Adult Dosing

• Not indicated in adults

Pediatric Dosing

Immunization against diphtheria, tetanus, pertussis, and poliomyelitis

• Children 4-6 yrs (prior to the seventh birthday)
• 0.5 mL IM in the deltoid muscle of the upper arm
• Administer as fifth dose in the DTaP immunization series and the fourth dose in the IPV immunization series in children whose first three doses of DTaP vaccine were with Infanrix and/or Pediarix and the fourth dose was with Infanrix

[Outline]

• Adult Dosing
• Pediatric Dosing

• Active immunization against diphtheria, tetanus, pertussis, and poliomyelitis as the fifth dose in the diphtheria, tetanus, and acellular pertussis (DTaP) vaccine series and the fourth dose in the inactivated poliovirus vaccine (IPV) series in children 4-6 yrs of age whose previous DTaP vaccine doses have been with Infanrix and/or Pediarix for the first 3 doses and Infanrix for the fourth dose

• Hypersensitivity to any of the ingredients of the product
• Hypersensitivity to neomycin, polymyxin B
• Encephalopathy within 1 wk of administration of a previous pertussis-containing vaccine
• Progressive neurologic disorder
• Infantile spasms
• Uncontrolled epilepsy
• Progressive encephalopathy

• N/A

Renal Dose Adjustment

• Renal impairment: Dose adjustments not defined

Hepatic Dose Adjustment

• Hepatic impairment: Dose adjustments not defined

• On development of Guillain-Barré syndrome within 6 wks following administration of vaccine containing tetanus toxoid, carefully consider potential benefits and possible risks before administration of any tetanus toxoid-containing vaccine. Give other available vaccines as indicated, if a decision is made to withhold tetanus toxoid
• Use of syringes containing natural rubber latex or dry natural latex rubber may be associated with allergic reactions in latex sensitive individuals
• Syncope accompanied by transient neurological signs such as visual disturbance, paresthesia, and tonic-clonic limb movements may occur in association with administration of this vaccine; undertake appropriate measures to avoid falling injury and to restore cerebral perfusion following syncope
• Following administration of a vaccine containing a pertussis component, if the patient develops temperature 40.5^oC (105^oF) within 48 hours not due to another identifiable cause, collapse or shock-like state within 48 hrs; persistent, inconsolable crying lasting 3 hrs within 48 hrs; and seizures with or without fever within 3 days, carefully consider potential benefits and possible risks before administration of any pertussis-containing vaccine. If a decision is made to withhold pertussis vaccination, continue with other available vaccines
• Administer an appropriate antipyretic at the time of vaccination in children at high risk for seizures, and for the ensuing 24 hrs to reduce the possibility of post-vaccination fever
• Obtain the patient's immunization history for possible vaccine sensitivity and previous vaccination-related adverse reactions prior to administration of this vaccine as it will help to assess benefits and risks. On occurrence of an acute anaphylactic reaction, immediately administer epinephrine and other appropriate agents

Cautions: Use cautiously in

• Hypersensitivity to latex (some prefilled syringe forms)
• History of reactions with pertussis vaccine
• Risk of seizure
• Immunosuppressed patients
• Concurrent immunosuppressive therapy

Pregnancy Category:C

Breastfeeding: Vaccines administered to a nursing mother do not affect the safety of breastfeeding for mothers or infants and breastfeeding is not a contraindication to DTP vaccine. Women who have not received acellular pertussis vaccine with tetanus and reduced diphtheria toxoids (Tdap) previously should be vaccinated with Tdap as soon as feasible in the postpartum period, even if they are breastfeeding, as long as they have not been vaccinated with tetanus and reduced diphtheria toxoids (Td) vaccine within the past 2 years. The injectable polio vaccine is inactivated and poses no risk when given to mothers who are breastfeeding. Breastfeeding also reduces infant side effects associated with routine childhood immunization. Vaccinate breastfed infants according to the routine recommended schedules. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 8 August 2011). Manufacturer advises caution.

• CNS: Drowsiness, cerebrovascular accident, seizures, stroke
• NEURO: Guillain-Barré syndrome
• GI: Loss of appetite
• METABOLIC: Dehydration, hypernatremia
• RESP: Apnea
• MUSC: Hypotonic-hyporesponsive episode
• HEMA: Thrombocytopenia
• LOCAL: Erythema, swelling, tenderness, pain, redness, urticaria
• HYPERSENSITIVITY: Anaphylactoid reactions, anaphylaxis, angioedema
• MISC: Fever, inconsolable crying, lymphadenopathy

• Vaccine; induces neutralizing antibodies against diphtheria/tetanus/acellular pertussis/inactivated poliovirus toxins
• Metabolism: Other
• Excretion: Other
• Half-life: Unknown

US Trade Name(s)

• Kinrix

US Availability

Kinrix

• INJ: 25 Lf of diphtheria toxoid, 10 Lf of tetanus toxoid, 25 mcg of inactivated pertussis toxoid (PT), 25 mcg of filamentous hemagglutinin (FHA), 8 mcg of pertactin (69 kiloDalton outer membrane protein), 40 D-antigen Units (DU) of Type 1 poliovirus (Mahoney), 8 DU of Type 2 poliovirus (MEF-1), and 32 DU of Type 3 poliovirus (Saukett) [0.5 mL vials]
• INJ: 25 Lf of diphtheria toxoid, 10 Lf of tetanus toxoid, 25 mcg of inactivated pertussin toxin (PT), 25 mcg of filamentous hemagglutinin (FHA), 8 mcg of pertactin (69 kiloDalton outer membrane protein), 40 D-antigen Units (DU) of Type 1 poliovirus (Mahoney), 8 DU of Type 2 poliovirus (MEF-1), and 32 DU of Type 3 poliovirus (Saukett) [0.5 mL prefilled syringes]

Canadian Trade Name(s)

• Adacel-Polio
• Boostrix-Polio
• Quadracel

Canadian Availability

Adacel-Polio

• INJ: 2 Lf of diphtheria toxoid, 5 Lf of tetanus toxoid, 2.5 mcg of inactivated pertussis toxoid (PT), 5 mcg of filamentous hemagglutinin (FHA), 3 mcg of pertactin, 40 Units of Type 1 poliovirus (Mahoney), 8 Units of Type 2 poliovirus (MEF-1), and 32 Units of Type 3 poliovirus (Saukett) [0.5 mL single dose vials]
• INJ: 2 Lf of diphtheria toxoid, 5 Lf of tetanus toxoid, 2.5 mcg of inactivated pertussis toxin (PT), 5 mcg of filamentous hemagglutinin (FHA), 3 mcg of pertactin, 40 Units of Type 1 poliovirus (Mahoney), 8 Units of Type 2 poliovirus (MEF-1), and 32 Units of Type 3 poliovirus (Saukett) [0.5 mL prefilled syringes]

Boostrix-Polio

• INJ: 2.5 Lf of diphtheria toxoid, 5 Lf of tetanus toxoid, 8 mcg of inactivated pertussis toxoid (PT), 8 mcg of filamentous hemagglutinin (FHA), 2.5 mcg of pertactin, 40 DU of Type 1 poliovirus (Mahoney), 8 DU of Type 2 poliovirus (MEF-1), and 32 DU of Type 3 poliovirus (Saukett) [0.5 mL single dose vials]
• INJ: 2.5 Lf of diphtheria toxoid, 5 Lf of tetanus toxoid, 8 mcg of inactivated pertussis toxoid (PT), 8 mcg of filamentous hemagglutinin (FHA), 2.5 mcg of pertactin, 40 DU of Type 1 poliovirus (Mahoney), 8 DU of Type 2 poliovirus (MEF-1), and 32 DU of Type 3 poliovirus (Saukett) [0.5 mL prefilled syringes]

Quadracel

• INJ: 15 Lf of diphtheria toxoid, 5 Lf of tetanus toxoid, 20 mcg of inactivated pertussis toxoid (PT), 20 mcg of filamentous hemagglutinin (FHA), 5 mcg of Fimbriae Types 2 and 3, 3 mcg of pertactin, 40 DU of Type 1 poliovirus (Mahoney), 8 DU of Type 2 poliovirus (MEF-1), and 32 DU of Type 3 poliovirus (Saukett) [0.5 mL single dose vials]

UK Trade Name(s)

• Infanrix-IPV
• Repevax

UK Availability

Infanrix-IPV

• INJ: >30 IU of diphtheria toxoid, >40 IU of tetanus toxoid, 25 mcg of inactivated pertussis toxoid, 25 mcg of filamentous hemagglutinin, 8 mcg of pertactin, 40 D-antigen Units (DU) of Type 1 poliovirus (Mahoney), 8 DU of Type 2 poliovirus (MEF-1), and 32 DU of Type 3 poliovirus (Saukett) [0.5 mL prefilled syringes]

Repevax

• INJ: 2 Lf of diphtheria toxoid, 5 Lf of tetanus toxoid, 2.5 mcg of inactivated pertussis toxoid, 5 mcg of filamentous hemagglutinin, 3 mcg of pertactin, 5 mcg of Fimbriae Types 2 and 3, 40 D-antigen Units (DU) of Type 1 poliovirus (Mahoney), 8 DU of Type 2 poliovirus (MEF-1), and 32 DU of Type 3 poliovirus (Saukett) [0.5 mL prefilled syringes]

Australian Trade Name(s)

• Adacel Polio
• Boostrix-IPV
• Infanrix IPV
• Quadracel

Australian Availability

Adacel Polio

• INJ: 2 IU of diphtheria toxoid, 20 IU of tetanus toxoid, 2.5 mcg of inactivated pertussis toxoid, 5 mcg of filamentous hemagglutinin, 3 mcg of pertactin, 5 mcg pertussis fimbriae types 2 and 3, 40 D-antigen Units (DU) of Type 1 poliovirus (Mahoney), 8 DU of Type 2 poliovirus (MEF-1), and 32 DU of Type 3 poliovirus (Saukett) [0.5 mL vial]
• INJ: 2 IU of diphtheria toxoid, 20 IU of tetanus toxoid, 2.5 mcg of inactivated pertussis toxoid, 5 mcg of filamentous hemagglutinin, 3 mcg of pertactin, 5 mcg pertussis fimbriae types 2 and 3, 40 D-antigen Units (DU) of Type 1 poliovirus (Mahoney), 8 DU of Type 2 poliovirus (MEF-1), and 32 DU of Type 3 poliovirus (Saukett) [0.5 mL prefilled syringes]

Boostrix-IPV

• INJ: 2 IU of diphtheria toxoid, 20 IU of tetanus toxoid, 8 mcg of inactivated pertussis toxoid, 8 mcg of filamentous hemagglutinin, 2.5 mcg of pertactin, 40 D-antigen Units (DU) of Type 1 poliovirus (Mahoney), 8 DU of Type 2 poliovirus (MEF-1), and 32 DU of Type 3 poliovirus (Saukett) [0.5 mL vials]
• INJ: 2 IU of diphtheria toxoid, 20 IU of tetanus toxoid, 8 mcg of inactivated pertussis toxoid, 8 mcg of filamentous hemagglutinin, 2.5 mcg of pertactin, 40 D-antigen Units (DU) of Type 1 poliovirus (Mahoney), 8 DU of Type 2 poliovirus (MEF-1), and 32 DU of Type 3 poliovirus (Saukett) [0.5 mL prefilled syringes]

Infanrix IPV

• INJ: 30 IU of diphtheria toxoid, 40 IU of tetanus toxoid, 25 mcg of inactivated pertussis toxoid (PT), 25 mcg of filamentous hemagglutinin, 8 mcg of pertactin (69 kiloDalton outer membrane protein), 40 D-antigen Units (DU) of Type 1 poliovirus (Mahoney), 8 DU of Type 2 poliovirus (MEF-1), and 32 DU of Type 3 poliovirus (Saukett) [0.5 mL vials]
• INJ: 30 IU of diphtheria toxoid, 40 IU of tetanus toxoid, 25 mcg of inactivated pertussin toxin (PT), 25 mcg of filamentous hemagglutinin (FHA), 8 mcg of pertactin (69 kiloDalton outer membrane protein), 40 D-antigen Units (DU) of Type 1 poliovirus (Mahoney), 8 DU of Type 2 poliovirus (MEF-1), and 32 DU of Type 3 poliovirus (Saukett) [0.5 mL prefilled syringes]

Quadracel

• INJ: 30 IU of diphtheria toxoid, 40 IU of tetanus toxoid, 20 mcg of inactivated pertussis toxoid, 20 mcg of filamentous hemagglutinin, 3 mcg of pertactin, 5 mcg pertussis fimbriae types 2 and 3, 40 D-antigen Units (DU) of Type 1 poliovirus (Mahoney), 8 DU of Type 2 poliovirus (MEF-1), and 32 DU of Type 3 poliovirus (Saukett) [0.5 mL vials]

[Outline]

Allergy & Immunology

Vaccine Combination

Infectious Disease

Vaccine Combination