PROVIDING A LASTING CURE INPEPTIC ULCER DISEASE

PHARMA DEKO

OUR VISION

• To be the leading healthcare company in Nigeria, through providing innovative healthy solutions, consistent re-evaluation of quality standards and complete customer/consumer care focus.

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OUR MISSION

• To engage in the manufacture of high quality, effective Pharmaceuticals and consumer care products, which promotes the well being of our customers at an affordable cost, using a highly skilled and motivated workforce, partnering our numerous suppliers, financial institutions and distributors. Thereby achieving excellent returns on investment and capital appreciation for our shareholders while playing the role of a good corporate citizen by maintaining good relationship with our host community.

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INTRODUCTION• Naturally the stomach produces gastric acid and pepsin to aid

the process of digestion• The stomach has a mucosal barrier to protect itself from the

deleterious effect of the acid, churning process of food digestion and other external influences

• An acid peptic disorder occurs when the injurious effects of acid and pepsin overwhelm the mucosal barrier of the stomach by eroding it.

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PEPTIC ULCER DISEASE• DEFINITION:PEPTIC ULCER are defects in the gastrointestinal

mucosa, extending through muscularis mucosae, which persist as a function of the acid-peptic activity in the gastric juice

• A peptic ulcer, also known as PUD or peptic ulcer disease, is the most common ulcer of an area of the gastrointestinal tract that is usually acidic and thus extremely painful

• It is defined as mucosal erosions equal to or greater than 0.5cm

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REGULATION OF GASTRIC ACID SECRETION• Gastric acid is produced and secreted by the parietal cell,

which is in the fundus and body of the stomach• The pH in the gastric lumen is often as low as 1 to 2 as

compared with pH of 7.4 in blood• The secretion of acid by parietal cells is stimulated by three

substances, namely : Acetylcholine Histamine Gastrin

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Cont’d• The parietal cells has separate receptors for these substances• Histamine interacts with the H2 receptor ; this can be blocked

by H receptor antagonist such as Cimetidine, ranitidine and famotidine

• Acetylcholine interacts with a cholinergic receptor ; this can be blocked by atropine

• Gastrin and Prostaglandin I2 and E2 also have receptors on the parietal cells that influence the acid secretion

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REGULATION OF GASTRIC ACID SECRETION

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STOMACH DEFENSE SYSTEM• The mucosal barrier is the site of primary defect in patients

with gastric ulcer and acute gastritis• The stomach defense system is made up of :

Mucus barrierComplimentMucinBicarbonate ionEpithelial cell turnoverPeristalsisGastric acid

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PEPTIC ULCER DISEASE• Protective mechanism attenuate but do not totally prevent cell

injury; rapid repair of epithelial defects and healing of an acute wound to the basement membrane are critical in maintaining mucosal integrity

• Ulcers occur when these repair mechanism are disrupted by superimposed process such as H. pylori infection and ingestion of NSAIDs

• Major bleeding occurs when the ulcerative process involves submucosal vessles

• Peptic ulcer bleeding accounts for about 50% of all cases of upper gastrointestinal bleeding

• Acute mortality may be as high as 14% PHARMA DEKO

GASTROESOPHAGEAL REFLUX DISEASE (GERD)

• Occasional gastroesophageal reflux; the movement of gastric content through the lower esophageal sphincter (LES) into the oesophagus is a normal occurrence in most individuals

• This reflux becomes pathological when it causes troublesome symptoms or complications

• Symptoms include heartburn, acid regurgitation and in some cases chest pain

• GERD is a clinical condition in which the symptoms of gastroesophageal reflux or its effects on esophageal tissue are severe enough to disrupt a patients life or cause injury to esophageal tissue

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LONGITUDINAL SECTION OF THE STOMACH

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CAUSES OF PEPTIC ULCER DISEASE

• The following factors are considered to be the cause of PUD Helicobacter pylori infection (accounts for 70-95%)Use of NSAIDs Inadequate mucosal barrier Increased acid secretion

Note: Peptic ulcers are not caused by stress or eating of spicy food, but both can make ulcer symptoms worse. Smoking and drinking can also worsen ulcers and prevent healing.

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PUD AND Helicobacter pylori• Helicobacter pylori is a gram-negative bacterium found on the

luminal surface of the gastric epithelium ; was discovered by Robin Warren and Barry J. Marshall in 1982 as the causative factor for ulcers

• 60% of gastric and up to 90% of duodenal ulcers are due to H. pylori infection

• Colonization of the stomach by H. pylori results in chronic gastritis; ulcers results when the defence mechanisms of the is overwhelmed

• In western countries the prevalence of H. pylori infection roughly matches age ( 20% at age 20, 30% at age 30, 80% at age 80 etc.)

• Prevalence is higher in third world countries• Transmission is by food contaminated groundwater and through

human saliva ( such as from kissing or sharing food utensils). Brown LM (2000) PHARMA

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COMPLICATIONS OF PUD• These includes:

Hemorrhage/Bleeding (most common)Penetration and PerforationGastric outlet obstructionGastric cancerRecurrence

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MANAGEMENT OF PEPTIC ULCER• There are six broad categories of ulcer healing drugs:

Proton pump inhibitors e.g OmeprazoleH2-receptor antagonists e.g CimetidineSelective antimuscarinics ; PirenzepineChelates and complexes e.g Peptobismuth, sucrafateProstaglandin Analogues ; MisoprostolAntacids and Simeticones

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Introducing…………

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DESCRIPTION• The active ingredient in OMEPRAZ delayed-release capsules is

Omeprazole a substituted Benzimidazole; a compound that inhibits gastric acid secretion

• Empirical formula is C17H19N3O3S• Molecular mass 345.4g/mol• It is rapidly degraded in acidic media but has acceptable

stability in alkaline conditions• It is formulated as enteric-coated granules in capsules for oral

administration

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MECHANISM OF ACTION• OMEPRAZ is proton-pump inhibitor that suppresses gastric

acid secretion by specific inhibition of H+/K+-ATPase in the gastric parietal cell

• By acting specifically on the proton-pump, OMEPRAZ blocks the final stage of the acid production, thus reducing the gastric acidity

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MECHANISM OF ACTION

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PHARMACOKINETICS• The absorption take place in the small intestine and it is

usually completed within 3-6 hours• Systemic bioavailability after repeated dose is 60%• Plasma half life is 0.5-1.0 hour• Absorption is affected by the presence of food (i.e fast for at

least 60 minutes before taking omeprazole)• Antacids reduces the absorption of omeprazole by up to 50%• Protein binding is 95%• About 80% of the orally administered dose is found in urine

and the remainder in the faeces.

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SIDE EFFECTS• Headache• Diarrhea• Abdominal pain• Nausea• Dizziness• Trouble awakening and sleep deprivation• Others may include iron and vitamin B12 deficiency

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INDICATIONS AND DOSAGES• Gastric and duodenal ulcers: 1 capsule of 20 mg. a day for a period

starting from 2 to 3 weeks.

• GERD: 1 capsule of 20 mg. daily for 4 weeks. In the case of patients with mucous that have not healed completely after the first treatment, may require additional treatment for another 4 weeks.

• Zollinger-Ellison starts treatment with a dose of 60 mg. daily thereafter be adjusted on an individual basis depending on the response and needs.

• Helicobacter pylori : For the eradication of this bacterium using omeprazole in combination with clarithromycin or amoxicillin at a dose of 20 mg., 500 mg. and 1000 mg. respectively, 2 times daily for 10 days.

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CONTRAINDICATIONS• Omeprazole delayed-released capsules are contraindicated in

patient with known hypersensitivity to any component of the formulation.

• Contraindicated in pregnancy and lactation

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SUMMARY• OMEPRAZ blocks the final step involved in acid secretion by

the parietal cell thereby inhibiting acid production; this stops acid secretion irrespective of the original stimulating factor

• Possibility of peptic ulcer recurrence is greatly reduced• Used as adjunct in the eradication of H. pylori which is

responsible for 60-90% 0f peptic ulcers• Absorption of Omeprazole is reduced by up to 50% when

administered with Antacids

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PRESENTATION• Each OMEPRAZ delayed-release capsule contains 20mg of

Omeprazole in the form of enteric-coated granules• Tropicalised Alu-Alu blister• Pack of 14’s (2x7)

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Next step……….

Prescribe/recommend OMEPRAZ with confidence for your next patient with PEPTIC ULCER DISEASE PHARMA

DEKO

THANK YOU

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