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Calculation of Doses PT Factors
Calculation of Doses PT Factors
Patient Parameters
FIRST YEAR BACHELOR OF PHARMACY
DR TAWFIK BA ABBAD
• As noted in the previous chapter, the usual dose of a
drug is the amount that ordinarily produces the desired
therapeutic response in the majority of patients in a
general, or otherwise defined, population group.
• The drug’s usual dosage range is the range of dosage
determined to be safe and effective in that same
population group. This provides the prescriber with
dosing guidelines in initially selecting a drug dose or a
particular patient and the flexibility to change that dose
as the patient’s clinical response warrants.
• Usual doses and dosage regimens are based on the
results o clinical studies conducted during the drug
development process as well as on clinical information
gathered following the initial approval and marketing o
the drug (postmarketing surveillance/postmarketing
studies).
• For certain drugs and or certain patients, drug
dosage is determined on the basis of specific
patient parameters. These parameters include
• the patient’s age, weight, body surface area,
and nutritional and functional status.
• Drug selection and drug dosage in patients
who are pregnant and in nursing mothers are
especially important considerations due to
potential harm to the fetus or child.
• Among patients requiring individualized dosage
are neonates and other pediatric patients,
• elderly patients with diminished biologic
functions, individuals of all age groups with
compromised liver and/or kidney function (and
thus reduced ability to metabolize and eliminate
drug substances),
• critically ill patients, and patients being treated
with highly toxic chemotherapeutic agents.
• Certain drugs with a narrow therapeutic window
often require individualized dosing based on
blood level determinations and therapeutic
monitoring. Digoxin, for example, at a blood level
of 0.9 to 2 ng/mL is considered therapeutic, but
above 2 ng/mL, it is toxic.1
• Since age, body weight, and body surface area
are often-used factors in determining the
doses of drugs or pediatric and elderly
patients, these parameters represent the
majority of the calculations presented in this
chapter.
• The dosing of chemotherapeutic agents also is
included because it represents a unique
dosing regimen compared with most other
categories of drugs.
Pediatric Patients
• children from birth through adolescence
• defined further as follows:
• - neonate (newborn), from birth to 1 month; -
-- infant, 1 month to 1 year;
- early childhood, 1 year through 5 years;
- late childhood, 6 years through 12 years; and
adolescence, 13 years through 17 years of age
• A neonate is considered premature if born at
less than 37 weeks’ gestation.
• Proper drug dosing of the pediatric patient
depends on a number of factors, including
• the patient’s age and weight, overall health
status, the condition of such biologic functions
as respiration and circulation, and the stage of
development of body systems for drug
metabolism
• (e.g., liver enzymes) and drug elimination (e.g., renal
system). In the neonate,
• these biologic functions and systems are underdeveloped.
Renal function, for example, develops over the span of the
first 2 years of life.
• This fact is particularly important because the most
commonly used drugs in neonates, infants, and young
children are antimicrobial agents, which are eliminated
primarily through the kidneys. If the rate of drug
elimination is not properly considered, drug accumulation
in the body could occur, leading to drug overdosage and
toxicity.
• Thus, the use of pharmacokinetic data (i.e., the rates and
extent of drug absorption, distribution, metabolism, and
elimination; together with individual patient factors and
therapeutic response, provides a rational approach to
pediatric drug dosage calculations.
Special Considerations in Dose
Determinations for Pediatric Patients
• The majority of medications commercially available are formulated
and labeled for adult use.
• When used for the pediatric patient, appropriate dosage
calculations must be made, and often, so must adjustments to the
concentration of the medication.
• In the absence of a suitable commercial preparation, pharmacists
may be called upon to compound a medication for a pediatric
patient.
• Among the special considerations in pediatric dosing are the
following3:
• Doses should be based on accepted clinical studies as reported in the
literature.
• Doses should be age appropriate and generally based on body
weight or body surface area.
Special Considerations in Dose
Determinations for Pediatric Patients
• Pediatric patients should be weighed as closely as possible to the
time of admittance to a health care facility and that weight recorded in
kilograms.
• As available, pediatric formulations rather than those intended for
adults should be administered.
• • All calculations of dose should be double-checked by a second
health professional.
• All caregivers should be properly advised with regard to dosage, dose
administration, and important clinical signs to observe.
• Calibrated oral syringes should be used to measure and administer
oral liquids.
Doses of drugs used in pediatrics, including neonatology, may be found
in individual drug product literature as well as in references, such as
those listed at the conclusion of this chapter.
Geriatric Patients
• Although the term elderly is subject to varying
definitions with regard to chronologic age, it is
clear that the functional capacities of most
organ systems decline throughout adulthood,
• and important changes in drug response occur
with advancing age. Geriatric medicine or
• geriatrics is the field that encompasses the
management of illness in the elderly.
• In addition to medical conditions affecting all
age groups, some conditions are particularly
• common in the elderly, including degenerative
osteoarthritis, congestive heart failure, venous
and arterial insufficiency, stroke, urinary
incontinence, prostatic carcinoma,
parkinsonism, and Alzheimer’s disease.
• Many elderly patients have coexisting
pathologies that require multiple-drug
therapies.
• Most age-related physiologic functions peak before age
30, with subsequent gradual linear decline.
• 2 Reductions in physiologic capacity and function are
cumulative, becoming more pronounced with age.
• Kidney function is a major consideration in drug dosing
in the elderly because reduced function results in
reduced drug elimination.
• Because reduced kidney function increases the
possibility of toxic drug levels in the body and adverse
drug effects, initial drug dosing in the elderly patient
often reflects a downward variance from the usual
adult dose.
• There is also a frequent need for dosage adjustment or
medication change due to adverse effects or otherwise
unsatisfactory therapeutic outcomes.
• There are a number of other common features
of medication use in the elderly, including
• the long-term use of maintenance drugs; the
need or multidrug therapy, with the attendant
• increased possibility of drug interactions and
adverse drug effects; and difficulties in patient
adherence.
• The latter is often due to impaired cognition,
confusion over the various dosing schedules of
multiple medications, and economic reasons in
not being able to afford the prescribed
medication.
Special Considerations in Dose
Determinations for Elderly Patients
Dose determinations for elderly patients frequently require consideration of
some or all of the following:
• • Therapy is often initiated with a lower-than-usual adult dose.
• • Dose adjustment may be required based on the therapeutic response.
• • The patient’s physical condition may determine the drug dose and the
route off administration used.
• • The dose may be determined, in part, on the patient’s weight, body
surface area, health and disease status, and pharmacokinetic factors.
• • Concomitant drug therapy may affect drug/dose effectiveness.
• • A drug’s dose may produce undesired adverse effects and may affect
patient adherence.
• • Complex dosage regimens or multiple drug therapy may affect patient
adherence.
• The adult dose of a drug is 500 mg every 8 hours.
For an elderly patient with impaired renal
• function, the dose is reduced to 250 mg every 6
hours. Calculate the reduction in the daily dose, in
• milligrams.
• Daily doses mg every hours mg
• mg
• :()
• ()
• 500 mg x3 (every 8 hours )= 1500
• 250 x 4= 1000 mg
• 500 -1000mg =500mg
Dosage Forms Applicable to Pediatric
and Geriatric Patients
• In the general population, solid dosage Forms, such as
tablets and capsules, are preferred
• because of their convenience, precise dose, ease os
administration, ready identification, transportation, and
lower cost per dose relative to other dosage Forms.
• However, solid dosage Forms are often difficult or
impossible for the pediatric, geriatric, or infurm patient to
swallow. In these instances, liquid forms are pre erred, such
as oral solutions, syrups, suspensions, and drops. With
liquid forms, the dose can be adjusted by changing the
volume administered.
Dosage Forms Applicable to Pediatric
and Geriatric Patients
• When necessary, liquid forms o medication
may be administered by oral feeding tube.
Pharmacists are sometimes asked to
compound an oral liquid rom a counterpart
• solid dosage form when a liquid product is not
available. Chewable tablets and solid gel forms
(medicated “gummy bears”) that disintegrate
or dissolve in the mouth are o ten used for
pediatric and geriatric patients.
• tablet splitting
• and tablet crushing are options or individuals
unable to swallow whole tablets.
• For systemic effects, injections may be used
rather than the oral route o administration
• when needed or pediatric and elderly
patients, with the dose or strength o the
preparation
• adjusted to meet the requirements o the
individual patient.
Drug Dosage Based on Age
• For reasons stated earlier, the young and the
elderly require special dosing considerations
• based on actors characteristic o these groups
Illustrative PEDIATRIC DOSAGES
OF Digoxin BASED ON AGE AND
Weight
• Before the physiologic differences between
adult and pediatric patients were clarified, the
latter were treated with drugs as if they were
merely miniature adults.
• Various rules of dosage in which the pediatric
dose was a fraction of the adult dose, based
on relative age, were created for youngsters
YOUNG’S RULE
𝑨𝒈𝒆
• Dose of Child= 𝐱 Adult Dose
𝐀𝐠𝐞 𝐱 𝟏𝟐
Cowling’s rule:
• CHILD DOSE
𝐴𝑔𝑒 𝑎𝑡 𝑛𝑒𝑥𝑡 𝑏𝑖𝑟𝑡ℎ𝑑𝑎𝑦 𝑖𝑛 𝑦𝑒𝑎𝑟𝑠 𝑥 𝑎𝑑𝑢𝑙𝑡 𝑑𝑜𝑠𝑒
=
24
Fried’s rule for infants:
𝐴𝑔𝑒 𝐼𝑛 𝑚𝑜𝑛𝑡ℎ x 𝑎𝑑𝑢𝑙𝑡 𝑑𝑜𝑠𝑒
• INFANT DOSE =
150
• (e.g., Young’s rule). Today these rules are not
in general use because age alone is no longer
considered a singularly valid criterion in the
determination of accurate dosage for a child,
especially when calculated from the usual
adult dose, which itself provides wide clinical
variations in response. Some of these rules are
presented in the footnote for perspective and
historical purposes.
• Currently, when age is considered in
determining dosage of a potent therapeutic
agent, it is used generally in conjunction with
another factor, such as weight. This is
exemplified in Table 8.1, in which the dose of
the drug digoxin is determined by a
combination of the patient’s age and weight.
Clark’s rule, based on weight:
𝐰𝐞𝐢𝐠𝐧𝐭 𝐢𝐧 𝐥𝐛𝐬 𝐱 𝒂𝒅𝒖𝒍𝒕 𝒅𝒐𝒔𝒆
• INFANT DOSE = 𝟏𝟓𝟎 (average weight of adult in lb)
• NOTE: The value of 150 in Fried’s rule was an estimate of the age (12.5
years or 150 months) of an individual who would normally receive an
adult dose, and the number 150 in Clark’s rule was an estimate of the
weight of an individual who likewise would receive an adult dose
Example Calculations of Dose Based on Age