What governing body regulates he development and sale of drugs?
U.S. Food and Drug Administration
Pregnancy Category A
Controlled studies in women fail to demonstrate a risk to the fetus in the 1st trimester and no evidence of risk in a later trimester. The possibility of fetal harm appears remote. i.e. prenatal multivitamins, insulin, thyroxine, folic acid
Pregnancy Category B
Either animal-reproduction studies have not demonstrated a fetal risk but there are no controlled studies in pregnant women OR animal-reproduction studies have shown an adverse effect that was not confirmed in controlled studies in women in the 1st trimester (and there is no evidence of risk in later trimesters). Ex. penicillins, cephalosporins, azithromycin, acetaminophen, ibuprofen (in 1st & 2nd)
Pregnancy Category C
Either studies in animals have revealed adverse effects on the fetus and no controlled studies in women OR studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the fetus. Ex. most prescriptions medicines; antimicrobials, SSRIs, corticosteroids, and most antihypertensives
Pregnancy Category D
There is positive evidence of human fetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation). Ex. ACE inhibitors, angiotensin receptor blockers (ARBs), carbamazepine, cyclophosphamide, NSAIDs, tetracyclines, etc
Pregnancy Category X
Studies in animals or human beings have demonstrated fetal abnormalities OR there is evidence of fetal risk based on human experience. The risk of the use of the drug in pregnant women clearly outweighs any possible benefit. The drug is contraindicated in women who are or may become pregnant. Ex. methotrexate, oral contraceptives, statins, testosterone, warfarin, etc.
A cellular molecule to which a medication binds to produce its effects is called a receptor. A receptor may be thought of as the drug's specific target.
a higher amount of drug often given only once or twice, that is administered to "prime" the bloodstream with a level sufficient to quickly induce a therapeutic response
the first step for medications towards reaching target cells. The process by which drug molecules move from their site of administration to the blood
3 broad categories: enteral, topical, parenteral
First pass effect
oral drug is metabolized in liver to an inactive (or less active) form before it has an opportunity to reach target cells
Blood brain barrier
special anatomic barrier that inhibits many chemicals and drugs from exiting the blood
a.k.a. metabolism. Process used by the body to chemically change a drug molecule's structure and function. The liver is the primary site of drug metabolism, although the kidneys and cells of the intestinal tract also have high metabolic rates.
removal from the body including: renal, pulmonary, glandular, fecal, or biliary
the length of time required for the plasma concentration of a drug to decrease by one half after administration
a biologic condition that occurs when the body adapts to a substance after repeated administration
the amount of drug present in the body after repeated doses
When an antibiotic kills the host's normal flora, additional nutrients and space are available for pathogenic microorganisms to grow unchecked. The microbe responsible is usually resistant to the treatment given for the initial infection. Broad-spectrum antibiotics are more likely to cause superinfections because they kill many microbial species, which sometimes includes host flora (i.e. Clostridium albicans in the vagina, streptococci in the oral cavity, and Clostridium difficile in the colon)
kidneys most common organ systems affected by drugs because they filter large volumes of blood, most drugs are excreted by the renal route, some drugs are reabsorbed or secreted by the kidney exposing renal tubule cells to high concentrations of these agents, few drugs cause crystalluria in the urinary tract.
Liver detoxifies foreign chemicals that enter the body; Symptoms of impairment are vague/nonspecific: RUQ pain, anorexia, bloating, fatigue, N/V. Chornic signs: jaundice, itching, easy bruising, inability to metabolize drugs resulting in high serum drug levels.
Where can you look up the effects of alternative therapies and herbal medications?
The National Center for Complementary and Alternative Medicine (branch of National Institute of Health) offers current info on research involving these products.
the study of medications and their interactions with living systems
a.k.a. Pharmacotherapeutics; the use of drugs to diganose, prevent, or treat disease
produced or originating from within a cell or organism
originating outside an organ or part
an adverse mental or physical condition induced in a patient though the effect of treatment (i.e. phlebitis from IV)
the drug which all other drugs in is classification are compared
Suffix for ACE Inhibitors
-"pril" sisters (i.e. Captopril, enalapril, lisinopril)
Suffix for Beta-Adrenergic Blockers
the "lol" team (ex. metoprolol, atrenolol, propranolol)
drug's ability to reach systemic circulation (time it takes to be absorbed)
controlled drug is one whose use and distribution is tightly controlled because of its abuse potential or risk. Ranked 1-4, with schedule 1 being drugs with a high abuse risk
movement of drug throughout the body: absorption, distribution, metabolism, excretion
measure of a drugs safety. the ratio of a drug's lethal dose to its effective dose
as the dosage increase, the response to the drug becomes larger
Efficacy / Maximal Efficacy
the largest effect that the drug can produce (peak)
refers to the amount of drug we must give to elicit an effect
most drugs produce their actions by activating or inhibiting specific cellular receptors thereby enhancing or inhibiting a physiological process
mimic the action of endogenous substances (ex. insulin mimics endogenous insulin on receptors)
prevents the action of the endogenous substance thereby producing their effects by preventing the activation of receptors by agonists (ex. antihistamine blocks histamine)
bind to and activate a receptor, but elicit a smaller response than a true or full agonist
concurrent use of a large number of drugs. It increases the likelihood of unwanted side effects and adverse drug-to-drug interactions. Of particular concern in the elderly.