omeprazole sodium bicarbonate

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Overview

What is omeprazole sodium bicarbonate?

Omeprazole and sodium bicarbonate is a combination of omeprazole, a proton-pump inhibitor, and sodium bicarbonate, an antacid. Omeprazole is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3,5dimethyl-2-pyridinyl)methyl]sulfinyl]-1-benzimidazole, a racemic mixture of two enantiomers that inhibits gastric acid secretion. Its empirical formula is CHNOS, with a molecular weight of 345.42. The structural formula is:

Omeprazole, USP is a white or almost white powder which melts with decomposition at about 155°C. Soluble in dichloromethane, practically insoluble 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.

Omeprazole and sodium bicarbonate is supplied as immediate-release capsules. Each capsule contains either 40 mg or 20 mg of omeprazole and 1100 mg of sodium bicarbonate with the following excipients: croscarmellose sodium and sodium stearyl fumarate. The capsules consist of gelatin and titanium dioxide. In addition the 20 mg/1100 mg capsule shell contains sodium lauryl sulfate and the 40 mg/1100 mg capsule shell contains FD&C Blue 1. The capsules are printed with edible ink containing black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, propylene glycol, potassium hydroxide, shellac and strong ammonia solution.

What does omeprazole sodium bicarbonate look like?

What are the available doses of omeprazole sodium bicarbonate?

Omeprazole and Sodium Bicarbonate Capsules, 20mg/1100 mg:

Omeprazole and Sodium Bicarbonate Capsules, 40 mg/1100 mg:

What should I talk to my health care provider before I take omeprazole sodium bicarbonate?

How should I use omeprazole sodium bicarbonate?

Omeprazole and sodium bicarbonate 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.

Gastric Ulcer

Omeprazole and sodium bicarbonate is indicated for short-term treatment (4-8 weeks) of active benign gastric ulcer.

Short-Term Treatment of Active Duodenal Ulcer: 20 mg once daily for 4 weeks (some patients may require an additional 4 weeks of therapy (14.1)) (2)

Gastric Ulcer: 40 mg once daily for 4-8 weeks (2)

Gastroesophageal Reflux Disease (GERD) (2)

Symptomatic GERD (with no esophageal erosions): 20 mg once daily for up to 4 weeks

Erosive Esophagitis: 20 mg once daily for 4-8 weeks

Maintenance of Healing of Erosive Esophagitis: 20 mg once daily* (2) *Studied for 12 months

What interacts with omeprazole sodium bicarbonate?

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What are the warnings of omeprazole sodium bicarbonate?

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What are the precautions of omeprazole sodium bicarbonate?

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What are the side effects of omeprazole sodium bicarbonate?

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What should I look out for while using omeprazole sodium bicarbonate?

Known hypersensitivity to any components of the formulation (4)

What might happen if I take too much omeprazole sodium bicarbonate?

Reports have been received of overdosage with omeprazole in humans. Doses ranged up to 2400 mg (120 times the usual recommended clinical dose). Manifestations were variable, but included confusion, drowsiness, blurred vision, tachycardia, nausea, vomiting, diaphoresis, flushing, headache, dry mouth, and other adverse reactions similar to those seen in normal clinical experience Symptoms were transient, and no serious clinical outcome has been reported when omeprazole was taken alone. No specific antidote for omeprazole overdosage is known. Omeprazole is extensively protein bound and is, therefore, not readily dialyzable. 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, a certified Regional Poison Control Center should be contacted. Telephone numbers are listed in the Physicians' Desk Reference (PDR) or local telephone book.

Single oral doses of omeprazole at 1350, 1339, and 1200 mg/kg were lethal to mice, rats, and dogs, respectively. Animals given these doses showed sedation, ptosis, tremors, convulsions, and decreased activity, body temperature, and respiratory rate and increased depth of respiration.

In addition, a sodium bicarbonate overdose may cause hypocalcemia, hypokalemia, hypernatremia, and seizures.

How should I store and handle omeprazole sodium bicarbonate?

Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F). [See USP Controlled Room Temperature.] Sterile, Nonpyrogenic, Preservative-free, DEHP-free.The container closure is not made with natural rubber latex.TERUMO and Surflo are registered trademarks of TERUMO CORPORATION. Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F). [See USP Controlled Room Temperature.] Sterile, Nonpyrogenic, Preservative-free, DEHP-free.The container closure is not made with natural rubber latex.TERUMO and Surflo are registered trademarks of TERUMO CORPORATION. Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F). [See USP Controlled Room Temperature.] Sterile, Nonpyrogenic, Preservative-free, DEHP-free.The container closure is not made with natural rubber latex.TERUMO and Surflo are registered trademarks of TERUMO CORPORATION. Omeprazole and Sodium Bicarbonate Capsules, 20mg/1100 mg: NDC: 69097-913-02 Bottles of 30sNDC: 69097-913-12 Bottles of 500sOmeprazole and Sodium Bicarbonate Capsules, 40 mg/1100 mg: NDC: 69097-914-02 Bottles of 30sNDC: 69097-914-12 Bottles of 500sStorage Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F). [See USP Controlled Room Temperature]. Keep this medication out of the hands of children. Keep container tightly closed. Protect from light and moisture. Omeprazole and Sodium Bicarbonate Capsules, 20mg/1100 mg: NDC: 69097-913-02 Bottles of 30sNDC: 69097-913-12 Bottles of 500sOmeprazole and Sodium Bicarbonate Capsules, 40 mg/1100 mg: NDC: 69097-914-02 Bottles of 30sNDC: 69097-914-12 Bottles of 500sStorage Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F). [See USP Controlled Room Temperature]. Keep this medication out of the hands of children. Keep container tightly closed. Protect from light and moisture. Omeprazole and Sodium Bicarbonate Capsules, 20mg/1100 mg: NDC: 69097-913-02 Bottles of 30sNDC: 69097-913-12 Bottles of 500sOmeprazole and Sodium Bicarbonate Capsules, 40 mg/1100 mg: NDC: 69097-914-02 Bottles of 30sNDC: 69097-914-12 Bottles of 500sStorage Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F). [See USP Controlled Room Temperature]. Keep this medication out of the hands of children. Keep container tightly closed. Protect from light and moisture. Omeprazole and Sodium Bicarbonate Capsules, 20mg/1100 mg: NDC: 69097-913-02 Bottles of 30sNDC: 69097-913-12 Bottles of 500sOmeprazole and Sodium Bicarbonate Capsules, 40 mg/1100 mg: NDC: 69097-914-02 Bottles of 30sNDC: 69097-914-12 Bottles of 500sStorage Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F). [See USP Controlled Room Temperature]. Keep this medication out of the hands of children. Keep container tightly closed. Protect from light and moisture. Omeprazole and Sodium Bicarbonate Capsules, 20mg/1100 mg: NDC: 69097-913-02 Bottles of 30sNDC: 69097-913-12 Bottles of 500sOmeprazole and Sodium Bicarbonate Capsules, 40 mg/1100 mg: NDC: 69097-914-02 Bottles of 30sNDC: 69097-914-12 Bottles of 500sStorage Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F). [See USP Controlled Room Temperature]. Keep this medication out of the hands of children. Keep container tightly closed. Protect from light and moisture. Omeprazole and Sodium Bicarbonate Capsules, 20mg/1100 mg: NDC: 69097-913-02 Bottles of 30sNDC: 69097-913-12 Bottles of 500sOmeprazole and Sodium Bicarbonate Capsules, 40 mg/1100 mg: NDC: 69097-914-02 Bottles of 30sNDC: 69097-914-12 Bottles of 500sStorage Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F). [See USP Controlled Room Temperature]. Keep this medication out of the hands of children. Keep container tightly closed. Protect from light and moisture. Omeprazole and Sodium Bicarbonate Capsules, 20mg/1100 mg: NDC: 69097-913-02 Bottles of 30sNDC: 69097-913-12 Bottles of 500sOmeprazole and Sodium Bicarbonate Capsules, 40 mg/1100 mg: NDC: 69097-914-02 Bottles of 30sNDC: 69097-914-12 Bottles of 500sStorage Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F). [See USP Controlled Room Temperature]. Keep this medication out of the hands of children. Keep container tightly closed. Protect from light and moisture. Omeprazole and Sodium Bicarbonate Capsules, 20mg/1100 mg: NDC: 69097-913-02 Bottles of 30sNDC: 69097-913-12 Bottles of 500sOmeprazole and Sodium Bicarbonate Capsules, 40 mg/1100 mg: NDC: 69097-914-02 Bottles of 30sNDC: 69097-914-12 Bottles of 500sStorage Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F). [See USP Controlled Room Temperature]. Keep this medication out of the hands of children. Keep container tightly closed. Protect from light and moisture. Omeprazole and Sodium Bicarbonate Capsules, 20mg/1100 mg: NDC: 69097-913-02 Bottles of 30sNDC: 69097-913-12 Bottles of 500sOmeprazole and Sodium Bicarbonate Capsules, 40 mg/1100 mg: NDC: 69097-914-02 Bottles of 30sNDC: 69097-914-12 Bottles of 500sStorage Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F). [See USP Controlled Room Temperature]. Keep this medication out of the hands of children. Keep container tightly closed. Protect from light and moisture.

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Clinical Information

Chemical Structure

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Clinical Pharmacology

Omeprazole belongs to a class of antisecretory compounds, the substituted benzimidazoles, that do not exhibit anticholinergic or H histamine antagonistic properties, but that suppress gastric acid secretion by specific inhibition of the H+/K+ ATPase enzyme system at the secretory surface of the gastric parietal cell. Because this enzyme system is regarded as the acid (proton) pump within the gastric mucosa, omeprazole has been characterized as a gastric acid-pump inhibitor, in that it blocks the final step of acid production. This effect is dose related and leads to inhibition of both basal and stimulated acid secretion irrespective of the stimulus. Animal studies indicate that after rapid disappearance from plasma, omeprazole can be found within the gastric mucosa for a day or more.

Omeprazole is acid labile and thus rapidly degraded by gastric acid. Omeprazole and sodium bicarbonate capsules are immediate-release formulations that contain sodium bicarbonate which raises the gastric pH and thus protects omeprazole from acid degradation.

Non-Clinical Toxicology

Known hypersensitivity to any components of the formulation (4)

Cevimeline should be administered with caution to patients taking beta adrenergic antagonists, because of the possibility of conduction disturbances. Drugs with parasympathomimetic effects administered concurrently with cevimeline can be expected to have additive effects. Cevimeline might interfere with desirable antimuscarinic effects of drugs used concomitantly.

Drugs which inhibit CYP2D6 and CYP3A3/4 also inhibit the metabolism of cevimeline. Cevimeline should be used with caution in individuals known or suspected to be deficient in CYP2D6 activity, based on previous experience, as they may be at a higher risk of adverse events. In an study, cytochrome P450 isozymes 1A2, 2A6, 2C9, 2C19, 2D6, 2E1, and 3A4 were not inhibited by exposure to cevimeline.

Symptomatic response to therapy with omeprazole does not preclude the presence of gastric malignancy.

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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

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).

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