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NEXIUM
Overview
What is NEXIUM?
The active ingredient in NEXIUM (esomeprazole magnesium) Delayed-Release Capsules and NEXIUM (esomeprazole magnesium) For Delayed-Release Oral Suspension is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1-benzimidazole-1-yl) magnesium trihydrate. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S- and R- isomers. (Initial U.S. approval of esomeprazole magnesium: 2001). Its molecular formula is (CHNOS)Mg x 3 HO with molecular weight of 767.2 as a trihydrate and 713.1 on an anhydrous basis. The structural formula is:
Figure 1
The magnesium salt is a white to slightly colored crystalline powder. It contains 3 moles of water of solvation and is slightly soluble in water. The stability of esomeprazole magnesium is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25°C and about 8 hours at 37°C.
NEXIUM is supplied in delayed-release capsules and in packets for a delayed-release oral suspension. Each delayed-release capsule contains 20 mg, or 40 mg of esomeprazole (present as 22.3 mg, or 44.5 mg esomeprazole magnesium trihydrate) in the form of enteric-coated granules with the following inactive ingredients: glyceryl monostearate 40-55, hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid copolymer type C, polysorbate 80, sugar spheres, talc, and triethyl citrate. The capsule shells have the following inactive ingredients: gelatin, FD&C Blue #1, FD&C Red #40, D&C Red #28, titanium dioxide, shellac, ethyl alcohol, isopropyl alcohol, n-butyl alcohol, propylene glycol, sodium hydroxide, polyvinyl pyrrolidone, and D&C Yellow #10.
Each packet of NEXIUM For Delayed-Release Oral Suspension contains 10 mg, 20 mg, or 40 mg of esomeprazole, in the form of the same enteric-coated granules used in NEXIUM Delayed-Release Capsules, and also inactive granules. The inactive granules are composed of the following ingredients: dextrose, xanthan gum, crospovidone, citric acid, iron oxide, and hydroxypropyl cellulose. The esomeprazole granules and inactive granules are constituted with water to form a suspension and are given by oral, nasogastric, or gastric administration.
What does NEXIUM look like?
What are the available doses of NEXIUM?
NEXIUM Delayed-Release Capsules, 20 mg - opaque, hard gelatin, amethyst colored capsules with two radial bars in yellow on the cap and NEXIUM 20 mg in yellow on the body.
NEXIUM Delayed-Release Capsules, 40 mg - opaque, hard gelatin, amethyst colored capsules with three radial bars in yellow on the cap and NEXIUM 40 mg in yellow on the body.
NEXIUM For Delayed-Release Oral Suspension, 10 mg, 20 mg or 40 mg - unit dose packet containing a fine yellow powder, consisting of white to pale brownish esomeprazole granules and pale yellow inactive granules.
What should I talk to my health care provider before I take NEXIUM?
How should I use NEXIUM?
Healing of Erosive Esophagitis
NEXIUM is indicated for the short-term treatment (4 to 8 weeks) in the healing and symptomatic resolution of diagnostically confirmed erosive esophagitis. For those patients who have not healed after 4 to 8 weeks of treatment, an additional 4 to 8 week course of NEXIUM may be considered.
Maintenance of Healing of Erosive Esophagitis
NEXIUM is indicated to maintain symptom resolution and healing of erosive esophagitis. Controlled studies do not extend beyond 6 months.
Symptomatic Gastroesophageal Reflux Disease
NEXIUM is indicated for short-term treatment (4 to 8 weeks) of heartburn and other symptoms associated with GERD in adults and children 1 year or older.
NEXIUM is supplied as delayed-release capsules for oral administration or in packets for preparation of delayed-release oral suspensions. The recommended dosages are outlined in the table below. NEXIUM should be taken at least one hour before meals.
The duration of proton pump inhibitor administration should be based on available safety and efficacy data specific to the defined indication and dosing frequency, as described in the Prescribing Information, and individual patient medical needs. Proton pump inhibitor treatment should only be initiated and continued if the benefits outweigh the risks of treatment.
Table 1
Please refer to amoxicillin and clarithromycin full prescribing information for Contraindications, Warnings and dosing in elderly and renally-impaired patients.
Special Populations
Geriatric
No dosage adjustment is necessary [
].
Renal Insufficiency
No dosage adjustment is necessary [].
Hepatic Insufficiency
In patients with mild to moderate liver impairment (Child Pugh Classes A and B), no dosage adjustment is necessary. For patients with severe liver impairment (Child Pugh Class C), a dose of 20 mg of NEXIUM should not be exceeded [].
Gender
No dosage adjustment is necessary [].
Administration Options
Directions for use specific to the route and available methods of administration for each of these dosage forms are presented below.
Table 2
NEXIUM Delayed-Release Capsules
NEXIUM Delayed-Release Capsules should be swallowed whole.
Alternatively, for patients who have difficulty swallowing capsules, one tablespoon of applesauce can be added to an empty bowl and the NEXIUM Delayed-Release Capsule can be opened, and the granules inside the capsule carefully emptied onto the applesauce. The granules should be mixed with the applesauce and then swallowed immediately. The applesauce used should not be hot and should be soft enough to be swallowed without chewing. The granules should not be chewed or crushed. The granules/applesauce mixture should not be stored for future use.
For patients who have a nasogastric tube in place, NEXIUM Delayed-Release Capsules can be opened and the intact granules emptied into a 60 mL catheter tipped syringe and mixed with 50 mL of water. It is important to only use a catheter tipped syringe when administering NEXIUM through a nasogastric tube. Replace the plunger and shake the syringe vigorously for 15 seconds. Hold the syringe with the tip up and check for granules remaining in the tip. Attach the syringe to a nasogastric tube and deliver the contents of the syringe through the nasogastric tube into the stomach. After administering the granules, the nasogastric tube should be flushed with additional water. Do not administer the granules if they have dissolved or disintegrated.
The suspension must be used immediately after preparation.
NEXIUM For Delayed-Release Oral Suspension
NEXIUM For Delayed-Release Oral Suspension should be administered as follows:
For patients who have a nasogastric or gastric tube in place, NEXIUM For Delayed-Release Oral Suspension can be administered as follows:
What interacts with NEXIUM?
Sorry No Records found
What are the warnings of NEXIUM?
Sorry No Records found
What are the precautions of NEXIUM?
Sorry No Records found
What are the side effects of NEXIUM?
Sorry No records found
What should I look out for while using NEXIUM?
NEXIUM is contraindicated in patients with known hypersensitivity to any component of the formulation [] or to substituted benzimidazoles. Hypersensitivity reactions, e.g., angioedema and anaphylactic shock, have been reported with NEXIUM use.
What might happen if I take too much NEXIUM?
A single oral dose of esomeprazole at 510 mg/kg (about 103 times the human dose on a body surface area basis), was lethal to rats. The major signs of acute toxicity were reduced motor activity, changes in respiratory frequency, tremor, ataxia, and intermittent clonic convulsions.
The symptoms described in connection with deliberate NEXIUM overdose (limited experience of doses in excess of 240 mg/day) are transient. Single doses of 80 mg of esomeprazole were uneventful. Reports of overdosage with omeprazole in humans may also be relevant. Doses ranged up to 2,400 mg (120 times the usual recommended clinical dose). Manifestations were variable, but included confusion, drowsiness, blurred vision, tachycardia, nausea, diaphoresis, flushing, headache, dry mouth, and other adverse reactions similar to those seen in normal clinical experience (see omeprazole package insert - ). No specific antidote for esomeprazole is known. Since esomeprazole is extensively protein bound, it is not expected to be removed by dialysis. In the event of overdosage, treatment should be symptomatic and supportive.
As with the management of any overdose, the possibility of multiple drug ingestion should be considered. For current information on treatment of any drug overdose contact a Poison Control Center at 1–800–222–1222.
How should I store and handle NEXIUM?
NEXIUM Delayed-Release Capsules, 20 mg, are opaque, hard gelatin, amethyst colored capsules with two radial bars in yellow on the cap and NEXIUM 20 mg in yellow on the body. They are supplied as follows:NDC 0186-5020-31 unit of use bottles of 30NDC 0186-5022-28 unit dose packages of 100NDC 0186-5020-54 bottles of 90NDC 0186-5020-82 bottles of 1000NEXIUM Delayed-Release Capsules, 40 mg, are opaque, hard gelatin, amethyst colored capsules with three radial bars in yellow on the cap and NEXIUM 40 mg in yellow on the body. They are supplied as follows:NDC 0186-5040-31 unit of use bottles of 30NDC 0186-5042-28 unit dose packages of 100NDC 0186-5040-54 bottles of 90NDC 0186-5040-82 bottles of 1000NEXIUM For Delayed-Release Oral Suspension is supplied as a unit dose packet containing a fine yellow powder, consisting of white to pale brownish esomeprazole granules and pale yellow inactive granules. NEXIUM unit dose packets are supplied as follows:NDC 0186-4010–01 unit dose packages of 30: 10 mg packetsNDC 0186-4020–01 unit dose packages of 30: 20 mg packetsNDC 0186-4040–01 unit dose packages of 30: 40 mg packetsStore at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F). [See USP Controlled Room Temperature]. Keep NEXIUM Delayed-Release Capsules container tightly closed. Dispense in a tight container if the NEXIUM Delayed-Release Capsules product package is subdivided.NEXIUM and the color purple as applied to the capsule are registered trademarks of the AstraZeneca group of companies.©AstraZeneca 2010NEXIUM Delayed-Release Capsules, 20 mg, are opaque, hard gelatin, amethyst colored capsules with two radial bars in yellow on the cap and NEXIUM 20 mg in yellow on the body. They are supplied as follows:NDC 0186-5020-31 unit of use bottles of 30NDC 0186-5022-28 unit dose packages of 100NDC 0186-5020-54 bottles of 90NDC 0186-5020-82 bottles of 1000NEXIUM Delayed-Release Capsules, 40 mg, are opaque, hard gelatin, amethyst colored capsules with three radial bars in yellow on the cap and NEXIUM 40 mg in yellow on the body. They are supplied as follows:NDC 0186-5040-31 unit of use bottles of 30NDC 0186-5042-28 unit dose packages of 100NDC 0186-5040-54 bottles of 90NDC 0186-5040-82 bottles of 1000NEXIUM For Delayed-Release Oral Suspension is supplied as a unit dose packet containing a fine yellow powder, consisting of white to pale brownish esomeprazole granules and pale yellow inactive granules. NEXIUM unit dose packets are supplied as follows:NDC 0186-4010–01 unit dose packages of 30: 10 mg packetsNDC 0186-4020–01 unit dose packages of 30: 20 mg packetsNDC 0186-4040–01 unit dose packages of 30: 40 mg packetsStore at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F). [See USP Controlled Room Temperature]. Keep NEXIUM Delayed-Release Capsules container tightly closed. Dispense in a tight container if the NEXIUM Delayed-Release Capsules product package is subdivided.NEXIUM and the color purple as applied to the capsule are registered trademarks of the AstraZeneca group of companies.©AstraZeneca 2010NEXIUM Delayed-Release Capsules, 20 mg, are opaque, hard gelatin, amethyst colored capsules with two radial bars in yellow on the cap and NEXIUM 20 mg in yellow on the body. They are supplied as follows:NDC 0186-5020-31 unit of use bottles of 30NDC 0186-5022-28 unit dose packages of 100NDC 0186-5020-54 bottles of 90NDC 0186-5020-82 bottles of 1000NEXIUM Delayed-Release Capsules, 40 mg, are opaque, hard gelatin, amethyst colored capsules with three radial bars in yellow on the cap and NEXIUM 40 mg in yellow on the body. They are supplied as follows:NDC 0186-5040-31 unit of use bottles of 30NDC 0186-5042-28 unit dose packages of 100NDC 0186-5040-54 bottles of 90NDC 0186-5040-82 bottles of 1000NEXIUM For Delayed-Release Oral Suspension is supplied as a unit dose packet containing a fine yellow powder, consisting of white to pale brownish esomeprazole granules and pale yellow inactive granules. NEXIUM unit dose packets are supplied as follows:NDC 0186-4010–01 unit dose packages of 30: 10 mg packetsNDC 0186-4020–01 unit dose packages of 30: 20 mg packetsNDC 0186-4040–01 unit dose packages of 30: 40 mg packetsStore at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F). [See USP Controlled Room Temperature]. Keep NEXIUM Delayed-Release Capsules container tightly closed. Dispense in a tight container if the NEXIUM Delayed-Release Capsules product package is subdivided.NEXIUM and the color purple as applied to the capsule are registered trademarks of the AstraZeneca group of companies.©AstraZeneca 2010NEXIUM Delayed-Release Capsules, 20 mg, are opaque, hard gelatin, amethyst colored capsules with two radial bars in yellow on the cap and NEXIUM 20 mg in yellow on the body. They are supplied as follows:NDC 0186-5020-31 unit of use bottles of 30NDC 0186-5022-28 unit dose packages of 100NDC 0186-5020-54 bottles of 90NDC 0186-5020-82 bottles of 1000NEXIUM Delayed-Release Capsules, 40 mg, are opaque, hard gelatin, amethyst colored capsules with three radial bars in yellow on the cap and NEXIUM 40 mg in yellow on the body. They are supplied as follows:NDC 0186-5040-31 unit of use bottles of 30NDC 0186-5042-28 unit dose packages of 100NDC 0186-5040-54 bottles of 90NDC 0186-5040-82 bottles of 1000NEXIUM For Delayed-Release Oral Suspension is supplied as a unit dose packet containing a fine yellow powder, consisting of white to pale brownish esomeprazole granules and pale yellow inactive granules. NEXIUM unit dose packets are supplied as follows:NDC 0186-4010–01 unit dose packages of 30: 10 mg packetsNDC 0186-4020–01 unit dose packages of 30: 20 mg packetsNDC 0186-4040–01 unit dose packages of 30: 40 mg packetsStore at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F). [See USP Controlled Room Temperature]. Keep NEXIUM Delayed-Release Capsules container tightly closed. Dispense in a tight container if the NEXIUM Delayed-Release Capsules product package is subdivided.NEXIUM and the color purple as applied to the capsule are registered trademarks of the AstraZeneca group of companies.©AstraZeneca 2010NEXIUM Delayed-Release Capsules, 20 mg, are opaque, hard gelatin, amethyst colored capsules with two radial bars in yellow on the cap and NEXIUM 20 mg in yellow on the body. They are supplied as follows:NDC 0186-5020-31 unit of use bottles of 30NDC 0186-5022-28 unit dose packages of 100NDC 0186-5020-54 bottles of 90NDC 0186-5020-82 bottles of 1000NEXIUM Delayed-Release Capsules, 40 mg, are opaque, hard gelatin, amethyst colored capsules with three radial bars in yellow on the cap and NEXIUM 40 mg in yellow on the body. They are supplied as follows:NDC 0186-5040-31 unit of use bottles of 30NDC 0186-5042-28 unit dose packages of 100NDC 0186-5040-54 bottles of 90NDC 0186-5040-82 bottles of 1000NEXIUM For Delayed-Release Oral Suspension is supplied as a unit dose packet containing a fine yellow powder, consisting of white to pale brownish esomeprazole granules and pale yellow inactive granules. NEXIUM unit dose packets are supplied as follows:NDC 0186-4010–01 unit dose packages of 30: 10 mg packetsNDC 0186-4020–01 unit dose packages of 30: 20 mg packetsNDC 0186-4040–01 unit dose packages of 30: 40 mg packetsStore at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F). [See USP Controlled Room Temperature]. Keep NEXIUM Delayed-Release Capsules container tightly closed. Dispense in a tight container if the NEXIUM Delayed-Release Capsules product package is subdivided.NEXIUM and the color purple as applied to the capsule are registered trademarks of the AstraZeneca group of companies.©AstraZeneca 2010NEXIUM Delayed-Release Capsules, 20 mg, are opaque, hard gelatin, amethyst colored capsules with two radial bars in yellow on the cap and NEXIUM 20 mg in yellow on the body. They are supplied as follows:NDC 0186-5020-31 unit of use bottles of 30NDC 0186-5022-28 unit dose packages of 100NDC 0186-5020-54 bottles of 90NDC 0186-5020-82 bottles of 1000NEXIUM Delayed-Release Capsules, 40 mg, are opaque, hard gelatin, amethyst colored capsules with three radial bars in yellow on the cap and NEXIUM 40 mg in yellow on the body. They are supplied as follows:NDC 0186-5040-31 unit of use bottles of 30NDC 0186-5042-28 unit dose packages of 100NDC 0186-5040-54 bottles of 90NDC 0186-5040-82 bottles of 1000NEXIUM For Delayed-Release Oral Suspension is supplied as a unit dose packet containing a fine yellow powder, consisting of white to pale brownish esomeprazole granules and pale yellow inactive granules. NEXIUM unit dose packets are supplied as follows:NDC 0186-4010–01 unit dose packages of 30: 10 mg packetsNDC 0186-4020–01 unit dose packages of 30: 20 mg packetsNDC 0186-4040–01 unit dose packages of 30: 40 mg packetsStore at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F). [See USP Controlled Room Temperature]. Keep NEXIUM Delayed-Release Capsules container tightly closed. Dispense in a tight container if the NEXIUM Delayed-Release Capsules product package is subdivided.NEXIUM and the color purple as applied to the capsule are registered trademarks of the AstraZeneca group of companies.©AstraZeneca 2010NEXIUM Delayed-Release Capsules, 20 mg, are opaque, hard gelatin, amethyst colored capsules with two radial bars in yellow on the cap and NEXIUM 20 mg in yellow on the body. They are supplied as follows:NDC 0186-5020-31 unit of use bottles of 30NDC 0186-5022-28 unit dose packages of 100NDC 0186-5020-54 bottles of 90NDC 0186-5020-82 bottles of 1000NEXIUM Delayed-Release Capsules, 40 mg, are opaque, hard gelatin, amethyst colored capsules with three radial bars in yellow on the cap and NEXIUM 40 mg in yellow on the body. They are supplied as follows:NDC 0186-5040-31 unit of use bottles of 30NDC 0186-5042-28 unit dose packages of 100NDC 0186-5040-54 bottles of 90NDC 0186-5040-82 bottles of 1000NEXIUM For Delayed-Release Oral Suspension is supplied as a unit dose packet containing a fine yellow powder, consisting of white to pale brownish esomeprazole granules and pale yellow inactive granules. NEXIUM unit dose packets are supplied as follows:NDC 0186-4010–01 unit dose packages of 30: 10 mg packetsNDC 0186-4020–01 unit dose packages of 30: 20 mg packetsNDC 0186-4040–01 unit dose packages of 30: 40 mg packetsStore at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F). [See USP Controlled Room Temperature]. Keep NEXIUM Delayed-Release Capsules container tightly closed. Dispense in a tight container if the NEXIUM Delayed-Release Capsules product package is subdivided.NEXIUM and the color purple as applied to the capsule are registered trademarks of the AstraZeneca group of companies.©AstraZeneca 2010NEXIUM Delayed-Release Capsules, 20 mg, are opaque, hard gelatin, amethyst colored capsules with two radial bars in yellow on the cap and NEXIUM 20 mg in yellow on the body. They are supplied as follows:NDC 0186-5020-31 unit of use bottles of 30NDC 0186-5022-28 unit dose packages of 100NDC 0186-5020-54 bottles of 90NDC 0186-5020-82 bottles of 1000NEXIUM Delayed-Release Capsules, 40 mg, are opaque, hard gelatin, amethyst colored capsules with three radial bars in yellow on the cap and NEXIUM 40 mg in yellow on the body. They are supplied as follows:NDC 0186-5040-31 unit of use bottles of 30NDC 0186-5042-28 unit dose packages of 100NDC 0186-5040-54 bottles of 90NDC 0186-5040-82 bottles of 1000NEXIUM For Delayed-Release Oral Suspension is supplied as a unit dose packet containing a fine yellow powder, consisting of white to pale brownish esomeprazole granules and pale yellow inactive granules. NEXIUM unit dose packets are supplied as follows:NDC 0186-4010–01 unit dose packages of 30: 10 mg packetsNDC 0186-4020–01 unit dose packages of 30: 20 mg packetsNDC 0186-4040–01 unit dose packages of 30: 40 mg packetsStore at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F). [See USP Controlled Room Temperature]. Keep NEXIUM Delayed-Release Capsules container tightly closed. Dispense in a tight container if the NEXIUM Delayed-Release Capsules product package is subdivided.NEXIUM and the color purple as applied to the capsule are registered trademarks of the AstraZeneca group of companies.©AstraZeneca 2010NEXIUM Delayed-Release Capsules, 20 mg, are opaque, hard gelatin, amethyst colored capsules with two radial bars in yellow on the cap and NEXIUM 20 mg in yellow on the body. They are supplied as follows:NDC 0186-5020-31 unit of use bottles of 30NDC 0186-5022-28 unit dose packages of 100NDC 0186-5020-54 bottles of 90NDC 0186-5020-82 bottles of 1000NEXIUM Delayed-Release Capsules, 40 mg, are opaque, hard gelatin, amethyst colored capsules with three radial bars in yellow on the cap and NEXIUM 40 mg in yellow on the body. They are supplied as follows:NDC 0186-5040-31 unit of use bottles of 30NDC 0186-5042-28 unit dose packages of 100NDC 0186-5040-54 bottles of 90NDC 0186-5040-82 bottles of 1000NEXIUM For Delayed-Release Oral Suspension is supplied as a unit dose packet containing a fine yellow powder, consisting of white to pale brownish esomeprazole granules and pale yellow inactive granules. NEXIUM unit dose packets are supplied as follows:NDC 0186-4010–01 unit dose packages of 30: 10 mg packetsNDC 0186-4020–01 unit dose packages of 30: 20 mg packetsNDC 0186-4040–01 unit dose packages of 30: 40 mg packetsStore at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F). [See USP Controlled Room Temperature]. Keep NEXIUM Delayed-Release Capsules container tightly closed. Dispense in a tight container if the NEXIUM Delayed-Release Capsules product package is subdivided.NEXIUM and the color purple as applied to the capsule are registered trademarks of the AstraZeneca group of companies.©AstraZeneca 2010NEXIUM Delayed-Release Capsules, 20 mg, are opaque, hard gelatin, amethyst colored capsules with two radial bars in yellow on the cap and NEXIUM 20 mg in yellow on the body. They are supplied as follows:NDC 0186-5020-31 unit of use bottles of 30NDC 0186-5022-28 unit dose packages of 100NDC 0186-5020-54 bottles of 90NDC 0186-5020-82 bottles of 1000NEXIUM Delayed-Release Capsules, 40 mg, are opaque, hard gelatin, amethyst colored capsules with three radial bars in yellow on the cap and NEXIUM 40 mg in yellow on the body. They are supplied as follows:NDC 0186-5040-31 unit of use bottles of 30NDC 0186-5042-28 unit dose packages of 100NDC 0186-5040-54 bottles of 90NDC 0186-5040-82 bottles of 1000NEXIUM For Delayed-Release Oral Suspension is supplied as a unit dose packet containing a fine yellow powder, consisting of white to pale brownish esomeprazole granules and pale yellow inactive granules. NEXIUM unit dose packets are supplied as follows:NDC 0186-4010–01 unit dose packages of 30: 10 mg packetsNDC 0186-4020–01 unit dose packages of 30: 20 mg packetsNDC 0186-4040–01 unit dose packages of 30: 40 mg packetsStore at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F). [See USP Controlled Room Temperature]. Keep NEXIUM Delayed-Release Capsules container tightly closed. Dispense in a tight container if the NEXIUM Delayed-Release Capsules product package is subdivided.NEXIUM and the color purple as applied to the capsule are registered trademarks of the AstraZeneca group of companies.©AstraZeneca 2010NEXIUM Delayed-Release Capsules, 20 mg, are opaque, hard gelatin, amethyst colored capsules with two radial bars in yellow on the cap and NEXIUM 20 mg in yellow on the body. They are supplied as follows:NDC 0186-5020-31 unit of use bottles of 30NDC 0186-5022-28 unit dose packages of 100NDC 0186-5020-54 bottles of 90NDC 0186-5020-82 bottles of 1000NEXIUM Delayed-Release Capsules, 40 mg, are opaque, hard gelatin, amethyst colored capsules with three radial bars in yellow on the cap and NEXIUM 40 mg in yellow on the body. They are supplied as follows:NDC 0186-5040-31 unit of use bottles of 30NDC 0186-5042-28 unit dose packages of 100NDC 0186-5040-54 bottles of 90NDC 0186-5040-82 bottles of 1000NEXIUM For Delayed-Release Oral Suspension is supplied as a unit dose packet containing a fine yellow powder, consisting of white to pale brownish esomeprazole granules and pale yellow inactive granules. NEXIUM unit dose packets are supplied as follows:NDC 0186-4010–01 unit dose packages of 30: 10 mg packetsNDC 0186-4020–01 unit dose packages of 30: 20 mg packetsNDC 0186-4040–01 unit dose packages of 30: 40 mg packetsStore at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F). [See USP Controlled Room Temperature]. Keep NEXIUM Delayed-Release Capsules container tightly closed. Dispense in a tight container if the NEXIUM Delayed-Release Capsules product package is subdivided.NEXIUM and the color purple as applied to the capsule are registered trademarks of the AstraZeneca group of companies.©AstraZeneca 2010NEXIUM Delayed-Release Capsules, 20 mg, are opaque, hard gelatin, amethyst colored capsules with two radial bars in yellow on the cap and NEXIUM 20 mg in yellow on the body. They are supplied as follows:NDC 0186-5020-31 unit of use bottles of 30NDC 0186-5022-28 unit dose packages of 100NDC 0186-5020-54 bottles of 90NDC 0186-5020-82 bottles of 1000NEXIUM Delayed-Release Capsules, 40 mg, are opaque, hard gelatin, amethyst colored capsules with three radial bars in yellow on the cap and NEXIUM 40 mg in yellow on the body. They are supplied as follows:NDC 0186-5040-31 unit of use bottles of 30NDC 0186-5042-28 unit dose packages of 100NDC 0186-5040-54 bottles of 90NDC 0186-5040-82 bottles of 1000NEXIUM For Delayed-Release Oral Suspension is supplied as a unit dose packet containing a fine yellow powder, consisting of white to pale brownish esomeprazole granules and pale yellow inactive granules. NEXIUM unit dose packets are supplied as follows:NDC 0186-4010–01 unit dose packages of 30: 10 mg packetsNDC 0186-4020–01 unit dose packages of 30: 20 mg packetsNDC 0186-4040–01 unit dose packages of 30: 40 mg packetsStore at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F). [See USP Controlled Room Temperature]. Keep NEXIUM Delayed-Release Capsules container tightly closed. Dispense in a tight container if the NEXIUM Delayed-Release Capsules product package is subdivided.NEXIUM and the color purple as applied to the capsule are registered trademarks of the AstraZeneca group of companies.©AstraZeneca 2010NEXIUM Delayed-Release Capsules, 20 mg, are opaque, hard gelatin, amethyst colored capsules with two radial bars in yellow on the cap and NEXIUM 20 mg in yellow on the body. They are supplied as follows:NDC 0186-5020-31 unit of use bottles of 30NDC 0186-5022-28 unit dose packages of 100NDC 0186-5020-54 bottles of 90NDC 0186-5020-82 bottles of 1000NEXIUM Delayed-Release Capsules, 40 mg, are opaque, hard gelatin, amethyst colored capsules with three radial bars in yellow on the cap and NEXIUM 40 mg in yellow on the body. They are supplied as follows:NDC 0186-5040-31 unit of use bottles of 30NDC 0186-5042-28 unit dose packages of 100NDC 0186-5040-54 bottles of 90NDC 0186-5040-82 bottles of 1000NEXIUM For Delayed-Release Oral Suspension is supplied as a unit dose packet containing a fine yellow powder, consisting of white to pale brownish esomeprazole granules and pale yellow inactive granules. NEXIUM unit dose packets are supplied as follows:NDC 0186-4010–01 unit dose packages of 30: 10 mg packetsNDC 0186-4020–01 unit dose packages of 30: 20 mg packetsNDC 0186-4040–01 unit dose packages of 30: 40 mg packetsStore at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F). [See USP Controlled Room Temperature]. Keep NEXIUM Delayed-Release Capsules container tightly closed. Dispense in a tight container if the NEXIUM Delayed-Release Capsules product package is subdivided.NEXIUM and the color purple as applied to the capsule are registered trademarks of the AstraZeneca group of companies.©AstraZeneca 2010NEXIUM Delayed-Release Capsules, 20 mg, are opaque, hard gelatin, amethyst colored capsules with two radial bars in yellow on the cap and NEXIUM 20 mg in yellow on the body. They are supplied as follows:NDC 0186-5020-31 unit of use bottles of 30NDC 0186-5022-28 unit dose packages of 100NDC 0186-5020-54 bottles of 90NDC 0186-5020-82 bottles of 1000NEXIUM Delayed-Release Capsules, 40 mg, are opaque, hard gelatin, amethyst colored capsules with three radial bars in yellow on the cap and NEXIUM 40 mg in yellow on the body. They are supplied as follows:NDC 0186-5040-31 unit of use bottles of 30NDC 0186-5042-28 unit dose packages of 100NDC 0186-5040-54 bottles of 90NDC 0186-5040-82 bottles of 1000NEXIUM For Delayed-Release Oral Suspension is supplied as a unit dose packet containing a fine yellow powder, consisting of white to pale brownish esomeprazole granules and pale yellow inactive granules. NEXIUM unit dose packets are supplied as follows:NDC 0186-4010–01 unit dose packages of 30: 10 mg packetsNDC 0186-4020–01 unit dose packages of 30: 20 mg packetsNDC 0186-4040–01 unit dose packages of 30: 40 mg packetsStore at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F). [See USP Controlled Room Temperature]. Keep NEXIUM Delayed-Release Capsules container tightly closed. Dispense in a tight container if the NEXIUM Delayed-Release Capsules product package is subdivided.NEXIUM and the color purple as applied to the capsule are registered trademarks of the AstraZeneca group of companies.©AstraZeneca 2010NEXIUM Delayed-Release Capsules, 20 mg, are opaque, hard gelatin, amethyst colored capsules with two radial bars in yellow on the cap and NEXIUM 20 mg in yellow on the body. They are supplied as follows:NDC 0186-5020-31 unit of use bottles of 30NDC 0186-5022-28 unit dose packages of 100NDC 0186-5020-54 bottles of 90NDC 0186-5020-82 bottles of 1000NEXIUM Delayed-Release Capsules, 40 mg, are opaque, hard gelatin, amethyst colored capsules with three radial bars in yellow on the cap and NEXIUM 40 mg in yellow on the body. They are supplied as follows:NDC 0186-5040-31 unit of use bottles of 30NDC 0186-5042-28 unit dose packages of 100NDC 0186-5040-54 bottles of 90NDC 0186-5040-82 bottles of 1000NEXIUM For Delayed-Release Oral Suspension is supplied as a unit dose packet containing a fine yellow powder, consisting of white to pale brownish esomeprazole granules and pale yellow inactive granules. NEXIUM unit dose packets are supplied as follows:NDC 0186-4010–01 unit dose packages of 30: 10 mg packetsNDC 0186-4020–01 unit dose packages of 30: 20 mg packetsNDC 0186-4040–01 unit dose packages of 30: 40 mg packetsStore at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F). [See USP Controlled Room Temperature]. Keep NEXIUM Delayed-Release Capsules container tightly closed. Dispense in a tight container if the NEXIUM Delayed-Release Capsules product package is subdivided.NEXIUM and the color purple as applied to the capsule are registered trademarks of the AstraZeneca group of companies.©AstraZeneca 2010NEXIUM Delayed-Release Capsules, 20 mg, are opaque, hard gelatin, amethyst colored capsules with two radial bars in yellow on the cap and NEXIUM 20 mg in yellow on the body. They are supplied as follows:NDC 0186-5020-31 unit of use bottles of 30NDC 0186-5022-28 unit dose packages of 100NDC 0186-5020-54 bottles of 90NDC 0186-5020-82 bottles of 1000NEXIUM Delayed-Release Capsules, 40 mg, are opaque, hard gelatin, amethyst colored capsules with three radial bars in yellow on the cap and NEXIUM 40 mg in yellow on the body. They are supplied as follows:NDC 0186-5040-31 unit of use bottles of 30NDC 0186-5042-28 unit dose packages of 100NDC 0186-5040-54 bottles of 90NDC 0186-5040-82 bottles of 1000NEXIUM For Delayed-Release Oral Suspension is supplied as a unit dose packet containing a fine yellow powder, consisting of white to pale brownish esomeprazole granules and pale yellow inactive granules. NEXIUM unit dose packets are supplied as follows:NDC 0186-4010–01 unit dose packages of 30: 10 mg packetsNDC 0186-4020–01 unit dose packages of 30: 20 mg packetsNDC 0186-4040–01 unit dose packages of 30: 40 mg packetsStore at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F). [See USP Controlled Room Temperature]. Keep NEXIUM Delayed-Release Capsules container tightly closed. Dispense in a tight container if the NEXIUM Delayed-Release Capsules product package is subdivided.NEXIUM and the color purple as applied to the capsule are registered trademarks of the AstraZeneca group of companies.©AstraZeneca 2010NEXIUM Delayed-Release Capsules, 20 mg, are opaque, hard gelatin, amethyst colored capsules with two radial bars in yellow on the cap and NEXIUM 20 mg in yellow on the body. They are supplied as follows:NDC 0186-5020-31 unit of use bottles of 30NDC 0186-5022-28 unit dose packages of 100NDC 0186-5020-54 bottles of 90NDC 0186-5020-82 bottles of 1000NEXIUM Delayed-Release Capsules, 40 mg, are opaque, hard gelatin, amethyst colored capsules with three radial bars in yellow on the cap and NEXIUM 40 mg in yellow on the body. They are supplied as follows:NDC 0186-5040-31 unit of use bottles of 30NDC 0186-5042-28 unit dose packages of 100NDC 0186-5040-54 bottles of 90NDC 0186-5040-82 bottles of 1000NEXIUM For Delayed-Release Oral Suspension is supplied as a unit dose packet containing a fine yellow powder, consisting of white to pale brownish esomeprazole granules and pale yellow inactive granules. NEXIUM unit dose packets are supplied as follows:NDC 0186-4010–01 unit dose packages of 30: 10 mg packetsNDC 0186-4020–01 unit dose packages of 30: 20 mg packetsNDC 0186-4040–01 unit dose packages of 30: 40 mg packetsStore at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F). [See USP Controlled Room Temperature]. Keep NEXIUM Delayed-Release Capsules container tightly closed. Dispense in a tight container if the NEXIUM Delayed-Release Capsules product package is subdivided.NEXIUM and the color purple as applied to the capsule are registered trademarks of the AstraZeneca group of companies.©AstraZeneca 2010
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Esomeprazole is a proton pump inhibitor that suppresses gastric acid secretion by specific inhibition of the H/K-ATPase in the gastric parietal cell. The S- and R-isomers of omeprazole are protonated and converted in the acidic compartment of the parietal cell forming the active inhibitor, the achiral sulphenamide. By acting specifically on the proton pump, esomeprazole blocks the final step in acid production, thus reducing gastric acidity. This effect is dose-related up to a daily dose of 20 to 40 mg and leads to inhibition of gastric acid secretion.
Non-Clinical Toxicology
NEXIUM is contraindicated in patients with known hypersensitivity to any component of the formulation [] or to substituted benzimidazoles. Hypersensitivity reactions, e.g., angioedema and anaphylactic shock, have been reported with NEXIUM use.Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72Tips
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Interactions
A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).