What is the most important information I should know about Eraloc (AcipHex, AcipHex Sprinkle)?
Eraloc can cause kidney problems. Tell your doctor if you are urinating less than usual, or if you have blood in your urine.
Diarrhea may be a sign of a new infection. Call your doctor if you have diarrhea that is watery or has blood in it.
Eraloc may cause new or worsening symptoms of lupus. Tell your doctor if you have joint pain and a skin rash on your cheeks or arms that worsens in sunlight.
You may be more likely to have a broken bone while taking this medicine long term or more than once per day.
Interactions that increase your risk of side effects
Taking Eraloc with certain medications raises your risk of side effects from these drugs. Examples of these drugs include:
- HIV drugs such as saquinavir. Using these drugs with Eraloc can cause very high levels of these drugs in your body. This can result in increased side effects.
- Warfarin. Increased side effects can include a higher INR (blood test result). This could cause abnormal bleeding. Your doctor may monitor your INR more closely.
- Cyclosporine. Your doctor may monitor your cyclosporine blood levels.
- Methotrexate. You may have increased side effects due to high levels of methotrexate in your body. Your doctor may monitor the level of methotrexate in your blood.
- Digoxin. You may have increased side effects due to high levels of digoxin in your body. Your doctor may monitor the level of digoxin in your blood.
The data described below reflect exposure to ACIPHEX 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 ACIPHEX delayed-release tablets.
An analysis of adverse reactions appearing in ≥2% of patients treated with ACIPHEX 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 ACIPHEX 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 ACIPHEX delayed-release tablets, respectively, while 169 (23%) patients received placebo and 83 (11%) received omeprazole.
The safety profile of Eraloc 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 (
Eraloc (Aciphex) is a PPI prescribed for the treatment of GERD, H. pylori infections, Zollinger-Ellison Syndrome, and ulcers of the stomach and duodenum. Side effects, drug interactions, pregnancy safety, and warnings and precautions should be reviewed prior to taking any medication.
1. About Eraloc
Eraloc reduces the amount of acid your stomach makes.
Eraloc is also taken to prevent and treat stomach ulcers. Sometimes, Eraloc is taken for a rare illness caused by a tumour in the pancreas or gut called Zollinger-Ellison syndrome.
Eraloc is only available on prescription. It comes as tablets.
What is Eraloc, and how does it work (mechanism of action)?
Eraloc is an oral drug that is used for the treatment of conditions caused by acid. It is in a class of drugs called proton pump inhibitors or PPIs which block the production of acid by the stomach. Other drugs in the same class include:
PPIs are used for the treatment of acid-caused conditions such as stomach and duodenal ulcers, gastroesophageal reflux disease (GERD) and Zollinger-Ellison Syndrome. Eraloc, like other PPIs, blocks the pump in the wall of the stomach that secretes acid into the stomach. By blocking the pump, the secretion of acid into the stomach is decreased, and this allows ulcers in the stomach and esophagus to heal. The FDA approved Eraloc in August 1999.
The pharmacokinetics of Eraloc was studied in 12 adolescent patients with GERD 12 to 16 years of age, in a multicenter study. Patients received 20 mg ACIPHEX delayed-release tablets once daily for five or seven days. An approximate 40% increase in Eraloc exposure was noted following 5 to 7 days of dosing compared with the exposure after 1 day dosing. Pharmacokinetic parameters in adolescent patients with GERD 12 to 16 years of age were within the range observed in healthy adult subjects.