Recommended Child and Adolescent Immunization Schedule 2022 PDF

1st dose 1st dose Pneumococcal conjugate (PCV13) Inactivated poliovirus (IPV <18 yrs) 2-430 9 mos 12 mos 15 mos ----- 4th dose ----- 3rd or 4th dose,  See Notes -- -- ----- 4th dose ------ ACCP Updates in Therapeutics® 2023: Pharmacotherapy Preparatory Review and Recertification Cou...

1st dose 1st dose Pneumococcal conjugate (PCV13) Inactivated poliovirus (IPV <18 yrs) 2-430 9 mos 12 mos 15 mos ----- 4th dose ----- 3rd or 4th dose,  See Notes -- -- ----- 4th dose ------ ACCP Updates in Therapeutics® 2023: Pharmacotherapy Preparatory Review and Recertification Course Range of recommended ages for all children  Range of recommended ages for certain high-risk groups  Recommended vaccination can begin in this age group  Recommended vaccination based on shared clinical decision-making  No recommendation/ not applicable Seropositive in endemic areas only (See Notes) See Notes See Notes Figure 2. Recommended immunization schedule for children and adolescents 18 years or younger - United States, 2022. For those who fall behind or start late, see the catch-up schedule at https://www.cdc.gov/vaccines/schedules/hcp/imz/catchup.html Source: CDC. Use of the material, including any links to the materials on the CDC, ATSDR or HHS websites, does not imply endorsement by CDC, ATSDR, HHS or the United States Government of American College of Clinical Pharmacy or its products, facility, service, or enterprise.  Dengue (DEN4CYD; 9-16 yrs) Pneumococcal polysaccharide (PPSV23) Meningococcal B (MenB-4C, MenBFHbp) 2nd dose Annual vaccination 1 dose only 1st dose See Notes 17–18 yrs Annual vaccination 1 dose only Meningococcal (MenACWY-D ≥9 mos, MenACWY-CRM ≥2 mos, MenACWY-TT ≥2years) 2nd dose 2nd dose or See Notes 2-dose series, See Notes ----- 1st dose ----- ----- 1st dose ----- 4th dose 5th dose 7–10 yrs 11–12 yrs 13–15 yrs Human papillomavirus (HPV) See Notes See Notes Annual vaccination 1 or 2 doses ---------------------------- 3rd dose ---------------------------- 3rd dose See Notes 3rd dose See Notes 4–6 yrs Annual vaccination 1 or 2 doses 18 mos 19–23 mos 2–3 yrs ---------------------------- 3rd dose ---------------------------- 6 mos 1 dose  2nd dose 2nd dose 2nd dose 2nd dose 2nd dose 4 mos Tetanus, diphtheria, acellular pertussis (Tdap ≥7 yrs) Hepatitis A (HepA) Varicella (VAR) Measles, mumps, rubella (MMR) Influenza (LAIV4) or Range of recommended ages for catch-up vaccination 1st dose Haemophilus influenzae type b (Hib) Influenza (IIV4) 1st dose Diphtheria, tetanus, acellular pertussis (DTaP <7 yrs) ----- 2nd dose ----- 2 mos 1st dose 1st dose Hepatitis B (HepB) 1 mo Rotavirus (RV): RV1 (2-dose series), RV5 (3-dose series) Birth Vaccine 16 yrs Recommended Child and Adolescent Immunization Schedule for ages 18 years or younger, United States, 2022 These recommendations must be read with the notes that follow. For those who fall behind or start late, provide catch-up vaccination at the earliest opportunity as indicated by the green bars. To determine minimum intervals between doses, see the catch-up schedule (Table 2). Table 1 Pediatrics 2-431 alternative to the traditional legal system for resolving vaccine injury claims. All routine child and adolescent vaccines are covered by VICP except for pneumococcal polysaccharide vaccine (PPSV23). For more information, see www.hrsa.gov/vaccinecompensation/index.html. y The National Vaccine Injury Compensation Program (VICP) is a no-fault preventable disease outbreak, contact your state or local health department. y For information about vaccination in the setting of a vaccine- Table 8-1, Vaccination of persons with primary and secondary immunodeficiencies, in General Best Practice Guidelines for Immunization at www.cdc.gov/vaccines/hcp/acip-recs/general-recs/ immunocompetence.html, and Immunization in Special Clinical Circumstances (In: Kimberlin DW, Brady MT, Jackson MA, Long SS, eds. Red Book: 2018 Report of the Committee on Infectious Diseases. 31st ed. Itasca, IL: American Academy of Pediatrics; 2018:67–111). y For vaccination of persons with immunodeficiencies, see is available at www.cdc.gov/travel/. y Information on travel vaccination requirements and recommendations interval are considered valid. Doses of any vaccine administered ≥5 days earlier than the minimum age or minimum interval should not be counted as valid and should be repeated as age appropriate. The repeat dose should be spaced after the invalid dose by the recommended minimum interval. For further details, see Table 3-1, Recommended and minimum ages and intervals between vaccine doses, in General Best Practice Guidelines for Immunization at www.cdc.gov/vaccines/hcp/acip-recs/general-recs/timing.html. y Vaccine doses administered ≤4 days before the minimum age or “through.” y Within a number range (e.g., 12–18), a dash (–) should be read as www.cdc.gov/vaccines/hcp/acip-recs/index.html. y For calculating intervals between doses, 4 weeks = 28 days. Intervals of ≥4 months are determined by calendar months. y Consult relevant ACIP statements for detailed recommendations at CDC’s interim clinical considerations for use of COVID-19 vaccines can be found at www.cdc.gov/vaccines/covid-19/clinicalconsiderations/covid-19-vaccines-us.html. COVID-19 vaccines are recommended for use within the scope of the Emergency Use Authorization or Biologics License Application for the particular vaccine. ACIP recommendations for the use of COVID-19 vaccines can be found at www.cdc.gov/ vaccines/hcp/acip-recs/vacc-specific/covid-19.html. COVID-19 Vaccination Additional information and dose 3 (final dose) at age 12–15 months or 8 weeks after dose 2 (whichever is later). y Dose 1 at age 12–14 months: Administer dose 2 (final dose) at least 8 weeks after dose 1. y Dose 1 at age 7–11 months: Administer dose 2 at least 4 weeks later Catch-up vaccination primary series at age 2, 4, and 6 months, followed by a booster dose* at age 12–15 months) - *Vaxelis® is not recommended for use as a booster dose. A different Hib-containing vaccine should be used for the booster dose. y PedvaxHIB®: 3-dose series (2-dose primary series at age 2 and 4 months, followed by a booster dose at age 12–15 months) y ActHIB®, Hiberix®, Pentacel®, or Vaxelis®: 4-dose series (3 dose Routine vaccination Haemophilus influenzae type b vaccination (minimum age: 6 weeks) 3 or more doses of tetanus-toxoid-containing vaccine: For all wounds except clean and minor wounds, administer DTaP if more than 5 years since last dose of tetanus-toxoid-containing vaccine. For detailed information, see www.cdc.gov/mmwr/volumes/67/rr/rr6702a1.htm. y Wound management in children less than age 7 years with history of Special situations y For other catch-up guidance, see Table 2. older and at least 6 months after dose 3. y Dose 5 is not necessary if dose 4 was administered at age 4 years or Catch-up vaccination early as age 12 months may be counted if at least 4 months have elapsed since dose 3. - Retrospectively: A 4th dose that was inadvertently administered as 12 months if at least 6 months have elapsed since dose 3. y 5-dose series at age 2, 4, 6, 15–18 months, 4–6 years - Prospectively: Dose 4 may be administered as early as age Routine vaccination Diphtheria, tetanus, and pertussis (DTaP) vaccination (minimum age: 6 weeks [4 years for Kinrix® or Quadracel®]) confirmation of previous dengue infection - 3-dose series administered at 0, 6, and 12 months y Endemic areas include Puerto Rico, American Samoa, US Virgin Islands, Federated States of Micronesia, Republic of Marshall Islands, and the Republic of Palau. For updated guidance on dengue endemic areas and pre-vaccination laboratory testing see www.cdc.gov/mmwr/ volumes/70/rr/rr7006a1.htm?s_cid=rr7006a1_w and www.cdc.gov/ dengue/vaccine/hcp/index.html Routine vaccination y Age 9–16 years living in dengue endemic areas AND have laboratory Dengue vaccination (minimum age: 9 years) Administer dose 3 (final dose) at least 8 weeks after dose 2. Age 12–59 months - Unvaccinated or only 1 dose before age 12 months: 2 doses, 8 weeks apart - 2 or more doses before age 12 months: 1 dose at least 8 weeks after previous dose Doses administered within 14 days of starting therapy or during therapy should be repeated at least 3 months after therapy completion. y Hematopoietic stem cell transplant (HSCT): - 3-dose series 4 weeks apart starting 6 to 12 months after successful transplant, regardless of Hib vaccination history y Anatomic or functional asplenia (including sickle cell disease): Age 12–59 months - Unvaccinated or only 1 dose before age 12 months: 2 doses, 8 weeks apart - 2 or more doses before age 12 months: 1 dose at least 8 weeks after previous dose Unvaccinated* persons age 5 years or older - 1 dose y Elective splenectomy: Unvaccinated* persons age 15 months or older - 1 dose (preferably at least 14 days before procedure) y HIV infection: Age 12–59 months - Unvaccinated or only 1 dose before age 12 months: 2 doses, 8 weeks apart - 2 or more doses before age 12 months: 1 dose at least 8 weeks after previous dose Unvaccinated* persons age 5–18 years - 1 dose y Immunoglobulin deficiency, early component complement deficiency: Age 12–59 months - Unvaccinated or only 1 dose before age 12 months: 2 doses, 8 weeks apart - 2 or more doses before age 12 months: 1 dose at least 8 weeks after previous dose *Unvaccinated = Less than routine series (through age 14 months) OR no doses (age 15 months or older) Special situations y Chemotherapy or radiation treatment: are not considered high risk: Do not require catch-up vaccination For other catch-up guidance, see Table 2. Vaxelis® can be used for catchup vaccination in children less than age 5 years. Follow the catch-up schedule even if Vaxelis® is used for one or more doses. For detailed information on use of Vaxelis® see www.cdc.gov/mmwr/volumes/69/ wr/mm6905a5.htm. y Unvaccinated at age 15–59 months: Administer 1 dose. y Previously unvaccinated children age 60 months or older who needed y 1 dose administered at age 15 months or older: No further doses (final dose) at 12–59 months and at least 8 weeks after dose 2. y 2 doses of PedvaxHIB® before age 12 months: Administer dose 3 y Dose 1 before age 12 months and dose 2 before age 15 months: Recommended Child and Adolescent Immunization Schedule for ages 18 years or younger, United States, 2022 For vaccination recommendations for persons ages 19 years or older, see the Recommended Adult Immunization Schedule, 2022. Notes Pediatrics ACCP Updates in Therapeutics® 2023: Pharmacotherapy Preparatory Review and Recertification Course Routine vaccination 2-432 ACCP Updates in Therapeutics® 2023: Pharmacotherapy Preparatory Review and Recertification Course soon as feasible (see Table 2). y Infants who did not receive a birth dose should begin the series as vaccine for doses administered before age 6 weeks) y 3-dose series at age 0, 1–2, 6–18 months (use monovalent HepB Routine series 1 month or hospital discharge (whichever is earlier and even if weight is still <2,000 grams). y Mother is HBsAg-positive: - Administer HepB vaccine and hepatitis B immune globulin (HBIG) (in separate limbs) within 12 hours of birth, regardless of birth weight. For infants <2,000 grams, administer 3 additional doses of vaccine (total of 4 doses) beginning at age 1 month. - Test for HBsAg and anti-HBs at age 9–12 months. If HepB series is delayed, test 1–2 months after final dose. y Mother’s HBsAg status is unknown: - Administer HepB vaccine within 12 hours of birth, regardless of birth weight. - For infants <2,000 grams, administer HBIG in addition to HepB vaccine (in separate limbs) within 12 hours of birth. Administer 3 additional doses of vaccine (total of 4 doses) beginning at age 1 month. - Determine mother’s HBsAg status as soon as possible. If mother is HBsAg-positive, administer HBIG to infants ≥2,000 grams as soon as possible, but no later than 7 days of age. - Infants <2,000 grams: Administer 1 dose at chronological age birth y Mother is HBsAg-negative: - All medically stable infants ≥2,000 grams: 1 dose within 24 hours of Birth dose (monovalent HepB vaccine only) Hepatitis B vaccination (minimum age: birth) endemic hepatitis A (www.cdc.gov/travel/): - Infants age 6–11 months: 1 dose before departure; revaccinate with 2 doses, separated by at least 6 months, between age 12–23 months. - Unvaccinated age 12 months or older: Administer dose 1 as soon as travel is considered. y Persons traveling to or working in countries with high or intermediate International travel 2-dose series (minimum interval: 6 months). y Persons who previously received 1 dose at age 12 months or older should receive dose 2 at least 6 months after dose 1. y Adolescents age 18 years or older may receive the combined HepA and HepB vaccine, Twinrix®, as a 3-dose series (0, 1, and 6 months) or 4-dose series (3 doses at 0, 7, and 21–30 days, followed by a booster dose at 12 months). y Unvaccinated persons through age 18 years should complete a Catch-up vaccination y 2-dose series (minimum interval: 6 months) at age 12–23 months 3-dose series, even for those who initiate vaccination at age 9 through 14 years. y History of sexual abuse or assault: Start at age 9 years. y Immunocompromising conditions, including HIV infection: Special situations start at age 9 years) and catch-up HPV vaccination recommended for all persons through age 18 years if not adequately vaccinated y 2- or 3-dose series depending on age at initial vaccination: - Age 9–14 years at initial vaccination: 2-dose series at 0, 6–12 months (minimum interval: 5 months; repeat dose if administered too soon) - Age 15 years or older at initial vaccination: 3-dose series at 0, 1–2 months, 6 months (minimum intervals: dose 1 to dose 2: 4 weeks / dose 2 to dose 3: 12 weeks / dose 1 to dose 3: 5 months; repeat dose if administered too soon) y Interrupted schedules: If vaccination schedule is interrupted, the series does not need to be restarted. y No additional dose recommended when any HPV vaccine series has been completed using the recommended dosing intervals. y HPV vaccination routinely recommended at age 11–12 years (can Routine and catch-up vaccination Human papillomavirus vaccination (minimum age: 9 years) normal immune status who were vaccinated as infants, children, adolescents, or adults. y Post-vaccination serology testing and revaccination (if anti-HBs < 10mlU/mL) is recommended for certain populations, including: - Infants born to HBsAg-positive mothers - Hemodialysis patients - Other immunocompromised persons For detailed revaccination recommendations, see www.cdc.gov/ vaccines/hcp/acip-recs/vacc-specific/hepb.html. y Revaccination is not generally recommended for persons with a Special situations schedule with at least 4 months between doses (adult formulation Recombivax HB® only). y Adolescents age 18 years or older may receive a 2-dose series of HepB (Heplisav-B®) at least 4 weeks apart. y Adolescents age 18 years or older may receive the combined HepA and HepB vaccine, Twinrix®, as a 3-dose series (0, 1, and 6 months) or 4-dose series (3 doses at 0, 7, and 21–30 days, followed by a booster dose at 12 months). y For other catch-up guidance, see Table 2. y Adolescents age 11–15 years may use an alternative 2-dose months. y Unvaccinated persons should complete a 3-dose series at 0, 1–2, 6 Catch-up vaccination containing HepB is used after the birth dose. y Minimum age for the final (3rd or 4th ) dose: 24 weeks y Minimum intervals: dose 1 to dose 2: 4 weeks / dose 2 to dose 3: 8 weeks / dose 1 to dose 3: 16 weeks (when 4 doses are administered, substitute “dose 4” for “dose 3” in these calculations) y Administration of 4 doses is permitted when a combination vaccine 2-dose series at age 12–15 months (12 months for children in high-risk areas) and dose 2 as early as 4 weeks later. y Unvaccinated children age 12 months or older: 2-dose series at least 4 weeks apart before departure y Infants age 6–11 months: 1 dose before departure; revaccinate with International travel Special situations y The maximum age for use of MMRV is 12 years. y Minimum interval between MMRV doses: 3 months apart y Unvaccinated children and adolescents: 2-dose series at least 4 weeks Catch-up vaccination Note: For dose 1 in children age 12–47 months, it is recommended to administer MMR and varicella vaccines separately. MMRV may be used if parents or caregivers express a preference. y 2-dose series at age 12–15 months, age 4–6 years y MMR or MMRV may be administered Routine vaccination Measles, mumps, and rubella vaccination (minimum age: 12 months for routine vaccination) respiratory distress) or required epinephrine or another emergency medical intervention: see Appendix listing contraindications and precautions y Severe allergic reaction (e.g., anaphylaxis) to a vaccine component or a previous dose of any influenza vaccine: see Appendix listing contraindications and precautions y Egg allergy with symptoms other than hives (e.g., angioedema, and health status annually y Egg allergy, hives only: Any influenza vaccine appropriate for age Special situations annually: - 2 doses, separated by at least 4 weeks, for children age 6 months–8 years who have received fewer than 2 influenza vaccine doses before July 1, 2021, or whose influenza vaccination history is unknown (administer dose 2 even if the child turns 9 between receipt of dose 1 and dose 2) - 1 dose for children age 6 months–8 years who have received at least 2 influenza vaccine doses before July 1, 2021 - 1 dose for all persons age 9 years or older y For the 2021-2022 season, see www.cdc.gov/mmwr/volumes/70/rr/ rr7005a1.htm. y For the 2022–23 season, see the 2022–23 ACIP influenza vaccine recommendations. Routine vaccination y Use any influenza vaccine appropriate for age and health status Influenza vaccination (minimum age: 6 months [IIV], 2 years [LAIV4], 18 years [recombinant influenza vaccine, RIV4]) vaccination not recommended until after pregnancy; no intervention needed if vaccinated while pregnant y Pregnancy: Pregnancy testing not needed before vaccination; HPV Recommended Child and Adolescent Immunization Schedule for ages 18 years or younger, United States, 2022 Hepatitis A vaccination (minimum age: 12 months for routine vaccination) Notes Pediatrics Routine vaccination Anatomic or functional asplenia (including sickle cell disease), HIV infection, persistent complement component deficiency, complement inhibitor (e.g., eculizumab, ravulizumab) use: y Menveo - Dose 1 at age 2 months: 4-dose series (additional 3 doses at age 4, 6 and 12 months) - Dose 1 at age 3–6 months: 3- or 4- dose series (dose 2 [and dose 3 if applicable] at least 8 weeks after previous dose until a dose is received at age 7 months or older, followed by an additional dose at least 12 weeks later and after age 12 months) - Dose 1 at age 7–23 months: 2-dose series (dose 2 at least 12 weeks after dose 1 and after age 12 months) - Dose 1 at age 24 months or older: 2-dose series at least 8 weeks apart y Menactra - Persistent complement component deficiency or complement inhibitor use:  Age 9–23 months: 2-dose series at least 12 weeks apart  Age 24 months or older: 2-dose series at least 8 weeks apart - Anatomic or functional asplenia, sickle cell disease, or HIV infection:  Age 9–23 months: Not recommended  Age 24 months or older: 2-dose series at least 8 weeks apart  Menactra® must be administered at least 4 weeks after completion of PCV13 series. y MenQuadfi® - Dose 1 at age 24 months or older: 2-dose series at least 8 weeks apart Travel in countries with hyperendemic or epidemic meningococcal disease, including countries in the African meningitis belt or during the Hajj (www.cdc.gov/travel/): y Children less than age 24 months: - Menveo® (age 2–23 months)  Dose 1 at age 2 months: 4-dose series (additional 3 doses at age 4, 6 and 12 months)  Dose 1 at age 3–6 months: 3- or 4- dose series (dose 2 [and dose 3 if applicable] at least 8 weeks after previous dose until a dose is received at age 7 months or older, followed by an additional dose at least 12 weeks later and after age 12 months)  Dose 1 at age 7–23 months: 2-dose series (dose 2 at least 12 weeks after dose 1 and after age 12 months) - Menactra® (age 9–23 months)  2-dose series (dose 2 at least 12 weeks after dose 1; dose 2 may be administered as early as 8 weeks after dose 1 in travelers) y Children age 2 years or older: 1 dose Menveo®, Menactra®, or MenQuadfi® First-year college students who live in residential housing (if not previously vaccinated at age 16 years or older) or military recruits: y 1 dose Menveo®, Menactra®, or MenQuadfi® Special situations y Age 16–18 years: 1 dose (minimum interval: 8 weeks) y Age 13–15 years: 1 dose now and booster at age 16–18 years Catch-up vaccination y 2-dose series at age 11–12 years; 16 years 2-433 y For other catch-up guidance, see Table 2. PCV13 series y 1 dose for healthy children age 24–59 months with any incomplete* Catch-up vaccination with PCV13 y 4-dose series at age 2, 4, 6, 12–15 months Routine vaccination with PCV13 Pneumococcal vaccination (minimum age: 6 weeks [PCV13], 2 years [PPSV23]) Anatomic or functional asplenia (including sickle cell disease), persistent complement component deficiency, complement inhibitor (e.g., eculizumab, ravulizumab) use: y Bexsero®: 2-dose series at least 1 month apart y Trumenba®: 3-dose series at 0, 1–2, 6 months Note: Bexsero® and Trumenba® are not interchangeable; the same product should be used for all doses in a series. For MenB booster dose recommendations for groups listed under “Special situations” and in an outbreak setting and additional meningococcal vaccination information, see www.cdc.gov/mmwr/ volumes/69/rr/rr6909a1.htm. Special situations 16–18 years) based on shared clinical decision-making: - Bexsero®: 2-dose series at least 1 month apart - Trumenba®: 2-dose series at least 6 months apart; if dose 2 is administered earlier than 6 months, administer a 3rd dose at least 4 months after dose 2. y Adolescents not at increased risk age 16–23 years (preferred age Shared clinical decision-making Meningococcal serogroup B vaccination (minimum age: 10 years [MenB-4C, Bexsero®; MenB-FHbp, Trumenba®]) Adolescent vaccination of children who received MenACWY prior to age 10 years: y Children for whom boosters are recommended because of an ongoing increased risk of meningococcal disease (e.g., those with complement deficiency, HIV, or asplenia): Follow the booster schedule for persons at increased risk. y Children for whom boosters are not recommended (e.g., a healthy child who received a single dose for travel to a country where meningococcal disease is endemic): Administer MenACWY according to the recommended adolescent schedule with dose 1 at age 11–12 years and dose 2 at age 16 years. Note: Menactra® should be administered either before or at the same time as DTaP. MenACWY vaccines may be administered simultaneously with MenB vaccines if indicated, but at a different anatomic site, if feasible. For MenACWY booster dose recommendations for groups listed under “Special situations” and in an outbreak setting and additional meningococcal vaccination information, see www.cdc.gov/mmwr/ volumes/69/rr/rr6909a1.htm. Underlying conditions below: When both PCV13 and PPSV23 are indicated, administer PCV13 first. PCV13 and PPSV23 should not be administered during same visit. Chronic heart disease (particularly cyanotic congenital heart disease and cardiac failure); chronic lung disease (including asthma treated with high-dose, oral corticosteroids); diabetes mellitus: Age 2–5 years y Any incomplete* series with: - 3 PCV13 doses: 1 dose PCV13 (at least 8 weeks after any prior PCV13 dose) - Less than 3 PCV13 doses: 2 doses PCV13 (8 weeks after the most recent dose and administered 8 weeks apart) y No history of PPSV23: 1 dose PPSV23 (at least 8 weeks after completing all recommended PCV13 doses) Age 6–18 years y No history of PPSV23: 1 dose PPSV23 (at least 8 weeks after completing all recommended PCV13 doses) Cerebrospinal fluid leak, cochlear implant: Age 2–5 years y Any incomplete* series with: - 3 PCV13 doses: 1 dose PCV13 (at least 8 weeks after any prior PCV13 dose) - Less than 3 PCV13 doses: 2 doses PCV13 (8 weeks after the most recent dose and administered 8 weeks apart) y No history of PPSV23: 1 dose PPSV23 (at least 8 weeks after any prior PCV13 dose) Age 6–18 years y No history of either PCV13 or PPSV23: 1 dose PCV13, 1 dose PPSV23 at least 8 weeks later y Any PCV13 but no PPSV23: 1 dose PPSV23 at least 8 weeks after the most recent dose of PCV13 y PPSV23 but no PCV13: 1 dose PCV13 at least 8 weeks after the most recent dose of PPSV23 Sickle cell disease and other hemoglobinopathies; anatomic or functional asplenia; congenital or acquired immunodeficiency; HIV infection; chronic renal failure; nephrotic syndrome; malignant neoplasms, leukemias, lymphomas, Hodgkin disease, and other diseases associated with treatment with immunosuppressive drugs or radiation therapy; solid organ transplantation; multiple myeloma: Age 2–5 years y Any incomplete* series with: - 3 PCV13 doses: 1 dose PCV13 (at least 8 weeks after any prior PCV13 dose) - Less than 3 PCV13 doses: 2 doses PCV13 (8 weeks after the most recent dose and administered 8 weeks apart) y No history of PPSV23: 1 dose PPSV23 (at least 8 weeks after any prior PCV13 dose) and a dose 2 of PPSV23 5 years later Age 6–18 years y No history of either PCV13 or PPSV23: 1 dose PCV13, 2 doses PPSV23 (dose 1 of PPSV23 administered 8 weeks after PCV13 and dose 2 of PPSV23 administered at least 5 years after dose 1 of PPSV23) y Any PCV13 but no PPSV23: 2 doses PPSV23 (dose 1 of PPSV23 administered 8 weeks after the most recent dose of PCV13 and dose 2 of PPSV23 administered at least 5 years after dose 1 of PPSV23) y PPSV23 but no PCV13: 1 dose PCV13 at least 8 weeks after the most recent PPSV23 dose and a dose 2 of PPSV23 administered 5 years after dose 1 of PPSV23 and at least 8 weeks after a dose of PCV13 Special situations Recommended Child and Adolescent Immunization Schedule for ages 18 years or younger, United States, 2022 Meningococcal serogroup A,C,W,Y vaccination (minimum age: 2 months [MenACWY-CRM, Menveo], 9 months [MenACWY-D, Menactra], 2 years [MenACWY-TT, MenQuadfi]) Notes Pediatrics ACCP Updates in Therapeutics® 2023: Pharmacotherapy Preparatory Review and Recertification Course 2-434 ACCP Updates in Therapeutics® 2023: Pharmacotherapy Preparatory Review and Recertification Course 2/17/2022 3-dose series. y Rotarix®: 2-dose series at age 2 and 4 months y RotaTeq®: 3-dose series at age 2, 4, and 6 months y If any dose in the series is either RotaTeq® or unknown, default to Routine vaccination Rotavirus vaccination (minimum age: 6 weeks) Series containing oral polio vaccine (OPV), either mixed OPV-IPV or OPV-only series: y Total number of doses needed to complete the series is the same as that recommended for the U.S. IPV schedule. See www.cdc.gov/ mmwr/volumes/66/wr/mm6601a6.htm?s_%20cid=mm6601a6_w. y Only trivalent OPV (tOPV) counts toward the U.S. vaccination requirements. - Doses of OPV administered before April 1, 2016, should be counted (unless specifically noted as administered during a campaign). - Doses of OPV administered on or after April 1, 2016, should not be counted. - For guidance to assess doses documented as “OPV,” see www.cdc.gov/mmwr/volumes/66/wr/mm6606a7.htm?s_ cid=mm6606a7_w. y For other catch-up guidance, see Table 2. or older. y IPV is not routinely recommended for U.S. residents age 18 years for travel to a polio-endemic region or during an outbreak. y In the first 6 months of life, use minimum ages and intervals only Catch-up vaccination final dose on or after age 4 years and at least 6 months after the previous dose. y 4 or more doses of IPV can be administered before age 4 years when a combination vaccine containing IPV is used. However, a dose is still recommended on or after age 4 years and at least 6 months after the previous dose. y 4-dose series at ages 2, 4, 6–18 months, 4–6 years; administer the Routine vaccination Poliovirus vaccination (minimum age: 6 weeks) *Incomplete series = Not having received all doses in either the recommended series or an age-appropriate catch-up series See Tables 8, 9, and 11 in the ACIP pneumococcal vaccine recommendations (www.cdc.gov/mmwr/pdf/rr/rr5911.pdf) for complete schedule details. MMWR at www.cdc.gov/mmwr/pdf/rr/rr5604.pdf) have a 2-dose series: - Age 7–12 years: routine interval: 3 months (a dose inadvertently administered after at least 4 weeks may be counted as valid) - Age 13 years and older: routine interval: 4–8 weeks (minimum interval: 4 weeks) - The maximum age for use of MMRV is 12 years. y Ensure persons age 7–18 years without evidence of immunity (see Catch-up vaccination (a dose inadvertently administered after at least 4weeks may be counted as valid) *Note: For dose 1 in children age 12–47 months, it is recommended to administer MMR and varicella vaccines separately. MMRV may be used if parents or caregivers express a preference. y 2-dose series at age 12–15 months, 4–6 years y VAR or MMRV may be administered* y Dose 2 may be administered as early as 3 months after dose 1 Routine vaccination Varicella vaccination (minimum age: 12 months) Centers for Disease Control and Prevention | Recommended Child and Adolescent Immunization Schedule, United States, 2022 *Fully vaccinated = 5 valid doses of DTaP OR 4 valid doses of DTaP if dose 4 was administered at age 4 years or older of 3 or more doses of tetanus-toxoid-containing vaccine: For clean and minor wounds, administer Tdap or Td if more than 10 years since last dose of tetanus-toxoid-containing vaccine; for all other wounds, administer Tdap or Td if more than 5 years since last dose of tetanus-toxoid-containing vaccine. Tdap is preferred for persons age 11 years or older who have not previously received Tdap or whose Tdap history is unknown. If a tetanus-toxoid-containing vaccine is indicated for a pregnant adolescent, use Tdap. y For detailed information, see www.cdc.gov/mmwr/volumes/69/wr/ mm6903a5.htm. y Wound management in persons age 7 years or older with history Special situations Tdap as part of the catch-up series (preferably the first dose); if additional doses are needed, use Td or Tdap. y Tdap administered at age 7–10 years: - Children age 7–9 years who receive Tdap should receive the routine Tdap dose at age 11–12 years. - Children age 10 years who receive Tdap do not need the routine Tdap dose at age 11–12 years. y DTaP inadvertently administered on or after age 7 years: - Children age 7–9 years: DTaP may count as part of catch-up series. Administer routine Tdap dose at age 11–12 years. - Children age 10–18 years: Count dose of DTaP as the adolescent Tdap booster. y For other catch-up guidance, see Table 2. y Persons age 7–18 years not fully vaccinated* with DTaP: 1 dose 1 dose Tdap, then Td or Tdap booster every 10 years y Adolescents age 13–18 years who have not received Tdap: Catch-up vaccination early part of gestational weeks 27–36. y Tdap may be administered regardless of the interval since the last tetanus- and diphtheria-toxoid-containing vaccine. y Adolescents age 11–12 years: 1 dose Tdap y Pregnancy: 1 dose Tdap during each pregnancy, preferably in Routine vaccination Tetanus, diphtheria, and pertussis (Tdap) vaccination (minimum age: 11 years for routine vaccination, 7 years for catch-up vaccination) Catch-up vaccination y Do not start the series on or after age 15 weeks, 0 days. y The maximum age for the final dose is 8 months, 0 days. y For other catch-up guidance, see Table 2. Recommended Child and Adolescent Immunization Schedule for ages 18 years or younger, United States, 2022 Chronic liver disease, alcoholism: Age 6–18 years y No history of PPSV23: 1 dose PPSV23 (at least 8 weeks after any prior PCV13 dose) Notes Pediatrics Pediatrics V. PEDIATRIC SEIZURE DISORDERS A. Incidence of Pediatric Seizures 1. Over 470,000 children in the United States with active epilepsy 2 Highest incidence in infants and decreases to less than 1% of children aged 6-17 years old. 3. Higher incidence with lower socioeconomic status and pre-existing developmental delays/disabilities 4. Additional risk factors for seizures include trauma, infection, fever, metabolic imbalances, toxic ingestions, drug withdrawal, neurologic conditions, and medications B. Febrile Seizures 1. Febrile seizures are the most common seizure disorder in childhood 2. Affects 2%–5% of children between the ages of 6 and 60 months 3. Simple versus complex febrile seizures a. Simple: brief (less than 15 minutes) generalized seizures that occur once during a 24-hour period in a febrile child; no evidence of intracranial infection, metabolic disturbance, or history of febrile seizures b. Complex: one of the following in a febrile child i. Prolonged (more than 15 minutes) seizure ii. Focal seizure iii. Occur more than once in a 24-hour period 4. Risk of developing epilepsy a. Children with simple febrile seizures have approximately the same risk of developing epilepsy as general population (about 1%) b. Higher risk if febrile seizures are recurrent, age younger than 12 months at time of first febrile seizure, or have a family history of epilepsy 5. High rate of recurrence even for simple febrile seizure a. First simple febrile seizure at less than 12 months old: 50% probability of recurrence b. First simple febrile seizure at 12 months or older: 30% probability of recurrence c. Second simple febrile seizure: 50% probability of at least one recurrence 6. Management of simple febrile seizures: a. Generally benign with excellent prognosis b. Risk of recurrence can be reduced with the following therapies; however, potential toxicities outweigh benefits, and these are not routinely recommended: i. Phenobarbital long-term therapy ii. Primidone long-term therapy iii. Valproic acid long-term therapy iv. Oral diazepam intermittent therapy for fevers c. Oral diazepam at fever recurrence can be considered when parental anxiety is severe d. Antipyretics are ineffective in preventing febrile seizures C. Metabolic causes of pediatric afebrile seizures 1. A metabolic screen should be considered with afebrile seizures, including glucose electrolytes with calcium and magnesium, and renal function. 2. More extensive metabolic testing looking for inborn errors of metabolism should be considered if other suggestive symptoms are present, including unexplained global delay or regression, organomegaly, unusual odor, similarly affected siblings, or an acute presentation with altered level of consciousness, multiorgan dysfunction, and vomiting. 3. Several metabolic causes of seizures can be treated. Examples include: a. Pyridoxine-dependent or pyridoxal-5-phosphate-dependent epilepsy (NOTE: pyridoxine is frequently empirically trialed in refractory seizures in infants younger than 1 year) ACCP Updates in Therapeutics® 2023: Pharmacotherapy Preparatory Review and Recertification Course 2-435 Pediatrics b. c. d. e. f. Biotinidase deficiency Glucose transporter deficiency Cerebral folate deficiency Creatine deficiency Serine deficiency D. Treatment Options Based on Seizure Type (Table 6) Table 6. Treatment Options Based on Seizure Type Seizure Type Drugs of Choice Alternatives Neonatal PB LEV, PHT Focal (formerly “partial”) CBZ, PHT, LTG, LEV, oxcarbazepine, topiramate, ZNS PB, gabapentin, tiagabine, lacosamide, VPAa Tonic-clonic CBZ, PHT, LTG, LEV, ZNS Topiramate, VPAa Myoclonic VPAa, LEV LTG, topiramate, ZNS, clobazam, rufinamide, felbamate Absence Ethosuximide, VPAa Lamotrigine, methsuximide, ZNS Lennox-Gastaut VPA , topiramate, lamotrigine Rufinamide, CBD, clobazam, felbamate, ZNS Infantile spasms ACTH injectable gel Vigabatrin, lamotrigine, tiagabine, topiramate, VPAa, ZNS Generalized a Valproic acid can cause major congenital malformations and has a U.S. black box warning stating that it should not be administered to women of childbearing potential unless other medications have failed to provide adequate symptom control or are otherwise unacceptable. ACTH = adrenocorticotropic hormone; CBD = cannabidiol; CBZ = carbamazepine; LEV = levetiracetam, LTG = lamotrigine; PB = phenobarbital; PHT = phenytoin; VPA = valproic acid; ZNS = zonisamide. a E. Comparison of Available Antiseizure Drugs (Table 7) Table 7. Comparison of Available Antiseizure Drugs Drug Adverse Effects Pharmacokinetic Considerations Other Comments Brivaracetam Dizziness Sleepiness Nausea and vomiting Behavioral reactions Substrate of CYP2C19 Poor metabolizers of CYP2C19 may require dose reduction FDA-approved medication guide must be dispensed with medication Cannabidiol Somnolence/fatigue Increased liver enzymes Hypersensitivity reactions Decreased appetite and weight loss Diarrhea Insomnia Moderate inhibitor of CYP2C19 High-fat/high-calorie meals increase extent of absorption Schedule C-V Sugar-free oral solution Carbamazepine Rash (Black Box Warning) Hyponatremia ↓ Bone density Teratogenic DRESS syndrome Bone marrow suppression Autoinduction ↓ Effectiveness of OCs Major CYP3A4 substrate Significant drug interactions Routine therapeutic drug monitoring NIOSH hazardous drug HLA-B*1502 associated with SJS/ TEN ACCP Updates in Therapeutics® 2023: Pharmacotherapy Preparatory Review and Recertification Course 2-436 Pediatrics Table 7. Comparison of Available Antiseizure Drugs (Cont’d) Drug Adverse Effects Pharmacokinetic Considerations Other Comments Clobazam Somnolence Dose adjustment needed in hepatic impairment Dose adjustment needed in CYP2C19 poor metabolizers Long half-life Long-acting benzodiazpine Tolerance may develop over time Eslicarbazepine Dizziness Nausea Diplopia Substrate of UGT2B4 Moderate inducer of CYP3A4 Dose adjustment needed with renal impairment. Avoid use in severe hepatic impairment. Significant drug interactions NIOSH hazardous drug Ethosuximide Abdominal pain, anorexia, diarrhea Drowsiness Substrate of CYP3A4 Ineffective for seizure types other than absence Felbamate Anorexia, nausea, weight loss Clearance approximately 50:50 renal/hepatic Insomnia, somnolence Aplastic anemia Hepatic failure Fenfluramine CNS depression ↓ Appetite, weight loss Hypertension Ocular effects (glaucoma) Pulmonary hypertension (Black Box Warning) Serotonin syndrome Valvular heart disease (Black Box Warning) Major substrate of CYP1A2 and CYP2B6 Minor substrate of CYP2C19, CYP2C9, CYP2D6, and CYP3A4 Avoid use with hepatic impairment Avoid use with moderate to severe renal impairment REMS program due to pulmonary hypertension and valvular heart disease risk Potential drug interaction with clobazam and stiripentol warranting dose reduction of fenfluramine Gabapentin Somnolence Weight gain ↑ Clearance in children < 6 yr Dose adjustment needed in renal insufficiency (no specific recommendations/studies for < 12 years old) Nonlinear pharmacokinetics Minimal drug interactions Minimal cognitive effects May worsen Lennox-Gastaut Lacosamide Prolonged PR interval Dizziness Headache Diplopia Dose adjustment needed in severe renal insufficiency Use with caution if severe cardiac disease or conduction problems; caution with beta-blockers and some Ca channel blockers because of potential prolonged PR interval, AV block, or bradycardia No other clinically significant drug interactions Lamotrigine Rash/SJS/DRESS syndrome (Black Box Warning) Autoinduction Rash: Children > adults Minimal cognitive effects NIOSH hazardous drug Levetiracetam Headache Somnolence Behavioral changes Renal excretion Clearance 40% ↑ in children No effect on CYP system Minimal drug interactions Behavioral effects (e.g., aggression, agitation, mood changes): children > adults Oxcarbazepine Hyponatremia (> CBZ) Rash (< CBZ but has cross-reactivity with CBZ) Clearance 40% ↑ in children < 6 yr Induces CYP3A4 Inhibits CYP2C19 ↓ Effectiveness of OCs Hyponatremia: adults > children Minimal cognitive effects NIOSH hazadous drug Significant drug interactions Aplastic anemia: Adults > children Requires signed informed consent ACCP Updates in Therapeutics® 2023: Pharmacotherapy Preparatory Review and Recertification Course 2-437 Pediatrics Table 7. Comparison of Available Antiseizure Drugs (Cont’d) Drug Adverse Effects Pharmacokinetic Considerations Other Comments Perampanel Dizziness Nausea Somnolence Fatigue Irritability Headache Substrate of CYP3A4 Minor substrate of CYP1A2 and CYP2B6 Black box warning for neuropsychiatric events Phenobarbital Cognitive dysfunction Sedation Rash ↓ Bone density DRESS syndrome High Protein Binding ↓ Effectiveness of OCs Autoinduction Long half-life Significant drug interactions Routine therapeutic drug monitoring Phenytoin and Fosphenytoin Rash Gingival hyperplasia Hirsutism ↓ Bone density Teratogenic Phlebitis and extravasation DRESS syndrome Arrhythmias Nonlinear pharmacokinetics ↓ Effectiveness of OCs Significant drug interactions NIOSH hazardous drug Reduced risk of extravasation and hypotension with fosphenytoin Routine therapeutic drug monitoring HLA B*1502 associated w/increased risk of SJS/TEN Shake well before use Adheres to feeding tubes Pregabalin Somnolence Behavioral problems Dizziness Weight gain Ataxia Angioedema AUC is ~30% lower while fasting Minimal drug interactions Rufinamide Somnolence Rash QT interval shortening ↑ Level with concurrent VPA Somnolence: Minimized with slow dose titration Rash: All reported cases are in children Administer with food Stiripentol Appetite/weight loss Drowsiness/dizziness Neutropenia Thrombocytopenia ↓ Clearance with increasing body weight (adolescents may require lower dosing than younger children) Valproate dose reduction by 30% may help minimize appetite/ weight loss Systemic exposure is slightly higher with the powder for suspension than with capsules Not approved for use as monotherapy. Should be used with clobazam (labeled use) or valproate (off-label) Approved for use in Dravet syndrome Tiagabine Dizziness Nonconvulsive status epilepticus (case reports) Clearance 50% ↑ in children Minimal cognitive effects Topiramate Cognitive dysfunction Weight loss Glaucoma Oligohidrosis Metabolic acidosis Nephrolithiasis ↑ Clearance in children Dose adjustment needed in renal insufficiency Weight loss more common in obese patients Children at higher risk of oligohidrosis than adults NIOSH hazardous drug ACCP Updates in Therapeutics® 2023: Pharmacotherapy Preparatory Review and Recertification Course 2-438 Pediatrics Table 7. Comparison of Available Antiseizure Drugs (Cont’d) Drug Adverse Effects Valproic acid Weight gain Menstrual irregularities Polycystic ovarian syndrome Hyperandrogenism Hepatotoxicity (Black Box Warning) Teratogenic (Black Box Warning) Thrombocytopenia Pancreatitis (Black Box Warning) Vigabatrin Vision loss (Black Box Warning) Weight gain Zonisamide Weight loss Rash Oligohidrosis Somnolence Agitation Hallucinations Metabolic acidosis Nephrolithiasis Pharmacokinetic Considerations CYP induction > in children Other Comments Significant drug interactions; Most cases of hepatotoxicity in children < 2 yr old (often if multiple AEDs) NIOSH hazardous drug Routine therapeutic drug monitoring Use sprinkles (opened caps) on food for ease of administration in small children Available only through restricted distribution program NIOSH hazardous drug Primarily renal excretion No effect on CYP system Better tolerated by children than by adults NIOSH hazardous drug CBZ = carbamazepine; CYP = cytochrome P450; DRESS = drug reaction with eosinophilia and systemic symptoms; NIOSH = National Institute for Occupational Safety and Health; OC = oral contraceptive; PHT = phenytoin; SJS = Stevens-Johnson Syndrome; TEN = toxic epidermal necrolysis; VPA = valproic acid; ↓ = decreased; ↑ = increased. Patient Case 10. A 14-year-old female adolescent with moderate obesity comes to the clinic with an erythematous pruritic rash. She was given oxcarbazepine about 3 weeks ago for the management of focal seizures. Her medical history is significant only for seizures. She recently became sexually active with a male and admits inconsistent contraceptive use. Which intervention is best for her? A. Change to carbamazepine. B. Change to levetiracetam. C. Change to valproic acid. D. No change in therapy is necessary. VI. ATTENTION-DEFICIT/HYPERACTIVITY DISORDER A. Clinical Presentation 1. Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria a. Either (i) or (ii) or combined presentation when all core features present i. Six or more (five or more if 17 years or older) of the following symptoms of inattention have been present for at least 6 months to a point that is disruptive and inappropriate: (a) Often does not give close attention to detail; makes careless mistakes (b) Often has trouble keeping attention on tasks and activities (c) Often does not seem to listen (d) Often does not follow instructions ACCP Updates in Therapeutics® 2023: Pharmacotherapy Preparatory Review and Recertification Course 2-439 AL GRAWANY Pediatrics (e) Often has trouble organizing activities (f) Often avoids or dislikes things that require long periods of mental effort (g) Often loses things needed for tasks or activities (h) Often is easily distracted (i) Often is forgetful ii. Six or more of the following symptoms of hyperactivity-impulsivity have been present for at least 6 months to a point that is disruptive and inappropriate: (a) Hyperactivity (1) Often fidgets or squirms (2) Often is unable to remain seated when it is expected (3) Often runs or climbs when and where it is not appropriate (4) Often has difficulty with quiet play or activities (5) Often is “on the go” (6) Often talks excessively (b) Impulsivity (1) Often blurts out answers (2) Often has difficulty waiting one’s turn (3) Often interrupts b. Some symptoms were present by 12 years of age. c. Some impairment from the symptoms is present in two or more settings. d. Clear evidence of significant impairment exists in social, school, or work functioning. e. No other mental disorder better describes the symptoms. 2. Comorbid disease states: 44%–87% of children with ADHD have at least one other disorder a. Oppositional defiant disorder i. Most common comorbid disorder in adolescents ii. Presence of ADHD increases the odds of oppositional defiant disorder almost 11-fold. b. Anxiety disorder: May exist in about 25% of children with ADHD c. Tics i. 21%–90% of children with Tourette syndrome may also have ADHD. ii. May not be exacerbated by stimulant agents, as once thought Patient Case 11. A 9-year-old boy has a new diagnosis of ADHD. At school, he is disruptive, talks when the teacher is talking, and runs around the classroom. His parents report extreme difficulty in getting him to do his homework after school. Which is best for his initial drug therapy? A. Methylphenidate OROS (Concerta) given once daily. B. Methylphenidate immediate release (Ritalin) given twice daily, with doses administered 4 hours apart. C. Guanfacine given at bedtime. D. B. d -Methylphenidate (Focalin) given twice daily, with doses administered 4 hours apart. Classification: Based on DSM-5 Criteria 1. ADHD, combined type: Criteria (i) and (ii) both are met. 2. ADHD, predominantly inattentive type: Criterion (i) is met, but (ii) is not met. 3. ADHD, predominantly hyperactive-impulsive type: Criterion (ii) is met, but (i) is not met. ACCP Updates in Therapeutics® 2023: Pharmacotherapy Preparatory Review and Recertification Course 2-440 Pediatrics C. Treatment Options: Combination of pharmacotherapy and behavioral therapy is more beneficial than either intervention alone. 1. Factors affecting choice of pharmacologic agent a. Desired length of coverage time for symptoms i. Consider time of day when symptoms occur. ii. Consider time of day when child’s activities occur (e.g., when is homework done, at what time are teenagers driving, when is child’s bedtime). b. Child’s ability to swallow pills or capsules c. Concomitant disease states (e.g., tic disorders) d. Adverse effect profile e. Concerns about abuse or diversion potential i. Children with ADHD are more likely to have a concurrent substance use disorder than those without ADHD. ii. Treatment with stimulant medication can reduce the risk of developing a substance use disorder. iii. Children treated with stimulants at a younger age are less likely to misuse or abuse substances than those in whom treatment is delayed. f. Expense 2. Available pharmacologic agents a. Stimulant medications: Highly effective for most children in reducing core symptoms of ADHD. Some children with ADHD respond better to one stimulant type than another; therefore, both methylphenidate- and amphetamine-containing products should be tried before stimulant treatment is deemed a failure. Stimulant medications vary in duration of action (see Table 8). Ideally, the duration of action of the medication selected should match the duration needed for symptom control. i. Methylphenidate-containing products (a) Ramp effect: Behavioral effects are proportional to the rate of methylphenidate absorption into the central nervous system. (b) See Table 8 for a comparison of available products. (c) Adverse effects and precautions (1) Headache, stomachache, loss of appetite, and insomnia (2) Use with caution in patients with glaucoma, tics, psychosis, and concomitant monoamine oxidase inhibitor use. (3) Insomnia, anorexia, and tics occur more often with transdermal patch; also mild skin reactions. ii. Amphetamine-containing products (a) See Table 8 for a comparison of available products. (b) Adverse effects and precautions (1) Loss of appetite, insomnia, abdominal pain, and nervousness (2) Can exacerbate preexisting hypertension and tic disorders (3) Labeling change warns of potential association with sudden cardiac death (SCD); therefore, these are not recommended for patients with known structural heart defects. iii. Potential association with SCD (a) No established evidence of causative relationship between stimulants and SCD (b) The frequency of SCD is no higher in children taking stimulants than in the general pediatric population. (c) The AAP recommends targeted cardiac history and careful physical examination before initiating stimulant therapy. (1) Routine electrocardiography is not recommended unless history and physical examination suggest cardiac disease. ACCP Updates in Therapeutics® 2023: Pharmacotherapy Preparatory Review and Recertification Course 2-441 Pediatrics (2) For otherwise healthy children, stimulant therapy should not be withheld because of the inability to obtain an electrocardiogram or assessment by a pediatric cardiologist. b. Non-stimulant medications: Demonstrated efficacy in reducing core symptoms of ADHD; however, less evidence to date compared with stimulant medications. i. Norepinephrine reuptake inhibitors (see Table 9): FDA-approved for the treatment of ADHD (a) Adverse effects: Dyspepsia, decreased appetite, weight loss, and fatigue (b) Labeling change warns of potential for severe liver injury, although routine monitoring of hepatic function is not necessary. (c) Black box warning about increased risk of suicidal ideation in children and adolescents (d) Does not exacerbate tics ii. α-Adrenergic receptor agonists (see Table 9): FDA-approved for the treatment of ADHD iii. Antidepressants: Non-FDA label approved for the treatment of ADHD (a) Noradrenergic antidepressant (e.g., bupropion [Wellbutrin]) (1) Can use immediate- or extended-release product given in two or three doses (2) Contraindicated for children with active seizure disorder (b) Tricyclic antidepressants (e.g., imipramine, nortriptyline) (1) Baseline electrocardiogram is recommended before therapy initiation and after each dose increase. (2) Desipramine should be used with extreme caution because of reports of sudden death. 3. AAP recommendations for treatment a. Children 4-5 years old: i. Behavior therapy as first-line treatment ii. Methylphenidate as second-line treatment b. Children 6-11 years old: i. Medication and behavioral therapy as first-line treatment (a) Stimulants have better evidence (b) Non-stimulants may be considered but evidence is weaker c. Adolescents 12-18 years old: i. Medication (with assent of child) as first-line treatment (a) Any FDA-approved medication ii. May also consider behavioral treatment Table 8. Stimulant Agents for the Treatment of ADHD Medication Doses Onset of Duration of per Day Effect Effect (hr) Other Comments Methylphenidate-Containing Products Methylphenidate immediate release (Ritalin, Methylin chewable tablets, Methylin oral solution) 2 or 3 20–60 min 3–5 50:50 racemic mixture of l-threo and d-threo isomers Dexmethylphenidate (Focalin) 2 or 3 20–60 min 3–5 Only d-threo isomer, thought to be pharmacologically active enantiomer d -Threo isomer has not been shown to hinder effectiveness or increase adverse effects Recommended doses are half those of methylphenidate immediate release Offers no proven pharmacoeconomic benefit over methylphenidate immediate-release products ADHD = attention-deficit/hyperactivity disorder. ACCP Updates in Therapeutics® 2023: Pharmacotherapy Preparatory Review and Recertification Course 2-442 Pediatrics Table 8. Stimulant Agents for the Treatment of ADHD (Cont’d) Medication Doses Onset of Duration of per Day Effect Effect (hr) Other Comments Methylphenidate-Containing Products (cont’d) Methylphenidate sustained release (Ritalin SR) 1 or 2 1–3 hr 2–6 Methylphenidate extended release (Ritalin LA) 1 20–60 min 6–8 Contains 50% immediate-release and 50% extended release beads Capsule may be opened and sprinkled on applesauce Efficacy may wane in after-school or late-afternoon hours, necessitating addition of methylphenidate immediate release for later-day coverage Methylphenidate modified release (Metadate CD) 1 20–60 min 6–8 Capsule contains 30% immediate-release and 70% extended-release beads (slowly released about 4 hr after ingestion) Capsule may be opened and sprinkled on applesauce Efficacy may wane in after-school or late afternoon hours, necessitating addition of methylphenidate immediate release for later-day coverage Methylphenidate extended release chewable tablet (QuilliChew ER) 1 45 min 8 Dexmethylphenidate extended release (Focalin XR) 1 20–60 min 8–12 Serdexmethylphenidate and dexmethylphenidate (Azstarsys) 1 (peak 2) 60 min 10 Methylphenidate extended release (Metadate ER, Relexxii) 1 60 min 12 Methylphenidate OROS (Concerta) 1 20–60 min 12 Outer capsule contains about 22% of the drug, allowing immediate release; tablet core contains remainder of drug, which is released over 10 hr, minimizing peak to trough fluctuations Swallow whole; do not chew, crush, or divide Methylphenidate orally disintegrating tablet (Cotempla XR-ODT) 1 60 min 12 Contains 25% IR and 75% ER methylphenidate. Tablet should remain in blister pack until ready to use. Do not crush or chew. Place on tongue to disintegrate. Methylphenidate transdermal system (Daytrana) 1 60 min 11–12 Apply to hip 2 hr before effect is needed Recommended to remove 9 hr after application; can be worn up to 16 hr Duration of effect is about 3 hr after patch removal Can be worn while swimming or exercising Alcohol concentration of 40% resulted in 90% of the methylphenidate being released in the first hour; avoid consuming alcohol during therapy. Bimodal drug release results in peak serum concentrations at 1½ and 6½ hr after dose administration Shorter duration of action than methylphenidate OROS, so afternoon symptom control is not as good Each capsule contains a fixed molar ratio of 30% dexmethylphenidate and 70% serdexmethylphenidate Serdexmethylphenidate is a pro-drug of dexmethylphenidate, which is converted in the lower gastrointestinal tract ADHD = attention-deficit/hyperactivity disorder. ACCP Updates in Therapeutics® 2023: Pharmacotherapy Preparatory Review and Recertification Course 2-443 Pediatrics Table 8. Stimulant Agents for the Treatment of ADHD (Cont’d) Medication Doses Onset of Duration of per Day Effect Effect (hr) Other Comments Methylphenidate-Containing Products (cont’d) Methylphenidate reconstituted oral suspension (Quillivant XR) 1 45 min 12 Contains sodium benzoate. Banana flavor. Store reconstituted suspension in original container for up to 4 months. Shake bottle ≥10 seconds prior to administration. Use the oral dosing dispenser provided. Once reconstituted with water forms an extended release suspension that contains approximately 20% immediate release and 80% extended release methylphenidate. Methylphenidate extended release (Aptensio XR, Adhansia XR, Jornay PM) 1 2 hr 12 Contains multi layered beads. Amphetamine-Containing Products Mixed amphetamine salts immediate release (Adderall) 1-3 20–60 min 6 Amphetamine/ dextroamphetamine tablets (Evekeo) 1-3 45 min 6 Dextroamphetamine oral solution (ProCentra) 1-3 60 min 4-6 Dextroamphetamine immediate-release tablets (Zenzedi) 1–2 30–90 min 4–6 Dextroamphetamine extended release capsule (Dexedrine spansules) 1-2 60-90 min 6-8 Bead-filled capsule (50% released immediately, 50% delayed release) Mixed amphetamine salts extended release (Adderall XR) 1 20–60 min 10-12 Contains 50% immediate-release and 50% extended release beads (released 4 hr after ingestion) Can be sprinkled on applesauce Amphetamine extended release oral suspension (Dyanavel XR, Adzenys ER) 1 60 min 12 Contains d-amphetamine and l-amphetamine in a 3:1 ratio. Shake bottle before use Amphetamine extended release oral disintegrating tablets (Adzenys XR-ODT) 1 20-60 min 10-12 Store in travel case provided. Lisdexamfetamine dimesylate (Vyvanse) 1 60 min 10–12 Prodrug with d-amphetamine covalently bound to l-lysine Designed for less abuse potential than amphetamine No clinical evidence of superiority over other amphetamine products Mixed amphetamine salts extended release (Mydayis) 1 2-4 hr 16 Administer immediately after waking due to long duration. Contains d-amphetamine and l-amphetamine in a 1:1 ratio. Bubblegum flavor. Shake suspension well before administration. May open capsule and sprinkle contents on food. ADHD = attention-deficit/hyperactivity disorder. ACCP Updates in Therapeutics® 2023: Pharmacotherapy Preparatory Review and Recertification Course 2-444 Pediatrics Table 9. Non-stimulant Agents for the Treatment of ADHD Medication Doses per Day Onset of Effec