Omeprazole and Sodium Bicarbonate

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Overview

What is Omeprazole and Sodium Bicarbonate?

Omeprazole and Sodium Bicarbonate capsules are a combination of omeprazole, a proton-pump inhibitor, and sodium bicarbonate, an antacid. Omeprazole is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1benzimidazole, 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 is a white to off-white crystalline powder which melts with decomposition at about 155ºC. It is a weak base, freely soluble in ethanol and methanol, and slightly soluble in acetone and isopropanol and very slightly soluble in water. The stability of omeprazole is a function of pH; it is rapidly degraded in acid media, but has acceptable stability under alkaline conditions. Omeprazole and Sodium Bicarbonate capsules are 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 black imprinting ink contains black iron oxide, propylene glycol, shellac, and potassium hydroxide.

What does Omeprazole and Sodium Bicarbonate look like?

What are the available doses of Omeprazole and Sodium Bicarbonate?

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What should I talk to my health care provider before I take Omeprazole and Sodium Bicarbonate?

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How should I use Omeprazole and Sodium Bicarbonate?

Omeprazole and Sodium Bicarbonate is available as a capsule in 20 mg and 40 mg strengths of omeprazole for adult use. Usual dosage for each indication are summarized in . All recommended doses throughout the labeling are based upon omeprazole.

Since both the 20 mg and 40 mg contain the same amount of sodium bicarbonate (1100 mg), two capsules of 20 mg are equivalent to one capsule of Omeprazole and Sodium Bicarbonate 40 mg; therefore, two 20 mg capsules of Omeprazole and Sodium Bicarbonate should not be substituted for one capsule of40 mg Omeprazole and Sodium Bicarbonate.

Omeprazole and Sodium Bicarbonate capsules should be taken on an empty stomach at least one hour before a meal.

Special Populations

Hepatic Insufficiency

Consider dose reduction, particularly for maintenance of healing of erosive esophagitis.

Administration of Capsules

Omeprazole and Sodium Bicarbonate Capsules should be swallowed intact with water. DO NOT USE OTHER LIQUIDS. DO NOT OPEN CAPSULE AND SPRINKLE CONTENTS INTO FOOD.

What interacts with Omeprazole and Sodium Bicarbonate?

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What are the warnings of Omeprazole and Sodium Bicarbonate?

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What are the precautions of Omeprazole and Sodium Bicarbonate?

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What are the side effects of Omeprazole and Sodium Bicarbonate?

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What should I look out for while using Omeprazole and Sodium Bicarbonate?

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Drug Interactions:

What might happen if I take too much Omeprazole and 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 and Sodium Bicarbonate?

Store at 20°C to 25°C (68°F to 77°F) excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from moisture.Dispense in tight, light-resistant containers.Store at 20°C to 25°C (68°F to 77°F) excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from moisture.Dispense in tight, light-resistant containers.Omeprazole and Sodium Bicarbonate 20 mg Capsules:NDC 27241-031-03 Bottles of 30 capsulesOmeprazole and Sodium Bicarbonate 40 mg Capsules:NDC 27241-032-03 Bottles of 30 capsulesStorageStore at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Keep container tightly closed. Protect from light and moisture.Omeprazole and Sodium Bicarbonate 20 mg Capsules:NDC 27241-031-03 Bottles of 30 capsulesOmeprazole and Sodium Bicarbonate 40 mg Capsules:NDC 27241-032-03 Bottles of 30 capsulesStorageStore at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Keep container tightly closed. Protect from light and moisture.Omeprazole and Sodium Bicarbonate 20 mg Capsules:NDC 27241-031-03 Bottles of 30 capsulesOmeprazole and Sodium Bicarbonate 40 mg Capsules:NDC 27241-032-03 Bottles of 30 capsulesStorageStore at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Keep container tightly closed. Protect from light and moisture.Omeprazole and Sodium Bicarbonate 20 mg Capsules:NDC 27241-031-03 Bottles of 30 capsulesOmeprazole and Sodium Bicarbonate 40 mg Capsules:NDC 27241-032-03 Bottles of 30 capsulesStorageStore at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Keep container tightly closed. Protect from light and moisture.Omeprazole and Sodium Bicarbonate 20 mg Capsules:NDC 27241-031-03 Bottles of 30 capsulesOmeprazole and Sodium Bicarbonate 40 mg Capsules:NDC 27241-032-03 Bottles of 30 capsulesStorageStore at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Keep container tightly closed. Protect from light and moisture.Omeprazole and Sodium Bicarbonate 20 mg Capsules:NDC 27241-031-03 Bottles of 30 capsulesOmeprazole and Sodium Bicarbonate 40 mg Capsules:NDC 27241-032-03 Bottles of 30 capsulesStorageStore at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Keep container tightly closed. Protect from light and moisture.

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Clinical Information

Chemical Structure

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Clinical Pharmacology

Non-Clinical Toxicology

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In adults, symptomatic response to therapy with Omeprazole and Sodium Bicarbonate capsules 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.

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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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Review

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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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