rotavirus oral vaccine, live (Rx) - Rotarix, RotaTeq

 
 
 

Adult Dosing & Uses

Not indicated

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Pediatric Dosing & Uses

Dosing Forms & Strengths

oral vaccine

  • Rotarix: 1mL/dose
  • RotaTeq: 2mL/dose

Rotavirus Gastroenteritis Prophylaxis

Live, attenuated oral vaccine indicated for immunization to prevent rotavirus gastroenteritis in infants and children

RotaTeq: 3 Dose Regimen

  • Pentavalent vaccine; prevention of rotavirus gastroenteritis caused by the G1, G2, G,3 and G4 serotypes, plus attachment protein serotype P7
  • Total of three 2 mL doses administered orally
  • First dose given at 6-12 weeks of age
  • Subsequent doses administered at 4-10 week intervals
  • Third dose should not be given after 32 weeks of age

Rotarix: 2-Dose Regimen

  • Prevention of rotavirus gastroenteritis caused by G1 and non-G! serotypes (G3, G4, and G9)
  • Total of two 1 mL doses administered orally
  • Administer first dose to infants beginning at 6 weeks of age
  • Administer second dose after an interval of at least 4 weeks and prior to 24 weeks of age

Additional Information

These products convey active immunity via stimulation of production of endogenously produced antibodies

The onset of protection from disease is relatively slow, but duration is long lasting (years)

CDC researchers observed rotavirus-associated diarrhea decreased by 75% and hospitalizations for diarrhea by 33% during 2007-2008 following 2006 introduction of pentavalent rotavirus vaccine; diarrhea-related incidence also decreased among age-matched unvaccinated children (NEJM 2011 Sept22;365:1108-1117)

Up-to-date vaccination schedules available at www.cdc.gov/nip/publications

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Drug Interactions

Interaction Checker

rotavirus oral vaccine, live and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            Suspected adverse events after administration of any vaccine may be reported to Vaccine Adverse Events Reporting System (VAERS), 1-800-822-7967

            Within 42 days of any dose

            >10%

            Diarrhea (24.1%)

            Vomiting (15.2%)

            Otitis media (14.5%)

            1-10%

            Nasopharyngitis (6.9%)

            Bronchospasm (1.1%)

            Postmarketing Reports

            Gastroenteritis with vaccine viral shedding in infants with severe combined immunodeficiency disease (SCID)

            Intussusception within first 31 days following first dose (particularly within first 7 days)

            Kawasaki disease

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            Contraindications & Cautions

            Contraindications

            Hypersensitivity

            Immunosuppression

            Infants with severe combined immunodeficiency disease (SCID) should not receive RotaTeq (pentavalent); reports of gastroenteritis, including severe diarrhea and prolonged viral shedding

            Infants aged <6 weeks and >32 weeks

            Rotarix: History of uncorrected congenital malformation of the GI tract that would predispose infant to intussusception

            Infants with a history of intussusception should not receive Rotarix

            Intussusception resulting in death after a second dose of Rotarix reported when administered following a history of intussusception after the first dose

            Cautions

            Do not reconstitute or dilute

            Weigh risk/benefit in pts with febrile illness

            Postmarketing reports of intussusception and hematochezia; interim postmarketing safety data from study suggest increased risk of intussusception in the 31 days following first dose (most often within the first 7 days)

            No clinical data available for post-exposure prophylaxis

            Postmarketing reports of Kawasaki disease in some recipient infants

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            View Category Definitions

            Pregnancy & Lactation

            Pregnancy Category: The vaccine is indicated for children

            Lactation: The vaccine is indicated for children

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Live, attenuated vaccine; following immunization, immunogenicity occurs by antibody response; seroconversion is defined as antirotavirus IgA antibodies >20 U/mL post-vaccination

            Replicates in small intestine and incudes immunity

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            Pricing & Images

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