Rotavirus vaccine, live (Oral route)
ROE-ta-vye-rus VAX-een, lyve
- Powder for Suspension
Uses of This Medicine:
Rotavirus vaccine live is used to prevent infants and children from getting a rotavirus stomach infection. It works by causing your body to produce its own protection (antibodies) against the virus.
Rotavirus is a serious infection that causes diarrhea and vomiting. It may also cause severe dehydration in infants and children.
This vaccine is to be administered only by or under the supervision of your child's doctor.
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:
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.
Appropriate studies have not been performed on the relationship of age to the effects of live rotavirus vaccine in infants younger than 6 weeks of age or older than 24 weeks of age. Safety and efficacy have not been established.
No information is available on the relationship of age to the effects of live rotavirus vaccine in geriatric patients.
|All Trimesters||C||Animal 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.|
Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.
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.
- Cytarabine Liposome
- Daunorubicin Citrate Liposome
- Doxorubicin Hydrochloride Liposome
- Gallium Nitrate
- Interferon Alfa
- Interferon Alfacon-1
- Interferon Beta
- Interferon Beta-1a
- Interferon Beta-1b
- Interferon Gamma
- Paclitaxel Protein-Bound
- Uracil Mustard
- Vincristine Sulfate Liposome
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.
- Certolizumab Pegol
- Immune Globulin
- Mycophenolic Acid
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.
- Vaccinia Immune Globulin, Human
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:
- Cancer or
- Weak immune system (e.g., from HIV or AIDS or medicines)—These conditions may increase the risk for serious side effects.
- Diarrhea or
- Vomiting—Use with caution. May make these conditions worse.
- Blocked or slow bowels, history of or
- Intussusception (serious bowel problem), history of or
- Meckel's diverticulum (a bowel disease), history of or
- Severe combined immunodeficiency disease (SCID) (an inherited disease)—Should not be used in patients with these conditions.
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 doctor if you have any questions.
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 (suspension):
- To prevent rotavirus infection:
- Infants and children older than 24 weeks of age—Use and dose must be determined by your doctor.
- Infants 6 to 24 weeks of age—The first dose should be given at around 6 weeks of age. The second dose should be given at least 4 weeks after the first dose. Both doses must be completed before the baby is 24 weeks of age (6 months).
- Infants younger than 6 weeks of age—Use and dose must be determined by your doctor.
- To prevent rotavirus infection:
Precautions While Using This Medicine:
It is very important that your child's doctor check your child's progress at regular visits to make sure that this vaccine is working properly and to check for unwanted effects.
Make sure your child's doctor knows if your child is receiving medicine or a procedure that may weaken the immune system, such as steroids, cancer medicines, or radiation. Tell your child's doctor if your child spends time with a person who has an immune system problem or is getting cancer medicines.
The oral applicator of this vaccine contains dry natural latex rubber. Make sure your child's doctor knows if your child has had an allergic reaction to latex rubber.
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 could be symptoms of a serious bowel problem called intussusception.
Side Effects of This Medicine:
- More common
- nausea and vomiting
- pain or cramping in the abdomen or stomach
- decreased urination
- dry mouth
- increase in heart rate
- loss of appetite
- rapid breathing
- sunken eyes
- unusual tiredness or weakness
- wrinkled skin
- Incidence not known
- Black, tarry stools
- blood in the urine
- bloody nose
- heavier menstrual periods
- pinpoint red spots on the skin
- red eyes
- red mouth
- skin rash
- swollen glands
- swollen hands and feet
- unusual bleeding or bruising
- More common
- crying, fussiness, or irritability
- runny nose
- Less common
- excess air or gas in the stomach or intestines
- full feeling
- passing gas
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 or nurse immediately if any of the following side effects occur:
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:
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: 11/4/2014