Lecture 3 (Over the Counter Drugs, Herbal and Dietary Supplements, Acid Controlling Drugs, and Potassium) Flashcards
How many classes of OTC drugs are there?
more than 80 classes
more than (BLANK) OTC products contain (BLANK) major active ingredients
more than 30,000 OTC products contain 800 major active ingredients
OTC drugs account for how much of the medications used in the US?
60%
how many ailments do OTC drugs cure?
more than 400 ailments
how many medications no longer need a RX to be used?
over 700 medications
how many people over the age of 65 take one OTC drug regularly?
up to 87%
how many people over the age of 65 use 5 or more OTC drugs or dietary supplements regularly?
over 5%
when did the FDA start an OTC drug review?
in 1972
describe the FDAs 1972 OTC drug review(5):
1) ensures safety and effectiveness of OTC drugs
2) established labeling standards
3) of 500 OTC products, 1/3 were found to be safe and effective for use
4) 1/3 of OTC drugs were found to be ineffective
5) The rest were found to be unsafe
since 2006, labeling of OTC drugs includes(5):
1) uses
2) directions
3) active and inactive ingredients
4) warnings
5) storage info
OTC drugs can be hazardous to patients with chronic diseases such as(5):
1) COPD
2) HTN
3) Diabetes
4) cardiovascular disease
5) glaucoma
what must a drug manufacturer do to have a prescription drug reclassified as an OTC drug?
The manufacturer must meet Indication for use, safety profile, and practicality for OTC use criteria through passing clinical trials
Describe the indication for use criteria manufacturers need to meet to reclassify a prescription drug to a OTC drug(3):
Consumers must be able to easily:
* Diagnose condition
* Monitor effectiveness
* Benefits of correct usage must outweigh risks
Describe the Safety profile criteria manufacturers need to meet to reclassify a prescription drug to a OTC drug(4):
Drug should have:
* Favorable adverse event profile
* Limited interaction with other drugs
* Low potential for abuse
* High therapeutic index
Describe the Practicality for OTC use criteria manufacturers need to meet to reclassify a prescription drug to a OTC drug(2):
Drugs should be:
* Easy to use
* Easy to monitor
how can the reclassification of prescription drugs to OTC drugs cost the consumer more money?
it can cause the consumer to pay more out of pocket due to it not being covered by insurance any longer
why are many OTC drugs misused?
lack of knowledge
what are some examples of prescription drugs that have been reclassified as OTC drugs(6)?
1) ibuprofen (Advil)
2) naproxen (Aleve)
3) diphenhydramine (Benadryl)
4) loratadine (Claritin)
5) famotidine (Pepcid AC)
6) omeprazole (Prilosec OTC)
describe the contents of Cough and Cold OTCs(4):
1) expectorants - loosen chest mucus
2) Nasal Decongestants - for stuffy nose
3) Antihistamines - for sneezing and runny nose
4) Antitussives - for coughs
What negative effects can acetaminophen (Tylenol) have if not used correctly?
can cause hepatic toxicity (liver failure); do not exceed 3-4g/day
what does non-steroidal anti-inflammatory drugs (NSAIDs) (Advil, Motrin, Aleve) increase your risk for?
1) GI ulceration
2) myocardial infarction
3) stroke
why are some nasal decongestants only sold behind pharmacy counters?
pseudoephedrine containing nasal decongestants are used to manufacture methamphetamine
what are some side effects that cough and cold products cause(4)?
1) over sedation
2) seizures
3) tachycardia
4) death in toddlers
how long should OTC drugs be used?
only in the short term treatment of common minor illnesses
what forms do dietary supplements come in(6)?
1) tablets
2) capsules
3) soft gels
4) gel caps
5) liquids
6) powders
how many people in the US are estimated to use supplements and how many of them have adverse reactions?
about 44 million people; 1/4 have adverse reactions
what are dietary supplements used for(3)?
1) treatment of diseases
2) prevention of disease
3) to preserve health
what sort of properties do herbs have?
medicinal and culinary
what percentage of herbs are used to make modern drugs?
about 30%
digitalis (Fox Glove) is used to make which pharmaceutical?
Digoxin
what sort of ailments are herbs used to treat(10)?
1) colds
2) coughs
3) upset stomach
4) constipation
5) depression
6) fever
7) headaches
8) anxiety
9) arthritis
10) insomnia
where are dietary supplements and herbs sold(6)?
1) grocery stores
2) pharmacies
3) health food stores
4) radio
5) television
6) internet
why does the general public think dietary supplements and herbs are safe?
they are advertised as natural
where are herbs found in nature(9)?
1) leaves
2) bark
3) berries
4) roots
5) gums
6) seeds
7) stems
8) flowers
9) plants
what are dietary supplements(9)?
1) vitamins
2) minerals
3) herbs and botanicals
4) amino acids
5) enzymes
6) organ tissue, glandular products
7) metabolites
8) extracts
9) concentrates
Describe Chamomile
characteristics: Anti-inflammatory
Considerations: Increased risk of bleeding with anticoagulants
Describe Cranberry
Characteristics: Prevention of UTIs
Considerations: Decreases how some medications are broken down in the liver
Describe Echinacea
Characteristics: Stimulates immune system
Considerations: May interact with counteraction immunosuppressant drugs
Describe Garlic
Characteristics: Cardiovascular use - decreases BP and helps lower LDL
Considerations: Increases risk of bleeding with anticoagulants and changes breakdown of medications in the liver
Describe Ginger Root
Characteristics: Decreases nausea and vomiting
Considerations: Can interfere with cardiac, antidiabetic, and anticoagulant drugs
Describe Gingko Biloba
Characteristics: Memory improvement
Considerations: Interacts with blood thinners
Describe St. Johns Wort
Characteristics: Used for depression
Considerations: Effects how meds are broken down. NOT to be used with antidepressants
what effect does the use of st. johns wort have when taken with serotonergic drugs?
it can lead to serotonin syndrome
what are serotonergic drugs?
selective serotonin reuptake inhibitors - anti-depressants
e.g. Celexa, Zoloft, and Effexor
what are symptoms of serotonin syndrome(7)?
1) fever
2) agitation
3) increased reflexes
4) tremor
5) sweating
6) dilated pupils
7) diarrhea
the Dietary Supplement and Health Education Act (DSHEA) was formed in 1994. what did it do at that time?
defined supplements and provided a regular framework; did not require proof of use, safety, or quality control
in 2010, the FDA required manufacturers of supplements provide data that demonstrates:(5)?
1) product identity
2) composition
3) quality
4) purity
5) strength of active ingredients
what are dietary supplements allowed to claim?
they can claim effect but not a specific cure
do dietary supplements need FDA approval?
no
what are antacids?
compounds that neutralize castric acidity but do not prevent the over production of acid
are antacids prescription or OTC?
1) common antacids are OTC; there are some antacids that are prescription
2) promote gastric mucosal defense mechanisms
what are some active ingredients of OTC antacids(4):
1) salts of aluminum
2) magnesium
3) calcium
4) sodium
describe how antacid pain reduction works
1) base-mediated inhibition of the protein-digesting ability of pepsin
2) increases the resistance of the stomach lining to irritation
3) increases the tone of the cardiac sphincter which reduces reflux in the stomach
what is the cardiac sphincter?
the sphincter that prevents stomach contents from going back up the esophagus
what are antacids used for(4)?
1) acute relief of acid reflux (Heart burn)
2) peptic ulcer
3) gastritis
4) gastric hypersensitivity
OTC antacids come in(6)…
1) capsules
2) tablets
3) powders
4) chewable tabs
5) suspensions
6) granules
what are some examples of magnesium antacids(3)?
1) Glaviscon
2) Milk of Magnesia
3) Mag-OX
what are some examples of aluminum antacids(2)?
1) Amphojel
2) Mylanta
what is an example of calcium antacids?
1) Tums
what are some examples of sodium antacids(2)?
1) bicarbonate salt
2) Alka-seltzer
what are the contraindications of antacids(4)?
1) allergy
2) renal failure
3) electrolyte imbalance
4) GI obstruction
what are some adverse effects of antacids(6)?
1) diarrhea from Milk of Magnesia
2) constipation from aluminum and calcium
3) kidney stones from calcium
4) overuse can cause systemic alkalosis from sodium bicarbonate
5) hyperacidity or acid rebound when antacids are stopped
6) long-term use can mask serious disease such as a bleeding ulcer or malignancy
what are the four basic interaction when it comes to antacids?
1) absorption of other drugs to antacids reduces the drug to be absorbed into the body
2) Chelation chemical inactivation of other drugs that produce insoluble complexes
3) increased stomach pH which increases the absorption of basic drugs and decreases the absorption of acidic drugs
4) Increased Urinary pH which increases the excretion of acidic drugs and decreases the excretion of basic drugs
to avoid antacid interaction with other drugs what should you do?
advise patients to dose any interacting drugs 1-2 hours before or after antacids are taken
what are some examples of drugs that interact with antacids(6)?
1) Allopurinol
2) Tetracycline
3) Captopril
4) Digoxin
5) Ciprofloxacin
6) Levofloxacin
what is used before histamine 2 receptor antagonists?
OTC anti-ulcer treatments
what do Histamine 2 receptor antagonists do(3)?
- competitively blocks H2 receptor of acid producing parietal cells; reduces, but does not completely alleviate acid secretion
- decreases stomach acidity
- relieves symptoms from hyperacidity related conditions
how long are typical histamine 2 receptor antagonist treatments?
4-6 weeks
what is Tagamet(3)?
1) first drug in this class to be released on the market
2) first major prescription drug to go OTC
3) rarely used now due to drug interactions; replaced by Pepcid
what are some conditions that histamine 2 receptor antagonist drugs are used to treat(3)?
1) GERD
2) stress ulcers
3) peptic ulcer disease
what is a parietal cell?
cell in the lining of the stomach that is the source of hydrochloric acid production and primary target for drugs used to treat acid-related disorders
describe hydrochloric acid(3)
- the primary substance secreted by the parietal cells in the stomach
- maintains stomach pH at 1-4
- aids in the proper digestion of food
what can cause overproduction of stomach acids?
- excessive consumption of large fatty foods or alcohol
- emotional stress
what are contraindications with histamine 2 receptor antagonists(3)?
1) drug allergy
2) liver dysfunction
3) kidney dysfunction
what are some adverse effects of histamine 2 receptor antagonists(13)?
1) headache
2) lethargy
3) agitation
4) confusion
5) hypotension with IV administration
6) diarrhea
7) nausea
8) cramps
9) increased prolactin secretion
10) increased blood urea nitrogen (BUN)
11) increased creatinine
12) elevated liver enzymes
13) anemia and rash
how often do adverse effects occur with histamine 2 receptor antagonists?
low incidence of adverse effects fewer than 3%
what are the interactions associated with Cimetidine (Tagamet)(3)?
1) highest risk of drug interactions in the older adult
2) inhibits metabolism of drugs in the liver and raises blood concentration of certain drugs
3) smoking decreases effectiveness of the drug
take histamine 2 receptor antagonists (BLANK) antacids
1-2 hours before
describe proton pump inhibitors (PPIs)
1) newest drug for treatment of acid-related disorders
2) more powerful than H(2) receptor antagonists
3) stops 90% of acid secretions over 24 hours
what are proton pump inhibitors (PPIs) indicated for(4)?
1) erosive esophagitis
2) GERD (reflux into esophagus) that is not relieved with H(2) receptor antagonists
3) benign gastric ulcers
4) Zollinger-Ellison Syndrome and Ulcers from NSAIDs
how do proton pump inhibitors work?
PPIs bind irreversibly and block all gastric secretions
what is Zollinger-Ellison Syndrome(2)?
- a tumor in the pancreas or upper small intestine (duodenum) which secretes large amounts of the hormone gastrin and causes the stomach to produce too much acid
- leads to peptic ulcers inside the lining of the stomach and upper portion of the large intestine
what are the proton pump inhibitor contraindication
drug allergy
are adverse effects with proton pump inhibitors common?
no, PPIs are well tolerated
what are possible adverse effects of PPIs(2)?
1) predisposes patient to GI tract infection because of a decrease in normal acid-mediated antimicrobial protection; PPIs are overprescribed
2) long-term use can cause osteoporosis due to inhibition of stomach acid; speeds up bone loss
how many drug interactions are associated with PPIs?
minimal drug interactions
what are the drug interactions associated with PPIs(4)?
1) may increase serum levels of diazepam (Valium) and phenytoin (Dilantin)
2) increases chances of bleeding if taken with warfarin
3) food decreases the absorption of PPIs
4) interferes with the absorption of ampicillin, iron, salts, and Digoxin
what are the selected proton pump inhibitors for this lecture(3)?
1) omeprazole (Prilosec)
2) lansoprazole (Prevacid)
3) pantoprazole (Protonix)
what is the most abundant cationic (positively charged) electrolyte in intracellular space (inside cells)?
potassium
what percentage of potassium is intracellular within the body?
95%
what is the normal extracellular (outside the cell) potassium level?
3.5 - 5 mEq/L
this level is critical for normal body function
what foods is potassium obtained from(5)?
1) juices
2) fruits
3) vegetables
4) fish
5) meat
what happens to excess dietary potassium?
it is excreted by the kidneys
what is potassium used for in the body(4)?
life-sustaining physiological functions such as:
1) muscle contraction
2) transmission of nerve impulses
3) regulation of heart beat
4) acid-base balance
what are the indications for potassium(3)?
Main Indication:
* treatment or prevention of potassium depletion when dietary means are inadequate
Other Therapeutic Uses:
* stopping irregular heartbeats
* management of tachydysrhythmias that can occur after cardiac surgery
what are the contraindications associated with potassium(7)?
1) allergy to potassium
2) hyperkalemia
3) severe renal disease
4) acute dehydration
5) Addison’s Disease (acute adrenal failure)
6) hemolytic disease
7) multiple trauma
what are the adverse effects possible with potassium?
oral(5);IV(2)
Oral Administration
* diarrhea
* nausea
* vomiting
* GI bleeding
* ulceration
IV Administration
* pain at injection site
* phlebitis
what can occur with excessive administration of potassium(2)?
1) hyperkalemia
2) toxic effects
what can cause hyperkalemia(10)?
1) potassium supplements
2) ACE inhibitors
3) electrolyte imbalance
4) reduced renal excretion
5) renal failure
6) excessive loss from cells
7) potassium-sparring diuretics
8) burns
9) trauma
10) infections
what can cause hypokalemia(9)?
1) decreased intake of potassium
2) electrolyte imbalance
3) diarrhea
4) vomiting
5) increased renal excretion
6) diuretics
7) steroids
8) antibiotics
9) digoxin toxicity
what levels of potassium in the blood is hyperkalemia?
> 5 mEq/L
what level of potassium in the blood is hypokalemia?
<3.5 mEq/L
what are the hyperkalemia manifestations(5)?
1) muscle weakness
2) fatigue
3) paresthesia
4) paralysis
5) cardia rhythm irregularities (can lead to V-Fib or cardiac arrest)
what is the treatment for hyperkalemia(2)?
1) IV sodium bicarbonate, calcium gluconate or calcium chloride, and dextrose with insulin
2) sodium polystyrene sulfonate or hemodialysis to remove excess potassium
the drugs correct hyperkalemia by causing rapid intracellular shift of potassium ions which reduces the serum concentration of potassium
what is paresthesia?
burning or prickling sensation in the hands, arms, legs, or feet
what are manifestations of hypokalemia(5 early; 3 late)?
Early symptoms
* hypotension
* lethargy
* mental confusion
* muscle weakness
* nausea
Late symptoms
* cardiac irregularities
* neuropathies
* paralytic ileus
what is the treatment for hypokalemia?
find cause and restore potassium levels with foods, or oral or parenteral potassium supplements
describe the oral dosage for potassium supplements
10 - 20 mEq potassium up to several times a day
what are some examples of potassium supplements given in the hospital?
1) acetate
2) bicarbonate
3) potassium chloride
4) potassium citrate
5) potassium gluconate
6) salts of potassium
these are oral tablets, solutions, elixirs, and powders
describe the IV administration dosage for potassium supplements
30 - 60 mEq potassium every 24 hours
describe kayexalate
- treats hyperkalemia
- given per NG tube or po powder or enema
- 15g/60mL 1 - 4 times per day
how does kayexalate work?
works in the intestine and exchanges potassium ions for sodium ions
