Composition Ofenteroquinpowderscientificfinal

1-Composition of Enteroquin Powder for oral Suspension
Each 5 ml after dispensing contains :

- Kaolin light 150 mg
- Phthalylsulphathiazole 150 mg
- Sulphadimidine 150 mg
- Homatropine Methylbromide 1 mg
-Vitamin B1 (Thiamine Hydrochloride) 2.5 mg
- Vitamin B2 (Riboflavin) 1 mg
- Vitamin B6 (Pyridoxine Hydrochloride) 1 mg
- Calcium Pantothenate 1.5 mg
- Nicotinamide 10 mg
2-Indications As stated in Enteroquin powder pamphlet which state that( attach 12)
-Bacillary dysentery
-Enteritis
-enterocolites
-Diahrrea
-Infantile summer diahrrea
3- These indications were proved from the following scientific facts
1-Kaolin
according to reference book Martindale page 1738 ( attach no 1)
a- Profile
-Light kaolin and light kaolin (natural) are adsorbent anti diarrhoealagents that have
been usedas adjuncts to rehydration therapyin themanagement of diarrhoea
.Uptoabout 24gdaily may be taken orally in divided doses.)p.1694(
.Kaolin is often combinedwithotherantidiarrhoeals,especially pectin
-.Light kaolin is also used as a food additive
b- Preparations
.BP 2008: Kaolin and Morphine Mixture; Kaolin Mixture; Kaolin Poultice
Proprietary Preparations (details are given in Part 3)
;†Braz.: Kaogel
.UK: Childrens Diarrhoea Mixture; Entrocalm
:Multi-ingredient
;†Arg.: Anusol-A; Argeal; Endomicina†; Gastranil†;Opocarbon; Opocler
Austral.: Bis-Pectin†; Chemists Own DiarrhoeaMixture†; Diarcalm; Donnagel;
;†Kaomagma with Pectin†; Kaomagma
;Belg.: Alopate; Neutroses
:Braz.: Atalin†; Digastril†; Eviprostat†; Gastrobene;Kaomagma;Kaopectin†; Chile
;Furazolidona
;Fr.: Anti-H†; Antiphlogistine†;Argeal;Gastropax;Kaobrol†;Kaologeais;Kaomuth
;Karayal;Keracnyl;Neutroses
;†Ger.:Kaoprompt-H;rohasal
;†Gr.:Fissan-Pate†;Kaopectate
;Hong Kong: Calamine-D†; Uni-Kaotin; Hung.: Bolus Adstringens;BolusLaxans
;Indon.:Kaopectate;NeoDiaform;NeoKaocitin;NeoKaolana;Neo Kaominal
;†Irl.:Kaopectate
;Israel:Digestif-Ara†Kaopectin;KapectinForte†;Zincod
;Ital.:Katoxyn; Neutrose S Pellegrino; Streptomagma
Malaysia: Beakopectin†; Kaopectate†; Mex.: Ameban; Caopecfar;Colfur; Contefur†;
oralzul; Depofin; Dia-Par Compuesto; Dibapec
;†Compuesto; Estibal; Exofur; Facetin-D; Farpectol; Furoxona CP; Fuzotyl
Hidromagma†; Isocar; K-Omistron; Kaomycin; Kaopectate; Kapecfuran; Kediar
;Lactopectin; Neokap; Neoxil; Olam; Optazol; Quimefuran; Suyodil ;
;Tapzol con Neomicina†; Treda; Trilor†; Yodozona; S.Afr.: Betapect; Bipectinol
;†Biskapect;BolusEucalyptiComp;Chloropect;Collodene;Enterolyte;Gastropect;Kao
;Kaopectin†;Kaostatex;Pectin-K;Pectrolyte;SBDiarrhoeaMixture
;†Singapore:Beakopectin;Kaomix;Kaopectate
Switz.:Argent†;Cicafissan;Fissan†; Gyrosan†;Neo-Decongestine;Neutroses;Padma-
;Lax;PadmedLaxan; Phlogantin
Thai.:Alkamine; Alumag; Alupep;Antacil†; Cenopec; Coccila†; Conmag; Di-Su-
;Frone†; Difuran; Disento; DisentoPF;Droximag†;Furasian;Furopectin†;Kaopectal
;†Med-Kafuzone
;UAE:Kaptin
;UK: Collis Browne’s; De Witt’s Antacid; Junior Kao-C; Kaodene†;KLN;Moorland
;Opazimes
;USA:K-C;Kao-Paverin;Kao-Spen;KaodeneNon-Narcotic;Mexsana
.†Venez.:Kaopecon†;Kaopectate†;Klincosal;Niosilin;Parepectolin†;Pec-Kao†;Sendafur
From these previous preparations (Tablets, suspensions,…etc )it was concluded the -
following facts Martinadale reference book(page 2464 to page 3043) Attach 2
-:a-Kaolin used in indications like
Diahrrea (reference countries USA,Austoria,Austorallia,UK,Germany) -1
Gastrointestinal pain (reference countries France) -2
)GIT disorderes (refrence country France&Hungry) -3
Dyspepsia (reference country UK)-4
b-these preparations contain Kaolin in combinations with other active ingredients and
no suspect that Kaolin can adsorb these actives
i.e Kaolin cannot reduce the activity of other actives the Enteroquin powder formula
and recently it was approved that though an Internal Study : (In-Vitro Study for the
Activity of Preparation : ( Neo-Carbotrina Tablets ) for Reduction of Intestinal Motility
in Comparison to belladonna extract raw Material and ( Enteroquine powder ) finished
products) , Ahmed M. Mansour, Mahmoud A. Taha , Al-Azhar University . 2014
( Attach no3)
which conclude that
Kaolin in Enteroquin powder have little or no effect on the anticholnergic activity of
Enteroquin powder
C- The Use of Kaolin in Diahrrea also approved in WHO (The treatment of Diahrrrea)
(Maternal new born,child and adolescent health)(attach no 4)
D- The adsorbtion activity of of Kaolin will not affect the activity of the other actives
in Enteroquin powder because no literature found states that like Shockley's Drug
interactions ( attach5)
2-Phthalylsulfathiazole
Also according to reference book Martindale (page 315 attach no 6)

Phthalylsulfathiazole is a sulfonamide with properties similar to those of
.sulfamethoxazole (p.340)
It is poorly absorbed, about 95% remaining in the intestine and only about 5% being
.slowly hydrolysed to sulfathiazole and absorbed
It is given, with other antibacterials, for its antibacterial action in
the gastrointestinal tract in the treatment of infections and for bowel decontamination
before surger i.e. - Phthalylsulfathiazole used in treatment of Bacillary dysentery (i.e.
against Shigella species in gut lumen ) see attach 6 page 6/8- 8/8 WHO (the rational use
of drugs in the management of acute diarrhoea in children)
Preparations
Proprietary Preparations (details are given in Part 3) see( attachement no8)
;Multi-ingredient: Arg.: Antidiar†; Carbon Tabs; Colistop; Colistoral†; Diarrocalmol
;Estreptocarbocaftiazol; Gemipasmol†; Lefa Enteril†; Opocarbon
;Opocler†; Braz.: Parenterin; Sanadiar†; Chile: Imecol; Liracol; Testisan
:Mex.: Bontal; Ditayod; Sultroquin†; Port.: Cloranpectina†; Spain
Estreptoenterol†; Thai.: Chlorotracin; Coccila†; Disento; Endothalyl; Mediocin
these preparations Prove that-
Pthalylsulphathiazole used in treatment of
Gastrointestinal infections (reference countries Spain& portugal)-1
Diahrrea& flatulence (Argentin non refrence country)-2
Gastrointestinal disorders, (reference country Italy)-3
Sulphadimidine-3
Also according to reference book Martindale (page 338 attach no 6)
Sulfadimidine is a short-acting sulfonamide with properties similar tothose of
sulfamethoxazole (p.340).
It is well absorbed from the gastrointestinal tract and is about 80 to 90% bound to
plasma proteins.
Because of the relatively high solubility of the drug and its acetyl metabolite,
crystalluria may be less likely than with sulfamethoxazole.
In the treatment of susceptible infections, sulfadimidine has been given orally
Sulphadimidine used in treatment of Bacillary dysentery (i.e. against Shigella species) -
In cases when the bacteria invade the gut and reach the blood stream) see attach 6 page
4/8
Homatropine Methylbromide -4
-Also according to reference book Martindale (page 1881-1882 attach no 7)

Homatropine Methylbromide used in -
Uses and Administration
Homatropine is a tertiary amine antimuscarinic with effects similarto those of atropine
.)p.1219(
It is used as the hydrobromide,alsoa tertiary amine,toproduce mydriasisand cycloplegia
itsactions are morerapidand ofshorter durationthanthoseof atropine,but it is ;)p.1874(
.less potentand has a relativelyweakcycloplegiceffect
Ingeneral, onset of action is between 30 and 60 minutes, and recovery within 1 to 3
.days
-Homatropine has also been used as the quaternary ammonium methobromide
derivative in the treatment of gastrointestinalspasm and as an adjunct in peptic ulcer
disease; homatropine methobromide has also been included in preparations used for
the treatment of coughs.
-Preparations
;BP 2008: Homatropine Eye Drops
;USP 31: Homatropine Hydrobromide Ophthalmic Solution
HomatropineMethylbromide Tablets; Hydrocodone Bitartrate and Homatropine
.MethylbromideTablets
Proprietary Preparations (details are given in Part 3)
;Arg.: Antiespasmodico; Dallapasmo; Espasmotropin; Paratropina
;†Braz.:Espasmo Flatol; Novatropina; Gr.: Nopar; Malaysia: Homa†; Mex.: Homasedin
;Homogrin;InfafrenSimple;Pasmolit
;Spain:Homatrop
.Venez.:Litropina
:Multi-ingredient
Arg.: Antispasmina; Asestor; Bellatotal; Bibol Leloup;Biliosan Compuesto†; Carbon
Tabs; Colistop; Dimaval; Espasmo Ibupirac†;Espasmofin; Factor AG Antiespasmodico;
Hepatodirectol; Ibupirac Fem;Opoenterol†; Paratropina Antigas; Paratropina
;Compuesta; Sumal;Zimerol
;†Braz.: Analgosedan†; Asmatiron†; Atapec†; Belacodid†; Bromalgina
Calmazin†;Codeverin†;Dipirol†;Enterobion†;Espasmalgon†;EspasmoColic†;Espasmo
;†Luftal;Etaverol†;FlagassBaby;Marsonil†;Migrane;Naquinto†;Pasmalgin
;†Plenocedan†;Sedalene; Sedalin;Spasmotropin;Tropinal;Vagoplex
;Chile:Codelasa
;Hung.:Bilagit†;Neo-Bilagit;Ridol†;Tropari num
;India: Dysfur-M†; Mex.: Bontal; Contefur†; Coralzul; Dialgin
Facetin-D; Fuzotyl†; Neopecsul; Neoxil; Sultroquin†; Tasakal†; Threchop;Trilor†;
;odozona
;Philipp.: Creamalin HM
;Spain: Cortenema
; Thai.:Polyenzyme-I
;USA: Hycodan; Hydromet; Hydropane; Tussigon
.†Venez.:Frevag†; Metilfedrin
5-Vitamin B 1,2,6 and Calcium Pantothenate, Nicotinamide

- Support the human body against loss of vitamins during the period of infection of
Diarrhea see attach 8
-: Finally it was concluded that

- Finally the egyptian pharmaceutical market contain combined Kaolin preparations
for example
1- Dysentrin compound powder for oral suspension Pharco company
Valid till 18-12-2018 (EDA MOH Egypt attach no9)
2-Entocid compound powder for oral suspension (sachet) Valid till 30-6-2019
(EDA MOH Egypt attach no9)
upon the previous scientific data and large different pharmaceutical preparations in -
the world (refrence countries&non refrence contries)
Enteroquin powder was proved to still as Safe and effective drug in treatment of
indications described in the pamphlet after the deletion of Diodohydroxy quinolin and
we hope from your respectable committee to accept the Re-registeration of Enteroquin
.powder in the Egyptian market due to its importance to egyptian patient
Best Regards
Dr/Abdel Aziz Ismail
R&D Expert
ARAB DRUG COMPANY

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1-Composition of Enteroquin Powder for oral Suspension

Each 5 ml after dispensing contains :

3- These indications were proved from the following scientific facts

according to reference book Martindale page 1738 ( attach no 1)

Also according to reference book Martindale (page 315 attach no 6)

-Also according to reference book Martindale (page 1881-1882 attach no 7)

5-Vitamin B 1,2,6 and Calcium Pantothenate, Nicotinamide

-: Finally it was concluded that

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