Zefxon

Omeprazole.

Combination carton consisting of one vial and one ampoule: Each vial contains: Omeprazole sodium 42.6 mg equivalent to Omeprazole 40 mg.
Each ampoule contains 10 ml of solvent for reconstitution.

ZEFXON INJECTION (omeprazole) is the proton/acid pump inhibitor which reduces gastric acid secretion by specific action; inhibition of the enzyme H⁺, K⁺-ATPase (The proton pump) in the parietal cell, the final step of acid secretion; thus inhibition acid secretion is occurred.
Pharmacokinetics: Onset of action: ~1 hour.
Duration: 72 hours.
Plasma protein binding: 95%.
Metabolism: by liver.
Excretion: as metabolites in urine, feces.

ZEFXON INJECTION is indicated for alternative use to oral medication in Duodenal ulcer; Gastric ulcer; Reflux oesophagitis; Zollinger-Ellison syndrome; Aspiration prophylaxis; Non-variceal upper Gl bleeding.

ZEFXON INJECTION 40 mg administration once daily is recommended where oral medication is inappropriate. This produces a mean decrease over 24 hours of approximately 90%. In patients with Zollinger-Ellison syndrome the recommended initial dosage of ZEFXON INJECTION is 60 mg once daily. Higher daily doses may be required and the dose should be divided and given twice daily. For aspiration prophylaxis, ZEFXON INJECTION 40 mg should be administered 1 hour before operation. For suspected non-variceal bleeding, bolus ZEFXON INJECTION 40 mg twice daily or ZEFXON INJECTION 80 mg stat followed by an infusion of 8 mg hourly for 72 hours should be administered.
For IV Injection: Dissolved ZEFXON INJECTION 1 vial with the solvent provided to get omeprazole concentration 4 mg/ml. After reconstitution the injection should be given slowly over a period of at least 5 minutes. The IV solution should be used within 4 hours after reconstitution. Do not use if any particles are present in the reconstituted solution and do not co-administered in the same injection area. Before and after administered should always rinse with normal saline or D5W.
For IV infusion: Dissolved ZEFXON INJECTION 1 vial with the solvent provided to get omeprazole concentration 4 mg/ml. Then diluted with normal saline for infusion (0.9% w/v sodium chloride) 40 ml or 5% dextrose for infusion (5% w/v of dextrose) 40 ml. After reconstitution, start the infusion immediately. The duration of IV infusion should be 10 - 30 minutes or continuous infusion 8 mg/hour.
Any unused portion should be discarded. Do not store in refrigerator and do not use if any particles are present in the reconstituted solution.
The constituted solution should not be mixed or co-administered in the same infusion set with any other drug.
The solution should be used within 12 hours when ZEFXON INJECTION is dissolved in normal saline and within 6 hours when dissolved in D5W.

Overdosage with omeprazole has been reported rarely. Doses ranged from 2,400 mg (120 times the usual recommended dose). Symptom were transient and included confusion, drowsiness, blurred vision, tachycardia, nausea, diaphoresis, flushing, headache and dry mouth. No serious clinical outcome has been reported.
No specific antidote for omeprazole overdosage is known.
Treatment: Omeprazole are extensively protein bound and are not readily dialyzable. Treatment should be symptomatic and supportive.

Known hypersensitivity to omeprazole.

When gastric ulcer is suspected, the possibility of malignancy should be excluded as treatment may alleviate symptoms and delay diagnosis.

Do not use this medicine in pregnancy and lactation. Unless its use is considered essential.

ZEFXON INJECTION (omeprazole) is generally well tolerated. Following events have occurred: headache, diarrhea, constipation, abdominal pain, nausea/vomiting and flatulence.
Rarely: Rash, urticaria and/or pruritus, dizziness, paraesthesia, somnolence, insomnia, vertigo, increased liver enzymes and malaise.
The following adverse effects occurred in 1% or more of patients: CNS: Asthenia, dizziness, headache.
GI: Abdominal pain, constipation, diarrhea, nausea, vomiting.
Miscellaneous: Back pain, cough, rash, upper respiratory tract infection.
The following adverse effects occurred in less than 1% of patients: Cardiovascular: Bradycardia, chest pain or angina, elevated blood pressure, palpitation, tachycardia.
CNS: Aggression, anxiety, apathy, confusion, depression, dream abnormalities, fatigue, hallucinations, hemifacial dysesthesia, insomnia, nervousness, paresthesia, somnolence, tremors, vertigo.
Dermatologic: Rash and rarely, cases of severe generalized skin reactions including toxic epidermal necrolysis (some fatal), Steven-Johnson syndrome and erythema multiforme (some severe), alopecia, angioedema, dry skin, hyperhidrosis, pruritus purpura and/or petechiae (some with rechallenge), skin inflammation, urticaria.
GI: Abdominal swelling, anorexia, dry mouth, esophageal candidiasis, local discoloration, flatulence, gastric fundic gland polyps (rare, reversible), irritable colon, mucosal atrophy of the tongue, pancreatitis (some fatal).
GU: Glycosuria, gynecomastia, hematuria interstitial nephritis (some with positive rechallenge), microscopic pyuria, proteinuria, testicular pain, urinary tract infection, urinary frequency.
Hematologic: Agranulocytosis (some fatal), anemia, hemolytic anemia, leukocytosis, neutropenia, pancytopenia (rare), thrombocytopenia.
Hepatic: Overt liver disease has occurred rarely, including hepatocellular, cholestatic, or mixed hepatitis, liver necrosis (some fatal), hepatic failure (some fatal), and hepatic encephalopathy.
Lab test abnormalities: Increased alkaline phosphatase, ALT, AST, bilirubin, elevated serum creatinine, γ-glutamyl transpeptidase.
Metabolic/Nutritional: Hyponatremia, hypoglycemia, peripheral edema, weight gain.
Musculoskeletal: Joint pain, leg pain, muscle cramps, muscle weakness, myalgia.
Respiratory: Epistaxis, pharyngeal pain.
Special senses: Anterior ischemia, optic neuropathy, blurred vision, double vision, dry eye syndrome, taste perversion, tinnitus, ocular irritation, optic atrophy, optic neuritis.
Miscellaneous: Allergic reactions, including, rarely anaphylaxis, fever, pain, malaise.

ZEFXON INJECTION (omeprazole) may interact with other drugs metabolized by mixed function oxidase. Reduced dose of these drugs; Diazepam, Warfarin and Phenytoin have been associated with concomitant use of omeprazole and should be carefully taken by these patients.
The absorption of ketoconazole will decrease during omeprazole treatment due to decreased intragastric acidity.
Plasma concentrations of omeprazole and clarithromycin are increased during concomitant administration.

Store at temperature not exceeding 30°C. Protect from light.

Antacids, Antireflux Agents & Antiulcerants

A02BC01 - omeprazole ; Belongs to the class of proton pump inhibitors. Used in the treatment of peptic ulcer and gastro-oesophageal reflux disease (GERD).

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