Dietary Supplements

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jannabogie
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47318
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Dietary Supplements
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2010-11-05 12:57:18
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Dietary Supplements
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Dietary Supplements - Therapeutics Week 10
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  1. Define dietary supplement
    • A product intended to supplement the diet
    • Not considered a food or a drug
  2. What did the Dietary Supplement Health and Education Act of 1994 set forth?
    • Definition of dietary supplement
    • Cannot refer to any specific disease. "Not evaluated by FDA, etc"
    • Remove product only when hazardous
    • Office of Dietary Supplements
    • No claims of efficacy. Only structure/fxn claims.
  3. Rules re: structure/function claims
    • Cannot name specific disease of class of diseases on label
    • Name of product cannot sound like a disease (e.g. hepatacure, raynaudin)
    • Citation of a title referring to a disease may be ok as long as not bolded on label.
    • May not use "disease" or "diseased"
    • May not use class names (antibiotic, analgesic)
  4. Give examples of OTC structure/function claims, as these ARE allowed on the labels
    • antacid
    • laxative
    • antigas
    • stool softener
    • stimulant
    • nighttime sleep-aid
  5. For each of the following, state whether it is a structure/function claim or a disease claim
    • Maintains healthy blood sugar (structure/fxn)
    • Controls blood sugar in persons with insufficient insulin (disease)
    • Alzheimer's (disease)
    • Support for menopausal women (str/fxn)
    • Mild memory problems assoc with aging (str/fxn)
    • Maintains healthy lungs in smokers (disease)
    • Osteoporosis (disease)
    • Healthy lung function, smoking alternative (str/fxn)
    • Maintains cholesterol within normal range (str/fxn)
    • Lowers cholesterol (disease)
  6. Labeling requirements for dietary supplements - Issued by FDA in 1997
    • Name of product
    • Supplement Facts panel (suggested serving size, net quantity of ingredients, dietary supplements and their RDAs if known, herbs must be identified by common plant name and what part of plant was used)
  7. Advantages of dietary supplements
    • patent autonomy
    • patient use
    • cheaper than rx meds
    • profit to be made?
  8. Disadvantages/limitations of dietary supplements
    • Fear of legal liability
    • Lack of reputable manufacturers
    • Absence of FDA approval
    • Difficulty identifying product content
    • Reviewing hundreds of products and indications
    • Health care provider concerns
  9. What is the German Federal Health Agency and what do they do?
    • They are like the FDA in Germany
    • Established Commission E in 1978 to evaluate safety and efficacy of herbs
    • Published 380 monographs of herbs (like a "textbook", but it hasn't been updated since the mid-90s)
  10. These dietary supplements are unsafe
    • Borage
    • Calamus
    • Coltsfoot
    • Comfrey
    • Life root
    • Sassafras
    • Butterbur
    • Chaparral
    • Germander
    • Pennyroyal oil
    • Heliotrope
    • Kava
    • Licorice
    • Ma Huang
    • Pokeroot
    • Willow bark
    • Jin Bu Huan
    • Stephania and Magnolia
    • Germanium
    • Lobelia
    • L-tryptophan
    • Phenylalanine
    • Yohimbe
  11. The dirty dozen UNSAFE supplements
    • Aconite
    • Bitter orange
    • Chapparal
    • Colloidal Silver
    • Coltsfoot
    • Comfrey
    • Country mallow
    • Germanium
    • Greater Celadine
    • Kava
    • Lobelia
    • Yohimbe
  12. What is the DVSP and what does it do?
    • Dietary Supplement Verification Program
    • Developed by USP
    • Volunteer-driven, not-for-profit, non-governmental program

    • Establish quality standards for dietary supplements
    • Audit mfg facilities for GMP compliance
    • Product testing (labeling, contamination, content, integrity of ingredients, dissolution, purity, safe manufacturing)

    • Do not address nutritional claims, safety or efficacy
    • Only check on mfr and make sure products are clean
  13. What is the Final Rule for CGMPs for Dietary Supplements?
    • Companies must comply with this rule
    • Mfrs must evaluate for:
    • - identity
    • - purity
    • - strength
    • - composition
  14. When should one stop using dietary supplements when they are scheduled for surgery?
    2-3 weeks prior
  15. St. John's Wort interacts with many medications. What effect does it generally have on these drugs?
    With most of them, it makes the other drug less effective

    (Antidepressants, Anti-retrovirals, Barbs, Clopidogrel, Cyclosporine, Digoxin, Irinotecan and imatinib, Methadone, Omeprazole, OCs, Statins, Tacrolimus, Theophylline, Triptans, Verapamil, Warfarin)
  16. What is the difference between efficacy and effectiveness?
    • Efficacy - well-controlled clinical studies
    • Effectiveness - real-world populations
  17. Describe limitations of some dietary supplement clinical studies
    • several ingredients studied
    • lack of standardization
    • adulterated or misbranded
    • foreign language only
    • small sample size
    • poorly defined inclusion/exclusion criteria
    • short study duration
  18. Black cohosh indications
    • premenstrual symptoms
    • painful menstruation
    • hot flashes
  19. CI/Precautions of black cohosh
    • pregnancy
    • don't take for longer than 6 months
    • estrogen receptor positive breast cancer (maybe)
    • liver disease
  20. DIs with black cohosh
    • decrease in cisplatin
    • hepatotoxic drugs??? CYP 2D6
  21. SEs of black cohosh
    • intestinal probs, weight gain, nausea
    • liver toxicity (monitor LFTs)
    • Autoimmune hepatitis
    • dizziness, HA, stiffness, trembling limbs (large doses)
  22. Indication for cranberry
    prevention of recurrent UTIs
  23. CI/Precautions for cranberry
    • BPH
    • urinary obstruction
    • nephrolithiasis
    • allergies/asthma (d/t high salicylic acid)
    • GERD/ulcers
    • (d/c 2 weeks prior to surgery)
  24. DIs with cranberry
    • Vitamin B12 (Increased absorption)
    • Warfarin (increased INR)
    • CYP 2D6 meds (phenytoin, warfarin)
    • Do not take with NSAIDS
  25. SEs of cranberry
    • N/V/D
    • nephrolithiasis
  26. Echinacea indications
    • Strengthens resistance to URT infx
    • Boosts immune system to help fight off infx
  27. CI/precautions of Echinacea
    • TB, leukosis, collagenosis, MS, AIDS, HIV infx, AI diseases (theoretically - thought to make them worse)
    • allergies to ragweed
    • pregnancy/lactation
    • 8 weeks of use max
    • asthma??
  28. DIs with echinacea
    • Immunosuppressants?
    • Inhibits CYP 1A2
    • Induces and inhibits CYP 3A4
  29. SEs of echinacea
    • N/V
    • allergic rxns (anaphylaxis, angioedema, urticaria)
    • acute asthma
    • leukopenia
    • may interfere with male fertility
  30. Indications for feverfew
    Prophylaxis of migraines
  31. CIs/Precautions for feverfew
    • pregnancy/lactation
    • children
  32. DIs with feverfew
    • Anticoagulants
    • CYP 1A2, 2C9, 2C19, 3A4
  33. SEs of feverfew
    • Mucosal and gastric irritation
    • Post-feverfew syndrome - includes anxiety, HA, insomnia, m and joint stiffness - may be d/t release of serotonin
  34. Indications for fish oil
    • (not evaluated by German Commission E)
    • HTN
    • hyperlipidemia
    • Mental health (bipolar, psychosis, depression)
    • Anticoagulant
    • coronary heart disease
    • stroke
  35. CIs/precautions with fish oil
    • seafood allergy
    • bipolar disorder
    • bleeding
    • cardiac disease
    • depression
    • diabetes
    • HTN
    • immunodeficiency
  36. DIs with fish oil
    • Anticoagulants/Antiplatelets/Thrombolytics (increase bleeding)
    • Antihypertensives (may reduce BP more)
    • Xenical, Alli, Orlistat (decrease abs of fish oil - separate by 2 hours)
  37. SEs of fish oil
    • Bleeding
    • Ecchymosis
    • Epistaxis
    • Hypervitaminosis A
    • Hypervitaminosis D
    • Rash
    • Dyspepsia
    • Eructation (burping)
    • N/V/D
    • Halitosis
    • Dysgeusia (taste perversion)

    It may help to freeze the capsules or use enteric coated capsules.
  38. Indications for flaxseed
    • (Not evaluated by German Commission E)
    • Constipation
    • Diarrhea
    • Diabetes
    • Menopause
    • HTN
    • Hyperlipidemia
    • CAD
  39. DIs with flaxseed
    • Anticoagulants
    • Antidiabetic agents (could cause hypoglycemia)
    • Estrogens
    • Decreased absorption of oral drugs (d/t fiber content)
  40. SEs of flaxseed
    • Bloating
    • Flatulence
    • Abdominal pain
    • Diarrhea
    • Constipation
    • Dyspepsia
    • Nausea
    • Allergic Reactions
  41. Indications for garlic
    • hyperlipoproteinemia
    • arteriosclerosis

    (possibly anticancer effects - may inhibit different chemical carcinogens)
  42. What is the compound in garlic that gives it the smell?
    Allicin
  43. CIs/Precautions for garlic
    • Diabetes (increased insulin - hypoglycemic effects)
    • Pregnancy/lactation/children
    • Peptic ulcers/GERD
    • D/C 2 weeks prior to surgery (it increases bleeding)
  44. DIs with garlic
    • Anticoagulants (esp warfarin!)
    • Protease inhibitors may be decreased (saquinavir, ritonavir)
    • NNRTIs may be decreased (nevirapine, efavirenz)
    • Inhibits CYP 2D6, 2C9, 2C19, 3A4, 2E1
    • Amphotericin B (increases its activity vs. cryptococcus neoformans)
    • Diabetic agents (hypoglycemia)
    • Antihypertensives (hypotension)
    • Protects against drug toxicities from doxorubicin, APAP, methotrexate, fluorouracil
  45. SEs with garlic
    • GI discomfort
    • sweating
    • dizziness, lightheadedness
    • allergic rxns: anaphylaxis, urticaria
    • bleeding, menorrhagia
    • smelling like garlic
  46. Indications for horse chestnut seed
    • venous conditions (alternative to compression stockings)
    • eczema
    • leg pains
    • hemorrhoids
    • phlebitis
    • menstruation
  47. CIs/Precautions with horse chestnut seed
    • Renal (nephropathy)
    • Hepatic (liver injury case)
    • Pediatric (poisonings reported)
    • Pregnancy/lactation
    • Diabetes (hypoglycemia)
    • GI irritation
    • Latex allergy (cross sensitivity)
  48. DIs with horse chestnut seed
    • Anticoagulants/antiplatelets
    • Antidiabetic drugs (hypoglycemia)
    • Lithium (d/t diuretic effect of horse chestnut seed)
  49. SEs of horse chestnut seed
    • GI irritation, pruritis, giddiness, HA
    • Toxic nephropathy
    • Bleeding/bruising

    Symptoms of poisoning: muscle twitching, weakness, loss of coordination, dilated pupils, vomiting, diarrhea, depression, paralysis, stupor
  50. Indications for ginkgo
    • Cerebral circulatory disturbances
    • Peripheral arterial circulatory disturbances
    • (maybe for memory? - but not actually an indication)
  51. CIs/Precautions with ginkgo
    • Epilepsy (ginkgotoxin may cause neurotoxicity and seizures)
    • Bleeding disorders (d/c 2 weeks prior to surgery)
    • Diabetes (hypoglycemia)
    • Infertility (male and female)
  52. Gingko DIs
    • Antiplatelets, NSAIDS, Warfarin
    • Aminoglycosides (increased ototoxicity)
    • Thiazides (increased BP)
    • Trazodone (coma)
    • Seizure threshold lowering drugs
    • Anticonvulsants
    • Antidiabetic drugs (hypoglycemia)
    • May mildly affect CYP 1A2, 2C9, 2C19, 2D6, 3A4 (efavirenz)
  53. Gingko SEs
    • GI disturbances
    • HA, dizziness, vertigo
    • Allergic skin rxns
    • spontaneous bleeding, intracerebral bleeding, spontaneous hyphema (bleeding/hemorrhage in eye)
    • Toxicity: seizures and unconsciousness - death
  54. Asian Ginseng indications
    • "adaptogen" for increasing resistance to environmental stress
    • lassitude and debility
    • lack of energy
    • inability to concentrate
    • convalescence
  55. CIs/precautions of Asian ginseng
    • HTN
    • emotional and psychological imbalances
    • HA
    • heart palpitations
    • insomnia
    • asthma
    • inflammation
    • infections
    • pregnancy/lactation
    • children
    • hx of bleeding
    • d/c 2 weeks prior to surgery
    • diabetes (hypoglycemia)
    • schizophrenia (may be exacerbated)
    • May stimulate breast cancer cells
  56. Ginseng DIs
    • MAOIs (phenelzine)
    • Warfarin (INR decreased)
    • Stimulants
    • Alcohol (excretion increased)
    • Hypoglycemics
    • ?hormonal therapy
    • ?antihypertensives
    • ?cardiac meds
    • ?asthma meds
    • Inhibits CYP 2D6 (amitriptyline and fluoxetine)
    • May interfere with immunosuppressants
  57. SEs of Asian Ginseng
    • Diffuse mammary nodularity
    • Vaginal bleeding
    • Gynecomastia
    • HTN
    • Hypoglycemia
    • Nervousness, excitation, insomnia
    • Inability to concentrate
    • Palpitations
    • Diarrhea
  58. Milk Thistle indications
    • Chronic inflammatory liver conditions
    • Cirrhosis
  59. Milk Thistle CIs/Precautions
    • pregnancy
    • allergy to ragweed, chrysanthemums
    • hormone sensitive cancers
  60. Milk thistle DIs
    • Inhibits CYP 2C9, 3A4
    • No intx with indinavir
  61. Milk thistle SEs
    • Diarrhea, nausea, dyspepsia, flatulence
    • Allergic rxns, rash
  62. Saw Palmetto indications
    BPH
  63. Saw palmetto CIs/Precautions
    • pregnancy
    • children
    • d/c 2 weeks prior to surgery
  64. Saw Palmetto DIs
    • Anticoagulants?
    • Contraceptive drugs or hormone replacement therapy? (antiestrogenic effects)
  65. Saw palmetto SEs
    • Intraoperative hemorrhage
    • HA
    • Stomach upset
    • Acute hepatitis and pancreatitis
  66. St. John's Wort indications
    • Anxiety
    • Depression
  67. CI/Precautions for St. John's Wort
    • Fair-skinned persons
    • Pregnancy/lactation (abortofacent)
    • Psychiatric conditions (may exacerbate bipolar, schizophrenia)
    • Alzheimer's Disease (may induce psychosis)
    • Hypothyroidism
    • Anesthesia (may cause CV collapse)
    • Surgical procedures (d/c 2 wk prior)
    • Infertility
    • (No negative influence on general performance, ability to operate car/heavy machinery)
  68. St. John's Wort DIs
    • CYP 1A2, 2C9, 2C19, 3A4
    • (decreases efficacy of the other drug unless otherwise specified)
    • Antidepressants
    • Anti-retrovirals
    • Barbs
    • Clopidogrel (increased efficacy)
    • Cyclosporine
    • Digoxin
    • Irinotecan and Imatinib
    • Methadone
    • Methylphenidate
    • Omeprazole
    • OCs
    • Phenytoin
    • Statins
    • Tacrolimus
    • Theophlline
    • Triptans?
    • Verapamil
    • Warfarin (decreased INR)
  69. St. John's Wort food interactions
    Tyramine containing foods (possibly)
  70. St. John's Wort SEs
    • Photodermatitis/phototoxicity
    • Nausea, constipation, GI distress
    • Allergic rxns
    • tiredness, restlessness, sleep disturbances
    • mania or hypomania
    • elevated TSH
    • elevated BP
    • male/female infertility
  71. Valerian indications
    • Restlessness
    • Nervous disturbance of sleep
  72. Valerian CIs/Precautions
    • Similar to Benzos, Barbs, Opiates
    • Caution while driving or performing tasks requiring alertness and coordination
  73. Valerian DIs
    • CNS depressants (may potentiate the sedative effect of barbs, benzos, opiates, alcohol, other sedatives)
    • Inhibits CYP 3A4
    • Sedatives
    • Anxiolytics
    • MAOIs
    • Alcohol
    • Antidepressants
  74. Valerian SEs
    • HA
    • Hangover
    • Excitability
    • Insomnia
    • Uneasiness
    • Cardiac disturbances
    • Hepatotoxicity
    • Toxicity: ataxia, hypothermia, hallucinations, increased muscle relaxation
  75. What is glucosamine and/or chondroitin used for?
    • osteoarthritis
    • improves cartilage
    • inhibits breakdown of existing cartilage
  76. Drug intx with glucosamine? With Chondroitin?
    • Glucosamine:
    • Antidiabetic agents (hypoglycemia)
    • May induce resistance to antimitotic chemotherapy (etopside, doxorubicin)
    • Warfarin?

    • Chondroitin:
    • Interacts with heparin/warfarin
  77. What kind of cartilage is glucosamine made with? Chondroitin?
    • G: Shellfish
    • C: Beef or shark
  78. CI/precautions with Glucosamine/Chondroitin
    diabetes, asthma, bleeding disorders
  79. Indications for Coenzyme Q-10
    • (not evaluated by German Comission E)
    • CHF
    • HTN
    • Stable angina
    • Ventricular arrhythmias
    • Cancer
    • Heart surgery
    • Peridontal disease
  80. Coenzyme Q-10 CIs/Precautions
    • Biliary obstruction
    • Diabetes (hypoglycemia)
    • Hepatic insufficiency
    • Renal insufficiency
    • Hyper and hypotension
  81. Coenzyme Q-10 DIs
    • Statins may lower the plasma conc of CoQ10
    • Oral hypoglycemic agents potentially inhibit effects of exogenous admin
    • Doxorubicin toxicity may be increased
    • Antihypertensives (additive effect)
    • Warfarin (CoQ10 structurally related to Vitamin K, so may have coagulant effects)
  82. Coenzyme Q-10 SEs
    • rash
    • GI disturbances
    • Elevations of LFTs
  83. Melatonin indications
    (similar to Ramelteon)

    Orphan drug status: Tx of circadian rhythm sleep disorders in blind ppl with no light perception

    Non-approved indications: jet lag, insomnia, depression, cancer
  84. Melatonin CIs/Precautions
    • Pregnancy
    • May aggravate depressive symptoms
    • May increase incidence of seizures
    • Diabetes (hyperglycemia)
    • HTN (exacerbated)
  85. Melatonin DIs
    • SSRIs (may increase serum conc of melatonin)
    • Other sedatives (may exacerbate effect)
    • Anticoagulants (increased effect)
    • Contraceptives (efficacy of melatonin could be increased)
    • Immunosuppressants
    • Caffeine (could decrease efficacy of melatonin)
    • Antidiabetic agents (may be less effective)
    • Verapamil (increases excretion of melatonin)
  86. Melatonin SEs
    • Drowsiness, daytime fatigue, HA, dizziness, transient depression
    • Long-term SEs unknown
  87. When counseling patients on dietary supplements, what should you tell them?
    • The FDA does not regulate the standardization, efficacy, safety, drug interactions
    • Tell them what we do know of the product from the available literature
  88. Why is documentation so important when counseling on dietary supplements?
    Potential liability

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