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
• 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
