Pico- Sodium picosulfate

1. PICO
Sodium Picosulfate
Presentation on,

2. Defecation (Poop)
Defecation (মলত্যাগ) is one of the most common activities
of human life cycle.
An average person excretes between 3X/Week to
3X/Day.
Even with healthy diet and exercise sometimes
Constipation occurs.
2

3. Bangladesh
3
‘Constipation’ is a common disorder where (2-30)% of people experiences symptoms at any
given time. Among Asians the prevalence (ব্যাপকত্া) of constipation is 14.3% approximately. Around
5% of people in Bangladesh suffers from Constipation mostly women, children and elderly.

4. Constipation
● Having fewer than three bowel
movements a week.
● Stools are dry and hard.
● Painful Defecation (মলত্যাগ) .
● Straining (জ াড় দিয়ে মলত্যাগ).
● Feeling that bowel is not fully emptied.
4

5. 5
Anatomy of
Colon
(Large Intestine)

6. Causes of
Constipation

7. 7
Constipation is a symptom not a disease. Which can be
caused due to several reasons-
1.Gender–Women : Affects twice as many women than men.
2. Age- Elderly and Children.
3. Bad Habits –
• Low caloric intake-Eating less food.
• Ignoring the urge to defecate.
4. Diet-
• Low fiber intake.
•Less water absorption.
5. Life Style- Sedentary : Less body movement or lack of
exercise.
6. Drug Induced- Overuse of medications like
painkillers(Opioids), CaCO3 etc..
7. Neural (স্নায়ুঘটিত) - Stress induced.
8. Pregnancy.

8. 8
Symptoms of
Constipation

9. 9
 Infrequent defecation (অসামঞ্জসযপূর্ণ মলতযাগ)
 Nausea, Vomiting
 Anorexia : loss of appetite for food (ক্ষুধামন্দা)
 Feeling full Quickly
 Stools that are small, hard, and/or difficult to evacuate
 Rectal bleeding (মলদ্বারে েক্তক্ষের্ )
 Weight loss (in chronic constipation)
Symptoms of Constipation

10. 10
*1-2 Indicates Constipation.

11. Peristalsis
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*Peristalsis : It is the involuntary constriction (সংয়কাচন) and relaxation (প্রসারণ) of the muscles of
the intestine or another canal, creating wave-like movements that push the contents of the
canal forward.

12. Constipation is related to many condition
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● Endocrine problems: Hypothyroidism, Diabetes, Hypercalcemia
● Irritable bowel/colon syndrome (IBS-C): It causes symptoms like stomach
cramps, bloating, diarrhea and constipation. Mainly treats IBS-C; for Constipation.
● Diverticular disease : a condition that occurs when small pouches, or sacs, form and
push outward through weak spots in the wall of your colon.
● Neurologic disorders:
1. Parkinson’s disease- a brain disorder that leads to shaking, stiffness, and
difficulty with walking, balance, and coordination. Imbalanced nerve issue may cause constipation.
2. Stroke- a serious life-threatening medical condition that happens when the blood supply
to part of the brain is cut off. Stroke may cause serious nerve damage which can lead to
constipation.
● Pregnancy.

13. Health Conditions
Constipation may lead to,
Like..

14. May lead to many severe conditions
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● Haemorrhoids : Piles.
● Faecal impaction :a large, hard
mass of stool (ব্ড় শক্ত মল) gets stuck in the colon
or rectum which is hard to push it out.
● Rectal prolapse : when the
rectum slides out of the anus.
● Colorectal Cancer (CRC or
Colon Cancer).

15. 15
1
2
3 4

16. Types of
Laxatives

17. 17
NAME
magnesium hydroxide (Milk of Magnesia), magnesium citrate,
sodium phosphate (Enema), lactulose, polyethylene glycol
methylcellulose, polycarbophil (Fiber),
psyllium (Ispaghula)
CLASS
Osmotic laxatives/Saline Laxative (Sodium Phosphate)-
(Osmosis-অভিস্রবর্ : Draws in water from less conc. area to more
conc. area).
Bulk-forming agents-
MECHANISM OF
ACTION
Draw water into the lumen to increase intestinal peristalsis. Water soluble fiber that draws in water into the intestine,
forming a bulky gel like mass, makes them soft & easy to
pass.
INDICATIONS Constipation
ROUTE(S) OF
ADMINISTRATION
•PO (orally)
•REC (rectal)
SIDE EFFECTS
•Diarrhea
•Fluid loss
For Lactulose-
1. Cramping
2. Bloating (ফ ালা)
3. Flatulence (ফপট াাঁপা)
•Nausea
•Vomiting
•Bloating
•Flatulence
•Diarrhea
CONTRAINDICATIONS
AND CAUTIONS
•Intestinal obstruction
•Severe abdominal pain
•Symptoms of appendicitis, diverticulitis, ulcerative colitis
•For saline laxatives:
•Renal, hepatic impairment
•Cardiac conditions
•For lactulose :
Diabetes mellitus
•Intestinal obstruction
•Severe abdominal pain
•Symptoms of appendicitis, diverticulitis, ulcerative colitis
-Safest for long term use.

18. 18
LAXATIVES, PART 2
DRUG NAME
Sodium Picosulfate,
Bisacodyl,
Senna
Docusate
CLASS
Stimulant laxatives Emollient laxatives (stool softeners)
MECHANISM OF ACTION
Irritate nerve endings in the intestinal walls, thereby
stimulating smooth muscle contraction and intestinal
peristalsis. Also draws in water to soften the stools.
Act as surfactant (decreases surface tension of the stool) that allows the
water to penetrate the stool and make it softer and easy to pass.
INDICATIONS Constipation, Colonoscopy Prevent constipation
ROUTE(S) OF
ADMINISTRATION
•PO
•REC
SIDE EFFECTS
•Abdominal cramping
•Nausea
•Vomiting
•Diarrhea
•Weakness
•Fluid and electrolyte imbalance
Senna
Reddish brown urine
•Melanosis coli (release of a pigment molecule called
lipofuscin — into the mucus membranes of the colon).
•Nausea
•Vomiting
•Abdominal cramping
•Diarrhea
CONTRAINDICATIONS
AND CAUTIONS
•Intestinal obstruction
•Severe abdominal pain
•Symptoms of appendicitis, diverticulitis, ulcerative colitis

19. Introducing
19
Pico
Sodium Picosulfate
Convenient, Faster & Better Acting Laxative
Stimulant Laxative

20. PICO: Brand Brief-
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Generic Name Sodium Picosulfate BP
Therapeutic Class Stimulant laxative
Dosage Form 10 mg Tablet, 100 ml Solution
Indication • Short-term relief of occasional constipation
• Bowel evacuation before investigational procedures (colonoscopy)
Strenght 10 mg Tab, 5 mg/5 ml Solution
Pack Size 15 × 2 (30’s), 100 ml × 1
Price TAB. MRP: 300 tk, SYR. MRP: 150 tk

21. 21
*Colonoscopy :
A colonoscopy is an
exam/test used to detect
abnormalities in the colon
and rectum. A long,
flexible tube
(colonoscope) is inserted
into the rectum which
contains a tiny video
camera at the tip of the
tube allows the doctor to
view the inside of the
entire colon.
Colonoscopy
*Pico is used before ‘Colonoscopy’ for bowel clearance

22. Mechanism of Action of
Pico

23. Mechanism of Action
23
Sodium Picosulfate works in a dual mechanism
Inhibits the absorption of
intestinal water &
electrolytes
Increases water
secretion in intestinal
lumen
Increases motility
Hydrolyzed by colonic
bacterial enzyme,
sulfatase
Becomes active
metabolite BHPM
Acts on colonic mucosa to
stimulate colonic peristalsis
(Direct Action)
**BHPM: Bis-hydroxyphenyl pyridyl-2-methane
1 2

24. Mechanism of Action (Cont.)
24

25. Mechanism of Action (Cont.)
1. Stimulating the propulsive (pushing forward- সাময়ন জেয়ল) activity by ‘Direct
Action’ on colon.
2. Inhibits the absorption of intestinal water & electrolytes.
3. Increases water secretion (পাদনর দনিঃসরণ ব্াড়াে) in intestinal lumen which in turn
promotes the accumulation of water providing stool can pass with ease.
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26. PICO: Dosage Guidelines
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Age Tablet (10 mg) Solution (100 ml)
Adult & >10 yrs : 5-10 mg daily 5- 10 ml or (1-2) tea spoonful/day.
Child 4-10 yrs : 2.5-5 mg daily
2.5- 5 ml or (1/2-1) tea spoonful/day.
1 month to < 4 yrs :
0.25 ml/kg BW daily.
Pregnancy & Lactation
Pregnancy Category: B
(Can be used in second & third trimester of pregnancy).
Does not excrete into the milk of lactating females hence it is safe
for lactating mothers.

27. Molecular Superiority
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Why Pico is the drug of
choice for constipation?

28. Overall Features, Advantages & Benefits (Selling Points)
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• FDA approved OTC (Over the Counter) laxative.
• Locally acting drug, shows selective response in constipation
• Drug of Dual Mechanism of action, ensures better result.
• Patient Convenience (জরাগীর সুদব্ধা) :
 Once Daily Dosing (Usually at night)- রায়ত্র জব্লা দিদনক একব্ার।
 Can be taken with or without food (as it’s a prodrug , so less food interaction).
• Onset of action : 6-12 Hours (which is why it is indicated to take at night).
• Safe & effective for pregnant (PC-B) & lactating mother.
• Safe for all age groups (1 month to older).
• Sugar Free (দচদন মুক্ত) : Safe for diabetic patients.
• Safe for Liver and Heart (Cardiac Patients) as it acts locally.
• No dependency on the drug (ওষুয়ধর উপর দনর্ভ রশীলত্া জনই).

29. 1. Bisacodyl - The use of Bisacodyl with milk or milk-food products (i.e., yogurt) can
cause the coating of the Bisacodyl tablet to dissolve too quickly. This may lead to an
upset stomach or a reduction in the amount of bisacodyl that is needed to relieve
constipation. While PS is the kind of prodrug which gets activated in colon.
2. Lubiprostone -
A. Can cause low blood pressure, especially after the first dose, though it can happen
with later doses as well. Also it may cause difficulty breathing.
B. Only available as a capsule that must be swallowed whole.
C. Can cause nausea and diarrhea.
D. Not approved for children.
E. Pregnancy Category C.
F. Prescription Only Product while PS is OTC.
G. Costly.
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Sodium Picosulfate Vs Other Laxatives

30. 30
Sodium Picosulfate Vs Lactulose (Dulac)

31. 1. Lactose Intolerance : Lactulose is produced by isomerization of lactose. Lactose
is in milk & is formed from glucose & galactose. The human body can’t absorb this
complex which is why it needs an enzyme called Lactase to cut down the complex. If
the body don't produce enough lactase in the small intestines, the body will not be
able to absorb the sugar.
Which is why it is not recommended for the people who have been diagnosed with
lactose intolerance. Taking this medication for lactose intolerant people can cause
cramping, diarrhea, bloating and stomach pain.
2. Diabetics: Although only a small fraction of lactulose undergoes systemic
absorption, diabetes patients must use it with caution due to a potential to cause
hyperglycemia in diabetic individuals as have been documented in a few studies.
3. Galactosemia : Lactulose can’t be given the people suffering from galactosemia.
This causes hepatomegaly (an enlarged liver), cirrhosis, kidney failure, cataracts, low
blood sugar (hypoglycemia), lethargy, brain damage, and ovarian failure.
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Sodium Picosulfate Vs Lactulose Cont.

32. 32
Total Market of
Constipation &
Bowel Cleansers
142 cr.
Rank Molecule
Yearly
Market (cr.)
Market
Share%
Growth
%
1 Lactulose 65 45 0
2 Lubiprostone 22 15 19
3 Magnesium 17 12 -8
4
Sodium
Picosulfate
9 7 32
5 Glycerol 8 6 16
Top 5 Molecules in Constipation
& Bowel Cleanser Market
***Data from IMS
Market Overview

33. 33
Sodium Picosulfate Market
***Data from IMS
Brand Company
Yearly
Market (cr.)
Market
Share%
Growth%
Sodium Picosulfate 9.5 7 32
Ezylife
Pharmasia
9.0 95 26
Ezylife Kid 0.4 4 999
Other Brands are-
 Ezyfeel - Euro Pharma Ltd.
 Picaso - Sharif Pharmaceuticals.
 Pico Plus - Everest Pharmaceuticals
 Picolax - Somatec Pharmaceuticals.

34. Target Prescriber
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1. Gastroenterologists
2. Medicine Specialists
3. Surgeons
4. Pediatricians
5. Gynaecologists
6. GPs
7. DMFs
8. RMPs
9. PCs.

35. Precautions
 Can’t be given within first trimester of pregnancy.
 Needs to drink plenty of fluids (at least 6-8 glasses) while taking SODIUM
PICOSULFATE to prevent dehydration.
 SODIUM PICOSULFATE should not be taken for more than a week as it
might cause dependency on the drug for a bowel movement.
 Drug-Disease Interaction : SODIUM PICOSULFATE may interact with
intestinal obstruction disorder, appendicitis, intestinal blockage, and bowel
inflammation.
 Drug-Drug Interaction : SODIUM PICOSULFATE may have interaction with
antibiotic (tetracycline), diuretics (furosemide), and steroids (prednisolone).
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36. PICO
Overnight Solution for Constipation