ESOMEPRAZOLE STRONTIUM

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Overview

What is ESOMEPRAZOLE STRONTIUM?

The active ingredient in the proton pump inhibitor esomeprazole strontium delayed-release capsules is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1-benzimidazole-1-yl) strontium tetrahydrate. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S- and R- isomers. The molecular formula of esomeprazole strontium is (CHNOS)·Sr·4HO with molecular weight of 848.50. The structural formula is:

Figure 1:

The strontium salt is a white or almost white crystalline powder. Each molecule contains 4 moles of water of solvation and is soluble in water.

Esomeprazole strontium is supplied in delayed-release capsules. Each delayed-release capsule contains 49.3 mg esomeprazole strontium equivalent to 40 mg esomeprazole, in the form of enteric-coated granules with the following inactive ingredients: calcium carbonate, hypromellose, methacrylic acid copolymer dispersion, mono- and diglycerides, polysorbate 80, sugar spheres, talc, triethyl citrate. The 49.3 mg capsule shells have the following inactive ingredients: gelatin, titanium dioxide, FD&C Blue #1, FD&C Red #40, FD&C Yellow #6.

Each 49.3 mg capsule contains 5.1 mg of strontium.

What does ESOMEPRAZOLE STRONTIUM look like?

What are the available doses of ESOMEPRAZOLE STRONTIUM?

Delayed-released capsules: 49.3 mg of esomeprazole strontium (equivalent to 40 mg of esomeprazole) - hard capsules with dark pink cap and body containing off white to pale brown granules with HMP 40 printed in black ink.

What should I talk to my health care provider before I take ESOMEPRAZOLE STRONTIUM?

How should I use ESOMEPRAZOLE STRONTIUM?

Healing of Erosive Esophagitis

Esomeprazole strontium 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 esomeprazole strontium may be considered.

Maintenance of Healing of Erosive Esophagitis

Esomeprazole strontium is indicated to maintain symptom resolution and healing of erosive esophagitis. Controlled studies do not extend beyond 6 months.

Symptomatic Gastroesophageal Reflux Disease

Esomeprazole strontium is indicated for short-term treatment (4 to 8 weeks) of heartburn and other symptoms associated with GERD in adults.

Esomeprazole strontium is indicated for the reduction in the occurrence of gastric ulcers associated with continuous NSAID therapy in patients at risk for developing gastric ulcers. Patients are considered to be at risk either due to their age (≥60) and/or documeted history of gastric ulcers. Controlled studies do not extend beyond 6 months.

Triple Therapy (esomeprazole stronitum plus amoxicillin and clarithromycin): esomeprazole strontium, in combination with amoxicillin and clarithromycin, is indicated for the treatment of patients with infection and duodenal ulcer disease (active or history of within the past 5 years) to eradicate . Eradication of has been shown to reduce the risk of duodenal ulcer recurrence [ and ]

In patients who fail therapy, susceptibility testing should be done. If resistance to clarithromycin is demonstrated or susceptability testing is not possible, alternative antimicrobial therapy should be instituted [ and the prescibing information for clarithromycin].

Esomeprazole strontium is indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellision Syndrome.

The duration of proton pump inhibitor administration should be based on avaliable safety and efficacy data specific to the defined indication and dosing frequency, as described in the prescibing information, and individual patient medical needs. Proton pump inihibitor treatment should only be initiated and continued if the benefits outweigh the risks of treatment.

Gastroesophageal Reflux Disease (GERD)

*[.] The majority of patients are healed within 4 to 8 weeks. For patients who do not heal after 4 to 8 weeks, an additional 4 to 8 weeks of treatment may be considered.

** Controlled studies did not extend beyond six months.

†The dosage of esomeprazole strontium in patients with pathological hypersecretory conditions varies with the individual patient. Dosage regimens should be adjusted to individual patient needs.

‡Doses up to 240 mg daily have been administered [].

a 49.3 mg of esomeprazole strontium is equivalent to 40 mg of esomeprazole

‡‡Studied for 12 months for Maintenance of Healing of Erosive Esophagitis

Refer to amoxicillin and clarithromycin full prescribing information for Contraindications, Warnings, and dosing in elderly and in renally-impared patients.

Special 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 24.65 mg of esomeprazole strontium (equivalent to 20 mg of esomeprazole) should not be exceeded [].

Administrative Options

Directions for use specific to the route and available methods of administration are presented in Table 2.

Table 2: Administration Options

Esomeprazole strontium delayed-release capsules should be swallowed whole. Do not chew or crush campsule.

Alternatively, for patients who have difficulty swallowing capsules, one tablespoon of applesauce can be added to an empty bowl and the esomeprazole strontium 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 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 it entirety, the remaining mixture should be discarded immediately.

For patients who have a nasogastric tube in place, esomeprazole strontium delayed-release capsules can be opened and the intact granules emptied in 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 strontium delayed-release capsules 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 ESOMEPRAZOLE STRONTIUM?

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What are the warnings of ESOMEPRAZOLE STRONTIUM?

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What are the precautions of ESOMEPRAZOLE STRONTIUM?

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What are the side effects of ESOMEPRAZOLE STRONTIUM?

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What should I look out for while using ESOMEPRAZOLE STRONTIUM?

For information about contraindications of antibacterial agents (clarithromycin and amoxicillin) indicated in combination with esomeprazole strontium, refer to the CONTRAINDICATIONS section of their package inserts.

What might happen if I take too much ESOMEPRAZOLE STRONTIUM?

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 esomeprazole 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 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 ESOMEPRAZOLE STRONTIUM?

Esomeprazole strontium delayed-release capsules, 49.3 mg (equivalent to 40 mg of esomeprazole), are hard capsules with dark pink cap and body containing off-white to pale brown granules with HMP 40 printed in black ink.It is available as follows:Unit of use bottle of 30 NDC 52246-400-30Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Keep esomeprazole strontium delayed-release capsules container tightly closed. Dispense in a tight container if the esomeprazole strontium delayed-release capsules product package is subdivided.Esomeprazole strontium delayed-release capsules, 49.3 mg (equivalent to 40 mg of esomeprazole), are hard capsules with dark pink cap and body containing off-white to pale brown granules with HMP 40 printed in black ink.It is available as follows:Unit of use bottle of 30 NDC 52246-400-30Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Keep esomeprazole strontium delayed-release capsules container tightly closed. Dispense in a tight container if the esomeprazole strontium delayed-release capsules product package is subdivided.Esomeprazole strontium delayed-release capsules, 49.3 mg (equivalent to 40 mg of esomeprazole), are hard capsules with dark pink cap and body containing off-white to pale brown granules with HMP 40 printed in black ink.It is available as follows:Unit of use bottle of 30 NDC 52246-400-30Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Keep esomeprazole strontium delayed-release capsules container tightly closed. Dispense in a tight container if the esomeprazole strontium delayed-release capsules product package is subdivided.Esomeprazole strontium delayed-release capsules, 49.3 mg (equivalent to 40 mg of esomeprazole), are hard capsules with dark pink cap and body containing off-white to pale brown granules with HMP 40 printed in black ink.It is available as follows:Unit of use bottle of 30 NDC 52246-400-30Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Keep esomeprazole strontium delayed-release capsules container tightly closed. Dispense in a tight container if the esomeprazole strontium delayed-release capsules product package is subdivided.

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Clinical Information

Chemical Structure

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Clinical Pharmacology

Esomeprazole is a proton pump inhibito that suppresses gastric acid secretion 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

For information about contraindications of antibacterial agents (clarithromycin and amoxicillin) indicated in combination with esomeprazole strontium, refer to the CONTRAINDICATIONS section of their package inserts.

When corticosteroids are administered concomitantly with potassium-depleting agents (e.g., ), patients should be observed closely for development of hypokalemia. In addition, there have been cases reported in which concomitant use of amphotericin B and hydrocortisone was followed by cardiac enlargement and congestive heart failure.

Macrolide antibiotics have been reported to cause a significant decrease in corticosteroid clearance (see ).

Concomitant use of anticholinesterase agents (e.g., ) and corticosteroids may produce severe weakness in patients with myasthenia gravis. If possible, anticholinesterase agents should be withdrawn at least 24 hours before initiating corticosteroid therapy. If concomitant therapy must occur, it should take place under close supervision and the need for respiratory support should be anticipated.

Coadministration of corticosteroids and usually results in inhibition of response to warfarin, although there have been some conflicting reports. Therefore, coagulation indices should be monitored frequently to maintain the desired anticoagulant effect.

Because corticosteroids may increase blood glucose concentrations, dosage adjustments of antidiabetic agents may be required.

Serum concentrations of may be decreased.

Since systemic steroids, as well as bupropion, can lower the seizure threshold, concurrent administration should be undertaken only with extreme caution; low initial dosing and small gradual increases should be employed.

Cholestyramine may increase the clearance of corticosteroids.

Increased activity of both cyclosporine and corticosteroids may occur when the two are used concurrently. Convulsions have been reported with this concurrent use.

Patients on digitalis glycosides may be at increased risk of arrhythmias due to hypokalemia.

Estrogens may decrease the hepatic metabolism of certain corticosteroids, thereby increasing their effect.

Postmarketing surveillance reports indicate that the risk of tendon rupture may be increased in patients receiving concomitant fluoroquinolones (e.g., ) and corticosteroids, especially in the elderly. Tendon rupture can occur during or after treatment with quinolones.

Drugs which cytochrome P450 3A4 (CYP 3A4) enzyme activity (e.g., ) may enhance the metabolism of corticosteroids and require that the dosage of the corticosteroid be increased. Drugs which CYP 3A4 (e.g., ) have the potential to result in increased plasma concentrations of corticosteroids. Glucocorticoids are moderate inducers of CYP 3A4. Coadministration with other drugs that are metabolized by CYP 3A4 (e.g., ) may increase their clearance, resulting in decreased plasma concentration.

Ketoconazole has been reported to decrease the metabolism of certain corticosteroids by up to 60%, leading to increased risk of corticosteroid side effects. In addition, ketoconazole alone can inhibit adrenal corticosteroid synthesis and may cause adrenal insufficiency during corticosteroid withdrawal.

Concomitant use of (or other ) and corticosteroids increases the risk of gastrointestinal side effects. Aspirin should be used cautiously in conjunction with corticosteroids in hypoprothrombinemia. The clearance of salicylates may be increased with concurrent use of corticosteroids; this could lead to decreased salicylate serum levels or increase the risk of salicylate toxicity when corticosteroid is withdrawn.

In postmarketing experience, there have been reports of both increases and decreases in phenytoin levels with dexamethasone coadministration, leading to alterations in seizure control. Phenytoin has been demonstrated to increase the hepatic metabolism of corticosteroids, resulting in a decreased therapeutic effect of the corticosteroid.

Increased doses of quetiapine may be required to maintain control of symptoms of schizophrenia in patients receiving a glucocorticoid, a hepatic enzyme inducer.

Corticosteroids may suppress reactions to skin tests.

Coadministration with thalidomide should be employed cautiously, as toxic epidermal necrolysis has been reported with concomitant use.

Patients on corticosteroid therapy may exhibit a diminished response to toxoids and live or inactivated vaccines due to inhibition of antibody response. Corticosteroids may also potentiate the replication of some organisms contained in live attenuated vaccines. Routine administration of vaccines or toxoids should be deferred until corticosteroid therapy is discontinued if possible (see ).

The following serious adverse reactions are descibed below and elsewhere in labeling:

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

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. 315.72

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Interactions

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