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Over the Counter (OTC) DrugsClinical Pharmacology SeminarDepartment of Pharmacology and Toxicology,Faculty of Pharmacy, Co...
OTC    “Over the Counter”    Non-prescription medicines    Medicinal products marketed as drugs - regulatory    approva...
Directive 2001/83/ECMedicinal products shall be subject to medicinal prescription where they:    Are likely to present da...
Criteria for OTC Designation    Low toxicity and low risk of serious adverse reactions    Not to mask any underlying con...
SwitchingSwitching = Move from prescriptional category into OTC
Self-medication    Treatment of common health problems with    medicines especially designed and labeled for    use witho...
Consumption - Slovakia       ATC category                               Packages Value in                                 ...
Gastric Acidity and Gastroesophageal                Reflux DiseaseAntacids    Buffering gastric acid > raising acidity  ...
Exocrine Pancreatic InsufficiencyTakasidase    Purified fungal (Aspergillus oryzae) enzymes    Digestion of oligosacchar...
ConstipationLactulose    Disaccharide that draw water into bowel – osmotic action    DUPHALACBisacodyl    Acts by irrit...
DiarrheaCloroxin, nifuroxazid    Antibacterial effects - used in infectious diarrhea including traveler`s diarrhea    EN...
Antimycotics (Antifungal Drugs)Skin, nails, vaginal fungal infectionsNystatine    Polyene antifungal used also in combina...
Disinfection, Antiseptics and                   AntibioticsWounds/skin disinfiction    Benzalkonium – DETTOL    Carbetho...
Nasal Preparations (Decongestants)    Applied in nasal spray/drops to relieve nasal    congestion in rhinitis    Vasocon...
AllergiesAnihistaminesH1 antagonists    Often used to relieve allergic rhinitis (hay fever). Neither loratadine nor    ce...
VasoprotectivesBioflavonoinds    Troxerutin – CILKANOL, VENORUTONCalcium dobesilate – DANIUMAescin    Saponine isolated ...
Analgesics (painkillers) and               AntipyreticsMajor classes    Paracetamol    Salicylates    Non-steroidal ant...
Paracetamol    Most widely used analgesic in the world, lacks anti-inflammatory properties    Mechanism of action is dis...
Acetylsalicylic Acid (ASA)    Most common salicylate is acetylsalicylic acid (ASA), others are    salycilamide, diflunisa...
Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)Ibuprofen    Indications include arthritis, dysmenorrhea, fever, migaine an...
Joint, Connective Tissue and     Rheumatism OTC PreparationsOther NSAIDs - Indometacin, Ketoprofen, Nimesulide (COX-2)Comb...
Cough MedicinesPharmacotherapy depends on type of cough    Productive – mucolytics    Non-productive – antitussics    − ...
AntitussicsOpioidDextromorphan    Used in combinationS with other substances such as pseudoephedrine,    paracetamol    ...
Mucolytic AgentsGuaifenesin    ROBITUSSIN EXPECTORANSAcetylcysteine    Potent mucolytic agent, antioxidative effect    ...
ContraceptionEmergency (postcoital) contraceptionLevonorgestrel in 1.5 mg dose    Estimated effectiveness is 84 %    ESC...
Psychoactive OTC PreparationsSedatives    Guaifenesin – moderate sedative effect - GUAJACURAN    Valerian, Humulus and L...
Vitamin and Mineral Supplements    Many preparations are on the market, some of them    are marketed as drugs others as n...
Where to Find InformationBooksV. Foltán: Voľnopredajné lieky, 2002Online Databases    NobelPLUS – Slovak database of phar...
Thank You For Your Attention !
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Over the Counter (OTC) Drugs

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Over the Counter (OTC) Drugs

  1. 1. Over the Counter (OTC) DrugsClinical Pharmacology SeminarDepartment of Pharmacology and Toxicology,Faculty of Pharmacy, Comenius UniversityNov 2009 Vladimir Patras, PharmD, MBA
  2. 2. OTC “Over the Counter” Non-prescription medicines Medicinal products marketed as drugs - regulatory approval (marketing authorization) is needed, which is issued on base of proof of safety and efficacy (legal or regulatory meaning) In broader sense all non-prescriptional medicines including traditional herbal medicines or nutritional supplements (pharmaceutical care meaning) Need not to be dispensed by pharmacist, in some countries sold also outside pharmacies
  3. 3. Directive 2001/83/ECMedicinal products shall be subject to medicinal prescription where they: Are likely to present danger, even when used correctly Are frequently and to very wide extent used incorrectly Contain substances which require further investigation Are to be administered parenterallyNon-prescription medicines when none of these criteria apply
  4. 4. Criteria for OTC Designation Low toxicity and low risk of serious adverse reactions Not to mask any underlying condition or increase resistance Correct self-assessment of the condition No known incorrect use Risk to public health limited in case of misuse Drugs are usually approved as prescription only first and just after they prove safety in clinical use they are recategorized as OTC
  5. 5. SwitchingSwitching = Move from prescriptional category into OTC
  6. 6. Self-medication Treatment of common health problems with medicines especially designed and labeled for use without medical supervision and approved as safe and effective for such use Desire of people to take responsibility for their own health and to reduce health expenditure Importance of patient education, pharmaceutical care Move toward self-medication has support of governments/regulatory agencies
  7. 7. Consumption - Slovakia ATC category Packages Value in sold (in millions of thousands) Sk Analgesics 14044 219158 Vitamins 8091 286327 Cough and cold preparations 4179 136299 Antiinflamatory/antirheumatic products 4143 159788 Antithrombotic agents 3092 41998 Phytopharmaca 2725 87566 Nasal preparations 2716 106153 Mineral supplements 2534 149027 Vasoprotectives 2143 102485 Topical products for joint and muscle pain 1736 94591 Digestives and enzymes 1297 150105Consumption of OTC products in Slovakia by categories, SIDC data, 2001
  8. 8. Gastric Acidity and Gastroesophageal Reflux DiseaseAntacids Buffering gastric acid > raising acidity Aluminium hydroxide - MAALOX Calcium carbonate - TUMSH2 antagonists Decrease acid production Ranitidine – ZANTAC, RANISAN Famotidine – FAMOTIDIN, QUAMATEL
  9. 9. Exocrine Pancreatic InsufficiencyTakasidase Purified fungal (Aspergillus oryzae) enzymes Digestion of oligosaccharides and polysaccharides ORENZYMEPurified animal pancreatin PANGROL, PANZYTRAT, KREON
  10. 10. ConstipationLactulose Disaccharide that draw water into bowel – osmotic action DUPHALACBisacodyl Acts by irritating of colon BISAKODYL-K, FENOLAXSodium picosulfate GUTTALAX, REGULAX
  11. 11. DiarrheaCloroxin, nifuroxazid Antibacterial effects - used in infectious diarrhea including traveler`s diarrhea ENDIARONLoperamide μ opioid receptor agonist – decreasing smooth muscles motility IMODIUMIntestinal Adsorbents – bind toxins in gastrointestinal tract Diosmectite – SMECTA Activated carbon - CARBOCIT, CARBOSORB
  12. 12. Antimycotics (Antifungal Drugs)Skin, nails, vaginal fungal infectionsNystatine Polyene antifungal used also in combinations FUNGICIDINImidazolesinhibition of ergosterol (component of fungal cell membrane) synthesis Clotrimazole – CANESTEN, CANDIBENE Ketoconazole – NIZORAL Others: Miconazole, Bifonazole, OxiconazoleAllylamines Terbinafine - LAMISIL
  13. 13. Disinfection, Antiseptics and AntibioticsWounds/skin disinfiction Benzalkonium – DETTOL Carbethopendecinium bromide – SEPTONEX (aer deo)Antiseptics for oral use Amylmetacresol, dichlorbenzyl alcohol – STREPSILS, NEO-ANGIN Chlorhexidine – SEPTOFORT, DRILLAntibiotics Fusafungine – the only OTC antibiotic Used as spray for treatment of nasal and throat infection BIOPAROX
  14. 14. Nasal Preparations (Decongestants) Applied in nasal spray/drops to relieve nasal congestion in rhinitis Vasoconstriction of blood vessels within the nasal cavity Should not be taken longer than 3 days in a row Xylometazoline – OLYNTH Oxymetazoline – NASIVIN Tramazoline – MUCONASAL PLUS Nafazoline – SANORIN
  15. 15. AllergiesAnihistaminesH1 antagonists Often used to relieve allergic rhinitis (hay fever). Neither loratadine nor cetirizine are causing sedationLoratadine CLARITINECetirizine ZODAC, ZYRTEC, CETIRIZINE-SANDOZCorticosteroidsBeclometazone OTC products as nasal spray BECLOMET NASAL AQUA
  16. 16. VasoprotectivesBioflavonoinds Troxerutin – CILKANOL, VENORUTONCalcium dobesilate – DANIUMAescin Saponine isolated from the horse chesnut (Aesculus hippocastanum) Induction of endothelial nitric oxide synthesis AESCIN, YELLON
  17. 17. Analgesics (painkillers) and AntipyreticsMajor classes Paracetamol Salicylates Non-steroidal anti-inflammatory drugs Most drugs of this group has both anti-inflammmatory and antipyretic effects through inhibition of biosynthesis of prostaglandins It is not recommended to use antypiretics in only slightly elevated temperature
  18. 18. Paracetamol Most widely used analgesic in the world, lacks anti-inflammatory properties Mechanism of action is disputed – COX 3 inhibition in brain (?) Preferred antipyretic agent in children, no side effects in gastrointestinal tract, is not contraindicated in pregnancy (ASA is preferred in first trimester) Some studies suggested link between heavy paracetamol use in early childhood and development of asthma. FDA issued Public Health Advisory recommending use of cold and cough medicines in children under 2 years only when necessary Possible liver and kidney damage in case of other liver/kidney disease or high doses Combinations with caffeine, dimenhydrinate, phenylephrine, pseudoephedrine, promethazine, guaifenesin, ascorbic acid PANADOL, PANADOL EXTRA, PARALEN, COLDREX, COLDREX HOT REM, ATARALGIN, VALETOL
  19. 19. Acetylsalicylic Acid (ASA) Most common salicylate is acetylsalicylic acid (ASA), others are salycilamide, diflunisal Irreversible cycloooxygenase (COX) inhibition > suppression of production of prostaglandins and tromboxanes (inflammation inhibitors) Common side effects are gastrointestinal bleeding, ulcers and tinnitus Not used in children due to risk of Reye`s syndrome May be used in first and second trimesters of pregnancy if benefit outweighs risk Often used in combinations with other drugs such as ascorbic acid, caffeine, paracetamol, phenacetin ASPIRIN, ASPIRIN-C, ASPIRIN PROTECT, ACYLPYRIN, ACYLCOFFIN, ACIFEIN, ALKA-SELTZER, ACIFEIN
  20. 20. Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)Ibuprofen Indications include arthritis, dysmenorrhea, fever, migaine and other conditions with involving inflammation. Investigational (clinical trials) use include also Alzheimer and Parkinson diseases. BRUFEN, NUROFEN, IBALGINNaproxen Pain in rheumatic conditions, marketed as relieve in pain of teeth ALEVE, NALGESIN SDiclofenac Treatment of pain of various origin – most commonly in rheumatism. It is possible to use antipyretic effects but other substances are preferred in fever Beside oral administration topical use is common VOLTAREN ACTIGO, VOLTAREN EMULGEL, VERAL, DICLOBENE
  21. 21. Joint, Connective Tissue and Rheumatism OTC PreparationsOther NSAIDs - Indometacin, Ketoprofen, Nimesulide (COX-2)Combination of enzymes such as trypsin, bromelaine, papain has presumed anti-inflammatory effect - WOBENZYMEChondroitin sulfate, Glucosamine sulfate Often used in combination in treatment of osteoarthritis. They are components of joint cartilage but have also anti-inflammatory effect CONDROSULFAntioedema local preparations - Heparin Glycosaminoglycan used in ointments/gels in oedemas and bruises. Anticoagulant effects LIOTON, HEPAROID
  22. 22. Cough MedicinesPharmacotherapy depends on type of cough Productive – mucolytics Non-productive – antitussics − Opioid − Non-opioid Mucolytics and antitusics shall not be used together FDA issued public health statement promoting cautious use of cough medicines in children under 4 years
  23. 23. AntitussicsOpioidDextromorphan Used in combinationS with other substances such as pseudoephedrine, paracetamol COLDREX NITE, PARALEN PLUSNon-opioidButamirate Used as drops or sirup, most common cough suppresant STOPTUSSIN, TUSSIN, SINECODDiphenhydramine Antihystamine with antitussic (sedative, anticholinergic and antiemetic) effects, drawsiness is common side effect BENADRYL N
  24. 24. Mucolytic AgentsGuaifenesin ROBITUSSIN EXPECTORANSAcetylcysteine Potent mucolytic agent, antioxidative effect SOLMUCOLAmbroxol Common mucolytic used as sirup or tablets MUCOSOLVAN, AMBROBENEBromhexine Metabolizes to ambroxol BROMHEXIN, BRONCHOSAN
  25. 25. ContraceptionEmergency (postcoital) contraceptionLevonorgestrel in 1.5 mg dose Estimated effectiveness is 84 % ESCAPELLELocal contraception – spremicidesNot efficient enough alone – should be complemented with other form of contraception (barrier contraception) Nonoxynol – PATENTEX OVAL N Benzalkonium chloride – PHARMATEX
  26. 26. Psychoactive OTC PreparationsSedatives Guaifenesin – moderate sedative effect - GUAJACURAN Valerian, Humulus and Lemon balm extractsAntidepressants St. John wort – multiple drug interaction through cytochrome P450 inductionNootropics Pirecetam – NOOTROPIL, PIRACETAM, OIKAMID Lecithin – phosphatidylcholine naturraly occuring in body with presumed nootropic effects
  27. 27. Vitamin and Mineral Supplements Many preparations are on the market, some of them are marketed as drugs others as nutritional supplements CENTRUM, GERIAVIT PHARMATON, REVALID Many nutritional supplements are associated with various health claims but efficacy is not required to be demonstrated in order to gain marketing authorization for nutritional supplements
  28. 28. Where to Find InformationBooksV. Foltán: Voľnopredajné lieky, 2002Online Databases NobelPLUS – Slovak database of pharmaceutical products: http://www.nobelplus.sk/ MedlinePlus – service of U.S. National Library of Medicine and National Institute of Health: http://www.nlm.nih.gov/medlineplus/druginformation.htmlIndustry Associations Association of the European Self-Medication Industry: http://www.aesgp.be
  29. 29. Thank You For Your Attention !

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