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Prevacid

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Prevacid

Indications
Dosage
How Supplied

INDICATIONS

Short-Term Treatment of Active Duodenal Ulcer

PREVACID is indicated for short-term treatment (for 4 weeks) for healing and symptom relief of active duodenal ulcer [see Clinical Studies].

H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence

Triple Therapy: PREVACID/amoxicillin/clarithromycin

PREVACID in combination with amoxicillin plus clarithromycin as triple therapy is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or one-year history of a duodenal ulcer) to eradicate H. pylori. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence [see Clinical Studies].

Please refer to the full prescribing information for amoxicillin and clarithromycin.

Dual Therapy: PREVACID/amoxicillin

PREVACID in combination with amoxicillin as dual therapy is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or one-year history of a duodenal ulcer) who are either allergic or intolerant to clarithromycin or in whom resistance to clarithromycin is known or suspected (see the clarithromycin package insert, MICROBIOLOGY section). Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence [see Clinical Studies].

Please refer to the full prescribing information for amoxicillin.

Maintenance of Healed Duodenal Ulcers

PREVACID is indicated to maintain healing of duodenal ulcers. Controlled studies do not extend beyond 12 months [see Clinical Studies].

Short-Term Treatment of Active Benign Gastric Ulcer

PREVACID is indicated for short-term treatment (up to 8 weeks) for healing and symptom relief of active benign gastric ulcer [see Clinical Studies].

Healing of NSAID-Associated Gastric Ulcer

PREVACID is indicated for the treatment of NSAID-associated gastric ulcer in patients who continue NSAID use. Controlled studies did not extend beyond 8 weeks [see Clinical Studies].

Risk Reduction of NSAID-Associated Gastric Ulcer

PREVACID is indicated for reducing the risk of NSAID-associated gastric ulcers in patients with a history of a documented gastric ulcer who require the use of an NSAID. Controlled studies did not extend beyond 12 weeks [see Clinical Studies].

Gastroesophageal Reflux Disease (GERD)

Short-Term Treatment of Symptomatic GERD

PREVACID is indicated for the treatment of heartburn and other symptoms associated with GERD [see Clinical Studies].

Short-Term Treatment of Erosive Esophagitis

PREVACID is indicated for short-term treatment (up to 8 weeks) for healing and symptom relief of all grades of erosive esophagitis. For patients who do not heal with PREVACID for 8 weeks (5 to 10%), it may be helpful to give an additional 8 weeks of treatment. If there is a recurrence of erosive esophagitis an additional 8-week course of PREVACID may be considered [see Clinical Studies].

Maintenance of Healing of Erosive Esophagitis (EE)

PREVACID is indicated to maintain healing of erosive esophagitis. Controlled studies did not extend beyond 12 months [see Clinical Studies].

Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome (ZES)

PREVACID is indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome [see Clinical Studies].

DOSAGE AND ADMINISTRATION

PREVACID is available as a capsule and an orally disintegrating tablet, and is available in 15 mg and 30 mg strengths. Directions for use specific to the route and available methods of administration for each of these dosage forms is presented below. PREVACID should be taken before eating. PREVACID products SHOULD NOT BE CRUSHED OR CHEWED. In the clinical trials, antacids were used concomitantly with PREVACID.

Recommended Dose

Indication Recommended Dose Frequency
Duodenal Ulcers
  Short-Term Treatment 15 mg Once daily for 4 weeks
  Maintenance of Healed 15 mg Once daily
H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence*
  Triple Therapy:
    PREVACID 30 mg Twice daily (q12h) for 10 or 14 days
    Amoxicillin 1 gram Twice daily (q12h) for 10 or 14 days
    Clarithromycin 500 mg Twice daily (q12h) for 10 or 14 days
  Dual Therapy:
    PREVACID 30 mg Three times daily (q8h) for 14 days
    Amoxicillin 1 gram Three times daily (q8h) for 14 days
Benign Gastric Ulcer
  Short-Term Treatment 30 mg Once daily for up to 8 weeks
NSAID-associated Gastric Ulcer
  Healing 30 mg Once daily for 8 weeks†
  Risk Reduction 15 mg Once daily for up to 12 weeks†
Gastroesophageal Reflux Disease (GERD)
  Short-Term Treatment of Symptomatic GERD 15 mg Once daily for up to 8 weeks
  Short-Term Treatment of Erosive Esophagitis 30 mg Once daily for up to 8 weeks*
Pediatric (1 to 11 years of age)
Short-Term Treatment of Symptomatic GERD and Short-Term Treatment of Erosive Esophagitis
   ≤ 30 kg 15 mg Once daily for up to 12 weeks§
   > 30 kg 30 mg Once daily for up to 12 weeks§
(12 to 17 years of age) Short-Term Treatment of Symptomatic GERD
  Nonerosive GERD 15 mg Once daily for up to 8 weeks
  Erosive Esophagitis 30 mg Once daily for up to 8 weeks
Maintenance of Healing of Erosive Esophagitis 15 mg Once daily
Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome 60 mg Once daily¶
*Please refer to amoxicillin and clarithromycin full prescribing information for CONTRAINDICATIONS and WARNINGS, and for information regarding dosing in elderly and renally-impaired patients.
†Controlled studies did not extend beyond indicated duration.
‡For patients who do not heal with PREVACID for 8 weeks (5 to 10%), it may be helpful to give an additional 8 weeks of treatment. If there is a recurrence of erosive esophagitis, an additional 8 week course of PREVACID may be considered.
§ The PREVACID dose was increased (up to 30 mg twice daily) in some pediatric patients after 2 or more weeks of treatment if they remained symptomatic. For pediatric patients unable to swallow an intact capsule please see Administration Options.
¶ Varies with individual patient. Recommended adult starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Dosages up to 90 mg twice daily have been administered. Daily dose of greater than 120 mg should be administered in divided doses. Some patients with Zollinger-Ellison Syndrome have been treated continuously with PREVACID for more than 4 years.

Patients should be instructed that if a dose is missed, it should be taken as soon as possible. However, if the next scheduled dose is due, the patient should not take the missed dose, and should be instructed to take the next dose on time. Patients should be instructed not to take 2 doses at one time to make up for a missed dose.

Special Populations

Renal impairment patients and geriatric patients do not require dosage adjustment. However, consider dose adjustment in patients with severe liver impairment [see Use in Specific Populations].

Important Administration Information

Administration Options

PREVACID Delayed-Release Capsules – Oral Administration

  • PREVACID Delayed-Release Capsules should be swallowed whole.
  • Alternatively, for patients who have difficulty swallowing capsules, PREVACID Delayed-Release Capsules can be opened and administered as follows:
    • Open capsule.
    • Sprinkle intact granules on one tablespoon of either applesauce, ENSURE pudding, cottage cheese, yogurt or strained pears.
    • Swallow immediately.
  • PREVACID Delayed-Release Capsules may also be emptied into a small volume of either apple juice, orange juice or tomato juice and administered as follows:
    • Open capsule.
    • Sprinkle intact granules into a small volume of either apple juice, orange juice or tomato juice (60 mL – approximately 2 ounces).
    • Mix briefly.
    • Swallow immediately.
    • To ensure complete delivery of the dose, the glass should be rinsed with two or more volumes of juice and the contents swallowed immediately.

PREVACID Delayed-Release Capsules – Nasogastric Tube ( ≥ 16 French) Administration

  • For patients who have a nasogastric tube in place, PREVACID Delayed-Release Capsules can be admin istered as follows:
    • Open capsule.
    • Mix intact granules into 40 mL of apple juice. DO NOT USE OTHER LIQUIDS.
    • Inject through the nasogastric tube into the stomach.
    • Flush with additional apple juice to clear the tube.

USE IN OTHER FOODS AND LIQUIDS HAS NOT BEEN STUDIED CLINICALLY AND IS THEREFORE NOT RECOMMENDED.

PREVACID SoluTab Delayed-Release Orally Disintegrating Tablets

  • PREVACID SoluTab should not be broken or cut.
  • PREVACID SoluTab should not be chewed.
    • Place the tablet on the tongue and allow it to disintegrate, with or without water, until the particles can be swallowed.
    • The tablet typically disintegrates in less than 1 minute.
    • Alternatively, for children or other patients who have difficulty swallowing tablets, PREVACID SoluTab can be delivered in two different ways.
      PREVACID SoluTab – Oral Syringe
      For administration via oral syringe, PREVACID SoluTab can be administered as follows:
    • Place a 15 mg tablet in oral syringe and draw up 4 mL of water, or place a 30 mg tablet in oral syringe and draw up 10 mL of water.
    • Shake gently to allow for a quick dispersal.
    • After the tablet has dispersed, administer the contents within 15 minutes.
    • Refill the syringe with approximately 2 mL (5 mL for the 30 mg tablet) of water, shake gently, and administer any remaining contents.
      PREVACID SoluTab – Nasogastric Tube ( ≥ 8 French) Administration
      For administration via a nasogastric tube, PREVACID SoluTab can be administered as follows:
    • Place a 15 mg tablet in a syringe and draw up 4 mL of water, or place a 30 mg tablet in a syringe and draw up 10 mL of water.
    • Shake gently to allow for a quick dispersal.
    • After the tablet has dispersed, inject through the nasogastric tube into the stomach within 15 minutes.
    • Refill the syringe with approximately 5 mL of water, shake gently, and flush the nasogastric tube.

HOW SUPPLIED

Dosage Forms And Strengths

  • 15 mg capsules are opaque, hard gelatin, colored pink and green with the TAP logo and “PREVACID 15” imprinted on the capsule.
  • 30 mg capsules are opaque, hard gelatin, colored pink and black with the TAP logo and “PREVACID 30” imprinted on the capsule.
  • 15 mg tablets are white to yellowish white, uncoated, colored orange to dark brown speckles with “15” debossed on one side of the tablet.
  • 30 mg tablets are white to yellowish white, uncoated, colored orange to dark brown speckles with “30” debossed on one side of the tablet.

Storage And Handling

PREVACID Delayed-Release Capsules, 15 mg, are opaque, hard gelatin, colored pink and green with “TAP” and “PREVACID 15” imprinted on the capsules. The 30 mg capsules are opaque, hard gelatin, colored pink and black with “TAP” and “PREVACID 30” imprinted on the capsules. They are available as follows:

NDC 64764-541-30 Unit of use bottles of 30: 15-mg capsules
NDC 64764-541-19 Bottles of 1000: 15-mg capsules
NDC
64764-541-11 Unit dose package of 100: 15-mg capsules
NDC
64764-046-13 Bottles of 100: 30-mg capsules
NDC
64764-046-19 Bottles of 1000: 30-mg capsules
NDC
64764-046-11 Unit dose package of 100: 30-mg capsules

PREVACID SoluTab Delayed-Release Orally Disintegrating Tablets, 15 mg, are white to yellowish white uncoated tablets with orange to dark brown speckles, with “15” debossed on one side of the tablet. The 30 mg are white to yellowish white uncoated tablets with orange to dark brown speckles, with “30” debossed on one side of the tablet. The tablets are available as follows:

NDC 64764-543-11 Unit dose packages of 100: 15-mg tablets
NDC 64764-544-11 Unit dose packages of 100: 30-mg tablets

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

Distributed by: Takeda Pharmaceuticals America, Inc. Deerfield, IL 60015. May 2012

Last reviewed on RxList: 5/18/2012
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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