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82 Cards in this Set
- Front
- Back
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US Governing Body for OTCs
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Food and drug administration (FDA)
Center for Drug Evaluation and research(CDE) Federal Trade Commission (FTC) CDE: Ensures proper labeling and that benefits outweigh risk 80 therapeutic categories FTC: Takes action against manufacturers that advertise misleading or unsubstantiated claims |
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General characteristics of OTC Drugs
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Benefits outweigh their risks
Potential for misuse and abuse is low Consumer can use for self diagnosed conditions They can be adequately labeled Health practitioners are not needed for the safe and effective use of the product |
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Advantages of OTCs
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Readily available
Cost (inexpensive) Decreases healthcare burden |
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Disadvantages of OTCs
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Self diagnosis/treatment
Serious problems not timely addressed Side effects Drug interactions |
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What does your patient take?
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A comprehensive medication history needs to include OTC and herbal products
Be cognizant of multi ingredient agents, your pt may not be. |
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Laxatives
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Used for short term treatment or prophylaxis of acute or chronic constipation
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Constipation
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Infreq of stool
Prolonged and difficult evacuation of stool Passage of painful and or hard stool Sensation of incomplete evacuation of stool |
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Causes of constipation(primary)
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Decreased fluid and fiber intake
Inadeq exercise Poor mastication Poor dentition Poor abd musculature Failure to respond to the urge to defecate |
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Causes of constipation (secondary)
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Bowel disorders
Neuro disorders Endocrine disorders Endocrine/metabolic disorders Drugs |
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Drugs associated with constipation
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Narcs
Aluminum containing products Calcium Iron Anidiarrheals Anticholinergics Antihistamines, antidepressants, antipsychotics |
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Laxatives
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Used for short term treatment or prophylaxis of acute or chronic constipation
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Constipation
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Infreq of stool
Prolonged and difficult evacuation of stool Passage of painful and or hard stool Sensation of incomplete evacuation of stool |
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Causes of constipation(primary)
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Decreased fluid and fiber intake
Inadeq exercise Poor mastication Poor dentition Poor abd musculature Failure to respond to the urge to defecate |
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Causes of constipation (secondary)
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Bowel disorders
Neuro disorders Endocrine disorders Endocrine/metabolic disorders Drugs |
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Drugs associated with constipation
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Narcs
Aluminum containing products Calcium Iron Anidiarrheals Anticholinergics Antihistamines, antidepressants, antipsychotics, antiparkinsons |
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Treatment of constipation
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Transient constipation is normal- non drug therapy is usually sufficient
Identify underlying causes and fix it |
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Six classes do laxatives based on their mechanism of action
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Bulk forming
Saline Stool softeners Stimulants Lubricants Hyperosmotics Vary in: Onset of action Route of administration Side effects |
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Bulk forming laxatives(increases stool bulk--does little to help with peristalsis
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Psyllium(Metamucil)
Methylcellulose(Citrucel) Guar gum (Benefiber) Polycarbophil (Fibercon) Dietary fiber ( also included) Consider in pts who are ambulatory and get adequate hydration and want something to maintain regularity. Must take with plenty of water Be aware of sugar Nd or sodium intent SE: bloating, gas, impaction |
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Saline laxatives
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Magnesium hydroxide MOM
mag citrate Sodium phosphates fleets Attract/retain water in the intestinal lumen Useful for patients with good renal function-especially if they are acutely constipated Onset: 0.5-3h PR>PO Don't use Mg containing products if CrCl>30ml/min Sodium content of some SE: cramping, diarrhea, electrolyte disturbances |
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Stool softeners
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Docusate sodium colace
Docusate calcium surfak Onset 24-72h Facilitates admixture of fat and water to soften stool(does not help with peristalsis) Consider in patients when straining should be avoided. S/P MI, post partum, rectal surgery |
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Treatment of constipation
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Transient constipation is normal- non drug therapy is usually sufficient
Identify underlying causes and fix it |
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Six classes do laxatives based on their mechanism of action
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Bulk forming
Saline Stool softeners Stimulants Lubricants Hyperosmotics Vary in: Onset of action Route of administration Side effects |
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Bulk forming laxatives(increases stool bulk--does little to help with peristalsis
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Psyllium(Metamucil)
Methylcellulose(Citrucel) Guar gum (Benefiber) Polycarbophil (Fibercon) Dietary fiber ( also included) Consider in pts who are ambulatory and get adequate hydration and want something to maintain regularity. Must take with plenty of water Be aware of sugar Nd or sodium intent SE: bloating, gas, impaction |
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Saline laxatives
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Magnesium hydroxide MOM
mag citrate Sodium phosphates fleets Attract/retain water in the intestinal lumen Useful for patients with good renal function-especially if they are acutely constipated Onset: 0.5-3h PR>PO Don't use Mg containing products if CrCl>30ml/min Sodium content of some SE: cramping, diarrhea, electrolyte disturbances |
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Stool softeners
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Docusate sodium colace
Docusate calcium surfak Onset 24-72h Tolerance occurs within 3 weeks rendering them ineffective for chronic constipation Combo with stimulants SE: rare -diarrhea Facilitates admixture of fat and water to soften stool(does not help with peristalsis) Consider in patients when straining should be avoided. S/P MI, post partum, rectal surgery |
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Stimulants aka irritants
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Bisacodyl Dulcolax
Senna Senokot Caster oil Cascara Considered for pts when other agents have failed or if pt is unable to push Onset: 0.5-6h Most potent class SE: severe cramping, N/V Dependence Avoid long term use if possible |
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Lubricant
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Mineral oil
Onset 6-8 h SE aspiration lipoid pneumonia perinatal irritation Can decrease absorption of vitamins ADEK Not recommended for the elderly Contraindicated in bedridden pts Coats the stool for easier passage - does not help with peristalsis |
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Hyperosmotics
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Sorbitol Rx
Lactulose chronulac Rx PEG 3350 Miralax go lytely Glycerin Good if bedridden or with poor fluid food intake.. Onset 0.5 pr- 48h SE flatulence, cramps, diarrhea Pts report bad sweet taste with sorbitol and lactulose Diarrhea-electrolyte disturbances. Increase intraluminal pressure and stimulates Used for pts who are constipated/impacted. Can be useful for chronic constipation( not FDA approved) |
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Cough and cold
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Used to treat symptoms of cough, congestion, and rhinorrhea
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Cough and cold (products available)
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Decogestants
Antihistamines Cough Suppressants Expectorants APAP or ibuprofen Available as single or multi-ingredient products Many names-same products Often combined with OTC pain reliever |
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Decongestants
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Sympathomimetics that activate alpha-adrenergic receptors-Relieve congestion
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Decongestants
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Nasal Sprays:
Oxymetazoline(Afrin) Phenylephrine (Neo-Synephrine) Sodium Chloride (Ayr, Ocean) Oral Agents: Pseudoephrine {PSE}-Sudafed Phenylephrine {PE} Phenylpropanolamine (PPA) removed from the market Onset: Nasal >PO Nasal: rebound congestion if >used 3-5 days Restrictions in availability with PSE SE: anxiety, increased BP, insomnia Caution: HTN, heart disease, diabetes, PVD, glaucoma, BPH MOA: moistens nasal mucosa without CV side effects, no rebound. |
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Methamphetamine Legislation
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PSE products = or > 30mg/dose must be kept behind the pharmacy counter
Restricted to = or > 18 yo -photo ID -computerized database-personal info, product info, signature Purchases limited (3.6 gm/day or 9gm/month) |
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Antihistamines
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H1 receptor antagonists-help with runny nose, watery eyes, sneezing
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Sedating(1st generation) Antihistamines
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Chlorpheniramine-Chlor Trimeton
Diphenhydramine {DPH} (Benadryl) Brompheniramine (Dimetapp) Clemastine (Alavert) |
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Non-sedating (2nd generation)
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Loratadine-Claritin
Cetirizine-Zyrtec |
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DPH
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Commonly found in OTC sleep aids
"PM" agents=DPH Effective for allergy or allergic-type symptoms 1st gen: rhinorrhea due to common cold AND helps with non-productive cough 2nd gen: chronic urticaria, perennial & seasonal allergic rhinits SE: anticholinergic, sedation Caution: glaucoma, sleep apnea, BPH, emphysema, chronic bronchitis |
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Expectorant
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Increases respiratory tract fluid secretions-helps to loosen phlegm and bronchial secretions
Guaifenesin (Robitussin) (Mucinex) best suited for the productive cough Long-acting product(Mucinex) is dosed twice daily SE: rare, but large doses have been associated with kidney stone formation Efficacy-patients advised to take plenty of water Per CHEST Guidelines: no better than placebo |
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Cough Suppressant
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Analog of codeine-works on the cough center in the medulla
-Dextromethorpan (DM), (Delsym) Non-additive Use with caution in someone with COPD, asthma, or acute bronchitis Per CHEST guidelines: no better than placebo Some patient s report efficacy with higher doses (eg 30 mg) SE: rare DDI: MAO inhibitors |
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Advisory Issued for OTC Cough and Cold Medication Use in Children 1/17/2008
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Public Health Advisory: FDA recommends that OTC cough and cold products not be used for Infants and Children under 2 years of age
FDA has completed its review of info about the safety of OTC cough and cold medicines in infants and children under 2 years of age. |
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FDA Pregnancy Categories
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Decogestants:
Category C- oxymetazoline, pseudoephedrine, phenylephrine Antihistamines: Category B- cetirizine, chlorpheniramine, clemastine, diphenhydramine, loratadine Category C-brompheniramine, carbinoxamine, chlorpheniramine Expectorant: Pregnancy C-guaifenesin Cough Suppressant: Pregnancy C-dextromethorphan |
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Pharmacology of Nicotine
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Rapidly absorbed via inhalation
High concentrations in the brain Increased HR, increased BP, peripheral vasoconstriction, enhances platelet aggregation Causes CNS stimulation Abrupt withdrawal-irritability, restlessness, anxiety, low concentration, increased cessation |
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Smoking Cessation Products
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Effective as an aid in smoking cessation and for relief of nicotine withdrawal symptoms
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Principles of Nicotine Replacement Products
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Reduces the physical effects (not psychological aspects) of smoking cessation
May be considered part of a comprehensive behavioral smoking cessation program Main reasons for failure: 1) underdosing and 2) incorrect use |
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Principles of Nicotine Replacement Products Continued
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-Do not "double-up"-stick with one product
-That includes cigarettes! *None are safe in pregnancy |
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Nicotine Patches
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Nicoderm CQ 21 mg, 14mg, 7 mg (24 hours)
Nicotrol 15mg, 10mg, 5mg (16 hours) Start at highest dose for 6-12 weeks, then lower doses x 2 weeks Start with lower doses if <10 cigarettes/day, <100lbs or cardiac disease. Advantages: concealable, one time daily application Disadvantage: adhesive allergy, 24 hr-vivid dreams Good for those who smoke at regular intervals |
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Nicotine Palacrilex
Gum and Lozenge |
GUM: Nicorette 2mg, 4mg
4mg for = or > 25 cigs/day; chew 1 piece q 1-2hx6wks; then self taper x 6 wks Usal dose 9 pieces/day; max 24 pieces/day Advantages: offers more control nicotine, good during cravings Disadvantages: decreased absorption with dentures, bad taste May work better for those who smoke at irregular intervals LOZENGE: Commit 2mg, 4mg First cigarette> 30 min after waking-2mg lozenge<30 min-4mg lozenge Pt self tapers Advantages: discrete Disadvantages: bad taste Consider if pt smokes more than 30 mins after waking |
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General Principles about Vitamins
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Vitamins are not synthesized by the body
May be useful with a poor diet or during times or acute stress or illness Nutritional intake(eg food) is preferred over supplements |
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General Principles about vitamins continued
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OTC vitamins are not usually covered by insurance
Toxicities, although rare, can and do occur In the US true deficiences are not common |
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Commonly Used Vitamins and Minerals
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Divided into 2 Main Categories:
Fat-Soluble Water-Soluble |
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Fat-Soluble Vitamins
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Vitamin ADEK
Deficiencies can be gradual and symptoms subtle Toxicities with replacement are more common Larger quantities require a prescription Found primarily in plant and animal oils or fats |
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Vitamins A
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Retinol and Carotenes
Uses: Vision, healthy skin and mucous membranes, key to immunity, tissue repair Toxicity-fatigue, malaise, N/V, HA, dizziness, blurred vision, birth defects |
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Vitamin D
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Claciferol
Uses: Aids in calcium and phosphorous absorption, prevents rickets and ostepmalacia, helps immune system function. Toxicity- Hypercalcemia, soft tissue calcification, N/V, anorexia, confusion, kidney damage |
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Vitamin D
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Metabolic Pathway of Activation
Rx only OTC |
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Vitamin E-alpha-tocopheral
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Uses:
Protects cell membrans, helps repair body tissue Neuroprotective-not proven Cancer prevention- no proven Cardioprotective-not proven Toxcity- Rare; growth retardation, poor bone calcification, anemia Dosages> 400iu/day- increase mortality |
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Vitamin K
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Phylloquinone, menadione
Uses: blood clotting and bone formation Toxicity-hemolytic anemia |
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Water-Soluble Vitamins
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The Bs
Vitamins C Toxicity is Rare!! |
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Thiamine (B1)
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Uses:
Aids in carbohydrate metabolism, assists in the function of the nervous system Deficiency= "beri-beri" ( peripheral neuritis) Alcoholics, intestinal malabsorption Fatigue, muscle weakness and atrophy, numbnesss, tingling, memory problems |
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Riboflavin (B2)
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Uses:
Helps maintain healthy skin Deficiency: When animal proteins are excluded from the diet |
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Niacin (B3)
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Uses:
Maintains healthy tissue growth, aids in the utilization of carbs, helps cholestrol regulation ( increased HDL) * usually for pts with cholestrol issues* Deficiency(rare)- pellagra Alcoholics SE: usually dose related -Flushing, stomach upset |
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Pyridoxine (B6)
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Uses
Utilization of amino acids Deficiency is usually drug-induced Isoniazid or penicillamine SE: usually dose-related Sensory neuropathy and ataxia |
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Folic Acid(B8)
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Uses:
DNA production, hyperhomocysteinemia Deficiency-RBC, Folated>Serum Folate Alcoholics, pregnant women Drugs-methotrexate, phenytoin *usually absorbed in gut* OTC doses=or< 0.8mg= or > 1mg is Rx only Can mask B12 deficiency |
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Cyanocobalamin (B12)
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Uses:
Energy production and growth, CNS function and blood cell formation Deficiency: Strict, vegetarians, absorption problems(eg intrinistic factor) S/S: anemia, neuropathy, cognitive impairment Oral treatment is OTC If not being absorbed-OTC won't work! Rx only (IM/SQ, intranasal) |
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Folate and B12 Deficiency
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Always rule out a B12 deficiency before treating a patient for folate deficiency
Both are macrocytic anemias (high MCV) S/S are very similiar; however if you treat a folate deficiency, but B12, the anemia will improve, but the neurologica sequela of B12, deficiency will worsen. |
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Ascorbic Acid (Vitamin C)
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Uses:
Maintains blood vessels, bones, tissues Does not prevent the common cold. Deficiency= scurvy Rare if 1 serving of fruit or vegetable is consumed per day. Toxicity can occur |
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Macronutrients
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Sodium (1000mg)
-Required for nerve and muscle function -Potassium (3500mg) -Required for bone and teeth formation, blood clotting, normal muscle functions, and for normal heart rhythmm -commonly purchased supplements. Phosphorus (700mg) -required for bone and teeth formation, and for energy production -Chloride (1000mg) -involved in electrolyte balance Magnesium (320-420mg) -Required for bone and teeth formation, for normal nerve and muscle function, and for the activation or enzymes. |
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Calcium
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Deficiency can be drug-induced
e.g. corticosteriods (prednison) Elemental calcium varies by salt e.g Carbonate 40%, Citrate 21% (actually being absorbed) Adequate Vitamin D is essential to good absortion |
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Magnesium
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Deficiency (CV, neuro, renal)
Mental status changes, poor coordination, ECG changes Toxicity is rare unless in the presence of renal insufficiency CNS depressant and hypotension (cardiac arrest) |
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Micronutrients
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Cooper (900mcg)- used for energu production for antioxidation, and for formation of the hormone epinephrine, red blood cells, bone and connective tissue
Fluoride (3-4mg)-required for the formation of bone and teeth. Iodine (150mcg)- Required for the formation of thyroid hormones Iron 8mg- required for enzyme formation; an importan component of muscle cells and of Hbg Selenium 55mcg-acts as an antioxidant; required for thyroid gland function Zinc 15mg- used to form many enzymes and insulin; required for healthy skin, healing of wounds, and growth, commonly purchased supplement. |
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Iron
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Deficiency:
anemia many causes Elemental iron varies by salt e.g. Sulfate 20%, fumarate 33% SE: (common) GI (n/v, constipation, diarrhea) |
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DRUGS
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Years of testing in the lab
Evaluated and approved by FDA Must prove safety and efficacy plus disclose it Quality control is strictly monitored |
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HERBS
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Years of use outside the lab
Not evaluated or approved by the FDA Little to no proof of safety, efficacy, or disclosure require Quality control is not required |
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Dietary Supplement health and Education Act (DSHEA)
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Passed in 1994 permitting the sale of herbs in the US as dietary supplemennts provided that no therapeutic or health clain appear on the label.
Labeling requirement-" this product has not been evaluated by the FDA and is not intended to diagnose, treat, cure, or prevent and any disease" |
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Caveat Emptor
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Let the buyer beware!
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Fact or fiction
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Adovacy literature-can only promote what research says.
Claims made are likely to be: -Exaggerated -Unsubstantiated -Testmonials They do have SE and can interact with each other and prescription drugs! |
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Selected Herbs/Supplements and Common Uses
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Black cohosh-hot flashes
Chondroitin-OA Echinacea-immune system booster Feverfew- Migraine HA Fish Oil- lower triglycerides, increase HDL Garlic- Cholesterol lowering Ginger- morning sickness Ginko biloba- dementia Glucosamine- OA Melatonin- sleep regulation Saw Palmetto- prostate problems St. John's Wort-depression |
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Echinacea
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Some reproted uses:
Antibacterial, antiviral, arthritis, genital herpes, URI, immunosuppression MOA: unknown, but anti-viral and immune system booster (in vitro) Reported SE: Dyspepsia, diarrhea, allergic-typer reactions DI: immunosuppressants, doxorubicin Evidence tells us: May decrease severity and intensity of the common cold (if started at first appearance of symptoms) Conflicting evidence Does not support chronic use Does not prevent a cold! |
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Ginger
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Some reported Uses:
-Antiemetic, dyspepsia, arthritis, diverticulitis, antiinflammatory MOA: The antiemetic activity of ginger has been shown to stimulated gastric secretion and peristalsis Reported SE: bleeding, no sedation DI: Warfarin, anti-platelet drugs |
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Ginger
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Evidence tells us:
Ginger is beneficial as an antiemetic, for both nausea and vomiting, in women 17 weeks gestation. |
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Problems with herbals
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Not consistently studied
-proper dose, monitoring, SE, DDI, etc are not always known Formulations are not equivalent -Remember no (or poor) quality control is a possibility -All ingredients do not have to be listed on the label Patients could be self-diagnosing and not seeking proper medical attention |
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FDA requirements of OTC Drug Product Labeling
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Name
Ingredients-Active(amount) and Inactive Purpose- pharmacologic class Uses-indications Warnings-do not use-absolute contraindications when product should not be used under any circumstances Ask doctor before use if you have-warnings for persons with certain preexisting conditions and for persons experience certains symptoms Ask doctor or pharmacist before use drug/drug interactions food/drug interactions SE that could occure and substances or activities to avoid. Watch for signs of toxicity and serious reactions Pregnancy, breastfeeding warning Keep out of reach of children/Accidental overdose warnings Directions-dosage and when, how, or how often to take |
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ALWAYS inquire about the use of all vitamins and supplements!
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In practice, use reputable references for your information!
Remember your patients may not be! |
