Poliovirus Vaccine Live Oral Trivalent

Poliovirus vaccine live oral trivalent is used intended for polio prophylaxis in infants 6-12 weeks of age, all unimmunized children up to 18 years of age, and high-risk adults. Adults, however, should receive the inactivated poliovirus vaccine (IPV).

Poliovirus vaccine live oral trivalent is available under the following different brand names: OPV, Orimune, Sabin, and TOPV.

Dosages of Poliovirus Vaccine Live Oral Trivalent:

• Single-dose pipette, 0.5 mL

Dosage Considerations – Should be Given as Follows:

For poliovirus prophylaxis:

• Adults: 0.5 mL orally initially, then repeated 8 weeks later. The third dose should be given 8-12 months after the second dose. When less than 4 weeks are available before immunization is required, a single 0.5 ml oral dose should be given.
• Children up to age 18 years: 0.5 mL orally initially, followed by the second dose preferably 8 weeks after the first dose. The third dose is given 8-12 months after the second dose (adolescents and older children may receive the third dose 6-8 weeks after the second dose if there is an increased risk of poliomyelitis). Booster doses are suggested upon starting school at 4-6 years of age unless the third dose of the primary series was given after the recipient's fourth birthday.
• Infants: The first 0.5 ml oral dose should be administered at 6-12 weeks of age. The second 0.5 ml oral dose should be administered preferably 8 weeks after the first dose. The third 0.5 ml oral dose should be administered at 6 months of age, however, if this time cannot be met, the third dose may be administered as late as 18 months of age.

Administration

• Poliovirus vaccine live oral, OPV is administered orally. OPV must not be administered parenterally.
• May be administered directly into the mouth using the single-dose pipette supplied by the manufacturer. Alternatively, mix with distilled or chlorine-free water, syrup, or milk, or adsorbed on bread, cake, or sugar cube.
• If a dose is not swallowed, spat out, or a substantial portion is regurgitated or vomited shortly after administration (i.e., within 5-10 minutes), a second dose should be given. If the second dose is not retained, do not count either dose, re-administer on the next visit.

Patients with renal impairment

• Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.

Side effects of poliovirus vaccine live oral trivalent include:

• Paralytic poliomyelitis
• Allergic reactions (itching and rash)
• Fever
• Guillain-Barre syndrome (rare)

Anaphylactic shock (rare) (symptoms include hives, itching, skin redness, conjunctivitis, and sudden or severe fatigue

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first.

• Poliovirus vaccine live oral trivalent may interact with:
  • Immunosuppressive drugs (corticosteroids, alkylating agents, antimetabolites, radiation therapy)
  • Other live virus vaccines (such as MMR)
  • Inactivated vaccines (cholera vaccine, typhoid vaccine, plague vaccine)

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. Check with your physician if you have health questions or concerns.

Warnings

• This medication contains poliovirus vaccine live oral trivalent. Do not take OPV, Orimune, Sabin, or TOPV if you are allergic to poliovirus vaccine live oral trivalent or any ingredients contained in this drug.
• Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

Contraindications

• The poliovirus vaccine should be used with caution in patients with a history of neomycin hypersensitivity or streptomycin hypersensitivity because these agents may be used in the preparation of OPV. A history of delayed-type allergic reactions is not an absolute contraindication to OPV administration.
• OPV may not be as immunogenic in elderly patients or patients suffering from immunosuppression (congenital, acquired, or iatrogenic). Furthermore, virus particle production can be potentiated in immunosuppressed patients, so OPV use is not recommended in these individuals. Patients with HIV infection may receive IPV or enhanced-potency IPV; however, OPV should be avoided.
• Patients with evidence of viral infection (diarrhea, vomiting) should not be given OPV because other enteroviruses within the intestinal tract can inhibit immunity by preventing OPV replication. Similarly, OPV inoculation should be postponed in patients with fever or a severe respiratory infection, although the minor illness does not preclude OPV administration.
• Intramuscular injections, especially antibiotics, should be avoided for at least 30 days in patients who have received the poliovirus vaccine live oral (OPV) or for 60 days in patients who acquired the disease by contact with vaccine recipients. Intramuscular injections were associated with an increased risk of developing paralytic poliomyelitis in patients receiving IM injections 30 days before the onset of paralysis.
• OPV is classified as pregnancy category C. Studies in humans have not been conducted. Problems in humans have not been reported, but routine administration of OPV during pregnancy is not recommended unless the benefits from vaccination outweigh the potential risks to the fetus. Poliovirus antibodies may be excreted into breast milk, and breastfeeding is not recommended for 2-3 hours before or after inoculation in neonates immunized at birth.
• Use of OPV is not recommended in neonates less than 6 weeks of age.
• Poliomyelitis has occurred after OPV administration both in those vaccinated and in their close contacts. Poliovirus may be shed in the feces (and possibly from the pharynx) of those vaccinated for 6-8 weeks after OPV administration. Contact individuals should be warned of the small risk of developing poliomyelitis and informed to wash hands carefully when exposed to feces or saliva of recently inoculated individuals.

Effects of Drug Abuse

• No information is available

Short-Term Effects

• See "What Are Side Effects Associated with Using Poliovirus Vaccine Live Oral Trivalent?”

Long-Term Effects

• See "What Are Side Effects Associated with Using Poliovirus Vaccine Live Oral Trivalent?”

Cautions

• No information is available

Pregnancy and Lactation

• Use poliovirus vaccine live oral trivalent with caution during pregnancy if benefits outweigh risks. Animal studies show risk and human studies are not available or neither animal nor human studies were done. Problems in humans have not been reported, but routine administration of OPV during pregnancy is not recommended unless the benefits from vaccination outweigh the potential risks to the fetus.
• Poliovirus antibodies may be excreted into breast milk, and breastfeeding is not recommended for 2-3 hours before or after inoculation in neonates immunized at birth.