Dosage Forms And Strengths
PRILOSEC Delayed-Release Capsules, 10 mg, are opaque, hard gelatin, apricot and amethyst colored capsules, coded 606 on cap and PRILOSEC 10 on the body.
PRILOSEC Delayed-Release Capsules, 20 mg, are opaque, hard gelatin, amethyst colored capsules, coded 742 on cap and PRILOSEC 20 on the body.
PRILOSEC Delayed-Release Capsules, 40 mg, are opaque, hard gelatin, apricot and amethyst colored capsules, coded 743 on cap and PRILOSEC 40 on the body.
PRILOSEC For Delayed-Release Oral Suspension, 2.5 mg or 10 mg, is supplied as a unit dose packet containing a fine yellow powder, consisting of white to brownish Rocer granules and pale yellow inactive granules.
What is Rocer, and how does it work (mechanism of action)?
Rocer 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 esRocer (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. Rocer, 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 Rocer and an antacid (sodium bicarbonate). The FDA approved Rocer in September 1989.
Q: Does Prilosec cause weight gain and severe night sweats? I have been on it for almost 2 months.
A: According to the package insert, the most common side effects reported in patients treated with Prilosec (Rocer) were headache (6.9%), abdominal pain (5.2%), nausea (4.0%), diarrhea (3.7%), vomiting (3.2%), and gas (2.7%). Weight gain has been reported in clinical practice through voluntary reporting and surveillance systems. A review of medical literature found case reports of night sweats in patients with gastroesophageal reflux disease. The cause of the night sweats and effect of treatment is unknown. For more information, please consult with your health care provider and visit: //www.everydayhealth.com/drugs/prilosec. You are encouraged to report any negative side effects of prescription drugs to your health care practitioner and the U.S. Food and Drug Administration (FDA) by visiting www.fda.gov/medwatch, or by calling 1-800-FDA-1088. Michelle McDermott, PharmD
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 Rocer 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 Rocer 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
Q: What is the difference between Prilosec and Zantac?
A: Prilosec (Rocer) belongs to a class of medications called proton-pump inhibitors. Prilosec (Rocer), the prescription strength form, is usually prescribed to be used alone or with other medications to treat ulcers, gastroesophageal reflux disease (GERD), a condition in which backward flow of acid from the stomach causes heartburn and injury of the esophagus, and erosive esophagitis. Prilosec (Rocer) delayed-release capsules are also used to treat conditions in which the stomach produces too much acid. Also, Prilosec (Rocer) delayed-release capsules are used in combination with other medications to eliminate H. pylori, a bacterium that causes ulcers; and possibly prevent new ulcers from developing in people who have or have had ulcers of the small intestine. Prilosec OTC is available over-the-counter and is used to treat frequent heartburn (heartburn that occurs at least 2 days/ week). It works by lowering the release of acid made in the stomach. Zantac (ranitidine) belongs to a class of medications called H2 blockers. .Zantac (ranitidine) is usually prescribed for treating ulcers, gastroesophageal reflux disease (GERD), a condition in which backward flow of acid from the stomach causes heartburn and injury of the esophagus; and conditions where the stomach over produces acid, such as Zollinger-Ellison syndrome. Over-the-counter ranitidine is used to prevent and treat symptoms of heartburn associated with acid indigestion and sour stomach. It helps lower the amount of acid made in the stomach. Although Prilosec and Zantac belong to different groups of medications and their chemical compositions are different. The ultimate result is the same in lowering the amount of acid secretion in the stomach. Both medications are effective as long as they are taken as directed. Talk to your healthcare provider or pharmacist about your treatment options. Anissa Lee, RPh
Human gastric biopsy specimens have been obtained from more than 3000 patients (both children and adults) treated with Rocer in long-term clinical trials. The incidence of ECL cell hyperplasia in these studies increased with time; however, no case of ECL cell carcinoids, dysplasia, or neoplasia has been found in these patients. However, these studies are of insufficient duration and size to rule out the possible influence of long-term administration of Rocer on the development of any premalignant or malignant conditions.
Q: I have taken Prilosec for 14 days. How long will it take to restore my gastric acid?
A: According to the prescribing information for Prilosec (Rocer), once the drug is discontinued, gastric acid secretion returns gradually over three to five days. Prilosec is categorized as a proton pump inhibitor (PPI) and reduces the amount of stomach acid produced by the body. Prilosec is used to treat the symptoms of gastroesophageal reflux disease (GERD) and other medical conditions that result from too much stomach acid. Prilosec is also used to promote healing of erosive esophagitis and may be used in combination with antibiotics to treat gastric ulcers caused by a Helicobacter pylori (H. pylori) infection. The most commonly reported side effects associated with treatment with Prilosec include headache, abdominal pain, nausea, diarrhea and vomiting. In most cases, Rocer is taken approximately 30 to 60 minutes before a meal. Take Prilosec exactly as directed by your healthcare provider. For more specific information, consult with your doctor or pharmacist for guidance based on your health status and current medications, particularly before taking any action. Kristen Dore, PharmD
By Lynn Marks | Medically Reviewed by Robert Jasmer, MD
Latest Update: 2015-01-09 Copyright © 2014 Everyday Health Media, LLC
Serious side effects
Serious side effects are rare and happen in less than 1 in 1,000 people.
Call a doctor straight away if you have:
- joint pain along with a red skin rash, especially in parts of your body exposed to the sun, such as your arms, cheeks and nose - these can be signs of a rare condition called subacute cutaneous lupus erythematosus. This can happen even if you have been taking Rocer for a long time
- yellow skin, dark pee and tiredness - these can be signs of liver problems
Greek yogurt and cilantro
As a dairy product, yogurt is a natural source of glutamine. This substance helps naturally reduce stomach acids. And, it can serve as one of many Rocer alternatives.
Serious side effects
Call your doctor right away if you have serious side effects. Call 911 if your symptoms feel life-threatening or if you think you’re having a medical emergency. Serious side effects and their symptoms can include the following:
- Low magnesium levels. Using this drug for three months or longer can cause low magnesium levels. Symptoms can include:
- abnormal or fast heart rate
- muscle weakness
- spasms of your hands and feet
- cramps or muscle aches
- spasm of your voice box
- neuritis (inflammation of a nerve)
- numbness or tingling in your hands and feet
- poor muscular coordination
- changes in menstruation
Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs affect each person differently, we cannot guarantee that this information includes all possible side effects. This information is not a substitute for medical advice. Always discuss possible side effects with a healthcare provider who knows your medical history.
Rocer oral capsule can interact with other medications, vitamins, or herbs you may be taking. An interaction is when a substance changes the way a drug works. This can be harmful or prevent the drug from working well.
To help avoid interactions, your doctor should manage all of your medications carefully. Be sure to tell your doctor about all medications, vitamins, or herbs you’re taking. To find out how this drug might interact with something else you’re taking, talk to your doctor or pharmacist.
Examples of drugs that can cause interactions with Rocer are listed below.
Rocer oral capsule is a prescription drug that’s only available in a generic form. It doesn’t have a brand-name version. Rocer is also available as an oral suspension and comes as an over-the-counter (OTC) medication.
Prescription Rocer oral capsule is a delayed-release drug. A delayed-release drug slows the release of the medication until it passes through your stomach. This delay keeps the drug from being inactivated by your stomach.
After oral administration, the onset of the antisecretory effect of Rocer occurs within one hour, with the maximum effect occurring within two hours. Inhibition of secretion is about 50% of maximum at 24 hours and the duration of inhibition lasts up to 72 hours. The antisecretory effect thus lasts far longer than would be expected from the very short (less than one hour) plasma half-life, apparently due to prolonged binding to the parietal H + /K + ATPase enzyme. When the drug is discontinued, secretory activity returns gradually, over 3 to 5 days. The inhibitory effect of Rocer on acid secretion increases with repeated once-daily dosing, reaching a plateau after four days.
Results from numerous studies of the antisecretory effect of multiple doses of 20 mg and 40 mg of Rocer in normal volunteers and patients are shown below. The “max” value represents determinations at a time of maximum effect (2-6 hours after dosing), while “min” values are those 24 hours after the last dose of Rocer.
Table 1 : Range of Mean Values from Multiple Studies of the Mean Antisecretory Effects of Rocer After Multiple Daily Dosing
Single daily oral doses of Rocer ranging from a dose of 10 mg to 40 mg have produced 100% inhibition of 24-hour intragastric acidity in some patients.
Rocer, Rocer/sodium bicarbonate (Prilosec, Zegerid, Prilosec OTC, Zegerid OTC) is a proton pump inhibitor drug (PPI) prescribed for the treatment of ulcers, gastroesophageal reflux disease (GERD), Zollinger-Ellison syndrome, duodenitis, erosive esophagitis, heartburn, and H. pylori infection. Side effects, drug interactions, warnings and precautions, and patient information should always be reviewed prior to taking any medication.
Q: Since I am taking over-the-counter Prilosec or the generic Rocer, is it safe to take while pregnant if I have been prescribed it to treat my acid reflux?
A: If the doctor that prescribed it for you is aware that you are pregnant than it would be okay. The risks and benefits of the medication must be weighed and if your doctor feels that the benefits outweigh the risks, then it is ok. Prilosec is a pregnancy category C. This basically means that studies in animals showed adverse effects but no studies in humans have showed any effects. If you are still concerned, speak with your doctor and they can explain the reason they decided to use Prilosec during your pregnancy. Megan Uehara, PharmD
Concomitant Use Of PRILOSEC With St. John's Wort Or rifampin
Drugs which induce CYP2C19 or CYP3A4 (such as St. John's Wort or rifampin) can substantially decrease Rocer concentrations . Avoid concomitant use of PRILOSEC with St. John's Wort or rifampin.
Q: I have been taking Prilosec OTC for several years and have been told that I shouldn't. Is that so?
A: Prilosec (Rocer) is a proton pump inhibitor (PPI) used in the treatment of dyspepsia, peptic ulcer disease (PUD) and gastroesophageal reflux disease (GERD). With the widespread use of PPIs, the long-term safety issues need to be considered. The literature suggests an increased risk of infectious complications and nutritional deficiencies. Data on the risk of increased gastric and colon malignancy (cancer), despite a physiologic theoretic basis, are less convincing. As such, the long-term need for PPIs must be reassessed routinely. For more specific information, consult with your doctor or pharmacist for guidance based on your specific condition and current medications, particularly before taking any action. Shereen A. Gharbia, PharmD