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PREVACID (lansoprazole) delayed-release capsules
2016-04-09 09:46:28 来源: 作者: 【 】 浏览:397次 评论:0
  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use PREVACID safely and effectively. See full prescribing information for PREVACID.
    PREVACID (lansoprazole) delayed-release capsules, for oral use
    PREVACID SoluTab (lansoprazole) delayed-release orally disintegrating tablets, for oral use
     
    Initial U.S. Approval: 1995
    INDICATIONS AND USAGE

    PREVACID is a proton pump inhibitor (PPI) indicated for:

    Short-Term Treatment of Active Duodenal Ulcer ( 1.1)
    H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence ( 1.2)
    Maintenance of Healed Duodenal Ulcers ( 1.3)
    Short-Term Treatment of Active Benign Gastric Ulcer ( 1.4)
    Healing of nonsteroidal anti-inflammatory drugs (NSAID)-Associated Gastric Ulcer ( 1.5)
    Risk Reduction of NSAID-Associated Gastric Ulcer ( 1.6)
    Gastroesophageal Reflux Disease (GERD) ( 1.7)
    Maintenance of Healing of Erosive Esophagitis (EE) ( 1.8)
    Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome (ZES) ( 1.9)
    DOSAGE AND ADMINISTRATION
    Indication Dose Frequency

    Duodenal Ulcers (1.1, 1.3)

    Short-Term Treatment

    15 mg

    Once daily for 4 wks

    Maintenance of Healed

    15 mg

    Once daily

    H. pylori Eradication to Reduce Recurrence of Duodenal Ulcer (1.2)

    Triple Therapy:

    PREVACID
    Amoxicillin
    Clarithromycin

    30 mg
    1 gram
    500 mg

    Twice daily for 10 or 14 days

    Dual Therapy:

    PREVACID
    Amoxicillin

    30 mg
    1 gram

    Three times daily for 14 days

    Benign Gastric Ulcer (1.4)

    Short-Term Treatment

    30 mg

    Once daily up to 8 wks

    NSAID-associated Gastric Ulcer (1.6)

    Healing

    30 mg

    Once daily for 8 wks

    Risk Reduction

    15 mg

    Once daily up to 12 wks

    GERD (1.7)

    Short-Term Treatment of Symptomatic GERD

    15 mg

    Once daily up to 8 wks

    Short-Term Treatment of EE

    30 mg

    Once daily up to 8 wks

    Pediatric (8.4)

    (1 to 11 years of age) Short-Term Treatment of Symptomatic GERD and Short-Term Treatment of EE

      ≤ 30 kg

    15 mg

    Once daily up to 12 wks

      > 30 kg

    30 mg

    Once daily up to 12 wks

    (12 to 17 years of age) Short-Term Treatment of Symptomatic GERD

    Nonerosive GERD

    15 mg

    Once daily up to 8 wks

    EE

    30 mg

    Once daily up to 8 wks

    Maintenance of Healing of EE (1.8)*

    15 mg

    Once daily*

    Pathological Hypersecretory Conditions (i.e., ZES) (1.9)

    60 mg

    Once daily

    *Studied for 12 months

    DOSAGE FORMS AND STRENGTHS

    Capsules and Tablets: 15 mg and 30 mg. (3)
    CONTRAINDICATIONS

    Contraindicated in patients with known severe hypersensitivity to any component of the PREVACID formulation. (4)
    WARNINGS AND PRECAUTIONS

    Gastric Malignancy: Symptomatic response with PREVACID does not preclude the presence of gastric malignancy. ( 5.1)
    Acute Interstitial Nephritis: Acute interstitial nephritis has been observed in patients taking PPIs. (5.2)
    Cyanocobalamin (vitamin B12) Deficiency: Daily long-term use (e.g., longer than 3 years) may lead to malabsorption or a deficiency of cyanocobalamin. ( 5.3)
    Clostridium difficile Associated Diarrhea: PPI therapy may be associated with increased risk of Clostridium difficile associated diarrhea. ( 5.4)
    Bone Fracture: Long-term and multiple daily dose PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist or spine. (
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