Nonprescription (OTC) Medications
Nonprescription (OTC) Medications
NAPLEX
PG 405
Major categories of products to review
Major categories of products to review
Most important antacids , antidiarrheals cough and cold remedies diabetes products dietary supplements internal analgesics laxatives motion sickness vitamins
Most important antacids , antidiarrheals cough and cold remedies diabetes products dietary supplements internal analgesics laxatives motion sickness vitamins
Less Important diet aids eye solutions external antiseptics hemmorhoidal preps mouthwashes nutritional supplements sunscreens
Less Important diet aids eye solutions external antiseptics hemmorhoidal preps mouthwashes nutritional supplements sunscreens
PG 405
Strategies for reviewingStrategies for reviewing
Be realistic – impossible to know all OTC products and their ingredients
Concentrate on the types of ingredients in each category cough suppressants – what’s available?
Be realistic – impossible to know all OTC products and their ingredients
Concentrate on the types of ingredients in each category cough suppressants – what’s available?
Strategies for reviewingStrategies for reviewing
Learn only the major (best-selling) OTC products and their ingredients and dosing Walk your shelves
Recognize the major problems (interactions, key warnings/precautions) with each ingredient
Be alert for Rx-to-OTC switches
Learn only the major (best-selling) OTC products and their ingredients and dosing Walk your shelves
Recognize the major problems (interactions, key warnings/precautions) with each ingredient
Be alert for Rx-to-OTC switches
AntacidsAntacids A pH range of between 3 and 4 should be maintained
during antacid therapy approximately 98% of all stomach acid is neutralized
but the gastric enzymes are still active for digestion
Antacids evaluated with USP “Acid Neutralizing Capacity Test” based on the mEq of HCl consumed by the antacid
while still maintaining a pH of 3.5
A pH range of between 3 and 4 should be maintained during antacid therapy approximately 98% of all stomach acid is neutralized
but the gastric enzymes are still active for digestion
Antacids evaluated with USP “Acid Neutralizing Capacity Test” based on the mEq of HCl consumed by the antacid
while still maintaining a pH of 3.5
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Major Ingredients of AntacidsMajor Ingredients of Antacids
IngredientAdvantages Disadvantages
Aluminum hydroxide
(Amphojel)
may cause constipation
decreased absorption of phosphates
Magnesium hydroxide
(MOM)
may cause diarrhea
accumulation of magnesium ion in blood – avoid if renal failure
Aluminum and magnesium combo
(Maalox, Mylanta)
Fewer side effects than plain Al or Mg
may still cause metabolic alkalosis and magnesium accumulation in renal failure
PG 406
Major Ingredients of AntacidsMajor Ingredients of Antacids
Ingredient Advantages Disadvantages
Calcium carbonate
(Tums, Alka-mints)
source of calcium for osteoporosis prevention
may cause hypercalcemia and kidney stones
Sodium bicarbonate
(alka-seltzer, Soda Mint, ie)
High pH may cause acid rebound
High sodium levels – CHF/HTN
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Plus=simethacone
From the Pharmacist’s Letter - 2008
From the Pharmacist’s Letter - 2008
You'll soon see a new formulation of Renagel called Renvela. The original Renagel is the hydrochloride salt of sevelamer... Renvela is a carbonate salt. Both work equally well to bind phosphates in the gut...and will cost about the same. The carbonate salt is an acid buffer...the hydrochloride is not. Therefore Renvela might help reduce the risk of acidosis. Keep in mind that Renagel will still be available for now. Watch for potential mix-ups with Renagel and Renvela...the names are very similar and the dosing is the same.
General Comments on AntacidsGeneral Comments on Antacids Gavison and Algicon are intended for the
treatment GERD (lower neutralizing capacity)
Separate administration of Rx meds and antacids by 2 hrs. iron, levodopa, quinolones, tetracyclines ketoconazole – needs lower pH for absorption
Can cause decrease activity of anticoagulants, digoxin, phenothiazines, tetracylines as well
Gavison and Algicon are intended for the treatment GERD (lower neutralizing capacity)
Separate administration of Rx meds and antacids by 2 hrs. iron, levodopa, quinolones, tetracyclines ketoconazole – needs lower pH for absorption
Can cause decrease activity of anticoagulants, digoxin, phenothiazines, tetracylines as well
PG 407
Which of the following agents is NOT an effective treatment for peptic ulcer disease?
a. nizatidine
b. calcium carbonate
c. cetirizine
d. omeprazole
e. pantoprazole
Which of the following agents is NOT an effective treatment for peptic ulcer disease?
a. nizatidine
b. calcium carbonate
c. cetirizine
d. omeprazole
e. pantoprazole
Which of the following agents is NOT an effective treatment for peptic ulcer disease?
a. nizatidine (Axid)
b. calcium carbonate (Tums)
c. cetirizine (Zyrtec)
d. omeprazole (Prilosec)
e. pantoprazole (Protonix)
Which of the following agents is NOT an effective treatment for peptic ulcer disease?
a. nizatidine (Axid)
b. calcium carbonate (Tums)
c. cetirizine (Zyrtec)
d. omeprazole (Prilosec)
e. pantoprazole (Protonix)
OTC H2-Antagonists & PPIOTC H2-Antagonists & PPI
Cimetidine (Tagamet), famotidine (Pepcid), ranitidine (Zantac), nizatidine (Axid) all have OTC status dosing – half of RX dose interactions with cimetidine are significant Pepcid Complete – famotidine + calcium
carbonate + magnesium hydroxide• provides rapid relief (CaCO3 and MgOH) plus
sustained acid suppression
Omeprazole (Prilosec OTC) 20 mg daily before a meal for 14 days
Cimetidine (Tagamet), famotidine (Pepcid), ranitidine (Zantac), nizatidine (Axid) all have OTC status dosing – half of RX dose interactions with cimetidine are significant Pepcid Complete – famotidine + calcium
carbonate + magnesium hydroxide• provides rapid relief (CaCO3 and MgOH) plus
sustained acid suppression
Omeprazole (Prilosec OTC) 20 mg daily before a meal for 14 days
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LaxativesLaxatives
Drugs known to cause constipation
Drugs known to cause constipation
Antacids (calcium and aluminum) Anticholinergics Anticonvulsants Antidepressants (TCAs) Beta-blockers Calcium Channel Blockers (verapamil) Diuretics Iron Opiates (stimulant laxative is a must) Clonidine Methyldopa
Antacids (calcium and aluminum) Anticholinergics Anticonvulsants Antidepressants (TCAs) Beta-blockers Calcium Channel Blockers (verapamil) Diuretics Iron Opiates (stimulant laxative is a must) Clonidine Methyldopa
PG 409
LaxativesLaxatives Classified into 5 categories
bulk-forming emollient lubricants saline stimulants
Categories have advantages/disadvantages.
Recognize abuse potential w/all laxatives
Classified into 5 categories bulk-forming emollient lubricants saline stimulants
Categories have advantages/disadvantages.
Recognize abuse potential w/all laxatives
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Bulk FormingBulk Forming
Good initial choice; mild action products swell and provide bulk for stool
formation onset is 12-24 hrs., must take full glass of H2O psyllium - Metamucil, Citracel, Fibercon cellusoses calcium polycarbophil
• Mitrolan and Equilactin• can be used for constipation or diarrhea• used in the treatment of IBS
Good initial choice; mild action products swell and provide bulk for stool
formation onset is 12-24 hrs., must take full glass of H2O psyllium - Metamucil, Citracel, Fibercon cellusoses calcium polycarbophil
• Mitrolan and Equilactin• can be used for constipation or diarrhea• used in the treatment of IBS
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Emollients (stool softeners) Emollients (stool softeners)
Used in patients w/severe HTN and cardiovascular disease, post-hemorrhoidal surgery act as a surfactant to soften stool Limits straining docusate (Colace) most common
• available in combination with a stimulant• docusate + senna (Peri-colace)• docusate + danthron (Doxidan)
Used in patients w/severe HTN and cardiovascular disease, post-hemorrhoidal surgery act as a surfactant to soften stool Limits straining docusate (Colace) most common
• available in combination with a stimulant• docusate + senna (Peri-colace)• docusate + danthron (Doxidan)
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LubricantsLubricants
Sometimes used in elderly patients also can act to soften stools mineral oil most commonly used disadvantage:
• impairs absorption of fat-soluble vitamins (A,D,E,K)• aspiration risk in debilitated elderly – pneumonia• avoid in pregnant women or patients on warfarin
Sometimes used in elderly patients also can act to soften stools mineral oil most commonly used disadvantage:
• impairs absorption of fat-soluble vitamins (A,D,E,K)• aspiration risk in debilitated elderly – pneumonia• avoid in pregnant women or patients on warfarin
PG 408
Saline LaxativesSaline Laxatives Used for acute bowel evacuation
acts by osmotic pressure to increase water in intestines/colon
Examples:• magnesium sulfate/citrate (Epsom salts) – avoid in
renal impairment• Phosphate salts (Fleets Phospho-soda) – have high
sodium levels• Lactulose (Chronulose) – also used in hepatic failure• Sorbitol
rapid onset of action – don’t go far from home
Used for acute bowel evacuation acts by osmotic pressure to increase water in
intestines/colon Examples:
• magnesium sulfate/citrate (Epsom salts) – avoid in renal impairment
• Phosphate salts (Fleets Phospho-soda) – have high sodium levels
• Lactulose (Chronulose) – also used in hepatic failure• Sorbitol
rapid onset of action – don’t go far from home
PG 409
Stimulants Stimulants Used alone or combination with other categories
stimulates GI motility glycerin suppositories – dual action of stimulant and
lubricant Senna (Senokot, Ex-Lax) bisacodyl (Dulcolax)
• acts on colon, action in 6-10 hours when given PO, 15-60 min rectally
• enteric coated to prevent stomach irritation (avoid with milk and antacids)
castor oil – too strong, not recommended
Used alone or combination with other categories stimulates GI motility glycerin suppositories – dual action of stimulant and
lubricant Senna (Senokot, Ex-Lax) bisacodyl (Dulcolax)
• acts on colon, action in 6-10 hours when given PO, 15-60 min rectally
• enteric coated to prevent stomach irritation (avoid with milk and antacids)
castor oil – too strong, not recommended
PG 409
Cold and Allergy ProductsCold and Allergy Products Classes of Agents to Know
Antihistamines Decongestants Antitussives Expectorants Analgesics / Antipyretics
Very many brand names, very few ingredients See top selling list on page 412
• NyQuil, Robitussin, Dimetap, Claritin, Sudafed,
Classes of Agents to Know Antihistamines Decongestants Antitussives Expectorants Analgesics / Antipyretics
Very many brand names, very few ingredients See top selling list on page 412
• NyQuil, Robitussin, Dimetap, Claritin, Sudafed,
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AntihistaminesAntihistamines Block H-1 receptors, decrease smooth muscle
response to histamine
Active Ingredients brompheniramine – Dimetapp, Dimetane chlorpheniramine – Chlor-Trimeton clemastine – Tavist (D w / pseudoephedrine) diphenhydramine – Benadryl Loratadine – Claritin & Alavert Cetirizine - Zyrtec Counseling Points
• may cause drowsiness, CNS stimulation in children• anticholingeric effects (dry mouth, tachycardia, urinary retention) can be
problematic in elderly patients, BPH • narrow angle glaucoma
Block H-1 receptors, decrease smooth muscle response to histamine
Active Ingredients brompheniramine – Dimetapp, Dimetane chlorpheniramine – Chlor-Trimeton clemastine – Tavist (D w / pseudoephedrine) diphenhydramine – Benadryl Loratadine – Claritin & Alavert Cetirizine - Zyrtec Counseling Points
• may cause drowsiness, CNS stimulation in children• anticholingeric effects (dry mouth, tachycardia, urinary retention) can be
problematic in elderly patients, BPH • narrow angle glaucoma
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DecongestantsDecongestants
Stimulate alpha-adrenergic receptors, causing vasoconstriction of blood vessels
Active Ingredients phenylephrine – Neo-Synephrine drops/spray oxymetazoline or Xylometazoline – Afrin spray
• caution patients on overuse and secondary rebound congestion – do not use for more than 3-5 consecutive days
pseudoephedrine – Sudefed, given po, 30-60mg q6h ; available in numerous combinations
Use with caution in patients with HTN
Cromolyn nasal spray – mast cell stabilizer for nasal allergies and allergic rhinitis – few side effects
Stimulate alpha-adrenergic receptors, causing vasoconstriction of blood vessels
Active Ingredients phenylephrine – Neo-Synephrine drops/spray oxymetazoline or Xylometazoline – Afrin spray
• caution patients on overuse and secondary rebound congestion – do not use for more than 3-5 consecutive days
pseudoephedrine – Sudefed, given po, 30-60mg q6h ; available in numerous combinations
Use with caution in patients with HTN
Cromolyn nasal spray – mast cell stabilizer for nasal allergies and allergic rhinitis – few side effects
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Antitussives / ExpectorantsAntitussives / Expectorants Antitussives - suppress cough reflex in the medullary cough
center dextromethorphan most common codeine limited by control drug laws
• may cause some drowsiness Delsym has dextromethorphan alone - longer acting formulation
Expectorants thin mucous secretions in bronchioles guaifenesin is only one available
• counsel patients to consume large amounts of water Robitussin +/- DM, Benylin, Mucinex
Antitussives - suppress cough reflex in the medullary cough center
dextromethorphan most common codeine limited by control drug laws
• may cause some drowsiness Delsym has dextromethorphan alone - longer acting formulation
Expectorants thin mucous secretions in bronchioles guaifenesin is only one available
• counsel patients to consume large amounts of water Robitussin +/- DM, Benylin, Mucinex
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Trade Names: Robitussin DM, Naldecon, Dimetapp, PediaCare, Vicks, Triaminic, Benylin
AnalgesicsAnalgesics Background on pain
highly subjective, individualized symptom numerous potential causes
• organic pain – pathologic disturbance
• psychogenic pain – emotional disturbance
• somatic pain – from musculoskeletal system or skin
• visceral pain – from organs, especially the stomach Internal analgesics most effective for:
• Headache, neuralgia, myalgia, arthralgia, RA
Available agents APAP, ASA, ibuprofen, naproxen, ketoprofen
Background on pain highly subjective, individualized symptom numerous potential causes
• organic pain – pathologic disturbance
• psychogenic pain – emotional disturbance
• somatic pain – from musculoskeletal system or skin
• visceral pain – from organs, especially the stomach Internal analgesics most effective for:
• Headache, neuralgia, myalgia, arthralgia, RA
Available agents APAP, ASA, ibuprofen, naproxen, ketoprofen
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Analgesics (cont.)Analgesics (cont.) Aspirin (ASA)
Available as 81mg, 325mg, EC, 81-325mg for CVD, 325-650mg TID for pain, high dose for inflammation, RA
avoid use in young children (Reye Syndrome)• Acquired encephalopathy in young children (infantcy-19 years)
Acetaminophen (APAP) 325mg, 500mg (extra strength), 650mg (max 4grms/day) no anti-inflammatory liver damage w/high dose, long-term, avoid alcohol, warfarin
interaction
Non-steroidal Anti-inflammatory Agents (NSAIDs) ibuprofen 200mg, naproxen 220mg, ketoprofen 12.5mg avoid if GI disorders, frail elderly, kidney disease
Aspirin (ASA) Available as 81mg, 325mg, EC, 81-325mg for CVD, 325-650mg
TID for pain, high dose for inflammation, RA avoid use in young children (Reye Syndrome)
• Acquired encephalopathy in young children (infantcy-19 years)
Acetaminophen (APAP) 325mg, 500mg (extra strength), 650mg (max 4grms/day) no anti-inflammatory liver damage w/high dose, long-term, avoid alcohol, warfarin
interaction
Non-steroidal Anti-inflammatory Agents (NSAIDs) ibuprofen 200mg, naproxen 220mg, ketoprofen 12.5mg avoid if GI disorders, frail elderly, kidney disease
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External AnalgesicsExternal Analgesics Used to treat local pain, itching from insect bites, burns,
muscle soreness
Anesthetics benzocaine 5% - 20% and lidocaine 2%
Anti-inflammatory hydrocortisone 0.5 – 1%, diphenhydramine 1-2%
Counterirritants methyl salicylate (Ben gay), menthol, camphor, eucalyptus capsaicin (inhibits substance P) – postherpetic neuralgia; use
continously, wash hands thoroughly, do not cover
Used to treat local pain, itching from insect bites, burns, muscle soreness
Anesthetics benzocaine 5% - 20% and lidocaine 2%
Anti-inflammatory hydrocortisone 0.5 – 1%, diphenhydramine 1-2%
Counterirritants methyl salicylate (Ben gay), menthol, camphor, eucalyptus capsaicin (inhibits substance P) – postherpetic neuralgia; use
continously, wash hands thoroughly, do not cover
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OTCs ContinuedOTCs Continued Sleep Aid Products
diphenydramine – note: Tylenol PM Doxylamine (Unisom and in Nyquil)
• be aware of many other products with antihistamines• do not use for long term; caution side effects• Not intended for kids <12 • Not to be taken with alcohol
Sunscreen Agents Sun Protection Factor = exposure time with skin protection exposure time without
SPF of 15 should protect “all day” although reapplication is recommended if swimming, sweating, ect.
Para-aminobenziod acid (PABA)• 5% usual level• Most common
Sleep Aid Products diphenydramine – note: Tylenol PM Doxylamine (Unisom and in Nyquil)
• be aware of many other products with antihistamines• do not use for long term; caution side effects• Not intended for kids <12 • Not to be taken with alcohol
Sunscreen Agents Sun Protection Factor = exposure time with skin protection exposure time without
SPF of 15 should protect “all day” although reapplication is recommended if swimming, sweating, ect.
Para-aminobenziod acid (PABA)• 5% usual level• Most common
PG 416
A patient who is experiencing a runny nose, sneezing, headache and watery eyes should be counseled to take which of the following OTC agents?
I. diphenhydramineII. acetaminophenIII. pseudoephedrine
a. I onlyb. III onlyc. I and II onlyd. II and III onlye. I, II, and III
A patient who is experiencing a runny nose, sneezing, headache and watery eyes should be counseled to take which of the following OTC agents?
I. diphenhydramineII. acetaminophenIII. pseudoephedrine
a. I onlyb. III onlyc. I and II onlyd. II and III onlye. I, II, and III
A patient who is experiencing a runny nose, sneezing, headache and watery eyes should be counseled to take which of the following OTC agents?
I. diphenhydramineII. acetaminophenIII. pseudoephedrine
a. I onlyb. III onlyc. I and II onlyd. II and III onlye. I, II, and III
A patient who is experiencing a runny nose, sneezing, headache and watery eyes should be counseled to take which of the following OTC agents?
I. diphenhydramineII. acetaminophenIII. pseudoephedrine
a. I onlyb. III onlyc. I and II onlyd. II and III onlye. I, II, and III
AntidiarrhealsAntidiarrheals Causes of diarrhea
microbes, drugs, IBS, colitis, foods Consultation w/ MD
Duration >2 days , children <3y/o, fever or blood in stool Agents
Adsorbants (water and toxins) – Kaopectate, pepto-bismol, (bismuth)
Bulking agents – calcium polycarbophil (Fibercon, Fiberall) Antiperistaltic agents – loperamide (Immodium 2mg)
• 2mg tabs, 1mg/5ml (Regimen – 4mg immediately, then 2mg until loose bowel movement)
Reestablish normal flora – lactobacillus acidophilus (Lactinex) “reseed” the bowel, supress pathogenic organisms---KEEP REFRIGERATED
Rehydrating solutions – Pedialyte, Infalyte
Causes of diarrhea microbes, drugs, IBS, colitis, foods
Consultation w/ MD Duration >2 days , children <3y/o, fever or blood in stool
Agents Adsorbants (water and toxins) – Kaopectate, pepto-bismol,
(bismuth) Bulking agents – calcium polycarbophil (Fibercon, Fiberall) Antiperistaltic agents – loperamide (Immodium 2mg)
• 2mg tabs, 1mg/5ml (Regimen – 4mg immediately, then 2mg until loose bowel movement)
Reestablish normal flora – lactobacillus acidophilus (Lactinex) “reseed” the bowel, supress pathogenic organisms---KEEP REFRIGERATED
Rehydrating solutions – Pedialyte, Infalyte
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OTC Agents (cont.)OTC Agents (cont.) Calcium Supplements
Important for women to supplement, esp. post-menopausal or those taking drugs for osteoporosis
Rec. doses: < age 50: 1000mg/day > 50: 1200-1500mg/d Calcium carbonate (Oscal, Caltrate) taken with food, requires acidic
environment for absorption in stomach Calcium citrate (Citracal) taken w/ or w/o, better absorbed in elderly
patients who have reduced stomach acid secretion DON’T FORGET VIT D
Head Lice Products (parasites) Permethrin (Nix) – caution if allergy to chrysanthemums Pyrethrins (A-200, Rid, Pronto) – avoid if allergic to ragweed
• Wash hair without conditioner• Leave on hair 10 minutes• May repeat in 1 week• Must comb out nits
Calcium Supplements Important for women to supplement, esp. post-menopausal or
those taking drugs for osteoporosis Rec. doses: < age 50: 1000mg/day > 50: 1200-1500mg/d Calcium carbonate (Oscal, Caltrate) taken with food, requires acidic
environment for absorption in stomach Calcium citrate (Citracal) taken w/ or w/o, better absorbed in elderly
patients who have reduced stomach acid secretion DON’T FORGET VIT D
Head Lice Products (parasites) Permethrin (Nix) – caution if allergy to chrysanthemums Pyrethrins (A-200, Rid, Pronto) – avoid if allergic to ragweed
• Wash hair without conditioner• Leave on hair 10 minutes• May repeat in 1 week• Must comb out nits
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Premenstrual Syndrome ProductsPremenstrual Syndrome Products
Analgesics – Reduce synthesis of prostaglandins Antihistamines – Pyrilamine - acts on smooth
muscles and reduce production of prolactin Diuretic – Reduce bloating
Ammonium Chloride, caffeine, pamabrom Combination Products
Aqua Ban, Midol, Midol PMS, Pamprin, Sunril
Analgesics – Reduce synthesis of prostaglandins Antihistamines – Pyrilamine - acts on smooth
muscles and reduce production of prolactin Diuretic – Reduce bloating
Ammonium Chloride, caffeine, pamabrom Combination Products
Aqua Ban, Midol, Midol PMS, Pamprin, Sunril
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Dietary SupplementsDietary Supplements
NAPLEX
PG 427
Dietary Supplements - DefinitionsDietary Supplements - DefinitionsDietary Supplements - DefinitionsDietary Supplements - Definitions Complimentary and Alternative Medicine
Medicine practices not considered conventional Includes herbal therapy, chiropractic, acupuncture,
homeopathy, biofeedback
Dietary Supplements Any product intended for ingestion as a supplement to the diet Includes herbal supplements, vitamins, minerals
Herbal Supplements Plant derived dietary supplements reported to have medicinal medicinal
and pharmacological effectsand pharmacological effects
Complimentary and Alternative Medicine Medicine practices not considered conventional Includes herbal therapy, chiropractic, acupuncture,
homeopathy, biofeedback
Dietary Supplements Any product intended for ingestion as a supplement to the diet Includes herbal supplements, vitamins, minerals
Herbal Supplements Plant derived dietary supplements reported to have medicinal medicinal
and pharmacological effectsand pharmacological effects
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Regulatory ProcessRegulatory ProcessRegulatory ProcessRegulatory Process
Industry began to take off in late-1980s herbal product use expanded, health concerns arose
FDA began scrutinizing companies in early ’90s
consumers and the industry demanded the right to take and sell these “dietary supplements”
wrote letters to Congress to campaign against regulations
FDA gave in and passed DSHEA of 1994 Dietary Health and Education Act
Industry began to take off in late-1980s herbal product use expanded, health concerns arose
FDA began scrutinizing companies in early ’90s
consumers and the industry demanded the right to take and sell these “dietary supplements”
wrote letters to Congress to campaign against regulations
FDA gave in and passed DSHEA of 1994 Dietary Health and Education Act
Dietary Supplement Health and Dietary Supplement Health and Education Act of 1994Education Act of 1994
Dietary Supplement Health and Dietary Supplement Health and Education Act of 1994Education Act of 1994
Categorized herbals, vitamins, protein bars, shakes as “dietary supplements” manufacturers are not required to demonstrate safety, purity
or efficacy of supplements labeling must include FDA statement:
• Statement not evaluated by FDA, not intended to diagnose, treat, cure or prevent disease
products cannot have specific claims on labels• use phrases like “helps boost, support, enhance…”
FDA can pull products if suspected unsafe Ephedra and Ma Huang - 2004
Categorized herbals, vitamins, protein bars, shakes as “dietary supplements” manufacturers are not required to demonstrate safety, purity
or efficacy of supplements labeling must include FDA statement:
• Statement not evaluated by FDA, not intended to diagnose, treat, cure or prevent disease
products cannot have specific claims on labels• use phrases like “helps boost, support, enhance…”
FDA can pull products if suspected unsafe Ephedra and Ma Huang - 2004
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DSHEA of 1994 - LimitationsDSHEA of 1994 - Limitations DSHEA of 1994 - LimitationsDSHEA of 1994 - Limitations
Safety is reactive, not proactive; limited safety information available
Available studies are small and poorly designed; a wide variety of products are not available in the US
There are no standards for manufacturing practices; labeled amounts and ingredients may be inaccurate
The FDA is considering imposing a requirement for good manufacturing practices (GMPs) for all dietary supplements.
Safety is reactive, not proactive; limited safety information available
Available studies are small and poorly designed; a wide variety of products are not available in the US
There are no standards for manufacturing practices; labeled amounts and ingredients may be inaccurate
The FDA is considering imposing a requirement for good manufacturing practices (GMPs) for all dietary supplements.
PG 426
The Top 20 Dietary The Top 20 Dietary SupplementsSupplements
The Top 20 Dietary The Top 20 Dietary SupplementsSupplements
Glucosamine/Chondroitin Echinacea Ginkgo biloba Ginseng Saw palmetto Fish oil St John’s Wort Garlic Melatonin Coenzyme Q10
Glucosamine/Chondroitin Echinacea Ginkgo biloba Ginseng Saw palmetto Fish oil St John’s Wort Garlic Melatonin Coenzyme Q10
Cranberry Feverfew Ginger Milk thistle Soy isoflavones Black cohosh Valerian Hawthorn SAM-e MSM
Cranberry Feverfew Ginger Milk thistle Soy isoflavones Black cohosh Valerian Hawthorn SAM-e MSM
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GlucosamineGlucosamineGlucosamineGlucosamine Not an herbal; glycoprotein derived from marine
exoskeletons or synthetically active compounds: glucosamine itself;(HCL or SO4)
Proposed Uses treatment of osteoarthritis; used in combination w/
chondroitin mechanism of action
• Glucosamine stimulates metabolism of chondrocytes in articular cartilage; preventing cartilage breakdown and potential regrowth
• Chondroitin believed to serve as substrate for production of joint matrix substances (minimally absorbed)
dosing• 500mg TID, (w/200-400mg of chondroitin)
Not an herbal; glycoprotein derived from marine exoskeletons or synthetically active compounds: glucosamine itself;(HCL or SO4)
Proposed Uses treatment of osteoarthritis; used in combination w/
chondroitin mechanism of action
• Glucosamine stimulates metabolism of chondrocytes in articular cartilage; preventing cartilage breakdown and potential regrowth
• Chondroitin believed to serve as substrate for production of joint matrix substances (minimally absorbed)
dosing• 500mg TID, (w/200-400mg of chondroitin)
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Glucosamine/Chondroitin - SafetyGlucosamine/Chondroitin - SafetyGlucosamine/Chondroitin - SafetyGlucosamine/Chondroitin - Safety
Few common or serious ADRs reported• GI, n/v, HA, drowsiness, similar to placebo
Interactions antidiabetic drugs - decreased effect
• anticoagulants w/chondroitin Caution in DM, HTN, Hyperlipidemia Caution in shellfish allergy
Few common or serious ADRs reported• GI, n/v, HA, drowsiness, similar to placebo
Interactions antidiabetic drugs - decreased effect
• anticoagulants w/chondroitin Caution in DM, HTN, Hyperlipidemia Caution in shellfish allergy
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Glucosamine/Chondroitin - EfficacyGlucosamine/Chondroitin - EfficacyGlucosamine/Chondroitin - EfficacyGlucosamine/Chondroitin - Efficacy Osteoarthritis
Widely studied w/most trials demonstrating benefits • shown to reduce pain and joint stiffness• studied against low-moderate dose NSAIDs• pain benefits modest but significant
Reginster et al. - effect on disease progression• 106 pts. w/knee OA treated for 3 years with
1500mg/day vs. 106 pts. on placebo• endpoints: radiographic changes, joint-narrowing• results: -0.06mm tx. vs. –0.31mm placebo, also
symptom improvements
Osteoarthritis Widely studied w/most trials demonstrating benefits
• shown to reduce pain and joint stiffness• studied against low-moderate dose NSAIDs• pain benefits modest but significant
Reginster et al. - effect on disease progression• 106 pts. w/knee OA treated for 3 years with
1500mg/day vs. 106 pts. on placebo• endpoints: radiographic changes, joint-narrowing• results: -0.06mm tx. vs. –0.31mm placebo, also
symptom improvements
Reginster JY et al. Lancet 2001; 357: 251-56Reginster JY et al. Lancet 2001; 357: 251-56
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Glucosamine/Chondroitin - EfficacyGlucosamine/Chondroitin - EfficacyGlucosamine/Chondroitin - EfficacyGlucosamine/Chondroitin - Efficacy
Some important counseling points requires 4-6 weeks of tx. for benefits to be seen not for PRN use, must continually use the sulfate salt is recommended, also some controversy on
combo w/chondroitin
May confer benefits unlike other OA treatments
cost is an issue, should insurance pay for it?
Some important counseling points requires 4-6 weeks of tx. for benefits to be seen not for PRN use, must continually use the sulfate salt is recommended, also some controversy on
combo w/chondroitin
May confer benefits unlike other OA treatments
cost is an issue, should insurance pay for it?
PG 426
EchinaceaEchinaceaEchinaceaEchinacea Extracts of E. purpurea and E. angustifolia
active compounds: several active constituents Proposed Uses
treating and preventing the common cold and URIs • immunostimulant for treatment of infections
mechanism of action• some direct antiviral activity, stimulates lymphocyte
activity, increases phagocytosis, also antifungal activity
dosing• 300mg TID for 7-14 days, must start at first sign of
sxs.• 6-9ml of E. purpurea juice daily
Extracts of E. purpurea and E. angustifolia active compounds: several active constituents
Proposed Uses treating and preventing the common cold and URIs
• immunostimulant for treatment of infections mechanism of action
• some direct antiviral activity, stimulates lymphocyte activity, increases phagocytosis, also antifungal activity
dosing• 300mg TID for 7-14 days, must start at first sign of
sxs.• 6-9ml of E. purpurea juice daily
PG 429
Echinacea- SafetyEchinacea- SafetyEchinacea- SafetyEchinacea- Safety Adverse Effects
allergic reactions, rash fever, n/v • a number of case reports of allergic reactions
Drug Interactions Immunosuppressants
• may interfere w/therapy May inhibit CYP450 enzymes (CYP3A4)
avoid in pts. w/ autoimmune disorders
Adverse Effects allergic reactions, rash fever, n/v
• a number of case reports of allergic reactions
Drug Interactions Immunosuppressants
• may interfere w/therapy May inhibit CYP450 enzymes (CYP3A4)
avoid in pts. w/ autoimmune disorders
PG 427
Echinacea – EfficacyEchinacea – EfficacyEchinacea – EfficacyEchinacea – Efficacy Prevention of colds/flu – benefits unclear
Grimm et al. Prevention w/ E.purpurea juice• 109 pts. w/>3 colds in prev. year• 4ml juice or placebo BID x 8 weeks • infx. rate: 65% vs. 74% (tx. vs. placebo) • no statistical benefit vs. placebo
Turner et al. Prevention of experimental colds • No statistical difference in infection or illness rates vs. placebo, but
trend toward benefit w/Echinacea
Prevention of colds/flu – benefits unclear Grimm et al. Prevention w/ E.purpurea juice
• 109 pts. w/>3 colds in prev. year• 4ml juice or placebo BID x 8 weeks • infx. rate: 65% vs. 74% (tx. vs. placebo) • no statistical benefit vs. placebo
Turner et al. Prevention of experimental colds • No statistical difference in infection or illness rates vs. placebo, but
trend toward benefit w/Echinacea
Grimm et al. Am J Med 1999;106:259-60Grimm et al. Am J Med 1999;106:259-60
Turner et al. Antimicrob Agents Chemother 2000;44:1708-9Turner et al. Antimicrob Agents Chemother 2000;44:1708-9
PG 427
Echinacea – EfficacyEchinacea – EfficacyEchinacea – EfficacyEchinacea – Efficacy
Treatment of cold and flu Overall data suggests modest reductions in
duration and severity of symptoms• studies varied in preparations used • All initiated therapy at first sign of symptoms• improvements seen on subjective symptoms severity and
duration questionnaires• reduction in duration of approx. 1-2 days
Treatment of cold and flu Overall data suggests modest reductions in
duration and severity of symptoms• studies varied in preparations used • All initiated therapy at first sign of symptoms• improvements seen on subjective symptoms severity and
duration questionnaires• reduction in duration of approx. 1-2 days
Barrett et al. J Fam Pract 1999;48:628-35Barrett et al. J Fam Pract 1999;48:628-35
PG 427
Gingko BilobaGingko BilobaGingko BilobaGingko Biloba Extract derived from leaves of tree
active compounds: flavonoids, terpenoids Proposed Uses
conditions assoc. w/cerebral vascular insufficiency• Alzheimer’s dementia, memory loss, vertigo, tinnitus• Others: intermittent claudication, motion sickness
mechanism of action• antioxidant activity, decrease blood viscosity
(inhibits platelet activation factor (PAF)), improve circulatory flow
dosing• 120-240mg of leaf extract day/divided doses
Extract derived from leaves of tree active compounds: flavonoids, terpenoids
Proposed Uses conditions assoc. w/cerebral vascular insufficiency
• Alzheimer’s dementia, memory loss, vertigo, tinnitus• Others: intermittent claudication, motion sickness
mechanism of action• antioxidant activity, decrease blood viscosity
(inhibits platelet activation factor (PAF)), improve circulatory flow
dosing• 120-240mg of leaf extract day/divided doses
PG 429
Gingko Biloba - SafetyGingko Biloba - Safety Gingko Biloba - SafetyGingko Biloba - Safety
Adverse Effects Few common or serious ADRs documented
• mild GI upset, constip. Dizziness, HA• high doses: diarrhea, restlessness, bleeding?
Drug Interactions** Anticoagulants, antiplatelet agents
• inhibits platelet activation factor (PAF) May inhibit CYP450 enzymes
• inhibits 1A2, 2D6; induce or inhibit 3A4
Caution in diabetes patients, epileptics
Adverse Effects Few common or serious ADRs documented
• mild GI upset, constip. Dizziness, HA• high doses: diarrhea, restlessness, bleeding?
Drug Interactions** Anticoagulants, antiplatelet agents
• inhibits platelet activation factor (PAF) May inhibit CYP450 enzymes
• inhibits 1A2, 2D6; induce or inhibit 3A4
Caution in diabetes patients, epileptics
PG 427
Gingko Biloba – EfficacyGingko Biloba – EfficacyGingko Biloba – EfficacyGingko Biloba – Efficacy Dementia: Alzheimer’s or vascular
meta-analysis in 1998: 50 studies identified, only 4 met criteria ( 212 pts. total, 3-6 mos. in duration)
• fairly consistent improvements in cognitive function shown (ADAS-Cog.)
• may delay progression
Memory Improvement some improvements in short-term memory and cognition in
adults w/o dementia Vertigo, Claudication
• few positive studies
Dementia: Alzheimer’s or vascular meta-analysis in 1998: 50 studies identified, only 4 met
criteria ( 212 pts. total, 3-6 mos. in duration) • fairly consistent improvements in cognitive function shown
(ADAS-Cog.)
• may delay progression
Memory Improvement some improvements in short-term memory and cognition in
adults w/o dementia Vertigo, Claudication
• few positive studies
Oken et al. Arch Neurol. 1998;55:1409-1415Oken et al. Arch Neurol. 1998;55:1409-1415
PG 427
GinsengGinsengGinsengGinseng Extract from plant root; three types (American,
Asian** (Panax), Siberian) active compounds: ginsenosides
Proposed Uses (panax ginseng) adaptogen (increases resistance to stress), improve immune
function, general tonic to improve energy mechanism of action
• wide range of possible effects, stimulate immune cells, affect adrenal gland secretion, increase cortisol levels, many others
dosing• 200mg – 600mg/day in capsule form, also in tea form
Extract from plant root; three types (American, Asian** (Panax), Siberian) active compounds: ginsenosides
Proposed Uses (panax ginseng) adaptogen (increases resistance to stress), improve immune
function, general tonic to improve energy mechanism of action
• wide range of possible effects, stimulate immune cells, affect adrenal gland secretion, increase cortisol levels, many others
dosing• 200mg – 600mg/day in capsule form, also in tea form
PG 429
Ginseng - SafetyGinseng - SafetyGinseng - SafetyGinseng - Safety Rare but potentially serious ADRs reported
• short term < 3 mos., insomnia, edema, HTN tachycardia
• Steven-Johnson syndrome • avoid long-term use as may increase ADRs
Interactions anticoagulants (warfarin, ASA); bleeding risk antidiabetic drugs; increased effect immunosuppresants; reduced effect may inhibit CYP2D6 caution in DM, cardiac dz., insomnia
Rare but potentially serious ADRs reported • short term < 3 mos., insomnia, edema, HTN
tachycardia• Steven-Johnson syndrome • avoid long-term use as may increase ADRs
Interactions anticoagulants (warfarin, ASA); bleeding risk antidiabetic drugs; increased effect immunosuppresants; reduced effect may inhibit CYP2D6 caution in DM, cardiac dz., insomnia
PG 429
Ginseng - EfficacyGinseng - EfficacyGinseng - EfficacyGinseng - Efficacy
Meta-analysis by Vogler et al. 16 trials met inclusion criteria
• most were poor in quality • numerous indications studied (energy/exercise
capacity, mood, immune function, memory)• few beneficial effects seen vs. placebo
Probably not the “energy pill” people want it to be • in low-doses, probably won’t hurt or help (placebo
effect)
Meta-analysis by Vogler et al. 16 trials met inclusion criteria
• most were poor in quality • numerous indications studied (energy/exercise
capacity, mood, immune function, memory)• few beneficial effects seen vs. placebo
Probably not the “energy pill” people want it to be • in low-doses, probably won’t hurt or help (placebo
effect)
PG 428
Saw PalmettoSaw PalmettoSaw PalmettoSaw Palmetto
Extract of fruit from native American tree active compounds: multiple fatty acid compounds
Proposed Uses treatment of symptoms of benign prostatic hypertrophy,
prostate CA, alopecia? mechanism of action
• appears to competitively inhibit 5-alpha reductase, preventing conversion of testosterone to dihydrotestosterone, leading to shrinking of prostate
– think finasteride (Proscar), dutasteride (Avodart)
• also has anti-inflammatory process dosing
• 160mg bid of extract containing 80-90% fatty acids
Extract of fruit from native American tree active compounds: multiple fatty acid compounds
Proposed Uses treatment of symptoms of benign prostatic hypertrophy,
prostate CA, alopecia? mechanism of action
• appears to competitively inhibit 5-alpha reductase, preventing conversion of testosterone to dihydrotestosterone, leading to shrinking of prostate
– think finasteride (Proscar), dutasteride (Avodart)
• also has anti-inflammatory process dosing
• 160mg bid of extract containing 80-90% fatty acids
PG 428
Saw Palmetto - SafetySaw Palmetto - SafetySaw Palmetto - SafetySaw Palmetto - Safety Few common or serious ADRs reported
• dizziness, n/v/d• sexual dysfunction (meta-analysis findings)
– 0.7% placebo– 1.1% saw palmetto– 4.9% finasteride
Drug Interactions few noted
• additive effect or ADRs w/finasteride?• hormone therapy
does not affect PSA levels
Few common or serious ADRs reported • dizziness, n/v/d• sexual dysfunction (meta-analysis findings)
– 0.7% placebo– 1.1% saw palmetto– 4.9% finasteride
Drug Interactions few noted
• additive effect or ADRs w/finasteride?• hormone therapy
does not affect PSA levels
PG 428
Saw Palmetto - EfficacySaw Palmetto - EfficacySaw Palmetto - EfficacySaw Palmetto - Efficacy
Benign Prostatic Hypertrophy Overall data suggests benefits
• multiple studies up to 48 wks have shown significant improvement in urinary symptoms (nocturia, urine flow)
• does not appear to affect prostate size • symptomatic effects seem comparable to finasteride,
less than alpha-blockers– not studied head-to-head w/alpha-blockers
Benign Prostatic Hypertrophy Overall data suggests benefits
• multiple studies up to 48 wks have shown significant improvement in urinary symptoms (nocturia, urine flow)
• does not appear to affect prostate size • symptomatic effects seem comparable to finasteride,
less than alpha-blockers– not studied head-to-head w/alpha-blockers
PG 430
Fish OilFish Oil
Derived from fatty fish (salmon, sardine, trout) EPA and DHA are essential fatty acids
Rx prescription – Omacor change to Lovaza
Proposed uses: heart disease, hypertriglyceridemia
Mechanism of action: competes with arachidonic acid in the COX and lipoxygenase pathways
Dosing: 1 g qd (CHD); 2-4 g/d for TGs
Derived from fatty fish (salmon, sardine, trout) EPA and DHA are essential fatty acids
Rx prescription – Omacor change to Lovaza
Proposed uses: heart disease, hypertriglyceridemia
Mechanism of action: competes with arachidonic acid in the COX and lipoxygenase pathways
Dosing: 1 g qd (CHD); 2-4 g/d for TGs
PG 430
Fish Oil - SafetyFish Oil - Safety
Most common Fishy aftertaste, GI intolerance, loose stools,
belching (dose-related) Allergies to fish protein not fish oil
Drug interactions Anticoagulants Antiplatelets
• Increase bleeding risk
• Does not appear to affect INR
Most common Fishy aftertaste, GI intolerance, loose stools,
belching (dose-related) Allergies to fish protein not fish oil
Drug interactions Anticoagulants Antiplatelets
• Increase bleeding risk
• Does not appear to affect INR
PG 431
Fish Oil - EfficacyFish Oil - Efficacy Prevention of CHD
Retrospective and prospective studies suggest benefits, especially in high-risk patients
Hypertriglyceridemia Studies suggest 25-30% reductions in triglycerides with use of
higher doses Small increase in LDL and HDL also seen
Flaxseed Oil - Also point out that the omega-3s in flaxseed and some nuts are different than the ones in fish. They contain alpha-linolenic acid (ALA) which is the precursor of EPA and DHA. But the amount of EPA and DHA the body converts from ALA is minimal. Diets high in these foods MIGHT help decrease heart disease...but NOT triglycerides.
Prevention of CHD Retrospective and prospective studies suggest benefits,
especially in high-risk patients
Hypertriglyceridemia Studies suggest 25-30% reductions in triglycerides with use of
higher doses Small increase in LDL and HDL also seen
Flaxseed Oil - Also point out that the omega-3s in flaxseed and some nuts are different than the ones in fish. They contain alpha-linolenic acid (ALA) which is the precursor of EPA and DHA. But the amount of EPA and DHA the body converts from ALA is minimal. Diets high in these foods MIGHT help decrease heart disease...but NOT triglycerides.
PG 431
St. John’s Wort (SJW)St. John’s Wort (SJW)St. John’s Wort (SJW)St. John’s Wort (SJW) Extract from buds, leaves & flowers of hypericum
perforatum active compounds: hypericin, hyperforin
Proposed Uses treatment of mild to moderate depression mechanism of action
• hypericin inhibits COMT & MAO, hyperforin modulates effects of serotonin, inhibits reuptake of various neurotransmitters
dosing• 300mg TID of extract standardized to 0.3% hypericin
content; other doses studies
Extract from buds, leaves & flowers of hypericum perforatum active compounds: hypericin, hyperforin
Proposed Uses treatment of mild to moderate depression mechanism of action
• hypericin inhibits COMT & MAO, hyperforin modulates effects of serotonin, inhibits reuptake of various neurotransmitters
dosing• 300mg TID of extract standardized to 0.3% hypericin
content; other doses studies
PG 431
St. John’s Wort - SafetySt. John’s Wort - SafetySt. John’s Wort - SafetySt. John’s Wort - Safety
Some adverse effects reported • gastrointestinal, dry mouth, restlessness / insomnia
more common • also vivid dreams, agitation, mania, dizziness, skin
rash, photosensitivity reported • ADR profile similar to TCAs, fewer cardiac effects• unsafe at high doses
Drug Interactions all antidepressants, triptans; Induces CYP450; reduce levels of cyclosporine, HIV meds,
OCs, CBZ, warfarin Caution in bipolar, schizophrenia, Alzheimer's
Some adverse effects reported • gastrointestinal, dry mouth, restlessness / insomnia
more common • also vivid dreams, agitation, mania, dizziness, skin
rash, photosensitivity reported • ADR profile similar to TCAs, fewer cardiac effects• unsafe at high doses
Drug Interactions all antidepressants, triptans; Induces CYP450; reduce levels of cyclosporine, HIV meds,
OCs, CBZ, warfarin Caution in bipolar, schizophrenia, Alzheimer's
PG 431
St. John’s Wort - EfficacySt. John’s Wort - EfficacySt. John’s Wort - EfficacySt. John’s Wort - Efficacy
Mild to Mod. Depression• widely studied in Europe
• most evidence suggests as effective as low dose TCAs, possibly as effective as SSRIs
• recent study reported no benefit; however pts. had more severe depression
• depression in NOT like the common cold ; self-tx. not safe in my mind
Mild to Mod. Depression• widely studied in Europe
• most evidence suggests as effective as low dose TCAs, possibly as effective as SSRIs
• recent study reported no benefit; however pts. had more severe depression
• depression in NOT like the common cold ; self-tx. not safe in my mind
PG 431
Garlic : Garlic : “Cholesterol’s natural enemy”?“Cholesterol’s natural enemy”?Garlic : Garlic : “Cholesterol’s natural enemy”?“Cholesterol’s natural enemy”?
Tasty spice used heavily in Italian cuisine active compounds: alliin, allicin
Proposed Uses hyperlipidemia, hypertension, prevention of atherosclerosis mechanism of action
• may act as an HMG-CoA reductase inhibitor, may vasodilate and relax smooth muscle, release NO
• may also reduce oxidation of LDL, inhibit platelet function
dosing• 600mg – 1200mg in divided doses for HTN,
hyperlipidemia– 4-6 cloves of wholes garlic/day
• most trials used garlic powder extract (1.3% alliin)
Tasty spice used heavily in Italian cuisine active compounds: alliin, allicin
Proposed Uses hyperlipidemia, hypertension, prevention of atherosclerosis mechanism of action
• may act as an HMG-CoA reductase inhibitor, may vasodilate and relax smooth muscle, release NO
• may also reduce oxidation of LDL, inhibit platelet function
dosing• 600mg – 1200mg in divided doses for HTN,
hyperlipidemia– 4-6 cloves of wholes garlic/day
• most trials used garlic powder extract (1.3% alliin)
PG 431
Garlic - SafetyGarlic - Safety Garlic - SafetyGarlic - Safety
Safe w/the exception of social side-effects • GI, heartburn, n/v, BAD BREATH
Drug Interactions antidiabetic medications
• risk of hypoglycemia anticoagulants (warfarin, ASA)
• can increase INR and bleeding risk induces CYP3A4
• cyclosporine, saquinivir, OCs
Safe w/the exception of social side-effects • GI, heartburn, n/v, BAD BREATH
Drug Interactions antidiabetic medications
• risk of hypoglycemia anticoagulants (warfarin, ASA)
• can increase INR and bleeding risk induces CYP3A4
• cyclosporine, saquinivir, OCs
PG 430
Garlic - EfficacyGarlic - EfficacyGarlic - EfficacyGarlic - Efficacy
Hyperlipidemia Meta-analysis by Stevinson et. al in 2002
– 13 of 39 trials met inclusion criteria– 796 pts., 8-24 wks, 900mg/day most common– overall reduction of 16mg/dl in TC (6% dec.)– small, non-significant changes in LDL, HDL
• long-term clinical CV benefits unknown
Hypertension 7.7 mmHg reduction in SBP after 4 weeks
Hyperlipidemia Meta-analysis by Stevinson et. al in 2002
– 13 of 39 trials met inclusion criteria– 796 pts., 8-24 wks, 900mg/day most common– overall reduction of 16mg/dl in TC (6% dec.)– small, non-significant changes in LDL, HDL
• long-term clinical CV benefits unknown
Hypertension 7.7 mmHg reduction in SBP after 4 weeks
Stevinson et. al. Ann Intern Med 2000;133:420-9Stevinson et. al. Ann Intern Med 2000;133:420-9
Silagy CA et al. J Hypertens 1994;12:463-8 Silagy CA et al. J Hypertens 1994;12:463-8
PG 432
MelatoninMelatonin
Not an herbal; hormone that control circadian rhythm and sleep-wake cycle
Proposed use: treatment of insomnia, jet lag Mechanism of action: stimulates binding of GABA in
the CNS; leading to neuroinhibitory effects Dosing:
Insomnia: doses range from 0.3-5 mg hs Jet lag: 0.5-5 mg on day of arrival and
continued for 2-5 days
Not an herbal; hormone that control circadian rhythm and sleep-wake cycle
Proposed use: treatment of insomnia, jet lag Mechanism of action: stimulates binding of GABA in
the CNS; leading to neuroinhibitory effects Dosing:
Insomnia: doses range from 0.3-5 mg hs Jet lag: 0.5-5 mg on day of arrival and
continued for 2-5 days
PG 432
Melatonin - SafetyMelatonin - Safety
Appears safe for short-term use (<2 mo)
ADRs Fatigue, drowsiness, anxiety, dizziness Avoid driving within 4-5 hours
Drug interactions Medications with CNS depressant effects May increasae BP and impair blood sugar control Potential antiplatelet effects
Appears safe for short-term use (<2 mo)
ADRs Fatigue, drowsiness, anxiety, dizziness Avoid driving within 4-5 hours
Drug interactions Medications with CNS depressant effects May increasae BP and impair blood sugar control Potential antiplatelet effects
PG 432
Melatonin - EfficacyMelatonin - Efficacy
Insomnia Results are mixed; may improve sleep
quality, especially in elderly subjects; may not increase sleep duration
Jet lag May reduce symptoms of jet lag when
dosed appropriately; efficacy results mixed
Insomnia Results are mixed; may improve sleep
quality, especially in elderly subjects; may not increase sleep duration
Jet lag May reduce symptoms of jet lag when
dosed appropriately; efficacy results mixed
PG 432
Which of the following herbal products does not have the potential to interact with anticoagulant / antiplatelet agents?
a. gingko biloba
b. ginseng
c. garlic
d. saw palmetto
e. feverfew
Which of the following herbal products does not have the potential to interact with anticoagulant / antiplatelet agents?
a. gingko biloba
b. ginseng
c. garlic
d. saw palmetto
e. feverfew
Which of the following herbal products does not have the potential to interact with anticoagulant / antiplatelet agents?
a. gingko biloba
b. ginseng
c. garlic
d. saw palmetto
e. feverfew
Which of the following herbal products does not have the potential to interact with anticoagulant / antiplatelet agents?
a. gingko biloba
b. ginseng
c. garlic
d. saw palmetto
e. feverfew
Coenzyme Q10Coenzyme Q10Coenzyme Q10Coenzyme Q10 Also not an herbal; substance found in all cells
active compounds: a.k.a. ubiquinone Proposed Uses
Treatment of congestive heart failure, angina, HTN mechanism of action
• found in higher concentrations in cells of heart, liver, lungs; has powerful antioxidant activity
• also serves as a co-factor for ATP in oxidative resp., appears to be beneficial in condition assoc. w/low levels of CoQ10 (CHF)
dosing• 100mg /day in divided doses (50mg BID)
Also not an herbal; substance found in all cells active compounds: a.k.a. ubiquinone
Proposed Uses Treatment of congestive heart failure, angina, HTN mechanism of action
• found in higher concentrations in cells of heart, liver, lungs; has powerful antioxidant activity
• also serves as a co-factor for ATP in oxidative resp., appears to be beneficial in condition assoc. w/low levels of CoQ10 (CHF)
dosing• 100mg /day in divided doses (50mg BID)
PG 433
Coenzyme Q10 - SafetyCoenzyme Q10 - SafetyCoenzyme Q10 - SafetyCoenzyme Q10 - Safety
Few common or serious ADRs reported very rare GI adverse effects noted
Drug Interactions
warfarin; reduced effect due to similarity to vit. K; antineoplastics; may protect tumor cells synergistic effects w/ anti-HTNs Statins lower CoQ10 levels; clinical signif. not known caution; LFTS, HTN
Few common or serious ADRs reported very rare GI adverse effects noted
Drug Interactions
warfarin; reduced effect due to similarity to vit. K; antineoplastics; may protect tumor cells synergistic effects w/ anti-HTNs Statins lower CoQ10 levels; clinical signif. not known caution; LFTS, HTN
PG 433
Coenzyme Q10 - EfficacyCoenzyme Q10 - EfficacyCoenzyme Q10 - EfficacyCoenzyme Q10 - Efficacy Treatment of congestive heart failure
conflicting data• a number of trials have shown benefits in QOL,
symptoms, hosp. Rates (poor design) • Khatta et al. – more severe disease (class III,IV)
– no benefit seen in EF or exercise tolerance in 55 pts. treated for 6 months
• possibly consider in mild/moderate CHF in pts. already on optimal Rx therapy
Angina, Hypertension• Minimal benefits seen
Treatment of congestive heart failure conflicting data
• a number of trials have shown benefits in QOL, symptoms, hosp. Rates (poor design)
• Khatta et al. – more severe disease (class III,IV) – no benefit seen in EF or exercise tolerance in 55
pts. treated for 6 months • possibly consider in mild/moderate CHF in pts.
already on optimal Rx therapy
Angina, Hypertension• Minimal benefits seen
Tran MT et al. Pharmacotherapy 2001;21:797-806Tran MT et al. Pharmacotherapy 2001;21:797-806
Khatta M et al. Ann Intern Med 2000;132:636-640 Khatta M et al. Ann Intern Med 2000;132:636-640
PG 431
Resources Resources Resources Resources Facts and Comparison: Review of Natural Products
good general info., poor on dosing
PDR for Herbal Medicines• Hard to find unless you know plant names
German Commission E Monographs monographs are not referenced, lack substance
Natural Medicine Comprehensive Database THE BEST, updated, referenced, thorough Costly ($132.00, book plus 1 year online) www. naturaldatabase.com
Facts and Comparison: Review of Natural Products good general info., poor on dosing
PDR for Herbal Medicines• Hard to find unless you know plant names
German Commission E Monographs monographs are not referenced, lack substance
Natural Medicine Comprehensive Database THE BEST, updated, referenced, thorough Costly ($132.00, book plus 1 year online) www. naturaldatabase.com
When taken orally, all of the following drugs may cause discoloration of soft-contact lenses EXCEPT:
a. rifampin
b. ferrous gluconate
c. tetracycline
d. phenazopyridine
e. estrogens
When taken orally, all of the following drugs may cause discoloration of soft-contact lenses EXCEPT:
a. rifampin
b. ferrous gluconate
c. tetracycline
d. phenazopyridine
e. estrogens
When taken orally, all of the following drugs may cause discoloration of soft-contact lenses EXCEPT:
a. rifampin
b. ferrous gluconate
c. tetracycline
d. phenazopyridine
e. estrogens
When taken orally, all of the following drugs may cause discoloration of soft-contact lenses EXCEPT:
a. rifampin
b. ferrous gluconate
c. tetracycline
d. phenazopyridine
e. estrogens
Oxymetazoline acts as a nasal decongestant by:
a. Causing a local anesthetic action
b. Blocking at the synaptic ganglia
c. Constricting blood vessels by alpha-adrenergic stimulation
d. Dilating blood vessels by beta-adrenergic stimulation
e. Blocking muscarinic receptors
Oxymetazoline acts as a nasal decongestant by:
a. Causing a local anesthetic action
b. Blocking at the synaptic ganglia
c. Constricting blood vessels by alpha-adrenergic stimulation
d. Dilating blood vessels by beta-adrenergic stimulation
e. Blocking muscarinic receptors
Oxymetazoline acts as a nasal decongestant by:
a. Causing a local anesthetic action
b. Blocking at the synaptic ganglia
c. Constricting blood vessels by alpha-adrenergic stimulation
d. Dilating blood vessels by beta-adrenergic stimulation
e. Blocking muscarinic receptors
Oxymetazoline acts as a nasal decongestant by:
a. Causing a local anesthetic action
b. Blocking at the synaptic ganglia
c. Constricting blood vessels by alpha-adrenergic stimulation
d. Dilating blood vessels by beta-adrenergic stimulation
e. Blocking muscarinic receptors
Ingredients in Mylanta include:I. Aluminum hydroxide
II. Magnesium hydroxide
III. Calcium carbonate
a. I only
b. III only
c. I and II only
d. II and III only
e. I, II, and III
Ingredients in Mylanta include:I. Aluminum hydroxide
II. Magnesium hydroxide
III. Calcium carbonate
a. I only
b. III only
c. I and II only
d. II and III only
e. I, II, and III
Ingredients in Mylanta include:I. Aluminum hydroxide
II. Magnesium hydroxide
III. Calcium carbonate
a. I only
b. III only
c. I and II only
d. II and III only
e. I, II, and III
Ingredients in Mylanta include:I. Aluminum hydroxide
II. Magnesium hydroxide
III. Calcium carbonate
a. I only
b. III only
c. I and II only
d. II and III only
e. I, II, and III
A pharmacist should caution a patient purchasing the dietary supplement glucosamine plus chondroitin if he/she is allergic to which of the following:
I. BisulfitesII. EggsIII. Shellfish
a. I onlyb. III onlyc. I and II onlyd. II and III onlye. I, II, and III
A pharmacist should caution a patient purchasing the dietary supplement glucosamine plus chondroitin if he/she is allergic to which of the following:
I. BisulfitesII. EggsIII. Shellfish
a. I onlyb. III onlyc. I and II onlyd. II and III onlye. I, II, and III
A pharmacist should caution a patient purchasing the dietary supplement glucosamine plus chondroitin if he/she is allergic to which of the following:
I. BisulfitesII. EggsIII. Shellfish
a. I onlyb. III onlyc. I and II onlyd. II and III onlye. I, II, and III
A pharmacist should caution a patient purchasing the dietary supplement glucosamine plus chondroitin if he/she is allergic to which of the following:
I. BisulfitesII. EggsIII. Shellfish
a. I onlyb. III onlyc. I and II onlyd. II and III onlye. I, II, and III
Concurrent administration of antacids will increase the plasma level of:
I. levodopaII. ciprofloxacinIII. warfarin
a. I onlyb. III onlyc. I and II onlyd. II and III onlye. I, II, and III
Concurrent administration of antacids will increase the plasma level of:
I. levodopaII. ciprofloxacinIII. warfarin
a. I onlyb. III onlyc. I and II onlyd. II and III onlye. I, II, and III
Concurrent administration of antacids will increase the plasma level of:
I. levodopaII. ciprofloxacinIII. warfarin
a. I onlyb. III onlyc. I and II onlyd. II and III onlye. I, II, and III
Concurrent administration of antacids will increase the plasma level of:
I. levodopaII. ciprofloxacinIII. warfarin
a. I onlyb. III onlyc. I and II onlyd. II and III onlye. I, II, and III
Which of the following is an/are active ingredient(s) in Children’s Dimetapp ND?
a. brompheniramine
b. brompheniramine and pseudoephedrine
c. loratadine
d. phenylephrine
e. pseudoephedrine
Which of the following is an/are active ingredient(s) in Children’s Dimetapp ND?
a. brompheniramine
b. brompheniramine and pseudoephedrine
c. loratadine
d. phenylephrine
e. pseudoephedrine
Which of the following is an/are active ingredient(s) in Children’s Dimetapp ND?
a. brompheniramine
b. brompheniramine and pseudoephedrine
c. loratadine
d. phenylephrine
e. pseudoephedrine
Which of the following is an/are active ingredient(s) in Children’s Dimetapp ND?
a. brompheniramine
b. brompheniramine and pseudoephedrine
c. loratadine
d. phenylephrine
e. pseudoephedrine
THANKS!!!!!THANKS!!!!!
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