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Rotavirus Vaccine, live, oral
RotaTeq®
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FDA Approval: |
February 2006 |
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Indication: |
Prevention of rotavirus gastroenteritis in infants and children |
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Pharmacology: |
Live pentavalent vaccine, serotypes G1, G2, G3, G4 |
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Usual Dose: |
Infants: 3 doses orally, 4 to 10 weeks apart
Initial dose at 6 to 12 weeks |
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Contraindications: |
Allergic symptoms after a previous doses of vaccine Hypersensitivity
to any ingredient |
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Warnings: |
Defer for febrile illness unless potential benefit outweighs risk
Low-grade fever and mild upper respiratory infection are not a
contraindication
Efficacy has not been established for postexposure prophylaxis
Clinical data do not suggest an increased risk of intussusception
with this vaccine compared to placebo
Safety and efficacy not established for immunocompromised or
immunodeficient infants, or infants who have received blood
transfusions, blood products, or immunoglobulins within 42 days
The live virus vaccine can theoretically be transmitted to
non-vaccinated persons; caution recommended if any close contacts are
immunosuppressed
Safety has been established in preterm infants and infants with
controlled GERD
Safety and efficacy not established in infants < 6 weeks or >32 weeks
of age |
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Side Effects: |
Bronchiolitis, gastroenteritis, pneumonia, fever, urinary tract
infection Intussusception, seizures, febrile seizures
Vomiting, diarrhea, irritability |
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Drug Interactions: |
Immune response to vaccine may be decreased by immunosuppressant
treatment such as irradiation, antimetabolites, alkylating agents,
cytotoxic agents, and large doses of corticosteroids |
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