This document contains information about pharmacopoeias, prescription writing, and drug names and forms. It defines key terms like pharmacopoeia, drug, medicinal form, and brand and generic names. It describes sections of pharmacopoeias including monographs, tables of drugs grouped by risk. Prescription writing guidelines are provided including who can write prescriptions, required elements, and special rules for controlled substances and antibiotics. Common medicinal forms and examples of prescriptions in the proper format are also summarized.
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Pharmacopoea-en.pptx
1. Available for download: http://pharmacology.jfmed.uniba.sk
Pharmacopoea
slides from lecture/seminar
Supported by
Culture and Education Grant Agency project KEGA 055UK-4/2012 „Case-studies inteaching
pharmacology and clinical pharmacology - use ofe-learning.“
and by
EuropeanSocial Fund project "Virtual and simulation teaching as a new form of education at JSMCU in
Martin" (ITMS code: 26110230071), co-financed from EU sources.
3. PHARMACOPEIA
book containing directions for the identification of
samples and the preparation of compound medicines
in a broader sense it is a reference work for drug
specifications (work of normative character)
4. - defines - requirements for the quality of drugs
- methods of the drugs evaluation
- establishment for production
for marking
for storage
for distribution of drugs
PHARMACOPEIA
7. definitions of the basic terms
tables
drug,s monographies
name, chemical structure, molecular weight, exam of
identity, purity, storage…
SLOVAK PHARMACOPEIA
8. Definitions of the basic terms
Remedy
the substance chemically homologous or heterogenous
the origin - synthetic or biological
the carrier of the biological (therapeutic) effect
used for protection, diagnosis, treatment
or modulation of physiological functions
9. remedy or remedy + pharmaceutical auxiliary agent
technological procedure
drug has medicinal form
Drug
10. Medicinal form
is characteristic for drug
it describes the form and the structure of the drug
liquid, solid, soft medicinal forms
12. Names of remedies
Chemical name
describes chemical structure of the drug
formula that indicates composition of the drug
long and complicated
Pharmacopoeia,s name
equal or similar to generic name (nonproprietory name;
name of an active substance)
13. name under which the drug is sold by a specific
manufacturer
also known as the Trade Name
name is owned by the drug company and no other
company may use that name
same drug may have several different brand names
Brand name, Proprietary Name
16. Table I
venena - poisons
very potent active substances
name - white letters on black label
atropini sulfas
17. Table II
separanda
potent active substances
name - red letters on white label
§ controlled (scheduled) drugs
§ morphine, amphetamine, opium, codeinum ...
18. use and distribution is tightly controlled because
of its risk of abuse
controlled drugs are rated in the order of their
abuse risk and placed in Schedules
the drugs with the highest abuse potential are placed in
Schedule I, and those with the lowest abuse potential are
in Schedule V
What is a controlled (scheduled) drug?
19. Schedule I
drugs with a high abuse risk
have no safe, are not accepted for medical use, only for
research
heroin, marihuana, LSD, crack, cocaine...
20. Schedule II
drugs with a high abuse risk, but have safe and accepted
medical uses
these drugs can cause severe psychological or physical
dependence
morphine, oxycodone, methylphenidate,
dextroamphetamine...
21. drugs with an abuse risk less than Schedule II
these drugs also have safe and accepted medical uses
Schedule III, IV or V
codeine, hydrocodone, diazepam, alprazolam,
propoxyphene, pentazocine...
22. therapeutic and maximal doses for adult
patients (single, daily)
other tables - therapeutic doses for children
manner of sterilisation
auxiliary agents, agent for diagnosis…
Table III
26. DRUGS
prescription drugs (or legend drugs)
require a prescription
because they are considered
to be potentially harmful if
not used under the
supervision of a licensed
health care practitioner
29. Definition of the prescription
A prescription is a
written or electronic
practitioner´s order to
prepare or dispense
a specific medication –
for an individual patient
31. Writing Prescriptions
Who can write a Rx?
• Practitioners
– physicians, veterinarians,
dentists, pediatrists
• Mid-level practitioners
– nurse practitioners,
physician assistants,
optometrists, pharmacists
- in some countries
34. Brand products
prepared in pharmaceutical companies
No individual approach
Costs – different – research
Brand products – trade names, generics
Long term stability (up to several years)
prescription – according to exact rules
39. EXTEMPORANEOUS DRUGS
prepared in pharmacy
individual approach
low cost
low stability (3-5 days)
precondition – skilful prescriber
prescription – according to exact rules
40. ORDER OF THE
SUBSTANCES
Scheme of prescription -
extemporaneous:
Ordinatio
1. Remedium cardinale
2. Remedium adjuvans
3. Remedium corrigens
4. Remedium constituens
41. RULES FOR PRESCRIPTION OF
EXTEMPORANEOUS DRUGS
Rp.
Codeinii dihydrogenphosphorici 0.3
Kalii bromati 0.1
Sirupi simplicis 30.0
Aquae destillatae ad 150.0
M. f. sol.
SUBSCRIPTIO
Da ad vitrum
S. three times per day 1 tablespoon
ORDINATIO/COMPOSITIO
SIGNATURA
42. Signatura
In the language of patient
Instructions for use – clear
Latin
Ad usum proprium
Ad usum medici
Ad manus medici
Suo nomine
Cum formula
43. ad manus medici / ad usum proprium (for medical hands)
cum formula (write the drug composition on the label of drug)
suo nominae (write original name of drug on the label)
sub signo veneni (sign drug as a poison)
Exceptions
44. 2 teaspoon twice daily
1 tablespoon before meal
for external use......
Signatura– extemporaneous drugs
45. Periculum in mora! (Danger in delay!)
Periculum in mortis! (Danger in death!)
- full address of the prescriber
Statim! (Instantly!)
Cito! (Rapidly!)
47. Opiates
Special blank – blue strip, three copies
Only one drug per blanket
Amount of drug in medicinal form – by
word in Latin
Validity of prescription – 5 days, only in
the region of prescribing physician
48. Controlled substances - opiates
separate rules for preparation, storage, prescription...
label has oblique blue stripe
prescription -1 original + 2 copies
or 1 original + 3 copies
1 kind of drug only
1 packing by Latin language §
49. It is not a legal prescription unless
it is signed and dated
50. current drugs - 7 days
- 5 days
- 3 days
- 24 hours
opiates
antibiotics
emergency
on 1 prescription - 2 kinds of drugs
- 3 packages of each
Validity of the prescription
51.
52. Prescribe 2 packages (30 tabletes in one package)
of 5.0 mg bisoprololum fumaras. Dosing regiment:
1 tablet twice daily.
1. prescription
- for p.o. use (tbl.) with only 1 active substance
- divided medicinal form - tbl.
- packing
53. Rp.
Bisoprololum fumaras p.o. tbl. á 5 mg
Scat. orig. á 30 tbl. No II (duas)
S. Take 1 tablet twice daily
Rp.
Bisoprololum fumaras p.o. tbl. flm. á 5 mg
(CONCOR 5 tbl flm)
Scat. orig. á 30 tbl. No II (duas)
S. Take 1 tablet twice daily
54. Prescribe 60 tablets of 5.0 mg bisoprololum
fumaras. Dosing regiment: 1 tablet in the morning.
2. prescription
- for p.o. use (tbl.) with only 1 active substance
- divided medicinal form - tbl.
- pieces
55. Rp.
Bisoprololum fumaras p.o. tbl. á 5 mg
Exp. orig. No LX (sexaginta)
S. Take 1 tablet in the morning
Rp.
Bisoprololum fumaras p.o. tbl. á 5 mg
Tab. orig. No LX (sexaginta)
S. Take 1 tablet in the morning
Rp.
Bisoprololum fumaras p.o. tbl. flm. á 5 mg
(CONCOR 5 tbl flm)
Exp. orig. No LX (sexaginta)
S. Take 1 tablet in the morning
56. Prescribe 2 packages of CANIFUG-LOSUNG 1%
sol der of 50 ml, dosing regiment: 2 times daily on
the affected skin.
3. prescription
- for not p.o. use (sol. der.)
- non-divided medicinal form - sol der
- packing
57. Rp.
CANIFUG-LOSUNG 1% sol der
Scat.orig. á 50 ml No II (duas)
S. Apply 2 times daily on the affected skin
Rp.
CANIFUG-LOSUNG 1% sol der
Exp.orig. á 50 ml No II (duas)
S. Apply 2 times daily on the affected skin
Rp.
CANIFUG-LOSUNG 1% sol der
Lag.orig. á 50 ml No II (duas)
S. Apply 2 times daily on the affected skin
58. 4. prescription
- for not p.o. use (sol.inj.)
- divided medicinal form - amp.
- pieces
- injection medicinal form
Prescribe 12 injections
of FUROSEMID BIOTIKA sol inj.
59. Rp.
FUROSEMID BIOTIKA sol inj
Exp. orig. á 2 ml No XII (duodecim)
S. Ad manus medici
Rp.
FUROSEMID BIOTIKA sol inj
Amp. orig. á 2 ml No XII (duodecim)
S. Ad manus medici
60. Prescribe 3 packages
of FUROSEMID BIOTIKA sol inj.
5. prescription
- for not p.o. use (sol.inj.)
- divided medicinal form - amp.
- packing
- injection medicinal form
62. 6. prescription
- for not p.o. use (sol.inj.)
- divided medicinal form - amp.
- pieces
- injection medicinal form
- controlled (scheduled) drug!
Prescribe 10 injections of (volume 1 ml)
§ MORPHIN BIOTIKA 1% sol inj.
63. Rp.
MORPHIN BIOTIKA 1% sol inj. (una pars
centesima or centigramma unum)
Exp.orig. á 1ml No X (decem)
S. Ad manus medici
Rp.
MORPHIN BIOTIKA 1% sol inj. (una pars
centesima or centigramma unum)
Amp.orig. á 1ml No X (decem)
S. Ad manus medici
65. in the right indication (bacterial infections - no virosis)
in the optimal doses
in regular time intervals (every 12,6... hours)
sufficient therapeutic periode (5 – 7 days)
for adult patients
for children - liquid medicinal forms
66. Prescribe ATB (for adult patient) with active
substance of Amoxicillinum in the concentration of
500mg in one medicinal form – tablet. Dosing
regiment: 1 tablet every 8 hours for 5 days
7. prescription
- for p.o. use (tbl.) with only 1 active substance
- divided medicinal form - tbl.
- ATB for adult patient!
67. Amoxicillin for adult patient:
dosage - 500 mg every 8 hours for 5 days
strength - tbl. á 1000, 125, 250, 375, 500, 750 mg
size of packing: 20x125 mg, 20x250 mg, 20x375 mg,
20x500 mg, 20x750 mg, 20x1000mg
we use for adult patient 500 mg
single dose – 500 mg = 1 tbl.
daily dose - 3 tbl.
for 5 days - 5 x 3 = 15 tbl.
1 packing with 20 tbl. (20x500mg)
68. Rp.
Amoxicillinum trihydricum p.o. tbl. á 500mg
(DUOMOX 500 tbl)
Scat. orig. à 20 tbl. No I (unam)
S. Take 1 tablet every 8 hours during 5 days
Rp.
Amoxicillinum trihydricum p.o. tbl. á 500mg
Scat. orig. à 20 tbl. No I (unam)
S. Take 1 tablet every 8 hours during 5 days
69. Prescribe ATB (for 3 years old child - weight of
child 15 kg) with active substances - Amoxicillinum
and Clavulan acid in the concentration of 156,25mg
in 5 ml of powder for oral suspension preparation.
Dosage for children is 25mg/kg/day. Dosing
regiment: take suspension every 8 hours during 7
days
8. prescription
- for p.o. use (tbl.) with 2 active substances
- non-divided medicinal form - suspension
- ATB for child!
70. AMOKSIKLAV for 3 years old child
- we use powder for oral suspension preparation (plu. por.)
- dosage for children 25 mg/kg/day
- daily dose to divide into 3 single doses
- weight of child – 15 kg
- therapeutic period: 7 days
- 5 ml of suspension contains 156,25 mg of effective
substances
- packing: 100 ml
- we use dose 25 mg/kg 25 x 15 = 375 mg = daily dose
-we divide daily dose into single dose - 375: 3 = 125 mg
- for 7 days: 7x375 mg = 2625 mg
- 5 ml of suspension contains 156,25 mg of effective substance
we use 4,0 ml for single dose
or we use 84 ml for the whole therapeutic period
- it is 100 ml of suspension in 1 packing
- 1 packing will be for 7 days (roughly)
71. Rp.
Amoksiklav 156,25 mg/5 ml plu por
Scat. orig. á 100 ml No I (unam)
S. Take 4 ml suspension every 8 hours for 7 days.
Shake before use!
Rp.
Amoksiklav 156,25 mg/5 ml plu por
Exp. orig. á 100 ml No I (unam)
S. Take 4 ml suspension every 8 hours for 7 days.
Shake before use!
Rp.
Amoksiklav 156,25 mg/5 ml plu por
Lag. orig. á 100 ml No I (unam)
S. Take 4 ml suspension every 8 hours for 7 days.
Shake before use!
72. Routes of drug administration
1. Topical route
Provides a local effect with few side effects
Drug can enter body through abrasions and cause systemic
effects
Solutions, emulsions, dry powders, ointments
They are applied on the skin, mucous membrane or into
body cavities (vaginal route...)
Epicutaneous (application onto the skin) e.g. allergy
testing, typical local anesthesia, inhalational (asthma
medications), eye drops (ATB for conjunctivitis), ear drops
(ATB, CS for otitis externa) ...
73. Routes of drug administration
2. Systemic route
Provides a systemic effect with side effects
Drug enters the blood circulation
enteral parenteral
74. Enteral administration
Involves any part of the gastrointestinal tract and has
systemic effects:
by mouth p.o. (orally) like tbl., cps. or drops
by gastric feeding tube, duodenal feeding tube or
gastrostomy (many drugs or enteral nutrition)
rectally, various drugs in suppository (50% of the drainage
of the rectal region bypasses the hepatic portal circulation ;
biotransformation of drugs that are metabolized by the liver is
minimized; prevention of side effects from GIT)
Drugs given by enteral administration may be subjected to significant first pass
metabolism, and therefore, the amount of drug entering the systemiccirculation
following administration may vary significantly for different individuals and
drugs.
75. same as oral route
more potent than oral route because drug directly enters
the blood and bypasses the liver
vasodilatans
Sublingual (s.l.) and buccal administration
76. intravenous (into a vein) e.g. many drugs, total
parenteral nutrition (i.v.) :
first-pass metabolism by the liver is avoided
may induce hemolysis, anaphylaxis ...
is used for drugs that are poorly absorbed from the GIT
is used for drugs that are unstable in GIT
treatment of unconscious patients
when we need the rapid onset of the action
Parenteral administration – intravenous i.v.
77. intra-arterial i.a. (into a artery) e.g. vasodilator drugs in the
treatment of vasospasm and thrombolytic drugs for tretamentof
embolism
intraosseous infusion (into the bone marrow), this route is
occasionally used for drugs and fluids in emergency medicineand
padiatrics when i.v. access is difficult
intra-muscular i.m. (e.g. depot preparations, many vaccines,ATB..)
subcutaneous s.c. (e.g.insulin ..)
transdermal – transdermal patch
intranasal – e.g. desmopressin (diabetes insipidus),calcitonin
(osteoporosis)
intrathecal – into cerebrospinal fluid (methotrexate – th malignacies)
Parenteral administration