Red Book : Errata. (Revised 12/15/03)

Transcription

1 Red Book : 2003 REPORT OF THE COMMITTEE ON INFECTIOUS DISEASES Errata (Revised 12/15/03) For the most up-to-date list of important Red Book errata, please visit the Red Book Online Web site at The list of errata is available in standard HTML format and as an easy-to-navigate and easy-to-print PDF file and is freely accessible to all visitors to the site. On Red Book Online, you can sign up for alerts to be notified automatically when new errata have been announced. Page 26: Table 1.6: The minimum interval between Dose 2 and Dose 3 for HepB should be changed from 3 wk (and 16 wk after first dose) to 8 wk (and 16 wk after first dose). (See page 3 for revised table.) Page 64: Table 1.11: Under the heading Intravenous administration, in the third sentence, change 1 mg/kg or 0.01 ml/kg to 0.01 mg/kg or 0.1 ml/kg. (See page 4 for revised table.) Page 111: Within Viruses: Non-A Through -E Hepatitis Viruses: Second paragraph, last sentence: crytogenic should be cryptogenic. (See page 5 for revised text.) Page 215: Under Treatment: Fourth sentence: the dosage for clindamycin ovules should be changed from 100 g to 100 mg. (See page 6 for revised text.) Page 255: Under Treatment: Fifth sentence: flucytosine serum concentrations should be changed from between 40 and 60 mg/ml to between 40 and 60 µg (micrograms)/ml. (See page 7 for revised text.) Page 411: Table 3.32: Under Drug(s) and Dose for Meningitis or encephalitis, the phrase but for days and the preceding comma should be omitted. (See page 8 for revised table.)

2 2 ERRATA Page 474: Under Treatment, second bullet, fifth sentence: maximum dosage for azithromycin dihydrate should be changed from 600 mg/day to 500 mg/day. (See page 9 for revised text.) Page 495: Table 3.45: In footnote 6, the following phrase should be omitted: is not approved for use in patients younger than 12 years of age and. The sentence should read: Drug is not recommended in patients with meningitis because of its potential epileptogenic properties. (See page 10 for revised table.) Page 495: Within Treatment: Otitis Media: Second paragraph, third sentence: the ratio of amoxicillin to clavulanate should be changed from the 7:1 formulation to the 14:1 formulation. (See page 10 for revised text.) Page 601: Within Treatment: Congenital Syphilis: Newborn Infants: Second sentence should be changed from If the mother s titer is 4 times higher than that of the infant, congenital syphilis still can be present to If the infant s titer is less than 4 times higher than that of the mother, congenital syphilis still can be present. (See page 11 for revised text.) Page 607: Within Treatment: Indications for Retreatment: Latent syphilis: Second paragraph, first sentence: 2.4 U should be changed to 2.4 million U. (See page 12 for revised text.) Page 659: Within Control Measures: BCG Vaccine, first sentence: The phrase livevirus vaccine should be changed to live vaccine. (See page 13 for revised text.) Page 663: Under Treatment: Fourth paragraph, third sentence: younger than 17 years of age should be changed to younger than 18 years of age. (See page 14 for revised text.) Page 708: Table 4.2: Under Comments for Ampicillin-sulbactam (Unasyn), the sentence should read Licensed for use in children 1 year of age and older. (See page 15 for revised table.) Page 733: Table 4.9: Under Drug (Abbreviation)/Trade Name for Abacavir (ABC)/ Ziagen, Component of Combivir should be changed to Component of Trizivir. (See page 16 for revised table.) Page 796: Under the heading Assessment of immunization status, the parentheses in item 6 should read (see Precautions and Contraindications, p 45). (See page 17 for revised text.)

3 Table 1.6. Catch-up Immunization Schedules for Children and Adolescents Who Start Late or Who Are >1 Month Behind* Children 4 Months Through 6 Years of Age Minimum Interval Between Doses Dose 1 (Minimum Age) Dose 1 to Dose 2 Dose 2 to Dose 3 Dose 3 to Dose 4 Dose 4 to Dose 5 DTaP (6 wk) 4 wk 4 wk 6 mo 6 mo 1 IPV (6 wk) 4 wk 4 wk 4 wk 2 HepB 3 (birth) 4 wk 8 wk (and 16 wk after first dose) MMR (12 mo) 4 wk 4 Varicella (12 mo) Hib 5 (6 wk) 4 wk: if first dose given at 4 wk 6 : if current age younger 8 wk (as final dose): this dose younger than 12 mo of age than 12 mo only necessary for children 8 wk (as final dose): if first dose 8 wk (as final dose) 6 : if current 12 mo to 5 y of age who given at 12 to 14 mo of age age 12 mo or older and second received 3 doses before 12 mo No further doses needed: if first dose given at younger than of age dose given at 15 mo of age 15 mo of age or older No further doses needed: if previous dose given at 15 mo of age or older PCV 7 : (6 wk) 4 wk: if first dose given at 4 wk: if current age younger 8 wk (as final dose): this dose younger than 12 mo of age than 12 mo only necessary for children and current age younger 8 wk (as final dose): if current 12 mo to 5 y of age who than 24 mo age 12 mo or older received 3 doses before 8 wk (as final dose): if first dose No further doses needed: for 12 mo of age given at 12 mo of age or older healthy children if previous dose or current age 24 to 59 mo given at 24 mo of age or older No further doses needed: for healthy children if first dose given at 24 mo of age or older ERRATA REVISED TABLE 3

4 4 ERRATA REVISED TABLE Table Epinephrine in the Treatment of Anaphylaxis 1 Intramuscular administration Epinephrine 1:1000 (aqueous): 0.01 ml/kg per dose, up to 0.5 ml, repeated every min up to 3 doses. 2 Intravenous administration An initial bolus of intravenous epinephrine is given to patients not responding to intramuscular epinephrine using a dilution of 1: rather than a dilution of 1:1000. This dilution can be made using 1 ml of the 1:1000 dilution in 9 ml of physiologic saline solution. The dose is 0.01 mg/kg or 0.1 ml/kg of the 1: dilution. A continuous infusion should be started if repeated doses are required. One milligram (1 ml) of 1:1000 dilution of epinephrine added to 250 ml of 5% dextrose in water, resulting in a concentration of 4 µg/ml, is infused initially at a rate of 0.1 µg/kg per minute and increased gradually to 1.5 µg/kg per minute to maintain blood pressure. 1 In addition to epinephrine, maintenance of the airway and administration of oxygen are critical. 2 If agent causing anaphylactic reaction was given by injection, epinephrine can be injected into the same site to slow absorption.

5 ERRATA REVISED TEXT 5 can be found in blood donors and can be transmitted by transfusion, neither agent has been found to be associated with development of post-transfusion hepatitis and, hence, are not hepatitis viruses. The SEN virus also is being evaluated as an agent of non-a through -E hepatitis. In one study, tests of stored sera from blood donors and cardiac surgery patients revealed that approximately 2% of donors tested positive for SEN virus DNA, and the proportion of cardiac surgery patients with evidence of new infection with SEN virus was 10 times higher among those who had received transfusions, compared with those who had not. Of 12 recipients with non-a through -E hepatitis, 11 (92%) became SENV positive after transfusion. Extending this early work will be essential to prove that SENV replicates inside hepatocytes. There are no data to date showing that SENV is a cause of fulminant liver failure, and its roles in chronic cryptogenic hepatitis and cirrhosis are uncertain.

6 6 ERRATA REVISED TEXT TREATMENT: The principal goal of treatment is to relieve vaginal symptoms and signs of infection and decrease the risk of infectious complications. All nonpregnant patients who are symptomatic require treatment. Nonpregnant patients with symptoms should be treated with metronidazole (1.0 g/day, orally, in 2 divided doses) for 7 days; or metronidazole gel, 0.75%, 5 g (1 applicator), intravaginally, once a day for 5 days; or clindamycin cream, 2%, 1 applicator (5 g), intravaginally, at bedtime for 7 days. Alternative regimens that have a lower efficacy for BV are metronidazole, 2 g, orally, in a single dose; clindamycin, 600 mg/day, orally, in 2 divided doses for 7 days; or clindamycin ovules, 100 mg, intravaginally, once at bedtime for 3 days. Clindamycin cream is oil-based and may weaken latex condoms for up to 72 hours after completion of therapy.

7 ERRATA REVISED TEXT 7 TREATMENT: Amphotericin B (see Drugs for Invasive and Other Serious Fungal Infections, p 725), in combination with oral flucytosine, is indicated for patients with meningeal and other serious cryptococcal infections. Combination antifungal therapy with flucytosine probably is superior to amphotericin B alone. Flucytosine can induce bone marrow suppression, which often necessitates discontinuation of the medication, especially in HIV-infected patients. Other flucytosine adverse effects are hepatic and renal dysfunction, rash, diarrhea, ulcerative colitis, and gastrointestinal tract bleeding, especially in patients with azotemia. When flucytosine is used, serum concentrations should be monitored and maintained between 40 and 60 µg (micrograms)/ml. Patients with meningitis should receive combination therapy for at least 2 weeks or until CSF culture results are negative; at least 6 weeks of total treatment should be completed with amphotericin B or 10 weeks if fluconazole alone is used for therapy. Lipid formulations of amphotericin B can be substituted for conventional amphotericin B in children with renal impairment. Patients with HIV infection should be treated for longer periods than should non HIV-infected patients, as should patients who are immunosuppressed as a result of organ transplantation. Patients with less severe disease may be treated with fluconazole or itraconazole, but data on use of these drugs for children with C neoformans infection are limited. Another potential treatment option for HIVinfected patients with less severe disease is combination therapy with fluconazole and flucytosine; the toxicity associated with this regimen often limits its usefulness.

8 8 ERRATA REVISED TABLE Table Recommended Treatment of Lyme Disease in Children Disease Category Drug(s) and Dose 1 Early localized disease 1 8 y of age or older Doxycycline, 100 mg, orally, twice a day for days All ages Amoxicillin, mg/kg per day, orally, divided into 2 doses (maximum 2 g/day) for days Early disseminated and late disease Multiple erythema migrans Same oral regimen as for early disease but for 21 days Isolated facial palsy Same oral regimen as for early disease but for days 2,3 Arthritis Same oral regimen as for early disease but for 28 days Persistent or recurrent arthritis 4 Ceftriaxone sodium, mg/kg, IV or IM, once a day (maximum 2 g/day), for days; or penicillin, U/kg per day, IV, given in divided doses every 4 h (maximum 20 million U/day) for days OR same oral regimen as for early disease Carditis Ceftriaxone or penicillin: see persistent or recurrent arthritis Meningitis or encephalitis Ceftriaxone or penicillin: see persistent or recurrent arthritis IV indicates intravenously; IM, intramuscularly. 1 For patients who are allergic to penicillin, cefuroxime axetil and erythromycin are alternative drugs. 2 Corticosteroids should not be given. 3 Treatment has no effect on the resolution of facial nerve palsy; its purpose is to prevent late disease. 4 Arthritis is not considered persistent or recurrent unless objective evidence of synovitis exists at least 2 months after treatment is initiated. Some experts administer a second course of an oral agent before using an IV-administered antimicrobial agent.

9 ERRATA REVISED TEXT 9 TREATMENT: Infants younger than 6 months of age and other patients with severe disease commonly require hospitalization for supportive care to manage apnea, hypoxia, feeding difficulties, and other complications. Intensive care facilities may be required. Antimicrobial agents given during the catarrhal stage may ameliorate the disease. After the cough is established, antimicrobial agents may have no discernible effect on the course of illness but are recommended to limit the spread of organisms to others. The drug of choice is erythromycin estolate (40 50 mg/kg per day, orally, in 4 divided doses; maximum 2 g/day). The recommended duration of therapy to prevent bacteriologic relapse is 14 days. Studies have documented that the newer macrolides, azithromycin dihydrate (10 12 mg/kg per day, orally, in 1 dose for 5 days; maximum 500 mg/day) or clarithromycin (15 20 mg/kg per day, orally, in 2 divided doses; maximum 1 g/day for 7 days), may be as effective as erythromycin and have fewer adverse effects and better compliance. Resistance to erythromycin (and other macrolide antimicrobial agents) by B pertussis has been reported rarely. Penicillins and first- and second-generation cephalosporins are not effective against B pertussis.

10 10 ERRATA REVISED TABLE Table Dosages of Intravenous Antimicrobial Agents for Invasive Pneumococcal Infections in Infants and Children 1 Antimicrobial Meningitis Nonmeningeal Infections Agent Dose, kg/day Dose Interval Dose, kg/day Dose Interval Penicillin G h h U U 2 Cefotaxime mg 8 h mg 8 h Ceftriaxone 100 mg h mg h Vancomycin 60 mg 6 h mg 6 h Rifampin 3 20 mg 12 h Not indicated Chloramphenicol mg 6 h mg 6 h Clindamycin 4 Not indicated mg 6 8 h Meropenem mg 8 h 60 mg 8 h Imipenem- 60 mg 6 h cilastatin 6 1 Doses are for children 1 month of age or older. 2 Because 1 U = 0.6 µg/ml, this range is equal to 150 to 240 mg/kg per day. 3 Indications for use are not defined completely. 4 Drug should be considered only for patients with life-threatening allergic response after administration of β-lactam antimicrobial agents. 5 Drug is approved for pediatric patients 3 months of age and older. 6 Drug is not recommended in patients with meningitis because of its potential epileptogenic properties. duration of therapy is 10 days, but uncomplicated cases among children older than 2 years of age can be treated for 5 days. On the basis of concentrations in middle ear fluid and in vitro activity, no currently available oral antimicrobial agent has better activity than amoxicillin against nonsusceptible S pneumoniae. For patients with clinically defined treatment failures when assessed after 3 to 5 days of initial therapy, suitable alternative agents should be active against penicillin-nonsusceptible pneumococci as well as β-lactamase producing Haemophilus influenzae and Moraxella catarrhalis. Such agents include oral cefdinir, cefuroxime axetil, intramuscular ceftriaxone, and high-dose oral amoxicillin-clavulanate potassium. Amoxicillin-clavulanate should be given at 80 mg/kg per day of the amoxicillin component (eg, the 14:1 formulation) to decrease the incidence of diarrhea. Erythromycin-sulfisoxazole acetyl, clarithromycin, and azithromycin dihydrate are appropriate alternatives for penicillin-allergic patients.

11 ERRATA REVISED TEXT 11 result is available and should be performed in a hospital setting.* Oral desensitization is regarded as safer and easier to perform. Desensitization usually can be completed in approximately 4 hours, after which the first dose of penicillin can be given. Congenital Syphilis: Newborn Infants (see Table 3.59, p 602). Infants should be treated for congenital syphilis if they have proven or probable disease demonstrated by one or more of the following: (1) physical, laboratory, or radiographic evidence of active disease; (2) positive placenta or umbilical cord test results for treponemes using DFA-TP staining or darkfield test; (3) a reactive result on VDRL testing of CSF; or (4) a serum quantitative nontreponemal titer that is at least fourfold higher than the mother s titer using the same test and preferably the same laboratory. If the infant s titer is less than 4 times higher than that of the mother, congenital syphilis still can be present. When an infant warrants evaluation for congenital syphilis (see Evaluation of Newborn Infants for Congenital Infection, p 598), the infant should be treated if test results cannot exclude infection, if the infant cannot be evaluated fully, or if adequate follow-up cannot be ensured.

12 12 ERRATA REVISED TEXT Signs or symptoms attributable to syphilis develop In all these instances, retreatment, when indicated, should be performed with 3 weekly injections of penicillin G benzathine, 2.4 million U, intramuscularly, unless CSF examination indicates that neurosyphilis is present, at which time treatment for neurosyphilis should be initiated. Retreated patients should be treated with the schedules recommended for patients with syphilis for more than 1 year. In general, only 1 retreatment course is indicated. The possibility of reinfection or concurrent HIV infection always should be considered when retreating patients with early syphilis.

13 ERRATA REVISED TEXT 13 BCG Vaccine. The BCG vaccine is a live vaccine prepared from attenuated strains of M bovis. Use of BCG vaccine is recommended by the Expanded Programme on Immunization of the World Health Organization for administration at birth (see Table 1.3, p 8) and currently is used in more than 100 countries. Bacille Calmette-Guérin vaccine is used to prevent disseminated and other life-threatening manifestations of M tuberculosis infection in infants and young children. However, BCG immunization does not prevent infection with M tuberculosis. The various BCG vaccines used throughout the world differ in composition and efficacy.

14 14 ERRATA REVISED TEXT TREATMENT: Many NTM are relatively resistant in vitro to antituberculosis drugs. In vitro resistance, however, does not necessarily correlate with clinical response. Only limited controlled trials have been performed in patients with NTM infections. The approach to therapy should be dictated by the following: (1) the species causing the infection; (2) the results of drug-susceptibility testing; (3) the site(s) of infection; (4) the patient s underlying disease (if any); and (5) the need to treat a patient presumptively for tuberculosis while awaiting culture reports that subsequently reveal NTM. For NTM lymphadenitis in otherwise healthy children, especially when the disease is caused by MAC, complete surgical excision almost always is curative. Antituberculosis chemotherapy offers no benefit. Therapy with clarithromycin combined with ethambutol or rifabutin may be beneficial for children in whom surgical excision is incomplete or for children with recurrent disease but has not been studied in a clinical trial (see Table 3.74, p 664). Isolates of rapidly growing mycobacteria (M fortuitum, M abscessus, and M chelonae) should be tested in vitro against drugs (such as amikacin sulfate, imipenem, sulfamethoxazole or trimethoprim-sulfamethoxazole, cefoxitin sodium, ciprofloxacin, gatifloxacin, clarithromycin, linezolid, and doxycycline), to which they commonly are susceptible and which have been used with some therapeutic success. Clarithromycin and at least one other agent commonly is the treatment of choice for cutaneous (disseminated) infections attributable to M chelonae. Details about choice of drugs, dosages, and duration should be reviewed with a consultant experienced in the management of NTM infections. In patients with AIDS and in other immunocompromised people with disseminated MAC infection, multidrug therapy is recommended. Single-drug therapy with a macrolide antimicrobial agent commonly results in development of antimicrobial resistance. Clinical isolates of MAC usually are resistant to many of the approved antituberculosis drugs, including isoniazid, but often are susceptible to clarithromycin, azithromycin dihydrate, ethambutol hydrochloride, rifabutin, rifampin, amikacin, streptomycin, and fluoroquinolones, which are not licensed for use in people younger than 18 years of age. The optimal regimen has yet to be determined. Treatment of disseminated MAC infection should be done in consultation with an expert. In addition, the following treatment guidelines should be considered: Susceptibility testing to drugs other than the macrolides is not predictive of in vivo response and should not be used to guide therapy. Unless there is clinical or laboratory evidence of macrolide resistance, treatment regimens should contain clarithromycin or azithromycin combined with ethambutol. Many clinicians have added a third agent (rifampin, rifabutin), and in some situations, a fourth agent (amikacin or streptomycin).

15 Table 4.2. Antibacterial Drugs for Pediatric Patients Beyond the Newborn Period, continued Dosage per kg per Day Mild to Drug, Generic Moderate Severe (Trade Name) Route Infections Infections Comments PENICILLINS 2 Broad-spectrum penicillins Ampicillin IV, IM mg in 4 doses mg in 4 doses Larger dosage recommended for treatment (numerous types) (daily adult dose, 2 4 g) (daily adult dose, 6 12 g) of meningitis. PO mg in 4 doses Inappropriate Diarrhea occurs in approximately 20% (daily adult dose, 2 4 g) of recipients. Ampicillin-sulbactam IV mg of ampicillin mg of ampicillin in Licensed for use in children 1 year of (Unasyn) in 4 doses 4 doses (daily adult dose, age and older g) Amoxicillin PO mg in 3 doses Inappropriate Larger dosage (80 90 mg in 2 doses) for (numerous types) (daily adult dose, otitis media caused by penicillin-resistant 750 mg 1.5 g) pneumococci. Amoxicillin-clavulanic acid (Augmentin, PO 45 mg of amoxicillin in Inappropriate 7:1 ratio) 2 doses (Augmentin PO 90 mg of amoxicillin in Inappropriate For multidrug-resistant pneumococcal otitis ES-600; 2 doses media and β-lactamase-positive 14:1 ratio) H influenzae. (Augmentin XR) PO 2 g, twice a day (total Inappropriate Oral extended-release formulation licensed 4000 mg) for adults. Mezlocillin (Mezlin) IV, IM mg in 4 doses mg in 4 6 doses (daily adult dose, 6 8 g) (daily adult dose, g) Piperacillin 5 (Pipracil) IV, IM mg in 4 doses mg in 4 6 doses (daily adult dose, 6 8 g) daily adult dose, g) ERRATA REVISED TABLE 15

16 Table 4.9. Characteristics of Antiretroviral Drugs: Nucleoside/Nucleotide Reverse Transcriptase Inhibitors Drug (Abbreviation)/ Trade Name Dosage 1 Special Instructions Abacavir (ABC)/Ziagen Component of Trizivir Didanosine (ddi)/videx Lamivudine (3TC)/Epivir Component of Combivir, Trizivir. Stavudine (d4t)/zerit Neonatal: 1 to 3 mo of age: 8 mg/kg, twice daily, is under study. Pediatric and adolescent: 8 mg/kg, twice daily; maximum dosage 300 mg, twice daily Adult: 300 mg, twice daily Usual pediatric range: mg/m 2, every 12 h Neonatal (<90 days of age): 100 mg/m 2 age 14 days to 6 wk Adolescent and adult: Weight >60 kg: 200 mg, twice daily Weight <60 kg: 125 mg, twice daily Videx EC, adolescent and adult: Weight >60 kg: 400 mg, once daily Weight <60 kg: 250 mg, once daily Pediatric: 4 mg/kg, every 12 h Neonatal (<30 days of age): under study in clinical trials: 2 mg/kg, every 12 h Adolescent and adult: 150 mg, twice daily Pediatric: 1 mg/kg, every 12 h (up to weight of 30 kg) Neonatal: birth to 13 days: 0.5 mg/kg, every 12 h, >13 days of age: 1 mg/kg, every 12 h Adolescent and adult: Weight >60 kg: 40 mg, twice daily Weight kg: 30 mg, twice daily An abacavir warning card, which lists signs and symptoms of abacavir hypersensitivity, should be provided with each prescription of abacavir. All formulations except Videx EC contain buffering agents or antacids. Food decreases absorption; administer ddi on an empty stomach (1 h before or 2 h after meal). Concomitant therapy with quinolones: ddi should be given 2 h after or 6 h before the quinolone dose. For oral solution: shake well and keep refrigerated; admixture stable for 30 days. Can be administered with or without food. For oral solution: store at room temperature. Decrease dosage for patients with impaired renal function. Can be administered with food. For oral solution: shake well and keep refrigerated; solution stable for 30 days. 16 ERRATA REVISED TABLE

17 ERRATA REVISED TEXT 17 Assessment of immunization status 5. Health care professionals review the immunization and health status of patients at every encounter to determine which vaccines are indicated (see Fig 1.1, p 24). 6. Health care professionals assess for and follow only medically accepted contraindications (see Precautions and Contraindications, p 45).