Concomitant Gastric Malignancy
Symptomatic response to therapy with Omig does not preclude the presence of gastric malignancy.
Omig 40 mg daily was given in combination with clarithromycin 500 mg every 8 hours to healthy adult male subjects. The steady state plasma concentrations of Omig were increased (Cmax , AUC0-24 , and T1/2 increases of 30%, 89% and 34% respectively) by the concomitant administration of clarithromycin. The observed increases in Omig plasma concentration were associated with the following pharmacological effects. The mean 24-hour gastric pH value was 5.2 when Omig was administered alone and 5.7 when co-administered with clarithromycin.
The plasma levels of clarithromycin and 14-hydroxy-clarithromycin were increased by the concomitant administration of Omig. For clarithromycin, the mean C max was 10% greater, the mean Cmin was 27% greater, and the mean AUC0-8 was 15% greater when clarithromycin was administered with Omig than when clarithromycin was administered alone. Similar results were seen for 14-hydroxy-clarithromycin, the mean Cmax was 45% greater, the mean C min was 57% greater, and the mean AUC0-8 was 45% greater. Clarithromycin concentrations in the gastric tissue and mucus were also increased by concomitant administration of Omig.
Table 2 : Clarithromycin Tissue Concentrations 2 hours after Dose 1
H. pylori Eradication in Patients with Duodenal Ulcer Disease
Triple Therapy (PRILOSEC/clarithromycin/amoxicillin)— Three U.S., randomized, double-blind clinical studies in patients with H. pylori infection and duodenal ulcer disease (n = 558) compared PRILOSEC plus clarithromycin plus amoxicillin with clarithromycin plus amoxicillin. Two studies (1 and 2) were conducted in patients with an active duodenal ulcer, and the other study (3) was conducted in patients with a history of a duodenal ulcer in the past 5 years but without an ulcer present at the time of enrollment. The dose regimen in the studies was PRILOSEC 20 mg twice daily plus clarithromycin 500 mg twice daily plus amoxicillin 1 g twice daily for 10 days; or clarithromycin 500 mg twice daily plus amoxicillin 1 g twice daily for 10 days. In studies 1 and 2, patients who took the Omig regimen also received an additional 18 days of PRILOSEC 20 mg once daily. Endpoints studied were eradication of H. pylori and duodenal ulcer healing (studies 1 and 2 only). H. pylori status was determined by CLOtest®, histology and culture in all three studies. For a given patient, H. pylori was considered eradicated if at least two of these tests were negative, and none was positive.
The combination of Omig plus clarithromycin plus amoxicillin was effective in eradicating H. pylori.
Table 5 : Per-Protocol and Intent-to-Treat H. pylori Eradication Rates % of Patients Cured PRILOSEC +clarithromycin +amoxicillin Clarithromycin +amoxicillin Per-Protocol † Intent-to-Treat‡ Per-Protocol † Intent-to-Treat‡ Study 1 *77 *69 43 37 (n = 64) (n = 80) (n = 67) (n = 84) Study 2 *78 *73 41 36 (n = 65) (n = 77) (n = 68) (n = 83) Study 3 *90 *83 33 32 (n = 69) (n = 84) (n = 93) (n = 99) † Patients were included in the analysis if they had confirmed duodenal ulcer disease (active ulcer, studies 1 and 2; history of ulcer within 5 years, study 3) and H. pylori infection at baseline defined as at least two of three positive endoscopic tests from CLOtest®, histology, and/or culture. Patients were included in the analysis if they completed the study. Additionally, if patients dropped out of the study due to an adverse event related to the study drug, they were included in the analysis as failures of therapy. The impact of eradication on ulcer recurrence has not been assessed in patients with a past history of ulcer. ‡Patients were included in the analysis if they had documented H. pylori infection at baseline and had confirmed duodenal ulcer disease. All dropouts were included as failures of therapy. *(p
On this page
- About Omig
- Key facts
- Who can and can't take Omig
- How and when to take it
- Side effects
- How to cope with side effects
- Pregnancy and breastfeeding
- Cautions with other medicines
- Common questions
How it works
Omig belongs to a class of drugs called proton pump inhibitors (PPIs). A class of drugs is a group of medications that work in a similar way. These drugs are often used to treat similar conditions.
Omig works by decreasing the amount of acid your stomach produces. It does this by blocking a system in the cells of your stomach called the proton pump. The proton pump works in the final step of acid production. When the proton pump is blocked, your stomach makes less acid. This can help decrease your symptoms.
Omig oral capsule doesn’t cause drowsiness. However, it can cause other side effects.
How to use Omig
If your doctor has prescribed this medication for you, read the Patient Information Leaflet if available from your pharmacist before you start taking Omig and each time you get a refill. If you are taking the over-the-counter product to self-treat, read and follow all directions on the product package before taking this medication.
Take this medication by mouth as directed, usually once daily before a meal. The dosage and length of treatment are based on your medical condition and response to treatment. In children, the dosage is also based on weight. Do not increase your dose or take this drug more often than directed. If you have any questions, ask your doctor or pharmacist.
Do not crush, break, or chew delayed release tablets. Doing so can release all of the drug at once, increasing the risk of side effects.
If you are using the disintegrating delayed release tablets, use dry hands to handle the tablets. Place the tablet on your tongue and let it dissolve. After the tablet has dissolved, it can be swallowed with or without water. The tablets can also be swallowed whole with water.
If needed, antacids may be taken along with this medication. If you are also taking sucralfate, take Omig at least 30 minutes before sucralfate.
Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day. Continue to take this medication for the prescribed length of treatment even if you are feeling better. If you are self-treating with the over-the-counter product, do not take it for more than 14 days unless directed by your doctor.
Tell your doctor if your condition lasts or gets worse. If you are self-treating, tell your doctor if your heartburn lasts after 14 days or if you need to use this medication more than once every 4 months. The risk of side effects goes up over time. Ask your doctor how long you should take this medication. If you think you may have a serious medical problem, get medical help right away.
You just feel crappy all the time.
Using proton-pump inhibitors, especially long term, can put you at a higher risk for vitamin B12 deficiency, a serious bacterial infection called clostridium difficile, bone fractures, and possibly kidney disease, Ravella says. These are very rare side effects, but you want to know the scary stuff too, right? "Because of these safety concerns, I try to keep patients on Omig for the least amount of time needed," she says.
What is Omig, and how does it work (mechanism of action)?
Omig is in a class of drugs called proton pump inhibitors (PPI) that block the production of acid by the stomach. Other drugs in the class include lansoprazole (Prevacid), rabeprazole (Aciphex), pantoprazole (Protonix), and esOmig (Nexium). Proton pump inhibitors are used for the treatment of conditions such as ulcers, gastroesophageal reflux disease (GERD) and the Zollinger-Ellison syndrome, which are all caused by stomach acid. Omig, like other proton-pump inhibitors, blocks the enzyme in the wall of the stomach that produces acid. By blocking the enzyme, the production of acid is decreased, and this allows the stomach and esophagus to heal. Zegerid contains Omig and an antacid (sodium bicarbonate). The FDA approved Omig in September 1989.
Interaction With Clopidogrel
Avoid concomitant use of PRILOSEC with clopidogrel. Clopidogrel is a prodrug. Inhibition of platelet aggregation by clopidogrel is entirely due to an active metabolite. The metabolism of clopidogrel to its active metabolite can be impaired by use with concomitant medications, such as Omig, that inhibit CYP2C19 activity. Concomitant use of clopidogrel with 80 mg Omig reduces the pharmacological activity of clopidogrel, even when administered 12 hours apart. When using PRILOSEC, consider alternative anti-platelet therapy .
Four published epidemiological studies compared the frequency of congenital abnormalities among infants born to women who used Omig during pregnancy with the frequency of abnormalities among infants of women exposed to H2-receptor antagonists or other controls.
A population-based retrospective cohort epidemiological study from the Swedish Medical Birth Registry, covering approximately 99% of pregnancies, from 1995-99, reported on 955 infants (824 exposed during the first trimester with 39 of these exposed beyond first trimester, and 131 exposed after the first trimester) whose mothers used Omig during pregnancy. The number of infants exposed in utero to Omig that had any malformation, low birth weight, low Apgar score, or hospitalization was similar to the number observed in this population. The number of infants born with ventricular septal defects and the number of stillborn infants was slightly higher in the Omig-exposed infants than the expected number in this population.
A population-based retrospective cohort study covering all live births in Denmark from 1996-2009, reported on 1,800 live births whose mothers used Omig during the first trimester of pregnancy and 837, 317 live births whose mothers did not use any proton pump inhibitor. The overall rate of birth defects in infants born to mothers with first trimester exposure to Omig was 2.9% and 2.6% in infants born to mothers not exposed to any proton pump inhibitor during the first trimester.
A retrospective cohort study reported on 689 pregnant women exposed to either H2-blockers or Omig in the first trimester (134 exposed to Omig) and 1,572 pregnant women unexposed to either during the first trimester. The overall malformation rate in offspring born to mothers with first trimester exposure to Omig, an H2-blocker, or were unexposed was 3.6%, 5.5%, and 4.1% respectively.
A small prospective observational cohort study followed 113 women exposed to Omig during pregnancy (89% first trimester exposures). The reported rate of major congenital malformations was 4% in the Omig group, 2% in controls exposed to non-teratogens, and 2.8% in disease-paired controls. Rates of spontaneous and elective abortions, preterm deliveries, gestational age at delivery, and mean birth weight were similar among the groups.
Several studies have reported no apparent adverse short-term effects on the infant when single dose oral or intravenous Omig was administered to over 200 pregnant women as premedication for cesarean section under general anesthesia.