Denavir

DRUG DESCRIPTION

Denavir contains penciclovir, an antiviral agent active against herpes viruses. Denavir (penciclovir) is available for topical administration as a 1% white cream. Each gram of Denavir contains 10 mg of penciclovir and the following inactive ingredients: cetomacrogol 1000 BP, cetostearyl alcohol, mineral oil, propylene glycol, purified water and white petrolatum.

Chemically, penciclovir is known as 9-[4-hydroxy-3-(hydroxymethyl) butyl]guanine. Its molecular formula is C10H15N5O3; its molecular weight is 253.26. It is a synthetic acyclic guanine derivative and has the following structure:

Denavir® (penciclovir) Structural Formula Illustration

Penciclovir

Penciclovir is a white to pale yellow solid. At 20°C it has a solubility of 0.2 mg/mL in methanol, 1.3 mg/mL in propylene glycol, and 1.7 mg/mL in water. In aqueous buffer (pH 2) the solubility is 10.0 mg/mL. Penciclovir is not hygroscopic. Its partition coefficient in n-octanol/water at pH 7.5 is 0.024 (logP= -1.62).

What are the possible side effects of penciclovir topical (Denavir)?

Serious side effects have not been reported with the use of penciclovir topical.

Other less serious side effects may be more likely to occur. Continue to use penciclovir topical and talk to your doctor if you experience:

  • headache;
  • local numbness or tingling where the cream is applied;
  • changes in taste;
  • rash; or
  • irritation at the application site.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems...

Read All Potential Side Effects and See Pictures of Denavir »

What are the precautions when taking penciclovir (Denavir)?

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. Discuss the risks and benefits with your doctor.

It is not known if this medication passes into breast milk. Consult your doctor before...

Read All Potential Precautions of Denavir »


Denavir Consumer (continued)

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.

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. Discuss the risks and benefits with your doctor.

It is not known if this medication passes into breast milk. Consult your doctor before breast-feeding.


Denavir Patient Information Including Side Effects

Brand Names: Denavir

Generic Name: penciclovir topical (Pronunciation: pen SYE kloe veer TAH pih kal)

  • What is penciclovir topical (Denavir)?
  • What are the possible side effects of penciclovir topical (Denavir)?
  • What is the most important information I should know about penciclovir topical (Denavir)?
  • Who should not use penciclovir topical (Denavir)?
  • How should I use penciclovir topical (Denavir)?
  • What happens if I miss a dose (Denavir)?
  • What happens if I overdose (Denavir)?
  • What should I avoid while using penciclovir topical (Denavir)?
  • What other drugs will affect penciclovir topical (Denavir)?
  • Where can I get more information?

What is penciclovir topical (Denavir)?

Penciclovir is an antiviral medication.

Penciclovir is used topically for the treatment of recurrent cold sores.

Penciclovir topical may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of penciclovir topical (Denavir)?

Serious side effects have not been reported with the use of penciclovir topical.

Other less serious side effects may be more likely to occur. Continue to use penciclovir topical and talk to your doctor if you experience:

  • headache;
  • local numbness or tingling where the cream is applied;
  • changes in taste;
  • rash; or
  • irritation at the application site.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about penciclovir topical (Denavir)?

Do not apply penciclovir topical to the inside of the nose or in or near the eyes, as it may cause irritation.

For best results, treatment with penciclovir topical should begin as soon as possible after symptoms appear.

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