Health Guide
Drug Guide

Rotavirus vaccine, live, pentavalent (Oral route)

Pronunciation:

ROE-ta-vye-rus VAX-een lyve, pen-ta-VAY-lent

Brand Names:

Dosage Forms:

Classifications:

Therapeutic

Vaccine

Uses of This Medicine:

Rotavirus vaccine live pentavalent is used to prevent infants and children from getting a rotavirus stomach infection. It works by causing your child's body to produce its own protection (antibodies) against the virus.

Rotavirus is a serious infection that causes diarrhea and vomiting. This infection may also lead to severe dehydration in infants and children.

This vaccine is to be administered only by or under the supervision of your child's doctor or other health care professional.

Before Using This Medicine:

In deciding to use a vaccine, the risks of taking the vaccine must be weighed against the good it will do. This is a decision you and your doctor will make. For this vaccine, 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 rotavirus vaccine live pentavalent in infants younger than 6 weeks of age or older than 32 weeks of age. Safety and efficacy have not been established.

Older adults

No information is available on the relationship of age to the effects of rotavirus vaccine live pentavalent in geriatric patients.

Pregnancy

Pregnancy CategoryExplanation
All TrimestersCAnimal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast-feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during 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 receiving this vaccine, 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.

Receiving this vaccine with any of the following medicines is not recommended. Your doctor may decide not to use this vaccine or change some of the other medicines you take.

Receiving this vaccine 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.

Receiving this vaccine 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.

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 vaccine. Make sure you tell your doctor if you have any other medical problems, especially:

Proper Use of This Medicine:

A nurse or other trained health professional will give your child this vaccine. It is given by mouth.

This medicine needs to be given on a fixed schedule. If your child missed the scheduled dose, call your child’s doctor for another appointment.

This medicine comes with a patient information leaflet. Read the information carefully. Ask your child's doctor if you have any questions.

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.

Precautions While Using This Medicine:

It is very important that your child return to your doctor's office at the right time for his or her next dose of this vaccine. Be sure to notify your child's doctor of any side effects that occur after your child receive this vaccine.

Make sure your child's doctor knows if your child has any type of cancer or is receiving a treatment that may weaken the immune system (steroid medicine, radiation treatment, or medicine to treat cancer). Tell you child's doctor if your child has received a blood transfusion or blood products within the past 42 days.

Tell your child's doctor if your child spends time with a person who has immune system problems or is receiving cancer treatment. Your doctor may recommend ways (e.g., proper hand washing after changing of diapers) to help prevent the spread of vaccine virus to other people.

Call your child's doctor right away if your child has diarrhea, blood in the stool, a high fever, severe stomach pain, or vomiting. These maybe symptoms of a serious bowel problem called intussusception.

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
Diarrhea
earache
fever
headache
irritability
muscle aches
sore throat
stuffy or runny nose
unusual tiredness or weakness
vomiting
Less common
Cough
difficulty with breathing
noisy breathing
shortness of breath
tightness in the chest
wheezing
Rare
Black, tarry stools
seizures
Incidence not known
Nausea
pain or cramping in the abdomen or stomach

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
Irritability
Incidence not known
Hives or welts
itching
redness of the skin
skin rash

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.


Last Updated: 12/4/2015

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