Nonprescription (OTC) Medications NAPLEX PG 405. Major categories of products to review Most important antacids, antidiarrheals cough and cold remedies

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

PG 406

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

PG 406

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


a. nizatidine

b. calcium carbonate

c. cetirizine

d. omeprazole

e. pantoprazole


a. nizatidine (Axid)

b. calcium carbonate (Tums)

c. cetirizine (Zyrtec)

d. omeprazole (Prilosec)

e. pantoprazole (Protonix)


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

PG 407

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

PG 407

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

PG 410

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)

PG 408

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,

PG 410

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

PG 410

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

PG 411

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

PG 411

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

PG 413

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

PG 415

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

PG 415

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










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

PG 417

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

PG 423

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

PG 425

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

PG 426

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

PG 426

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

PG 426

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)

PG 426

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

PG 428

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

PG 428

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


a. gingko biloba

b. ginseng

c. garlic

d. saw palmetto

e. feverfew


a. gingko biloba

b. ginseng

c. garlic

d. saw palmetto

e. feverfew


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


a. rifampin


c. tetracycline

d. phenazopyridine

e. estrogens


a. rifampin


c. tetracycline

d. phenazopyridine

e. estrogens


a. rifampin


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



















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. I only

b. III only

c. I and II only

d. II and III only

e. I, II, and III




a. I only

b. III only

c. I and II only

d. II and III only

e. I, II, and III




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











Concurrent administration of antacids will increase the plasma level of:

I. levodopaII. ciprofloxacinIII. warfarin











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


a. brompheniramine


c. loratadine

d. phenylephrine

e. pseudoephedrine


a. brompheniramine


c. loratadine

d. phenylephrine

e. pseudoephedrine


a. brompheniramine


c. loratadine

d. phenylephrine

e. pseudoephedrine

THANKS!!!!!THANKS!!!!!

Documents

Nonprescription (OTC) Medications NAPLEX PG 405. Major categories of products to review Most important antacids, antidiarrheals cough and cold remedies