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RATIONALITY STUDY OF
I DIARRHOEAL FORMULATIONS
Dr. SHISHIR J MODAK
RATIONAL DRUG CELL
MEDICO FRIEND CIRCLE
PUBLISHED BY
RATIONALITY STUDY OF
ANTI DIARRHOEAL FORMULATIONS
Dr. SHISHIR J MODAK
RATIONAL DRUG: CELL
MEDICO FRIEND CIRCLE
1
PUBLISHED BY
KERALA SASTRA SAHITHYA PARISHAD
a.
(English)
Rationality Study of Anti Diarrhoeal
Formulations
IVr/Ken by:
Dr. SHISHIR J, MODAK
Rational Drug cell
Medico Friend Circle
50 LIC Quarters, University Road
Pune 411016.
First Published October 1985
Prinetd and Published by
Kerala Sastra Sahitya Parishad
Trivandrum-695037
Printed at
Prathibha Printers
Trivandrum-695037
'1 ‘
I
1 r~\ L
Price Rs. two
«<
’■
bangalore
KSSP
322/85
booooi.
PAM (eng)
d/8
1/1000
RATIONALITY STUDY OF
ANTIDIARRHOEAL FORMULATIONS
Diarrhoea is the frequent passage of loose stools. Diarr
hoeas are extremely common and endemic in our country.
Almost every child upto the age of 5 years gets 1 -2 episodes
of acute diarrhoea in a year. It is a number-one killer in in
fants and small children. Therefore, every doctor should be
thoroughly trained, regarding proper management of acute
diarrhoeas.
A large number of formulations are sold in the market
as antidiarrhoeal agents. They are usually broad spectrum
and claimed to be effective in diarrhoeas due to different
aetiological factors ranging from bacterial, protozoal,
nonspecific..etc. However, doubts are always raised about
rationality of all these preparations.. The purpose of this study
is to assess the rationality and effectivity of multiple
antidiarrhoeal preparations available in the market.
Material and Methods
The 47 different formulations listed under the heading,
'Antidiarrhoeals' in Current Index of Medical Specialities
(CIMS) - May 1984 issue were studied. Each ingredient of
every formulation was evaluated separately on its own merit.
The comments are based on the available scientific literature
on this topic, published in recent standard text books and
periodicals. Finally, each product was graded according to
the resultant rationality of its ingredients.
Antimicrobials as single ingredients (e.g. Ampicillin.
Tetracycline...etc.) are not included in this assessment.
RATIONALITY STUDY OF
ANTIDIARRHOEAL FORMULATIONS
Diarrhoea is the frequent passage of loose stools. Diarr
hoeas are extremely common and endemic in our country.
Almost every child upto the age of 5 years gets 1-2 episodes
of acute diarrhoea in a year. It is a number-one killer in in
fants and small children. Therefore, every doctor should be
thoroughly trained, regarding proper management of acute
diarrhoeas.
A large number of formulations are sold in the market
as antidiarrhoeal agents. They are usually broad spectrum
and claimed to be effective in diarrhoeas due to different
aetiological factors ranging from bacterial, protozoal,
nonspecific..etc. However, doubts are always raised about
rationality of all these preparations.. The purpose of this study
is to assess the rationality and effectivity of multiple
antidiarrhoeal preparations available in the market.
Material and Methods
The 47 different formulations listed under the heading/
'Antidiarrhoeals' in Current Index of Medical Specialities
(CIMS) - May 1984 issue were studied. Each ingredient of
every formulation was evaluated separately on its own merit.
The comments are based on the available scientific literature
on this topic, published in recent standard text books and
periodicals. Finally, each product was graded according to
the resultant rationality of its ingredients.
Antimicrobials as single ingredients (e.g. Ampicillin.
Tetracycline...etc.) are not included in this assessment.
(English)
Rationality Study of Anti Diarrhoeal
Formulations
Written by:
Dr. SHISHIR J. MODAK
Rational Drug cell
Medico Friend Circle
50 L1C Quarters, University Road
Pune 411016.
First Published October 1985
Prinetd and Published by
Kerala Sastra Sahitya Parishad
Tri vandrum-69 5037
Printed at
Prathibha Printers
Trivandrum-695037
Price Rs. two
X^-s00 00'-
KSSP
322/85
PAM (eng)
d/8
1/1000
RATIONALITY STUDY OF
ANTIDiARRHOEAL FORMULATIONS
Diarrhoea is the frequent passage of loose stools. Diarr
hoeas are extremely common and endemic in our country.
Almost every child upto the age of 5 years gets 1-2 episodes
of acute diarrhoea in a year. It is a number-one killer in in
fants and small children. Therefore, every doctor should be
thoroughly trained, regarding proper management of acute
diarrhoeas.
A large number of formulations are sold in the market
as antidiarrhoeal agents. They are usually broad spectrum
and claimed to be effective in diarrhoeas due to different
aetiological factors ranging from bacterial, protozoal,
nonspecific..etc. However, doubts are always raised about
rationality of all these preparations. The purpose of this study
is to assess the rationality and effectivity of multiple
antidiarrhoeal preparations available in the market.
Material and Methods
The 47 different formulations listed under the heading/
'Antidiarrhoeals' in Current Index of Medical Specialities
(CIMS) - May 1984 issue were studied. Each ingredient of
every formulation was evaluated separately on its own merit.
The comments are based on the available scientific literature
on this topic, published in recent standard text books and
periodicals. Finally, each product was graded according to
the resultant rationality of its ingredients.
Antimicrobials as single ingredients (e.g. Ampicillin.
Tetracycline...etc.) are not included in this assessment.
o
RESULTS
Please see the accompanying Table and the resuitantj
gradation of each formulation in the table. The overal
resultant gradation of each formulation has been done as
follows .-
A.
Use of the product is justified.
B.
Electrolytes or other irrational ingredients should be
deleted.
C.
The proportion of the ingredients should be altered,
D. The drug should be avoided and
available strictly against prescription.
E.
it should be
The formulation should be officially banned.
The resultant tally of these formulations was as follows::
ABODE
No. of products :
7 6 9 8 20.
Grade
(Total products studied are 47. Excess number in the
above table is due to some ^products having more than one
grade at a time).
Brand Name
Sr. No.
1)
2)
Aristogyl F
(Aristo)
90 ml : Rs. 8.00
Composition
Per 5 ml:
Furazolidone 30 mg
Comments
Grading
C
13, 14,
12, 18.
2
E
3, 17,
5
• Shotgun therapy, incorrect ratio
bet: Fura & Metro. The ratio
should be 1:5.
Pectin - 20 mg
Light Kaolin-1 gm
: Of cosmetic use if at all.
inadequate dose. May actually
increase electrolyte loss.
Chlorambin
suspension'
(Anglo-French)
Per 5 ml:
Light Kaolin-1 gm
Pectin-50 mg.
„
60 ml: 6.11
Neomycin - 50 mg.
: Inadequate dose of Neomycin,
Many strains are becoming resi
stant lo Neomycin.
Di-iodo-150 mg.
: Di-iodo. not a safe drug espe
cially in children. May produce
SMON. Should not be used in
fixed dose combination.
z
Reference
Sr.No.
Brand Name
Composition
Tincture belladona
- 0.06 ml
3)
Chlorostrep
(Cap. & Sus
pension)
(Parke Davis)
Combactin
(CEL Pharma)
60-ml; 5.19
Grading
Per 30 ml:
Neomycin-300 mg
Reference
Antimotility drugs should be
avoided in childhood diarrhoea;
should never be added in fixed
dose mixtures.
Per Cap. per 4 ml
:
(Chloramphenicol-125 mg) Chloro-not useful in Salmonella
gastroenteritis; severe side
effects; carrier state may be
prolonged after chloro.
60-ml:Rs. 10.59 Streptomycin
sulphate-125 mg
4)
Comments
E
5, 7, 1,
2, 10, 12,
Shigella & other enteropatho: genic organisms have become resis
tant to Streptomycin; rapid develop
ment of resistance; sensitization;
should not be combined with
Chloramphenicol for fear of
increased risk of optic neuritis.
E
3, 5, 12, 17,
. Dose of Neomycin inadequate;
Many strains resistant to Neo.
Sr. No.
Brand Name
Composition
Comments
Grading
Dicyclomine-10 mg
: Antispasmodic drugs should
not be added in fixed dose mixtures.
Light Kaolin-6 mg
Peet in-130 mg
: As in (1) above
Sod. Lactate-800 mg.
Pot. Chloride-300 mg
Sod. Chloride-470 mg
: Electrolytes should not be
: included in antidiarrhoeal
preparation; inadequate and
wrong proportion.
Reference
See WHO formula
5)
Darzin with
Neomycin
(Chemage)
Per 10 ml:
Light Kaolin-2 gm
Peet in-43 mg
: As in (1) above
60-ml: 6.88
Neomycin-125 mg
: As in (2) above
Sod. Lactate-267 mg
Sod. Chloride-157 mg
Pot. Chloride-100 mg
: As in (4) above
Piptal-4 mg
E
Antispasmodic drugs should not
be added in fixed-dose mixtures.
5,
2 and 12
Sr. No. Brand Name
9)
12 tabs:
Quinioidochlor-200 mg:
2.91
Diarmycin-N
(Nicholas)
60ml: Rs. 5.10
Diarrest
(Ebers)
50ml: Rs. 7.00
E
C
CO
8)
Per tablet:
Furazolidone-100 mg.
References
Effective antibacterial agent,
also useful in Giardiasis.
May produce SMON; not con
fined to Japan; 7 cases were
reported in Bombay; not a safe
drug; should not be used in
fixed dose combination.
Per 10 mi:
Neomycin Sulph. 100mg
Sulphadimidine - 134mg
Pectin-67mg
Light Kaolin-1.34gm
Per 5mi:
:
:
As in (1) above
Most of the bacteria are
resistant to sulphas by now.
As in (1) above.
Metronidazole - 100mg
Furazolidone - 33mg
Pectin - 75mg
Kaolin - 700mg
:
Same as in (1) above.
2, 12, 16
C
10 tabs; Rs. 1.32 Chloroquinaldol -lOOmg:
13, 14, 2
12.
D
Dysenchtor Tab Per tab
(S. G. Pharm)
As in (6) above.
ID
7)
Depends! Tabs
(Eskaylab)
Grading
CN
6)
Comments
Composition
2
Sr. No.
10)
11)
Brand Name:
Emantid
Per 30ml:
(MM Labs)
60ml: Rs. 6.25 -Furazolidone - 200mg
Pectin - 130mg
hight Kaolin - 6mg
Enteromac
(Mac)
Comments
Composition
:
Grading
References
E
2, 12, 3, 7
C
5, 17, 2, 12.
E
3,7
Effective antibacterial agent;
also used in Giardiasis.
As in (1) above
Tincture belladone-0.6ml :
Same as in (2) above.
Sod. Lactate - 800mg
Pot. Chloide - 330mg
Sold. Chloride - 470mg
As in (4) above.
Per 5ml
Neomycin - 75mg
:
Same as in (2) above.
Ligt Kaolin - 750mg
Pectin-30mg.
:
See (1) above.
Irrelevant & useless as
64ml: Rs. 4.21
Diphenhydramine-3mg.
12)
Enterosan
(Wockhardt)
Per tab .
. ...
Berberine HC 1-40mg
May cause hemolytic jaundice.-
Di-iodo-300mg
As in (2) above.
10: Rs. 1.86
/.
antidiarrihoeal.
Homotropine-0.8mg
Sr. No. Brand Name
Composition
13)
Enterostrep
(Dey's)
Per Cap. Er per 4ml:
T
12: Rs. 5.16
60: ml: 6.76
Chloro - 125mg
Strepto - 125 mg
14)
Enterov ioform
(Ciba)
500: Rs. 54.00
Per tab
Furamide Compound (Boots)
Per tab.
15)
10:
Comments
Grading
References
...
. E
Same asin
Chlorostrep
Same as in Chlorostrep
(3) above.
D
As in (6) above
Quiniodochlor - 250mg
...
Diloxamide
Furate-250mg
:
Useful in cyst-passers; not
the drug of choice in acute
amoebiasis.
Strepto - 120 mg
:
Shigella & other entero
pathogenic organisms have
become resistant to stre
ptomycin; rapid develop
ment of resistance;
sensitisation.
Chloroquine - 50 mg
:
Unnecessary; not indicated
in amoebic dysentry.
Rs. 4.55
B &C
15,
5
Sr. No. Brand Name
16)
17)
Comments
Composition
Furamide Susp.
with Neomycin
Per 10 ml.
:
(Boots)
60 ml: Rs. 5.18
Dilo. Furoate-250 mg.
:
Not the drug of choice
for amoebiasis.
Neomycin Sulph-80 mg. :
Very inadequate dose;
strains becoming
resistant to neomycin.
Furoxone Susp.
(Eskaylab)
Grading
References
BBC
3,
Per 5 ml:
Furazolidone-35.7 mg
As in (6) above.
Pectin-75. mg
Light Kaolin-1 gm
As in (1) above.
5-
A
2, 18.
D
7, 3
57 ml: Rs. 4.90
18)
Imotii
(Cevee Pharma)
4: Rs. 2.75
Loperamide HCI-2 mg
caps.
:
Antiperistaltic drugs should
not be used in children below
2 yrs. Even in older children
they should be avoided.
Sr. No. Brand Name
19)
Kaltin with
Neomycin
(Abbott)
Composition
Per 5 ml.
Kaolin-1 gm
Pectin-22 mg
As in (1) above.
Belladona-0.05 ml
Neomycin-50 mg
As in (2) above.
Sod. Lactate-133 mg.
Sod. Chlor. 67.2 mg.
Pot. Chlor. - 55 mg.
As in (4) above.
60 ml : Rs. 5.20
20)
Lactisyn
(Griffon)
Comments
Per ampoule:
Lactobacillus
lattis - 490 milli.
6 amp: Rs. 12.73
Lactobacillus
acidophillus-490 milli
Streptococcus
thermophillus-10 milli
Streptococcus
Lactis-10 million
Grading
Reference
E
2,18,3,
7,3,5.
WHO formula
A
May be useful in infectious
diarrhoeas but results are
not proved by controlled
trials.
18.
Sr. No. Brand Name
Composition
21)
Per Capsule:
Dried yeast powder10 million cells
of saccharomyces
Cerevisiae-250 mg.
Laviest
(Franco-Indian)
12 caps.
Rs. 10.04
22)
23)
Linopec
(Pharma
Research)
110 ml.
Rs. 5 40
Per 5 ml:
Lomofen
(Searle)
10 tabs :
Per tab.
Rs. 1.97
Comments
Reference
18.
Light Kaolin-2 gm
B
2,12,18.
E
3,7.
As (1) above
Diphenoxylate
HCI-2.5 mg
Atropine Sulphate
0.025 mg
Furazolidone-50 mg
Grading
Antimotility drugs should not
be used in children below
2 yrs. Even in older children
they should be avoided;
should not be added in
fixed - dose mixture.
:
As (6) above
Sr. No. Brand Name
Composition
24)
Per tablet & per 5 ml:
Lomotil
(Searle)
Comments
Diphenoxylate
10 tabs :
HCI-2.5 mg.
Rs. 1.84
Atropine Sulph-1.025mg.
60 ml : Rs. 6. 59
25)
Lopamide
(Torrent Labs)
Grading
Reference
D
3,7
D
3,7
E
18.
C
13, 14, 1,
12, 18.
As in (18) above.
Per tablet:
As in (18) above.
Loperamide HCI-2 mg
10 tabs: Rs. 3-00
26)
Mabino!
Complex (Mac)
Per tablet:
Chlorophenoximide-0.2mg.
As in (15) above.
10 : Rs. 4.67
streptomycin 0.16 mg.
lodochlorhydroxyquinoline-0.15 mg.
27)
Metroquin F Sus
pension (Noel)
60 ml : Rs. 8.95
As in (2) above.
Per 5 ml:
Metronidazole-100 mg
Furazolidone - 35 mg
Kaolin - 1 gm
Pectin - 75 mg
:
As (1) above.
:
As (1) above.
Sr. No. Brand Name
28)
Composition
Comments
E
per tab:
Mexaform
(Hind. Ciba Geigy)
Quinodochlor - 200 mg
:
As (6) above.
Phanquone - 20 mg
:
Not the drug of choice;
other better drugs available
for amoebiasis.
10 = Rs. 1.80
Oxyphenonium bromide2 mg
29)
Grading
3,7
As (23) above.
B, C
Neldar
(Phar-East)
Per 5 ml
60 ml : Rs. 8.18
Neomycin Sulph-50 mg
:
As (2) above
Sulphadimidine-100 mg
:
Most bacteria are now
resistant to sulfas.
:
As in (1) above.
Kaolin-1 gm, Pectin30 mg
Pot. Dihydrogen Phos25 mg
Sod. Lact - 150 mg
Pot. Chlor- 60 mg
Sod. Chlor-100 mg.
Reference
5, 3, 13
12, 18,
WHO formula
As in (4) above.
Sr. No. Brand Name
30)
.31)
32)
33)
Neo Combact in
(CFL) Pharma)
60 ml: Rs. 5.26
Pectokab
(Chemage)
100 ml :
Rs. 5.98
Pectokab-MF
(Chemage)
Peiopem
(Mercury)
Composition
Comments
Per 30 ml
Dicyclomine HCI-10 mg :
As (4) above
E
Light Kaolin - 600 mg
Pectin-130 mg
Neomycin Sulph-300 mg :
Sod. Lact-800 mg
As (1) above
Pot. Chlor-330 mg
Sod. Chlor-470 mg.
As (4) above
Per 5 ml
Pectin - 60 mg
Kaolin
1 gm
Per 5 ml
Metronidazole - 100 mg :
Furazolidone - 35 mg.
Light Kaolin - 1 gm
Pectin - 75 mg.
Grading
References
2, 12,
18, 3,
WHO formula
B
2, 12, 18
C
1. 13, 14
As (1) above
As (1) above
12, 18
D
Loperamide HCI - 2 mg :
As (18) above
3, 7
Sr. No. Brand Name
Composition
34)
Per 15 ml:
Pthalyl Sulphathiazone1 gm
Pe suHn-0
(Cadila)
Comments
E
Prepared attaPulgite
(Dextromed)
B
:
Sod. Chlor-100mg
Sod. Bicarb-81 mg
Pot. Chlor-99mg
Pot. Dihydro Phos-99mg
cal. gluconate-21 mg.
36)
•
Protoquit
(PFI)
60 ml: Rs. 7.50
12, 18, 3, 7
As (2) above
Per 6 gm powder
Attapulgite-3
References
Most of the bacterial strains
are now resistant.
As (1) above
Pectin 0.15 gm
Kaolin 3 gm
Tincture opium - 0.08 ml
35)
Grading
Limited cosmetic value; does
not decrease fluid loss.
As (4) above.
E
per 5 ml
Furazolidone-50 mg
lodochlorhydroxyquino:
line-125 mg
Pectin - 75 mg
As (6) above
As (2) above
As (1) above
1, 12, 18
Sr. No. Brand Name
37)
38)
39)
40)
Renokab Sus.
(Manners)
Comments
Composition
Per 4 ml:
Streptomycin base 50 mg:
Neomycin base- 25 mg
Pectin 50 mg
Kaolin - 0.75 mg
Belladona tincture0.05 mg
:
Sod Chlor - 25 mg
Pot. Chlor-10 mg
Cal. Lact-10 mg.
Ridol
Loperamide-2 mg. tab
(Gufic)
Salazopyrin
Per tab:
(Carter Wallace)
Salicylazo
50: Rs. 57.35
sulphopyridin 0.5 gm
Per 5 ml :
Salvaol
Grading
E
As (15) above
: As (2) above
As (1) above
As (2) above
As (4) above
D
:
Neomycin Sulph-50 mg :
(Associated)
60 ml : Rs. 7.60 Belladona tincture0.05 mg
Light Kaolin-750 mg
:
Pectin-50 mg
Sod. Lacate - 135 mg
Pot. Chlor-55 mg.
Sod. chlor. 75 mg
References
3,7
As (18) above.
A
Effective in ulcerative colitis
E
As (2) above.
As (1) above.
As (4) above.
3, 5, 12.
18, 3, 7
WHO formula.
Sr. No. Brand Name
41)
Saril
(Rallies) (TCE)
Per tab’.
Streptomycin
Sulfate - 240 mg
As (15) above.
Pthalyl Sulphaphiazole:
200 mg
As (34) above.
Tannic Acid-50 mg.
Not useful
Pectin - 10 mg
As (1) above.
Di-iodo. 125 mg
42)
Sofrakay
(Roussel)
Pectin - 50 mg
Spor/ac
(Uni Sankyo)
•
Very limited effectlvity
:
As in (1) abeve.
:
Grading
References
E
5, 2, 1
12, 18.
A
5, 12, 18
A
18
As (6) above.
Per tab:
Lactobacillus 60 million
10: Rs. 4.97
:
Per 5 ml:
Soframycin-50 mg
60 ml : Rs. 9.55 Kaolin - 0.5 mg
43)
Comments
Composition
Effectivily not yet proved
by controlled trials.
Sr. No, Brand Name
44)
Streptomagma
Suspension
(Wyeth)
350 ml: Rs. 17.10
45)
Strepto Paraxin
(Boehringer
Knoll)
10 mg 6 09
Comments
Composition
Grading
Per 5 ml:
Streptomycin Sulfate
50 mg.
Kaolin-0.5 gm
Pectin-45 mg
Aluminium
hydroxide - 66 mg
D
2. 18, 5
12
E
2,
As (15) above.
As (1) above.
:
It is not an antidiarrhoeal,
of limited use.
Per 5 ml:
Chloro - 125 mg
strepto - 125 mg
Reference
:
As (3) above.
46)
Streptophenicol
(Mercury)
50 ml : 7.05
47)
Wallamycin
Per 5 ml:
(Suspension)
Collistin Sulph-12.5 mg :
(Carter Wallace)
Kaolin - 438 mg.
Local antibiotic, of
limited use.
30 ml: Rs. 5.67
As (1)above,
5,
7, 10.
E
Pectin - 33 mg.
A
12, 18
DISCUSSION OF COMMENTS
In the table, the comments are written briefyly against
each ingredient. There is a great amount of repetition as
similar ingredients appear again and again in different formu
lations. Here we would discuss merits and demerits of
different group of drugs.
A)
Antibacterial drugs:
As is now well known, these play little part in the treat
ment of the acute stage of gastroenteritis. Certainly none in
viral gastroenteritis. They may infact do harm by furtherupsetting bowel flora. They can't, in any case, act fast
enough to stop further loss of fluid in a dehydrated child. It
must enough to stop further loss of fluid in adehydrated child.
It must therefore be seriously considered whether they have
any part to to play in the treatment of gastroenteritis5 . If no
pathogens are isolated, there is clearly no point in giving
antibiotics, and it is of interest to note that in 40 to 50%
of cases no organisms can be isolated from stool samples.
Particular mention must be made about some antibiotics
which are inadvertantly used in antidiarrhoeal formulations.
Chloramphenicol
It is a broad spectrum antibiotic effective against several
gram positive and gram negative organisms. However, it is
a potentially toxic drug,. It can produce aplasic anaemia,
other blood dyscrasias, optic neuritis, super-infection . etc.
There is always a danger of development of resistance. There
fore, this drug should be used only in typhoid fever and its
misuse in trivial infections should be stopped at once.
Contrary to expectations, chloramphenicol is not effective in
non-typhoid salmonella gastroenteritis. 5,7 If chloramphenicol
is combined with ’ streptomycin, risk of optic neutitis
increases2 . Therefore,this combination should be condemned.
20
Streptomycin
It is an aminoglycoside antibiotic effective against Myco
bacterium; but also effective against E. Coli, Proteus, H. infludenzae...etc. Formerly, this antibiotic was used in bacillary
agastroenteritis as many organisms have become resistant to
it. 5 Besides there is a danger of rapid development of resisance and sensitisation after oral use.2 The use of this drug
should be reserved for the treatment of Tuberculosis. It
should never be combined with Chloramphenicol as disussed
earlier.
Neomycin
This is a locally acting aminoglycoside antibiotic. It i
effective against some strains of E. Coli. However, organi
sms are fast becoming resistant to this antibiotic. Th
recommended therapeutic dose of neomycin is 100 to 150 mg/
kg/ day. 3 However, almost all the antidiarrhoeal preparations
containing neomycin provide a very inadequate dose of this
antibiotic.
Sulphonamides
Some antidiarrhoeal formulations contain sulphonamide
preparations. However, effectivity of sulpha preparations has
recently gone down considerably. Most of the organisms
re resistant to them and hence their use is wasteful and
gives rise only to side effects.
Furazolidone
Furazolidone is an anti bacterial agent effective against a
variety of bacteria. Shigella, Salmonella, E. Coli, Enterococci
are susceptible to it. It is also effective against Giardia. It
is a cheap drug with few side effects. So, it may be widely
used as an antidiarrhoeal drug.
Metronidazole
Metronidazole is the drug of choice in amoebiasis a n
Giardiasis. Therefore, it is commonly found in antidiarrhoeal
21.
formulations. Ideally in each case of diarrhoea, stool should
be examined, organisms should be identified and then specific
treatment should be started. However, in our country, where
majority of people cannot afford the cost of stool investigation
and hence, the stool is not examined, the causative organism
is not identified, the combination of metronidazole + Fura
zolidone may be justified as broad spectrum antidiarrhoeal.
Aminoquinolines
Quinidochlor or other hydroxyquinoline derivatives are
known to produce Subacute Myelo Optic Neuropathy (SMON)
after prolonged administration. This side effect is not
restricted to Japanese people but several cases have been
reported in Bombay. The exact safe dose and duration of
this drug is not determined especially in children; and, there
fore, this drug should not be used routinely for any nonspecific
diarrhoea. Certainly it should not form part of any fixed doss
antidiarrhoeal mixture.
B)
Antimotility and Antispasmodic Agents:
Lomotil (Diphenoxylate-|-Atropine), Loperamide and
opium derivatives are antiperistaltic drugs. They stop the
loose motions temporarily. They give a false sense of secu
rity without curing the underlying cause. 3 Paralytic ileus,
respiratory depression, cardiac toxicity etc. have been repor
ted in children following ingestion of lomotil. It is not pos
sible to predict the toxic dose in children and while some
may have only the mildest symptoms with relatively large
doses, others develop severe toxicity on ingesting normal
therapeutic dose. Therefore, lomotil should not be used in
children below 2 years; and even in older children these drugs
should be avoided in the presence of infection. These drugs
should be available strictly only against prescription. The
fixed dose fontiulations containing these drugs may prove
dangerous and should be banned.
Antispasmodic agents like dicyclomine should be used
very carefully to relieve spasmodic pain. They can cause
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22
paralytic ileus and should never be included'in an antidia
rrhoea I fixed dose combination.
As a rule any drug with higher risk of serious toxicity
should not be used in a fixed dose combination, since
in such a combination it is more likely to be used when
not really indicated. Hence, it is recommended that all
such preparations be banned as has been pointed out
above.
C)
Absorbents, Astringents, and binding agents:
Pectin, Kaolin, Bismuth salts are the drugs belonging
to this group. Light Kaolin is a hydrated and purified
aluminium silicate. It is supposed to absorb bacteria and
bacterial toxins. Pectin is purified carbohydrate product
obtained from citrus fruit extracts. It is claimed to form
stools. However, the dose of these drugs provided in
antidiarrhoeal mixtures is too inadequate. Secondly, it is
reported that these drugs may cause loss of electrolytes
by preventing absorption through gastrointestinal tract. These
drugs, if at all, are only of cosmetic value and may actually
mask the severity of the disease.
D)
Electrolytes:
In the management of diarrhoeas, administration of
water and electrolytes takes precedence over all other forms
of treatment. However, electrolytes should never be mixed
in antidiarrhoeal drugs. Electrolytes must be administered
with water in proper formula and as per need of indivi
dual patient. Electrolytes provided in the antidiarrhoeal
mixtures are in wrong proportion and too inadequate. They
give rise to false sense of security and may prove harmful-
CONCLUSIONS
1.
Antibacterial drugs should be used very judiciously
and only if absolutely necessary in the management of
diarrhoea;
2.
All formulations containing combination of chloramphe
nicol and streptomycin should be banned as antidiarrhoeal agents;
3.
All formulations containing streptomycin or chloramp
henicol [alone] should be avoided;
4.
All other antibacterial agents if combined in antidiarrhoeal formulations, should be provided in adequate
dosage, eg. Neomycin, Colistin, Furazolidone, Cotrimexazole
etc.
5.
Hydroxyquinoline derivatives should not be added in
any of the fixed dose combination. As far as possible
these agents should be avoided and should be available
strictly against prescription.
6.
Antiperistaltic drugs [ lomotil, Loperamide, Opium ]
should not be used in children below 2 years and
when used in children, should be used very cautiously
in proper dosage and for very short period of time.
They should not be added in any fixed dose formu
lations. Antispasmodic drugs like dicyclomine should
be carefully used in children and should never be
added in fixed-dose combinations.
7.
Electrolytes should never be added in fixed-dose
combinations with antidiarrhoeal agents. That gives
false sense of security and may prove harmful.
REFERENCES
Goodman & Gillman, 'The Pharmacological basis of
Therapeutics', 6th edition-1980, Macmillan Publishing
Company.
2. Satoskar, Kale, Bhandarkar's 'Pharmacology and Pharmacotherapeutics".
3. Acute Gastroenteritis, Chapter 7, P-69 in "Infectious
diseases of Children' by Saul Krugman & Samual Katz,
7th Edn; The C. T. Mosby Co., 1981.
4. Current Paediatric Therapy - 10 by Sydney Gells &
Benjamin Kagan-1982 WB Saunders Co.
5. Infectious diseases, Epidemiolog & Clinical Practice by
A. B, Christie, 3rd Edn-1980, Churchil Livingstone-P
116, 188, 190.
6. Textbook of Paediatric Infectious Diseases by Feigin
& Cherry, Vol. 1-1983.
7. 'Paediatrics" 17th Edn. by Abraham Rudolph - 1982
(Appleton-Century Crofts), P-1549.
8. NEJM 262-864-921/1960.
New England Journal of
Medicine
9. NEJM 256, 1121, 1957.
10, Valman H. B., Wlman M. J., Use of Antibiotics in
Acute Gastroenteritis among Infants in Hospital, BMJ1
1971.
11. Goetzee M. Leary P. M. — Gentamycin in E. Coli
Gastroenteritis, Arch. dis. Child. 46, 1971.
12. Diarrhoeas in children: Indian Journal of Paediatrics
July-Agusut 1980.
13. Essentials of Paediatrics-by O. P. Ghai/1980.
14. Textbook of Paediatrics, Vol-2 by Forfar & Arneil, 1984.
15. Report 1966: Annual Report on the work of the Infec
tious disease hospital & their associated laboratory ser
vices, Western regional board hospital, Scot-land, U. K
16. Davis Joan R., Farrant W. N., Uflely Anne: Antibiotic
Resistance of Shigella Sonnei, Lancet, 2:1157*1970
17. Ibid, 1968, 479.
18. AMA drug evaluations: 1984, 5th Edn.
19. Curtis JA & Goel KM-" Lomotil poisoning in Children' in
Arch of Disease in Child: 54; 1979-p-222.
Qren ln
1.
Kerala Sastra Sahitya Parishad Demands
□
Urgent steps for production and distribution of Essential
and life saving drugs at low costs.
□
Immediate ban on the imports and production of nonessential and hazardous drugs.
□
Strict quality control of drugs.
□
Implementation of the Hathi Committee recommendations.
□
Implementation of People's Drug Policy.
ALL INDIA DRUG ACTION NETWORK
This study is a part of the work of the All-lndia Drug
Action Network {Al-DAN).
Al-DAN is a loosely knit
network of more than ten groupsforganizations from different
part of the country committed to oppose the irrationalities
in the production and use of drugs in India and to foster
a Rational Drug Policy.
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