BANGLADESH J CHILD HEALTH 2014; VOL 38 (3) : 151-156

Prescription of Drugs in Children with Impaired Renal Function

SYED SAIMUL HUQUE,1 MD. HABIBUR RAHMAN2

Introduction: of some prodrugs (e.g. fosphenytoin)5. On the other

Paediatric nephrologist often needs to consider hand, drugs that are administered by the oral route or
multiple factors to drug dosing for children with impaired other extravascular sites are absorbed only a fraction
renal function. They usually convert adult dosing of the total dose. In the gastrintestinal tract drugs are
guidelines into paediatric doses and adjust them to absorbed across the intestinal epithelium, a tissue
the patient’s renal function, a procedure that is time- rich in drug-metabolizing enzymes (e.g. cytochromes
consuming and error-prone. It is said that drug P-450) and transporters (e.g. P-glycoprotein). After
absorption, distribution, metabolism and excretion is oral administration, most drugs cross the intestinal
different in children than adults.1 In newborn, the epithelium by passive diffusion along a concentration
elimination of drugs is low because of insufficient drug gradient in unbound (free) and non-ionized form5.
metabolizing capacity of the liver and immaturity of The movement of drugs may be affected by the pH
kidney function. These alterations of drug metabolism gradient. High gastric pH may be responsible for
are correlated to age-adjusted hormonal changes.2 In impairment of drug absorption. At birth until age 2-3
this review, dosing tables of some important and yr the gastric pH remain high approximately 6-8. So
commonly used antimicrobials are provided for easy medications that require acid milieu for drug absorption
and quick reference in order to facilitate prescription (phenytoin and phenobarbital) cannot be absorbed
for children with impaired renal function. completely at these age groups6. In children with
Effects of impaired kidney function on kidney disease, drug absorption may be altered by a
pharmacokinetics & pharmacodynamics of drug: number of mechanisms, including genetic factors (e.g.
polymorphisms of drug-metabolizing enzymes or drug
Kidney is one of the major regulators of internal fluid
transporters), disease-induced changes in the
environment. So any disease in kidney not only alters
structure and physiology of the absorptive site (e.g.
it‘s function but can also affect multiple organ systems.
first-pass effect) and interactions among drugs (e.g.
Therefore, physiological changes that can be induced
phosphate binders with antibiotics or iron-containing
by the reduced renal function, can have pronounced
supplements)5,7. Common causes of impairment of
effects on the pharmacokinetics (PK) and the
drug absorption occur due to uraemia induced delayed
pharmacodynamics (PD) of many drugs 3,4 .
gastric emptying or vomiting or oedema of the
Pharmacokinetics is defined by the individual patient‘s
gastrointestinal tract8. Bioavailability of some drugs
ability to absorb, distribute, metabolize and eliminate
is limited by intestinal metabolism via the cytochrome
the drug from the body. On the other hand,
P-450 (CYP) enzymes (mainly CYP3A4/5). For
pharmacodynamics is characterized by how drugs
example, administration of strong CYP3A inhibitors,
affect the body. Clinicians must have a basic
such as ketoconazole or diltiazem, can decrease the
understanding of the PK and PD as well as biochemical
metabolism of cyclosporine or tacrolimus in the gut
and physiologic effects of drugs in patients with renal
and increase the amount of active drug reaching the
disease. Therefore, it is essential to have a basic
systemic circulation9,10. The enhanced absorption of
understanding on the fundamental principles of
active drug can result in an increase in blood
pharmacology.
concentrations and toxicity. That is why; in developing
The amount of drug absorbed into the systemic countries diltiazem/ketoconazole-cyclosporine11 or
circulation is primarily affected by the route of diltiazem/ketoconazole-tacrolimus12 interaction has
administration. When the drug is given intravenously, been used to decrease the treatment costs of
its absorption is considered complete with exception immunosuppressive agents among transplant patient.

1. Assistant Professor, Department of Paediatric Nephrology, Children with kidney dysfunction have decreased
Bangabandhu Sheikh Mujib Medial University, Shahbag, Dhaka protein synthesis and increased protein elimination,
2. Professor, Department of Paediatric Nephrology, Bangabandhu which can increase drug toxicities. For example, about
Sheikh Mujib Medial University, Shahbag, Dhaka
Correspondence: Saimul [email protected] 97% of mycophenolate in the plasma is bound to
 BANGLADESH J CHILD HEALTH 2014; VOL 38 (3) : 152

albumin while 2-3% is free. Hypoalbuminaemia (<2.5 calculated by measuring the amount of creatinine in
gm/dl) causes increased risk of toxicities due to an an accurately timed urine collection and a
increased concentration of free mycophenolate in the midcollection plasma creatinine. Dosages of drugs
plasma13. Beside these, uraemia can induce changes cleared by the kidney should usually be adjusted
in the albumin structure. So that mycophenolate like according to creatinine clearance.19 It can be quickly
acidic drugs can bind less avidly, this can misinterpret estimated by measuring the child‘s serum creatinine
the measurement of the drug concentrations. Because and length.20
most drug assays reflect sum of the bound and active
unbound species.
CCr = Length(cm) × k/ Plasma Cr(mg/dl)
Quantitatively, the liver and gastrointestinal tracts are
the most important organs of drug metabolism. Different constant values(k) for schwartz
However, for some drugs, kidney is the primary site of formula for the estimation of GFR
drug metabolism and kidney disease can impact the Cr mg/dl Cr µmol/L
biotransformation profile. For example, imipenem is a
â-lactam antibiotic that is rapidly hydrolyzed by Low birth wt infants(<1 yr) 0.33 29.2
dipeptidases located on the brush border or the Full term infants (>1 yr) 0.45 39.8
proximal renal tubule. Kidney failure impairs the normal Children (2-12 yrs) 0.55 48.6
metabolism and results in an accumulation of
imipenem and an increased risk of seizures14. In Females (13-21 yrs) 0.55 48.6
general, microsomal enzyme systems are immature Males (13-21 yrs) 0.70 61.9
in infants and neonates. It has been shown that drug
metabolism is slower in the children than adult at this It is important to understand that the normal
stage of life.15 relationship among serum creatinine, length and GFR
is altered in disturbances of creatinine biosynthesis
Drugs and drug metabolites are eliminated from the
(e.g. muscular disease and malnutrition) and in clinical
body through various excretory pathways, including
settings where the serum creatinine is rapidly changing
kidney, biliary, salivary, mammary, sweat, lung and
(e.g. acute renal failure and dialysis). In these
intestinal. Among them kidney is the most important
situations, a timed urine collection is required for an
route of drug excretion. Drug removal rate is typically
accurate estimate of GFR.
expressed as elimination half-life (t½), the time
required for the plasma concentration to decrease by Aspects of drug dosing in children with reduced
50%. The half-life is dependent on volume of distribution renal function:
(Vd) and clearance (renal, hepatic or other) as
Adjustment of dosage and frequency of a drug in
expressed by the following formula-
children with impaired renal function is often delicate
t½ = 0.693 × Vd / clearance to calculate. Several factors and issues should take
As the renal clearance decreases, t½ will increase under consideration for prescribing drugs during
(assuming that Vd is unchanged). It should be noted impaired renal function of a child. Most studies on
that active drug metabolites may also be excreted by drug dosage in patients with renal failure are performed
the kidney and therefore have a prolonged half-life in in adults. Thus, off-label use is common in paediatrics.
renal failure.16 To overcome these problems and improve the safety
and efficacy of pharmaceuticals for children, Senate
Assessment of kidney function: and House of Representatives of the United States of
Renal function should be measured before prescribing America enacted the “Best Pharmaceuticals for
any drug. Because the rate of elimination of drugs Children Act” in January 4, 2002 (Public Law 107-
excreted by the kidneys is proportional to glomerular 109).21 Similar legislation is also initiated in Europe
filtration rate (GFR).17The measurement of GFR can for clearing the way for appropriate clinical trials in
be accomplished by using some exogenous children.22 In one study (1999) over 90% of neonates
substances. Urinary clearance of inulin, which is the and 70% of paediatric patients were receiving a drug
gold standard, is rarely performed except for research which was not approved in the paediatric population.23
purposes because of the limited availability of the Most drug dosing are based on `targeted effects` or
substance and the labor intensity of the procedure `concentration effects`. Children even in good renal
and the assay.18 Measurement of GFR can also be function metabolize drugs differently than adults. Renal
possible by utilizing endogenous compound like dysfunction adds a further level of complexity to drug
creatinine or cystatine C. Creatinine clearance is dosing.
BANGLADESH J CHILD HEALTH 2014; VOL 38 (3) : 153 Prescription of Drugs in Children with Impaired

Basic principles of drug dosing weights are removed mainly by diffusion, whereas
Following basic principles of drug dosing are needed drugs with middle or large molecular weights are
to be considered in patients with impaired renal function: removed by convection.

1. Drug therapy should be limited to the smallest Drug removal during haemodialysis is a function of the
possible number of substances to reduce dialysis dose, (Kt/V), ‘K‘ being the dialyzer clearance,
accumulation of toxic metabolites that may result ‘t‘ the time on dialysis and ‘V‘ the urea volume of
in unknown or unexpected interactions.24 distribution which is equivalent to total body water. Since
total body water is smaller in children, some authors
2. Modification of drug doses in renal disease is suggested that dialytic drug should be higher in children
usually necessary only when the glomerular than in adults, if ‘K‘ and ‘t‘ are the same.28,29
filtration rate (GFR) is less than 30–40 ml/min/
1.73m2.25 Some drug characteristics also affect drug
dialyzability. These are:
3. Drugs with long plasma half-lives need to extend
the dosing interval. This may help to improve the 1. Molecular weight and size: Drugs with small
patient’s compliance by simplifying drug molecular size or volume (<500 D) are more
schedules but can fluctuate the plasma readily dialyzable than larger one.
concentration. For example, glycopeptide 2. Drugs that are highly protein bound (>80%), are
antibiotic, Vancomycin.26 poorly dialyzable whereas low protein bound drugs
4. Drugs with a narrow therapeutic range need to are more readily dialyzable.30
reduce the dosage size instead of the interval.
3. The volume of distribution of drugs also affects
Because prescription of these drugs in impaired
dialyzability. Drugs with low volume of distribution
renal function may result in toxic or nontherapeutic
(â-lactam antibiotics, aminoglycosides and
levels. So these drugs dose should be reduced
glycopeptides), are usually confined to the
proportionally to the predicted reduction in drug
intravascular and extracellular spaces and
clearance. This may be advantageous for drugs
therefore are effectively removed by dialysis. On
in which a relatively constant steady-state level
the other hand, drugs with large volume of
is desired, such as antibiotics or antiarrhythmic
distribution are usually highly tissue bound and
drugs with short plasma half-lives.24
cannot be removed by the dialysis.31,32,33,34
5. Though most published guidelines do not
recommend a loading dose but the volume of Drug Dosing Strategy in Renal Dysfunction
distribution of many drugs, especially hydrophilic
antibiotics, including â-lactams, cephalosporins, Step # 1: Identify cause of renal dysfunction: acute
and penems, are significantly increased in the and/or chronic
presence of reduced kidney function, the
administration of aggressive loading doses (25– Step # 2: Estimate GFR (Frequently, if acute
50% greater than normal) are highly recommended dysfunction)
specially the drug with long half-life.27
6. Drug monitoring should be performed in reduced
renal function if facilities are available. Drugs such Step # 3: Corroborate Drug Dosing with GFR
as aminoglycoside antibiotics or certain cardiac
glycosides have a narrow therapeutic range and
almost entirely depend on renal excretion for their Step # 4: Adjust drug dose or dosing interval, based
on the action that best promotes efficacy
elimination. Regular monitoring of plasma levels
is imperative for these drugs.
Step #5 Analyze effect of Supplement dose
Effects of dialysis on drugs: dialysis on drug dose needed
Drug removal during dialysis is an important factor to
consider when prescribing drug therapy for the patient
Step # 6: Consider drug Labs ?
with ESRD. Among variety of factors, dialyzer pore specific safety monitoring Drug levels ?
size or flux, surface area, ultrafiltration rate and blood
flow rate are probably the most important. During
dialysis drug clearance occurs by the processes of Steop # 7: Consider interactions with other current
diffusion and convection. Drugs with small molecular prescribed drugs
 BANGLADESH J CHILD HEALTH 2014; VOL 38 (3) : 154

Recommendation for dosage of antimicrobials for children with normal and reduced kidney Function:
Antibacterial Antibiotics35-40
Aminoglycoside Antibiotics
Drug Dose for normal renal Adjusment for renal failure
function GFR ml/min/1.73m2
30-50 10-29 <10
Amikacin 5-7.5 mg/kg/dose q8h q12-18h q18-24h q48-72h
Gentamicin 2.5 mg/kg/dose q8h q12-18h q18-24h q48-72h
Streptomycin 20-40 mg/kg/dose q24h 7.5 mg/kg/dose q24h 7.5 mg/kg/dose q48h 7.5 mg/kg/dose q72-96h
Cephalosporine Antibiotics
Drug Dose for normal renal Adjusment for renal failure
function GFR ml/min/1.73m2
30-50 10-29 <10
Cefaclor 20-40 mg/kg/day q8-12h 100% 100% 50%
Cefadroxil 30 mg/kg/day q12h 100% 15mg/kg q24 h 15mg/kg q36h
Cefazolin 50-100 mg/kg/day q8h 100% 25mg/kg/dose q12 h 25mg/kg/dose q24h
Cefepime 50 mg/kg/dose q8-12h 50mg/kg/dose q24h 50mg/kg/dose q24h 50mg/kg/dose q48h
Cefotaxime 100-200 mg/kg/day q8h 35-70 mg /kg /dose 35-70 mg /kg /dose 35-70mg / kg /
q8-12h q12h dose q24h
Ceftazidime 75-150 mg/kg/day q8h 50mg/kg/dose q12h 50mg/kg/dose q24h 50mg/kg/dose q48h
Ceftriaxone 50-100 mg/kg/day q12-24h 100% 100% All doses q24h
Cefuroxime Axetil 30 mg/kg/day q12h 100% 15mg/kg/ dose q12 h 15mg/kg/ dose q24h
Cefuroxime Sodium 75-150 mg/kg/day q8h 100% 25-50 mg/kg/ dose q12 h 25-50 mg/kg/ dose q24h
Cephalexin 25-50 mg/kg/day q6h 5-10 mg/kg/ dose q8h 5-10mg/kg/dose q12h 5-10 mg/kg/ dose q24h
Cephradine 25-50 mg/kg/day q6-12h;For 12.5-50 mg/ kg/dose q12h 12.5-50 mg/ kg/dose q24h 12.5-50 mg/kg/dose q36h
OM:75-100 mg/kg/ day q6-12h
Miscealneous Antibacterial Antibiotics
Drug Dose for normal renal Adjusment for renal failure
function GFR ml/min/1.73m2
30-50 10-29 <10
Azythromycin 10 mg/kg once, then 100% 100% 100%
5 mg/kg/day q24h
Clarithromycin 15 mg/kg/day q12h 100% 4 mg/kg/dose q12h 4 mg/kg/dose q24h
Clinndamycin Oral: 10-30 mg/kg/day q6-8h; 100% 100% 100%
IV: 25-40 mg/kg/day q6h
Dapsone 1-2 mg/kg/day q24h 100% 100% 100%
Erythromycin 30-50 mg/kg/day q6-8h 100% 100% 10-17 mg/kg/dose q8h
Imipenem/Cilastatin 60-100 mg/kg/day q6h 7-13 mg/kg/dose q8h 7.5-12.5 mg/kg/dose q12h 7.5-12.5 mg/kg/dose q24h
Meropenem 60-120 mg/kg/day q8h 20-40 mg/kg/dose q12h 10-20 mg/kg/dose q12h 10-20 mg/kg/dose q24h
Metronidazole 15-30 mg/kg/day q6-8h 100% 100% 4 mg/kg/dose q6h
Rifampin 10-20 mg/kg/day q12-24h 100% 100% 100%
Trimethoprim / 5-20 mg/kg/day q6-12h 5-7.5 mg/kg/dose q8h 5-10 mg/kg/dose q12h Not recommended, but if
Sulfamethoxazole need5-10 mg/kg/dose q24h
Vancomycin 10-15 mg/kg/dose q6-8h 10 mg/kg/dose q12h 10 mg/kg/dose q18-24h 10 mg/kg/dose as needed
per serum conc.
Penicillins
Drug Dose for normal renal function Adjusment for renal failure
GFR ml/min/1.73m2
30-50 10-29 <10
Amoxicillin 25-50 mg/kg/day q8h 100% 8-20 mg/kg/dose q12h 8-20 mg/kg/dose q24h
Amoxicillin / 20-40 mg/kg/day q8h 100% 8-20 mg/kg/dose q12h 8-20 mg/kg/dose q24h
Clavulanate
Ampicillin 100-200 mg/kg/day q6h 35-50 mg/kg/dose q6h 35-50 mg/kg/dose q8-12h 35-50 mg/kg/dose q12h
Piperacillin 200-300 mg/kg/day q6h 50-75 mg/kg/dose q8h 50-75 mg/kg/dose q12h 50-75 mg/kg/dose q12h
Piperacillin / 200-300 mg/kg/day q6h 35-50 mg/kg/dose q6h 35-50 mg/kg/dose q8h 35-50 mg/kg/dose q8h
Tazobactam
Qulnolone Antibiotics
Drug Dose for normal renal function Adjusment for renal failure
GFR ml/min/1.73m2
30-50 10-29 <10
Ciprofloxacin 20-30 mg/kg/day q12h 100% 10-15 mg/kg/dose q18h 10-15 mg/kg/dose q24h
Levofloxacin <5 yr: 5-10 mg/kg/dose q12h 100% All ages: 5-10 mg/kg/dose All ages: 5-10 mg/kg/dose
>5 yr: 5-10 mg/kg/dose q24h q24h q48h
Oflaxacin 15 mg/kg/day q12h 7.5 mg/kg/dose q24h 7.5 mg/kg/dose q24h 7.5 mg/kg/dose q48h
Doxycyline >8 yr: 2-4 mg/kg/day q12-24h 100% 100% 1 mg/kg/dose q12h
BANGLADESH J CHILD HEALTH 2014; VOL 38 (3) : 155 Prescription of Drugs in Children with Impaired

Conclusion: 10. Katari SR, Magnone M, Shapiro R. Clinical

In general, dosages of drugs cleared renally should features of acute reversible tacrolimus (FK 506)
be adjusted according to creatinine clearance or nephrotoxicity in kidney transplant recipients.
glomerular filtration rate. Recommended methods for Clin Transplant 1997;11:237-242
maintenance dose adjustments are dose reduction,
11. Berkovitch M, Bitzan M, Matsui D, Finkelstein
lengthening the dose interval, or both. Usually
H, Balfe JW, Koren G. Pediatric clinical use of
fluctuations of GFR occur in children with impaired
the ketoconazole/cyclosporine interaction.
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PediatrNephrol 1994;8:492-493
nephrotoxic drugs should be avoided in these
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commonly used medications that require dose Sobh MA. ketoconazole-tacrolimusco
adjustments. administration in kidney transplant recipients:
Two-year results of a prospective randomized
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