Product Details

CONTRAINDICATIONS
– Omeprazole is contraindicated in patients with known hypersensitivity to
any component of the formulation.
– Sodium bicarbonate is contraindicated in patients with metabolic alkalosis
and hypocalcemia.
PRECAUTIONS
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.
– Omeprazole powder for oral suspension contains sodium in the form of
sodium bicarbonate. This should be taken into consideration for patients
on a sodium-restricted diet.
– Sodium bicarbonate should be used with caution in patients with Bartter’s
syndrome, hypokalemia, respiratory alkalosis, and problems with acidbase balance. Long- term administration of bicarbonate with calcium or
milk can cause milk-alkali syndrome.

Pregnancy:
There are no adequate and well controlled studies on the use of omeprazole
in pregnant women. Omeprazole should be used during pregnancy only if
the potential benefit to pregnant women justifies the potential risk to the fetus.
Nursing Mothers:
Omeprazole is excreted in human milk. Because of the potential for serious
adverse reactions in nursing infants from omeprazole; a decision should be
made whether, to discontinue nursing or to discontinue the drug, taking into
account the importance of the drug to the mother. In addition, sodium
bicarbonate should be used with caution in nursing mothers.
Drug Interactions
– Omeprazole can prolong the elimination of diazepam, warfarin and
phenytoin, drugs that are metabolized by oxidation in the liver. There
have been reports of increased INR and prothrombin time in patients
receiving proton pump inhibitors, including omeprazole, and warfarin
concomitantly. Increases in INR and prothrombin time may lead to abnormal
bleeding and even death. Patients treated with proton pump inhibitors
and warfarin may need to be monitored for increases in INR and
prothrombin time. Although in normal subjects no interaction with
theophylline or propranolol was found, there have been clinical reports
of interaction with other drugs metabolized via the cytochrome P-450
system (e.g., cyclosporine, disulfiram, benzodiazepines). 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).
– Concomitant administration of omeprazole and atazanavir has been
reported to reduce the plasma levels of atazanavir.
– Concomitant administration of omeprazole and tacrolimus may increase
the serum levels of tacrolimus.
– Co-administration of omeprazole and clarithromycin have resulted in
increases of plasma levels of omeprazole, clarithromycin, and 14-hydroxyclarithromycin.
OVERDOSAGE
In doses ranged up to 2400mg, manifestations were variable, but included
confusion, drowsiness, blurred vision, tachycardia, nausea, vomiting,
diaphoresis, flushing, headache, dry mouth, and other adverse reactions
similar to those seen in normal clinical experience. No specific antidote for
omeprazole overdosage is known. Omeprazole is extensively protein bound
and is, therefore, not readily dialyzable. In the event of overdosage, treatment
should be symptomatic and supportive. In addition, a sodium bicarbonate
overdose may cause hypocalcemia, hypokalemia, hypernatremia, and seizures.
STORAGE
Store below 30°C.
The expiration date refers to the product correctly stored at the required
conditions.