Drug Uses
Denavir is a topical antiviral medication used for recurrent cold sores (herpes labialis) on the lips and face in otherwise healthy adult patients. Denavir topical may also be used for purposes other than those listed in this medication guide.
How Taken
Apply Denavir every two hours during waking hours for four days to your cold sore with your finger or a cotton swab. Wash hands with soap and water to prevent it from coming into contact with your eyes or other areas; to prevent irritation and to prevent spread of the herpes virus.
Warnings/Precautions
Denavir is a topical cream that is applied externally on the lips and face. Do not apply Denavir on mucous membranes inside the mouth, nose, genital or rectal areas.
Denavir topical is in the FDA pregnancy category B. This means that it is unlikely to harm an unborn baby. Do not use Denavir topical during pregnancy without first talking to your doctor.
It is not known whether Denavir topical passes into breast milk. Do not use Denavir topical if you are breast-feeding a baby without first talking to your doctor.
Missed Dose
Use the missed dose as soon as you remember. However, if it is almost time for your next dose, skip the dose you missed and use only your next regularly scheduled dose.
Possible Side Effects
Serious side effects have not been reported with the use of Denavir topical.
Other less serious side effects may be more likely to occur. Continue to use Denavir topical and talk to your doctor if you experience: headache; local numbness or tingling where the cream is applied; changes in taste; rash; 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.
Storage
Store at controlled room temperature, 20°-25°C (68°-77°) away from moisture and heat.
Overdose
An overdose of Denavir topical is unlikely to threaten life. If an excessive amount of the cream has been used, or if the cream has been ingested, contact a poison control left or an emergency room for advice.
More Information
Do not use other topical medications to treat the same area at them same time as Denavir topical, unless otherwise directed by your doctor.
No other medicines have been reported to interact with Denavir topical. Talk to your doctor or pharmacist before taking other prescription or over-the-counter medications during treatment with Denavir topical.
Disclaimer
This drug information is for your information purposes only, it is not intended that this information covers all uses, directions, drug interactions, precautions, or adverse effects of your medication. This is only general information, and should not be relied on for any purpose. It should not be construed as containing specific instructions for any particular patient. We disclaim all responsibility for the accuracy and reliability of this information, and/or any consequences arising from the use of this information, including damage or adverse consequences to persons or property, however such damages or consequences arise. No warranty, either expressed or implied, is made in regards to this information.
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The FDA has approved the drug Famvir as the first and only one-day antiviral treatment for recurrent genital herpes and cold sores in people with healthy immune systems.
The drug’s maker, Novartis Pharmaceuticals Corp., announced the FDA approval in a news release dated July 28.
At least 45 million people age 12 and older in the U.S. have had a genital herpes infection -- or about one in five in that age range, says the CDC.
Before, genital herpes required five days of Famvir treatment -- although at a lower dose. Famvir was not FDA approved for cold sores in people with healthy immune systems (meaning those without aids).
The new approval shortens Famvir treatment to a single day at the start of an outbreak and adds cold sores to the drug’s approved uses.
What’s Your Risk for Genital Herpes?
Famvir Dosage
Patients would take 1,000 milligrams of Famvir twice daily for one day at the first sign of genital herpes symptoms, and 1,500 milligrams of Famvir once for one day at the first sign of cold sore symptoms to shorten outbreaks and reduce symptoms.
The drug, available only by prescription, is taken orally.
It does not cure genital herpes or cold sores. Currently, there is no cure for herpes. Antiviral drugs such as Famvir, Zovirax and Valtrex can only help treat or suppress the infection.
Famvir earned FDA approval in 1994 and is used to treat shingles, as well as the herpes virus which causes both genital herpes and cold sores.
Vaginal Gel Blocks HIV, Herpes
Timing Counts
Single-day Famvir should be started within six hours of the first sign of symptoms, such as tingling, itching, burning, or the appearance of herpes sores, says Novartis.
There is “a narrow window of opportunity for treatment” at the start of an outbreak of herpes or cold sores, says Novartis.
Timing is crucial because the virus copies itself most actively in an outbreak’s first hours. Interrupting that process may shorten the outbreak and reduce its severity.
Get the Facts on Sexually Transmitted Diseases
Herpes Virus
There are two types of the herpes simplex virus: herpes simplex virus 1 (HSV-1) and herpes simplex virus 2 (HSV-2).
Cold sores are typically caused by the former, which can spread by kissing an infected person or sharing eating utensils, towels, or razors.
Genital herpes is a sexually transmitted disease (STD) and is usually caused by HSV-2, although it can result from HSV-1.
Most genital herpes patients have few or no symptoms, the CDC notes.
When symptoms appear, there are usually one or more blisters around the genitals or rectum. The blisters can break, leaving tender sores that may take several weeks to heal.
Clinical Trials
Single-day Famvir was tested in clinical trials for treatment of recurrent genital herpes and cold sores.
The genital herpes trial included 329 patients. At the first sign of a herpes outbreak, they got one of two treatments, without knowing which they received:
1,000 milligrams of Famvir twice daily for one day A pill containing no medicine (placebo).
The Famvir group had milder symptoms and shorter outbreaks that lasted about four days, instead of six days with the placebo, Novartis reports.
Single-dose Famvir had a similar effect on the length and severity of cold sores in the cold sores trial, which included 481 patients, according to Novartis.
Novartis is a WebMD sponsor.
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