Microsoft word - emperole

EMPEROLE®
FORMULATION:
Equivalent to omeprazole Ph.Eur…….20mg DESCRIPTION:
EMPEROLE® (Omeprazole 20mg) reduces gastric secretion through a high selective mechanism of action. It produces specific dose dependent
inhibition of the enzyme H+, K+-ATPASE (the proton pump) in parietal cell. As this action inhibits the stage of gastric acid formation, there is
effective inhibition of both basal and stimulus acid secretion irrespective of the stimulus to acid formation. EMPEROLE® has no effect on
acetylcholine or histamine receptors and no clinically significant pharmacodynamic effects have been observed other than those explained by the
effect of EMPEROLE® on acid secretion. The onset of action is rapid and reversible control of gastric acid secretion is achieved with once daily
dosing. EMPEROLE® is rapidly absorbed from the intestine and peak plasma levels are obtained within 0.5-3 hours. Protein binding is
approximately 95%. The absolute bioavailability is about 30-40%.Although the half-life of EMPEROLE® is only 0.5-1hour, the body takes
around 24 hours to synthesize new proton pumps. Therefore the acid suppression lasts for more than 24 hours. The major route of elimination of
the drug is urinary tract.
INDICATIONS:
EMPEROLE® is indicated for the treatment of duodenal ulcer, Gastric ulcer, Reflux Esophagitis, Helicobacter Pylori associated with the use of
NSAIDs.
CONTRA-INDICTIONS:
In patients with a known hypersensitivity to the drug of any component of the formulation. PRECAUTIONS:
When gastric ulcer is suspected, the possibility of malignancy should be excluded as treatment may alleviate symptoms and delay diagnosis.
EMPEROLE® should not be given during pregnancy and lactation unless its use is unavoidable.
ADVERSE EFFECTS:
EMPEROLE® is very well tolerated. The following events may in some cases: headache, diarrhea, and skin rashes have been reported in few
patients. All these reactions are generally mild and transient and their relation to the treatment has not been established. Other adverse effects
reported rarely include arthralgia and myalgia, paraesthesia, aggression. Blurred vision, taste, disturbances, peripheral oedema hyponatraemia and
blood disorder including agranulocytosis and thrombocytopenia.
OVERDOSAGE:
Two cases of overdose have been reported. The major clinical features were drowsiness, headache and tachycardia. The patients were fully recovered without specific treatment. DOSAGE AND ADMINISRATION:
EMPEROLE® is given by mouth as capsules, which should be whole and not crush or chew.In patients with swallowing difficulties, the
contents of capsule may be mixed with a little fruit juice or yogurt and swallowed.
Peptic ulcer
The usual recommended dose is 20mg EMPEROLE® once daily in severe cases. In patients with Duodenal ulcer, symptom relief is rapid and
healing occurs within 2weeks in most cases. For those patient who patients who may not have the initial course, healing usually occurs during a
further weeks treatment period. A dose of 20mg is recommended for maintenance.
Gastric-Esophageal Reflux Disease
The usual dose for the treatment of gastro-esophageal reflux disease is 20 to 40 mg by mouth once daily for 4 to 12weeks; thereafter maintenance therapy can be continue with 20 mg once daily. In children, doses in the range of 0.7 to 1.4 mg per kg body weight daily, up to a maximum daily dose of 40mg for 4 to 12 weeks. Gastro-esophageal reflux a potential exacerbating factor for asthma, and acid suppressive therapy with EMPEROLE® can be used to reduce
asthma symptoms.
Helicobacter Pylori
For the eradication of H. pylori in peptic ulceration EMPEROLE® may be combined with antibacterial in triple therapy. Effective triple therapy
regimens include EMPEROLE® 40 mg once daily combined with: Amoxicillin 500mg and Metronidazole 400 mg (or tinidazole 500mg) both
three times daily; or with Amoxicillin 1g and clarithromycin 500 mg both twice daily. These regimens are given for 1 week.
Dyspepsia
For the acid related dyspepsia EMPEROLE® is given in usual of 20mg daily by mouth for 2 to 4 weeks.
Zollinger-Ellison Syndrome
The initial recommended dosage for patients with the Zollinger-Ellison syndrome is 60mg by mouth once daily, but doses up to 120mg three times daily have been administered. Doses above 80mg should be divided and given twice daily; treatment should be continued for as long as indicated. Acid Aspiration
EMPEROLE® is also used for the prophylaxis of acid aspiration, in a dose of 40mg the evening before surgery and a further 40mg on the day of
surgery, 2 to 6 hours before the procedure.
Ulcer associated with the use of NSAIDs
Doses of 20mg daily are used in the treatments ulceration associated with the use of NSAIDs, dose of 20mg daily may also be used for the prophylaxis in susceptible patients. INTERACTIONS:
EMPEROLE® inhibits the cytochrome P 450 system and alter the metabolism of some other drugs metabolism by these enzymes. It may
prolong the elimination of Diazepam, phenytoin and warfarin. The decreased gastric acidity caused by EMPEROLE® may effect the absorption
of other drugs given concomitantly.
STORAGE:
Keep all medicines out of reach of children. PRESENTATION
EMPEROLE® capsules are available in Alu/Alu blister packing of 14 capsules.
Manufactured by:
Raazee Therapeutics (pvt.) Ltd.
48 KM, Lahore-Kasur Road, Kasur-pakistan. ISO 9001 Certified Co.

Source: http://www.pharmaplus.com.ng/sites/default/files/leaflet/emperole.pdf