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Trade Names:
Pediarix
- Injection 25 Lf diphtheria toxoid, 10 Lf tetanus toxoid, 25 mcg inactivated pertussis toxin (PT), 25 mcg filamentous hemagglutinin (FHA), 8 mcg pertactin, 10 mcg hepatitis B surface antigen (HBsAg), 40 D-antigen units (DU) type 1 poliovirus, 8 DU type 2 poliovirus, and 32 DU type 3 poliovirus per 0.5 mL

Mechanism of Action

Pharmacology

Diphtheria and tetanus toxoids induce antibodies against toxins made by Corynebacterium diphtheriae and Clostridium tetani ; pertussis vaccine protects against Bordetella pertussis ; hepatitis B vaccine induces specific antibodies against hepatitis B virus (HBV); poliovirus vaccine induces protective antipoliovirus antibodies, reducing pharyngeal excretion of poliovirus types 1, 2, and 3.

Indications and Usage

Active immunization against diphtheria, tetanus, pertussis, all known types of HBV and poliomyelitis (caused by types 1, 2, and 3).

Contraindications

Use of this vaccine after a serious allergic reaction temporally associated with a previous dose of the vaccine or with any components of this vaccine; encephalopathy (eg, coma, decreased level of consciousness, prolonged seizures) within 7 days of administration of a previous dose of a pertussis-containing vaccine not attributable to another identifiable cause; progressive neurologic disorder (including infantile spasms, uncontrolled epilepsy, or progressive encephalopathy) until a treatment regimen has been established and the condition has stabilized; hypersensitivity to any component of the vaccine (including yeast, neomycin, and polymyxin B).

Dosage and Administration

IM 3 doses of 0.5 mL at 6- to 8-wk intervals (preferably 8 wk); customary age for the first dose is 2 mo.

IM 3 doses of 0.5 mL according to the recommended schedule.

IM Pediarix may be used to complete the first 3 doses of the DTaP series in infants who have received 1 or 2 doses of Infanrix and also are scheduled to receive the other vaccine components of Pediarix .

IM Pediarix may be used to complete the first 3 doses of the IPV series in infants who have received 1 or 2 doses of IVP and who are also scheduled to receive the other vaccine components of Pediarix .

It is recommended that Pediarix be given for all 3 doses because data are limited regarding the safety and efficacy of using acellular pertussis vaccines from different manufacturers for successive doses of the pertussis vaccination series. Because of a lack of data, Pediarix is not recommended for completion of a DTaP vaccination series initiated with a DTaP vaccine from a different manufacturer. However, Pediarix may be used to complete hepatitis B vaccination series initiated with a licensed hepatitis B (recombinant) vaccine from a different manufacturer and may be used complete the first 3 doses of the IPV vaccination series initiated with IPV from a different manufacturer.

General Advice

• If any recommended dose of pertussis vaccine cannot be given, DT (for pediatric use), hepatitis B (recombinant), and IPV should be given as needed to complete the series. Children who have received a 3-dose primary series of Pediarix should be given a fourth dose of IPV at 4 to 6 yr of age and a fourth dose DTaP vaccine at 15 to 18 mo of age.
• For IM injection only.
• Interruption of recommended schedule with a delay between doses does not interfere with development of final immunity. There is no need to start the series over again.
• Use vaccine as supplied; no dilution or reconstitution is necessary.
• Shake vial or syringe vigorously immediately prior to use to obtain a uniform suspension. Do not use if vaccine cannot be resuspended.
• Examine vial or syringe after shaking. Suspension should be homogeneous and white. Do not use if particulate matter or discoloration are noted or if vaccine cannot be resuspended.
• Administer immediately after drawing vaccine into syringe.
• Administer IM in anterolateral thigh in infants or the deltoid muscle of the upper arm in toddlers and young children. Avoid injection into gluteal area or areas where there may be a major nerve trunk or blood vessel. Gluteal injections may result in a suboptimal hepatitis B immune response.
• Use separate syringes and different sites for concomitant administration of other vaccines.
• Always record manufacturer's name and vaccine lot number in patient's permanent medical record file along with date of administration, and name and title of person administering vaccine.

Storage/Stability

Store vials in refrigerator (36° to 46°F). Do not freeze. Discard if vaccine has been frozen.

Drug Interactions

Children may not respond optimally to active immunization.

Do not mix other vaccine in the same syringe or vial.

Laboratory Test Interactions

None well documented.

Adverse Reactions

Cardiovascular

Cyanosis; edema; pallor.

CNS

Seizure (including febrile seizure, infantile spasms); sleeping more than usual; convulsive disorder; demyelinating diseases of the CNS; peripheral and cranial mononeuropathy; lethargy; convulsions; encephalopathy; headache; hypotonia; hypotonic-hyporesponsive episode; somnolence; crying; irritability.

Dermatologic

Alopecia; erythema; erythema multiforme; petechiae; pruritus; rash; urticaria.

EENT

Ear pain.

GI

Loss of appetite; abdominal pain; anorexia; diarrhea; intussusception; nausea; vomiting.

Hematologic

Idiopathic thrombocytopenia purpura; lymphadenopathy; thrombocytopenia.

Hepatic

Jaundice; LFT abnormalities.

Respiratory

Respiratory tract infection.

Miscellaneous

Injection site reactions (eg, pain, redness or swelling); fussiness/restlessness; fever; swelling; congenital immunodeficiency with sepsis; sudden infant death (causal relationship not established); anaphylactic reaction (including, hives, swelling of the mouth, difficulty breathing, hypotension, or shock); arthus-type hypersensitivity reactions (characterized by severe local reactions); asthenia; malaise; angioedema; cellulitis; arthralgia; limb swelling.

Precautions

Pregnancy

Category C .

Children

Safety and efficacy not established in children younger than 6 wk of age. Pediarix is not recommended for people 7 yr of age or older.

Elderly

Not recommended for use in the adult population.

Special Risk Patients

Use with caution and consider the benefits and risks in the following conditions: temperature of 40.5°C (105°F) within 48 h not due to an identifiable cause; collapse or shock-like state within 48 h; persistent, inconsolable crying lasting at least 3 h, occurring with 48 h; seizures with or without fever occurring within 3 days.

Acute febrile illness

Consider delaying immunization during course of moderate or severe acute febrile illness.

Bleeding disorders

Use with caution in children with bleeding disorders (eg, hemophilia or thrombocytopenia) with steps taken to avoid the risk of hematoma following the injection.

Patient Information

• Provide and review vaccine information sheet prior to immunization.
• Review immunization schedule and advise parent or guardian that entire series must be completed to provide maximum benefit.
• Provide parent or guardian with immunization history record.
• Advise parent or guardian to use OTC analgesics (eg, acetaminophen or ibuprofen) for fever, pain, or discomfort at injection site.
• Advise parent or guardian to notify health care provider if bothersome side effects last more than 24 h.