Omexac-20/Omexac-40

Omexac-20/Omexac-40

omeprazole

Manufacturer:

D & G Pharma

Distributor:

D & G Pharma
Full Prescribing Info
Contents
Omeprazole or with sodium.
Description
Omexac-20: Each capsule contains: Omeprazole 20 mg.
Omeprazole belong to a class of antisecretory compounds, the substituted Benzimidazoles, that do not exhibit anticholinergic or H2 histamine antagonistic properties, but 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 is the "acid (proton) pump" within the gastric mucosa, Omeprazole has been characterized as a gastric acid pump inhibitor. It blocks the final step of acid production. The effect is dose related & inhibit both basal & stimulated acid secretion regardless of the stimulus.
Omexac-40: Each vial contains: Omeprazole sodium BP eq. to Omeprazole 40 mg.
Each ampoule contains: Sterile Water for Injection 10 mL.
Action
Pharmacology: Mechanism of Action: Omexac-20: Suppresses gastric acid secretion by inhibiting the parietal cell H+/K ATP pump.
Omexac-40: Omeprazole, a racemic mixture of two enantiomers reduces gastric acid secretion through a highly targeted mechanism of action. It is a specific inhibitor of the acid pump in the parietal cell. It is rapidly acting and provides control through reversible inhibition of gastric acid secretion with once daily dosing.
Omeprazole is a weak base and is concentrated and converted to the active form in the highly acidic environment of the intracellular canaliculi within the parietal cell, where it inhibits the enzyme H+,K+-ATPase - the acid pump. This effect on the final step of the gastric acid formation process is dose dependent and provides for highly effective inhibition of both basal acid secretion and stimulated acid secretion, irrespective of stimulus.
Pharmacokinetics: Omexac-20: Onset of anti-secretory action: Oral within 1 hour.
Peak effects: 2 hour.
Duration: 72 hour.
Protein binding: 95%.
Metabolism: Extensive in the liver.
Half-life: 0.5-1 hour.
Indications/Uses
Omexac-20: Short-term (4-8 weeks) treatment of severe erosive esophagitis (grade 2 or above), diagnosed by endoscopy and short-term treatment of symptomatic gastroesophageal reflux disease (GERD) poorly responsible to customary conditions; peptic ulcer disease; gastric ulcer therapy; maintenance of healing of erosive esophagitis; approved for combination use in the eradication of H. pylori in patients with active duodenal ulcer.
Omexac-40: Used in benign gastric and duodenal ulcers, Zollinger-Ellison syndrome, gastric acid reduction, gastroesophageal reflux disease, acid reflux disease, acid-related dyspepsia.
Dosage/Direction for Use
Omexac-20: Adults: Oral.
GERD or erosive esophagitis: 20 mg/day for 4-8 weeks.
Pathologically hypersecretory conditions: 60 mg once daily to start; doses up to 120 mg 3 times/day have been administered; administered daily doses >80 mg in divided doses.
Helicobacter pylori: combination therapy with bismuth subsalicylate, tetracycline, and clarithromycin; or with clarithromycin alone.
Adult dose: Oral: 20 mg twice daily.
Gastric ulcers: 40 mg/day for 4-8 weeks, or as prescribed by the physician.
Omexac-40: Alternative to oral therapy: In patients where the use of oral medicinal products is inappropriate, Omeprazole 40 mg IV once daily is recommended. In patients with Zollinger-Ellison syndrome the recommended initial dose of Omeprazole given intravenously is 60 mg daily. Higher daily doses may be required and the dose should be adjusted individually. When doses exceeds 60 mg daily, the dose should be divided and given twice daily. Omeprazole solution for injection must be given only as an intravenous injection and it must not be added to infusion solutions. After reconstitution the injection should be given slowly over a period of at least 2.5 minutes at a maximum rate of 4 mL per minute. Or as prescribed by the physician.
Special Population: Impaired renal function: Dose adjustment is not needed in patients with impaired renal function.
Impaired hepatic function: In patients with impaired hepatic function a daily dose of 10-20 mg may be sufficient.
Elderly (>65 years old): Dose adjustment is not needed in the elderly.
Pediatric patients: There is limited experience with Omeprazole for intravenous use in children.
Overdosage
Omexac-40: There is limited information available on the effects of overdoses of Omeprazole in humans. Nausea, vomiting, dizziness, abdominal pain, diarrhea and headache have been reported occasionally, and no serious outcome has been reported. Intravenous doses of up to 270 mg on a single day and up to 650 mg over a three-day period have been given in clinical trials without any dose-related adverse reactions.
Contraindications
Omexac-20: Known hypersensitivity to omeprazole.
Omexac-40: Hypersensitivity to Omeprazole, substituted benzimidazoles or to any of the excipients.
Omeprazole like other proton pump inhibitors (PPIs) should not be used concomitantly with nelfinavir.
Special Precautions
Omexac-20: In long-term (2-years) studies in rats, Omeprazole produced a dose-related increase in gastric carcinoid tumors. While available endoscopic evaluations and histologic examinations of biopsy specimens for human stomach have not detected a risk from short-term exposure to omeprazole, further human data on the effect of sustained hypochlorhydria and hypergastrinemia are needed to rule out the possibility of an increased risk for the development of tumors in humans receiving therapy. Bioavailability may be increased in the elderly.
Omexac-40: In the presence of any alarm symptoms (e.g., significant unintentional weight loss, recurrent vomiting, dysphagia, haematemesis or melena) and when gastric ulcer is suspected or present, malignancy should be excluded, as treatment may alleviate symptoms and delay diagnosis. Co-administration of atazanavir with proton pump inhibitors is not recommended. If the combination of atazanavir with a proton pump inhibitor is judged unavoidable, close clinical monitoring (e.g., virus load) is recommended in combination with an increase in the dose of atazanavir to 400 mg with 100 mg of ritonavir; Omeprazole 20 mg should not be exceeded. Omeprazole, as all acid-blocking medicines, may reduce the absorption of vitamin B12 (cyanocobalamin) due to hypo- or achlorhydria. This should be considered in patients with reduced body stores or risk factors for reduced vitamin B12 absorption on long term therapy.
Use In Pregnancy & Lactation
Omexac-40: Pregnancy: Results from three prospective epidemiological studies (more than 1000 exposed outcomes) indicate no adverse effects of Omeprazole on pregnancy or on the health of the fetus /newborn child. Omeprazole can be used during pregnancy.
Lactation: Omeprazole is excreted in breast milk but is not likely to influence the child when therapeutic doses are used.
Adverse Reactions
Omexac-20: The side effects reported most frequently with Omeprazole capsule have been diarrhoea, skin rashes, and headache; they have been sometimes been severe enough to require discontinuation of treatment. Effects on the central nervous system, including reversible states in severely ill patients, have occurred. Other adverse effects reported rarely include arthralgia and myalgia, blood disorder including leukopenia and thrombocytopenia, interstitial, nephritis, and hepatotoxicity.
Omexac-40: The most common side effects (1-10% of patients) are headache, abdominal pain, constipation, diarrhea, flatulence and nausea/vomiting. Irreversible visual impairment has been reported in isolated cases of critically ill patients who have received Omeprazole intravenous injection, especially at high doses, but no causal relationship has been established.
Drug Interactions
Omexac-40: Nelfinavir, atazanavir: The plasma levels of nelfinavir and atazanavir are decreased in case of co-administration with Omeprazole.
Digoxin: Concomitant treatment with Omeprazole (20 mg daily) and digoxin in healthy subjects increased the bioavailability of digoxin by 10%. Digoxin toxicity has been rarely reported.
Clopidogrel: Results from studies in healthy subjects have shown a pharmacokinetic (PK)/pharmacodynamic (PD) interaction between clopidogrel (300 mg loading dose/75 mg daily maintenance dose) and Omeprazole (80 mg p.o. daily) resulting in a decreased exposure to the active metabolite of clopidogrel by an average of 46% and a decreased maximum inhibition of (ADP induced) platelet aggregation by an average of 16%.
Other active substances: The absorption of Posaconazole, Erlotinib, Ketoconazole and Itraconazole is significantly reduced and thus clinical efficacy may be impaired. For Posaconazole and Erlotinib concomitant use should be avoided.
Storage
Store at temperatures not exceeding 30°C.
Directions for Reconstitution: Reconstitute with 10 mL of Sterile Water for Injection to provide a solution of 4 mg/mL of Omeprazole.
MIMS Class
Antacids, Antireflux Agents & Antiulcerants
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
Omexac-20: DR cap 20 mg x 100's. Omexac-40: Powd for inj 40 mg (10 mL vial + 10 mL diluent) x 1's.
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