Poltekkes

Surakarta

14. KHASIAT OBAT

apt. Nur Atikah, M.Sc.
GOLONGAN OBAT
KHASIAT OBAT BERDASARKAN GOLONGAN OBAT

OBAT BEBAS OBAT KERAS

01 Parasetamol, antacid, vitamin dan
mineral
02 Antibiotik, antifungi oral, anti-
hipertensi, antidiabetes, obat hiper-
lipidemia, obat saluran
cerna,psikotropika, dll

OBAT BEBAS TERBATAS NARKOTIKA

03 Bromhexin, decadryl, neo ultracilin,
peditox, Actifed, antihistamin (CTM,
04 Codein, morfin, codipront, petidhin

difenhidramin, dimenhidrinat),
antiemetik (antimo), piperazin,
prometazon, mebendazol, klorokuin,
kalii kloras, suppositoria, obat tetes
mata untuk iritasi ringan, dll.
 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,
understandable
• Consistent within/across drug and therapeutic class, where possible
• Aids the indexing of indications in electronic drug data bases, medical
information systems
 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
 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

endocrine-based therapy for the treatment of postmenopausal women with
hormone receptor (HR)-positive, human epidermal growth factor receptor 2
(HER2)-negative advanced or metastatic breast cancer.

DRUG-X is indicated for the treatment of carcinoid syndrome diarrhea in

combination with somatostatin analog (SSA) therapy in adults
inadequately controlled by SSA therapy.
 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
refractory 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)
and 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.
 Efek samping obat
An adverse drug reaction (ADR) can be defined as ‘an appreciably harmful or
unpleasant reaction resulting from an intervention related to the use of a
medicinal product; adverse effects usually predict hazard from future
administration and warrant prevention, or specific treatment, or alteration of
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 are unlicensed or
being used off-label in addition to the authorised use of a medicinal product in
normal dose
 Efek samping obat

Traditionally, ADRs have been classified into two types:

1. Type A reactions–sometimes referred to as augmented reactions –
which are ‘dose-dependent’ and predictable on the basis of the
pharmacology of the drug
2. Type B reactions–bizarre reactions–which are idiosyncratic and not
predictable on the basis of the pharmacology
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
forms (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
taken.

The dosage form is the physical form of a dose of drug. Common dosage forms include
tablets, capsules, creams, ointments, aerosols and patches. Each dosage form may also have
a number 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).

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
side effects.

There are many factors taken into consideration when deciding a dose of drug -
including age of the patient, weight, sex, ethnicity, liver and kidney function and
whether 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
found on the packaging and inserts of over-the-counter medicines.

Dosis obat
Thank you