Transcript Children`s dosage forms

CHILDREN’S DOSAGE FORMS
•Children's dosage forms - a specific group
of drugs that require special conditions of
preparation, the strictest observance of
asepsis, operational discipline, full
responsibility for the preparation, quality
control and design to dispense drugs.
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Children's medicines - these
are drugs that are allowed for
use in pediatric practice in the
relevant age child doses, the
dosage forms that provide
therapeutic benefits and
convenience of currently
CLASSIFICATION PERIODS OF CHILDHOOD:
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- Infants (first 4 weeks of life)
- Chest age (1 to 12 months)
- Infancy (from one to three
years)
- Preschool age (from three
to seven years old)
- School age (from seven to
eighteen years).
Requirements for children's
medical forms
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High efficiency and high therapeutic bioavailability
Sterility (for newborns);
Stability;
No pyrogenic (for Babies);
Lack of allergic
No toxic.
Microbiological purity
Ease of use
Pleasant organoleptic properties (color, taste, effect, smell)
should provide a positive psychological - physiological effects on a child
(kind of dosage form, color, taste, effect, smell) - it is advisable not to use
injections;
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Drugs which are allowed to
take in pediatric practice,
shall not contain substances
that affect the growth or
development of tissues,
lowers immunity, are toxic,
do not contain preservatives
and dyes. For example,
violate Tetracycline tooth
enamel in children, affecting
the growth of bones,
streptomycin
and
gentamicinum can cause lo
toxicity.
Prohibited
medication
containing
alcohol for children under 1
year.
WHEN PRESCRIBING DRUGS TO CHILDREN SHOULD
FOLLOW THESE GUIDELINES:
 Antibiotics and sulphamids set
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Assign only the intended
according to etiology, the
dose of medicine according
properties of microorganisms, not
to age, body weight.
prescribe those drugs, which
often cause side effects, be
 Conduct preliminary test of
desirable after a preliminary test
tolerance and sensitivity to
for allergies and sensitivity to
drugs intended (perhaps the
appropriate groups A / B
mother).
(research and possibly mother)
 Consider the functional state
 Do not allow amplified drug
of vital organs of the body.
therapy for benign disease,
medication use short courses.
 Do not use both drugs with the
same mechanism of action.
FEATURES OF PRESCRIPTION DOSAGE FORM
FOR CHILDREN.
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• Medications for children are issued
on separate forms prescriptions
marked "Baby" and point the exact age
and weight of the child.
• Taking prescription should be
checked and potent doses of toxic
substances and the compatibility of
registered ingredients to consider the
rationality of the combination of
antibiotics, sulphanilamides and other
drugs.
• Doses of toxic and strong affective
substances in suppositories , compare
with doses for oral acceptance.
DOSAGE CHILDREN'S MEDICAL FORMS
Carried out taking into account several factors which
include:
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pharmacokinetics and pharmacodynamics of drugs;
child's age and weight;
the nature and severity of disease;
state of the liver, kidneys, heart;
individual sensitivity of the child;
household conditions of life, especially food;
climatic and geographical factors
medical anamnesis.
TO DETERMINE DOSES OF DRUGS IN
PEDIATRICS HAVE LONG USED TWO
METHODS:
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Empirical - your dose of the drug calculated for
children of different age groups based on the effect
which was observed from the drug in varying
doses.
The method is based on the selection of doses
that are determined by coeficients or special
formulas.
EMPIRICAL WHEN THE DOSE OF MEDICATION TO REDUCE
CHILDREN FROM ADULT DOSES ACCORDING TO AGE. IT IS
NOT QUITE ACCURATE, AS CHILDREN THE SAME AGE HAVE
DIFFERENT BODY WEIGHT, LODGING, MEALS, ETC.
ACCORDING TO THE METHOD PRESCRIBED TO CHILDREN:
LESS THAN 1 YEAR - 1 / 24 AND 1 / 12 OF THE ADULT
DOSE;
FROM 1 TO 2 YEARS - 1 / 12;
FROM 2 TO 4 YEARS - 1 / 6;
FROM D 4 TO 6 YEARS - 1 / 4;
FROM 6 YEARS TO 7 YEARS - 1 / 3;
FROM 7 YEARS TO 14 YEARS - 1 / 2;
FROM 14 TO 18 - 3 / 4;
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According to SPU dose for children can be expected depending
on age, taking the dose per unit.
For calculation drug dose can apply the formula:
 Child dose =dose of adult • weight of body of the child
70
 Child dose = dose adult • child's age in years
Child Age in years + 12
To calculate dose of sedative and narcotic drugs:
 Child dose = B (4 • а)+ 20 ,
100
B - dose for adult
a - the child's age in years.
ALL DOSAGE FORMS FOR CHILDREN PREPARING FOR THE GENERAL
RULES OF PREPARATION. PREREQUISITE FOR FOR PREPARING
MEDICAL SUBSTANCES FOR CHILDREN UNDER 1 YEAR - STERILITY
(MEDICINE FOR EXTERNAL AND INTERNAL USE, OIL) OR ASEPTIC
MANUFACTURING (OINTMENTS, SUPPOSITORIES, POWDERS).
ALL STERILIZATION MEDICATION TRY TO TASTE.
POWDERS PREPARED FOR THE GENERAL RULES WITH SUBSEQUENT
STERILIZATION IN AIR STERILIZER AT T = 180 ° C – 1 HOUR AND STORE 15
DAYS. TERMO LIABILITY SUBSTANCES ADDED IN ASEPTIC CONDITIONS.
ALL DOSAGE FORMS FOR CHILDREN PREPARING FOR THE GENERAL
RULES OF PREPARING. PREREQUISITE FOR LB FOR CHILDREN
UNDER 1 YEAR - STERILITY (MEDICINE FOR EXTERNAL AND
INTERNAL USE, OIL) OR ASEPTIC MANUFACTURING (OINTMENTS,
SUPPOSITORIES, POWDERS).
ALL STERILIZATION MEDICATION TO TRY TO TASTE.
POWDERS PREPARED UNDER THE GENERAL RULES WITH SUBSEQUENT
STERILIZATION IN AIR STERILIZER AT T = 180 ° C - 1:00 AND STORE 15
DAYS. TERMO LIABILITY SUBSTANCES ADDED IN ASEPTIC CONDITIONS.
MIXTURES PREPARED IN ACCORDANCE WITH THE ORDER
№197, "INSTRUCTIONS FOR PREPARATION OF LDF IN
PHARMACIES.” STERILIZING AT T = 120 ° C - 8 MINUTES. DO
NOT USE PRESERVATIVES AND STABILIZERS. TO IMPROVE
TASTE ADD FRUIT SYRUPS, LEMON ACID NOT ALLOW
PACKING MORE THAN 100 ML PER PRESCRIPTION.
SOLUTIO 0.02% DYMEDROLI PACKING NO MORE THAN 10
ML. SOLUTIONS FOR EXTERNAL USE - THE SAME AS
MEDICINE.
OILS FOR CHILDREN, SUCH AS PEACH, OLIVE, SUNFLOWER,
PETROLATUM IN STERILIZED IN THE BOTTLES FOR BLOOD
SUBSTITUTES ,T = 180 ° C - 30 MINUTES. MOST OF THESE
DOSAGE FORMS ARE STORED FOR 30 DAYS.
Often used mixtures, suppositories,
powders in pediatric practice .
 They are prepared by the general rules of
preparation of medical forms for adults,
following aseptic conditions
 Dosage form for infants must be sterile
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The technological process of preparing
children's medicine for babies includes the
following stages:
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Preparation of aseptic conditions
Preparation of dishes and accessories.
Preparation of solvents and drugs.
Dissolution of drugs.
Quality control solutions.
filtering solutions, checking the absence of mechanical
inclusions.
closing, preparation for sterilization (marking).
Sterilization.
Quality control and design of drugs for dispense.
Rp.: Phenobarbitali 0,1
Solutionis Natrii bromidi 3% 100 ml
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Misce. Da. Signa. 1 teaspoon 3 times a
day (child 3 weeks)
higher single dose Phenobarbitali =0,005
higher daily dose Phenobarbitali =0,01
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Design to dispence
RP.: SOL. GLUCOSI 10% - 100 ML
ACIDI GLUTAMINICI 1,0
M.D.S. TEASPOON THREE TIMES A
DAY (CHILD 11 MONTHS)
WCP (R.S.)
GLUCOSE : 10.0
ACIDI GLUTAMINICI 1.0.
SOLIDS SUBSTANCES> 3% CONSIDER
RATE OF INCREASE OF
AQUAE PURIFICATE 100 –
(10Х0,64+1Х0,62) = 93 ML.
WCP (F.S.)
DATE
№ PRESCRIPTION
AQUAE PURIFICATAE 93 ML.
ACIDI GLUTAMINICI 1,0
GLUCOSI 10,0
V=100ML
STERILIS
PREPARED
CHECKED