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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