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In most patients, treatment of hypomagnesemia required magnesium replacement and discontinuation of the PPI.For patients expected to be on prolonged treatment or who take PPIs with medications such as digoxin or drugs that may cause hypomagnesemia (e.g., diuretics), healthcare professionals may consider monitoring magnesium levels prior to initiation of PPI treatment and periodically Literature suggests that concomitant use of PPIs with methotrexate (primarily at high dose; 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.The data described below reflect exposure to Aciphex delayed-release tablets in 1064 adult patients exposed for up to 8 weeks. The percentages of patients with endoscopic healing are presented below:At Weeks 2 and 4, significantly more patients in the Aciphex 20 and 40 mg groups reported complete resolution of ulcer pain frequency (p≤0.018), daytime pain severity (p≤0.023), and nighttime pain severity (p≤0.035) compared with placebo patients. For those patients who have not healed after 8 weeks of treatment, an additional 8-week course of Aciphex may be considered.Aciphex 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). Available for Android and iOS devices.
Normalization of 24-hour intraesophageal acid exposure was correlated to gastric pH greater than 4 for at least 35% of the 24-hour period; this level was achieved in 90% of subjects receiving Aciphex 20 mg and in 100% of subjects receiving Aciphex 40 mg. With Aciphex 20 mg and 40 mg per day, significant effects on gastric and esophageal pH were noted after one day of treatment, and more pronounced after seven days of treatment.The median fasting gastrin level increased in a dose-related manner in patients treated once daily with Aciphex delayed-release tablets for up to eight weeks for ulcerative or erosive esophagitis and in patients treated for up to 52 weeks to prevent recurrence of disease.
Approximately 35% of these treated subjects developed serum gastrin concentrations above the upper limit of normal.Increased serum gastrin secondary to antisecretory agents stimulates proliferation of gastric ECL cells which, over time, may result in ECL cell hyperplasia in rats and mice and gastric carcinoids in rats, especially in females In over 400 patients treated with Aciphex delayed-release tablets (10 or 20 mg) once daily for up to one year, the incidence of ECL cell hyperplasia increased with time and dose, which is consistent with the pharmacological action of the proton-pump inhibitor. It may be used alone or along with stimulants .
The majority of patients presented with rash; however, arthralgia and cytopenia were also reported.Avoid administration of PPIs for longer than medically indicated.
There have been reports of increased INR and prothrombin time in patients receiving a proton pump inhibitor and warfarin concomitantly. In juvenile animal studies rabeprazole sodium was administered orally to rats for up to 5 weeks and to dogs for up to 13 weeks, each commencing on Day 7 post-partum and followed by a 13-week recovery period. Atomoxetine is an active ingredient most frequently used to treat attention-deficit hyperactivity syndrome (ADHD).
Significant reductions in daily antacid use were also noted in both Aciphex groups compared to placebo at Weeks 2 and 4 (p<0.001).An international randomized, double-blind, active-controlled trial was conducted in 205 patients comparing 20 mg Aciphex delayed-release tablets once daily with 20 mg omeprazole once daily. Unit Dose Blisters Package of 100 (10 x 10) (NDC 62856-243-41)Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) Advise the patient to read the FDA-approved patient labeling (Medication Guide).What is the most important information I should know about Aciphex?Aciphex may help your acid-related symptoms, but you could still have serious stomach problems.
Its demethylated-metabolite was also positive in the Ames test. However, the background risk in the U.S. general population of major birth defects is 2 to 4% and of miscarriage is 15 to 20% of clinically recognized pregnancies.
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