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Rotarix Generic Name & Formulations
Legal Class
Rx
General Description
Live, attenuated human G1P[8] rotavirus vaccine; lyophilized pwd for oral administration after reconstitution; preservative-free.
How Supplied
Vials—10 (w. prefilled diluent in oral applicator)
Manufacturer
Generic Availability
NO
Rotarix Indications
Indications
Prevention of rotavirus gastroenteritis caused by G1 and non-G1 types (G3, G4, and G9) in infants and children.
Rotarix Dosage and Administration
Adult
Not applicable.
Children
<6 weeks or >24 weeks of age: not recommended. Each oral dose is 1mL. Give 1st dose beginning at 6 weeks of age, 2nd dose at least 4 weeks later; complete 2-dose series by 24th week of age. May give a replacement dose at same vaccination visit if dosing is incomplete or regurgitated.
Rotarix Contraindications
Contraindications
Uncorrected congenital GI tract malformation (eg, Meckel's diverticulum) (increased risk of intussusception). History of intussusception. Severe combined immunodeficiency disease.
Rotarix Boxed Warnings
Not Applicable
Rotarix Warnings/Precautions
Warnings/Precautions
Acute diarrhea or vomiting (delay immunization). Chronic GI disorders. Immunodeficiency or immunosuppressed close contacts (live virus shedding may allow transmission to others). Latex allergy. Pregnancy (Cat.C): not applicable.
Rotarix Pharmacokinetics
See Literature
Rotarix Interactions
Interactions
May give with concomitant vaccines (eg, DTaP, Hep B, Inactivated Poliovirus Vaccine Combined, Hib conjugate). Immunosuppressants (eg, irradiation, chemotherapy, high-dose steroids): may get suboptimal response.
Rotarix Adverse Reactions
Adverse Reactions
Fussiness/irritability, cough/runny nose, fever, loss of appetite, vomiting, diarrhea, dehydration, pneumonia; rare: Kawasaki disease.
Rotarix Clinical Trials
See Literature
Rotarix Note
Notes
Report adverse events to VAERS at (800) 822-7967 and to GlaxoSmithKline at (888) 825-5249.
Rotarix Patient Counseling
See Literature
