Download Lactulose and Ispaghula Husk Granules

Only for the use of a Registered Medical Practitioner or a Hospital or a Laboratory
120g
Composition:
Each 20 g of granules contains:
Lactulose Concentrate USP
Equivalent to Lactulose
10 g
Ispaghula Husk IP
3.5 g
Excipients
q.s.
Colour : Quinoline Yellow
Lactulose and
Ispaghula Husk
Granules
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BULKOSE
BULKOSE
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Lactulose and Ispaghula
Husk Granules
Description:
Lactulose is a synthetic disaccharide in the form of crystals for
reconstitution prior to use for oral administration. The chemical
name for Lactulose is 4-O-b-D-Galactopyranosyl-Dfructofuranose. The molecular formula is C12H22O11. The molecular
weight is 342.30. It is freely soluble in water. Ispaghula Husk (also
known as psyllium husk) is a well-known, safe, natural, non-habit
forming, effective bulk forming laxative (agent that facilitates
bowel evacuation).
Clinical Pharmacology:
Lactulose is a synthetic disaccharide that consists of fructose and
galactose. As there is no corresponding disaccharidase in the
human intestinal mucosal cells, Lactulose is not split in the small
intestine and therefore it is not absorbed. In the colon it is
metabolized to organic acids in short chains (acetic and lactic
acids) by the gut flora. This fermentation acidifies the content of
the intestine and it has an osmotic effect. The higher the dose of
Lactulose, the stronger the osmotic effect. Lactulose is poorly
absorbed from the gastrointestinal tract and no enzyme capable
of hydrolysis of this disaccharide is present in human
gastrointestinal tissue. As a result, oral doses of Lactulose reach
the colon virtually unchanged, in the colon; Lactulose is broken
down primarily to lactic acid, by the action of colonic bacteria,
which result in an increase in osmotic pressure and slight
acidification of the colonic contents.
This in turn causes an increase in stool water content and softens
the stool. Since Lactulose does not exert its effect until it reaches
the colon, and since transit time through the colon may be slow,
24 to 48 hours may be required to produce desired bowel
movement. Lactulose given orally to man and experimental
animals resulted in only small amounts reaching the blood.
Urinary excretion has been determined to be 3% or less and
essentially complete within 24 hours.
Ispaghula Husk is capable of absorbing up to 40 times its own
weight of water in vitro, and part of its activity can be attributed to
its action as a simple bulking agent. In addition, colonic bacteria
are believed to use the hydrate material as a metabolic substrate.
This results in an increase in the bacterial cell mass with
consequent softening of the faeces.
DRUG INTERACTIONS:
Nonabsorbable antacids given concurrently with Lactulose may
inhibit the desired Lactulose-induced drop in colonic pH.
Therefore, a possible lack of desired effect of treatment should be
taken into consideration before such drugs are given
concomitantly with Lactulose. Concomitant use of antibiotic with
Lactulose may inhibit the desired Lactulose induced drop in
colonic pH by interfering with the bacterial activity which might
affect laxative activity and activity in treatment of hepatic
encephalopathy. Hence status of the Lactulose-treated patient
with hepatic encephalopathy should be closely monitored in the
event of concomitant oral anti-infective therapy. Use of Ispaghula
Husk concomitant with thyroid hormones require medical
supervision because the doses of the thyroid hormones may have
to be adjusted.
PREGNANCY AND LACTATION:
If drug therapy is needed during pregnancy & lactation, the use of
this drug is accepted.
ADVERSE REACTION:
TM
BULKOSE may produce flatulence and intestinal cramps, which
are usually transient. A small amount of abdominal distension
may sometime occur.
INDICATION :
For the treatment of chronic idiopathic constipation in adult
patient only.
DOSAGE AND ADMINISTRATION:
TM
Adult: 20 g of BULKOSE to be taken orally twice daily with plenty
of water or as directed by the Physician.
DIRECTION OF USE:
TM
Disperse four spoonful of BULKOSE in 150 ml of water. Stir
briskly and consume the contents immediately. After consuming
the dispersed liquid, drink a glass of water.
OVERDOSAGE:
Lactulose: There have been no reports of accidental over dosage.
Excessive dosage of Lactulose can lead to diarrhea with potential
complications such as loss of fluids, hypokalemia, and
hypernatremia. Nausea and vomiting have been reported.
Medication should be terminated. Dialysis data are not available
for Lactulose. Its molecular similarity to sucrose, however, would
suggest that it should be dialyzable.
Ispaghula Husk: The patient may notice abdominal discomfort
and flatulence and attention should be paid in maintaining an
adequate fluid intake.
CONTRAINDICATIONS:
Lactulose may contain very small amount of galactose, hence it is
contraindicated in patients who require a low galactose diet.
Ispaghula Husk is contra-indicated in case of intestinal
obstruction, faecal impaction and colonic atony such as senile
TM
mega colon. BULKOSE
is contraindicated in following
conditions: Patients with a sudden change in bowel habit that
persists for more than 2 weeks. Patients with undiagnosed rectal
bleeding.
STORAGE:
Store below 30°C. Protect from moisture. Keep container tightly
closed after use.
PRESENTATION: Container of 120g.
Patients who fail to defecate following the use of laxatives.
Patients with diseases of the oesophagus and cardia. Patients who
have difficulty in swallowing or any other throat problems.
Patients with Phenylketonuria.
Although this complication has not been reported with Lactulose,
patients on Lactulose therapy undergoing such procedure should
have a thorough bowel cleansing with a non-fermentable
solution. Insufflation of CO2 as an additional safeguard may be
pursued but is considered to be a redundant measure. Ispaghula
Husk: It should not be given to patients with phenylketonuria.
PRECAUTIONS:
Since Lactulose contains very small amount of galactose and
lactose, it should be used with caution in diabetic. Ispaghula husk
contains aspartame because of which it should not be given to
patients with phenylketonuria.
LABORATORY TEST:
Elderly, debilitated patients who receive Lactulose for more than
six months should have serum electrolytes (potassium, chloride,
carbon dioxide) measured periodically.
For further details, please contact:
Medical Advisor
Biocon Limited
20th KM, Hosur Road, Electronics City,
Bangalore - 560 100. India
Manufactured by:
Biocon Limited
at, Village & P.O. Manpura,
Tehsil Nalagarh, Distt. Solan, Himachal Pradesh - 174101.
Marketed by:
Biocon Limited
20th KM, Hosur Road, Electronics City, Bangalore - 560 100. India
TM - Trade Mark of Biocon Limited
To report adverse events and/or product complaints visit our
website www.biocon.com or call toll free No: 1800 102 9465 or
e mail us at [email protected]
BF/LL/0166/01
WARNINGS:
Lactulose: A theoretical hazard may exist for patients being
treated with Lactulose who may be required to undergo
electrocautery procedure during proctoscopy or colonoscopy.
Accumulation of H2 gas in significant concentration in the
presence of an electrical spark may result in an explosive reaction.