3. KHASIAT OBAT BERDASARKAN GOLONGAN OBAT
Parasetamol, antacid, vitamin dan
mineral
OBAT BEBAS
01 Antibiotik, antifungi oral,
antihipertensi, antidiabetes, obat
hiperlipidemia, obat saluran
cerna,psikotropika, dll
OBAT KERAS
02
Bromhexin, decadryl, neo ultracilin,
peditox, Actifed, antihistamin (CTM,
difenhidramin, dimenhidrinat), antie
metik (antimo), piperazin, prometazo
n, mebendazol, klorokuin, kalii kloras
, suppositoria, obat tetes mata untuk
iritasi ringan, dll.
OBAT BEBAS TERBATAS
03 Codein, morfin, codipront, petidhin
NARKOTIKA
04
4.
5.
6.
7. Indikasi obat
• Concise but clear; no ambiguity specificity when needed)
• Allows ready identification of approved indication(s)
• Reflects scientific evidence accurately (review issue)
• Uses current terminology that is clinically relevant, scientifically valid, unders
tandable
• Consistent within/across drug and therapeutic class, where possible
• Aids the indexing of indications in electronic drug data bases, medical informatio
n systems
8. Indikasi obat
Basic structure and required elements:
DRUG-X is indicated
..... for the treatment, prevention, mitigation, cure, or diagnosis
(or relief of symptoms)
..... of a disease or condition (or manifestation thereof)
...... in {age group, e.g., adults and pediatric patients age Y years and older}
Include:
a. Age group
b. Other information necessary to describe appropriate use
• Descriptors identifying indicated population(patient/disease sub group)
• Adjunctive or concomitant therapy, if part of indicated use
• Specific tests needed for patient selection for therapy
9. Indikasi obat
Examples of Including Descriptors
Required Adjunctive or Concomitant Therapy
and Patient/Disease Subgroup
DRUG-X is indicated in combination with an aromatase inhibitor as initial en
docrine-based therapy for the treatment of postmenopausal women with horm
one receptor (HR)-positive, human epidermal growth factor receptor 2 (HE
R2)-negative advanced or metastatic breast cancer.
DRUG-X is indicated for the treatment of carcinoid syndrome diarrhea in combi
nation with somatostatin analog (SSA) therapy in adults inadequately contr
olled by SSA therapy.
10. Indikasi obat
Example of Including Descriptors –
Patient/Disease Subgroup; and
Tests Needed for Patient Selection
Acute Myeloid Leukemia
DRUG-X is indicated for the treatment of adult patients with relapsed or refract
ory acute myeloid leukemia (AML) with an isocitrate dehydrogenase-2 (IDH2)
mutation as detected by an FDA-approved test.
Patient Selection
Select patients for the treatment of AML with DRUG-X based on the presence of
IDH2 mutations in the blood or bone marrow [see Indications and Usage (1.1) an
d Clinical Studies (14.1)]. Information on FDA-approved tests for the detection of
IDH2 mutations in AML is available at http://www.fda.gov/CompanionDiagnostics
.
11. Efek samping obat
An adverse drug reaction (ADR) can be defined as ‘an appreciably harm
ful or
unpleasant reaction resulting from an intervention related to the use of a
medicinal product; adverse effects usually predict hazard from future ad
ministration and warrant prevention, or specific treatment, or alteration o
f the dosage regimen,or withdrawal of theproduct.
Since 2012, the definition has included reactions occurring as a result of
error, misuse or abuse, and to suspected reactions to medicines that ar
e unlicensed or being used off-label in addition to the authorised use of
a medicinal product in normal dose
12. Efek samping obat
Traditionally, ADRs have been classified into two types:
1. Type A reactions–sometimes referred to as augmented reactions – w
hich are ‘dose-dependent’ and predictable on the basis of the pharm
acology of the drug
2. Type B reactions–bizarre reactions–which are idiosyncratic and not p
redictable on the basis of the pharmacology
13. Dosis obat
The dose is the amount of drug taken at any one time. This can be expressed as the weight of
drug (e.g. 250 mg), volume of drug solution (e.g. 10 mL, 2 drops), the number of dosage form
s (e.g. 1 capsule, 1 suppository) or some other quantity (e.g. 2 puffs).
The dosage regimen is the frequency at which the drug doses are given. Examples include 2.
5 mL twice a day, one tablet three times a day, one injection every four weeks.
The total daily dose is calculated from the dose and the number of times per day the dose is t
aken.
The dosage form is the physical form of a dose of drug. Common dosage forms include tablet
s, capsules, creams, ointments, aerosols and patches. Each dosage form may also have a nu
mber of specialized forms such as extended-release, buccal, dispersible and chewable tablets
. The strength is the amount of drug in the dosage form or a unit of the dosage form (e.g. 500
mg capsule, 250 mg/5 mL suspension).
14. Dosis obat
The route of administration is the way the dosage form is given. Common routes
of administration include oral, rectal, inhalation, nasal and topical.
The optimal dosage is the dosage that gives the desired effect with minimum sid
e effects.
There are many factors taken into consideration when deciding a dose of drug - i
ncluding age of the patient, weight, sex, ethnicity, liver and kidney function and w
hether the patient smokes. Other medicines may also affect the drug dose.
Dosage instructions are written on the doctor's prescription or hospital chart, and
on the pharmacy label of a prescribed medicine. Dosage instructions are also fou
nd on the packaging and inserts of over-the-counter medicines.
