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PRULITOP
PRUCALOPRIDE 1MG/2MG TABLET
(MEDICAL + MARKETING)
CONSTIPATION
 Constipation is one of the most common gastrointestinal
disorders encountered in clinical practice.
 Up to one-fifth of the general population suffers from chronic
constipation during their lifetime.
Am J Gastroenterology 2012;107:18-25.
 It is estimated that 130 million Indians suffer from constipation
Special report from World Gastroenterology Organization
CHRONIC CONSTIPATION
 Hard feces that are difficult to expel.
 Colon absorbed too much water from
the food while passing through it.
 Food moves slow through the
digestive tract, consequently the
feces become dry and hard.
CHRONIC CONSTIPATION-CRITERIA
ROME III Diagnostic Criteria* for Adults
 Chronic constipation must include 2 or more of the following:
CAUSES
SYMPTOMS
Symptoms include:
 Stomach ache
 Stomach cramps
 Feeling bloated and nauseous
 Losing appetite
 Difficulty and straining
 Passing less stools than usual
DIAGNOSIS
The doctor may suggest the following tests to rule out other health
conditions:
 Blood tests
 Sigmoidoscopy
 Colonoscopy
 Balloon expulsion test
 Anorectal manometry
TREATMENT
 Stimulants: These make the muscles in
the intestines contract rhythmically.
 Lubricants: These help the stool move
down the colon more easily.
 Stool softeners: These moisten the
stool.
 Fiber supplements: Called as bulk
laxatives.
TREATMENT
 Osmotics: These facilitate the movement
of fluids through the colon.
 Saline laxatives: These draw water into
the colon.
 Chloride channel activators: These
require a prescription and include
lubiprostone.
 5-HT-4 agonists: Increase secretion of
fluid in intestines and speed up the rate at
which food passes through the colon.
THERAPY FLOW CHART
RISKS ASSOCIATED WITH LAXATIVE THERAPY
 Cramping, bloating, and nausea in
some people.
 Dependent on laxatives and may mask
important constipation symptoms.
 Laxatives interfere with absorption of
other medications, avoid taking laxative
two hours of taking other medications.
 Laxative abuse result in dangerous
dehydration, weakness, fainting, and
kidney damage.
LAXATIVE ABUSE
 Electrolyte and mineral imbalances
 Severe dehydration
 Laxative dependence
 Chronic constipation
 Internal organ damage
 Increased colon cancer risk
PRUCALOPRIDE
 Agonist of 5HT4 receptors found in the
gut.
 Chronic constipation and slow transit,
develop tolerance, are also eligible for
Prucalopride treatment.
 Most of the dose is excreted unchanged
in the urine.
 Cisapride and Tegaserod removed
because of serious cardiovascular
adverse effects.
PRUCALOPRIDE MECHANISM OF ACTION
INTRODUCING
PRULITOP-1
&
PRULITOP-2
MARKET & COMPETITORS
 Total No. of Brands = 7
 Total Market 17.98 Crs
BRAND LAUNCH DATE COMPANY MAT VAL FEB 18
Grand Total 17.98
PRUVICT Apr-17 TORRENT 12.28
PRESMOVAC Jun-17 TORRENT 2.22
CONSTICALO Jun-17 TORRENT 1.90
PRUEASE Dec-17 SUN 0.77
PRUWEL Dec-17 INTAS 0.63
PRUDAC Jan-18 ZYDUS CADILA 0.16
MUVPRU Jan-18 EMCURE 0.02
As per Awacs AIOCD Feb’18
TARGETED DOCTORS & INDICATIONS
 Chronic Constipation
 Laxative resistant constipation
 Impaired GI motility
Gastroenterologists
Physicians
PRODUCT PRESENTATION
1 Strip = 10 Tabs
1 Box = 10 X 10 Tabs
DOSAGE
 Recommended adult dose for Prulitop 2 mg once daily with or without
food, at any time of the day.
 Older people (>65 years): Start with 1 mg once daily, if needed the
dose can be increased to 2 mg once daily.
 Patients with renal impairment: The dose for patients with severe
renal impairment (GFR < 30 ml/min) is 1 mg once daily.
LAUNCH LBL
Prucalopride

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Prucalopride

  • 2.
  • 3. CONSTIPATION  Constipation is one of the most common gastrointestinal disorders encountered in clinical practice.  Up to one-fifth of the general population suffers from chronic constipation during their lifetime. Am J Gastroenterology 2012;107:18-25.  It is estimated that 130 million Indians suffer from constipation Special report from World Gastroenterology Organization
  • 4. CHRONIC CONSTIPATION  Hard feces that are difficult to expel.  Colon absorbed too much water from the food while passing through it.  Food moves slow through the digestive tract, consequently the feces become dry and hard.
  • 5. CHRONIC CONSTIPATION-CRITERIA ROME III Diagnostic Criteria* for Adults  Chronic constipation must include 2 or more of the following:
  • 7. SYMPTOMS Symptoms include:  Stomach ache  Stomach cramps  Feeling bloated and nauseous  Losing appetite  Difficulty and straining  Passing less stools than usual
  • 8. DIAGNOSIS The doctor may suggest the following tests to rule out other health conditions:  Blood tests  Sigmoidoscopy  Colonoscopy  Balloon expulsion test  Anorectal manometry
  • 9. TREATMENT  Stimulants: These make the muscles in the intestines contract rhythmically.  Lubricants: These help the stool move down the colon more easily.  Stool softeners: These moisten the stool.  Fiber supplements: Called as bulk laxatives.
  • 10. TREATMENT  Osmotics: These facilitate the movement of fluids through the colon.  Saline laxatives: These draw water into the colon.  Chloride channel activators: These require a prescription and include lubiprostone.  5-HT-4 agonists: Increase secretion of fluid in intestines and speed up the rate at which food passes through the colon.
  • 12. RISKS ASSOCIATED WITH LAXATIVE THERAPY  Cramping, bloating, and nausea in some people.  Dependent on laxatives and may mask important constipation symptoms.  Laxatives interfere with absorption of other medications, avoid taking laxative two hours of taking other medications.  Laxative abuse result in dangerous dehydration, weakness, fainting, and kidney damage.
  • 13. LAXATIVE ABUSE  Electrolyte and mineral imbalances  Severe dehydration  Laxative dependence  Chronic constipation  Internal organ damage  Increased colon cancer risk
  • 14. PRUCALOPRIDE  Agonist of 5HT4 receptors found in the gut.  Chronic constipation and slow transit, develop tolerance, are also eligible for Prucalopride treatment.  Most of the dose is excreted unchanged in the urine.  Cisapride and Tegaserod removed because of serious cardiovascular adverse effects.
  • 16.
  • 18. MARKET & COMPETITORS  Total No. of Brands = 7  Total Market 17.98 Crs BRAND LAUNCH DATE COMPANY MAT VAL FEB 18 Grand Total 17.98 PRUVICT Apr-17 TORRENT 12.28 PRESMOVAC Jun-17 TORRENT 2.22 CONSTICALO Jun-17 TORRENT 1.90 PRUEASE Dec-17 SUN 0.77 PRUWEL Dec-17 INTAS 0.63 PRUDAC Jan-18 ZYDUS CADILA 0.16 MUVPRU Jan-18 EMCURE 0.02 As per Awacs AIOCD Feb’18
  • 19. TARGETED DOCTORS & INDICATIONS  Chronic Constipation  Laxative resistant constipation  Impaired GI motility Gastroenterologists Physicians
  • 20. PRODUCT PRESENTATION 1 Strip = 10 Tabs 1 Box = 10 X 10 Tabs
  • 21. DOSAGE  Recommended adult dose for Prulitop 2 mg once daily with or without food, at any time of the day.  Older people (>65 years): Start with 1 mg once daily, if needed the dose can be increased to 2 mg once daily.  Patients with renal impairment: The dose for patients with severe renal impairment (GFR < 30 ml/min) is 1 mg once daily.