Each capsule contains Omeprazole 20mg in the form of enteric-coated pellets.
Pharmacology: Zenpro Capsule (omeprazole) reduces gastric acid secretion through inhibition of gastric acid pump in the parietal cells. The pharmacological effects of omeprazole are largely confined to inhibition of gastric acid secretion and effects that result therefrom.
Pharmacokinetics: Orally administered omeprazole is absorbed rapidly but to a variable extent. Absorption of omeprazole is not affected by food. Its bioavailability depends upon dose and gastric pH, and it may reach 70% with repeated administration.
It is extensively (more than 95%) bound to plasma protein.
Omeprazole is almost completely metabolized in the liver and rapidly eliminated, mostly in urine. Although the elimination half-life from plasma is short, being reported to be about 0.5 to 3 hours, its duration of action with regard to inhibition of acid secretion is much longer allowing it to be used in single daily doses. It is suggested that its distribution to the tissues, and particularly to the gastric parietal cells, account for this action.
In patients with chronic hepatic disease, the bioavailability increased to approximately 100%, reflecting decreased first-pass effect, and the plasma half-life of the drug increased to nearly 3 hours compared to the half-life in normals of 0.5 to 1 hour.
In patients with chronic renal impairment, elimination of omeprazole is slowed in proportion to the decreased creatinine clearance because urinary excretion is a primary route of excretion. However, bioavailability is not markedly affected.
Zenpro Capsule is indicated for: Treatment of duodenal and benign gastric ulcers.
Eradication of Helicobacter pylori in peptic ulcer disease.
Treatment of reflux oesophagitis and symptomatic treatment of heartburn and regurgitation in gastro-oesophageal reflux disease (GORD).
Treatment of Pathological Hypersecretory Conditions (Zollinger-Ellison syndrome).
Prophylactic treatment in patients with an increased risk of NSAIDs associated peptic ulcer, gastro-duodenal erosion or dyspeptic symptoms.
Treatment of NSAIDs induced peptic and gastro-duodenal erosion.
Zenpro Capsules are recommended to be given in the morning and swallowed whole with liquid.
For patients with swallowing difficulties the capsule might be opened and the contents swallowed or suspended in a slightly acidic fluid e.g. juice or soured milk. The suspension should be taken within 30 minutes. Alternatively these patients can suck the capsule and swallow the contents.
The contents of capsule should not be chewed or crushed.
Short-term treatment of duodenal and benign gastric ulcers: The recommended adult oral dose is 20mg once daily. Most patients with duodenal ulcer heal within 4 weeks, while majorities of patients with benign gastric ulcer are healed after 8 weeks. In severe cases, the dose may be increased to 40mg once daily, and healing is usually achieved within 4 weeks.
Long-term therapy for patients with a history of recurrent duodenal ulcer: The recommended dosage is 20mg Zenpro Capsule once daily.
Prevention of relapse in patients with duodenal ulcer: The recommended dose is 10mg once daily. If needed, the dose can be increased to 20mg once daily.
The effectiveness of Zenpro Capsule is not affected by concomitant NSAID treatment, and the usual dose and duration of treatment is recommended.
Eradication of Helicobacter pylori in peptic ulcer disease: Dual Therapy: The usual dose is Zenpro Capsule 40mg daily with oral amoxicillin 1.5g daily (given as 750mg b.d.) for 2 weeks. In clinical studies daily doses of 1.5 to 2g of amoxicillin have been used, or Zenpro Capsule 40mg daily with clarithromycin 500mg t.i.d. for 2 weeks.
Triple Therapy: Zenpro Capsule 20mg, amoxicillin 1g and clarithromycin 500mg, all twice a day for 7 days or Zenpro Capsule 20mg, clarithromycin 250mg and metronidazole 400mg (or tinidazole 500mg), all twice a day for 7 days or Zenpro Capsule 40mg once daily with amoxicillin 500mg and metronidazole 400mg both three times a day for one week.
Reflux Esophagitis: The recommended dosage is 20mg once daily. Symptom resolution is rapid and in most patients healing occurs within 4 weeks. For those patients who may not be fully healed after the initial course, healing usually occurs during a further 4 weeks treatment period.
In patients with severe reflux oesophagitis, Zenpro Capsule 40mg once daily is recommended and healing is usually achieved within 8 weeks.
Symptomatic treatment of gastro-oesophageal reflux disease: The recommended dosage is Zenpro Capsule 20mg daily. Symptom relief is rapid: If symptom control has not been achieved after 4 weeks treatment with Zenpro Capsule 20mg daily, further investigation is recommended.
Pathological Hypersecretory Conditions: For Zollinger-Ellison Syndrome, the recommended starting dose is 60mg once daily. The dosage should be adjusted individually and treatment continued as long as clinically indicated. Doses up to 120mg daily have been administered. Daily dosages of greater than 80mg should be administered in divided doses.
NSAID associated gastric ulcer: For duodenal ulcer or gastroduodenal erosions in patients with or without continued NSAID treatment, the recommended dosage of Zenpro Capsule is 20mg once daily. Symptom resolution is rapid and in most patients healing occurs within 4 weeks.
For those patients who may not be fully healed after the initial course, healing usually occurs during further 4 weeks treatment period.
For the prevention of NSAID associated gastric ulcers, duodenal ulcers, gastroduodenal erosions and dyspeptic symptoms, the recommended dosage of Zenpro Capsule is 20mg once daily.
Impaired Renal Function: Dose adjustment is not required in patients with impaired renal function.
Impaired Hepatic Function: As bioavailability and plasma half-life of omeprazole are increased in patients with impaired hepatic function, a daily dose of 20mg may be sufficient.
Use in Children: There is no experience of the use of omeprazole capsule in children.
Use in Elderly: Dose adjustment is not required in the elderly.
There is no experience to date with deliberate overdosage. Dosages of up to 360 mg/day have been well tolerated. No specific antidote is known.
Omeprazole is extensively protein bound and is, therefore, not readily dialyzable. In the event of overdosage, treatment should be symptomatic and supportive.
Zenpro Capsule is contraindicated in patients with known hypersensitivity to any component of the formulation.
General: Symptomatic response to therapy with omeprazole does not preclude the presence of gastric malignancy.
Atrophic gastritis has been noted occasionally in gastric corpus biopsies from patients treated long-term with omeprazole.
The possibility of malignancy should be excluded before treatment with omeprazole is instituted.
Hypomagnesemia: Hypomagnesemia symptomatic and asymptomatic, has been reported rarely in patients treated with PPIs for at least three months, in most cases after a year of therapy. Serious adverse events include tetany, arrhythmias, and seizures. In most patients, treatment of hypomagnesemia required magnesium replacement and discontinuation of the PPI.
For patients expected to be on prolonged treatment or who take PPIs with medications such as digoxin or drugs that may cause hypomagnesemia (e.g. diuretics), health care professionals may consider monitoring magnesium levels prior to initiation of PPI treatment and periodically.
Gastrointestinal Infections: Decreased gastric acidity due to any means, including proton pump inhibitors. Increase gastric counts of bacteria normally present in the gastrointestinal tract. Treatment with proton pump inhibitors may lead to slightly increased risk of gastrointestinal infections such as Salmonella and Campylobacter and possibly Clostridium difficile.
Clostridium difficile-associated diarrhoea: Published observational studies suggest that proton pump inhibitor (PPI) therapy like Zenpro may be associated with an increased risk of Clostridium difficile-associated diarrhoea (CDAD), especially in hospitalised patients. This diagnosis should be considered for diarrhoea that does not improve (see Adverse Reactions). Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated. CDAD has been reported with use of nearly all antibacterial agents. For more information specific to antibacterial agents (clarithromycin and amoxicillin) indicated for use in combination with Zenpro, refer to Precautions of package inserts.
Bone Fracture: Several published observational studies suggest that proton pump inhibitor (PPI) therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist or spine. The risk of fracture was increased in patients who received high-dose, defined as multiple daily doses, and long-term PPI therapy (a year or longer). Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated. Patients at risk for osteoporosis-related fractures should be managed according to established treatment guidelines (see Dosage & Administration and Adverse Reactions).
Use in Pregnancy and Lactation: As with most drugs, omeprazole should be used during pregnancy and lactation only if the potential benefit justifies the potential risk. It is not known whether omeprazole is excreted in human milk.
Use in Children: Safety and effectiveness in children have not been established.
As with most drugs, omeprazole should be used during pregnancy and lactation only if the potential benefit justifies the potential risk. It is not known whether omeprazole is excreted in human milk.
Omeprazole was generally well tolerated.
The adverse effects reported most frequently with omeprazole have been diarrhoea (especially Clostridium difficile
-associated diarrhoea) skin rashes, and headache; they have sometimes been severe enough to require discontinuation of treatment. Effects on the central nervous system, including reversible confusional states in severely ill patients, have occured. Other side effects reported include pruritus, dizziness, fatigue, constipation, nausea, vomiting, flatulence, abdominal pain, urticaria, dry mouth, arthralgia, muscular weakness and myalgia; blood disorders including leucopenia, thrombocytopenia, agranulocytosis and pancytopenia; intestinal nephritis; hepatotoxicity; visual disturbances; tinnitus and taste perversion; Clostridium difficile
-associated diarrhoea (CDAD); fractures.
Omeprazole can prolong the elimination of diazepam, warfarin and phenytoin, drugs that are metabolized by oxidation in the liver. Although in normal subjects no interaction with theophylline or propranolol was found, there have been clinical reports of interaction with other drugs metabolised via the cytochrome P-450 system (e.g., cyclosporine, disulfiram, benzodiazepine). Patients should be monitored to determine if it is necessary to adjust the dosage of these drugs when taken concomitantly with omeprazole.
Because of its profound and long lasting inhibition of gastric acid secretion, it is theoretically possible that omeprazole may interfere with absorption of drugs where gastric pH is an important determinant of their bioavailability (e.g., ketoconazole, ampicillin esters, and iron salts).
Avoid concomitant use of clopidogrel and omeprazole. Coadministration of clopidogrel with 80mg omeprazole, a proton pump inhibitor that is an inhibitor of CYP2C19, reduces the pharmacological activity of clopidogrel if given concomitantly or if given 12 hours apart.
Concomitant use of Proton Pump Inhibitor (PPIs) with Methotrexate: Literature suggests that concomitant use of PPIs with methotrexate (primarily at high doses; see methotrexate prescribing information) may elevate and prolong serum levels of methotrexate and/or its metabolite, possibly leading to methotrexate toxicities. A temporary withdrawal of the PPI may be considered in some patients receiving treatments with high dose methotrexate. Case reports, published population pharmacokinetic studies, and retrospective analyses suggest that concomitant administration of PPIs and methotrexate (primarily at high dose; see methotrexate prescribing information) may elevate and prolong serum levels of methotrexate and/or its metabolite hydroxymethotrexate. However, no formal drug interaction studies of methotrexate with PPIs have been conducted.
Store in a cool dry place below 25°C.
Keep all medicines out of reach of children.
A02BC01 - omeprazole ; Belongs to the class of proton pump inhibitors. Used in the treatment of peptic ulcer and gastro-oesophageal reflux disease (GERD).
Cap 20 mg (size 2, brown-light brown hard gelatin capsule, printed with "Zenpro 20") x 14's.