Trade Names:Pentacel- Injection diphtheria toxoid 15 Lf, tetanus toxoid 5 Lf, inactivated pertussis toxin 20 mcg, filamentous hemagglutinin 20 mcg, pertactin 3 mcg, fimbriae types two and three 5 mcg, type 1 poliovirus 40 D-antigen units, type 2 poliovirus 8 D-antigen units, type 3 poliovirus 32 D-antigen units, Haemophilus influenzae type b capsular polysaccharide bound to 24 mcg of tetanus toxoid 10 mcg per 0.5 mL
Diphtheria and tetanus toxoids induce antibodies against toxins made by Corynebacterium diphtheriae and Clostridium tetani , respectively; pertussis vaccine protects against Bordetella pertussis ; poliovirus vaccine induces protective antipoliovirus antibodies, reducing pharyngeal excretion of poliovirus types 1, 2, and 3; and Haemophilus b conjugate vaccine induces protective antibodies against Haemophilus influenza type b (Hib).
Active immunization against diphtheria, tetanus, pertussis, poliomyelitis, and invasive disease caused by Hib.
A severe allergic reaction after a previous dose of any component of the product, or any other tetanus toxoid, diphtheria toxoid, pertussis-containing vaccine, inactivated poliovirus vaccine or Hib vaccine; encephalopathy (eg, coma, decreased level of consciousness, prolonged seizures) within 7 days of a previous dose of a pertussis-containing vaccine not attributable to another cause; progressive neurologic disorder, including infantile spasms, uncontrolled epilepsy, and progressive encephalopathy.
IM 4 doses of 0.5 mL at 2, 4, 6, and 15 to 18 months of age. The first dose may be given as early as 6 wk of age (fourth dose is a booster for these diseases).
Store at 35° to 46°F. Do not freeze. Use immediately after reconstitution.
Optimal response to active immunization may be reduced.Other vaccines
Do not administer other vaccines in the same syringe.
Urine antigen detection may not have definitive diagnostic value in Hib disease within 1 wk following administration of Pentacel vaccine.
Cyanosis, pallor (postmarketing).
Fussiness/irritability (77%); inconsolable crying (59%); decreased activity/lethargy (46%); decreased consciousness, meningitis, screaming, seizure, somnolence (postmarketing).
Erythema, hypersensitivity including rash and urticaria, skin discoloration (postmarketing).
Gastroenteritis; diarrhea, vomiting (postmarketing).
Tenderness (56%); increase in arm circumference (34%); redness (17%); swelling (10%); extensive swelling of the injected limb, including swelling involving the adjacent joints; injection-site reactions, including abscess, inflammation, mass, and sterile abscess; vaccination failure/therapeutic response decreased (postmarketing).
Decreased appetite; dehydration (postmarketing).
Apnea, asthma, cough, pneumonia; rhinitis (postmarketing).
Fever (13%); death associated with asphyxia caused by suffocation, head trauma, neuroblastoma, sudden infant death syndrome, and suffocation; hypotonic-hyporesponsive episode, viral infection (postmarketing).
Prior to administration, review the patient's immunization history for possible vaccine sensitivity and previous vaccination-related adverse reactions.
Category C .
Not indicated in adults.
Not approved for children 5 yr of age or older.
Not approved for adult patients.
If any of the following events occurred in temporal relation with receipt of a whole-cell pertussis– or acellular pertussis–containing vaccine, base administration of Pentacel vaccine or any pertussis-containing vaccine on careful consideration of potential benefits and possible risks: temperature of 105°F or higher within 48 h that is not attributable to another cause; collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 h; persistent, inconsolable crying lasting 3 h or more within 48 h; seizure with or without fever within 3 days.
Epinephrine hydrochloride solution (1:1,000) and other appropriate agents and equipment must be available for immediate use in case of occurrence of an anaphylactic or acute hypersensitivity reaction.
If Guillain-Barré syndrome occurred within 6 wk of administration of a prior vaccine containing tetanus toxoid, base the decision to give Pentacel vaccine or any vaccine containing tetanus toxoid on careful consideration of potential benefits and possible risks.
For infants and children at risk of seizures, an appropriate antipyretic may be administered at the time of vaccination and for the following 24 h, to reduce possible postvaccination fever.
Copyright © 2009 Wolters Kluwer Health.