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University of Sargodha
DRUG PROFILE
Drug name(Generic name): lactulose
1.PRODUCT DESCRIPTION:
Sr.No
Brand Name
Manufacturer
Dosage form
Strength
Storage
conditions
1
ABBOTT
LABORATORIES
(PAKISTAN)
LIMITED.
Syrup
12ml and
240 ml, 10g
sachet
3.35g/5ml
Store between
10-25°C in a dry
place.
2
SEARLE
PAKISTAN (PVT.)
LTD.
Suspension
60 ml
3.35g/5ml
Store between
10-25°C in a dry
place.
3
Nenza
Pharmaceuticals Pvt
Ltd
60ml
suspension
3.35g/5ml
Store between
10-25°C in a dry
place.
4
Getz Pharma
60ml or 120
ml syrup
3.35g/5ml
Store between
10-25°C in a dry
place.
5
Asian Continental
120ml
3.35g/5ml
Store between
10-25°C in a dry
place.
2.PRODUCT PROPERTIES:
Chemical properties
Physical properties
Chemical Class
Chemical structure
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Lactulose is a
disaccharide,
carbohydrates
Melting point: ~169 °C (dec.) storage
temp. Freely soluble in water, sparingly
soluble in methanol, practically
insoluble in toluene
3.PHARMACOKINETICS:
Absorption: Poorly absorbed in after the oral administration and reaches the colon and
metabolized by the bacteria
Bioavailability
% of
Protein
binding
Volume of
distribution
BBB/Placental
barier
Time for
onset of
action
Time for peak
blood level
Negligible
amount is bio
available
Hence it is
poorly
absorbed
there is no
significance
protein
binding
activity
No data
about
volume of
distribution
due to
poorly
absorption
N/L
8 to 48
hours
N/L
Metabolism and Excretion:
Site of Metabolism
Active Metabolites
Half Life
Route of Excretion
It is metabolized by the
colon bacteria and
removed by the feces.
First converted to
monosaccharides, and
then to volatile fatty
acids, hydrogen, and
methane.
1.72 hours
Mostly through feces.
Only 3% is excreted
by the urine
4.CLINICAL PHARMACOLOGY:
Therapeutic/Pharm
acological class
Anti-constipate
Mechanism of
action
Two mechanisms are believed to be involved in the laxative action of
lactulose:
1) Metabolism of lactulose by bacteria results in reduced
colonic pH, which stimulates peristalsis and decreases stool
transit time. In turn,decreased water reabsorption from the
feces further facilitates the passage of soft, well formed stools.
CH
2
OH
HO
H
O
H
H
H
H
OH
OH
H
H
H
O
O
CH
2
OH
OH
CH
2
OH
HO
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2) Increased osmotic pressure of fecal material secondary to an
increase in colonic organic acids results in accumulation of
fluid from surrounding tissues, helping to soften stool mass.
Indication/
Therapeutic use
• Constipation.
• Portal systemic encephalopathy (hepatic encephalopathy)
including stages of hepatic pre-coma and coma.
Adverse effects
Lactulose may cause abdominal discomfort associated with
flatulence or cramps. Nausea and vomiting have occasionally
been reported after high doses. Prolonged use or excessive
dosage may result in diarrhea with excessive loss of water and
electrolytes, particularly potassium.
Contraindications/P
recautions
Lactulose is contraindicated in:
Patients who require a low galactose diet.
Patients with galactosemia or disaccharide deficiency.
Patients with intestinal obstruction.
PRECAUTIONS
General
Those who develop gastrointestinal symptoms (flatus,
bloating, and diarrhea) with the use of dietary fiber should
exercise caution in the
use of lactulose.
• Care should be taken in patients who are lactose
intolerant.
• Lactulose syrup contains galactose and lactose and should
be used
with caution in diabetics as blood glucose levels may be
elevated,
usually after extended use.
In the overall management of portal-systemic
encephalopathy, it should
be recognized that there is serious underlying liver disease
with
complications such as electrolyte disturbance (e.g.,
hypokalemia) for
which other specific therapy may be required.
Hypernatremia has
been reported.
• Infants receiving lactulose may develop dehydration.
5.DOSAGE AND ADMINISTRATIONS:
Sr.No
Indications
Recommended Dosage Range
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Route of
administrati
on
Infants/neonat
es Mg/kg/day
and frequency
Child
Adult
Duration
of therapy
1.
Constipation
Oral
Infants under
one year
2.5ml twice
daily
Children: for
5-10 year 10
ml twice
daily under 5
year 5ml
twice daily
15 mL
orally once
a day OR
1-3 sachets,
correspond
ing to 10-30
g lactulose
Therapy
should be
continued
until
normal
bowel
function
resumes
2.
Portal
systemic
encephalopat
hy
Oral or
enema
Infants: 1.7 to
6.7 g/day (2.5
to 10 mL)
orally daily
divided in 3 to
4 doses
Children:
26.7 to 60
g/day (40 to
90 mL) orally
daily divided
in 3 to 4
doses
Initial
dose:
30-50 mL
orally 3
times a day
or
300 mL in
700 mL
water or
normal
saline as an
enema
retained
for 30 to 60
minutes
every 4 to 6
hours.
Maintenan
ce dose: 30
to 45 mL
orally 3
times a day
It may be
short term
or long
term
directed
according
to the
patient
3.
4.
6.GUIDELINES:
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For oral route:
Drug food interaction
Could be crushed
No/Yes
Directions for
reconstitution incase
of suspension
Directions for use
You should not use this
medication if you are on
a special diet low
in galactose (milk
sugar).
No
1-3 sachets,
corresponding to 10-
30 g lactulose- For
3ml dose one sachet
of 10 gram should be
added in q.s water to
make up the volume
of 30ml
Used Orally/ in the case
of enema 300 mL in
700 mL water or
normal saline as an
enema retained for 30
to 60 minutes every 4
to 6 hours.
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For IV route:
Compatible IV fluids
Incompatibilities
Storage time and temperature
after reconstitution
No available
N/A
Store between 10 to 25
o
C
7.INTERACTIONS:
Drug-Drug Interaction
Drug-Lab Interaction
Interaction
Mechanism
Pharmacist
Recommendation
Anti -
infective(Neomycin)
Antacids
Theoretically,the
elimination of
certain colonic
bacteria
byneomycin and
possibly other
anti-infective
agents may
interfere with the
desired
degradationof
lactulose.
Results of
preliminary
studies suggest
that
nonabsorbable
antacids Given
concurrently
with lactulose
may inhibit the
desired lactulose
induced drop in
colonic pH.
Should not be given
with these anti-
infetive drugs
There should be 2
hours gap between
antacids and
lactulose
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Other laxatives
Other laxatives
should not be
used, especially
during the initial
phase of therapy
for portal-
systemic
encephalopathy
because the loose
stools resulting
from their use
may falsely
suggest that
adequate
lactulose dosage
has been
achieved.
8.TOXICOLOGY:
Toxic dose
Signs and Symptoms
Lethal dose
Management/Treatment
48.8 mL/kg in
Abdominal cramps
and diarrhea
18160ng/kg
In case of abdominal cramps
relax and taker complete rest.
In case of diarrhea drink
plenty of water to avoid
dehydration
9.MOST SUITABLE BRAND(with reason):
10.PREGNANCY CATEGORY: FDA pregnancy category B
11.STATUS OF “FDA” APPROVED:
13.INCLUDED IN “NEDL” OR NOT:
Student signature:…………………… Teachers
signature:…………….....

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University of Sargodha DRUG PROFILE Drug name(Generic name): lactulose 1.PRODUCT DESCRIPTION: Sr.No Brand Name Manufacturer Dosage form Strength 1 ABBOTT LABORATORIES (PAKISTAN) LIMITED. SEARLE PAKISTAN (PVT.) LTD. Syrup 12ml and 240 ml, 10g sachet Suspension 60 ml 3.35g/5ml 3.35g/5ml Store between 10-25°C in a dry place. DUPHALAC 2 LUXAVE Storage conditions Store between 10-25°C in a dry place. 3 Easybowl suspension Nenza Pharmaceuticals Pvt Ltd 60ml suspension 3.35g/5ml Store between 10-25°C in a dry place. 4 Lilac® Getz Pharma 60ml or 120 ml syrup 3.35g/5ml Store between 10-25°C in a dry place. 5 Kolac Suspension Asian Continental 120ml 3.35g/5ml Store between 10-25°C in a dry place. 2.PRODUCT PROPERTIES: Chemical properties Chemical Class Chemical structure Physical properties CH 2OH Lactulose is a disaccharide, carbohydrates CH 2OH HO O H H H O OH H H OH H O OH HO H H Melting point: ~169 °C (dec.) storage temp. Freely soluble in water, sparingly soluble in methanol, practically insoluble in toluene CH 2OH 3.PHARMACOKINETICS: • Absorption: Poorly absorbed in after the oral administration and reaches the colon and metabolized by the bacteria Bioavailability Negligible amount is bio available • % of Protein binding Hence it is poorly absorbed there is no significance protein binding activity Volume of BBB/Placental Time for distribution barier onset of action No data N/L 8 to 48 about hours volume of distribution due to poorly absorption Metabolism and Excretion: Site of Metabolism Active Metabolites It is metabolized by the First converted to colon bacteria and monosaccharides, and removed by the feces. then to volatile fatty acids, hydrogen, and methane. Half Life 1.7–2 hours Time for peak blood level N/L Route of Excretion Mostly through feces. Only 3% is excreted by the urine 4.CLINICAL PHARMACOLOGY: Therapeutic/Pharm Anti-constipate acological class Mechanism of action Two mechanisms are believed to be involved in the laxative action of lactulose: 1) Metabolism of lactulose by bacteria results in reduced colonic pH, which stimulates peristalsis and decreases stool transit time. In turn,decreased water reabsorption from the feces further facilitates the passage of soft, well formed stools. 2) Increased osmotic pressure of fecal material secondary to an increase in colonic organic acids results in accumulation of fluid from surrounding tissues, helping to soften stool mass. Indication/ Therapeutic use • Constipation. • Portal systemic encephalopathy (hepatic encephalopathy) including stages of hepatic pre-coma and coma. Adverse effects Lactulose may cause abdominal discomfort associated with flatulence or cramps. Nausea and vomiting have occasionally been reported after high doses. Prolonged use or excessive dosage may result in diarrhea with excessive loss of water and electrolytes, particularly potassium. Contraindications/P Lactulose is contraindicated in: recautions • Patients who require a low galactose diet. • Patients with galactosemia or disaccharide deficiency. • Patients with intestinal obstruction. PRECAUTIONS General • Those who develop gastrointestinal symptoms (flatus, bloating, and diarrhea) with the use of dietary fiber should exercise caution in the use of lactulose. • Care should be taken in patients who are lactose intolerant. • Lactulose syrup contains galactose and lactose and should be used with caution in diabetics as blood glucose levels may be elevated, usually after extended use. • In the overall management of portal-systemic encephalopathy, it should be recognized that there is serious underlying liver disease with complications such as electrolyte disturbance (e.g., hypokalemia) for which other specific therapy may be required. Hypernatremia has been reported. • Infants receiving lactulose may develop dehydration. 5.DOSAGE AND ADMINISTRATIONS: Sr.No Indications Recommended Dosage Range 1. Constipation 2. Portal systemic encephalopat hy Route of administrati on Oral Infants/neonat es Mg/kg/day and frequency Infants under one year 2.5ml twice daily Oral or enema Infants: 1.7 to 6.7 g/day (2.5 to 10 mL) orally daily divided in 3 to 4 doses Child Adult Duration of therapy Children: for 5-10 year 10 ml twice daily under 5 year 5ml twice daily 15 mL orally once a day OR 1-3 sachets, correspond ing to 10-30 g lactulose Children: 26.7 to 60 g/day (40 to 90 mL) orally daily divided in 3 to 4 doses Initial dose: 30-50 mL orally 3 times a day or 300 mL in 700 mL water or normal saline as an enema retained for 30 to 60 minutes every 4 to 6 hours. Therapy should be continued until normal bowel function resumes It may be short term or long term directed according to the patient Maintenan ce dose: 30 to 45 mL orally 3 times a day 3. 4. 6.GUIDELINES: • For oral route: Drug food interaction You should not use this medication if you are on a special diet low in galactose (milk sugar). Could be crushed No/Yes No Directions for reconstitution incase of suspension Directions for use 1-3 sachets, corresponding to 1030 g lactulose- For 3ml dose one sachet of 10 gram should be added in q.s water to make up the volume of 30ml Used Orally/ in the case of enema 300 mL in 700 mL water or normal saline as an enema retained for 30 to 60 minutes every 4 to 6 hours. • For IV route: Compatible IV fluids No available Incompatibilities N/A Storage time and temperature after reconstitution Store between 10 to 25 o C 7.INTERACTIONS: Drug-Drug Interaction Interaction Mechanism • Theoretically,the Anti infective(Neomycin) elimination of certain colonic bacteria byneomycin and possibly other anti-infective agents may interfere with the desired degradationof lactulose. • Antacids Results of preliminary studies suggest that nonabsorbable antacids Given concurrently with lactulose may inhibit the desired lactulose induced drop in colonic pH. Drug-Lab Interaction Pharmacist Recommendation Should not be given with these antiinfetive drugs There should be 2 hours gap between antacids and lactulose • Other laxatives Other laxatives should not be used, especially during the initial phase of therapy for portalsystemic encephalopathy because the loose stools resulting from their use may falsely suggest that adequate lactulose dosage has been achieved. 8.TOXICOLOGY: Toxic dose 48.8 mL/kg in Signs and Symptoms Abdominal cramps and diarrhea Lethal dose 18160ng/kg Management/Treatment In case of abdominal cramps relax and taker complete rest. In case of diarrhea drink plenty of water to avoid dehydration 9.MOST SUITABLE BRAND(with reason): 10.PREGNANCY CATEGORY: FDA pregnancy category B 11.STATUS OF “FDA” APPROVED: 13.INCLUDED IN “NEDL” OR NOT: Student signature:…………………… signature:……………..... Teachers Name: Description: ...
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