Description
Valacyclovir is used to treat cold sores (herpes labialis), shingles (herpes zoster), and genital herpes. It is also used to control genital herpes outbreak in patients with human immunodeficiency virus-1 (HIV-1). This medicine is also used to treat cold sores and chickenpox 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.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Tablet
Before Using
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.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of valacyclovir in children younger than 12 years of age for the treatment of cold sores, in children younger than 2 years of age for the treatment of chickenpox, and in children for the treatment of other conditions. Safety and efficacy have not been established.
Geriatric
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.
Breastfeeding
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.
Drug Interactions
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
- Mycophenolate Mofetil
- Nitisinone
- Tenofovir Alafenamide
- Teriflunomide
- Vadadustat
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:
- Bone marrow transplant or
- Infection (eg, HIV or AIDS) or
- Kidney transplant or
- Skin reactions to valacyclovir or acyclovir, severe, history of—Use with caution. May make these conditions worse.
- Kidney disease (eg, patients receiving dialysis)—You may need a dose adjustment. Talk with your doctor if you have concerns about this.
Proper Use
Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.
If you are taking valacyclovir for the treatment of chickenpox, cold sores, shingles, or genital herpes, it is best to start taking valacyclovir as soon as possible after the first sign of the rash or blisters appear, usually within one day.
This medicine comes with a patient information leaflet. Read and follow the instructions carefully. Ask your doctor if you have any questions.
You may take this medicine with or without food.
Tell your doctor if your child cannot swallow the tablets. Your doctor can prescribe this medicine as an oral suspension.
If you are using the oral suspension, shake well before using. 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 3 times a day for 5 days. However, the dose is usually not more than 1000 mg 3 times a day.
- For treatment of cold sores:
- Adults and children 12 years of age and older—2000 milligrams (mg) 2 times a day every 12 hours for one day.
- Children younger than 12 years of age—Use and dose must be determined by your doctor.
- For treatment of genital herpes, first outbreak:
- Adults—1000 milligrams (mg) 2 times a day for 10 days.
- Children—Use and dose must be determined by your doctor.
- For treatment of genital herpes, recurrent outbreaks:
- Adults—500 milligrams (mg) 2 times a day for 3 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) 3 times a day for 7 days.
- Children—Use and dose must be determined by your doctor.
- For treatment of chickenpox:
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.
Store the oral liquid in the refrigerator. Throw away unused oral liquid after 28 days.
Precautions
It is very important that your doctor check your or your child's progress at regular visits to make sure this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.
It is important to remember that this medicine will not keep you from spreading herpes to others.
This medicine may cause thrombotic thrombocytopenic purpura/hemolytic uremic syndrome (in patients who have HIV or had a bone marrow or kidney transplant). Tell your doctor right away if you have black, tarry stools, blood in the urine, change in mental status, decreased or increased urination, difficulty speaking, fever, pale skin, pinpoint red spots on the skin, seizures, stomach pain, swelling of the face, fingers, feet, or lower legs, unusual bleeding or bruising, unusual tiredness or weakness, or yellow eyes or skin.
Check with your doctor right away if you have bloody urine, decreased amount of urine, increased thirst, lower back or side pain, loss of appetite, nausea or vomiting, swelling of the face, fingers, or lower legs, trouble breathing, or weight gain. These may be symptoms of serious kidney problems.
This medicine may cause nervous system problems. Check with your doctor right away if you have aggressive behavior, confusion, coma, hallucinations, shaky movements, speech problems, or unsteady movement.
This medicine may cause serious skin reactions, including acute generalized exanthematous pustulosis (AGEP), drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis. Chek with your doctor right away if you have black, tarry stools, blistering, peeling, or loosening of the skin, chest pain, chills, cough, diarrhea, fever, itching, joint or muscle pain, painful or difficult urination, red irritated eyes, red skin lesions, often with a purple center, sore throat, sores, ulcers, or white spots on the lips or in the mouth, swollen glands, trouble breathing, unusual bleeding or bruising, or unusual tiredness or weakness.
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
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
- trouble breathing
- yellow eyes or skin
Incidence not known
- Actions that are out of control
- agitation
- anxiety
- back, leg, or stomach pains
- black, tarry stools
- bleeding gums
- blistering, peeling, or loosening of the skin
- 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
- chest pain or tightness
- 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
- joint or muscle pain
- lightheadedness when getting up from a lying or sitting position
- light-colored stools
- loss of consciousness
- mood or mental changes
- nausea and vomiting
- nervousness
- painful or difficult urination
- pale 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
- red irritated eyes
- red skin lesions, often with a purple center
- 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
- sore throat
- 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
- trembling or shaking of the hands or feet
- trouble in speaking
- unsteadiness, trembling, or other problems with muscle control or coordination
- unusual behavior
- unusual bleeding or bruising
- unusual tiredness or weakness
- upper right abdominal or stomach pain
- vomiting
- weight gain
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 pain or stiffness
- pain
- sneezing
- stuffy or runny nose
Less common
- Constipation
- diarrhea
Incidence not known
- Hair loss or thinning of the hair
- increased sensitivity of skin to sunlight
- 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.
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