UNIT 4 Flashcards
Trade names found in a specific country or region manufacturer specific
brand name
Used to refer to the drug in scientific and professional literature
generic name
Other names or accepted abbreviations of the generic drug
synonyms
Unique systematic classification of medications
It is defined by their therapeutic use (the pathology they are intended to treat
therapeutic category
Information pertaining to appropriate indications of the drug
May include both FDA approved and non-FDA approved indications
Use
Controlled substance classification for the Drug Enforcement Agency (DEA)
US schedules are l to V varies by country and sometimes by state
restrictions
Five categories established by the FDA to indicate the potential of a systemically absorbed drug for causing birth defects
pregnancy risk factor
Information pertinent to or associated with the use of the drug as it relates to cinical effects on fetus breast-feedingflactation and clinical effects on infants
pregnancy/breast feeding implications
Information pertaining to inappropriate use of the drug
An absolute prohibition to the use of the drug
Contraindications
Side effects of the drug usually grouped by percentage of incidence and/or body system.
It is an unwanted or harmful reaction experienced following the administration of a drug or combination of drugs under normal conditions of use and is suspected to be related to the drug
Adverse Reactions
Precautionary considerations hazardous conditions related to use of the drug and disease states or patient populations in which the drug should be cautiously used
__________ are less restrictive alert to health professionals
__________ are information used to alert health professionals to certain dangers or restrictions in the Use of certain drugs
Warnings/Precautions
- Precautions
- Warnings
Comments and/or considerations offered when appropriate
Includes signs and symptoms of excess drug and suggested management of the patient
overdosage/toxicology
Indicates the capability of a drug to alter the effects of another drug once they are given together
Identifies whether a drug is an inhibitor, an inducer or a substance of specific enzyme.
drug interactions
Information regarding storage of product or steps for reconstitution
Provides the time and conditions for which a solution or mixture will maintain full potency
The degree to which or the length of time that the drug is resistant to change
stability
How the drug works to elicit a response
It is the specific means by which a drug achieves its effect
mechanism of action
The magnitude of a drug’s effect depending on its concentration at the site of action
____________ is expressed in onset of action and duration of action. It refers to the biological response of drugs, expressed in terms of absorption, distribution, metabolism and excretion
_____________ refers to the movement of drugs through the body
Pharmacodynamics
Pharmacokinetics
Pharmacodynamics and Pharmacokinetics
Amount of the drug to be typically given or taken during therapy for children and adults
Includes dosing adjustment or comments for renal or hepatic impairment, and other suggested dosing requirements.
usual dosage
Information offered for appropriate food, nutrition and/or alcohol
dietary consideration
The process of giving a therapeutic agent to a patient
Information regarding the recommended final concentrations, rates of administration for parenteral drugs, or other guidelines when giving the medication
administration
Laboratory tests and patient physical parameters that should be monitored for safely and efficacy of drug therapy
The parameters used to attain therapeutic response that is safe and prevent toxicity
monitoring parameters
Therapeutic and toxic serum concentrations listed including peak and trough levels
reference range
Listing of assay Interferences, when relevant
May indicate the alterations brought about by drug use on blood, serum and urine tests
testing interactions
Specific information pertinent for the patient
patient information
Includes additional instructions for the administration of the drug and monitoring tips from the nursing perspective
Are used to asses a patient and his environment before medication administration and monitor for skie effects and effectiveness of medication after administration
nursing implications
Information with regard to form strength and availability of the drug
It is defined as the physical form of a dose of a chemical compound used as a drug or medication
Intended for administration or consumption to treat or prevent an illness of disease.
dosage forms
Directions usually for preparing liquid formulations frorn solid drug products
May include stability information and references
a drug specially prepared by a pharmacist because an appropriate drug is not readily available
extemporaneous preparations
pharmaceutical dosage forms
- dosage form
- drug product
- active pharmaceutical ingredient
- excipient
A formulation containing a specific quantity of active ingredients in combination with one or more excipients
dosage forms
The finished dosage from that contains the active ingredient
drug product
The active pharmaceutical ingredient (API) or the component that produces the pharmacologic activity
API
The inactive ingredient present in the dosage form
excipient
Dispensing ophthalmic, nasal, otic or oral liquids to be administered by drop
dropper bottles
Dispensing solid dosage forms such as capsules or tablets
round vials
Dispensing liquids of low viscosity
prescription bottles
Dispensing bulk powders, large quantities of tablets or capsules or viscous liquids that cannot be poured readily from a narrow-neck standard prescription bottles
wide mouth bottles
Dispensing semi-solid dosage forms such as ointment, cream and gel
collapsible tubes
Dispensing powders applied by sprinkling
sifter top containers
Dispensing suppositories and powders prepared in packets
hinged-lid/slide boxes
For applying liquid medication onto the skin or wound
applicator boxes
Pressurized metal or plastic bottle used to dispense liquid or powder content as mist or foam
aerosols
A type of bottle required by pharmaceutical standards for preparations sensitive to light
amber-colored bottles
The least reactive glass available for containers which can be used for all applications
used for all laboratory apparatus in general
package water for injection
USP TYPE 1
borosilicate glass
It contains higher levels of sodium hydroxide and calcium oxide therefore making it less resistant to leaching that Type 1 but it is more resistant than Type 2: can be used for all products that remain below pH 7 for their shelf life
USP TYPE 2
soda-lime-silica-glass
The container acceptable for packaging some dry powders which are subsequently dissolved to make solutions or buffers
It is also suitable for packaging liquid formulations that prove to be insensitive to alkali
USP TYPE 3
soda-lime glass
A general-purpose glass and is used for non-parenteral applications where chemical durability and heat shock are not factors
these are frequent containers for capsules, tablets and topical products
USP TYPE NP Soda lime glass
Used in prescriptions and finished manufactured products except parenteral and ophthalmic solutions
purified water USP
Free of pyrogen, used as solvent for the preparation of parenteral solutions
water for injection
Packaged in single-dose containers of type I and II and does not exceed capacity of 1L
sterile water for injection
contains one or more suitable microbial agents. It is packaged in single or multi-dose containers of type I and II and does not exceed capacity of 30mL
bacteriostatic water for injection
Does not contain microbial agents and is not used for parenteral administration or sterile dosage forms.
sterile water for inhalation
Sterilized and does not contain microbial agents or added substances
sterile water for irrigation
