Pronunciation:

val-ay-SYE-kloe-vir

Brand Names:

• Valtrex

Dosage Forms:

• Tablet

Classifications:

Therapeutic—

Antiviral

Pharmacologic—

Viral DNA Polymerase Inhibitor

Chemical—

Guanosine Nucleoside Analog

Uses of This Medicine:

Valacyclovir is used to treat herpes virus infections, including herpes labialis (also known as cold sores), herpes zoster (also known as shingles), and herpes simplex (also known as genital herpes) in adults. It is also used to treat chickenpox and cold sores in children.

In your body, valacyclovir becomes the anti-herpes medicine, acyclovir. Although valacyclovir will not cure shingles or genital herpes, it does help relieve the pain and discomfort and helps the sores heal faster.

Valacyclovir is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of valacyclovir in children below 12 years of age with cold sores, and children below 2 years of age with chickenpox. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of valacyclovir in the elderly. However, elderly patients are more likely to have age-related kidney disease, which may require an adjustment in the dose of patients receiving valacyclovir.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Dichlorphenamide
• Emtricitabine
• Fexinidazole
• Foscarnet
• Leflunomide
• Nitisinone
• Tenofovir Alafenamide
• Teriflunomide

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Fosphenytoin
• Phenytoin
• Valproic Acid

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Advanced human immunodeficiency virus (HIV) infection or
• Bone marrow transplantation or
• Kidney transplantation—Patients with these medical problems may have an increased risk of severe side effects.

• Kidney disease—The effects may be increased because of slower removal of this medicine from the body.

Proper Use of This Medicine:

Valacyclovir works best if it is used within 48 hours after the first symptoms of shingles or genital herpes (e.g., pain, burning, or blisters) begin to appear. For recurrent outbreaks of genital herpes, valacyclovir works best if it is used within 24 hours after the symptoms begin to appear.

If you are taking valacyclovir for the treatment of chickenpox, it is best to start taking valacyclovir as soon as possible after the first sign of the chickenpox rash appears, usually within one day.

Valacyclovir may be taken with meals or on an empty stomach.

If you are using the oral suspension, use a specially marked measuring spoon or other device to measure each dose accurately. The average household teaspoon may not hold the right amount of liquid.

Drink extra fluids so you will pass more urine while you are using this medicine. This will keep your kidneys working well and help prevent kidney problems.

To help clear up your infection, keep taking valacyclovir for the full time of treatment, even if your symptoms begin to clear up after a few days. Do not miss any doses. However, do not use this medicine more often or for a longer time than your doctor ordered.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • For treatment of chickenpox:
    • Adults and children below 2 years of age—Use and dose must be determined by your doctor.
    • Children 2 to 18 years of age—Dose is based on body weight and must be determined by your doctor. The usual dose is 20 milligrams (mg) per kilogram (kg) of body weight, taken three times a day for 5 days. However, the dose is usually not more than 1000 mg three times a day.
  • For treatment of cold sores:
    • Adults—2000 milligrams (mg) every 12 hours for one day.
    • Children 12 years of age and above—2000 milligrams (mg) every 12 hours for one day.
    • Children below 12 years of age—Use and dose must be determined by your doctor.
  • For treatment of genital herpes, first outbreak:
    • Adults—1000 milligrams (mg) two times a day for ten days.
    • Children—Use and dose must be determined by your doctor.
  • For treatment of genital herpes, recurrent outbreaks:
    • Adults—500 milligrams (mg) two times a day for three days.
    • Children—Use and dose must be determined by your doctor.
  • To prevent recurrent outbreaks of genital herpes:
    • Adults—500 milligrams (mg) or 1000 mg once a day.
    • Children—Use and dose must be determined by your doctor.
  • For treatment of shingles:
    • Adults—1000 milligrams (mg) three times a day for seven days.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

If you or your child's symptoms do not improve within a few days, or if they become worse, check with your doctor.

The areas affected by genital herpes, chickenpox, or shingles should be kept as clean and dry as possible. Also, wear loose-fitting clothing to avoid irritating the sores (blisters).

It is important to remember that this medicine will not keep you from spreading herpes to others.

Herpes infection of the genitals can be caught from or spread to your partner during any sexual activity. Even though you may get herpes if your partner has no symptoms, the infection is more likely to be spread if sores are present. This is true until the sores are completely healed and the scabs have fallen off. Therefore, it is best to avoid any sexual activity if either you or your sexual partner has any symptoms of herpes. The use of a latex condom (“rubber") may help prevent the spread of herpes. However, spermicidal (sperm-killing) jelly or a diaphragm will probably not help.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Discouragement

feeling sad or empty

irritability

lack of appetite

loss of interest or pleasure

tiredness

trouble concentrating

trouble sleeping

Rare

Black, tarry stools

chest pain

chills

cough

decreased frequency or output of urine

fever

flu-like symptoms

headache

lower back or side pain

reduced mental alertness

shortness of breath

yellow eyes or skin

Incidence not known

Actions that are out of control

agitation

anxiety

back, leg, or stomach pains

bleeding gums

blood in urine or stools

blurred vision

change in consciousness

change in mental status

changes in behavior, especially in interactions with other people

changes in patterns and rhythms of speech

dark or bloody urine

difficult or labored breathing

difficulty speaking

difficulty swallowing

dizziness

drowsiness

dry mouth

fast, pounding, or irregular heartbeat or pulse

feeling that others are watching you or controlling your behavior

feeling that others can hear your thoughts

feeling, seeing, or hearing things that are not there

general tiredness and weakness

hyperventilation

increased thirst

itching

lightheadedness when getting up from a lying or sitting position

light-colored stools

loss of consciousness

mood or mental changes

nausea and vomiting

nervousness

pale color of skin

pinpoint red spots on the skin

pounding in the ears

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

redness of the skin

restlessness

seeing, hearing, or feeling things that are not there

seizures

severe mood or mental changes

shakiness and unsteady walk

shakiness in the legs, arms, hands, or feet

skin rash

slurred speech

sores, ulcers, or white spots on the lips or in the mouth

stiff neck

swelling of the face, fingers, or lower legs

swollen or painful glands

talking, feeling, and acting with excitement

tightness in the chest

trembling or shaking of the hands or feet

trouble in speaking

troubled breathing

unsteadiness, trembling, or other problems with muscle control or coordination

unusual behavior

unusual bleeding or bruising

unusual tiredness or weakness

upper right abdominal pain

vomiting

weight gain

wheezing

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Body aches or pain

cramps

difficulty in moving

ear congestion

heavy bleeding

loss of voice

muscle aches

muscle pain or stiffness

nasal congestion

pain

pain in joints

sneezing

sore throat

stuffy or runny nose

Less common

Constipation

diarrhea

Incidence not known

Blistering, peeling, or loosening of the skin

hair loss or thinning of the hair

hives or welts

increased sensitivity of skin to sunlight

red, irritated eyes

redness or other discoloration of the skin

severe sunburn

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.