• Immunizing agent (active)

Rotavirus ( ROE-ta VYE-rus) vaccine live oral is an immunizing agent used to prevent infection by the rotavirus. It works by causing your body to produce its own protection (antibodies) against the virus.

Rotavirus infection is the single most important cause of diarrhea and vomiting in infants and young children both in developed and developing countries. If untreated, severe rotaviral diarrhea in infants can rapidly become life-threatening. The risk of serious complications and death from rotaviral infection is greater for infants and younger children than for adults.

Immunization against rotavirus infection is recommended for infants 2 to 6 months of age. The first dose of rotavirus vaccine live oral may be administered at as early as 6 weeks of age.

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

The medicine was withdrawn from the U.S. market in October 1999.

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 rotavirus vaccine live oral, the following should be considered:

Allergies—Tell your doctor if your child has ever had any unusual or allergic reaction to rotavirus vaccine live oral, aminoglycosides, or amphotericin B. Also tell your health care professional if your child is allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Studies on the effects of rotavirus vaccine live oral on pregnancy have not been done in either humans or animals. Use is not recommended in persons older than 6 months of age.

Breast-feeding—Rotavirus vaccine live oral has not been reported to cause problems in nursing babies.

Children—Use is not recommended in children older than 6 months of age.

Older adults—Rotavirus vaccine live oral has been tested only in infants and there is no specific information about its use in older patients. Use is not recommended in persons older than 6 months of age.

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. Tell your health care professional if your child is using any other prescription or nonprescription (over-the-counter [OTC]) medicine.

• Diarrhea or
• Vomiting—The condition may reduce the useful effect of the vaccine

• Fever—The symptoms of the condition may be confused with possible side effects of the vaccine

• Immune deficiency conditions (or family history of)—The condition may increase the chance of side effects of the vaccine

Dosing—

The following information includes only the average doses of rotavirus vaccine live oral.

• For oral dosage form (oral solution):
  • For prevention of rotavirus infection:
    • Adults, children and infants older than 6 months of age—Use is not recommended.
    • Infants 2 to 6 months of age—One dose is given at 2 months of age, a second dose is given at 4 months of age, and a third dose is given at 6 months of age.

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 as soon as possible if any of the following side effects occur:

• More common
  • Fever of 100.4 to 102.2 °F (38 to 39 °C) 
  
  

• Rare
  • Fever of 102.2 °F (39 °C) or more 
  
  

Other 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. However, check with your doctor if any of the following side effects continue or are bothersome:

• More common
  • Decreased activity;  decreased appetite ;  irritability 
  
  

• Less common
  • Abdominal cramping 
  
  

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