Antimicrobials ( A- C )
The antibiotic dosing charts reflect the fact that the renal function and drug elimination are most strongly correlated with Postmenstrual Age ("PMA", equivalent to Cestational Age plus Postnatal Age). Postmenstrual age is therefore used as the primary determinant of dosing interval, with Postnatal Age as the secondary qualifier.
Example: A baby born at 28 weeks gestation is now 21 days old. To determine the dosing interval for cefotaxime, first go to the row on the chart containing his Postmenstrual Age of 31 weeks (30 to 36), and then his Postnatal Age of 21 days (>14) to yield a dosing interval of 8 hours.
Dose & Administration
20 mg/kg per dose Q8 hours IV infusion by syringe pump över 1 hour. Prolong the dosing interval in prematüre infants <34 weeks PMA, or in patients with significant renal impairment or hepatic failure. Treat localized herpes simplex infections for 14 days, disseminated or CNS infections for 21 days.
Chronic suppression: 75 mg/kg per dose PO Q12 hours. Uses
Treatment of neonatal herpes simplex infections, varicella zoster infections with CNS and pulmonary involvement, and herpes simplex encephalitis.
Monitoring
Periodic CBC. Serum concentrations two hours after a dose should be approximately 2 mcg/mL. Follow renal and hepatic function. Monitor IV site for phlebitis—if noted, make infusion solution more dilute.
Adverse Effects/Precautions
Neutropenia occurs in approximately 20% of patients - decrease dose or treat with GCSF if ANC remains less than 500/mm3. Phlebitis may occur at IV site due to alkaline pH of 10. Risk of transient renal dysfunction and crystalluria is minimized by slow infusion rates and adequate patient hydration. Resistant viral strains may emerge during long-term therapy; these patients are at high risk for progressive life- threatening disease.
Pharmacology
Antiviral drug that is preferentially taken up by infected cells; inhibits viral DNA synthesis. CSF concentrations are 30 to 50% of serum concentrations. Oral absorption is 15 to 30%. Most of administered dose is excreted unchanged in urine, primarily via glomerular filtration.
Acyclovir
Protein binding and metabolism are minimal. Serum half-life is 3 to 4 hours in patients with normal renal and hepatic function.
Special Considerations/Preparation
İntravenous formulations available as solution (50 mg/mL) or as powder for solution in 500-mg and 1-g vials. Prepare powder for solution by dissolving contents of 500-mg vial in 10 mL sterile water for injection. Reconstituted solution is stable at room temperature for 12 hours. Do not refrigerate.
İnfusion solution concentration should be no greater than 7 mg/mL.
A 5-mg/mL dilution may be made by adding 1 mL of 50 mg/mL concentration to 9 mL of preservative-free normal saline. Dilution should be used within 24 hours.
Oral suspension available in 200 mg/5 mL concentration. Store at room temperature. Shake well
before administration.
Solution Compatibility: D5W, D10W, and NS.
Solution Incompatibility: Dex/AA.
Terminal İnjection Site Compatibility: Amikacin, ampicillin, aminophylline, cefazolin, cefotaxime, cefoxitin, ceftazidime, ceftriaxone, chloramphenicol, cimetidine, clindamycin, dexamethasone, erythromycin lactobionate, famotidine, fluconazole, gentamicin, heparin, hydrocortisone succinate, imipenem/cilastatin, linezolid, lorazepam, meropenem, metoclopramide, metronidazole, milrinone, morphine, nafcillin, oxacillin, penicillin C, pentobarbital, piperacillin, potassium chloride, propofol, ranitidine, remifentanil, sodium bicarbonate, theophylline, ticarcillin/clavulanate, tobramycin, trimethoprim-sulfamethoxazole, vancomycin, and zidovudine.
Incompatibility: Fat emulsion. Aztreonam, caffeine citrate, cefepime, dobutamine, dopamine, and piperacillin-tazobactam.
Selected References
♦ Tiffany KF, Benjamin DK Jr, Palasanthiran P, et al: Improved neurodevelopmental outcomes following long-term high-dose acyclovir therapy in infants with central nervous system and disseminated herpes simplex disease. ) Perinato12005;25:156-161.
♦ Kimberlin DW, Lin C-Y, Jacobs RF, et al: Safety and efficacy of high-dose intravenous acyclovir in the management of neonatal herpes simplex infections. Pediatrics 2001;108:230-238.
♦ American Academy of Pediatrics. Herpes simplex. İn: Pickering LK, ed. 2003 Red Book: Repon of Ihe Committee on Infectious Diseases. 26th ed. Elk Grove Village, İL: American Academy of Pediatrics;2003: p 347.
♦ Rudd C, Rivadeneira ED, Gutman LT: Dosing considerations for oral acyclovir following neonatal herpes disease. Açta Paediatr 1994;83:1237-43.
♦ Whitley R, Arvin A, Prober C, et al: A controlled trial comparing vidarabine with acyclovir in neonatal herpes simplex virüs infection. N Engl I Med 1991;324:444.
♦ Englund )A, Zimmerman BS, Swierkosz EM, et al: Herpes simplex virüs resistant to acyclovir: A study in a tertiary care center. Ann Intern Med 1990;112:416.
♦ McDonald L, Tartaglione TA, Mendelman PM, et al: Lack of toxicity in two cases of neonatal acyclovir overdose. Pediatr Infect Dis J 1989;8:529.
Amikacin
Dose & Administration
IV infusion by syringe pump över 30 minutes. Administer as a separate infusion from penicillin-containing compounds. İM injection is associated with variable absorption, especially in the very small infant.
To use dosing chart, please refer to explanatory note on page 1.
Dosing Chart
PMA | Postnatal | Dose | İnterval |
(weeks) | (days) | (mg/kg) | (hours) |
O to 7 | 18 | 48 | |
<29* | 8 to 28 | 15 | 36 |
>29 | 15 | 24 | |
30 to 34 | O to 7 | 18 | 36 |
>8 | 15 | 24 | |
>35 | ALL | 15 | 24 |
* or significant asphyxia. PDA, or treatment with indomethacin | |||
Uses
Restricted to treatment of infections caused by gram-negative bacilli that are resistant to other aminoglycosides. Usually used in combination with a B-lactam antibiotic.
Monitoring
Measure serum concentrations when treating for more than 48 hours. Obtain peak concentration 30 minutes after end of infusion, and trough concentration just prior to the next dose. When treating patients with serious infections or significantly changing fluid or renal status consider measuring the serum concentration 24 hours after a dose, and use the chart below for the suggested dosing interval. Blood samples obtained to monitor serum drug concentrations should be spun and refrigerated or frozen as soon as possible.
Therapeutic serum concentrations:
Peak: 20 to 30 mcg/mL (or Cmax /MIC ratio greater than 8:1) (Draw 30 minutes after end of infusion, 1 hour after IM injection.) Trough: 2 to 5 mcg/mL
Suggested Dosing Intervals
Level at 24 hrs (mcg/mL) | HalMife (hours) | Suggested Dosing İnterval (hours) |
<5 | ~ 9 | 24 |
5.1 to 8.0 | ~ 12 | 36 |
8.1 to 10.5 | ~ 16 | 48 |
> 10.6 | Measure level in 24 hours |
Adverse Effects/Precautions
Black Box Warning
According to the manufacturer's black box warning, aminoglycoside therapy has been associated with potential neurotoxicity, ototoxicity, and nephrotoxicity. Patients with impaired renal function, dehydration, and those who receive high dosage or prolonged therapy are at an increased risk of toxicity. Discontinue therapy or adjust dose if there is evidence of ototoxicity or nephrotoxicity. Aminoglycoside ototoxicity is usually irreversible.
Transient and reversible renal tubular dysfunction may occur, resulting in increased urinary losses of sodium, calcium, and magnesium. Vestibular and auditory ototoxicity may occur. The addition of other nephrotoxic and/or ototoxic medications (e.g. furosemide, vancomycin) may increase these adverse effects. İncreased neuromuscular blockade (i.e. neuromuscular weakness and respiratory failure) may occur when used with pancuronium or other neuromuscular blocking agents and in patients with hypermagnesemia.
Pharmacology
Dosing recommendations are based on: (1) Higher peak concentrations increase concentration-dependent bacterial killing; (2) There is a post- antibiotic effect on bacterial killing, especially when treating concurrently with a fi-lactam antibiotic; (3) There may be less toxicity with less frequent dosing, due to less renal drug accumulation. Volume of distribution is increased and clearance is decreased in patients with PDA. Serum half-life is prolonged in prematüre and asphyxiated newborns. Inactivation of amikacin by penicillin-containing compounds appears to be a time-, temperature-, and concentration- dependent process. This is probably clinically significant only when penicillin-containing compounds are mixed in IV solutions or when the blood is at room temperature for several hours before the assay is performed.
Special Considerations/Preparation
Available in concentrations of 50 mg/mL and 250 mg/mL. For IV use, dilute with a compatible solution to a concentration of 5 mg/mL.
Solution Compatibility: D5W, D10W, D20W, and NS. Terminal İnjection Site Compatibility: Dex/AA solutions. Acyclovir, aminophylline, amiodarone, aztreonam, caffeine citrate, calcium chloride, calcium gluconate, cefazolin, cefepime, cefotaxime, cefoxitin, ceftazidime, ceftriaxone, chloramphenicol, cimetidine, clindamycin, dexamethasone, enalaprilat, epinephrine, esmolol, fluconazole, furosemide, heparin (concentration unit/mL),
hydrocortisone succinate, hyaluronidase, linezolid, lorazepam, metronidazole, midazolam, milrinone, morphine, nicardipine, pentobarbital, phenobarbital, potassium chloride, ranitidine, remifentanil, sodium bicarbonate, vancomycin, vitamin K,, and zidovudine.
Incompatibility: Fat emulsion. Amphotericin B, ampicillin, azithromycin, carbenicillin, heparin (concentrations >1 unit/mL), imipenem/cilastatin, methicillin, mezlocillin, nafcillin, oxacillin, penicillin C, phenytoin, propofol, thiopental, and ticarcillin/ clavulanate.
Selected References
♦ Contopoulos-loannidis DC, Ciotis ND, Baliatsa DV, loannidis JPA: Extended-interval aminoglycoside administration for chiidren: a meta-analysis. Pediatrics 2004; 114:el 11 - ellö.
♦ Langhendries JP, Battisti O, Bertrand |M, et al: Adaptation in neonatology of the once- daily concept of aminoglycoside administration: Evaluation of a dosing chart for amikacin in an intensive care unit. Biol Neonate 1998;74:351-362.
♦ Product İnformation, Bedford Laboratories, 2004
Adverse Effects/Precautions updated 1/2009
Monitoring, Compatibilities and References updated 3/2005
Dose & Administration
0.5 to 1 mg/kg Q24 hours IV infusion over 2 to 6 hours. Dosage modification for renal dysfunction is only necessary if serum creatinine increases >0.4 mg/dL during therapy - hold dose for 2 to 5 days.
Uses
Treatment of systemic fungal infections and severe superficial mycoses.
Monitoring
Monitor CBC, electrolytes, urine output, BUN, and serum creatinine at least every other day. Observe IV site for irritation—phlebitis is common. Serum amphotericin concentrations are not routinely followed.
Adverse Effects/Precautions
Decreases renal blood flow and CFR by 20% to 60%. Injures tubular epithelium with resultant urinary loss of potassium and magnesium, decreased reabsorption of sodium, and renal tubular acidosis. Sodium intake > 4 mEq/kg per day may prevent or decrease nephrotoxicity. Anemia, thrombocytopenia, hypokalemia, nausea/vomiting, and fever/ chills. Consider analgesia before beginning infusion. Cardiac arrest has occurred in patients who received 10 times the recommended dose. Black Box Warning According to the manufacturer's black box warning, it is recommended that the product name and dosage are verified if the prescribed dose exceeds 1.5 mg/kg.
Pharmacology
Amphotericin B binds to ergosterol in the membrane of sensitive fungi and may be fungicidal or fungistatic. The therapeutic concentration range is not well-defined. Highly protein-bound (greater than 90%). Elimination half-life is approximately 15 days. Drug may accumulate in tissues to a significant concentration and be excreted renally for months.
Special Considerations/Preparation
Available as powder for injection in 50-mg vials. Reconstitute using D5W or Preservative free SW to a concentration of 5 mg/mL, then dilute further using DSW to a concentration no greater than 0.1 mg/mL for infusion. Reconstituted solution stable for 24 hours at room temperature or 7 days in refrigerator. Do not flush IV or mix amphotericin with şaline solution— precipitation will occur. May filter if necessary; mean pore diameter should not be less than 1 micron.
Protect from light.
Solution Compatibility: D5W, DI0W, D15W, and D20W.
Solution Incompatibility: Dex/AA solutions and NS.
Terminal İnjection Site Compatibility: Amiodarone, heparin, hydrocortisone, sodium bicarbonate, and zidovudine.
Incompatibility: Fat emulsion. Amikacin, aztreonam, calcium chloride, calcium gluconate, cefepime, cimetidine, ciprofloxacin, dopamine, enalaprilat, fluconazole, gentamicin, linezolid, magnesium sulfate, meropenem, netilmicin, penicillin G, piperacillin-tazobactam, potassium chloride, propofol, ranitidine, remifentanil, and tobramycin.
Selected References
♦ Holler B, Omar SA, Farid MD, Patterson M]: Effects of fluid and electrolyte management on amphotericin B-induced nephrotoxicity among extremely low birth weigh: infants. Pediatrics 2004;113:e608-e616.
♦ Chapman RL: Candida infections in the neonate. Curr Opin Pediatr 2003;15:97-102.
♦ Bliss |M, Wellington M, Gigliotti F: Antifungal pharmacotherapy for neonatal candidiasis. Semin Perinatol 2003;27:365-374.
♦ Lyman CA, Walsh TJ: Systemically administered antifungal agents: A review of their clinical pharmacology and therapeutic applications. Drugs 1992;44:9.
♦ Baley JE, Meyers C, Kliegman RM, et al: Pharmacokinetics, outcome of treatment, and toxic effects of amphotericin B and 5-fluorocytosine in neonates. I Pediatr 1990; 116:791.
♦ Starke JR, Mason EL, Kramer WG, Kaplan SL: Pharmacokinetics of amphotericin B in infants and children. ) Infect Dis 1987;155:766.
♦ Dodds Ashley ES, Lewis R, Lewis JS, et al. Pharmacology of systemic antifungal agents. Clin Infect Dis 2006;43:S29-39.
♦ Product İnformation, Bristol-Myers Squibb, 2006.
Adverse Effects/Precautions updated 1/2009
References updated 3/2007 Compatibilities updated 3/2005Dose & Administration
5 mg/kg per dose Q24 hours IV infusion by syringe pump over 2 hours.
Uses
Treatment of systemic fungal infections resistant to conventional amphotericin B therapy or in patients with renal or hepatic dysfunction.
Monitoring
Serum amphotericin B concentrations are not routinely followed. Monitor urine output. Periodic CBC for thrombocytopenia, electrolytes for hypokalemia, BUN, serum creatinine, and hepatic transaminases.
Adverse Effects/Precautions
Anemia, thrombocytopenia, hypokalemia, nausea/vomiting, and fever/ chills.
Pharmacology
ABELCET® consists of amphotericin B complexed with two phospholipids in a 1:1 drug-to-lipid ratio. Acts by binding to the sterol component of a celi membrane leading to alterations in the celi wall permeability and death. Penetrates the celi wall of susceptible t'ungi. Concentrates in the liver and spleen. Less nephrotoxic than conventional amphotericin B. Mean serum half-life in adults 24 to 38 hours. The pharmacokinetics of amphotericin B lipid complex is nonlinear.
Special Considerations/Preparation
Available as a ready-to-use admixture containing 100-mg ABELCET® in 20-mL suspension (5 mg/mL). Shake the vial gently until there is no evidence of any yellow sediment on the bottom. Withdraw the appropriate dose into a syringe using an 18 gauge needle. Remove the needle and replace with the supplied 5 micron filter needle. Inject the drug into a different syringe containing a measured amount of D5W so that the final infusion concentration is 1 to 2 mg/mL. Shake until thoroughly mixed. Check for complete dispersion. The diluted admixture is stable for 48 hours refrigerated and an additional 6 hours at room temperature. Do not freeze. Protect from light.
Do not flush IV or mix ABELCET® with saline solutions - precipitation will occur.
Solution Compatibility: D5W at 1 to 2 mg/mL, D10W and D15W at 1 mg/mL dilution.
Solution Incompatibility: Dex/AA and NS. Terminal İnjection Site Compatibility: No available data.
Selected References
♦ Adler-Shohet F, Waskin H, Lieberman I M: Amphotericin B lipid complex for neonatal invasive candidiasis . Arch Dis Child Fetal Neonatal £d2001;84:F13l-F133.
♦ Walsh T), Seibel NL, Arndt C, et al: Amphotericin B lipid complex in pediatric patients with invasive fungal infections. Pediatr Infect Dis J 1999;18:702-708.
♦ Wong-Beringer A, Jacobs RA, Guglielmo BJ: Lipid formulations of amphotericin B: Clinical efficacy and toxicities. din Infect Dis 1998;27:603-618.
♦ Dodds Ashley ES, Lewis R, Lewis JS, et al. Pharmacology of systemic antifungal agents. CUn Infect Dis 2006;43:S29-39.
♦ Product İnformation, Enzon, 2002
Compatibilities updated 3/2005, Dose and References updated 3/2007.
Dose & Administration
5 to 7 mg/kg per dose Q24 hours IV infusion by syringe pump over 2 hours.
Uses
Treatment of systemic fungal infections resistant to conventional amphotericin B therapy or in patients with renal or hepatic dysfunction.
Monitoring
Serum amphotericin B concentrations are not routinely followed. Monitor urine output. Periodic CBC for thrombocytopenia, electrolytes for hypokalemia, BUN, serum creatinine, and hepatic transaminases.
Adverse Effects/Precautions Anemia, thrombocytopenia, hypokalemia, nausea/vomiting, and fever/ chills.
Pharmacology
AmBisome® consists of amphotericin B intercalated within a single bilayer liposomal drug delivery system. Acts by binding to the sterol component of a celi membrane leading to alterations in the celi wall permeability and death. Penetrates the celi wall of susceptible fungi. Concentrates in the liver and spleen but penetrates the CNS less than conventional amphotericin B. Less nephrotoxic than conventional amphotericin B. Mean serum half-life in adults 24 to 38 hours. The pharmacokinetics of amphotericin B liposome is nonlinear.
Special Considerations/Preparation Available as powder for injection in 50 mg vials. Reconstitute by adding 12 mL of sterile water for injection to a yield a concentration of 4 mg/mL. Immediately shake vial vigorously for 30 seconds. Check for complete dispersion. Reconstituted suspension stable for 24 hours refrigerated.
Do not freeze. Protect from light.
Before administration, AmBisome® must be diluted with D5W to a final concentration less than 2 mg/mL. A 1 mg/mL dilution may be made by filtering (using 5 micron filter) 1 mL of reconstituted solution into 3 mL of D5W. Use one filter per vial of AmBisome®. Use dilution immediately.
Do not flush IV or mix Ambisome® with şaline solutions-precipitation
will occur.
Solution Compatibility: D5W.
Solution Incompatibility: Dex/AA and NS.
Dose & Administration
25 to 50 mg/kg per dose by IV slow push, or IM.
Some experts recommend 100 mg/kg/dose when treating meningitis
and severe group B streptococcal sepsis.
To use dosing chart, please refer to explanatory note on page 1.
Dosing İnterval Chart
PMA | PostNatal | İnterval |
(weeks) | (days) | (hours) |
<29 | O to 28 >28 | 12 8 |
30 to 36 | O to 14 >14 | 12 8 |
37 to 44 | O to 7 >7 | 12 8 |
>45 | ALL | 6 |
Uses
Broad-spectrum antibiotic useful against group B streptococcus, Listeria monocytogenes, and susceptible E coli species.
Monitoring
Serum concentration can be measured but is not usually necessary.
Adverse Effects/Precautions
Very large doses may result in CNS excitation or seizure activity. Hypersensitivity reactions (maculopapular rash, urticarial rash, or fever) are rare in neonates. Pharmacology
Ampicillin is a semisynthetic penicillin that is bactericidal. Clearance is primarily by the renal route and is inversely related to postnatal age. Serum half-life in term infants younger than 7 days is approximately 4 hours.
Special Considerations/Preparation
Available as powder for injection in 125-, 250-, 500-mg, 1-g, and 2-g vials. Reconstitute using sterile water for injection. Maximum concentration for IV infusion is 100 mg/mL. Mix to a final concentration of 250 mg/mL for IM administration. Reconstituted solution must be used within 1 hour of mixing because of loss of potency.
Solution Compatibility: D5W and NS.
Solution Incompatibility: Dex/AA.
Terminal İnjection Site Compatibility: Fat emulsion. Acyclovir, aminophylline, aztreonam, calcium gluconate, cefepime, chloramphenicol, cimetidine, clindamycin, dopamine, enalaprilat, epinephrine, famotidine, furosemide, heparin, hydrocortisone succinate, insulin, lidocaine, linezolid, metronidazole, milrinone, morphine, phytonadione, potassium chloride, propofol, ranitidine, remifentanil, sodium bicarbonate, and vancomycin. Incompatibility: Amikacin, amiodarone, erythromycin lactobionate, fluconazole, gentamicin, hydralazine, metoclopramide, midazolam, nicardipine, and tobramycin.
Selected References
♦ Shaffer CL, Davey AM, Ransom JL, el al: Ampicillin-induced neurotoxicity in very-low- birth-weight neonates. Ann Pharmacother 1998;32:482-484.
♦ Prober CG, Stevenson DK, Benitz WE: The use of antibiotics in neonates weighing less than 1200 grams. Pediatr Infect Dis ) 1990;9:111.
♦ Kaplan JM, McCracken GH, Horton L], et al: Pharmacologic studies in neonates given large dosages of ampicillin. / Pediatr 1974;84:571.
♦ Boe RW, Williams CPS, Bennett JV, Oliver TK Jr: Serum levels of methicillin and ampicillin in newborn and prematüre infants in relation to postnatal age. Pediatrics 1967;39:194.
♦ Axline SG, Yaffe S), Simon H): Clinical pharmacology of antimicrobials in prematüre infants: II. Ampicillin, methicillin, oxacillin, neomycin, and colistin. Pediatrics 1967:39:97.
♦ Product İnformation, Sandoz 2004
Updated 3/2001 Compatibilities updated 3/2005
Dose & Administration
Treatment of Pertussis infections: 10 mg/kg per dose orally, once daily for 5 days.
Treatment of Chlamydia trachomatis conjunctivitis and pneumonitis:
20 mg/kg per dose orally, once daily for 3 days. İntravenous treatment is limited to those who cannot be treated orally. To date no clinical studies have been conducted to evaluate the safety or efficacy of IV azithromycin in the pediatric population. Suggested IV dose: 5 mg/kg per dose once daily.
Uses
Treatment and postexposure prophylaxis against Bordetella pertussis. As a substitute for penicillin in situations of significant allergic intolerance.
Monitoring
Assess gastrointestinal tolerance.
Adverse Effects/Precautions
Limited data in neonates. Diarrhea and/or vomiting occur in 5% to 12% of patients. Irritability, rash, and blood in stool have also been reported. There is one new case report of pyloric stenosis in 2 of 3 triplets treated with azithromycin for pertussis.
Pharmacology
Azithromycin is classified as an azalide, a subclass of macrolide antibiotics. İn vitro activity has been demonstrated against Bordetella pertussis, as well as Streptococci (Groups C, F, G and Viridans), Ureaplasma urealyticum, and Peptostreptococcus species. Eradication of B. pertussis in unimmunized individuals (e.g., neonates) takes longer and requires higher doses than immunized individuals. Oral bioavailability is 38% in adults and children and is not affected by food. Primarily excreted unchanged in the bile, with some hepatic metabolism to inactive metabolites. The prolonged terminal half-life (approximately 80 hours) is thought to be due to extensive uptake and subsequent release of drug from tissues.
Special Considerations/Preparation
Oral suspension is available in 300, 600, 900, and 1,200 mg bottles. Reconstitute 300 mg bottle with 9 mL of water to provide a final concentration of 100 mg per 5 mL (20 mg/mL). Shake well before administration. Do not refrigerate. Use within 10 days once bottle has been opened.Azithromycin for intravenous injection is supplied in single use vials containing 500 mg lyophilized powder. Reconstitute by adding 4.8 mL Sterile Water for İnjection, then shake the vial until ali the drug is dissolved. The concentration of the reconstituted solution is 100 mg/mL. İt is stable at room temperature for 24 hours. Dilute prior to administration using a compatible solution to a final concentration of 1 to 2 mg/mL. Diluted solution stable for 24 hours at room temperature or 7 days in refrigerator. Do not use higher concentrations due to local IV site reactions. Infuse över at least 60 minutes.
Solution Compatibility: D5W, NS, 5% Dextrose in 0.45%NaCI with 20 mEq/L KCI, and Lactated Ringer's.
Terminal İnjection Site Compatibility: Do not infuse other drugs through the same IV line.
Incompatibility: Amikacin, aztreonam, cefotaxime, ceftazidime, ceftriaxone, cefuroxime, clindamycin, famotidine, fentanyl, furosemide, gentamicin, imipenem-cilastatin, morphine, piperacillin- tazobactam, potassium chloride, ticarcillin-clavulanate, and tobramycin.
Selected References
♦ American Academy of Pediatrics. Chlamydia trachomatis, and Pertussis. İn: Pickering LK, Baker CJ, Long SS, McMillan JA, eds. Red Book: 2006 Repon of the Committee on Infectious Diseases. 27th ed. Elk Crove Village, İL: American Academy of Pediatrics; 2006: pp 255, and 500-502.
♦ Centers for Disease Control and Prevention. Recommended antimicrobial agents for the treatment and postexposure prophylaxis of pertussis. 2005 CDC guidelines. MMWR 2005;54(No. RR-14):pp. 4, 10.
♦ Friedman DS, Curtis CR, Schauer SL, et al. Surveillance for transmission and antibiotic adverse events among neonates and adults exposed to a healthcare worker with pertussis. Infect Control Hosp Epidemiol 2004;25:967-73.
♦ Langley JM, Halperin SA, Boucher FD, et al. Azithromycin is as effective and better tolerated than erythromycin estolate for the treatment of pertussis. Pediatrics 2004;114:96-101.
♦ jacobs RF, Maples HD, Aranda JV, et al. Pharmacokinetics of intravenously administered azithromycin in pediatric patients. Pediatr Infect Dis S 2005;24:34-39.
♦ Morrison W. Infantile hypertrophic pyloric stenosis in infants treated with azithromycin. Pediatr Infect Dis J 2007;26:186-188.
♦ Product İnformation, Pfizer, Inc., 2007.
Updated 3/2007
Dose & Administration
30 mg/kg per dose IV slow push over 5 to 10 minutes, or IM.
To use dosing chart, please refer to explanatory note on page 1.
Dosing İnterval Chart
PMA | PostNatal | İnterval |
(weeks) | (days) | (hours) |
<29 | O to 28 >28 | 12 8 |
30 to 36 | O to 14 >14 | 12 8 |
37 to 44 | O to 7 >7 | 12 8 |
>45 | ALL | 6 |
Uses
Treatment of neonatal sepsis caused by susceptible gram-negative organisms (e.g. E coli, H influenzae, Klebsiella, Pseudomonas, and Serratia). Generally used in combination with ampicillin (empirical treatment of sepsis) or an aminoglycoside (for synergism against Pseudomonas and Enterobacteriaceae).
Monitoring
Cherk serum glucose one hour after administration. Measuring serum concentration is not usually necessary. Periodic CBC, AST, ALT.
Adverse Effects/Precautions
Aztreonam contains 780 mg L-arginine per gram of drug (23.4 mg/kg body weight per dose), Adequate amounts of glucose must be provided to prevent hypoglycemia. Side effects are rare but include eosinophilia, elevation of serum transaminases, and phlebitis at the injection site.
Pharmacology
Aztreonam is a synthetically-produced monocyclic (3-lactam antibiotic. Although bactericidal against aerobic gram-negative bacteria, it has virtually no activity against aerobic gram-positive and anaerobic bacteria, thereby producing little alteration of bowel flora. Cood tissue and fluid penetration has been demonstrated in adults, along with protein-binding of 50 to 65%. Eliminated renally, primarily as unchanged drug. Serum half-life in neonates is 3 to 9 hours. Aztreonam does not interfere wth bilirubin-albumin binding.
Special Considerations/Preparation
Available as powder for injection in 1-g, and 2-g vials. Reconstitute 1-g vial with 10 mL of either sterile water for injection or NS (100 mg/mL).
Shake immediately and vigorously. Reconstituted solution stable for 48 hours at room temperature, 7 days refrigerated.
Solution Compatibility: D5W, D10W, and NS.
Terminal İnjection Site Compatibility: Dex/AA and fat emulsion. Amikacin, aminophylline, ampicillin, bumetanide, calcium gluconate, cefazolin, cefepime, cefotaxime, cefoxitin, ceftazidime, ceftriaxone, cimetidine, clindamycin, dexamethasone, dobutamine, dopamine, enalaprilat, famotidine, fluconazole, furosemide, gentamicin, heparin, hydrocortisone succinate, imipenem, insulin, linezolid, metoclopramide, mezlocillin, morphine, netilmicin, nicardipine, piperacillin, piperacillin/tazobactam, potassium chloride, propofol, quinupristin/dalfopristin, ranitidine, remifentanil, sodium bicarbonate, ticarcillin/clavulanate, tobramycin, vancomycin, and zidovudine.
Incompatibility: Acyclovir, amphotericin B, azithromycin, ganciclovir, lorazepam, metronidazole, and nafcillin.
Selected References
♦ Uauy R, Mize C, Argyle C, McCracken CH: Metabolic tolerance to arginine: Implications for the safe use of arginine salt-aztreonam combination in the neonatal period. 1 Pediatr 1991:118:965.
♦ Cuzzolin L, Fanos V, Zambreri D, et al: Pharmacokinetics and renal tolerance of aztreonam in prematüre infants. Antimicrob Agents Chemother 1991;35:1726.
♦ Prober CC, Stevenson DK, Benitz WE: The use of antibiotics in neonates weighing less than 1200 grams. Pediatr Infect Dis J 1990;9:111.
♦ Likitnukul S, McCracken CH, Threlkeld N, et al: F*harmacokinetics and plasma bactericidal activity of aztreonam in low-birth-weight infants. Antimicrob Agents Chemother 1987;31:81.
♦ Product İnformation, Bristol-Myers Squibb, 2007
Added 3/96
Compatibilities updated 3/2007
Dose & Administration
25 mg/m2 (or approximately 2 mg/kg) per dose Q24h, IV infusion via syringe pump over at least 1 hour.
Uses
Treatment of patients with refractory Candidemia, intra-abdominal abscesses, peritonitis and pleural space infections, and those patients intolerant of amphotericin B. Treatment of invasive Aspergillosis in patients who are refractory to or intolerant of other therapies. There are case reports, but not controlled clinical trials, treating endocarditis, osteomyelitis, and meningitis due to Candida.
Monitoring
Assess IV site for signs of irritation. Periodic measurement of serum potassium, calcium, and hepatic transaminases.
Adverse Effects/Precautions
Adverse effects reported in neonates (small number of patients): thrombophlebitis, hypercalcemia, hypokalemia, elevated liver enzymes, and isolated direct hyperbilirubinemia. İn adult studies the primary adverse effects are fever, headache, vomiting, diarrhea, signs of histamine release and irritation at the injection site. These occurred less frequently than with amphotericin B or with AmBisome®.
Pharmacology
Caspofungin is the first of a new class of antifungal agents (echinocandins) that inhibit the synthesis of 3-(1,3)-D-glucan, an integral component of the fungal celi wall. İt is fungicidal against Candida species, but fungistatic against Aspergillus. The echinocandins are excreted primarily by the liver, presumably metabolized through an O-methyltransferase. They are not metabolized through the CYP enzyme system and therefore have significantly fewer drug-drug interactions than the azoles. Dexamethasone, phenytoin, carbamazepine, nevirapine, and rifampin ali induce caspofungin drug clearance, lowering serum concentrations.
Special Considerations/Preparation
Cancidas® is supplied as a white to off-white powder cake in single use vials, containing either 50- or 70 mg. To prepare the 50 mg Cancidas® infusion: 1) Equilibrate the refrigerated vial to room temperature. 2) Aseptically add 10.5 mL Normal Şaline or Sterile Water for İnjection to the vial. The powder cake will dissolve completely with gentle mixing. This reconstituted solution can be stored at room temperature for up to one hour. Visually inspect the reconstituted solution for particulate matter or discoloration. Do not use if the solution is cloudy or has precipitated. 3) Aseptically transfer 10 mL of the reconstituted solution to 250 mL bag or bottle of 0.9%, 0.45%, or 0.225% Sodium Chloride İnjection, or Lactated Ringer's İnjection. This final patient infusion solution has a concentration of 0.2 mg/mL caspofungin, and can be stored for up to 24 hours at room temperature or up to 48 hours refrigerated. May also be diluted in 100 mL of compatible diluent for fluid restricted patients. Do not use diluents containing dextrose.
Solution Compatibility: Normal Şaline, Lactated Ringer's. Solution Incompatibility: Ali solutions containing dextrose. Terminal İnjection Site Compatibility: Do not co-infuse with any other medications. (No data).
Selected References
♦ Saez-Llorens X, Macias M, Maiya P, el al. Pharmacokinetics and safety of caspofungin in neonates and infants less than 3 months of age. Antimicrob Agents Chemother 2009;53:869-875.
♦ Smith PB, Steinbach W), Cotton CM, et al. Caspofungin for the treatment of azole resistant candidemia in a prematüre infant. ] Perinatol 2007;27:127-129.
♦ Manzar S, Kamat M, Pyati S. Caspofungin for refractory candidemia in neonates. Pediatr Infect Dis / 2006;25:282-283.
♦ Odio CM, Araya R, Pinto Le, et al. Caspofungin therapy of neonates with invasive candidiasis. Pediatr Infect Dis ) 2004;23:1093-1097.
♦ Steinbach W], Benjamin DK. New agents under development in children and neonates. Curr Opin Infect Dis 2005;18:484-489.
♦ Pannaraj PS, Walsh T), Baker CJ. Advances in antifungal therapy. Pediatr Infect Dis ) 2005;10:921-923.
♦ Walsh TJ, Adamson PC, Seibel NL, et al. Pharmacokinetics, safety, and tolerability of caspofungin in children and adolescents. Antimicrob Agents Chemother 2005;49:4536-4545.
♦ Dodds Ashley ES, Lewis R, Lewis JS, et al. Pharmacology of systemic antifungal agents. Clin Infect Dis 2006;43:S29-39.
♦ Product İnformation, Merck & Co„ 2008.
Dose and References updated 03/2009
Added 3/2007
Dose & Administration
25 mg/kg per dose IV slow push, or IM.
To use dosing chart, please refer to explanatory note on page 1.
Dosing İnterval Chart
PMA | PostNatal | İnterval |
(weeks) | (days) | (hours) |
<29 | O to 28 >28 | 12 8 |
30 to 36 | O to 14 >14 | 12 8 |
37 to 44 | O to 7 >7 | 12 8 |
>45 | ALL | 6 |
Uses
Use in neonates is generally limited to perioperative infection prophylaxis and treatment of urinary tract and soft tissue infections caused by susceptible organisms, e.g. penicillin-resistant Staph. aureus, Klebsiella, and Proteus.
Monitoring
Serum concentrations are not routinely monitored.
Adverse Effects/Precautions
Adverse effects are rare, but include phlebitis and eosinophilia.
Pharmacology
First generation cephalosporin that is bactericidal against many gram- positive and a fevv gram-negative organisms. Inactivated by P-lactamase producing organisms. Poor CNS penetration. Renally excreted as unchanged drug. Half-life in neonates is 3 to 5 hours.
Special Considerations/Preparation
Available as povvder for injection in 500-mg, and 1000-mg vials. Reconstitute 500-mg vial using 2 mL of NS or sterile vvater for injection to a concentration of 225 mg/mL. Reconstituted solution stable for 24 hours at room temperature or 10 days in refrigerator. A 20 mg/mL dilution may be made by adding 1-mL of reconstituted solution to 10 mL sterile vvater for injection, or DSW.
Solution Compatibility: D5W, D10W, and NS.
Terminal İnjection Site Compatibility: Dex/AA and fat emulsion. Acyclovir, amikacin, aminophylline, aztreonam, calcium gluconate, clindamycin, enalaprilat, esmolol, famotidine, fluconazole, heparin, insulin, lidocaine, linezolid, midazolam, milrinone, morphine, metronidazole, multivitamins, nicardipine, pancuronium bromide, propofol, prostaglandin E,, ranitidine, remifentanil, and vecuronium.
Incompatibility: Amiodarone, cimetidine, pentobarbital, and vancomycin. No data are currently available for potassium chloride.
Selected References
♦ Saez-Llorens X, McCracken GH: Clinical pharmacology of antibacterial agents. İn: Remington JS, Klein JO (eds): Infectious Diseases of the Fetus and Nevvborn Infant, ed S. Philadelphia: WB Saunders Co, 2001.
♦ Pickering LK, O'Connor DM, Anderson D, et al: Clinical and pharmacologic evaluation of cefazolin in children. / Infect Dis 1973;128:S407.
♦ Product İnformation, Orchid Healthcare, 2006
Added 3/96
Compatibilities updated 3/2005
Dose & Administration
Term and preterm infants >28 days of age: 50 mg/kg per dose Q12 hr.
Term and preterm infants <28 days of age: 30 mg/kg per dose Q12 hr.
Meningitis and severe infections due to Pseudomonas aeruginosa or Enterobacter spp.: 50 mg/kg per dose Q 12 hr.
Administer via IV infusion by syringe pump över 30 minutes, or IM. To reduce pain at IM injection site, cefepime may be mixed vvith 1% lidocaine vvithout epinephrine.
Uses
Treatment of serious infections caused by susceptible gram-negative organisms (e.g. E coli, H influenzae, Enterobacter, Klebsiella, Morganella, Neisseria, Serratia, and Proteus species), especially Pseudomonas aeruginosa that are resistant to 3,d generation cephalosporins. Treatment of serious infections caused by susceptible Cram-positive organisms (e.g. Strep pneumoniae, Strep. pyogenes, Strep. agalactiae, and Staph. aureus).
Monitoring
Measuring serum concentration is not usually necessary.
Adverse Effects/Precautions
Safety has been documented to be the same as commonly used second- and third-generation cephalosporins. Reported adverse effects are uncommon but include rash, diarrhea, elevatea hepatic transaminases, eosinophilia, and positive Coombs' test.
Pharmacology
Cefepime is a fourth-generation cephalosporin vvith treatment efficacy equivalent to third-generation cephalosporins. Potential advantages include: more rapid penetration through the celi vvall of Gram-negative pathogens; enhanced stability to hydrolysis by p-lactamases; and enhanced affinity for penicillin-binding proteins. The drug distributes vvidely in body tissues and fluids (i.e. CSF, bile, bronchial secretions, lung tissue, ascitic fluid, middle ear). Protein binding is lovv ( ~ 20%), and it is primarily excreted unchanged in the urine. Serum half-life in infants older than 2 months of age is approximately 2 hours.
Special Considerations/Preparation
Available as povvder for injection in 500-mg and 1-g, and 2-g vials. Reconstitute 500-mg vial vvith 5 mL of sterile vvater for injection to a concentration of 100 mg/mL. Maximum concentration for IV administration is 160 mg/mL, and for İM administration 280 mg/mL. Reconstituted solution stable for 24 hours at room temperature, 7 days refrigerated.
Solution Compatibility: D5W, D10W, D5LR, and NS.
Terminal İnjection Site Compatibility: Dex/AA solutions. Amikacin, ampicillin, aztreonam, bumetanide, calcium gluconate, clindamycin, dexamethasone, fluconazole, furosemide, heparin, hydrocortisone succinate, imipenem/cilastatin, lorazepam, methylprednisolone, metronidazole, milrinone, piperacillin-tazobactam, potassium chloride, ranitidine, sodium bicarbonate, ticarcillin/clavulanate, trimethoprim/ sulfamethoxazole, and zidovudine.
Incompatibility: Acyclovir, aminophylline, amphotericin B, cimetidine, diazepam, dobutamine, dopamine, enalaprilat, famotidine, ganciclovir, gentamicin, magnesium sulfate, metoclopramide, morphine, netilmicin, tobramycin, and vancomycin.
Selected References
♦ Lima-Rogel V, Medina-Rojas EL, del Carmen Milan-Segovia R, et al: Population pharmacokinetics of cefepime in neonates vvith severe nosocomial infections. ) Clif Pharm Ther 2008;33:295-306.
♦ Capparelli E, Hochvvald C, Rasmussen M, et al: Population pharmacokinetics of cefepime in the neonate. Antimicrob Agents Chemother 2005;49:2760-2766.
♦ Gutierrez K: Newer antibiotics: cefepime. NeoRevievvs 2004;5:e382-386.
♦ Blumer |L, Reed MD, Knupp C: Revievv of the pharmacokinetics of cefepime in children. Pediatr Infect Dis J 2001;20:337-342.
♦ Bradley JS, Arrieta A: Empiric use of cefepime in the treatment of lovver respiratory tract infections in children. Pediatr Infect Dis I 2001:20:343-349.
♦ Saez-Llorens XO, O'Ryan M: Cefepime in the empiric treatment of meningiıis in children. Pediatr Infect Dis J 2001;20:356-361.
♦ Kessler RE: Cefepime microbiologic profile and update. Pediatr Infect Dis ) 2001 ; 20:331-336.
♦ Product İnformation, Bristol-Myers Squibb, 2007
Dose and References updated 1/2009 Added 3/2002
Dose & Administration
50 mg/kg per dose IV infusion by syringe pump över 30 minutes, or İM.
Gonococcal infections: 25 mg/kg per dose IV över 30 minutes, or İM.
Gonococcal ophthalmia prophylaxis in nevvborns vvhose mothers have gonorrhea at the time of delivery: 100 mg/kg IV över 30 minutes or İM, single dose. (Note: topical antibiotic therapy alone is inadequate and is unnecessary if systemic treatment is administered.)
To use dosing chart, please refer to explanatory note on page 1.
Dosing İnterval Chart
PMA | PostNatal | İnterval |
(weeks) | (days) | (hours) |
<29 | O to 28 >28 | 12 8 |
30 to 36 | O to 14 >14 | 12 8 |
37 to 44 | O to 7 >7 | 12 8 |
>45 | ALL | 6 |
Uses
Treatment of neonatal meningitis and sepsis caused by susceptible gram-negative organisms (e.g. E coli, H influenzae, and Klebsiella). Treatment of disseminated gonococcal infections.
Monitoring
Measuring serum concentration is not usually necessary. Periodic CBC.
Adverse Effects/Precautions
Side effects are rare but include rash, phlebitis, diarrhea, leukopenia, granulocytopenia, and eosinophilia.
Pharmacology
Cefotaxime is one of many third-generation cephalosporin antibiotics. The mechanism of action appears to be by bacterial celi vvall disruption. Metabolized in the liver to an aetive compound, desacetylcefotaxime. The drug distributes vvidely (i.e. CSF, bile, bronehial secretions, lung tissue, ascitic fluid, middle ear). Excreted renally.
Serum half-life in the prematüre infant is approximately 3 to 6 hours.
Special Considerations/Preparation
Available as povvder for injection in 500-mg, 1-g, and 2-g vials. The 500-mg vial is reconstituted vvith 10 mL sterile vvater for injection to yield a concentration of 50 mg/mL. Reconstituted solution stable for 24 hours at room temperature, 7 days refrigerated. Solution Compatibility: D5W, D10W, and NS.
Terminal İnjection Site Compatibility: Dex/AA solutions, fat emulsion. Acyclovir, amikacin, aztreonam, caffeine citrate, clindamycin, famotidine, heparin, lorazepam, metronidazole, midazolam, milrinone, morphine, potassium chloride, propofol, and remifentanil.
Incompatibility: Aminophylline, azithromycin, fluconazole, sodium bicarbonate, and vancomycin.
Selected References
♦ Centers for Disease Control and Prevention: Sexually transmitted diseases treatment guidelines 2006. MMWR 2006;55(No. RR-11):47-48.
♦ Prober CC, Stevenson DK, Benitz WE: The use of antibiotics in neonates vveighing less than 1200 grams. Pediatr Infect Dis } 1990;9:111.
♦ Kearns CL, Jacobs RF, Thomas BR, et al: Cefotaxime and desacetylcefotaxime pharmacokinetics in very low birth vveight neonates. i Pediatr 1989; 114:461.
♦ de Louvois ), Mulhall A, Hurley R: The safety and pharmacokinetics of cefotaxime in the treatment of neonates. Pediatr Pharmacol 1982;2:275.
♦ Kafetzis DA, Brater DC, Kapiki AN: Treatment of severe neonatal infections vvith cefotaxime: Effıcacy and pharmacokinetics. I Pediatr 1982; 100:483.
♦ Product İnformation, Abraxis Pharmaceutical Products, 2006
References updated 3/2007
Compatibilities updated 3/2007
Dose & Administration
25 to 33 mg/kg per dose IV infusion by syringe pıımp över 30 minutes.
To use dosing chart, please refer to explanatory note on page 1.
Dosing İnterval Chart
PMA | Post Nata1 | İnterval |
(weeks) | (days) | (hours) |
<29 | O to 28 >28 | 12 8 |
30 to 36 | O to 14 >14 | 12 8 |
37 to 44 | O to 7 >7 | 12 8 |
>45 | ALL | 6 |
Uses
Use in neonates is generally limited to treatment of skin, intra- abdominal and urinary tract infections caused by susceptible bacteria - anaerobes (e.g. Bacteroides fragilis), gram positives (e.g. Staphylococcus aureus, Streptococcus pneumorıiae, and other streptococci except enterococcus) and gram negatives (e.g. Haemophilus influenzae, Klebsiella sp., E. coli, Proteus vulgaris, and Neisseria gonorrhoeae) .
Monitoring
Serum concentrations are not routinely monitored.
Adverse Effects/Precautions
Adverse effects are rare. Transient eosinophilia and elevation of hepatic transaminases have been reported in < 3% of treated patients. Severe overdose can cause tachypnea, pallor, hypotonia, and metabolic acidosis.
Pharmacology
Broad spectrum bactericidal second generation cephalosporin that has enhanced activity against anaerobic bacteria. Inhibits bacterial celi vvall synthesis by binding to one or more penicillin-binding proteins. Not inactivated by fi-lactamase. Poor CNS penetration. Highly protein bound. Renally excreted as unchanged drug (85 to 90%). Half-life in term neonates is approximately 1.4 hours, and 2.3 hours in preterm neonates —considerably longer than children (0.6 hours) and adults (0.8 hours).
Special Considerations/Prcparation
Available as povvder for injection in 1-g, and 2-g vials.
IV administration: Reconstitute 1-g vial vvith 9.5 mL sterile vvater for injection to a concentration of 100 mg/mL. A 40 mg/mL dilution may be made by adding 4 mL of reconstituted solution to 6 mL sterile vvater for injection, or DSW. Stable for 18 hours at room temperature or 7 days refrigerated.
Solution Compatibility: D5W, D10W, and NS.
Terminal İnjection Site Compatibility: Dex/AA and fat emulsion. Acyclovir, amikacin, aztreonam, cimetidine, clindamycin, famotidine, fluconazole, gentamicin, heparin, insulin, lidocaine, linezolid, magnesium sulfate, metronidazole, morphine, multivitamins, potassium chloride, propofol, ranitidine, remifentanil, sodium bicarbonate, tobramycin and vecuronium.
Incompatibility: Vancomycin
Selected References
♦ Regazzi MB, Chirico C, Cristiani D, et al: Cefoxitin in newborn infants. Eur I Clin Pharmacol 1983;25:507-509.
♦ Yogev R. Delaplane D, VViringa K: Cefoxitin in a neonate. Ped Infect Dis ! 1983;2:342- 343.
♦ Farmer K: Use of cefoxitin in the nevvbom. New Zealand Med ] 1982;95:398.
♦ Marget W: Tenfold overdose of cefoxitin in a newborn. Infection 1982;10:243.
♦ Brogden RN, Heel RC, Speight TM, et al: Cefoxitin: A revievv of its antibacterial activity, pharmacological properties and therapeutic use. Drugs 1979;17:1-37.
♦ Feldman WE, Moffitt S, Sprovv N: Clinical and pharmacokinetic evaluation of parenteral cefoxitin in infants and children. Antimicrob Agents Chemother 1980;17:669-674.
♦ Product İnformation, Abraxis Plıarmaceutical Produts, 2006
Added 3/2001
Compatibilities updated: 3/2003 Text updated 3/2008
Dose & Administration
30 mg/kg per dose IV infusion by syringe pump över 30 minutes, or İM. To reduce pain at İM injection site, ceftazidime may be mixed vvith 1% lidocaine vvithout epinephrine.
To use dosing chart, please refer to explanatory note on page 1.
Dosing İnterval Chart
PMA | PostNatal | İnterval |
(weeks) | (days) | (hours) |
<29 | O to 28 >28 | 12 8 |
30 to 36 | O to 14 >14 | 12 8 |
37 to 44 | O to 7 >7 | 12 8 |
>45 | ALL | 8 |
Uses
Treatment of neonatal meningitis and sepsis caused by susceptible gram-negative organisms (e.g. E coli, H influenzae, Neisseria, Klebsiella, and Proteus species), especially Pseudomonas aeruginosa. Resistance among strains of Serratia and Enterobacteriaceae is increasing.
Monitoring
Measuring serum concentration is not usually necessary.
Adverse Effects/Precautions
Reported adverse effects are uncommon but include rash, diarrhea, elevated hepatic transaminases, eosinophilia, and positive Coombs' test.
Pharmacology
Ceftazidime is one of many third-generation cephalosporins. The drug distributes vvidely in body tissues and fluids (i.e. CSF, bile, bronchial secretions, lung tissue, ascitic fluid, middle ear). Protein binding is lovv, and it is excreted unchanged in the urine. Ceftazidime is synergistic vvith aminoglycosides. Serum half-life in neonates is 3 to 12 hours.
Special Considerations/Preparation
Available as povvder for injection in 500-mg and 1-g, 2-g, and 6-g vials.
İntravenous solution: Reconstitute 500-mg vial vvith 10 mL of sterile vvater for injection to make a concentration of 50 mg/mL. Reconstituted solution stable for 12 hours at room temperature, 3 days refrigerated. Intramuscular solution: Prepared by reconstituting 500-mg vial vvith 2.2 mL of 1% lidocaine vvithout epinephrine or Sterile Water to a concentration of 200 mg/mL. Solution is stable for 12 hours at room temperature, 3 days refrigerated.
Ali dosage forms approved for pediatric use contain sodium carbonate; vvhen reconstituted, carbon dioxide bubbles vvill form. Using a vented needle may help reduce spraying and leaking.
Solution Compatibility: D5W, D10W, and NS.
Terminal İnjection Site Compatibility: Dex/AA solutions, fat emulsion. Acyclovir, amikacin, aminophylline, aztreonam, cimetidine, ciprofloxacin, clindamycin, enalaprilat, esmolol, famotidine, furosemide, gentamicin, heparin, linezolid, metronidazole, milrinone, morphine, potassium chloride, propofol, ranitidine, remifentanil, sodium bicarbonate, tobramycin, and zidovudine.
Incompatibility: Amiodarone, azithromycin, erythromycin lactobionate, fluconazole, midazolam, nicardipine, and vancomycin.
Selected References
♦ Prober CG, Stevenson DK, Benitz WE: The use of antibiotics in neonates vveighing less than 1200 grams. Pediatr Infect Dis J 1990;9:111.
♦ Tessin I, Thiringer K, Trollfors B, Brorson JE: Comparison of serum concentrations of ceftazidime and tobramycin in nevvborn infants. Eur ) Pediatr 1988;147:405.
♦ Odio CM, Umana MA, Saenz A, et al: Comparative efficacy of ceftazidime vs. carbenicillin and amikacin for treatment of neonatal septicemia. Pediatr Infect Dis 1987;6:371.
♦ McCracken GH, Threlkeld N, Thomas ML: Pharmacokinetics of ceftazidime in nevvborn infants. Antimicrob Agents Chemother 1984;26:583.
♦ Product İnformation, GlaxoSmithKline, 2007
Updated 1/93 - Compatibilities updated 3/2007
Dose & Administration
Sepsis and disseminated gonococcal infection: 50 mg/kg Q24 hours.
Meningitis: 100 mg/kg loading dose, then 80 mg/kg Q24 hours .
Uncomplicated gonococcal ophthalmia: 50 mg/kg (maximum 125 mg) single dose. (Note: topical antibiotic therapy alone is inadequate and is unnecessary if systemic treatment is administered.)
IV administration: İnfusion by syringe pump över 30 minutes. Avoid administration of calcium-containing solutions or products vvithin 48 hours of the last administration of ceftriaxone.
İM administration: To reduce pain at the injection site, reconstitute vvith 1% lidocaine vvithout epinephrine.
Uses
Treatment of neonatal sepsis and meningitis caused by susceptible gram-negative organisms (e.g. E coli, Pseudomonas, Klebsiella, H influenzae). Treatment of gonococcal infections.
Monitoring
CBC for eosinophilia, thrombocytosis, leukopenia. Serum electrolytes, BUN, creatinine. AST, ALT, bilirubin. Consider abdominal ultrasonography.
Adverse Effects/Precautions
Not recommended for use in neonates vvith hyperbilirubinemia.
Displaces bilirubin from albumin binding sites, resulting in higher free bilirubin serum concentrations. Concurrent administration of ceftriaxone and calcium-containing solutions or products in nevvborns is not recommended. Fatal reactions vvith calcium-ceftriaxone precipitates have been reported in neonates (lung and kidney). Administration of calcium-containing solutions or products vvithin 48 hours of the last administration of ceftriaxone is not recommended. Eosinophilia, thrombocytosis, leukopenia. İncrease in bleeding time. Diarrhea. İncrease in BUN and serum creatinine. İncrease in AST and ALT. Skin rash. Transient gallbladder precipitations occasionally associated vvith colicky abdominal pain, nausea, and vomiting.
Pharmacology
Ceftriaxone is one of many third-generation cephalosporin antibiotics. The drug distributes vvidely (i.e. CSF, bile, bronchial secretions, lung tissue, ascitic fluid, middle ear). İt is eliminated unchanged by both biliary (40%) and renal mechanisms. Serum half-life in prematüre infants is 5 to 16 hours. Dosage adjustment is necessary only for patients vvith combined hepatic and renal failure.
Special Considerations/Preparation İntravenous solution: Available as a povvder for injection in 250-mg, 500-mg, 1-g, and 2-g vials. Prepared by reconstituting povvder vvith compatible solution (sterile vvater for injection, D5W, or D10W) to a concentration of 100 mg/mL. Reconstituted solution is stable for 2 days at room temperature, 10 days refrigerated. A dark color may appear after reconstitution; hovvever, potency is retained. To make 40-mg/mL solution add 6.2 mL to the 250-mg vial.
Intramuscular solution: Prepared by reconstituting 250-mg vial vvith 0.9 mL of 1% lidocaine vvithout epinephrine to a concentration of 250 mg/mL. Solution is stable for 24 hours at room temperature, 3 days refrigerated.
Solution Compatibility: D5W, D10W, and NS.
Solution Incompatibility: Any calcium-containing solution.
Terminal İnjection Site Compatibility: Dex/AA solutions, fat emulsion. Acyclovir, amikacin, amiodarone, aztreonam, clindamycin, famotidine, gentamicin, heparin, lidocaine, linezolid, metronidazole, morphine, potassium chloride, propofol, remifentanil, sodium bicarbonate, and zidovudine.
Incompatibility: Aminophylline, azithromycin, calcium chloride, calcium gluconate, fluconazole and vancomycin.
Selected References
♦ Centers for Disease Control and Prevention: Sexually transmitted diseases treatment guidelines 2006. MMWR 2006;55(No. RR-11):47-48.
♦ Prober CG, Stevenson DK, Benitz WE: The use of antibiotics in neonates vveighing less than 1200 grams. Pediatr Infect Dis ! 1990;9:111.
♦ Schaad UB, Suter S, Gianella-Borradori A, et al: A comparison of ceftriaxone and cefuroxime for the treatment of bacterial meningitis in children. N Engl I Med 1990;332:141.
♦ Fink S, Karp W, Robertson A: Ceftriaxone effect on bilirubin-albumin binding. Pediatrics 1987,80:873.
♦ Laga M, Naamara W, Brunham RC, et al: Single-dose therapy of gonococcal ophthalmia neonatorum vvith ceftriaxone. N Engl J Med 1986;315:1382.
♦ Yogev R, Shulman ST, Chadvvick E, et al: Once daily ceftriaxone for central nervous system infections and other serious pediatric infections. Pediatr Infect Dis I 1986;5:298.
♦ Martin E, Koup JR, Paravicini U, Stoeckel K: Pharmacokinetics of ceftriaxone in neonates and infants vvith meningitis. / Pediatr 1984;105:475.
♦ Schaad UB, Stoeckel K: Single-dose pharmacokinetics of ceftriaxone in infants and young children. Antimicrob Agents Chemother 1982:21:248.
♦ Product İnformation, Roche, 2007.
Text and References updated 7/2007 Compatibilities updated 7/2007
Dose & Administration Loading dose: 20 mg/kg IV infusion by syringe pump över 30 minutes.
Maintenance dose: (Begin 12 hours after loading dose.) Prematüre infants under 1 month of age: 2.5 mg/kg per dose Q6 hours. Fullterm infants under 1 week of age and prematüre infants över 1 month of age: 5 mg/kg per dose Q6 hours.
Fullterm infants över 1 vveek of age: 12.5 mg/kg per dose Q6 hours. (Absorption of oral chloramphenicol palmitate is erratic in nevvborns.)
Uses
A vvide-spectrum antimicrobial bacteriostatic agent. May be bactericidal to species such as H influenzae and Neisseria meningitidis.
Monitoring
Close monitoring of serum concentration is mandatory. Small changes in dose and interval can lead to disproportionately large changes in serum concentration. Therapeutic peak serum concentration: 10 to 25 mcg/mL. Monitor CBC and reticulocyte counts. Assess hepatic and renal function.
Adverse Effects/Precautions
Reversible bone marrow suppression, irreversible aplastic anemia. Serum concentration greater than 50 mcg/mL has been associated vvith the "gray baby" syndrome (i.e. abdominal distention, paüid cyanosis, vasomotor collapse; may lead to death vvithin hours of onset). Fungal overgrovvth.
Black Box Warning
According to the manufacturer's black box vvarning, serious and fatal blood dyscrasias (aplastic anemia, hypoplastic anemia, thrombocytopenia, and granulocytopenia) are knovvn to occur. There have been reports of aplastic anemia vvhich later terminated in leukemia. Blood dyscrasias have occurred after both short-term and prolonged therapy vvith this drug. İt is essential that adequate blood studies be made during treatment.
Pharmacology
Both esters (succinate and palmitate) are biologically inactive prodrugs. Hydrolysis to the active compound is erratic in nevvborns. Metabolized by hepatic glucuronyl transferase. Hepatically and renally eliminated. Inhibits metabolism of phenobarbital, phenytoin, and other agents.
Special Considerations/Preparation
Chloramphenicol succinate is available as povvder for injection in a 1-g vial. Reconstitute vvith 10 mL sterile vvater for injection, or DSW to a concentration of 100 mg/mL.
Solution Compatibility: DSW, D10W, and NS.
Terminal İnjection Site Compatibility: Dex/AA solutions, fat emulsion. Acyclovir, amikacin, aminophylline, ampicillin, calcium chloride, calcium gluconate, dopamine, enalaprilat, erythromycin lactobionate, esmolol, heparin, hydrocortisone succinate, lidocaine, magnesium sulfate, methicillin, metronidazole, morphine, nafcillin, nicardipine, oxacillin, penicillin G, pentobarbital, potassium chloride, ranitidine, sodium bicarbonate, and vitamin K,.
Incompatibility: Fluconazole, metoclopramide, phenytoin, and vancomycin.
Selected References
♦ Roberts R): Drug Therapy in İnfants. Philadelphia: WB Saunders Co, 1984, p 70.
♦ Rajchgol P, Prober CC, Soldin S: Initiation of chloramphenicol therapy in the nevvborn infant. ) Pediatr 1982; 101:1018.
♦ Glazer |P, Danish MA, Plotkin SA, Yaffe SJ: Disposition of chloramphenicol in lovv birth vveight infants. Pediatrics 1980;66:573.
♦ Product İnformation, Abraxis, 2006
Adverse Effects/Precautions updated 1/2009
Compatibilities updated 3/2005
Dose & Administration
5 to 7.5 mg/kg per dose IV infusion by syringe pump över 30 minutes, or PO.
İncrease dosing interval in patients vvith significant liver dysfunction. To use dosing chart, please refer to explanatory note on page 1.
Dosing İnterval Chart
PMA | PostNatal | İnterval |
(weeks) | (days) | (hours) |
<29 | O to 28 >28 | 12 8 |
30 to 36 | O to 14 >14 | 12 8 |
37 to 44 | O to 7 >7 | 12 8 |
>45 | ALL | 6 |
Uses
Bacteriostatic antibiotic used for the treatment of bacteremia and pulmonary and deep tissue infections caused by anaerobic bacteria and some gram-positive cocci. Clindamycin should not be used in the treatment of meningitis.
Monitoring
Assess liver function. Monitor Gl status closely. Therapeutic serum concentration ranges from 2 to 10 mcg/mL (bioassay yields variable results).
Adverse Effects/Precautions
Black Box Warning
According to the manufacturer's black box warning, diarrhea, colitis, and pseudomembranous colitis have been reported, and may begin up to several vveeks follovving cessation of therapy.
Discontinue clindamycin if any of these signs or symptoms occur, begin bovvel rest and TPN, and consider treatment vvith oral metronidazole.
Pharmacology
Clindamycin inhibits bacterial protein synthesis and is primarily bacteriostatic at therapeutically attainable concentrations. VVidely distributed into most tissues, especially the lung. Poor CSF penetration. Oral clindamycin is completely absorbed from the Cl tract. Highly protein bound. Almost complete metabolism in the liver, vvith excretion via bile and feces. Available data in neonates suggest extremely variable clearance, especially in prematüre infants. No data are available regarding conversion of ester to active drug.
Special Considerations/Preparation
Oral preparation (clindamycin palmitate) is reconstituted vvith sterile vvater for injection, yielding a 75 mg per 5 mL solution. Do not refrigerate. Stable at room temperature for 2 vveeks.
IV preparation (clindamycin phosphate) is available as a 150 mg/mL solution in 2-mL, 4-mL, and 6-mL vials containing 9.45 mg/mL benzyl alcohol. İt should be diluted using D5W, NS, or LR to a maximum concentration of 18 mg/mL, and infused at a rate no greater than 30 mg/min. Also available in premixed bags (50 mL) vvithout benzyl alcohol containing 300 mg, 600 mg or 900 mg of clindamycin.
Solution Compatibility: DSW, D10W, and NS.
Terminal İnjection Site Compatibility: Dex/AA solutions, fat emulsion. Acyclovir, amikacin, amiodarone, ampicillin, aztreonam, caffeine citrate, cefazolin, cefepime, cefotaxime, cefoxitin, ceftazidime, ceftriaxone, cimetidine, enalaprilat, esmolol, gentamicin, heparin, hydrocortisone succinate, linezolid, magnesium sulfate, metoclopramide, metronidazole, midazolam, milrinone, morphine, netilmicin, nicardipine, penicillin C, piperacillin, piperacillin/ tazobactam, potassium chloride, propofol, prostaglandin E,, ranitidine, remifentanil, sodium bicarbonate, tobramycin, and zidovudine.
Incompatibility: Aminophylline, azithromycin, barbiturates, calcium gluconate, ciprofloxacin, fluconazole, and phenytoin.
Selected References
♦ Koren C, Zarfın Y, Maresky D, et al: Pharmacokinetics of intravenous clindamycin in nevvborn infants. Pediatr Pharmacol 1986;5:287.
♦ Bell MJ, Shackelford P, Smith R, Schroeder K: Pharmacokinetics of clindamycin phosphate in the first year of life. 1 Pediatr 1984,105:482.
♦ Feigin RD, Pickering LK, Anderson D, et al: Clindamycin treatment of osteomyelitis and septic arthritis in children. Pediatrics 1975;55:213.
♦ Lvvin N, Collipp PJ: Absorption and tolerance of clindamycin 2-palmitate in infants belovv 6 months of age. Curr Ther Res Clin Exp 1970; 12:648.
♦ Product İnformation, Pfizer, 2003
Adverse Effects/Precautions updated 1/2009 Special Considerations updated 3/2008 Compatibilities updated 3/2007
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