Indications of Opal 40 mg/vial
Opal 40 mg/vial is indicated for the treatment of-
Duodenal and gastric ulcer.
Gastric and duodenal ulcers brought on by NSAIDs.
In individuals who have a history of duodenal and stomach ulcers brought on by NSAIDs, as a preventative treatment.
The disease of gastroesophageal reflux.
care of acid reflux illness throughout the long term.
dyspepsia brought on by acid.
severe reflux esophagitis with ulcers.
prevention of aspiration of acid while under general anesthesia.
syndrome of Zollinger-Ellison.
Peptic ulcer brought on by Helicobacter pylori.
Theropeutic Class
Proton Pump Blocker
Pharmacology
An inhibitor of stomach acid secretion is Opal 40 mg/vial, a benzimidazole replacement. By inhibiting the hydrogen-potassium-adenosine triphosphatase (H+/K+ ATPase) enzyme system in the gastric parietal cell, it prevents the release of gastric acid. Following oral administration, the antisecretory effect starts to take effect in about an hour, peaks in two hours, and the inhibition of secretion lasts up to 72 hours. Secretory activity gradually resumes when the medicine is stopped, over a period of 3 to 5 days.
Dosage of Opal 40 mg/vial
Oral-
Benign gastric and duodenal ulcer: 20 mg once daily for 4 weeks in duodenal ulceration, 8 weeks in gastric ulceration; in severe or recurrent cases, dose to be increased to 40 mg daily; maintenance dose for recurrent duodenal ulcer, 20 mg once daily; in prevention of relapse in duodenal ulcer, 10-20 mg daily.
NSAID-associated duodenal or gastric ulcer: 20 mg once daily for 4 weeks, continued for further 4 weeks, if not fully healed. 20 mg once daily is used as prophylaxis in patients with a history of NSAID-associated duodenal or gastric ulcers.
Gastro-esophageal reflux disease: 20 mg once daily for 4 weeks, continued for further 4-8 weeks, if not fully healed; 40 mg once daily has been given for 8 weeks in gastro-esophageal reflux disease, refractory to other treatment; maintenance dose is 20 mg once daily.
Long-term management of acid reflux disease: 10-20 mg daily.
Acid-related dyspepsia: 10-20 mg once daily for 2-4 weeks.
Prophylaxis of acid aspiration: 40 mg on the preceding evening, then 40 mg 2-6 hours before surgery.
Zollinger-Ellison syndrome: Initially 60 mg once daily; usual range 20-120 mg daily (If daily dose is more than 80 mg, 2 divided dose should be used).
Helicobacter pylori eradication regimen in peptic ulcer disease: Opal 40 mg/vial is recommended at a dose of 20 mg twice daily in association with antimicrobial agents as detailed below: Amoxicillin 500 mg and Metronidazole 400 mg both three times a day for one week, or Clarithromycin 250 mg and Metronidazole 400 mg both twice a day for one week, or Amoxicillin 1 g and Clarithromycin 500 mg both twice a day for one week.
Paeditaric use in severe ulcerating reflux esophagitis (Child>1 year): If body-weight 10-20 kg, 10-20 -mg once daily for 4-12 weeks; if body-weight over 20 kg, 20-40 mg once daily for 4-12 weeks.
IV Injection-
Prophylaxis of acid aspiration: Opal 40 mg/vial 40 mg to be given slowly (over a period of 5 minutes) as an intravenous injection, one hour before surgery.
Duodenal ulcer, gastric ulcer or reflux oesophagitis: In patients with duodenal ulcer, gastric ulcer or reflux oesophagitis where oral medication is inappropriate, Opal 40 mg/vial IV 40 mg once daily is recommended.
Zollinger- Ellison syndrome (ZES): In patients with Zollinger-Ellison Syndrome the recommended initial dose of Opal 40 mg/vial given intravenously is 60 mg daily. Higher daily doses may be required and the dose should be adjusted individually. When doses exceed 60 mg daily, the dose should be divided & given twice daily.
Administration of Opal 40 mg/vial
Direction for use of IV Injection: Opal 40 mg/vial lyophilized powder and water for injection should only be administered intravenously; it cannot be administered in any other way. Slow intravenous injections of Opal 40 mg/vial should be administered. By adding 10 ml of water for injection to the vial containing the powder, the solution for IV injection can be created. The injection should be administered slowly after reconstitution over a period of at least 2 to 5 minutes at a maximum flow rate of 4 ml/minute. Use just recently made solutions. After reconstitution, the solution must be used within four hours. Opal 40 mg/vial IV infusion should be administered as an intravenous infusion over a period of at least 20 to 30 minutes. One vial's contents need to be dissolved in 100 ml of either 5% dextrose or saline for infusion. When Opal 40 mg/vial is dissolved in saline, the solution must be used within 12 hours; when it is dissolved in 5% dextrose, it must be used within 6 hours. No other medication should be mixed or administered in the same infusion set as the reconstituted solution.
Interaction of Opal 40 mg/vial
Warfarin, phenytoin, and diazepam might all take longer to leave the body when taken with Opal 40 mg/vial. Due to this, when Opal 40 mg/vial is added to the treatment, a reduction in the dose of warfarin or phenytoin may be required. Theophylline, propranolol, or antacids have not been shown to interact with Opal 40 mg/vial.
Contraindications
Those who have a history of recognized hypersensitivity to any of the formulation's ingredients should not take Opal 40 mg/vial.
Side Effects of Opal 40 mg/vial
Most people tolerate Opal 40 mg/vial well. It has been reported that mild and temporary side effects such as nausea, stomach cramping, paresthesia, dizziness, and headache rarely require dosage adjustments.
Pregnancy & Lactation
Opal 40 mg/vial is within the C pregnancy category according to the US FDA. Three prospective epidemiological studies' findings, however, show that Opal 40 mg/vial has no negative impact on pregnancy or the health of the fetus or baby. Opal 40 mg/vial's entry into breast milk and its effects on the developing baby are not known. So, if Opal 40 mg/vial use is deemed necessary, breastfeeding should be stopped.
Precautions & Warnings
Before starting therapy with Opal 40 mg/vial for a suspected stomach ulcer, it is important to rule out the possibility of gastric cancer because the medication may make the symptoms worse and postpone a diagnosis.
Storage Conditions
Keep dry and away from heat and light. Keep out of children's reach.
Drug Classes
Proton Pump Blocker
Mode Of Action
A benzimidazole replacement called Opal 40 mg/vial inhibits the production of stomach acid. By inhibiting the hydrogen-potassium-adenosine triphosphatase (H+/K+ ATPase) enzyme system in the gastric parietal cell, it prevents the release of gastric acid. Upon oral administration, the antisecretory effect begins to take effect within an hour, reaches its peak within two hours, and the inhibition of secretion lasts up to 72 hours. After the medicine is stopped, secretory activity gradually resumes over a period of 3 to 5 days.
Pregnancy
Opal 40 mg/vial is within the C pregnancy category according to the US FDA. Three prospective epidemiological studies' findings, however, show that Opal 40 mg/vial has no negative impact on pregnancy or the health of the fetus or baby. Opal 40 mg/vial's entry into breast milk and its effects on the developing baby are not known. So, if Opal 40 mg/vial use is deemed necessary, breastfeeding should be stopped.