diphtheria & tetanus toxoids/ acellular pertussis vaccine/poliovirus vaccine inactivated/haemophilus influenzae type b vaccine (Rx)

Brand and Other Names:Pentacel, DTaP/ IPV/ Hib
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Dosing & Uses

AdultPediatric

Not indicated for adults

Dosage Forms & Strengths

Lf = limits of flocculation

diphtheria toxoid/tetanus toxoid/pertussis toxin detoxified/filamentous hemagglutinin/pertactin/fimbriae types 2 and 3/inactivated poliovirus type 1 (Mahoney)/type 2 (MEF-1)/ type 3 (Saukett)/Haemophilus influenzae type B capsular polysacharide (bound to tetanus toxoid)

Injection suspension

  • (15 Lf/5 Lf/20mcg/20mcg/3mcg/5mcg/40 D-antigen units/8 D-antigen units/32 D-antigen units/10mcg [tetanus toxoid 24mcg])/0.5mL
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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

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Interactions

Interaction Checker

and diphtheria & tetanus toxoids/ acellular pertussis vaccine/poliovirus vaccine inactivated/haemophilus influenzae type b vaccine

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            Adverse 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

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            Warnings

            Contraindications

            History serious reaction to prior DTP vaccination

            History of Arthus reaction to prior tetanus vaccination (unless 10 years have elapsed)

            History of encephalopathy (within 7 days of administration not attributable to other causes), progressive neurologic disorder with pertussis-containing vaccine

            History of progressive neurologic disease, including infantile spasms, uncontrolled epilepsy, or progressive encephalopathy (ACIP guidelines recommend defering immunization until health status assessed or condition stabilized)

            Cautions

            Immediate treatment, including epinephrine 1 mg/mL, should be available for anaphylactoid and/or hypersensitivity reactions during vaccine administration

            Not for administration to patients with a history of Arthus-type reaction following diphtheria toxoid or tetanus toxoid-containing vaccine dose; do not give routine or emergency doses of tetanus toxoid more frequently than every 10 years, even if using for wound management with wounds that are not clean or minor

            Use caution in patients with history of fever ≥105° F (40.5° C within 48 hr of unknown cause; seizures with or without fever occurring within 3 days, persistent inconsolable crying lasting ≥ 3 hr and occurring within 48 hours, collapse or shock like state occurring within 48 hr

            Preterm infants should be vaccinated at chronological age as full-term infants

            Administer with caution if history of Guillain-Barre syndrome have occurred within 6 weeks of prior tetanus toxoid-containing vaccine

            During periods of severe immunosuppression, including patients receiving chemo/radiation therapy or other immunosuppressive therapy, including high-dose corticosteroids, may cause patient to have reduced response to vaccination; consider deferring immunization; inactivated vaccines should be administered ≥2 weeks prior to planned immunosuppression when feasible

            Syncope, which may result in secondary injuries, including skull fracture or cerebral hemorrhage reported within 15 minutes after vaccination in adolescents and young adults; vaccine location should have procedures in place to avoid injuries from falling and to restore cerebral perfusion if syncope occurs

            Defer administration in patients with moderate or severe acute illness, with or without fever; delay of vaccination should not occur in patients with mild acute illness, with or without fever

            Use caution in patients with bleeding disorders, including thrombocytopenia; bleeding/hematoma may occur from IM administration; in patients receiving antihemophilia treatment or similar therapy, schedule IM injection shortly after such therapy administered

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            Pregnancy & 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.

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            Pharmacology

            Mechanism of Action

            Conveys active immunity via stimulation of production of endogenously produced antibodies to diphtheria, tetanus, pertussis, poliovirus, and Haemophilus influenzae type b

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            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 and administer IM

            IM Administration

            <1 years: 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

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            Formulary

            FormularyPatient Discounts

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            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.