zegerid with magnesium hydroxide- omeprazole, sodium bicarbonate and magnesium hydroxide tablet, chewable

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

08-06-2006

इस उत्पाद के लिए कुछ दस्तावेज़ वर्तमान में उपलब्ध नहीं हैं, आप हमारी ग्राहक सेवा को अनुरोध भेज सकते हैं और जैसे ही हम उन्हें प्राप्त करने में सक्षम होंगे, हम आपको सूचित करेंगे।
अनुरोध भेजा।

सक्रिय संघटक:

omeprazole (UNII: KG60484QX9) (omeprazole - UNII:KG60484QX9), sodium bicarbonate (UNII: 8MDF5V39QO) (sodium bicarbonate - UNII:8MDF5V39QO), magnesium hydroxide (UNII: NBZ3QY004S) (magnesium hydroxide - UNII:NBZ3QY004S)

थमां उपलब्ध:

Santarus, Inc.

INN (इंटरनेशनल नाम):

omeprazole, sodium bicarbonate and magnesium hydroxide

फार्मास्यूटिकल फॉर्म:

TABLET, CHEWABLE

रचना:

20 mg

प्रशासन का मार्ग:

ORAL

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

ZEGERID with Magnesium Hydroxide is indicated for short-term treatment of active duodenal ulcer. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy. ZEGERID with Magnesium Hydroxide is indicated for short-term treatment (4-8 weeks) of active benign gastric ulcer. (See CLINICAL PHARMACOLOGY, Clinical Studies, Gastric Ulcer.) ZEGERID with Magnesium Hydroxide is indicated for the treatment of heartburn and other symptoms associated with GERD. ZEGERID with Magnesium Hydroxide is indicated for the short-term treatment (4-8 weeks) of erosive esophagitis which has been diagnosed by endoscopy. (See CLINICAL PHARMACOLOGY, Clinical Studies.) The efficacy of ZEGERID with Magnesium Hydroxide used for longer than 8 weeks in these patients has not been established. In the rare instance of a patient not responding to 8 weeks of treatment, it may be helpful to give up to an additional 4 weeks of treatment. If there is recurrence of erosive esophagitis or GERD symptoms (eg, hea

उत्पाद समीक्षा:

ZEGERID with Magnesium Hydroxide 20-mg Chewable Tablets: Each pink, 18 mm in diameter, round tablet, inscribed with the number “2031” on one side and the Santarus logo on the other side, contains 20 mg omeprazole and 600 mg sodium bicarbonate plus 700 mg magnesium hydroxide. NDC 68012-152-30 Bottles of 30 chewable tablets ZEGERID with Magnesium Hydroxide 40-mg Chewable Tablets: Each pink, 18 mm in diameter, round tablet, inscribed with the number “4031” on one side and the Santarus logo on the other side, contains 40 mg omeprazole and 600 mg sodium bicarbonate plus 700 mg magnesium hydroxide. NDC 68012-154-30 Bottles of 30 chewable tablets Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F). [See USP Controlled Room Temperature]. Do not store this product at temperatures above 30°C (86°F). Rx Only

उत्पाद विशेषताएं

ZEGERID WITH MAGNESIUM HYDROXIDE- OMEPRAZOLE, SODIUM BICARBONATE AND
MAGNESIUM HYDROXIDE TABLET, CHEWABLE
SANTARUS, INC.
----------
ZEGERID® WITH MAGNESIUM HYDROXIDE
(OMEPRAZOLE/SODIUM BICARBONATE/MAGNESIUM HYDROXIDE)
RX ONLY
CHEWABLE TABLETS
DESCRIPTION
ZEGERID® with Magnesium Hydroxide (omeprazole/sodium
bicarbonate/magnesium hydroxide) is a
combination of omeprazole, a proton-pump inhibitor, and sodium
bicarbonate plus magnesium
hydroxide, both of which are antacids. Omeprazole is a substituted
benzimidazole, 5-methoxy-2-[[(4-
methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1_H_-benzimidazole,
a racemic mixture of two
enantiomers that inhibits gastric acid secretion. Its empirical
formula is C
H N O S, with a molecular
weight of 345.42. The structural formula is:
Omeprazole is a white to off-white crystalline powder which 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.
ZEGERID with Magnesium Hydroxide is available in two strengths, 40 mg
and 20 mg of omeprazole,
and is formulated as an immediate-release chewable tablet. Each
chewable tablet contains either 40 mg
or 20 mg of omeprazole and 600 mg of sodium bicarbonate plus 700 mg of
magnesium hydroxide with
the following inactive ingredients: hydroxypropyl cellulose,
croscarmellose sodium, xylitol,
sucralose, flavoring, magnesium stearate, and FD&C Red #40 Aluminum
Lake.
CLINICAL PHARMACOLOGY
Omeprazole is acid labile and thus rapidly degraded by gastric acid.
ZEGERID with Magnesium
Hydroxide is an immediate-release chewable tablet formulation that
contains an antacid component
(sodium bicarbonate plus magnesium hydroxide) which raises the gastric
pH and thus protects
17
19
3
3
omeprazole from acid degradation.
PHARMACOKINETICS :
Absorption
When ZEGERID with Magnesium Hydroxide chew

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