Paracetamol

Drug Nomenclature
Date of monograph revision: 31-Jul-1997; 13-Jul-1998; 21-Mar-2000; 09-Nov-2001; 29-Jul-
2003; 18-Jun-2004; 05-Oct-2004; 31-May-2006; (last modified: 21-Jun-2006)
Synonyms: N-Acetyl-p-aminophenol; Acetaminophen; Paracetamol; Paracetamolis;
Paracetamolum; Parasetamoli
BAN: Paracetamol
I NN: Paracetamol [rINN (en)]
I NN: Paracetamol [rINN (es)]
I NN: Paractamol [rINN (fr)]
I NN: Paracetamolum [rINN (la)]
I NN: [rINN (ru)]
Chemical name: 4-Hydroxyacetanilide; N-(4-Hydroxyphenyl)acetamide
Molecular formula: C
8
H
9
NO
2
=151.2
CAS: 103-90-2
ATC code: N02BE01
Read code: YM3tX; y04Fy

Chemical Structure of Paracetamol
NOTE:
Compounded preparations of paracetamol may be represented by the following names:
Co-bucafAPAP (PEN)butalbital, paracetamol, and caffeine
Co-codamol x/y (BAN)where x and y are the strengths in milligrams of codeine
phosphate and paracetamol respectively
Co-codAPAP (PEN)paracetamol and codeine phosphate
Co-dydramol (BAN)dihydrocodeine tartrate 1 part and paracetamol 50 parts
(w/w)
Co-hycodAPAP (PEN)hydrocodone tartrate and paracetamol
Co-methiamol x/y (BAN)where x and y are the strengths in milligrams of DL-
methionine and paracetamol respectively
Co-oxycodAPAP (PEN)oxycodone and paracetamol
Co-proxamol (BAN)dextropropoxyphene hydrochloride 1 part and paracetamol
10 parts (w/w)
Co-proxAPAP (PEN)dextropropoxyphene napsilate and paracetamol.
Pharmacopoeias:
In Chin., Eur. (see ), I nt., J pn, Pol., US, and Viet.
Ph. Eur. 5.5 (Paracetamol). A white crystalline powder. Sparingly soluble in water; freely
soluble in alcohol; very slightly soluble in dichloromethane. Protect from light.
USP 29 (Acetaminophen). A white odourless crystalline powder. Soluble 1 in 20 of boiling
water, 1 in 10 of alcohol, and 1 in 15 of 1N sodium hydroxide. Store in airtight containers.
Protect from light. Protect from moisture and heat.
Adverse Effects and Treatment
Adverse effects of paracetamol are rare and usually mild, although haematological reactions
including thrombocytopenia, leucopenia, pancytopenia, neutropenia, and agranulocytosis
have been reported. Skin rashes, and other hypersensitivity reactions occur occasionally.
Overdosage with paracetamol can result in severe liver damage and sometimes acute renal
tubular necrosis. Prompt treatment with acetylcysteine or methionine is essential and is
discussed under Overdosage, .
References.
1. 1. Graham GG, et al. Tolerability of paracetamol. Drug Safety 2005; 28: 22740.
PubMed
Effects on the kidneys.
For reference to evidence that abuse or prolonged excessive use of analgesics, including
paracetamol, can produce nephropathy, see under NSAIDs, .
See also under Overdosage, .
Effects on the respiratory tract.
The results of a case-control study
1
have suggested that the frequent (daily or weekly) use of
paracetamol may be associated with asthma. However, the UK CSM has commented that the
results of this study do not alter any advice regarding the use of paracetamol and that it
remains a safe and effective pain killer for many patients including asthmatics.



















Alcohol
Drug Nomenclature
Date of monograph revision: 18-Feb-1998; 14-Sep-1998; 26-Feb-2001; 16-Nov-2001; 14-Jun-2004;
30-May-2006; (last modified: 09-Aug-2006)
Synonyms: Aethanolum; Alcohol; Alcool; Etanol; Etanoli; Etanolis; Ethanol; Ethanolum; Ethyl Alcohol
Molecular formula: C
2
H
5
OH =46.07
CAS: 64-17-5
ATC code: D08AX08; V03AB16; V03AZ01

Chemical Structure of Alcohol
NOTE:
The following terms have been used as 'street names' (see ) or slang names for various forms of
alcohol:
Booze; Drinks; Juice; Lunch head; Sauce; Schwillins.
Use in Sport. Alcohol may be restricted in certain sports (see ) and competitors should
check with the appropriate sports authorities.
Pharmacopoeias:
Various strengths are included in Br., Chin., Eur. (see ), I nt., J pn, Pol., US, and Viet.
Also in USNF.
In Martindale the term alcohol is used for alcohol 95 or 96% v/v.
Ph. Eur. 5.5 (Ethanol, Anhydrous; Ethanolum Anhydricum; Ethanol BP 2005). It contains
not less than 99.5% v/v or 99.2% w/w of C
2
H
5
OH at 20 degrees. A colourless, clear, volatile,
flammable, hygroscopic liquid; it burns with a blue, smokeless flame. B.p. about 78 degrees.
Miscible with water and with dichloromethane. Protect from light.
The BP 2005 gives Absolute Alcohol and Dehydrated Alcohol as approved synonyms.
Ph. Eur. 5.5 (Ethanol (96 per cent)). It contains not less than 95.1% v/v or 92.6% w/w and
not more than 96.9% v/v or 95.2% w/w of C
2
H
5
OH at 20 degrees, and water. A colourless,
clear, volatile, flammable, hygroscopic liquid; it burns with a blue, smokeless flame. B.p.
about 78 degrees. Miscible with water and with dichloromethane. Protect from light.
The BP 2005 gives Alcohol (96 per cent) as an approved synonym.
BP 2005 (Dilute Ethanols). The monograph describes several dilute alcohols containing
between 20 and 90% v/v of C
2
H
5
OH, and one of these, ethanol (90%), is also known as
rectified spirit.
USP 29 (Alcohol). It contains not less than 92.3% w/w or 94.9% w/v and not more than
93.8% w/w or 96.0% w/v of C
2
H
5
OH at 15.56 degrees. A clear, colourless, mobile, volatile
liquid with a characteristic odour and burning taste; it is flammable. B.p. about 78 degrees.
Miscible with water and with almost all other organic solvents. Store in airtight containers.
Protect from light.
USP 29 (Dehydrated Alcohol). It contains not less than 99.5% v/v or 99.2% w/w of C
2
H
5
OH
(sp. gr. not more than 0.7962 at 15.56 degrees). Store in airtight containers. Protect from
light.
USNF 24 (Diluted Alcohol). It contains 48.4 to 49.5% v/v or 41 to 42% w/w of C
2
H
5
OH.
Store away from fire in airtight containers.
Physicochemical Characteristics
Alcoholic strength.
This is expressed as a percentage by volume of alcohol. It was previously often expressed in
terms of proof spirit. Proof spirit contained about 57.1% v/v or 49.2% w/w of C
2
H
5
OH, and
was defined as 'that which at the temperature of 51 degreesF weighs exactly twelve-
thirteenths of an equal measure of distilled water'. Spirit of such a strength that 100 volumes
contained as much ethyl alcohol as 160 volumes of proof spirit was described as '60 OP'
(over proof). Spirit of which 100 volumes contained as much alcohol as 40 volumes of proof
spirit was described as '60 UP' (under proof).
An alternative method of indicating spirit strength was used on the labels of alcoholic
beverages in the UK when the strength was given as a number of degrees, proof spirit being
taken as 100 degrees. In the USA alcoholic strength is expressed in degrees, the value of
which is equal to twice the percentage by volume. Thus 70 degrees proof (old UK system) is
equivalent to 40% v/v, and therefore to 80 degrees proof (USA system).
Adverse Effects
Adverse effects of alcohol arise chiefly from the intake of alcoholic beverages. The
concentration of alcohol in the blood producing a state of intoxication varies between
individuals.
Low concentrations (up to 180 mg/100 mL) of alcohol may result in impaired vision,
reaction time, and coordination and emotional lability.
At low to moderate concentrations (180 to 350 mg/100 mL), alcohol acts as an apparent
stimulant; depression of cortical function causes loss of judgement, slurred speech,
diplopia, blurred vision, ataxia, lack of coordination, blackouts, sweating, tachycardia,
nausea, vomiting, and incontinence. Alcohol inhibits the release of antidiuretic hormone
resulting in enhanced diuresis. Acidosis (especially in children), hypoglycaemia, and
hypokalaemia may occur.
High concentrations (350 to 450 mg/100 mL) of alcohol result in cold clammy skin,
hypothermia, hypotension, stupor, coma, dilated pupils, and depressed or absent tendon
reflexes. Severe hypoglycaemia, convulsions, respiratory depression, and metabolic
acidosis may occur. Cardiac arrhythmias such as atrial fibrillation and AV block have been
recorded.
The median lethal blood-alcohol concentration is generally estimated to be about 400 to
500 mg/100 mL. Death may occur at lower blood-alcohol concentrations due to inhalation of
vomit during unconsciousness.
Chronic excessive consumption of alcohol may cause damage to many organs, particularly
the brain and the liver. Possible direct toxic effects of alcohol on the brain, as well as
thiamine deficiency, may lead to Wernicke-Korsakoff syndrome. Fat deposits may occur in
the liver and there may be a reduction in various blood-cell counts. Nutritional diseases may
occur due to inadequate diet. High alcohol consumption has been associated with pancreatitis,
and an increased risk of cardiovascular disease, although some consider that moderate
consumption might have a protective effect against ischaemic heart disease.
Alcohol consumption has also been associated with an increased risk of some types of cancer.
The term 'alcoholism' may be used to denote dependence on alcohol, which is of the
barbiturate-alcohol type (see Amobarbital, ) and usually involves tolerance to other
sedatives and anaesthetics. After prolonged periods of excessive alcohol consumption, a drop
in blood-alcohol concentration may precipitate a withdrawal syndrome characterised by
tremor, agitation, feelings of dread, nausea, vomiting, and sweating; hallucinations, seizures,
and delirium tremens may also develop.
A fetal alcohol syndrome has been identified in some infants born to some alcoholic
mothers; such infants have characteristic features and abnormalities. There have been some
reports of the syndrome and other adverse effects on the fetus being associated with moderate
alcohol intake in pregnancy; it is generally suggested that alcohol is best avoided during
pregnancy.
Frequent application of alcohol to the skin produces irritation and dry skin.
Effects on the skin.
A 70% solution of alcohol, containing povidone-iodine, caused partial thickness chemical
burns beneath tourniquets in 3 young children.
1
Other adverse effects on the skin reported
with the topical application of alcohols have included necrosis after skin cleansing of preterm
neonates with methylated spirits
2,3
and haemorrhagic skin necrosis due to the alcohol content
of chlorhexidine in spirit used as a disinfectant in umbilical artery catheterisation in preterm
infants.
4








Glycerol
Drug Nomenclature
Date of monograph revision: 23-Mar-1998; 01-Sep-1998; 30-Jan-2001; 09-Nov-2001; 03-Jun-2004;
12-Jul-2004; 25-Jul-2006
Synonyms: E422; Glicerin; Glicerol; Glicerolis; Glycerin; Glycerine; Glycerol; Glycerolum; Glyseroli
INN: Glycerol [rINN (en)]
INN: Glicerol [rINN (es)]
INN: Glycrol [rINN (fr)]
INN: Glycerolum [rINN (la)]
INN: *rINN (ru)+
Chemical name: Propane-1,2,3-triol
Molecular formula: C
3
H
8
O
3
=92.09
CAS: 56-81-5
ATC code: A06AG04; A06AX01
Read code: y03Ls; y07jQ

Chemical Structure of Glycerol
NOTE:
Use in Sport. Glycerol may be restricted in certain sports, see , as it is considered to be a
member of a prohibited group (Diuretics); competitors should check with the appropriate
sports authorities.
Pharmacopoeias:
In Chin., Eur. (see ) ,Int.,Jpn,US, and Viet.
Eur. and I nt. also include Glycerol (85 per cent).
Pol. includes Glycerol (86 per cent).
Ph. Eur. 5.5 (Glycerol). A clear, colourless or almost colourless, very hygroscopic, syrupy
liquid, unctuous to the touch. Miscible with water and with alcohol; slightly soluble in
acetone; practically insoluble in fixed oils and in essential oils. Store in airtight containers.
USP 29 (Glycerin). A clear, colourless, hygroscopic, syrupy liquid. Has not more than a
slight characteristic odour, which is neither harsh nor disagreeable. Miscible with water and
with alcohol; insoluble in chloroform, in ether, and in fixed and volatile oils. Its solutions are
neutral to litmus. Store in airtight containers.
Physicochemical Characteristics
Incompatibility.
Strong oxidising agents form explosive mixtures with glycerol. Black discoloration has been
reported with glycerol and bismuth subnitrate or zinc oxide when exposed to light.
Adverse Effects and Precautions
The adverse effects of glycerol are primarily due to its dehydrating action.
When taken by mouth glycerol may cause headache, nausea, and vomiting; diarrhoea, thirst,
dizziness, and mental confusion may occur less frequently. Cardiac arrhythmias have been
reported.
Glycerol increases plasma osmolality resulting in the withdrawal of water from the
extravascular spaces. The consequent expansion of extracellular fluid, especially if sudden,
can lead to circulatory overload, pulmonary oedema, and heart failure; glycerol must
therefore be used with caution in patients at risk, such as those with hypervolaemia, cardiac
failure, or renal disease. Severe dehydration can occur and glycerol should be used cautiously
in dehydrated patients. Patients with diabetes mellitus may additionally develop
hyperglycaemia and glycosuria after metabolism of glycerol. Nonketotic hyperosmolar
hyperglycaemic coma is rare, but fatalities have been reported.
Haemolysis, haemoglobinuria, and acute renal failure have also been associated with glycerol
when given intravenously (see Raised Intracranial Pressure,