penciclovir (Rx)

Brand and Other Names:Denavir
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

cream

  • 0.1%

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

  • 0.1%

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

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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

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Warnings

Contraindications

Hypersensitivity

Cautions

Use gloves to apply because may inoculate other areas

External use only

Effects in immunocompromised patients not established

For use in lips/face only

NOT for use in mucous membranes not recommended

NOT for use in or near eyes

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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.

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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

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Images

BRAND FORM. UNIT PRICE PILL IMAGE
Denavir topical
-
1 % cream

Copyright © 2010 First DataBank, Inc.

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Patient Handout

Patient Education
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 every 2 hours (except during sleep) for 4 days or as directed by your doctor.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 persists or worsens after treatment is finished.

SIDE EFFECTS: Redness, burning, stinging, or numbness may occur. If any of these effects persist or worsen, 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, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: 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: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use.Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

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 August 2021. Copyright(c) 2021 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.

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Formulary

FormularyPatient Discounts

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.

The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.