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Pharmacokinetics
Absorption, Distribution, Metabolism, Elimination (ADME)
Absorption
drug molecules travel from the site of administration, across cell membranes and into the circulatory system
Distribution
Drug travels from the circulatory system accross barrier membranes to the site of action.
Metabolism
conversion of active drugs to a compound that can be easily removed or the conversion of pro drugs to active drugs
Elimination
which a drug is removed from the body.
A
FDA considers to be therapeutically equivalent to other pharmaceutical equivalent products
AA
Products in conventional dosage forms not presenting bioequivalnce problems
AB 1-3
products meeting necessary bioequivalnce requirements
B
Drug products that the FDA at this time considers not to the be theraputically equivalent to other pharmaceutically equivalent products
B*
drug products requireming further FDA investigation and review to determine theraputic equivalence
BT
bioeqvalence issues
BX
data is insufficient
addition
the combined effect of two drugs is equal to the sum of their effects of each drug taken alone
antagonism
one drug works against the action of another drug
potentiation
one drug increases or prolongs the effects of another drug, the total effect is greater than the sum of the effects of each drug alone
synergism
the joint action in which their combined affect is more intense or longer in duration than the sum of the effects of two drugs
Black Boxed warning
designed to call attention to serious or life-threatening risks
pregnancy and lactation labeling ruling (PLLR)
3 subsections, 8.1(pregnancy), 8.2(lactation), 8.3(the females and males reproductive potential)
Chemical name
determined by chemical structure of the drug entitiy
proprietary (brand or trade) name
assigned by the drug manufacturer and is protected through a patent
non proprietary (generic) name
assigned to a medication and contains a word stem that has been issued by the U.S. Adopted Names Council
Dysrthrythmia
an irregular heartbeat resulting from a malfunction of the cardiac conduction system
atrial flutter
a type of abnormal heart rate, or arrhythmia, occurs when the upper Chambers of the heart beat too fast
atrial fibrillation
an irregular, often rapid heart rate that commonly causes poor blood flow. The hearts rates upper chamber beat out of coordination with the lower chambers
bradycardia
a heart rate of less than 60 beats per minute
tachycardia
a heart rate of more than 100 beats per minute
congested heart failure (CHF)
the pumping ability of the heart is unable to meet the metabolic needs of the body’s tissues, resulting in the heart pumping less blood than it receives and blood accumulates in the Chambers of the heart.
Myocardial infraction (heart block)
the heart muscle does not receive enough oxygen because of a reduced blood supply, and muscle cells die.
angina pectoris
chest pain is experienced because of an imbalance between oxygen supply and demand. Characterized by a severe squeezing or pressure-like chest pain.
unstable angina
acute coronary syndrome, causes unexpected chest pain and usually occures while resting
prinzmetals (variant angina)
occurs when a person is at rest, usually between midnight and early morning.
hypertension
systolic pressure greater than 140 mm Hg and diastolic pressure greater than 90 mm Hg. (does not have symptoms)
stroke
interruption of the oxygen supply to a specific area of the brain caused by a rupture or obstruction of the blood vessel, resulting in a loss of consciousness.
Hemorrhagic
type of stroke occurs when a weekend blood vessel ruptures
ischemic
a temporary reduction in oxygen and blood in a portion of the brain
hyperglycemia
an elevation of one o more of the lipoprotein levels
atherosclerosis
a buildup of fatty materials or plaque, usually cholesterol, in the arterial blood vessels
COPD
includes chronic bronchitis and emphysema and is chronic lung disease that makes it hard to breathe.
Emphysema
destruction of alveoli, walls, or air sacs, of the lungs, resulting in the obstruction of the airflow.
Capsules instabilty
changes in physical appearance of the capsule or its contents, such as hardening, brittleness, or softening of the shell
solutions/elixirs/syrups instability
formation of precipitates, discoloration, haziness , gas, and microbial growth, unclear and inappropriate color or odor
suspensions instability
difficulty in re suspending, crystal growth, nonuniform particle size distribution and viscosity
emlusions instability
nonuniform globule size distribution and viscosity, breaking, creaming, gas formation, discoloration, and microbial growth.
ointment instability
nonuniform appearance and uncharacteristic growth, grittiness, and change in consisten
creams
nonuniform appearance or uncharacteristic growth, emulsion breakage, shrinking die to evaporation, crystal growth, microbial contamination and discoloration
gel instability
nonuniform appearance and uncharacteristic odor, shrinkage, seperation of liquid from gels, oil stains on the packaging
suppository instability
nonuniform appearance, excessive softening, drying, hardening, shriveling
Chemical incompatibility
oxidation-reduction, hydrolysis, intrionic compatibility, decarboxylation, racemization, epimerization
freezer
-25C through -10C (-13F through 14F)
cold
not to exceed 8C (46F)
cool
8C through 15C (46F through 59F
room temperature
15C through 30C (59F through 86F)
warm
30C through 40C (86F through 104F)
excessive heat
any temperature above 40C (104F)
dry temperature
conditions do not exceed 40% humidity at controlled room temperature
BUD (beyond use date)
the day after which a compound preparation shall not be used and is determined from the data when the preparation is compounded
USP 795
nonsterile products
USP 797
sterile products
USP 800
hazardous products