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ROTATEQ
Vaccines
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Drug Name:

ROTATEQ Rx

Generic Name and Formulations:
Pentavalent, live rotavirus vaccine; oral susp; contains fetal bovine serum (trace); preservative-free.

Company:
Merck & Co., Inc.

Therapeutic Use:

Indications for ROTATEQ:

Rotavirus gastroenteritis vaccination in infants 6–32 weeks of age.

Adult:

Not recommended.

Children:

<6 weeks or >32 weeks: not established. Each dose is 1 tube. Give 1st dose orally at 6–12 weeks of age; give 2nd and 3rd dose at 4–10 week intervals for a total of 3 doses. If incomplete dose is given, do not give replacement dose; continue with remaining doses in the recommended series.

Contraindications:

Severe combined immunodeficiency disease. History of intussusception.

Warnings/Precautions:

Immunocompromised (blood dyscrasias, leukemia, lymphomas, or other malignancies; primary and acquired immunodeficiency states, HIV/AIDS; cellular immune deficiencies; and hypogammaglobulinemic and dysgammaglobulinemic states; received blood transfusion or blood products, including immunoglobulins within 42 days). Febrile illness. Active or history of GI disorders. Chronic diarrhea. Failure to thrive. History of congenital abdominal disorders. Abdominal surgery. Risk of intussusception. Immunodeficient close contacts. Pregnancy (Cat. C), women of child-bearing potential: not recommended.

Interactions:

Immunosuppressants (eg, irradiation, chemotherapy, high-dose steroids): may get suboptimal response. Concomitant vaccines: see full labeling; oral polio vaccine: not recommended.

Adverse Reactions:

Diarrhea, vomiting, irritability, otitis media, nasopharyngitis, bronchospasm; rare: intussusception, hematochezia, seizures, Kawasaki disease.

How Supplied:

Single-use tube (2mL)—10, 25

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