Prilosec

Prilosec

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Questions & Answers

副作用和不良反应

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法律问题

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Uses

1 INDICATIONS AND USAGE 1.1 Duodenal Ulcer (adults)

奥美拉唑短期治疗的指示active duodenal ulcer in adults. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy.

PRILOSEC in combination with clarithromycin and amoxicillin, is indicated for treatment of patients withH. pyloriinfection and duodenal ulcer disease (active or up to 1-year history) to eradicateH. pyloriin adults.

PRILOSEC, in combination with clarithromycin is indicated for treatment of patients withH. pyloriinfection and duodenal ulcer disease to eradicateH. pyloriin adults.

根除H. pylorihas been shown to reduce the risk of duodenal ulcer recurrence [see Clinical Studies (14.1) and Dosage and Administration (2)].

在治疗失败的患者中,与三重治疗相比,用克拉霉素的Prilosec更可能与克拉霉素耐药性的发展有关。在治疗失败的患者中,应进行敏感性测试。如果证明对克拉霉素的耐药性或不可能进行敏感性测试,则应进行替代性抗菌治疗。[[See Microbiology section (12.4)],以及Clarithromycin包装插入,微生物学部分。

1.2胃溃疡(成人)

PRILOSEC is indicated for short-term treatment (4-8 weeks) of active benign gastric ulcer in adults. [参见临床研究(14.2)]

1.3治疗胃食管反流疾病(GERD)(成人和小儿患者)

有症状的GERD

PRILOSEC is indicated for the treatment of heartburn and other symptoms associated with GERD in pediatric patients and adults.

侵蚀性食管炎

PRILOSEC is indicated for the short-term treatment (4-8 weeks) of erosive esophagitis that has been diagnosed by endoscopy in pediatric patients and adults. [参见临床研究(14.4)]

The efficacy of PRILOSEC used for longer than 8 weeks in these patients has not been established. If a patient does not respond to 8 weeks of treatment, an additional 4 weeks of treatment may be given. If there is recurrence of erosive esophagitis or GERD symptoms (eg, heartburn), additional 4-8 week courses of omeprazole may be considered.

1.4 Maintenance of Healing of Erosive Esophagitis (adults and pediatric patients)

PRILOSEC is indicated to maintain healing of erosive esophagitis in pediatric patients and adults.

Controlled studies do not extend beyond 12 months. [参见临床研究(14.4)]

1.5 Pathological Hypersecretory Conditions (adults)

PRILOSEC is indicated for the long-term treatment of pathological hypersecretory conditions (eg, Zollinger-Ellison syndrome, multiple endocrine adenomas and systemic mastocytosis) in adults.

History

There is currently no drug history available for this drug.

其他信息


11 DESCRIPTION

Prilosec(Omeprazole)延迟释放胶囊中的活性成分是一种取代的苯咪唑,5-甲氧基-2- [[((4-甲氧基-3,5-甲氧基-3,5-二甲基-2-吡啶基)甲基]甲基] - 1-1H-benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C17H19N3O3S,分子量为345.42。结构公式是:

STRUCTURE IMAGE


STRUCTURE IMAGE


Omeprazole is a white to off-white crystalline powder that melts with decomposition at about 155°C. It is a weak base, freely soluble in ethanol and methanol, and slightly soluble in acetone and isopropanol and very slightly soluble in water. The stability of omeprazole is a function of pH; it is rapidly degraded in acid media, but has acceptable stability under alkaline conditions.

The active ingredient in PRILOSEC (omeprazole magnesium) for Delayed Release Oral Suspension, is 5-Methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole, magnesium salt (2:1)

Omeprazole magnesium is a white to off white powder with a melting point with degradation at 200°C. The salt is slightly soluble (0.25 mg/ml) in water at 25°C, and it is soluble in methanol. The half-life is highly pH dependent.

The empirical formula for omeprazole magnesium is (C17H18N3O3S)2Mg, the molecular weight is 713.12 and the structural formula is

STRUCTURE IMAGE 2


STRUCTURE IMAGE 2


PRILOSEC is supplied as delayed-release capsules for oral administration. Each delayed-release capsule contains either 10 mg, 20 mg or 40 mg of omeprazole in the form of enteric-coated granules with the following inactive ingredients: cellulose, disodium hydrogen phosphate, hydroxypropyl cellulose, hypromellose, lactose, mannitol, sodium lauryl sulfate and other ingredients. The capsule shells have the following inactive ingredients: gelatin-NF, FD and C Blue #1, FD and C Red #40, D and C Red #28, titanium dioxide, synthetic black iron oxide, isopropanol, butyl alcohol, FD and C Blue #2, D and C Red #7 Calcium Lake, and, in addition, the 10 mg and 40 mg capsule shells also contain D and C Yellow #10.

Each packet of PRILOSEC For Delayed-Release Oral Suspension contains either 2.8 mg or 11.2 mg of omeprazole magnesium (equivalent to 2.5 mg or 10 mg of omeprazole ), in the form of enteric-coated granules with the following inactive ingredients: glyceryl monostearate, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid copolymer C, polysorbate, sugar spheres, talc, and triethyl citrate, and also inactive granules. The inactive granules are composed of the following ingredients: citric acid, crospovidone, dextrose, hydroxypropyl cellulose, iron oxide and xantham gum. The omeprazole granules and inactive granules are constituted with water to form a suspension and are given by oral, nasogastric or direct gastric administration.

Prilosec Manufacturers


  • Stat RX USA LLC
    Prilosec(奥美拉唑镁)胶囊[Stat Rx USA LLC]
  • Astrazeneca Lp
    Prilosec (Omeprazole Magnesium) Capsule, Delayed Release Prilosec (Omeprazole Magnesium) Granule, Delayed Release [Astrazeneca Lp]

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