INDEX

PAGE.
SR.NO TITLE
NO

1. Introduction 02

2. Pharmacokinetics Properties of Neonates and Infants 03

3. Pharmacodynamic in Neonates and Infants 05

4. Pediatrics Drug Dosage 06

5. Metabolic Disturbance and Drug Response 07

6. Genetic Predisposition and Drug Response 07

7. ADR In Neonates and Infants 09

8. Rules of prescribing for Pediatrics Population 10

9. Pharmacokinetics In Geriatrics Care 11

10. Pharmacodynamic In Geriatrics Care 12

11. Rules Of Prescribing For Elderly Population 13

12. ADR In Geriatrics 14

13. Conclusion 15

14. Reference 16

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 Drug Therapy of Neonates Paediatrics and Geriatrics

1. Introduction

To study drug deposition in children the extra uterine period of growth and development can be divided
into 5 stages.

a. Newborn Infants Born Before 9 Months Of Gestational Period Are Known As Premature.
b. Those Between 1 Day And 1 Month Of Age Are Called Neonates.
c. Those Between 1 Month To 1 Year Of Age Are Called Infant.
d. Those Between 1 Year To 11 Years Of Age Are Called Children. ( during 1-4 years of age drug
deposition are almost stable and in age of 5-11 years the drug elimination is even superior then
adult )
e. Those Between 12-16year Of Age Called Adolescents. ( Pharmacokinetics Is Fully Matured )

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Objectives:-

a. Discuss the principles of prescribing in paediatrics and geriatric age groups.

b. Discuss the pharmacokinetics and pharmacodynamic difference in paediatric, geriatric and adult age
groups.
c. Describe how the efficiencies of drugs vary according to age.
d. Describe different paediatrics dosage forms and compliance in children.
e. Discuss important adverse drug reaction occurring in geriatric and paediatrics age groups.

What is the different from normal adult prescribing?

Children cannot be regarded as miniature adults in drug response, due to difference in body
constitution, drug absorption and elimination, and sensitivity to adverse reaction.

2. Drug Absorption and Bioavailability in Neonates and Infant:-

 From Gastro Intestinal Tract:-

Two factors affecting the absorption of drug from GIT

I. GASTRIC ACID:-
Gastric PH is elevated in premature infants due to under developed acid secretion process. In
premature infants high serum concentration of acid sensitive drug e.g. penicillin G and ampicillin
is observed.

II. GASTRIC EMPTYING :-

Gastric emptying is slowing in premature so the drugs are 100% absorbed because of prolonged
contact time GIT mucosa. e.g. G. E. R and pyloric serosis. Diarrhoea impairs absorption.

Bile salt production is 50% in premature and infants. Vitamin absorption is only 30% in premature and
infants. If Gastric emptying time is prolong the drug are more absorbed from stomach but small intestine
absorption is delayed.

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  From intra muscular sites :-

Premature infants slow erratic drug absorption from intra muscular because of their small muscle mass
and heamo dynamic instability.

3. Drug distribution in neonates and infants:-

Distribution of drugs in neonates in different paediatric age group depends upon.

 body water
 extra cellular fluid volume
 fat content
 permeability through blood brain barrier
 presence of pathologic conditions

All these factors affect the drug therapy. Thus water soluble drug with low tissue protein binding. The
disease states also affect the gastric emptying:-sulphonamide, benzyl penicillin, amoxicillin will be
retained mostly in E.C.F.

Fat content may also affect drug concentration because of some highly lipid soluble drugs
e.g. diazepam (distribution less widely in premature and newborn infant)

The newborn have low protein binding. The permeability through blood brain barrier is different in
neonates and infants as compared to adults. The development of blood brain barrier is incomplete in
newborn and there is increase permeability of lipid soluble drug. e.g. sedative, narcotics, analgesic,
tetracycline etc. Other factors like adosis, hypoglycaemia and hypothermia also alter the blood brain
barrier permeability of infants.

4. Drug metabolism in neonates and infants:-

Drug metabolism is substantially slower in premature, neonates and infants as compared to older children
and adults.

a) Phase-I:- Developed capacity for demethylation and not of hydroxylation.

b) Phase-II:- Developed capacity for sulphate conjugation.

The causes of Chloramphenicol induced fatal “Gray baby syndrome” in newborn. It increases the
metabolism of chloramphenicol by glucoronyl transferees to inactive glucoronide metabolite.

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Metabolism of drugs such as theophyllin, Phenobarbital and phonation by phase-I oxidation is also
impaired in newborn infants. Premature full term infants and newborns have a low capacity of phase-I
hydroxylation.

5. Drug elimination in neonates and infants:-

Globular filtration in the neonate is only 30-40% of the adult value. It is even lower in premature neonates
by 4-8 months it reaches the adult value.

Tubular secretion and reabsorption process is only 20% of adult value in full term neonates. The renal
elimination also depends on two factors.

a) Renal blood flow:- Renal blood flow which is reduced both premature and full term neonates and
the adult value are 6-12 months of age.
b) Protein binding:- Protein binding which affects globular filtration through glomerulus.

All the process reflects the efficiency of renal excretion as a result of neonates requires lesser dose and
less frequent dosing intervals for various antibiotics. Antibiotics have a primary route of administration in
renal. e.g. amino glycosides are administered every 8 hrs in children and every 12 hrs in newborn and
every 24 hrs in premature. Renal excretion of penicillin, Furosemide and indomethacin is also very low in
newborn.

6. Pharmacodynamic in neonates and infants:-

Indomethacin which causes the rapid closure of potent ducts arteriosus that would otherwise require
surgery on a normal infant heart.

Infusion of PGE1 to maintain the potency of the duct us arteriosus which can be life saving in infants

Methyl phenidate which is used paradoxically to treat hyper kinetic children.

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7. Paediatric drug dosage:-

Most drugs approved for use in children have recommended paediatric doses, generally stated as
milligrams per kilogram.

7.1. Proportioned to age:-

a) Young’s formula:-

Dose for child = ×

b) Dilling formula:-

Dose for child = ×

c) Fried’s formula:-

Dose for child = ×

7.2 Proportioned to body weight:-

Dose for child = ×

7.3 Proportioned to body surface area:-

Dose for child = ×
.

7.4 Clark’s formula:-

Dose for child = ×

7.5 Cowling’s formula:-

( )
Dose for child = ×

7.6 Bastedo’s formula:-

( )
Dose for child = ×

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8. Metabolic disturbance and drug response:-

Factor like acidosis’ fever also affect drug response in paediatric therapy. In sick children the
disturbances in acid base balance and acidosis is more common. Thus acidosis children are more prone
to suffer with aspirin toxicity metabolic acidosis. Aspirin uptake in CNS and other tissue increased.

9. Genetic predisposition and drug response:-

Malignant hyperthermia followed by general anaesthetic is more frequent in children between the ages of
5 to10. e.g. halothane, succinyl choline.

The Normal Child:-

Growth and development are important indicators of a child’s general well-being and paediatrics
practitioners should be aware of the normal development milestones in childhood. The world health
organization (WHO) has published the widely used growth charts.

Three important tools in developmental assessment

 Height
 Weight
 Head circumference

In addition to the above, assessments of hearing, vision, motor development and speech are undertaken at
the child health clinics.

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Monitoring parameters:-
Paediatric vital sings, biochemical and haematology parameters change throughout childhood.
It gives idea about therapy management in prolonged treatment.

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Paediatrics dosage forms and compliance:-

 a) Children under the age of five years may have difficulty in swallowing even small tablets, and
hence oral preparations which tasted pleasant are often necessary to improve compliance. ( Elixirs
and suspensions)
 b) Pressurized aerosols (e.g. salbutamol inhaler) in children over the age of ten years, as
coordinated deep inspiration is required. Nebulizers may be used.
 c) Children find intravenous infusions uncomfortable and restrictive. Rectal administration is a
convenient alternative (e.g. metronidazole to treat anaerobic infections). Rectal diazepam is
particularly valuable in the treatment of status epilepticus. Rectal administration should also be
considered if the child vomiting.

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10. Adverse Drug Reaction:-

Some specific adverse drug reaction is:-

a) Aspirin: - Reyes syndrome in children

b) Chloramphenicol: - Gray baby syndrome

c) Diazepam: - Respiratory depression

D) Ethambutol: - Visual impairment

e) Furosemide: - Nephro calcinosis

f) Indomethacin: - Renal toxicity

g) Tetracycline: - Dental hypoplasi

11. Rules of prescribing for paediatric populations:-

 Calculation the doses for prescribed drugs based on weight of the patients.
 Ensure proper instructions to the care given, including when the child vomits the given medication
after consumption.
 Ensure that all medicines are strictly out of reach of children at all times.
 Avoid prolonged treatment with drug that have delayed complications ( steroids ).
 Use antibiotics sparingly and only when require.
 Medications affecting the CNS need to be extensively reviewed and routinely monitored to ensure
minimal growth disturbances.

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12. Geriatric care:-

Rapid physiological changes take place with aging process, which make elderly patients unable to cope
with body stresses. This also leads to alteration in pharmacokinetic and pharmacodynamic profiles of
drugs administration. Drug toxicity, side effect and adverse drug reaction (ADR) appear more life
threatening in such patients. Among the elderly people senses like memory, vision, vestibular function,
and muscular strength are decreased. In addition to this, they are also susceptible to infections and to
contacting chronic ailments.

13. Age related changes:-

a) Advance age brings inevitable changes like slow muscular atrophy.

b) There is 20-30% decrease in lean body mass, especially from 30 to 80 years of age.

c) Fat-free mass diminishes from 60-80%

d) Albumin pool is reduced by 20%

e) Cellular mass decreases from 30 to 65%

f) Fat increases with age especially in men from 18 to 36%

g) Reduction in motor function, often leads to vehicular accidents.

h) Visual and auditory degeneration causes misunderstanding and confusion.

14. Age related pharmacological changes:-

There is a significant alteration to drug response, as a result of physiological and pharmacological

changes. Some of them are as follows:

Drug absorption: - Little evidence of any major alteration in drug absorption with age. However,
condition associate with age may alter rate at which some drugs are absorbed. (Diabetic gastroparaesis,
laxative abuse)

Distribution: - Elder have reduced lean body mass, reduced body water.
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Metabolism: - Capacity of liver to metabolize drugs does not appear to decline consistently with age
for all drugs.

Elimination: - Kidney is major organ for clearance of drugs from body, age related decline of renal
functional capacity is important.

15. Pharmacodynamics:-

Pharmacodynamic changes in the elderly occur mainly due to decrease in neurotransmission activity
related to acetylcholine, DOPA and serotonin. Receptor sites are altered and CNS receptor is decreased.
CNS stimulants show decrease activity and CNS depressants show increased activity. All these changes
lead to various types of adverse drug events (ADR/ADE) which are discussed below.

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 16. Rules of prescribing for the elderly:-

I. Think about the necessity for drugs.

II. Avoid drugs with negligible or doubtful benefits.
III. Think about the dose.
IV. Think about the drug formulation.
V. Assume any new symptoms may be due to drug side effect.
VI. Take a careful drug history.
VII. Use fixed combinations of drugs rarely.
VIII. Check compliance.
IX. Think before adding a new drug to the regimen.
X. Stopping is as important as starting.

17. Adverse drug reactions in geriatrics:-

Adverse drug reaction manifests more in people above 60 years of age than in younger people. Reasons
for this may be stated as:

a) Multiple chronic disorders among the elderly require administration of large number of
medication.
b) Several physicians prescribe independently for different disease conditions and patients are on
multiple drug therapy.

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c) Inappropriate identification of adverse drug reaction (ADR), due to complexity of
pathophysiological changes.
d) Patients not complying or self medicating improperly due to lack of understanding.
e) Inadequate patient education for prescription drugs and over the counter (OTP) drugs.

Drugs Preferably To Be Avoided In the Elderly

DRUGS REASON

 All barbiturates Confusion

 Bthanidine Severe postural hypotension

 Carbenoxolone Fluid retention and congestive cardiac failure

 Chlorthalidone Prolonged dieresis, incontinence

 Debrisoquine Postural hypotension

 Gaunethidine Postural hypotension

 Pentazocine Confusion, variable efficiency

 Rserpine Depression

 Streptomycin Ototoxicity

 Tetracycline Rising blood urea in the presence of impaired renal

function.

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CONCLUSION:-

The use of drugs in the neonates requires careful consideration and monitoring by the healthcare team.
The pharmacokinetic parameters differ from those of adults, because of the unique characteristics and
needs of this special population. A number of drugs have been used very successfully and, as more
experience is gained with a wider variety of therapeutic agents, more options, as well as additional
challenges, will arise.

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 REFRENCES:-

1. Introduction of neonates and infant from Wikipedia, the free encyclopaedia. Available from:
http://en.wikipedia.org/wiki/introduction of neonates and infant.org

2. Natalie Schellack article, Pharmacokinetics and Pharmacodynamic properties of neonates and

infant page no 06, 2014

3. Dr. Atmaram, Modern Dispensing Pharmacy, dosage form of paediatrics and neonates page no
78-83, career publication.

4. Dr. Arif Hashmi article , rules of prescribing dosage in paediatric populations.

5. Dr. H. P. Tipnis and Dr. Amrita Bajaj, Pharmacokinetics and Pharmacodynamic properties of
geriatrics. Page no 80-82, career publication third edition.

6. Rules of prescribing for the elderly from Wikipedia, the free encyclopaedia. Available from:
http://en.wikipedia.org/wiki/introduction of Rules of prescribing for the elderly.org

7. Adverse drug reaction in elderly from Dr. H. P. Tipnis and Dr. Amrita Bajaj, page no 80-83
Career publication third edition.

8. Age related changes in elderly from Dr. H.P. Tipnis and Dr. Amrita Bajaj, page no.80 Career
publication third edition.

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 DECLARATION
I the undersigned, Shaikh MD Altaf Hussain student of. B Pharm IVth year of
Y. B. Chavan College of Pharmacy, Aurangabad, hereby declare that the Project
work entitled “Parentrals” has been carried out by me
I under the supervision and guidance of Mr. Altamash Ansari in the Y. B.
Chavan College of Pharmacy affiliated to Dr. Babasaheb Ambedkar Marathwada
University, Aurangabad, during 2017-18. The contents, presented in the Project,
are my own original research contribution and the same are not submitted to any
other college or university for award of any degree or diploma.
Date:-
Place: Aurangabad Mr. Shaikh Md. Altaf Hussain

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