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Aciphex

"Dec. 20, 2010 -- New research suggests that one out of every 200 patients being treated with gastric acid-suppressive drugs for heartburn and other conditions may develop pneumonia.

Researchers led by Chun-Sick Eom, MD, MPH, from Seoul "...

Aciphex

Indications
Dosage
How Supplied

INDICATIONS

Healing Of Erosive Or Ulcerative GERD In Adults

ACIPHEX is 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 ACIPHEX may be considered.

Maintenance Of Healing Of Erosive Or Ulcerative GERD In Adults

ACIPHEX is 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.

Treatment Of Symptomatic GERD In Adults

ACIPHEX is indicated for the treatment of daytime and nighttime heartburn and other symptoms associated with GERD in adults for up to 4 weeks.

Healing Of Duodenal Ulcers In Adults

ACIPHEX is indicated for short-term (up to four weeks) treatment in the healing and symptomatic relief of duodenal ulcers. Most patients heal within four weeks.

Helicobacter Pylori Eradication To Reduce The Risk Of Duodenal Ulcer Recurrence In Adults

ACIPHEX, in combination with amoxicillin and clarithromycin as a three drug regimen, is 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 [see Clinical Studies and Table 1].

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 [see CLINICAL PHARMACOLOGY and the clarithromycin package insert, CLINICAL PHARMACOLOGY].

Treatment Of Pathological Hypersecretory Conditions, Including Zollinger-Ellison Syndrome In Adults

ACIPHEX is indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome.

Short-term Treatment Of Symptomatic GERD In Adolescent Patients 12 Years Of Age And Older

ACIPHEX is indicated for the treatment of symptomatic GERD in adolescents 12 years of age and above for up to 8 weeks.

Treatment Of GERD In Pediatric Patients 1 To 11 Years Of Age

ACIPHEX is indicated for treatment of GERD in children 1 to 11 years of age for up to 12 weeks.

DOSAGE AND ADMINISTRATION

Healing Of Erosive Or Ulcerative GERD In Adults

The recommended adult oral dose is one ACIPHEX 20 mg Delayed-Release tablet to be taken once daily for four to eight weeks [see INDICATIONS AND USAGE]. For those patients who have not healed after 8 weeks of treatment, an additional 8-week course of ACIPHEX may be considered.

Maintenance Of Healing Of Erosive Or Ulcerative GERD In Adults

The recommended adult oral dose is one ACIPHEX 20 mg Delayed-Release tablet to be taken once daily. Controlled studies do not extend beyond 12 months [see INDICATIONS AND USAGE].

Treatment Of Symptomatic GERD In Adults

The recommended adult oral dose is one ACIPHEX 20 mg Delayed-Release tablet to be taken once daily for 4 weeks [see INDICATIONS AND USAGE]. If symptoms do not resolve completely after 4 weeks, an additional course of treatment may be considered.

Healing Of Duodenal Ulcers In Adults

The recommended adult oral dose is one ACIPHEX 20 mg Delayed-Release tablet to be taken once daily after the morning meal for a period up to four weeks [see INDICATIONS AND USAGE]. Most patients with duodenal ulcer heal within four weeks. A few patients may require additional therapy to achieve healing.

Helicobacter Pylori Eradication To Reduce The Risk Of Duodenal Ulcer Recurrence In Adults

TABLE 1 : THREE DRUG REGIMENa

ACIPHEX Delayed-Release Tablet 20 mg Twice Daily for 7 Days
Amoxicillin 1000 mg Twice Daily for 7 Days
Clarithromycin 500 mg Twice Daily for 7 Days
All three medications should be taken twice daily with the morning and evening meals.
aIt is important that patients comply with the full 7-day regimen [see Clinical Studies].

Treatment Of Pathological Hypersecretory Conditions, Including Zollinger-Ellison Syndrome In Adults

The dosage of ACIPHEX in patients with pathologic hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Some patients may require divided doses. Doses up to 100 mg QD and 60 mg BID have been administered. Some patients with Zollinger-Ellison syndrome have been treated continuously with ACIPHEX for up to one year.

Short-term Treatment Of Symptomatic GERD In Adolescent Patients 12 Years Of Age And Older

The recommended oral dose for adolescents 12 years of age and older is one 20 mg Delayed-Release Tablet once daily for up to 8 weeks [see Use in Specific Populations and Clinical Studies].

Treatment Of GERD In Pediatric Patients 1 To 11 Years Of Age

The recommended dosage of ACIPHEX Sprinkle for pediatric patients 1 to 11 years of age by body weight is:

  • Less than 15 kg: 5 mg once daily for up to 12 weeks with the option to increase to 10 mg if inadequate response [see Clinical Studies].
  • 15 kg or more: 10 mg once daily for up to 12 weeks [see Clinical Studies].

Elderly, Renal, And Hepatic Impaired Patients

No dosage adjustment is necessary in elderly patients, in patients with renal disease, or in patients with mild to moderate hepatic impairment. Administration of rabeprazole to patients with mild to moderate liver impairment resulted in increased exposure and decreased elimination. Due to the lack of clinical data on rabeprazole in patients with severe hepatic impairment, caution should be exercised in those patients.

Administration Recommendations

TABLE 2 : ADMINISTRATION RECOMMENDATIONS

Formulation Population Instructions
Delayed- Release Tablet Adults and adolescents 12 years of age and older Swallow tablets whole. Do not chew, crush, or split tablets. Tablets can be taken with or without food.
Delayed- Release Capsule Pediatric patients 1 to 11 years of age The dose should be taken 30 minutes before a meal. The granules should not be chewed or crushed. Open capsule and sprinkle entire contents on a small amount of soft food (e.g., applesauce, fruit, or vegetable based baby food, or yogurt) or empty contents into a small amount of liquid (e.g., infant formula, apple juice, or pediatric electrolyte solution). The whole dose should be taken within 15 minutes of preparation. Food or liquid should be at or below room temperature. Do not store mixture for future use.

HOW SUPPLIED

Dosage Forms And Strengths

ACIPHEX Delayed-Release Tablets are provided in strength of 20 mg.

ACIPHEX Sprinkle Delayed-Release Capsules are provided in strengths of 5 and 10 mg. The 5 mg strength is a transparent blue and opaque white No. 2 capsule. The cap of the capsule is imprinted with “↑” and the body is imprinted with “ACX 5mg”. The 10 mg strength is a transparent yellow and opaque white No. 2 capsule. The cap of the capsule is imprinted with “↑” and the body is imprinted with “ACX 10mg”.

Storage And Handling

ACIPHEX 20 mg is supplied as delayed-release light yellow enteric-coated tablets. The name and strength, in mg, (ACIPHEX 20) is imprinted on one side.

Bottles of 30 (NDC 62856-243-30)
Bottles of 90 (NDC 62856-243-90)
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) [see USP Controlled Room Temperature]. Protect from moisture.

ACIPHEX Sprinkle (5 mg) is supplied as transparent blue and opaque white capsules containing enteric coated granules. Identification and strength (ACX 5mg) are imprinted on the body of the capsule. An arrow (↑) imprint on the capsule cap indicates direction for opening a capsule.

Bottles of 30 (NDC 13551-205-01)

ACIPHEX Sprinkle (10 mg) is supplied as transparent yellow and opaque white capsules containing enteric coated granules. Identification and strength (ACX 10mg) are imprinted on the body of the capsule. An arrow (↑) imprint on the capsule cap indicates direction for opening a capsule.

Bottles of 30 (NDC 13551-210-01)

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Protect from moisture.

Distributed by FSC Laboratories, Inc., Charlotte, NC 28210. Revised December 2014

Last reviewed on RxList: 1/9/2015
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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