Exam 2 Flashcards
*How are dietary supplements defined?
Dietary Supplement Health and Education Act (DSHEA) -
Includes herbal medicines in the definition of a dietary supplement,
assures consumers access to all supplements on the market as long as
they are not determined to be unsafe, and allows for structure and
function claims to appear on the label.
“dietary ingredients” in dietary supplements may include
vitamins,
minerals, herbs, and amino acids as well as substances such as
enzymes, organ tissues, metabolites, extracts or concentrates.
Dietary supplements can be found in many forms such as
pills, tablets, capsules,
liquids or powders.
They must be identified on the label as a
dietary
supplement.
*How are dietary supplements treated differently from drugs by the FDA?
- No safety data required for products available before
DSHEA enacted - Previously no mandatory reporting of adverse events
- No requirement for product potency or consistency
unless labeled as such (USP) - No requirements that inferred benefits are true or
Tested
Variability in DS product content is
potentially high
* Product content is not stipulated by FDA
* Most studies are small
– High likelihood of negative publication bias
* Most studies are short
– Long term benefit and/or toxicities less well
characterized
Unsafe Botanicals are the Exception
- Drug-Herb Interactions appear to have far greater potential
for unintended harm than adverse effects arising directly from
common supplements - Exceptions (Recognized herbs with specific adverse effects):
– Aconite Guar Gum (obstruction)
– Licorice Root Pennyroyal
– Pyrrolizidine alkaloids Mistletoe/Skullcap
– Allergic Reactions Aristolochic Acid
– Broom Chapparal
– Comfrey Ephedra
– Germander Heavy Metal Adulteration
*What guidance is provided by the FDA on the appropriate use of
dietary supplements?
- If the FDA (law) dose not allow supplements
to carry drug claims, then the FDA cannot say
whether they are effective or not - Product content cannot be stipulated
- Similarly, the FDA cannot state that one brand
or mixture of dietary supplement is more
effective than another.
– It would again infer that the “better” one had
drug-like effects, which cannot be claimed.
Some Supplements can provide data
to support “Health Claims”
example: calcium
– “Regular exercise and a healthy diet with enough
calcium helps teen and young adult white and
Asian women maintain good bone health and may
reduce their high risk of osteoporosis later in life.”
Soy Health Claim
- “Diets low in saturated fat and cholesterol that include 25 grams of soy protein a day may reduce the risk of heart disease. One serving of (name of food) provides __ grams of soy protein.”
To qualify for the claim foods must contain per serving:
* 6.25 grams of soy protein
* low fat (less than 3 grams)
* low saturated fat (less than 1 gram)
* Low cholesterol (less than 20 milligrams)
* sodium value of less than 480 milligrams for individual foods, less than 720 milligrams if considered a main dish, and less than 960 milligrams if considered a meal.
DSHEA - Labeling Requirements
* Labeling must not:
– Claim to diagnose, prevent, mitigate, treat, or cure
a specific disease or class of diseases;
- Labeling may:
– Describe the role of a nutrient or dietary
ingredient intended to affect the structure or
function in humans
Examples of Labeling
- Silymarin
– Prohibited: Improves alcoholic cirrhosis
– Allowed: Supports normal liver function
- Echinacea
– Prohibited: Prevents colds and flu
– Allowed: Helps support immune function
If the FDA (law) dose not allow supplements
to carry drug claims, then the FDA cannot say
whether they are effective or not
* Product content cannot be stipulated
* Similarly, the FDA cannot state that one brand
or mixture of dietary supplement is more
effective than another.
– It would again infer that the “better” one had
drug-like effects, which cannot be claimed.
Protecting Intellectual Property
- Supplement manufacturers often will combine
ingredients into “proprietary blends”.
proprietary blends label
– The label must include the components and the
total weight of the mixture
– The label DOES NOT need to include the exact
amount of each ingredient
* As with foods, the most prevalent component is listed
first, etc..
* No need to demonstrate benefit of mixture
Dietary supplement labels
suggested use and dose as a claim and is not required
also does not necessarily have to match SFB information
all other ingreedients including excipients, lubricants, and capsule material must be listed below SFB
A growing number of dietary supplements
have been shown to have beneficial activity in
well controlled clinical trials
- There is no current control over the content of
even the “effective” products - Even “certified” products may vary over time
Agnus Castus (Vitex)
Common uses:
symptoms of premenstrual syndrome (PMS), premenstrual dysphoric disorder (PMDD), dysmenorrhea, mastalgia, and menopausal symptoms.
Agnus Castus (Vitex) Adverse effects:
GI complaints occur occasionally with use of chasteberry. Other symptoms include dry mouth, headache, rashes, itching, acne, menstrual disorders, and agitation. Chasteberry should be avoided during pregnancy because of insufficient data to support safe use and the possibility of lactation suppression. Theoretically, chasteberry may interact with medications that impact dopamine, as well as hormone replacement therapies and oral contraceptives.
Curcumin/Tumeric
Common uses:
arthritis and inflammatory conditions.
Curcumin/Tumeric
Adverse Effects
The most common side effects are GI discomfort and nausea. Human studies show good tolerance with doses as high as 12,000 mg daily.
Curcumin inhibits platelet aggregation, so patients on antithrombotic agents should use curcumin cautiously.
Glucosamine Common uses
osteoarthritis (OA) and joint health
Glucosamine Adverse Effects
Adverse effects for both components include mild GI upset, nausea, diarrhea,
and constipation, which can often be alleviated by taking divided doses with
meals. Drowsiness, headache, and skin reactions have been reported infrequently with glucosamine
Bitter Melon
Common uses:
increased cellular glucose uptake, decreased gluconeogenesis in the liver, and increased insulin secretion.
was able to significantly reduce fasting plasma glucose, postprandial glucose
Bitter Melon Adverse Effects
Well tolerated with primarily GI side effects, such as nausea, heartburn, and diarrhea.
Enchinacea Common Uses
prevent and treat colds and other respiratory infections
Enchinacea adverse effects
allergic reactions may occur with use of echinacea. Patients with a history of asthma or atopy should avoid echinacea; a severse allergy to the Asteraceae/Compositae family, which includes ragweed and chrysanthemums, is also a contraindication. Adverse effects include mild GI discomfort and headache. More serious reactions are possible: after taking an echinacea root product for 5 days while ill with a flu-like syndrome, one patient developed acute cholestatic hepatitis, which resolved quickly after product
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discontinuation.
Echinacea should not be used by patients with severe
systemic illnesses such as HIV infection or AIDS, multiple sclerosis,
tuberculosis, and autoimmune disorders, and by patients taking
Saw Palmetto
Common uses:
used to treat BPH. Benign prostatic hyperplasia (BPH) — also called prostate gland enlargement
Saw Palmetto Adverse Effects
In comparative studies, saw palmetto was better tolerated than finasteride and tamsulosin. Mild GI complaints, along with fatigue and headache, were the most common symptoms. Significant bleeding has been seen. Individuals taking antithrombotic agents should be avoided. Should not be used in pregnancy and lactation.
Cinnamon common uses :
lower blood glucose
cinnamon adverse effects
Patients should not confuse cinnamon supplements with cinnamon oil; hypersensitivity reactions to the oil can occur, as well as pediatric poisoning. Severe adverse effects of dry cinnamon powder, other than allergic reactions, no adverse events. One case of medication probable induced hepatitis.
Feverfew
Common uses:
prevent migraines and to treat dysmenorrhea, arthritis, and psoriasis
Feverfew Adverse Effects
GI adverse effects may result from ingestion of feverfew. Oral ulcers can occur from chewing fresh leaves. Post-feverfew syndrome has been reported after abrupt withdrawal from chronic use, resulting in anxiety, headaches, insomnia, and muscle stiffness. Patients who are allergic to plants in the Asteraceae/ Compositae family should avoid use of feverfew, as should women who are pregnant or breastfeeding. Possible antiplatelt effects, so patients taking antithrombotic agents should use with caution
Ginseng
Common uses:
boost physical and mental energy and to produce a sense of well-being
Ginseng Adverse Effects
Ginseng may cause nervousness, excitation, inability to concentrate, estrogenic effects, Stevens–Johnson syndrome, allergy, and hypoglycemic effects; may interact with several drugs including warfarin, digoxin, and alcohol.
Garlic
Common uses:
hyperlipidemia, hypertension, type 2 diabetes mellitus,
Garlic Adverse Effects
though well tolerated, garlic may cause GI adverse effects including nausea, reflux, vomiting, and heartburn, especially with higher dosages or in the first week of therapy. Garlic breath and body odor also may occur. Allergic reactions have been reported rarely.
Garlic should be stopped 10–14 days prior to surgical procedures to avoid
excessive bleeding. Patients taking antithrombotic agents should use garlic
supplements with caution because of the potential risk of bleeding, which
may vary with the type of product; however, dietary amounts of garlic do not affect platelet function
Ginger
Common uses:
The primary use of ginger has been to relieve nausea and vomiting associated with pregnancy, motion sickness, chemotherapy, and surgery. Ginger also has been used for indigestion, colic, and arthritis.
Ginger adverse effects
Adverse Effects:
Mild heartburn and belching have been reported with ginger. Ginger may increase the risk of hypoglycemia.
Ginger may alter platelet function,
although findings are mixed; ginger should be used with caution by individuals taking antithrombotic agents.
Ginko Biloba Common uses
Ginkgo has been used for Alzheimer’s disease (AD), vascular dementia, attention-deficit/hyperactivity disorder (ADHD), tardive dyskinesia, intermittent claudication, tinnitus, acute mountain sickness, and age-related macular degeneration.
Ginko Biloba Adverse Effects
Studies have shown ginkgo to be generally well tolerated. Mild GI adverse effects, headache, dizziness, and allergic skin reactions have been reported
Ginkgo should be avoided during pregnancy and lactation because of the lack
of safety information. Several potential drug interactions with ginkgo are listed
Increased bleeding risk has been associated with use of ginkgo, although the evidence has been associated with the use of ginkgo
Black Cohosh
Common uses:
Black cohosh has been used to treat the symptoms of premenstrual syndrome, dysmenorrhea, menopause, and rheumatoid arthritis.
Black Cohosh Adverse Effects
adverse effects are mild and include GI complaints, headache, rash, and
weight gain. Hepatitis, seizures, and cardiovascular disease have been reported
in patients taking combination products that contain black cohosh, although a casual relationship has not been established. Potential hepatoxicity
Ashwaganda Common uses
calm the brain, reduce swelling, lower blood pressure, and alter the immune system
Ashwaganda Adverse effects
gastrointestinal upset, diarrhea, nausea and vomiting,
Elder Berry
Common uses:
Common uses:
used primarily for prevention or treatment of influenza and other upper respiratory illnesses.
Elder Berry Adverse Effects
Commercially available elderberry extracts are well tolerated, with few adverse effects reported. Insufficiently cooked or unripe berries can have GI tract issues.
*What agency sets the Daily Required Intake of nutrients and vitamins?
Food and Nutrition Board of the National Academies of Sciences Engineering, and Medicine.
Most interactions between supplements and
drugs are likely to be
pharmacodynamic
– Increasing or decreasing the effect of a drug
Few established pharmacokinetic interactions
- Increasing or decreasing the concentration of a
drug
*What topics, questions, or suggestions can be offered when
counseling someone asking about the use of dietary supplements?
Are you taking any vitamins?
* Are you taking any minerals, such as calcium?
* Are you taking any herbal products to improve
your health?
* Are you taking any fish oil or therapeutic
plant-based oils?
* Any body-building supplements like protein or
amino acid supplements?
Do you take this / these products regularly,
occasionally, or when you think about it?
* Do you notice an improvement in your ___
when you take the supplement?
* Are you noticing any side effects around times
when you are taking the supplement?
Assuming you have a good medical and other
Rx/OTC history…
* Are there issues with your Rx/OTCs that are
bothering you, or lack of sufficient benefit?
* What do you hope that this supplement will
do for you?
* How will you know that it is working?
* How long do you plan to try it for benefit?
*What are the most commonly used herbal dietary supplements?
(from text: )What are they commonly used for, and what side effects
are common?
– Elder berry
-Echinacea
– Horehound
- Garlic
– Cranberry
-Fenugreek
– Tumeric
-Wheat grass
– Apple Cider Vinegar
Saw Palmetto
– Ginger
- Ashwaganada
Why might the ingestion of dietary supplements or high doses of
vitamins be unwise in patients being treated for cancer, HIV, or organ
Transplants?
Try to avoid …
* Immune enhancers in patients with organ
transplants or auto-immune disorders:
–Echinacea
–Astralgus
–Ginseng
–Various mushrooms
Try to avoid …
* High doses of strong antioxidants in patients
undergoing chemotherapy or radiation for
cancer:
–Vitamin C
–Vitamin E
–Co-Q10
–Selenium
Try to avoid …
* Most herbals with warfarin:
–Red clover
–Dong quai
–Ginkgo biloba
–Feverfew
–Garlic
–Curcumin
–Ginseng
–Ginger
Try to avoid …
* Supplements touted as hypoglycemics in
patients with diabetes
–Bitter Melon
–Chromium salts
–Vanadium
–Gymnema
–Cinnamon
–Fenugreek
Easy Suggestions for DS
- Cheap and documented benefits
–Daily vitamin if diet poor
–Calcium
–Vitamin D
–Green Tea (de-caffeinated, if desired)
–Fish Oil / Krill Oil
*What barriers exist for pharmacists to properly advise patients and
clients on the proper and safe use of dietary supplements?
Patients are not likely going to offer what DS
they are taking
–They may not think of them as such
–Embarrassed
–Forget or time pressured
* They may not get them from your store
–Internet
–Direct marketing (Herbalife, Nutrilite, etc)
–Sold at Gyms, etc.
Significant decrease in drug concentration
– St John’s wort
– Garlic (maybe)
- Significant increase in drug concentration
– Berberine (Goldenseal)
- Significant risk with concurrent warfarin or other
anticoagulants (low molecular weight heparin)
and with:
– Danshen (increased warfarin conc)
– Platelet inhibitors (ginkgo, feverfew, etc.)
– Coumarin-containing (additive anticoagulation)
St John’s wort
- Increases the removal rate of many drugs
(>50% of those used) through induction of
increased activity of:
– Metabolizing enzymes - CYP3A4, 2E1, 2C19
- Glucuronidation
– Transporting proteins (pGP and BCRP) - Increased removal from blood
- Increased removal from brain and tumors
- Return from intestinal epithelium to gut lumen
St. John’s wort decreases the blood
concentrations of:
– Cancer chemotherapy (CPT-11)
– Heart failure therapy (digoxin)
– HAART HIV therapy (protease inhibitors)
– Immunosuppresants (cyclosporin)
– Anti-epileptics (phenytoin)
– Oral contraceptives
Increased Warfarin Risk
- Decreased platelet function
– Adherence and Aggregation
– Degranulation and cascade activation
- Several supplements have been associated with
this in a convincing manner:
– Ginkgo biloba
– Feverfew
– Garlic
Warfarin anticoagulation with herbs
containing coumarins will increase effect
(increased INR, risk of bleeding)
- Dong Quai
- Papaya
- Red Clover
Pharmacodynamic Interactions
(Modification of the Effect arising from a given Drug
Concentration)
diabetes potentiation
– Vanadium
– Ginkgo
– Bitter melon
– Cinnamon
- Hyperkalemic effect
– Spironolactone (K+ sparing) + licorice root
Enhanced effect – Synergy
Licorice root
- Licorice root has aldosterone-like effects
– Sodium, water retention
– Potassium loss - Antagonism of diuretics and
antihypertensives - Theoretical interaction with lithium
- Pro-toxic effect with digoxin if K+ is low
Enhanced effect – Synergy
- Hawthorne seed extract for heart failure,
plus:
– ACE inhibitors, AR antagonists, digoxin? - Sildenafil and similar phosphodiesterase
inhibitors
– Ginkgo
– DHEA
– Possible hypotension and syncope
How credible are case reports?
- Cranberry –warfarin interaction
– Suvarna R, et al. BMJ 2003; 327: 1454
– 70 yo male with recent treatment for a chest
infection (Tx with cefalexin)
– Rx: digoxin, phenytoin, warfarin
– Poor appetite –was drinking only cranberry
juice x 2-6 weeks
– Hospitalized with an INR > 50 (usual range 2-3) - Died of GI and Pericardial hemorrhage
7 other cases mentioned to have been reported
to the British authorities
– 4 cases not dramatic
– 2 cases, patients had previously unstable INR
– 1 case, the INR DECREASED
– Compliance / Adherance to regimen is unclear
- From these cases, should cranberry juice be
proscribed in patients who are taking warfarin?
– As beverage?
– As UTI prophylaxis?
Dietary Supplements to
Support Cancer Patients
- Cancer patients may take supplements to:
– Prevent or slow growth of disease
– Increase their immune response
– Decrease the toxic effects of the treatment
– “Turn a new leaf” of a healthier lifestyle. - Changes in diet and exercise are typically not a
concern. We are concerned about
– Institution of antioxidants (may affect apoptosis)
– Institution of immunostimulant
- Ginseng (Panax ginseng)
– Increases neutrophil, WBC count recovery in
mice treated with cytotoxics
– Effect is similar to that sought from G-CSF
– Concurrent use of P. ginseng may increase
toxicity of chemo- or radiotherapy by putting
stem cells in growth fraction
– Ginseng should be stopped >3d before Tx
Impairment of Chemotherapy by
Supplements that are Anti-Oxidants?
- Chemotherapy and radiotherapy in part act by damaging cells,
leading to self-destruction (apoptosis)
– Many activation steps of apoptosis are initiated by
oxidative stress
– Antioxidants may decrease these steps leading to
apoptosis, decreasing the benefit of cytotoxic treatment
– Some pre-clinical studies show a BENEFIT of antioxidants
(high dose Vit C, E, K3) - These effects appear to be concentration-dependent
- Free radicals formed from XRT may be too short-lived to react
with anti-oxidants, but the apoptotic signaling after cell
damage may be attenuated with antioxidants
Examples of Antioxidants that may Attenuate
the Effect of Cancer Treatment
- Ascorbate (Vitamin C)
- Retinoids / -carotene
- Coenzyme Q10
- Tocopherol (Vitamin E)
- Green / Black Tea
- Grape Seed Extract
- Milk Thistle
- Pycnogenol (pine bark extract)
Most widely available dietary supplements are
safe when taken in
Suggested doses
There is a greater risk when dietary
supplements
combined with other
prescribed therapy
- Interactions with medications are
usually not known
High risk patients shout not
unilaterally start taking dietary supplements
- Heartburn
- Burning in the stomach or lower chest; may extend up toward neck, & occasionally to the back
- Other terms people may use synonomously:
- Indigestion, acid regurgitation, acid indigestion, “sour stomach”, “bitter belching”
Main symptom of GERD
heartburn
Heart burn usually occurs
within 1 hour after eating; often after large meal; worsened by lying down
GERD
- Chronic condition; frequent reverse flow of stomach acid and contents into the esophagus
- Heartburn 2 or more times per week
GERD complications
esophagitis, esophageal stricture, Barrett’s esophagus (pre-cancerous condition)
* Dyspepsia
symptoms of gerd generate from
gastroduodenal region
symptoms of gerd include
postprandial fullness, ___epigastric pain__________
* Associated symptoms: anorexia, belching, nausea, vomiting, upper abdominal bloating, heartburn, regurgitation
Heart burn aggravating factors
bending over, lying down
heart burn associated symptoms
- Regurgitation (bitter acid fluid in back of throat)
- Water brash (sudden appearance of clear, salty fluid from salivary glands)
- Burping
- Hiccups
- Nausea
- Vomiting
- Symptom classifications
mild heartburn
a little bothersome but dont affect normal activities
moderate heartburn
somewhat annoying or interfere with activities
severe heartburn
alarm symptoms
UES
upper esophageal sphincter
UES to
esophagus
Esophagus to
LES lower esophageal sphinicter
LES to
diaphragm
diaphragm to
stomach
help to keep acid &
stomach contents in stomach
LES and diaphragm
LES ______________ at rest
contracts
Heart burn risk factors
alcohol, acidic, caffeine, chocolate, exterme emotions, excersize, stress, obseity, asprin and nsaids, postasium.
Do not self treat: heart burn
- Alarm symptoms
- Dysphagia*, odynophagia, vomiting, GI bleeding, unexplained weight loss
- Atypical symptoms
- Noncardiac chest pain, asthma, voice changes, feeling of “lump in the throat”,
chronic cough, trouble sleeping/staying asleep, dental erosion
Goals of therapy
- Provide complete symptom relief
- Reduce symptom recurrence
- Prevent/manage OTC medication side effects
Complementary and non-pharmacologic options
- Acupunture for reflux, GERD sx, dyspepsia
- Melatonin (limited data)
- Weight loss (even 10% body weight helpful)
- No food within 2-3 hours of bedtime
- Sleep on left side—why? Shape of stomach, where pouch is, gravity and the angle of connection of the stomach to the esophagus is important. The left side helps to keep acid and stomach contents in the stomach rather than laying on the right side.
- Elevate head of bed with 6-8 inch blocks underneath legs or foam GERD pillow*
- Stop tobacco use
- ______Meditarrian_________diet
- Symptom diary to help ID trigger foods (avoid triggers)
- Assess Rx & OTC meds!
- Modify lifestyle (see risk factors table)
Consider: OTC options
- Symptoms: frequency, duration, severity
- Medication cost
- Drug-drug interactions
- Adverse effects
- Patient ____preference___________
Medications: Heartburn
- Antacids
- Histamine-2 receptor antagonists
(H2RAs) - Proton pump inhibitors (PPIs)
- Bismuth subsalicylate
mild-mod, infrequent heart burn or dyspepsia & only need short-term relief
antacid or H2RA
antacid
rapid symptom relief
short term relief if take without food
interchangeable at recommended doses
antacid/alginic acid more effective in combo
h2RA
slower relief
can use with antacid
can use to prevent HB if take 30-60 min prior to known cause of symptoms
lower dose for mild symptoms, higher dose for moderate
mild, mod infrequent or dyspepsia but need longer lasting relief
H2RA
hb 2 or more days per week
PPI or H@RA
ppi daily x 14 days
H2RA as needed
anatacids onset of relief and duration on empty stomach and food in stomach
within 5 minutes
empty: 20-30 min
food: up to 3 hours
H2RA’s onset and duration
30-45 minutes
4-8 hours
4-10 hours 9( famotidine)
Combo H2RA+ antacid onset and duration
within 5 minutes and lasts 8-10 hours
PPI single dose onset and duration
1-3 hours may need 1-4 days for full effect
12-24 hours
Follow-up Recommendations
- If initial therapy with (1) antacid or (2) alginic acid/antacid
combo or (3) OTC H2RA or (4) H2RA/antacid combo not
helpful after expected time to effect:
- Try different agent OR medical referral
2. If initial therapy above IS helpful: - Continue with lifestyle/diet changes and PRN meds
- Re-evaluate if any change in symptoms/frequency
3. If heartburn 2 or more days per week & take PPI once daily x
14 days OR H2RA as needed: - Not better after 2 weeks: refer
- Better: continue with lifestyle/diet changes, stop PPI; may repeat PPI
every _4__ months if needed or continue H2RA PRN
antacid products
- Aluminum (hydroxide, phosphate)
Branded products: Alternagel®, Amphogel® - Calcium carbonate
Branded product: TUMS® - Magnesium (hydroxide, carbonate, trisilicate)
Branded product: Mylanta® - Sodium bicarbonate
Branded product: Alka-Seltzer®
Antacid MOA
neutralize gastric acid, increase __LES__ pressure
protective barrier)
Alginic acid + sodium bicarb in saliva = layer of sodium alginate on top of stomach contents
Indication:
treatment of mild, infrequent heartburn, sour stomach, and acid
indigestion
- Pharmacodynamics:
- Onset:
within 5 minutes
Liquid formulations faster
faster than tablets; quick-dissolving tablets next fastest
shortest duration
magnesium hydroxide
empty stomach
20-30 min
food in stomach
2-3 hours
pregnancy
calcium and magnesium antacids ok
lactation
aluminium, calcium, magnesium antacids ok
Antacids (continued)
* Dosing:
* Product-
recommended doses; do not exceed
repeat dose in
1-2 hours if needed
re-evaluate if
- Using more than twice a week
- Regularly for more than 2 weeks
main side effects
aluminum
constipation, hypophosphatemia (long-term use)
main side effects
calcium carbonate
belching, intestinal gas, constipation; hypercalcemia if
kidney dysfunction.
main side effects
magnesium
diarrhea. Manage by __product that has a combination with aluminum
main side effects sodium bicarb
belching, intestinal gas
memory trick
aluminum, A comes before Magnesium, M in the alphabet so Constipation comes before Diarrhea in the alphabet
calcium carbonate causes
constipation
3, C’s
antacids drug interactions
many
itraconazole, amphetamines
rosuvastatin
enteric coated meds
dasatinib
calcium carbonate, mag hydroxide, aluminum hydroxide rug interactions
levothryoxine
tetracyclines
fluroquinololnes
seperate by 4 hours for the first two
antibiotic 2 hours prior or 6 hours after antacid
aluminum or magnesium drug interaction
azithromycin
seperate by at least two hours
sodium bicarb drug interactions
Quinidine (decreased excretion)
Salicylates (increased excretion)
avoid concurrent use or monitor carefully
Antacids (last slide)
* Avoid:
- Dyspepsia*
- Aluminum or calcium if kidney dysfunction
- Calcium: Total daily MAX calcium intake (food + meds):
- 2500 mg (age 19-50)
- 2000 mg (age 51 and older)
- Magnesium if CrCl less than 30 mL/min
avoid sodium bicard
Sodium restriction (274 mg sodium/gram sodium bicarbonate)
* Heart failure, kidney failure, cirrhosis, pregnancy
* Taking with calcium supplements
* Concomitant aspirin therapy
Histamine type 2 recepotor antagonists (H2RA)
- Cimetidine
Branded product: Tagamet HB® - Famotidine
Branded product: Pepcid AC®
Cimetidine, famotidine
* MOA
reduce acid secretion by inhibiting histamine at the H2 receptors on parietal cells, do not neutralize aicd (that is the antacid MOA)
- Indication:
- Mild to moderate, infrequent or episodic HB or prevention of HB
- Combo with antacid:
postprandial HB if not premedicated with H2RA
- Pharmacodynamics:
- Onset
30-45 min
- Duration:
- 4-8 hours (cimetidine)
- 4-10 hours (famotidine)
- Side effects:
Infrequent
Both: headache, diarrhea, constipation, drowsiness, dizziness reported
Cimetidine side effects
high doses may cause decreased libido, impotence or _____gyneocomastia, enlargement of the breasts____ due to weak antiandrogenic effect
- Avoid: (h2)
- older adults at high risk for delirium, sodium-sensitive health conditions
- Younger than __12__ years old
pregnancy (h2)
ok to use though meta-analysis suggested association of childhood asthma
Lactation:
famotidine preferred due to lower milk concentration but cimetidine ok per AAP
H2RA drug interactions
erlotinib, dasantinib, gefritnib, other TKIs, ripvirine, ledipasir, sofoburvir, itraconzabole, ketoconazole, atazanavir, iron sulfate, calcium carbonate
decreased absorption
avoid concurrent use
H2RA
* Dosing
- Onset of symptoms OR _30-60___ min prior to when HB is expected
- Note: Rx doses may need adjustment if kidney dysfunction
cimedtidine dose
200 mg once daily
famatodine dose
10-20 mg once or twice daily (max 40mg in 24 hours)
Proton pump inhibitors (PPIs)
- Esomeprazole magnesium 22.3 mg
* Delayed release tablet or capsule
*Branded product: Nexium® - Lansoprazole 15 mg
* Capsule containing enteric-coated granules
* Delayed-release orally disintegrating tablet
*Branded product: Prevacid® - Omeprazole
* Omeprazole magnesium 20.6 mg
* Delayed release tablet
*Branded product: Prilosec®
* Omeprazole 20 mg + sodium bicarbonate 1100 mg
* Immediate release
*Branded product: Zegerid®
PPIs
* MOA:
inhibit hydrogen potassium ATPase (proton pump) in stomach parietal cells
Indication: (PPIs)
heartburn symptoms 2 or more days per week
PPIs onset
1-3 hours start of relief (may need 1 to 4 days for full effect)
PPI’s duration
12-24 hours (single dose)
Side effects PPIs
uncommon
* Headache, abdominal pain, diarrhea, constipation, gas
* Increased risk ___traveler’s diarrhea_____ and _____C. Diff infection___ (PPI’s change ph in stomach, more basic)
- Avoid: PPIS
- crush/chew tablets or capsules
- severe diarrhea/gastroenteritis symptoms (seek care)
- Younger than _18___ years old
pregnancy PPI’s
low risk omeprazole, lansoprazole; possible childhood asthma risk (refer if frequent HB)
Lacatation PPIs
low milk amounts of omeprazole, esomeprazole (less than infant Rx)
Dosing: PPIS
30-60 min prior to
meal (esp breakfast); max 14
days; 1 course every 4 months
max*
PPI drug interactions
omprazole, esomeprozole- clopidogrel, clistazol, diazepam avoid concurrent use
PPIs- erlotinib, sasatinib, vir, itraconziole, irone sulfate, calcium carbonate, warfarin, theophyliine, tacrolimus, digoxin
avoid conccurent use.
Bismuth subsalicylate Branded product: Pepto-Bismol®
MAO
protects gastric mucosa
bismuth indication
heartburn, upset stomach, indigestion, nausea, diarrhea
bismuth onset
30-60 minutes
duration bismuth
30-60 minutes
side effects bismuth
black-colored tongue, stool, tinnitus^
drug interaction bismuth
- Warfarin (avoid)
- Tetracycline antibiotics (avoid)
- Methotrexate (avoid)
avoid- bismuth
children*, salicylate sensitivity/allergy, bleeding risks
dosing bismuth
262-525 mg every 30-60 minutes PRN
–chew tablets thoroughly (if chewable)
–nonchew: full glass water
–max 48 hours of therapy
pregnancy bismuth
use alternative drug if possible 1st , 2nd trimesters; avoid 3rd trimester
lactation bismuth
use alternative drug
Special populations
*Pregnancy
first
* First-line OTC:
* Max food/OTC calcium per day:
- Lifestyle/food changes first
- First-line OTC: calcium or magnesium antacids
- Max food/OTC calcium per day: 2500 mg
*Children older than 2 years with mild, transient, infrequent HB or sour
Stomach
- Refer if
- MAX total daily calcium for children (including food/beverages):
- Ages 2-3:
- Ages 4-8:
- Ages 9-18:
- Children’s formulas of calcium carbonate antacid + lifestyle/food changes
- Refer if frequent HB or antacid ineffective
- MAX total daily calcium for children (including food/beverages):
- Ages 2-3: 700 mg
- Ages 4-8: ___1,000__ mg
- Ages 9-18: 1300 mg
Older adults
- Avoid H2RAs if
Triage carefully as HB can be symptom of more serious pathology, especially in older adults
* Consider drug-drug interactions
* Consider other health conditions & kidney function
* Avoid H2RAs if high risk for delirium
* Short course PPI likely ok but long-term risk for C. difficile infection, fractures; long-term use
only if ok with ___recommendation from a medical provider
intestinal gas causes
- Swallowing (food/air/saliva)
- Especially if gulp/eat too fast
- Smoking
- Gum chewing
- Sucking on hard candy
- Carbonated beverages
- Anxiety & hyperventilating
- Sugar alcohols in food (e.g.
sorbitol, mannitol) - Fiber in diet
- Some medical conditions (see
next slide) - Genetics
- Altered gut bacteria
- Food intolerances*(e.g.
lactose, fructose, sucrose;
stone fruits; wheat)
Medical conditions associated with increased
intestinal gas
- Irritable bowel syndrome: 5-15% of U.S. population
- Lactose intolerance/malabsorption: 29% of U.S. population
- Celiac disease
- 1-3% of U.S. population
- 10% of first-degree relatives of people with celiac disease
- Pancreatic insufficiency: <1% of U.S. population
7
Note: healthy people have about 200 mL
of intestinal gas at all times
Medications that contribute to intestinal gas
- Meds that affect gut biome (e.g. lactulose, antibiotics)
- Agents that affect metabolism of glucose & dietary substances
- E.g. acarbose/miglitol, metformin, orlistat (= GI lipase inhibitor)
- Drugs that affect GI motility
- E.g. narcotics, anticholinergics, calcium channel blockers, psyllium,
cholestyramine - Meds that contain or release gas (e.g. Alka-seltzer)
Presenting symptoms of intestinal gas
- Eructation: belching of swallowed air
- Bloating:
- Indigestion
- Abdominal pain/cramping
- Borborygmi: audible bowel sounds
- Flatulence: passage of air out through the rectum
Do not self-treat- gas
- Symptoms persist for more than a few days or occur several times a
month - Symptoms so severe they are debilitating
- Sudden change in the location of abdominal pain or significant
increase in frequency or severity of symptoms - New onset of symptoms in people older than 40 years
- Significant discomfort or sudden bowel function change (diarrhea or
constipation) - Gas occurs in conjunction with other symptoms such as severe or
persistent diarrhea or constipation, GI bleeding, fatigue, unintentional
weight loss, or frequent symptoms at night
Goals of therapy
- Reduce symptoms (frequency/intensity/duration)
- Minimize gas impact on_____a persons lifestyle__________
- NOT eliminate gas since it’s a normal part of GI tract function
Complementary and non-pharmacologic options
- Probiotics (single and combination)
- 14-day trial
- Fermented food products with live active cultures (kombucha tea,
kefir) - Herbal carminatives (fennel seed, Japanese mint, peppermint,
spearmint) - Insufficient evidence
- Avoid if GERD since carminatives lower LES tone/pressure
- Avoid fennel seed in pregnancy, lactation
OTC Options- prevention of gas
- alpha-galactosidase
- Lactase enzyme
OTC treatment of gas
- Simethicone
- Activated charcoal
Follow-up Recommendations
__try these agents for one week and if things arent better than to refer_________
Alpha-galactosidase
Branded product: Beano (food)
* MOA:
hydrolyzes oligosaccharides into component parts
Alpha-galactosidase- indication
prevention of intestinal gas
Alpha-galactosidase
onset
within 30 minutes
Alpha-galactosidase duration
at least 5 hours
Alpha-galactosidase side effects
possible allergic reaction (rash, swelling, hives, difficulty, breathing)
Alpha-galactosidase drug interactions
none known
Alpha-galactosidase avoid in
people with galactosemia, mold allergies
Alpha-galactosidase pregnancy
likely okay check with healthcare provider
Alpha-galactosidase lactation
likely ok, check with healthcare provider
dosing adults and adolescents Alpha-galactosidase
300-450 units per food serving
Alpha-galactosidase dose children
ask HCP
Lactase enzyme
Branded product: Lactaid
* MOA:
replacement enzyme that breaks down lactose into glucose +
galactose
lactase enzyme indication
dairy intolerance
onset lactase
immediate
duration lactase
while digesting dairy product
side effect lactase
non possible stomach pain
lactase drug interactions, avoid
?
Dosing for all ages* (first bite):
lactase
oringial, extr, ultra
Original strength: 3__caplets
Extra strength: __2 caplets
Ultra strength: 1 caplet (max 2)
*from website
lactase pregnancy
likely safe but check with HCP
lactase lactaton
no info available on excretion into milk; likely safe but check with HCP
Simethicone
Branded product: Gas-X
* MOA:
defoaming agent; reduces surface tension of gas bubbles in
GI tract mucus -> eliminated more easily
simethicone indication
intestinal gas
simethicone onset
within 30 minutes
simethicone duration
up to 4 hours
simethicone side effects, drug interactions, avoid
?
dosing after meals + bedtime
adults and adolescents: simethoicone
- 40-125 mg 4x daily PRN
- Children 2 to 12 years: simethicone
- 40-50 mg 4x daily PRN
children younger than 2 years: simethicone
20 mg 4x daily PRN
pregnancy and lactation
safe to use
Activated charcoal Branded product: CharcoCaps (supplement)
* MOA
?adsorb gas given charcoal large surface area
charcoal indication
promoted for relief of intestinal gas (not approved nor
shown to be effective)
- Onset:
- Duration:
charcoal
?
side effects charcoal
poor palatibility, capsule form found
drug interactions carchoal
may decrease drug absorption
avoid taking charcoal
within 1 hour after medications
dosing charcoal adults:
500-520 mg after meals PRN, may reapeat hourly
dosing adolescents children
?
pregnancy- charcoal
likely safe for occasional use, check with healthcare provider
lactation- charcoal
likely safe for occasional use; check with healthcare provider
- Hemorrhoid definition:
- inflamed, swollen blood vessels in
the rectum and anus that protrude
during bowel movements
Internal hemorrhoid
- Inside rectum
- Can’t see or feel; __rarely cause discomfort_______
External hemorrhoid
- Under skin around anus
- Usually have symptoms
presenting symptoms for internal
*Internal hemorrhoid
* Rare discomfort
* Stool passage may cause
painless bleeding (red on toilet
tissue but not dripping into toilet
bowl)
external hemorrhoid presenting symptoms
- Itching (pruritis)
- General discomfort/irritation
- Burning
- Inflammation
- Swelling
do not self treat hemorrhoids
- Younger than ____12____
- Ulcerative colitis or Crohn’s Disease
- Family history colon cancer
- Anorectal disorder previously dx by medical provider (e.g. fistula,
abscess) - Acute onset severe pain; bleeding (more than just a little on toilet
tissue); seepage; black tarry stools; severe symptoms (see prior
slide) - Minor symptoms not responding to _7__ days of self-care
goals of therapy hemorrhoids
- Resolve symptoms
- Keep stool soft; prevent straining with bowel movements
- Maintain remission of symptoms
- Prevent complications
Complementary and non-pharmacologic options- hemmorrhoids
- Dietary modification
- Avoid alcohol, caffeine, citrus foods, fatty foods
- Adequate fiber (more info in nutrition lecture)
- Avoid lifting heavy objects
- Proper bowel habits
- Defecation
- Toilet sitting time
- Avoid excessive cleaning
- AVOID commercial wipes/pads
- Sitz baths
Severe hemorrhoids
may require surgery
OTC treatment options- hemmoroids
- Local anesthetics
- Vasoconstrictors
- Protectants
- Astringents
- Keratolytics
- Analgesics, anesthetics,
antipruritics - Corticosteroids
Follow-up Recommendations - __one week of self care- refer______
Local Anesthetics: benzocaine, benzyl alcohol, dibucaine,
dyclonine, lidocaine, pramoxine, tetracaine
MOA
block transmission of nerve impulses
local anestetics indication
temporary relief of external anal symptoms
local anestetics duration
depends on agent; mostly 4 hours
side effects local anestetics
allergic reactions, dermatitis
drug interactions local anestetics
no significant interactions
