Medication Guide App

Lipsovir

Generic Name: acyclovir and hydrocortisone
Date of Approval: July 31, 2009
Company: Medivir Pharma
Treatment for: Cold Sores

FDA Approves Lipsovir

The US Food and Drug Administration (FDA) has approved Lipsovir (acyclovir and hydrocortisone) for the early treatment of recurrent herpes labialis (cold sores) to reduce the likelihood of ulcerative cold sores and to shorten the lesion healing time. Treatment is approved for adults and children 12 years or older.

What is Lipsovir?

Lipsovir is a cream containing a combination of acyclovir and hydrocortisone.

Acyclovir is an antiviral drug. It slows the growth and spread of the herpes virus so that the body can fight off the infection. Acyclovir will not cure herpes, but it can lessen the symptoms of the infection.

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Hydrocortisone is a topical steroid. It reduces the actions of chemicals in the body that cause inflammation, redness, and swelling.

Lipsovir is used for the early treatment of cold sores to reduce the likelihood of ulcerative cold sores and to shorten the lesion healing time.

What is the most important information I should know about Lipsovir?

Use this medication for the entire length of time prescribed by your doctor. Your symptoms may get better before the infection is completely treated.

Treatment with Lipsovir should be started as soon as possible after the first appearance of symptoms (such as tingling, burning, blisters).

Wear a glove or a finger cot or use a cotton swab when applying Lipsovir to avoid spreading the virus to other body parts and to other people.

Avoid getting this medication in your eyes.

Herpes infections are contagious and you can infect other people, even while you are being treated with Lipsovir. Avoid letting infected areas come into contact with other people. Avoid touching an infected area and then touching your eyes. Wash your hands frequently to prevent passing the infection to others.

What should I discuss with my healthcare provider before using Lipsovir?

Do not use this medicine if you are allergic to acyclovir or hydrocortisone.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether Lipsovir passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Do not use this medication on a child under the age of 12 years.

See also: Pregnancy and breastfeeding warnings (in more detail)

How should I use Lipsovir?

Use this medication exactly as it was prescribed for you. Do not use the medication in larger amounts, or use it for longer than recommended by your doctor. Follow the directions on your prescription label.

Treatment with Lipsovir should be started as soon as possible after the first appearance of symptoms (such as tingling, burning, blisters).

Wear a glove or a finger cot or use a cotton swab when applying Lipsovir to avoid spreading the virus to other body parts and to other people.

Apply enough Lipsovir to cover the lesion(s) completely. Follow your doctor's instructions.

Use this medication for the entire length of time prescribed by your doctor. Your symptoms may get better before the infection is completely treated.

Store Lipsovir at room temperature away from moisture and heat.

What happens if I miss a dose?

Use the medication as soon as you remember. If it is almost time for the next dose, skip the missed dose and use the medicine at the next regularly scheduled time. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. An overdose of Lipsovir applied to the skin is not expected to produce life-threatening symptoms.

What should I avoid?

Avoid getting this medication in your eyes. If this does happen, rinse with water.

Herpes infections are contagious and you can infect other people, even while you are being treated with acyclovir. Avoid letting infected areas come into contact with other people. Avoid touching an infected area and then touching your eyes. Wash your hands frequently to prevent passing the infection to others.

Lipsovir side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Less serious side effects are more likely to occur, such as itching, swelling, or pain where the medicine is applied.

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.

There may be other drugs that can affect Lipsovir. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

See also: Side effects (in more detail)

More about Lipsovir (acyclovir / hydrocortisone topical)

Consumer resources

Related treatment guides

Where can I get more information?

Your pharmacist has information about acyclovir topical written for health professionals that you may read.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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