Aciphex Tablets

Aciphex is a medicine known as a proton pump inhibitor (PPI) that is used to treat and maintain healing of gastroesophageal reflux disease (GERD). It is also used to treat heartburn symptoms associated with GERD, duodenal ulcers (ulcers in the upper intestine), and for long-term treatment of conditions where your stomach makes too much acid, such as Zollinger-Ellison syndrome. It is also used with other medicines to eliminate the bacteria that often cause ulcers (known as Helicobacter pylori).

How does this medication work?

Aciphex is a delayed-release medicine (releases medicine into your body at a later time from when you take it). It works by reducing the acid in your stomach.

What are the beneficial effects of this medication and when should I begin to have results?

What:

GERD: By reducing stomach acid, Aciphex may help heal acid-related damage to the lining of your esophagus (the tube that connects your mouth and stomach) and relieve symptoms such as heartburn.

Duodenal Ulcers: Aciphex may help heal and reduce the frequency and severity of pain associated with duodenal ulcers, and can help reduce the amount of antacids you take.

H. pylori Infection: When used in combination with other medicines, Aciphex may cure this infection and reduce your risk of having another ulcer.

Conditions Causing Increased Stomach Acid Production: Aciphex may reduce the acid produced in the stomach, thereby relieving symptoms associated with this condition.

When:

GERD: Aciphex may start relieving your symptoms of heartburn and works throughout the day. Studies show that Aciphex can start healing damage in your esophagus, thereby reducing the frequency of heartburn after 4 weeks of therapy.

Duodenal Ulcers: Aciphex is shown to improve symptoms of daytime and nighttime pain by the end of the first week of therapy.

H. pylori Infection: When used in combination with other medicines in a 7- or 10-day treatment course, Aciphex has been shown to keep 75-85% of people infection-free for at least 6 weeks after completing therapy.

Conditions Causing Increased Stomach Acid Production: Everyone responds differently to treatment, so try to be patient and follow your healthcare provider's directions. It is important that you take Aciphex exactly as your healthcare provider has prescribed.

How do I know it is working?

You may start to notice a reduction in the severity or frequency of your heartburn. This is a good indicator that your medication is working. Your healthcare provider will ask you questions from time to time to assess how well your heartburn and/or pain is controlled and to check for improvement of your condition.

The following is not a full list of side effects. Side effects cannot be anticipated. If any develop or change in intensity, tell your healthcare provider as soon as possible. Only your healthcare provider can determine if it is safe for you to continue taking this medication.

Adults

More common side effects may include: sore throat, gas, pain, infection, constipation.

Adolescents

More common side effects may include: headache, diarrhea, nausea, vomiting, abdominal (stomach area) pain.

Less common side effects of Aciphex may include:

Diarrhea that does not go away and kidney problems.

Increased risk of fractures of the hip, wrist, or spine if you take multiple doses a day for long periods.

Low blood magnesium levels with symptoms such as seizures, irregular heartbeat, jerking movements or shaking, muscle weakness, spasms of your hands and feet, cramps or muscle aches, or spasm of your voice box.

Aciphex may also cause low vitamin B12 levels in the blood.

Do not take Aciphex if you are allergic to it or any of its ingredients.

Do not take Aciphex if you are taking certain medicines containing rilpivirine.

Tell your healthcare provider about all prescription, over-the-counter, and herbal medications you are taking before beginning treatment with Aciphex. Also, talk to your healthcare provider about your complete medical history, especially if you have low blood magnesium levels or liver problems.

The information below is based on the dosage guidelines your healthcare provider uses. Depending on your condition and medical history, your healthcare provider may prescribe a different regimen. Do not change the dosage or stop taking your medication without your healthcare provider's approval.

Treatment of GERD

Adults: The recommended dose is one 20-milligram (mg) tablet once a day for 4-8 weeks.

Maintain Healing of GERD

Adults: The recommended dose is one 20-mg tablet once a day.

Heartburn Symptoms Associated with GERD

Adults: The recommended dose is one 20-mg tablet once a day for up to 4 weeks.

Adolescents ≥12 years: The recommended dose is one 20-mg tablet once a day for up to 8 weeks.

Treatment of Duodenal Ulcers

Adults: The recommended dose is one 20-mg tablet once a day after the morning meal for up to 4 weeks.

Treatment of H. pylori Infection

Adults: This treatment involves taking 3 different medications. The usual dose for the triple therapy is: Aciphex 20 mg twice a day for 7 days, amoxicillin 1000 mg twice a day for 7 days, and clarithromycin 500 mg twice a day for 7 days.

Conditions Causing Increased Stomach Acid Production (Such as Zollinger-Ellison Syndrome)

Adults: The recommended dose is 60 mg once a day. Your healthcare provider might prescribe a different dose or duration based on your condition.

Your healthcare provider may consider an additional course of treatment for certain conditions. Always follow your healthcare provider's instructions.

Take Aciphex exactly as prescribed by your healthcare provider.

Take Aciphex with or without food. Swallow the tablets whole. Do not chew, crush, or split the tablets.

For the treatment of duodenal ulcers, take Aciphex after a meal. For the treatment of H. pylori, take Aciphex with food. For all other conditions, take Aciphex with or without food.

Do not change your dose or stop taking Aciphex without first talking to your healthcare provider.

If Aciphex is taken with certain other drugs, the effects of either could be increased, decreased, or altered. Aciphex may interact with numerous medications. Therefore, it is very important that you tell your healthcare provider about any other medications you are taking.

The effects of Aciphex during pregnancy and breastfeeding are unknown. Tell your healthcare provider immediately if you are pregnant, plan to become pregnant, or are breastfeeding.

If you miss a dose of Aciphex, take it as soon as you remember. However, if it is almost time for your next dose, skip the one you missed and return to your regular dosing schedule. Do not take two doses at once.

Store at room temperature. Protect from moisture.

In the event of a medical emergency call your doctor or 9-1-1 immediately. In the event of overdose, call your doctor or poison control for further instructions.
National Poison Control#: Call 1-800-222-1222

This PDR+ drug information has been developed by the Physicians’ Desk Reference Network (PDRN), a source of medication information trusted by doctors for over 65 years.

This monograph summarizes the most important information about your medication and does not cover all the information you may need. If you have any questions or concerns or want to learn more about your medication, ask your healthcare provider; he/she will be able to provide answers to your questions. This medication should only be used by the patient for whom it was prescribed and should not be shared with other people.

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