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Omag-DR®
Composition:
Omag-DR®: Each Delayed-release tablet contains Omeprazole Magnesium 20.6 mg equivalent
to 20 mg Omeprazole BP.
Pharmacology:
After acid activation in the parietal cells, Omeprazole binds irreversibly to the cell's H+/K+
ATPase pump, permanently disabling the acid secretary ability of that cell. This irreversible
action accounts for Omeprazole's powerful inhibitory effects on acid secretion and its long
duration of action despite a very short serum half-life (about 0.5-1 hour). Resumption of normal
gastric acid secretion involves regeneration of the proton pump, a process that occurs
progressively during a period of 3-5 days. While Omeprazole is effective on the first dose, the
maximum inhibition of gastric acid is seen after 3 or more days of dosing.
Indication and Use:
Treatment of frequent heartburn, defined as 2 or more days per week. Omag-DR® is also
indicated in the treatment of conditions where a reduction of gastric acid secretion is required,
such as: duodenal ulcer; gastric ulcer; NSAID-associated gastric and duodenal ulcers; reflux
esophagitis; symptomatic gastroesophageal reflux disease (GERD); dyspepsia; Zollinger-Ellison
syndrome (pathological hypersecretory condition); eradication of H. pylori. Omag-DR®, in
combination with Clarithromycin, Amoxicillin and Metronidazole, is indicated for the treatment
of patients with peptic ulcer disease associated with H. pylori infection.
Dosage and Administration:
Treatment of Frequent Heartburn (2 or more days per week):
Adults: One tablet taken once daily with a full glass of water 15-60 minutes before eating the
first meal of the day for 14 consecutive days. Patients should not continue therapy beyond 14
days unless directed to do so by a physician. The course of therapy can be repeated once every 4
months
Children: The safety and effectiveness of Omeprazole Magnesium tablets in children have not
been established.
Duodenal Ulcer:
The recommended adult oral dose is 20 mg once daily for 2 weeks. In patients not healed after
this initial course of therapy, an additional 2 weeks of treatment is recommended.
Gastric Ulcer or Reflux Esophagitis:
The recommended adult dose is 20 mg given once daily for 4 weeks. In patients not healed after
this initial course of therapy, an additional 4 weeks of treatment is recommended.
Symptomatic Gastroesophageal Reflux Disease:
The recommended adult dose is 20 mg given once daily. Symptom relief should be rapid. If
symptom control is not achieved after 4 weeks, further investigation is recommended.
NSAID-Associated Gastric or Duodenal Ulcers:
Acute Therapy: The recommended adult dose is 20 mg given once daily for 4 weeks. For those
patients not healed after this initial course of therapy, an additional 4 weeks of treatment is
recommended.
Maintenance Therapy: For the prevention of relapse in patients with NSAID-associated gastric
or duodenal ulcers, the recommended adult dose is 20 mg given once daily, for up to 6 months.
Dyspepsia:
If the dyspeptic symptoms are not of organic disease, the recommended daily dose of OmagDR® is 20 mg once daily for 2 to 4 weeks.
H. pylori Associated Peptic Ulcer Disease:
Omag-DR® twice daily, Amoxicillin (500 mg) thrice daily and Metronidazole (400 mg) thrice
daily for seven days. Or,
Omag-DR®, Amoxicillin (1000 mg) and Clarithromycin (500 mg) all twice daily for seven days.
Or,
Omag-DR®, Clarithromycin (500 mg) and Metronidazole (400 mg) all twice daily for seven
days.
*When used in combination with antibiotics, the Prescribing Information/Product Monograph for
those antibiotics should be consulted.
Zollinger-Ellison Syndrome:
The recommended initial dose is 60 mg, given once daily. More than 90% of the patients with
the severe form of the disease and inadequate response to other therapies have been adequately
controlled with doses of 20 to 120 mg Omeprazole daily. With doses greater than 80 mg, the
dose should be divided and given twice daily. Doses should be adjusted to the individual
patient's need and should continue as long as clinically indicated.
Contraindication:
Use of Omag-DR® is absolutely contraindicated only in patients who are hypersensitive to
Omeprazole.
Use In Pregnancy and Lactation:
Safety of Omeprazole during pregnancy is not proven. So, its use is not recommended unless the
potential benefits exceed the potential risks to the fetus. Safety of Omeprazole during breastfeeding is similarly unknown, and use should be evaluated based on potential risks and benefits.
Adverse Effects:
Diarrhoea, headache, nausea, abdominal pain and rash occur infrequently and are usually selflimiting.
Special Populations:
As the product has a short serum half-life (0.5-1 hour) and as it is prescribed once daily, no
dosage adjustment is needed in patients with decreased renal function. The daily dose in patients
with severe liver disease should not exceed 20 mg. No dosage adjustment is needed in geriatrics.
Warning:
Omag-DR® is not to be used if the patient has trouble or pain swallowing food, vomits with
blood or yields bloody or black stool. These may be signs of underlying serious conditions.
Drug Interactions:
Absorption of Ketoconazole, Itraconazole and Digoxin is reduced. Clearance of Benzodiazepines
is decreased. Serum concentration of Warfarin is increased. Hence, patients taking these drugs
should consult doctors before taking Omag-DR®.
Storage conditions:
Store Omag-DR® at 20-25ºC (68-77ºF), keep out of high heat & humidity and protect from
moisture. Keep it out of the reach of children.
Packaging Quantities:
Omag-DR®: Each box containing 10 X10 tablets in Alu-Alu blister pack.