Over the Counter Drugs (OTC)

OTC – What is it?

       “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 dispenced by pharmacist, in some countries sold also outside pharmacies

Medicinal 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 parenterally

Non-prescription medicines when none of these criteria apply

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

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

Consumption

Gastric Acidity and Gastroesophageal Reflux Disease

Antacids

       Buffering gastric acid > raising acidity

       Aluminium hydroxide - MAALOX

       Calcium carbonate - TUMS

H2 antagonists

       Decrease acid production

       Ranitidine – ZANTAC, RANISAN

       Famotidine – FAMOTIDIN, QUAMATEL

Constipation

Lactulose

       Disaccharide that draw water into bowel – osmotic action

       DUPHALAC

Bisacodyl

       Acts by irritating of colon

       BISAKODYL-K, FENOLAX

Sodium picosulfate

       GUTTALAX, REGULAX

Diarrhea

Cloroxin, nifuroxazid

       Antibacterial effects - used in infectious diarrhea including traveler`s diarrhea

       ENDIARON

Loperamide

        μ opioid receptor agonist – decreasing smooth muscles motility

       IMODIUM

Intestinal Adsorbents – bind toxins in gastrointestinal tract

       Diosmectite – SMECTA

       Activated carbon - CARBOCIT, CARBOSORB

Antimycotics (Antifungal Drugs)

Skin, nails, vaginal fungal infections

Nystatine

       Polyene antifungal used also in combinations

       FUNGICIDIN

Imidazoles

Inhibition of ergosterol (component of fungal cell membrane) synthesis

       Clotrimazole – CANESTEN, CANDIBENE

       Ketoconazole – NIZORAL

       Others: Miconazole, Bifonazole, Oxiconazole

Allylamines

       Terbinafine - LAMISIL

Disinfection, Antiseptics and Antibiotics

Wounds/skin disinfiction

       Benzalkonium – DETTOL

       Carbethopendecinium bromide – SEPTONEX (aer deo)

Antiseptics for oral use

       Amylmetacresol, dichlorbenzyl alcohol – STREPSILS, NEO-ANGIN

       Chlorhexidine – SEPTOFORT, DRILL

Antibiotics

       Fusafungine – the only OTC antibiotic

       Used as spray for treatment of nasal and throat infection

       BIOPAROX

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

Allergies

Anihistamines

H1 antagonists

       Often used to relieve allergic rhinitis (hay fever). Neither loratadine nor cetirizine are causing sedation

Loratadine

       CLARITINE

Cetirizine

       ZODAC, ZYRTEC, CETIRIZINE-SANDOZ

Corticosteroids

Beclometazone

       OTC products as nasal spray

       BECLOMET NASAL AQUA

Vasoprotectives

Bioflavonoinds

       Troxerutin – CILKANOL, VENORUTON

Calcium dobesilate – DANIUM

Aescin

       Saponine isolated from the horse chesnut (Aesculus hippocastanum)

       Induction of endothelial nitric oxide synthesis

       AESCIN, YELLON

Analgesics (painkillers) and antipyretics

Major 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

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

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

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.

Naproxen

       Pain in rheumatic conditions, marketed as relieve in pain of teeth

Diclofenac

       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

Joint, Connective Tissue and Rheumatism OTC preparations

Other NSAIDs - Indometacin, Ketoprofen, Nimesulide (COX-2)

Combination of enzymes such as trypsin, bromelaine, papain has presumed anti-inflammatory effect - WOBENZYME

Chondroitin sulfate, Glucosamine sulfate

       Often used in combination in treatment of osteoarthritis. They are components of joint cartilage but have also anti-inflammatory effect

       CONDROSULF

Antioedema local preparations - Heparin

       Glycosaminoglycan used in ointments/gels in oedemas and bruises. Anticoagulant effects

       LIOTON, HEPAROID

Cough Medicines

Pharmacotherapy 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

Antitussics

Opioid

Dextromorphan

       Used in combinationS with other substances such as pseudoephedrine, paracetamol

       COLDREX NITE, PARALEN PLUS

Non-opioid

Butamirate

       Used as drops or sirup, most common cough suppresant

       STOPTUSSIN, TUSSIN, SINECOD

Diphenhydramine

       Antihystamine with antitussic (sedative, anticholinergic and antiemetic) effects, drawsiness is common side effect

       BENADRYL N

Mucolytic Agents

Guaifenesin

       ROBITUSSIN EXPECTORANS

Acetylcysteine

       Potent mucolytic agent, antioxidative effect

       SOLMUCOL

Ambroxol

       Common mucolytic used as sirup or tablets

       MUCOSOLVAN, AMBROBENE

Bromhexine

       Metabolizes to ambroxol

       BROMHEXIN, BRONCHOSAN

Contraception

Emergency (postcoital) contraception

Levonorgestrel in 1.5 mg dose

       Estimated effectiveness is 84 %

       ESCAPELLE

Local contraception – spremicides

Not efficient enough alone – should be complemented with other form of contraception (barrier contraception)

       Nonoxynol – PATENTEX OVAL N

       Benzalkonium chloride – PHARMATEX

Psychoactive OTC preparations

Sedatives

       Guaifenesin – moderate sedative effect - GUAJACURAN

       Valerian, Humulus and Lemon balm extracts

Antidepressants

       St. John wort – multiple drug interaction through cytochrome P450 induction

Nootropics

       Pirecetam – NOOTROPIL, PIRACETAM, OIKAMID

       Lecithin – phosphatidylcholine naturraly occuring in body with presumed nootropic effects

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

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