rotavirus vaccine, live, oral

Contraindicated in:

Hypersensitivity;
History of intussusception;
Severe combined immunodeficiency disease.

Use Cautiously in:

Acute diarrhea or vomiting (delay immunization);
Chronic gastrointestinal disorders (safety and efficacy not established);
Febrile illness;
Immunosuppression due to disease (including HIV), concurrent immunosuppressive drug therapy, malignant neoplasms affecting bone marrow/lymphatic system, or receipt of blood transfusion or blood products (including immunoglobulins) (safety and effectiveness not established).

Adv. Reactions/Side Effects ⬆ ⬇

EENT: runny nose

GI: INTUSSUSCEPTION, flatulence, loss of appetite, rotavirus shedding in stool, vomiting

Resp: cough

Misc: fussiness/irritability

Interactions ⬆ ⬇

Drug-drug:

Concurrent immunosuppressants, antineoplastics, corticosteroidsor radiation therapy may ↓ antibody response and ↑ risk of adverse reactions.

Availability ⬆ ⬇

Powder for oral suspension (Rotarix) (requires reconstitution): 1 mL prefilled oral applicator (applicator contains latex)
Oral solution (Rotateq): 2 mL prefilled dosing tube

Route/Dosage ⬆ ⬇

Rotarix

PO (Infants 6–24 wk): 2 dose series; first dose at 6 wk of age, followed at least 4 wk later with a second dose; series should be completed by 24 wk of age.

Rotateq

PO (Infants 6–32wk): 3 dose series; first dose at 6–12 wk of age, followed by the 2nd and 3rd doses at 4–10 wk intervals; series should be completed by 32 wk of age.

US Brand Names ⬆ ⬇

Action ⬆ ⬇

Live attenuated vaccine replicates in the small intestine and produces immunity.

Therapeutic effects:

Prevention of rotavirus gastroenteritis and its sequelae.

Classifications ⬆ ⬇

Therapeutic Classification: vaccines/immunizing agents

Pharmacologic Classification: active immunizer

Pharmacokinetics ⬆ ⬇

Absorption: Unknown.

Distribution: Remains in GI tract.

Metabolism/Excretion: Excreted in feces.

Half-Life: Unknown.

Time/Action Profile ⬆ ⬇

ROUTE	ONSET	PEAK	DURATION
PO	unknown	unknown	unknown

Patient/Family Teaching ⬆ ⬇

Instruct parents or guardians to read Patient Information before first dose and prior to second dose and ask any questions they may have during the visit. Provide parent or guardian with the Vaccine Information Statements available at www.cdc.gov/nip. Emphasize the importance of completing the immunization series.
Advise parent to contact health care professional immediately if signs of intussusception (vomiting, diarrhea, severe stomach pain, severe crying, blood in the stool, or change in bowel movements) occur even if it has been several mo since last vaccine dose.

Pronunciation ⬆ ⬇

ro-ta-VYE-russ vak-SEEN

Code ⬆

NDC Code

58160- GlaxoSmithKline Biologicals SA
- 58160-854- ROTARIX
  - 58160-854-52- 1 KIT in 1 CARTON (58160-854-52) * 1 mL in 1 APPLICATOR (58160-853-02) * 10 VIAL in 1 CARTON (58160-851-10) > 1 mL in 1 VIAL (58160-851-01)

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Indications ⬇

Contraind./Precautions ⬆ ⬇