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esomeprazole magnesium
Overview
What is PharmapureRx ESOMEP-EZS?
The active ingredient in the proton pump inhibitor Esomeprazole Magnesium Delayed-Release Capsules USP for oral administration is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1-benzimidazole-1-yl) magnesium dihydrate. 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.) It has a molecular weight of 749.2 as a dihydrate and 713.1 on an anhydrous basis. The structural formula is:
(CHNOS)Mg • 2 HO M.W. 749.2
The magnesium salt is an off-white to pale yellow colored crystalline powder. It contains 2 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.
Each Esomeprazole Magnesium Delayed-Release Capsule USP contains either 20 mg or 40 mg of esomeprazole (present as 21.69 mg or 43.38 mg esomeprazole magnesium dihydrate) in the form of enteric-coated granules. In addition, each delayed-release capsule contains the following inactive ingredients: FD&C blue #1, gelatin, hypromellose, methacrylic acid copolymer dispersion, polysorbate 80, propylene glycol, shellac, sugar spheres, talc, titanium dioxide, triethyl citrate, and yellow iron oxide.
What does PharmapureRx ESOMEP-EZS look like?
What are the available doses of PharmapureRx ESOMEP-EZS?
Esomeprazole Magnesium Delayed-Release Capsules: 20 mg and 40 mg. ()
What should I talk to my health care provider before I take PharmapureRx ESOMEP-EZS?
How should I use PharmapureRx ESOMEP-EZS?
Healing of Erosive Esophagitis
Esomeprazole Magnesium Delayed-Release Capsules are 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 Esomeprazole Magnesium Delayed-Release Capsules may be considered.
Maintenance of Healing of Erosive Esophagitis
Esomeprazole Magnesium Delayed-Release Capsules are indicated to maintain symptom resolution and healing of erosive esophagitis. Controlled studies do not extend beyond 6 months.
Symptomatic Gastroesophageal Reflux Disease
Esomeprazole Magnesium Delayed-Release Capsules are 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.
Esomeprazole Magnesium Delayed-Release Capsules are supplied as delayed-release capsules for oral administration. The recommended dosages are outlined in . Esomeprazole Magnesium Delayed-Release Capsules 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: Recommended Dosage Schedule for Esomeprazole Magnesium Delayed-Release Capsules
Please refer to amoxicillin and clarithromycin prescribing information for Contraindications, Warnings, and dosing in elderly and renally-impaired patients.
Specific Populations
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 esomeprazole magnesium delayed-release capsules should not be exceeded [].
Directions for use specific to the route and available methods of administration for each of these dosage forms are presented in .
Table 2: Administration Options
Esomeprazole magnesium 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 esomeprazole magnesium 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: do not store for future use. 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. If the granules/applesauce mixture is not used in its entirety, the remaining mixture should be discarded immediately.
For patients who have a nasogastric tube in place, esomeprazole magnesium 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 esomeprazole magnesium 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 mixture must be used immediately after preparation.
What interacts with PharmapureRx ESOMEP-EZS?
Sorry No Records found
What are the warnings of PharmapureRx ESOMEP-EZS?
Sorry No Records found
What are the precautions of PharmapureRx ESOMEP-EZS?
Sorry No Records found
What are the side effects of PharmapureRx ESOMEP-EZS?
Sorry No records found
What should I look out for while using PharmapureRx ESOMEP-EZS?
Esomeprazole magnesium is contraindicated in patients with known hypersensitivity to substituted benzimidazoles or to any component of the formulation. Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute interstitial nephritis, and urticaria [
].
For information about contraindications of antibacterial agents (clarithromycin and amoxicillin) indicated in combination with esomeprazole magnesium, refer to the CONTRAINDICATIONS section of their package inserts.
What might happen if I take too much PharmapureRx ESOMEP-EZS?
A single oral dose of esomeprazole at 510 mg/kg (about 124 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 esomeprazole magnesium 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 PharmapureRx ESOMEP-EZS?
Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). Do not freeze.Protect from lightDiscard unused portion. Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). Do not freeze.Protect from lightDiscard unused portion. Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). Do not freeze.Protect from lightDiscard unused portion. Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). Do not freeze.Protect from lightDiscard unused portion. Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg, are available as off-white to pale yellow granule-filled, light turquoise blue, opaque, hard-gelatin capsules, spin-printed “” and “6450” on the cap and “20 mg” on the body in gold ink containing 20 mg esomeprazole packaged in bottles of 30, 90, and 1000 capsules.NDC 0093--56 bottle of 30NDC 0093--98 bottle of 90NDC 0093--10 bottle of 1000Esomeprazole Magnesium Delayed-Release Capsules USP, 40 mg, are available as off-white to pale yellow granule-filled, light turquoise blue, opaque, hard-gelatin capsules, spin-printed “” and “6451” on the cap and “40 mg” on the body in gold ink containing 40 mg esomeprazole packaged in bottles of 30, 90, and 1000 capsules.NDC 0093--56 bottle of 30NDC 0093-6451-98 bottle of 90NDC 0093--10 bottle of 1000Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Dispense in a tight container as defined in the USP, with a child-resistant closure (as required).KEEP CONTAINER TIGHTLY CLOSED.KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg, are available as off-white to pale yellow granule-filled, light turquoise blue, opaque, hard-gelatin capsules, spin-printed “” and “6450” on the cap and “20 mg” on the body in gold ink containing 20 mg esomeprazole packaged in bottles of 30, 90, and 1000 capsules.NDC 0093--56 bottle of 30NDC 0093--98 bottle of 90NDC 0093--10 bottle of 1000Esomeprazole Magnesium Delayed-Release Capsules USP, 40 mg, are available as off-white to pale yellow granule-filled, light turquoise blue, opaque, hard-gelatin capsules, spin-printed “” and “6451” on the cap and “40 mg” on the body in gold ink containing 40 mg esomeprazole packaged in bottles of 30, 90, and 1000 capsules.NDC 0093--56 bottle of 30NDC 0093-6451-98 bottle of 90NDC 0093--10 bottle of 1000Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Dispense in a tight container as defined in the USP, with a child-resistant closure (as required).KEEP CONTAINER TIGHTLY CLOSED.KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg, are available as off-white to pale yellow granule-filled, light turquoise blue, opaque, hard-gelatin capsules, spin-printed “” and “6450” on the cap and “20 mg” on the body in gold ink containing 20 mg esomeprazole packaged in bottles of 30, 90, and 1000 capsules.NDC 0093--56 bottle of 30NDC 0093--98 bottle of 90NDC 0093--10 bottle of 1000Esomeprazole Magnesium Delayed-Release Capsules USP, 40 mg, are available as off-white to pale yellow granule-filled, light turquoise blue, opaque, hard-gelatin capsules, spin-printed “” and “6451” on the cap and “40 mg” on the body in gold ink containing 40 mg esomeprazole packaged in bottles of 30, 90, and 1000 capsules.NDC 0093--56 bottle of 30NDC 0093-6451-98 bottle of 90NDC 0093--10 bottle of 1000Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Dispense in a tight container as defined in the USP, with a child-resistant closure (as required).KEEP CONTAINER TIGHTLY CLOSED.KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg, are available as off-white to pale yellow granule-filled, light turquoise blue, opaque, hard-gelatin capsules, spin-printed “” and “6450” on the cap and “20 mg” on the body in gold ink containing 20 mg esomeprazole packaged in bottles of 30, 90, and 1000 capsules.NDC 0093--56 bottle of 30NDC 0093--98 bottle of 90NDC 0093--10 bottle of 1000Esomeprazole Magnesium Delayed-Release Capsules USP, 40 mg, are available as off-white to pale yellow granule-filled, light turquoise blue, opaque, hard-gelatin capsules, spin-printed “” and “6451” on the cap and “40 mg” on the body in gold ink containing 40 mg esomeprazole packaged in bottles of 30, 90, and 1000 capsules.NDC 0093--56 bottle of 30NDC 0093-6451-98 bottle of 90NDC 0093--10 bottle of 1000Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Dispense in a tight container as defined in the USP, with a child-resistant closure (as required).KEEP CONTAINER TIGHTLY CLOSED.KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg, are available as off-white to pale yellow granule-filled, light turquoise blue, opaque, hard-gelatin capsules, spin-printed “” and “6450” on the cap and “20 mg” on the body in gold ink containing 20 mg esomeprazole packaged in bottles of 30, 90, and 1000 capsules.NDC 0093--56 bottle of 30NDC 0093--98 bottle of 90NDC 0093--10 bottle of 1000Esomeprazole Magnesium Delayed-Release Capsules USP, 40 mg, are available as off-white to pale yellow granule-filled, light turquoise blue, opaque, hard-gelatin capsules, spin-printed “” and “6451” on the cap and “40 mg” on the body in gold ink containing 40 mg esomeprazole packaged in bottles of 30, 90, and 1000 capsules.NDC 0093--56 bottle of 30NDC 0093-6451-98 bottle of 90NDC 0093--10 bottle of 1000Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Dispense in a tight container as defined in the USP, with a child-resistant closure (as required).KEEP CONTAINER TIGHTLY CLOSED.KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg, are available as off-white to pale yellow granule-filled, light turquoise blue, opaque, hard-gelatin capsules, spin-printed “” and “6450” on the cap and “20 mg” on the body in gold ink containing 20 mg esomeprazole packaged in bottles of 30, 90, and 1000 capsules.NDC 0093--56 bottle of 30NDC 0093--98 bottle of 90NDC 0093--10 bottle of 1000Esomeprazole Magnesium Delayed-Release Capsules USP, 40 mg, are available as off-white to pale yellow granule-filled, light turquoise blue, opaque, hard-gelatin capsules, spin-printed “” and “6451” on the cap and “40 mg” on the body in gold ink containing 40 mg esomeprazole packaged in bottles of 30, 90, and 1000 capsules.NDC 0093--56 bottle of 30NDC 0093-6451-98 bottle of 90NDC 0093--10 bottle of 1000Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Dispense in a tight container as defined in the USP, with a child-resistant closure (as required).KEEP CONTAINER TIGHTLY CLOSED.KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg, are available as off-white to pale yellow granule-filled, light turquoise blue, opaque, hard-gelatin capsules, spin-printed “” and “6450” on the cap and “20 mg” on the body in gold ink containing 20 mg esomeprazole packaged in bottles of 30, 90, and 1000 capsules.NDC 0093--56 bottle of 30NDC 0093--98 bottle of 90NDC 0093--10 bottle of 1000Esomeprazole Magnesium Delayed-Release Capsules USP, 40 mg, are available as off-white to pale yellow granule-filled, light turquoise blue, opaque, hard-gelatin capsules, spin-printed “” and “6451” on the cap and “40 mg” on the body in gold ink containing 40 mg esomeprazole packaged in bottles of 30, 90, and 1000 capsules.NDC 0093--56 bottle of 30NDC 0093-6451-98 bottle of 90NDC 0093--10 bottle of 1000Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Dispense in a tight container as defined in the USP, with a child-resistant closure (as required).KEEP CONTAINER TIGHTLY CLOSED.KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg, are available as off-white to pale yellow granule-filled, light turquoise blue, opaque, hard-gelatin capsules, spin-printed “” and “6450” on the cap and “20 mg” on the body in gold ink containing 20 mg esomeprazole packaged in bottles of 30, 90, and 1000 capsules.NDC 0093--56 bottle of 30NDC 0093--98 bottle of 90NDC 0093--10 bottle of 1000Esomeprazole Magnesium Delayed-Release Capsules USP, 40 mg, are available as off-white to pale yellow granule-filled, light turquoise blue, opaque, hard-gelatin capsules, spin-printed “” and “6451” on the cap and “40 mg” on the body in gold ink containing 40 mg esomeprazole packaged in bottles of 30, 90, and 1000 capsules.NDC 0093--56 bottle of 30NDC 0093-6451-98 bottle of 90NDC 0093--10 bottle of 1000Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Dispense in a tight container as defined in the USP, with a child-resistant closure (as required).KEEP CONTAINER TIGHTLY CLOSED.KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg, are available as off-white to pale yellow granule-filled, light turquoise blue, opaque, hard-gelatin capsules, spin-printed “” and “6450” on the cap and “20 mg” on the body in gold ink containing 20 mg esomeprazole packaged in bottles of 30, 90, and 1000 capsules.NDC 0093--56 bottle of 30NDC 0093--98 bottle of 90NDC 0093--10 bottle of 1000Esomeprazole Magnesium Delayed-Release Capsules USP, 40 mg, are available as off-white to pale yellow granule-filled, light turquoise blue, opaque, hard-gelatin capsules, spin-printed “” and “6451” on the cap and “40 mg” on the body in gold ink containing 40 mg esomeprazole packaged in bottles of 30, 90, and 1000 capsules.NDC 0093--56 bottle of 30NDC 0093-6451-98 bottle of 90NDC 0093--10 bottle of 1000Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Dispense in a tight container as defined in the USP, with a child-resistant closure (as required).KEEP CONTAINER TIGHTLY CLOSED.KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg, are available as off-white to pale yellow granule-filled, light turquoise blue, opaque, hard-gelatin capsules, spin-printed “” and “6450” on the cap and “20 mg” on the body in gold ink containing 20 mg esomeprazole packaged in bottles of 30, 90, and 1000 capsules.NDC 0093--56 bottle of 30NDC 0093--98 bottle of 90NDC 0093--10 bottle of 1000Esomeprazole Magnesium Delayed-Release Capsules USP, 40 mg, are available as off-white to pale yellow granule-filled, light turquoise blue, opaque, hard-gelatin capsules, spin-printed “” and “6451” on the cap and “40 mg” on the body in gold ink containing 40 mg esomeprazole packaged in bottles of 30, 90, and 1000 capsules.NDC 0093--56 bottle of 30NDC 0093-6451-98 bottle of 90NDC 0093--10 bottle of 1000Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Dispense in a tight container as defined in the USP, with a child-resistant closure (as required).KEEP CONTAINER TIGHTLY CLOSED.KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg, are available as off-white to pale yellow granule-filled, light turquoise blue, opaque, hard-gelatin capsules, spin-printed “” and “6450” on the cap and “20 mg” on the body in gold ink containing 20 mg esomeprazole packaged in bottles of 30, 90, and 1000 capsules.NDC 0093--56 bottle of 30NDC 0093--98 bottle of 90NDC 0093--10 bottle of 1000Esomeprazole Magnesium Delayed-Release Capsules USP, 40 mg, are available as off-white to pale yellow granule-filled, light turquoise blue, opaque, hard-gelatin capsules, spin-printed “” and “6451” on the cap and “40 mg” on the body in gold ink containing 40 mg esomeprazole packaged in bottles of 30, 90, and 1000 capsules.NDC 0093--56 bottle of 30NDC 0093-6451-98 bottle of 90NDC 0093--10 bottle of 1000Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Dispense in a tight container as defined in the USP, with a child-resistant closure (as required).KEEP CONTAINER TIGHTLY CLOSED.KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg, are available as off-white to pale yellow granule-filled, light turquoise blue, opaque, hard-gelatin capsules, spin-printed “” and “6450” on the cap and “20 mg” on the body in gold ink containing 20 mg esomeprazole packaged in bottles of 30, 90, and 1000 capsules.NDC 0093--56 bottle of 30NDC 0093--98 bottle of 90NDC 0093--10 bottle of 1000Esomeprazole Magnesium Delayed-Release Capsules USP, 40 mg, are available as off-white to pale yellow granule-filled, light turquoise blue, opaque, hard-gelatin capsules, spin-printed “” and “6451” on the cap and “40 mg” on the body in gold ink containing 40 mg esomeprazole packaged in bottles of 30, 90, and 1000 capsules.NDC 0093--56 bottle of 30NDC 0093-6451-98 bottle of 90NDC 0093--10 bottle of 1000Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Dispense in a tight container as defined in the USP, with a child-resistant closure (as required).KEEP CONTAINER TIGHTLY CLOSED.KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg, are available as off-white to pale yellow granule-filled, light turquoise blue, opaque, hard-gelatin capsules, spin-printed “” and “6450” on the cap and “20 mg” on the body in gold ink containing 20 mg esomeprazole packaged in bottles of 30, 90, and 1000 capsules.NDC 0093--56 bottle of 30NDC 0093--98 bottle of 90NDC 0093--10 bottle of 1000Esomeprazole Magnesium Delayed-Release Capsules USP, 40 mg, are available as off-white to pale yellow granule-filled, light turquoise blue, opaque, hard-gelatin capsules, spin-printed “” and “6451” on the cap and “40 mg” on the body in gold ink containing 40 mg esomeprazole packaged in bottles of 30, 90, and 1000 capsules.NDC 0093--56 bottle of 30NDC 0093-6451-98 bottle of 90NDC 0093--10 bottle of 1000Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Dispense in a tight container as defined in the USP, with a child-resistant closure (as required).KEEP CONTAINER TIGHTLY CLOSED.KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg, are available as off-white to pale yellow granule-filled, light turquoise blue, opaque, hard-gelatin capsules, spin-printed “” and “6450” on the cap and “20 mg” on the body in gold ink containing 20 mg esomeprazole packaged in bottles of 30, 90, and 1000 capsules.NDC 0093--56 bottle of 30NDC 0093--98 bottle of 90NDC 0093--10 bottle of 1000Esomeprazole Magnesium Delayed-Release Capsules USP, 40 mg, are available as off-white to pale yellow granule-filled, light turquoise blue, opaque, hard-gelatin capsules, spin-printed “” and “6451” on the cap and “40 mg” on the body in gold ink containing 40 mg esomeprazole packaged in bottles of 30, 90, and 1000 capsules.NDC 0093--56 bottle of 30NDC 0093-6451-98 bottle of 90NDC 0093--10 bottle of 1000Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Dispense in a tight container as defined in the USP, with a child-resistant closure (as required).KEEP CONTAINER TIGHTLY CLOSED.KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
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
Esomeprazole magnesium is contraindicated in patients with known hypersensitivity to substituted benzimidazoles or to any component of the formulation. Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute interstitial nephritis, and urticaria [ ]. For information about contraindications of antibacterial agents (clarithromycin and amoxicillin) indicated in combination with esomeprazole magnesium, refer to the CONTRAINDICATIONS section of their package inserts.Additive adverse effects resulting from cholinergic blockade may occur when hyoscyamine sulfate is administered concomitantly with other antimuscarinics, amantadine, haloperidol, phenothiazines, monoamine oxidase (MAO) inhibitors, tricyclic antidepressants or some antihistamines.
Antacids may interfere with the absorption of hyoscyamine sulfate. Administer Hyoscyamine Sulfate Sublingual Tablets before meals; antacids after meals.
In adults, symptomatic response to therapy with esomeprazole magnesium does not preclude the presence of gastric malignancy. Consider additional follow-up and diagnostic testing in adult patients who have a suboptimal response or an early symptomatic relapse after completing treatment with a PPI. In older patients, also consider an endoscopy.
The following serious adverse reactions are described below and elsewhere in labeling:
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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