SERATEX-10

GENERIC NAME:

Serratiopeptidase

COMPOSITION
Each tablet of SERROPEP-10 contains:

Serratiopeptidase . . .10 mg

DOSAGE FORM:

For oral use in adults with TID dosage

DESCRIPTION:

Serratiopeptidase

is a prot eolyt ic enzyme (prot ease)

produced by enterobacterium

Serratia

sp. E-15.

This microorganism was originally isolated in the late 1960s from silkworm

Bombyx mori

L. (intestine),
Serrat iopeptidase is present in t he silkworm int est ine and allows t he emerging mot h t o dissolve it s
cocoon. Serrat iopept ase is produced by purif icat ion f rom cult ure of Serrat ia E-15 bact eria. Today,
SERA TEX -10 is produced by fermentation technology.

PHARMACODYNAMIC AND PHARMACOKINETIC PROPERTIES
* Mechanism of Action

SERA TEX -10 is an enzyme derived f rom t he bact eria belonging t o genus Serrat ia.

The Serratia E15
species of bact eria was originally discovered in t he gut of silkworm.

Serrat ia E15 produces large
quantities of this enzyme.

SERA TEX -10 binds t o 2-macroglobulin in t he blood in a 1:1 rat io.

This helps t o mask it s ant igenicity
but retains its enzymatic activity. Levels of

serratiopeptidase are slowly transferred to the exudates at
the site of infection and

inflammation and gradually blood levels decline.

The mechanism of action of SERA TEX -10 appears t o be

hydrolysis of hist amine, bradykinin and
serot onin, and a prot eolyt ic and f ibrinolyt ic

ef f ect . Primarily t his is achieved by dissolving t he
complement (specif ic prot eins

responsible f or inf lammat ion) and increasing t he plasmin act ivit y by
inhibiting the

plasmin inactivators.

By t he af orement ioned mechanisms, SERA TEX -10 reduces

capillary permeabilit y induced by
hist amine, bradykinin and serot onin; breaks downabnormal exudat es and prot eins; f acilitates t he
absorption of decomposed products

through blood and lymphatics.

Thus, SERA TEX -10 promotes wound healing and repair, and rest ore t he skin t emperat ure of t he
inf lamed area, burn

or t rauma t o normal.

The addit ion of met al ions like zinc, manganese and cobalt
to

SERA TEX -10 stabilizes and ensures the efficacy of the

formulation.

Serratiopeptidase has been shown to be absorbed from the digestive tract. On oral

administration, it
is absorbed unchanged into the systemic circulation, from where it

penetrates into all the tissues. It
reaches higher concentrations in the inflamed tissues.

It attains peak levels in one hour.

CLINICAL STUDIES : SEROPEP-10 IN SINUSITIS AND BRONCHITIS
Research and clinical use of serrat iopept idase f or sinusit is and bronchit is also proved successf ul. In
bot h condit ions, t here is inf lammat ion and swelling of t he lining of t he airways t hat prevent drainage
of mucus. The airways then become even more obstructed.

The mucus in t hese areas becomes t hick and packed and t hus is not easy t o expel. This t hick mucus
pack also becomes a breeding ground f or bact erial inf ect ions and more inf lammat ion. St uf f y nasal
passages and congest ed bronchial areas are of t en t reated wit h ant ihist amines which dry up t he
mucus even more, making it even more difficult for the body to break up and expel.

Ant ibiot ics are also f requent ly prescribed f or t hese condit ions, of t en wit h lit t le success. The t hick
mucus remains int act af t er ant ibiot ic t herapy and provides a breeding ground f or more bact eria, and
the pat ient begins an endless cycle of inf lammat ion and ant ibiot ics. Some of t he drugs used t o t reat
t hese problems deplete mucus, while Serrat iopept idase alt ers t he elast icity of mucus wit hout
depleting it.

Serrat iopeptidase act ually reduces t he t hickness and viscosit y of t he mucus and improves t he
eliminat ion of it t hrough bronchopulmonary secret ions.14 Pat ient s t reat ed wit h serrat iopept idase f or
laryngit is and sinusit is experienced a signif icant reduct ion in severit y of pain, rapid improvement of
symptoms after 3-4 days, as well as reduction in nasal stuffiness, infected secretions, and fever.

SERATEX-10

IN INFECTION AND ATHEROSCLEROSIS
Ot her st udies have shown t hat t his enzyme can act ually t eam up wit h ant ibiot ics and deliver
increased concent rat ions of ant ibiot ics t o t he sit e of t he inf ect ion. Bact eria can go t hrough a process
of producing biof ilm, which result s in resist ance t o ant ibiot ics. A st udy by a t eam of It alian
researchers suggest s t hat prot eolytic enzymes such as serrat iopept idase could signif icant ly enhance
t he ef f ect iveness of ant ibiot ics against biof ilm and can inhibit biof ilm f ormat ion. Serrat iopeptidase
has been shown t o enhance t he act ivit y of several ant ibiot ics including ampicillin, ciclacillin,
cephalexin, minocylcine and cef ot iam.

A nother promising area is t he use of Serrat iopept idase t o break down art herosclerotic plaque. Hans
A. Nieper, M.C. an int ernist f rom Hannover, Germany, studied t he ef f ect s of serrat iopept idase on
plaque accumulat ion in t he art eries. Because the enzyme digest s non-living t issue and leaves live
t issue alone, it may be ef f ect ive in removing t he deposit s of f at t y subst ances, cholest erol, cellular
waste products, calcium and fibrin on the inside of the arteries. The fibrinolytic (clot removal) activity
of serrat iopept idase may also be able t o help wit h t hickened blood, increased risk of st roke, and
phlebitis/thrombophlebitis.

SERATEX-10

IN CARPAL TUNNEL SYNDROME
Carpal t unnel syndrome is an inf lammat ory disorder of t he hand and wrist t hat is charact erized by
int ense, long-last ing pain, inf lammat ion and disabilit y. The U.S. Dept . of Labor has st at ed t hat of all
t he occupational hazards, more days are needed t o recover f rom t his disorder t han any ot her.
Treat ment has been by NSAIDs and surgery. In a promising small t rial, serrat iopept idase improved
t he inf lammat ion and pain of carpal t unnel syndrome. Sixt y f ive percent of t he pat ient s showed
clinical improvement . No signif icant side ef fect was observed.
INDICATIONS : SERA TEX-10 is indicated for,

Resolution of inflammation due

to bone and soft tissue injury, Musculoskeletal and rheumatic
disorders.

Reducing inflammation associated with episiotomy and perineal laceration.

Reducing

breast engorgement in puerperium.

Resolves

postpartum

haematomas and pregnancy related

thrombophlebitis.

A s adjuvant therapy after hysterectomy.

Hastening absorption of subconjunctival haemorrhage, hyphaemas, and vitreous

hemorrhage.

Post Surgery especially in trauma and plastic surgery, post-operative cases shorten
convalescence period.

A djuvant

therapy with antibiotics in ocular infections like keratitis, uveitis and

endophthalmitis.

Resolution of inflammatory oedema in acute infections like tonsillitis, pharyngitis,

laryngitis
and pain following tonsillectomy, also resolves mucus and pus in

sinusitis, and otitis media.

A s adjuvant in chronic obstructive pulmonary disease, bronchitis, pulmonary

tuberculosis,
bronchial asthma, septic abortion, pelvic inflammatory disease and

salpingitis,

Controlling haematoma and pain following tooth extraction, odontectomy,

traumatic, alveolar
or tooth fractures.

Dermatological conditions resulting in skin inflammation.

A djuvant in infections such as alveolar

abscess and periodontitis.

Besides it is also useful for reducing elasticity as well as viscosity of respiratory secretions. When
advocated during infections, serratiopeptidase breaks down biofilm so as to eliminate
colonization by relatively resistant bacteria.

CONTRAINDICATION
SERA TEX -10 is contraindicated in those who are hypersensitive to its ingredients.

DOSAGE & ADMINISTRATION
SERA TEX -10 MG Tablet three times daily -1 hour before or 1-2 hours after meals; maximum for
3-4 months.

Maximum daily dosage can be administered up to 360 mg / day

(360,000 I.U).

Up to 36 tablets

per day in divided dosages in acute need

can be taken. The

highest dose of
SERA TEX -10 should be used for 7 days until the symptoms decrease substantially and then the
dosage has to be reduced

to 1-2 tablets

per dose /day.

OVERDOSE
No antidote known for overdose

with Serratiopeptidase and withdrawal from the therapy is
recommended.

USE IN SPECIAL POPULATION

Pregnancy

& Lactation

SERA TEX -10 must be advocated during pregnancy and lactation only if necessary.

Children

Safety and efficacy of Serratiopeptidase (SERA TEX -10) in children has not been demonstrated.

PRECAUTIONS
Caref ul administ rat ion of SERA TEX -10 should be made to pat ient s

wit h coagulat ion disorders,
severe hepatic and renal disturbances.

DRUG -DRUG INTERACTIONS
Patients on anticoagulant therapy should be observed carefully because of possible

potentiation of
anticoagulant effects by SERA TEX -10.

UNDESIRABLE EFFECTS
Serrat iopeptidase has few adverse ef f ect s on oral administ rat ion. It s use may cause

occasional
hypersensit ivit y, diarrhoea, nausea, vomit ing, epist axis and haemopt ysis.

Serratiopeptidase
(SERA TEX -10) can cause hypersensitivity reactions such as rash or redness, besides gastrointestinal
side effects like anorexia, abdominal discomfort, nausea and vomiting.

INCOMPATIBILITIES
No incompatibilities reported till date

ADDITIONAL BENEFITS
SERA TEX -10 is provided in ent eric coat ed acid resist ant

t ablet s derived f rom a cont rolled
f ermentat ion of t he bact erial st rain, Serrat ia sp. T-1, t hat

secretes t his enzyme in medium.
Successive purif icat ion st eps, f or example micro-f ilt rat ion, ammonium sulphyhat e, f ract ionat ion,
DEA E-Cellulase column chromat ography, gel filt rat ion f ollowed by repeat asept ic f ilt rat ion and
f reeze drying yields t his product in a highly purif ied f orm, enabling it t o be used f or medicinal
purpose. SERA TEX -10 is a st ronger f ibrinolyt ic agent t han any ot her known alkaline or neutral
prot ease such as bromelain

or pronase.

PRESENTATION
SERA TEX -10 is available in blister pack of 10 tablets

SHELF LIFE
2 years from the date of manufacturing

STORAGE AND HANDLING INSTRUCTIONS
Recommended to store in a cool & dry place, preferably below 25
0

C, protect from sunlight &
moisture.

CLINICAL REFERENCES