Proceptin

Proceptin

omeprazole

Manufacturer:

Beximco Pharma

Distributor:

Pharmatech Resources
Full Prescribing Info
Contents
Omeprazole.
Description
Each Proceptin capsule contains 20 mg of omeprazole.
Action
Pharmacology:Pharmacodynamics: Mechanism of Action: Omeprazole belongs to a new class of anti-secretory compounds, the substituted benzimidazoles, that suppress gastric acid secretion by specific inhibition of the H+/K+ ATPase enzyme system at the secretory surface of the gastric parietal cell. Because this enzyme system is regarded as the acid [proton] pump within the gastric mucosa, omeprazole has been characterized as a gastric acid pump inhibitor, in that it blocks the final step of acid production.
Indications/Uses
Proceptin has been found to produce faster symptom relief and higher healing rates in a greater percentage of patients than either cimetidine or ranitidine, confirming the 'therapeutic gains' achievable with Proceptin over existing therapies. Omeprazole offers significant therapeutic gains in the treatment of acid related diseases: healing rates are high in duodenal ulcer, gastric ulcer and erosive reflux oesophagitis; acid production is controlled effectively in Zollinger-Ellison Syndrome, and symptom relief is prompt and sustained in all indications. Less clear-cut indications where benefit might be expected but where data are limited include: Prevention of stress ulceration, prevention of the acid aspiration syndrome.
Dosage/Direction for Use
Proceptin should be taken before meals. Patients with severe liver disease should not require more than 20 mg omeprazole daily. Long term maintenance treatment with omeprazole is not recommended.
Contraindications
Omeprazole capsule is contraindicated in patients with known hypersensitivity to any component of the formulation.
Warnings
In long term [2 years] studies in rats, omeprazole produced a dose-related increase in gastric carcinoid tumours. While available endoscopic evaluations and histologic examinations of biopsy specimens from human stomach have not detected a risk from short-term exposure to omeprazole, further human data on the effects of sustained hypochlorhydria and hypergastinemia are needed to rule out the possibility of an increased risk for the development of tumours in humans receiving long term therapy with Omeprazole.
Clostridium difficile-associated diarrhea: Published observational studies suggest that proton pump inhibitor [PPI] therapy like Proceptin may be associated with an increased risk of Clostridium difficile-associated diarrhea [CDAD], especially in hospitalized patients. This diagnosis should be considered for diarrhea 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.
Bone Fracture: Several published observational studies suggest that 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).
Hypomagnesaemia: Hypomagnesaemia, 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 hypomagnesaemia 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 hypomagnesaemia [e.g., diuretics], health care professionals may consider monitoring magnesium levels prior to initiation of PPI treatment and periodically.
Concomitant use of Proceptin with Methotrexate: Literature suggests that concomitant use of PPIs with methotrexate [primarily at high dose] may elevate and prolong serum levels of methotrexate and/or its metabolite, possibly leading to methotrexate toxicities. In high-dose methotrexate administration a temporary withdrawal of PPI may be considered in some patients (see Interactions).
Special Precautions
Syptomatic response to therapy with omeprazole does not preclude the presence of gastric malignancy.
Paediatric Use: Safety and effectiveness in children have not been established.
Use In Pregnancy & Lactation
As with all new drugs, omeprazole should not be given during pregnancy and lactation unless its use is considered essential.
Adverse Reactions
Side effects reported with omeprazole in clinical studies have included nausea, diarrhoea, constipation, flatulence, abdominal colic, paresthesia, dizziness and headache but are rare. Skin rashes, leucopenia and transient elevation of plasma activation of hepatic aminotransferases have been observed occasionally in few patients and there has been no consistent relationship with treatment. Clostridium difficile-associated diarrhea [CDAD]; fractures.
Drug Interactions
Omeprazole can delay the elimination of diazepam, phenytoin and warfarin. Monitoring of patients receiving warfarin or phenytoin is recommended and a reduction of warfarin or phenytoin dose may be necessary when omeprazole is added to treatment. Omeprazole does not interfere with theophylline or propranolol metabolism.
Case reports, published population pharmacokinetic studies, and retrospective analyses suggest that concomitant administration of PPIs and methotrexate [primarily at high dose] 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 [see Warnings].
Caution For Usage
Information to patients: Patients should be cautioned that the Proceptin should not be opened, chewed or crushed and should be swallowed whole.
Incompatibilities: No data has been reported.
Storage
Store in a cool & dry place below 25°C, protected from light.
ATC Classification
A02BC01 - omeprazole ; Belongs to the class of proton pump inhibitors. Used in the treatment of peptic ulcer and gastro-oesophageal reflux disease (GERD).
Presentation/Packing
Cap 20 mg (enteric coated gastroresistant granules) x 3 x 10's.
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