diphtheria and tetanus toxoids/ acellular pertussis vaccine/poliovirus vaccine inactivated/haemophilus influenzae type b vaccine (Pentacel, DTaP/ IPV/ Hib)

Dosing and uses of Pentacel, DTaP/ IPV/ Hib (diphtheria and tetanus toxoids/ acellular pertussis vaccine/poliovirus vaccine inactivated/haemophilus influenzae type b vaccine)

• Adult
• Pediatric

 

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