Each vial contains: Omeprazole Sodium Lyophilized equivalent to 40 mg of Omeprazole.
Pharmacology: Omeprazole is an antisecretory agent, benzimidazole derivative, which suppresses gastric acid secretion by inhibition of the H+/K+ ATPase enzyme activity (proton pump) at the secretory surface of the gastric parietal cell at pH <4. Omeprazole which binds to proton (H+) will be changed rapidly to sulfenamide, an active proton-pump inhibitor.
Omeprazole is absorbed rapidly. 95% of Omeprazole is bound to plasma protein. Omeprazole is completely metabolized, especially in the liver. Approximately 80% of its metabolite is excreted through the urine and the remainder is excreted into the faeces.
ZOLACAP powder for injection is the drug of choice in cases when the aforementioned conditions cannot be treated with oral therapy: Duodenal ulcer, gastric ulcer, reflux esophagitis and Zollinger-Ellison syndrome.
Omeprazole intravenous is only used if oral treatment is not possible e.g., in debilitated patients. The usual dose is 40 mg once daily.
Zollinger-Ellison syndrome: The dosage should be adjusted according to individual response.
Dosage adjustment of ZOLACAP powder for injection is not required in patients with liver disease, renal dysfunction and in elderly patients.
There is no experience in the use of ZOLACAP powder for injection in children.
Administration: Dilute ZOLACAP powder for injection by 10 mL solvent (10 mL/ampoule). Do not use other infusions. The diluted solution should be given within 2.5 mins at a maximum rate of 4 mL/min.
Store reconstituted solution at temperature below 25°C, use within 4 hours.
Preparation: Note: Stages 1 to 5 should be done in immediate sequence.
1. With a syringe draw 10 mL of solvent from the ampoule.
2. Add approximately 5 mL of the solvent to the vial with the lyophilized powder.
3. Withdraw as much air as possible from the vial back into the syringe in order to reduce pressure. This will make it easier to add the remaining solvent.
4. Add the remaining solvent into the vial, make sure that the syringe is empty.
5. Rotate and shake the vial to ensure all the lyophilized powder has been dissolved.
There is no information available on the effects of overdosage in man and specific recommendations for treatment cannot be given.
Single oral doses of up to 160 mg and single i.v. doses of up to 80 mg have been well tolerated. I.V. doses of up to 200 mg on a single day and up to 520 mg over a 3-day period have been given without adverse reactions.
Patients with hypersensitivity to Omeprazole.
Prior to initiating treatment of gastric ulcer, any possibility of malignancy should first be excluded as Omeprazole therapy may mask the symptoms and delay diagnosis.
Omeprazole inhibits the metabolism of several drugs which are metabolized through the cytochrome P-450 enzyme system of the liver and may enhance the plasma concentration of diazepam, phenytoin and warfarin.
Patients with impaired hepatic function: Significant increase in bioavailability, reduction of total plasma clearance and prolonged half-life up to 4 times the normal values are observed in patients with impaired liver function. However, urinary recovery within 96 hours is still unchanged, indicating that there is no accumulation of Omeprazole or its metabolites.
There are no controlled or adequate studies of Omeprazole in pregnant women. Omeprazole is only to be given in these patients if the usage is considerably essential. Although Omeprazole is excreted in low concentration into the breastmilk of female rats, it is not known whether Omeprazole is excreted in human breastmilk. Therefore, the use of Omeprazole during nursing period is not recommended.
ZOLACAP powder for injection is commonly well tolerated. The following adverse reactions have been reported in patients who are receiving Omeprazole therapy in clinically controlled situations: Headache, diarrhea, abdominal pain, nausea, vomiting, upper respiratory tract infection, vertigo, rash, constipation, cough, asthenia, low back pain. Most adverse reactions are mild and temporary and do not have any consistent relationship with the treatment.
Omeprazole may prolong elimination of diazepam, warfarin and phenytoin.
Store dry powder below 30°C, away from light.
Store reconstituted solution below 30°C, use within 4 hours.
A02BC01 - omeprazole ; Belongs to the class of proton pump inhibitors. Used in the treatment of peptic ulcer and gastro-oesophageal reflux disease (GERD).
Zolacap DI powd for inj 40 mg
(+ 10 mL amp solvent) 1's (Rp124,550/boks)
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