drug-information.ru

|Poliovirus Vaccine, Live, Oral, Trivalent

Poliovirus Vaccine, Live, Oral, Trivalent

Trade Names:
Orimune
- Suspension, oral Mixture of 3 viruses (Types 1, 2, and 3) propagated in monkey kidney tissue culture

Mechanism of Action

Pharmacology

Induces protective antibodies, reducing intestinal and pharyngeal excretion of poliovirus. OPV administration simulates natural infection, inducing active mucosal and systemic immunity against poliovirus types 1, 2, and 3.

Indications and Usage

Prevention of poliomyelitis. Infants as young as 6 to 12 wk and all unimmunized children and adolescents up to 18 yr are usual candidates for routine OPV prophylaxis. OPV is also recommended for control of epidemic poliomyelitis. If less than 4 wk remain before protection is needed, single dose of OPV is recommended, with remaining vaccine doses given later if person remains at increased risk. Immunization with IPV may be indicated for unimmunized parents and those in other special situations in which protection may be needed. In household with immunocompromised member or other close contacts or in household with unimmunized adult, use only IPV for all those requiring poliovirus immunization.

Primary immunization with inactivated polio vaccine is recommended whenever feasible for unimmunized adults subject to increased risk of exposure, such as by travel to or contact with epidemic or endemic areas (eg, developing countries) and for those employed in medical and sanitation facilities.

Contraindications

Do not administer OPV to any person with immunosuppression or to any household member of immunodeficient person. This includes combined immunodeficiency, hypogammaglobulinemia, agammaglobulinemia, thymic abnormalities, leukemia, lymphoma, generalized malignancy, and lowered resistance to infection from therapy with corticosteroids, alkylating drugs, antimetabolites, or radiation. Advise vaccine recipients to avoid contact with such persons for at least 6 to 8 wk. Do not give OPV to member of household in which there is family history of immunodeficiency until immune status of intended recipient and other children in family is determined to be normal. IPV is preferred for immunizing all persons in these circumstances.

Dosage and Administration

PO 0.5 mL. Give 2 doses no less than 6 wk apart (or 8 wk apart or less ) followed by third dose 6 to 12 mo later.

PO 0.5 mL. Administer at 2, 4, and 15 to 18 mo. A fourth dose is given when child begins school if third dose of primary series was administered before child"s fourth birthday. OPV may be administered with any of following: distilled water, chlorinated tap water, simple syrup, milk, bread, sugar cube, cake.

Drug Interactions

Immune globulin (IG) does not interfere with immunity following OPV. However, do not administer OPV less than 7 days after IG administration unless unavoidable, such as unexpected travel to or contact with epidemic or endemic areas or persons. If OPV is given within 1 wk after IG, the OPV dose should probably be repeated 3 mo later, if immunity is still needed. Like all live viral vaccines, administration to patients or contacts of patients receiving immunosuppressant drugs, including steroids or radiation may predispose patients to disseminated infections or insufficient response to immunization. They may remain susceptible despite immunization. Several routine pediatric vaccines may safely and effectively be administered simultaneously at separate injection sites (eg, DTP, MMR, IPV, Hib, hepatitis B, influenza). National authorities recommend simultaneous immunization at separate sites as indicated by age or health risk. Live virus vaccines may cause delayed-hypersensitivity skin test results (eg, tuberculin, histoplasmin) to appear falsely negative. Effect may persist for several weeks after vaccination. Give tuberculin tests either prior to live-virus vaccination, simultaneously with it, or at least 6 wk after vaccination.

Laboratory Test Interactions

None well documented.

Adverse Reactions

Miscellaneous

Vaccine-associated paralysis occurs with frequency of 1 case per 2.6 million OPV vaccine doses distributed.

Precautions

Pregnancy

Category C . Use OPV in pregnancy if exposure is imminent and immediate protection is needed.

Lactation

Breastfeeding does not generally interfere with successful immunization of infants, despite IgA antibody secretion in breast milk.

Immunodeficient patients

Do not use OPV in immunodeficient people, including people with congenital or acquired immune deficiencies, whether because of genetics, disease, drug or radiation therapy. Contains live viruses. Avoid use in HIV-positive persons, regardless of whether symptomatic or asymptomatic. Poliovirus is shed for 6 to 8 wk in vaccinee"s stool and by pharyngeal route.

Patient Information

• Advise women to abstain from breastfeeding 2 to 3 hr before and after vaccination of infants to permit establishment of viruses in gut.
• Explain risks and benefits of vaccination. Point out to parents or patient that vaccine produces protective antibodies against poliomyelitis.
• Tell parents that child should receive dose at 2, 4, and 15 or 18 mo and at 4 to 6 yr to be fully immunized.
• Explain that attenuated live virus vaccine may be shed for a few weeks following vaccination. This virus is not harmful to normal individuals but may cause disease in immunocompromised patients. Therefore vaccine recipient must stay away from immunocompromised individuals.