diphtheria and tetanus toxoids/ acellular pertussis vaccine/poliovirus vaccine inactivated/haemophilus influenzae type b vaccine (Pentacel, DTaP/ IPV/ Hib)
Classes: Vaccines, Combos
- Dosing and uses of Pentacel, DTaP/ IPV/ Hib (diphtheria & tetanus toxoids/ acellular pertussis vaccine/poliovirus vaccine inactivated/haemophilus influenzae type b vaccine)
- Pentacel, DTaP/ IPV/ Hib (diphtheria & tetanus toxoids/ acellular pertussis vaccine/poliovirus vaccine inactivated/haemophilus influenzae type b vaccine) adverse (side) effects
- Warnings
- Pregnancy
- Pharmacology of Pentacel, DTaP/ IPV/ Hib (diphtheria & tetanus toxoids/ acellular pertussis vaccine/poliovirus vaccine inactivated/haemophilus influenzae type b vaccine)
- Administration
Dosing and uses of Pentacel, DTaP/ IPV/ Hib (diphtheria and tetanus toxoids/ acellular pertussis vaccine/poliovirus vaccine inactivated/haemophilus influenzae type b vaccine)
Adult dosage forms and strengths
Not indicated for adults
Pediatric dosage forms and strengths
Lf = limits of flocculation
diphtheria toxoid/tetanus toxoid/pertussis toxin detoxified/filamentous hemagglutinin/pertactin/fimbriae types 2 and 3/type 1 inactivated poliovirus (Mahoney)/type 2 inactivated poliovirus (MEF-1)/ type 3 inactivated poliovirus (Saukett)/lyophilized polyribosyl-ribilol-phosphate of Haemophilus influenzae type B [bound to tetanus toxoid 24 mcg]
Injection Suspension
- (15 Lf/5 Lf/20mcg/20mcg/3mcg/5mcg/40 D-antigen units/8 D-antigen units/32 D-antigen units/10mcg [bound to tetanus toxoid 24mcg])/0.5mL
Primary Immunization
Approved for use as a 4 dose series in children 6 weeks through 4 years of age (prior to 5th birthday)
Ideally, administer Pentacel 4 dose series at 2, 4, 6, and 15-18 months old
First dose (0.5 mL) may be given as early as age 6 weeks
Follow with 5th dose of DTaP vaccine at 4-6 years
Pentacel, DTaP/ IPV/ Hib (diphtheria and tetanus toxoids/ acellular pertussis vaccine/poliovirus vaccine inactivated/haemophilus influenzae type b vaccine) adverse (side) effects
Suspected adverse events after administration of any vaccine may be reported to Vaccine Adverse Events Reporting System (VAERS), 1-800-822-7967
>10%
Injection site reactions including redness, swelling, tenderness (39-56%)
Fever (6-16%)
Lethargy/decreased activity (24-46%)
Inconsolable crying (36-60%)
Irritability/fussiness (54-77%)
1-10%
Swelling (5-10%)
<1%
Apnea
Anorexia
Decreased consciousness
Diarrhea
Hypotonia
Encephalopathy
Bronchiolitis
Erythema
Asthma
Cough
Cyanosis
Skin discoloration
Warnings
Contraindications
History serious reaction to prior DTP vaccination
History of Arthus reaction to prior tetanus vaccination (unless 10 yr have elapsed)
History of encephalopathy (within 7 days of administration not attributable to other causes), progressive neurologic disorder with pertussis-containing vaccine
Progressive Neurologic Disorder
Infantile spasms, uncontrolled epilepsy, progressive encephalopathy
Do not administer pertussis vaccine until neurologic status is stabilized
Cautions
Previous events after administration of whole-cell or acellular pertussis
Temperature >40.5°C ( >105°F) within 48hrs
Collapse or hypotonic-hyporesponsive episode (HHE) within 48 hr
Persistent crying lasting >3 hr within 48 hr
Seizure within 3 days following immunization
Tetanus toxoid carries risk for brachial neuritis, Guillain-Barre syndrome and anaphylaxis
Caution in Guillain-Barre syndrome within 6 wk of prior tetanus toxoid vaccine
Syncope accompanied by transient disturbances, tonic-clonic movements, or weakness reported
Consider postponing administration iin patients with moderate or severe acute illness (with or without fever)
Use caution in patients with a history of bleeding disorders (including thrombocytopenia) and or patients on anticoagulants
Pregnancy and lactation
Pregnancy category: C
Lactation: Not known if excreted in breast milk
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of Pentacel, DTaP/ IPV/ Hib (diphtheria and tetanus toxoids/ acellular pertussis vaccine/poliovirus vaccine inactivated/haemophilus influenzae type b vaccine)
Mechanism of action
Conveys active immunity via stimulation of production of endogenously produced antibodies to diphtheria, tetanus, pertussis, poliovirus, and Haemophilus influenzae type B
Administration
Preparation
Consists of a liquid vaccine component (DTaP-IPV component) and a lyophilized vaccine component (haemophilus influenza B (ActHIB) vaccine); reconstitute ActHIB vaccine component with the DTaP-IPV component immediately before administration
Gently shake vial of DTaP-IPV, withdraw all liquid and inject into vial of lyophilized ActHIB vaccine to reconstitute
Shake vial thoroughly until cloudy, uniform suspension forms
Withdraw 0.5 mL from vial & administer Im
IM Administration
<1 years old: Inject anterolateral aspect of thigh
Older children: use deltoid muscle, do NOT inject into gluteal area
Do NOT administer IV or SC
Storage
Refrigerate at 2-8°C (35-46°F)
Do not freeze