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What is the most important information I should know about Rbx?
Patients with known hypersensitivity to Rbx, substituted benzimidazoles or to any excipients used in Rbx.
Use in pregnancy: There are no data on the safety of Rbx in human pregnancy.
Reproduction studies performed in rats and rabbits have revealed no evidence of impaired fertility or harm to the fetus due to Rbx, although low feto-placental transfer occurs in rats. Rbx is contraindicated during pregnancy.
Use in lactation: It is not known whether Rbx is excreted in human breast milk. No studies in lactating women have been performed. Rbx is, however, excreted in rat mammary secretions. Therefore, Rbx should not be used during breastfeeding.
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What are the possible side effects of Rbx?
The following serious adverse reactions are described below and elsewhere in labeling:
Because clinical trials are conducted under varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
AdultsThe data described below reflect exposure to Rbx delayed-release tablets in 1064 adult patients exposed for up to 8 weeks. The studies were primarily placebo-and active-controlled trials in adult patients with Erosive or Ulcerative Gastroesophageal Reflux Disease (GERD), Duodenal Ulcers and Gastric Ulcers. The population had a mean age of 53 years (range 18-89 years) and had a ratio of approximately 60% male: 40% female. The racial distribution was 86% Caucasian, 8% African American, 2% Asian, and 5% other. Most patients received either 10 mg, 20 mg or 40 mg per day of Rbx delayed-release tablets.
An analysis of adverse reactions appearing in ≥2% of patients treated with Rbx delayed-release tablets (n=1064) and with a greater frequency than placebo (n=89) in controlled North American and European acute treatment trials, revealed the following adverse reactions: pain (3% vs. 1%), pharyngitis (3% vs. 2%), flatulence (3% vs. 1%), infection (2% vs. 1%), and constipation (2% vs. 1%).
Three long-term maintenance studies consisted of a total of 740 adult patients; at least 54% of adult patients were exposed to Rbx delayed-release tablets for 6 months and at least 33% were exposed for 12 months. Of the 740 adult patients, 247 (33%) and 241 (33%) patients received 10 mg and 20 mg of Rbx delayed-release tablets, respectively, while 169 (23%) patients received placebo and 83 (11%) received omeprazole.
The safety profile of Rbx in the maintenance studies in adults was consistent with what was observed in the acute studies.
Less common adverse reactions seen in controlled clinical trials (<2% of patients treated with Rbx delayed-release tablets and greater than placebo) and for which there is a possibility of a causal relationship to Rbx, include the following: headache, abdominal pain, diarrhea, dry mouth, dizziness, peripheral edema, hepatic enzyme increase, hepatitis, hepatic encephalopathy, myalgia, and arthralgia.
Combination Treatment with Amoxicillin and ClarithromycinIn clinical trials using combination therapy with Rbx plus amoxicillin and clarithromycin (RAC), no adverse reactions unique to this drug combination were observed. In the U.S. multicenter study, the most frequently reported drug related adverse reactions for patients who received RAC therapy for 7 or 10 days were diarrhea (8% and 7%) and taste perversion (6% and 10%), respectively.
No clinically significant laboratory abnormalities particular to the drug combinations were observed.
For more information on adverse reactions or laboratory changes with amoxicillin or clarithromycin, refer to their respective prescribing information, Adverse Reactions section.
PediatricsIn a multicenter, open-label study of adolescent patients 12 to 16 years of age with a clinical diagnosis of symptomatic GERD or endoscopically proven GERD, the adverse event profile was similar to that of adults. The adverse reactions reported without regard to relationship to Rbx delayed-release tablets that occurred in ≥2% of 111 patients were headache (9.9%), diarrhea (4.5%), nausea (4.5%), vomiting (3.6%), and abdominal pain (3.6%). The related reported adverse reactions that occurred in ≥2% of patients were headache (5.4%) and nausea (1.8%). There were no adverse reactions reported in this study that were not previously observed in adults.
Postmarketing ExperienceThe following adverse reactions have been identified during post approval use of Rbx. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure: sudden death; coma; hyperammonemia; jaundice; rhabdomyolysis; disorientation and delirium; anaphylaxis; angioedema; systemic lupus erythematosus, bullous and other drug eruptions of the skin; severe dermatologic reactions, including toxic epidermal necrolysis (some fatal), Stevens-Johnson syndrome, cutaneous lupus erythematosus and erythema multiforme; interstitial pneumonia; interstitial nephritis; TSH elevations; bone fractures; hypomagnesemia and Clostridium difficile-associated diarrhea. In addition, agranulocytosis, hemolytic anemia, leukopenia, pancytopenia, and thrombocytopenia have been reported. Increases in prothrombin time/INR in patients treated with concomitant warfarin have been reported.
Rbx delayed-release tablets are indicated for short-term (4 to 8 weeks) treatment in the healing and symptomatic relief of erosive or ulcerative gastroesophageal reflux disease (GERD). For those patients who have not healed after 8 weeks of treatment, an additional 8-week course of Rbx may be considered.
1.2 Maintenance of Healing of Erosive or Ulcerative GERD in Adults
Rbx delayed-release tablets are indicated for maintaining healing and reduction in relapse rates of heartburn symptoms in patients with erosive or ulcerative gastroesophageal reflux disease (GERD Maintenance). Controlled studies do not extend beyond 12 months.
1.3 Treatment of Symptomatic GERD in Adults
Rbx delayed-release tablets are indicated for the treatment of daytime and nighttime heartburn and other symptoms associated with GERD in adults for up to 4 weeks.
1.4 Healing of Duodenal Ulcers in Adults
Rbx delayed-release tablets are indicated for short-term (up to four weeks) treatment in the healing and symptomatic relief of duodenal ulcers. Most patients heal within four weeks.
1.5 Helicobacter pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence in Adults
Rbx delayed-release tablets, in combination with amoxicillin and clarithromycin as a three drug regimen, are indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or history within the past 5 years) to eradicate H. pylori. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence.
In patients who fail therapy, susceptibility testing should be done. If resistance to clarithromycin is demonstrated or susceptibility testing is not possible, alternative antimicrobial therapy should be instituted.
1.6 Treatment of Pathological Hypersecretory Conditions, Including Zollinger-Ellison Syndrome in Adults
Rbx delayed-release tablets are indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome.
1.7 Treatment of Symptomatic GERD in Adolescent Patients 12 Years of Age and Older
Rbx delayed-release tablets are indicated for the treatment of symptomatic GERD in adolescents 12 years of age and above for up to 8 weeks.
Rbx is a proton pump inhibitor that decreases the amount of acid produced in the stomach.
Rbx is used to treat symptoms of gastroesophageal reflux disease (GERD) in adults and children who are at least 1 year old.
Rbx is used only in adults to treat conditions involving excessive stomach acid, such as Zollinger-Ellison syndrome. Rbx is also used to promote healing of erosive esophagitis (damage to your esophagus caused by stomach acid).
Rbx may also be given with an antibiotic to prevent gastric ulcer caused by infection with helicobacter pylori (H. pylori).
Rbx is not for immediate relief of heartburn symptoms.
Rbx may also be used for purposes not listed in this medication guide.
NIKP-Rbx enteric coated tablet 10 mg contains 10 mg of Rbx, equivalent to 9.42 mg Rbx.
NIKP-Rbx enteric coated tablet 20 mg contains 20 mg of Rbx, equivalent to 18.85 mg Rbx.
Excipients/Inactive Ingredients: D-mannitol, magnesium oxide, hydroxypropylcellulose, carmellose calcium, talc, magnesium stearate, hypromellose phthalate, glycerol esters of fatty acids, titanium oxide, yellow ferric oxide, carnauba wax, microcrystalline cellulose (for 10 mg), ethyl cellulose (for 20 mg).
Use Rbx delayed-release capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ask your health care provider any questions you may have about how to use Rbx delayed-release capsules.
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.Rbx is used to treat certain stomach and esophagus problems (such as acid reflux, ulcers). It works by decreasing the amount of acid your stomach makes. It relieves symptoms such as heartburn, difficulty swallowing, and persistent cough. This medication helps heal acid damage to the stomach and esophagus, helps prevent ulcers, and may help prevent cancer of the esophagus. Rbx belongs to a class of drugs known as proton pump inhibitors (PPIs).
How to use Rbx SprinkleRead the Medication Guide and the Patient Information Leaflet if available from your pharmacist before you start taking Rbx and each time you get a refill. If you have any questions, ask your doctor or pharmacist.
If you are using the tablets, take your dose by mouth with or without food as directed by your doctor, usually 1 to 2 times daily. Swallow the tablet whole with water. Do not crush, chew, or split the tablet. Doing so can release all of the drug at once, increasing the risk of side effects.
If you are using the capsules, take the dose 30 minutes before a meal as directed by your doctor, usually once daily. Do not swallow the capsule whole. Open the capsule and sprinkle the contents onto a small amount of soft food (such as applesauce or yogurt) or liquid. The food or liquid that you use should be at or below room temperature. Swallow the entire mixture within 15 minutes of preparing it. Do not chew or crush the prepared mixture.
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.
If needed, antacids may be taken along with this medication. If you are also taking sucralfate, take Rbx 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(s) each day. Continue to take this medication for the prescribed length of treatment even if you are feeling better.
Tell your doctor if your condition persists or worsens. The risk of side effects goes up over time. Ask your doctor how long you should take this medication.
Adults/Elderly: Duodenal Ulcer, Gastric Ulcer, Stomal Ulcer and Reflux Esophagitis: The usual adult dose is 10 mg of Rbx administered orally once daily. However, the dosage may be increased up to 20 mg orally once daily depending on the severity of symptoms. For the treatment of gastric ulcer, stomal ulcer and reflux esophagitis, the usual administration should be restricted up to 8 weeks, and for duodenal ulcer 6 weeks.
Gastro-Esophageal Reflux Disease Long-term Management (GERD Maintenance): For long-term management, a maintenance dose of NIKP-Rbx enteric coated tablet 10 mg or 20 mg once daily can be used depending upon patient response.
Symptomatic Treatment of Moderate to Very Severe Gastro-Esophageal Reflux Disease (Symptomatic GERD): 10 mg once daily in patients without esophagitis. If symptom control has not been achieved during four weeks, the patient should be further investigated. Once symptoms have resolved, subsequent symptom control can be achieved using an on-demand regimen taking 10 mg once daily when needed.
Zollinger-Ellison Syndrome: The dose varies with the individual patient. A starting dose of 60 mg daily and doses of up to 100 mg once daily, or 60 mg twice daily have been used. Some patients may require divided doses. Dosing should continue for as long as clinically necessary. Some patients with Zollinger-Ellison Syndrome have been treated continuously for up to one year.
Eradication of H. pylori: Patients with H. pylori infection should be treated with eradication therapy. The following combination given for 7 days is recommended: NIKP-Rbx enteric coated tablet 20 mg twice daily + clarithromycin 500 mg twice daily and amoxicillin 1 g twice daily.
Children: It is not recommended for use in children, as there is no experience of its use in this group.
Renal and Hepatic Impairment: No dosage adjustment is necessary for patients with renal or hepatic impairment.
See Precautions for use of NIKP-Rbx in the treatment of patients with hepatic impairment.
Administration: For indications requiring once daily treatment, NIKP-Rbx should be taken in the morning, before eating; and although neither the time of day nor food intake was shown to have any effect on Rbx activity, this regimen will facilitate treatment compliance.
Patients should be cautioned that the NIKP-Rbx should not be chewed or crushed, but should be swallowed whole.
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What other drugs will affect Rbx?
Rbx, as is the case with other members of the PPI class of compounds, is metabolized through the cytochrome P-450 (CYP450) hepatic drug metabolizing system. Studies in healthy subjects have shown that Rbx does not have clinically significant interactions with the drugs studied, including warfarin, phenytoin, theophylline or diazepam metabolized by the CYP450 system.
Rbx produces a profound and long-lasting inhibition of gastric acid secretion. An interaction with compounds whose absorption is pH-dependent may occur, therefore, the potential for such interaction was investigated. Co-administration of Rbx results in a 33% decrease in ketoconazole levels and a 22% increase in trough digoxin levels in normal subjects. Therefore, individual patients may need to be monitored to determine if a dosage adjustment is necessary when such drugs are taken concomitantly with Rbx. Rbx does not adversely influence plasma concentrations of amoxicillin or clarithromycin when co-administered for the purpose of eradicating upper gastrointestinal H. pylori infection.
In clinical trials, antacids were used concomitantly with the administration of Rbx and in a specific study designed to define this interaction, no interaction with liquid antacids was observed. There was no clinically relevant interaction with food.
Co-administration of atazanavir 300 mg/ritonavir 100 mg with omeprazole (40 mg once daily) or atazanavir 400 mg with lansoprazole (60 mg once daily) to healthy volunteers resulted in a substantial reduction in atazanavir exposure. The absorption of atazanavir is pH-dependent. Although co-administration with Rbx was not studied, similar results are expected with other PPIs. Therefore, PPIs including Rbx, should not be co-administered with atazanavir.
In vitro studies with human liver microsomes indicated that Rbx is metabolized by isoenzymes of CYP450 (CYP2C19 and CYP3A4). In these studies, at expected human plasma concentrations, Rbx neither induces nor inhibits CYP3A4; and although in vitro studies may not always be predictive of in vivo status, these findings indicate that no interaction is expected between Rbx and cyclosporin.
Incompatibilities: None.
