Denavir is a topical antiviral medication used for recurrent cold sores (herpes labialis) on the lips and face in otherwise healthy adult patients. Denavir is a topical cream that is applied externally on the lips and face. It is not indicated for internal use on mucous membranes inside the mouth, nose, genital or rectal areas.
Apply Denavir every two hours during waking hours for four days to your cold sore with your finger or a cotton swab. Wash hands to prevent it from coming into contact with your eyes or other areas to prevent irritation.
After applying Denavir to a cold sore, the active ingredient, penciclovir, penetrates into the infected cells to block the multiplying of the virus that causes the cold sore.
Denavir was generally well tolerated in all clinical trials the most frequently reported adverse events with Denavir and placebo in the pivotal trials, respectively, were headache (5.3% vs 5.8%) and application site reaction (1.3% vs 1.8%). In the most recent trial the adverse events were no different.
Important Patient InformationPENCICLOVIR CREAM - TOPICAL (pen-SYE-kloe-vir) COMMON BRAND NAME(S): Denavir
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.
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. Therefore, 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 your doctor has prescribed this medication because he or she 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.
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.
This product information is intended for United States residents only. Before prescribing, please refer to the patient information. You can view the document and also download it on your computer. You may also consider printing out a copy for yourself. View US Prescribing Information - PDF Version
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