs to a class of medications known as antivirals. It works by stopping the growth of the virus. This medication does not cure herpes, and it does not prevent passing the infection to someone else. It does not prevent future occurrences.
HOW TO USE: Use this medication at the first sign of infection (such as tingling, burning, redness, or sores). Wash your hands with soap and water before and after applying this medication. Clean and dry the affected areas before applying the medication. Apply a thin layer of penciclovir cream to completely cover the area of the cold sore or the area of tingling/itching/redness/swelling, and rub in gently. Apply the cream as directed by your doctor, usually every 2 hours (except during sleep) for 4 days.Apply to skin only. Do not apply this medication in or near the eyes since this medication can irritate the eyes. If you do get medication in your eyes, flush with plenty of water. Do not apply inside the mouth or nose.Dosage is based on your medical condition and response to treatment. Do not use this drug more often or for longer than prescribed.Use this medication regularly to get the most benefit from it. This medication works best when the amount of drug absorbed by the skin stays at a constant level. Use this drug at evenly spaced intervals. To help you remember, use it at the same times each day.Cold sores (herpes) can spread easily. Penciclovir cream does not prevent the spread of herpes. Avoid close physical contact with others (such as kissing) during an outbreak until the cold sores have completely healed. Also, try not to touch the cold sore, and wash your hands if you do touch the cold sore.Tell your doctor if your condition lasts or gets worse after treatment is finished.
SIDE EFFECTS: Redness, burning, stinging, or numbness 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.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 penciclovir, tell your doctor or pharmacist if you are allergic to it; or to famciclovir; 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.Tell your doctor if you are pregnant before using this medication.This medication does not pass into breast milk. 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.
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. Doing so may spread the infection.Cold sore outbreaks can be triggered 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.
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 this medication 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 September 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
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