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Omeprazole and Sodium Bicrabonate

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Overview

What is Omeprazole and Sodium Bicrabonate?

Omeprazole and sodium bicarbonate capsules are a combination of omeprazole USP, a proton-pump inhibitor, and sodium bicarbonate USP, an antacid. Omeprazole USP is a substituted benzimidazole,5-methoxy-2-[[(4-methoxy-3,5-dimethyl-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 to off-white powder, melts between 150°C and 160°C with decomposition. It is soluble in dichloromethane, sparingly soluble in methanol and in alcohol. The stability of omeprazole USP 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 USP and 1100 mg of sodium bicarbonate USP with the following excipients: colloidal silicon dioxide, croscarmellose sodium and sodium stearyl fumerate. Each hard gelatin capsule contains: FD&C Blue No.1 (for 40 mg) FD&C Red No.40 (for 40 mg), gelatin, sodium lauryl sulfate and titanium dioxide. White Imprinting Ink contains: Potassium hydroxide, propylene glycol, shellac, strong ammonia solution and titanium dioxide. Blue Imprinting Ink (for 40 mg) contains: FD&C Blue no.2 aluminum lake, propylene glycol, shellac, strong ammonia solution.



What does Omeprazole and Sodium Bicrabonate look like?



What are the available doses of Omeprazole and Sodium Bicrabonate?

Omeprazole and sodium bicarbonate 20 mg/1100 mg capsules:

Omeprazole and sodium bicarbonate 40 mg/1100 mg capsules:

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

How should I use Omeprazole and Sodium Bicrabonate?

Omeprazole and sodium bicarbonate is available as a capsule in 20 mg and 40 mg strengths of omeprazole for adult use. Directions for use for each indication are summarized in Table 1. 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 of omeprazole and sodium bicarbonate 40 mg.

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

Table 1: Recommended Doses of Omeprazole and Sodium Bicarbonate Capsules by Indication for Adults 18 Years and Older

Clinical Studies ()

Indications and Usage ()

Clinical Studies ()]

Special Populations

Hepatic Insufficiency

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

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 Bicrabonate?

Sorry No Records found


What are the warnings of Omeprazole and Sodium Bicrabonate?

Sorry No Records found


What are the precautions of Omeprazole and Sodium Bicrabonate?

Sorry No Records found


What are the side effects of Omeprazole and Sodium Bicrabonate?

Sorry No records found


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

Omeprazole and sodium bicarbonate is contraindicated in patients with known hypersensitivity to any components of the formulation. Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute interstitial nephritis, and urticaria. [See


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

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. [See ] 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 Bicrabonate?

Store at 20°-25°C (68°-77°F) (see USP Controlled Room Temperature).Dispense in a tight, light-resistant container.Store at 20°-25°C (68°-77°F) (see USP Controlled Room Temperature).Dispense in a tight, light-resistant container.Omeprazole and sodium bicarbonate capsules, 20 mg/1100 mg: Bottles of 30                                                                           NDC 55111-363-30Bottles of 100                                                                         NDC 55111-363-01Bottles of 500                                                                         NDC 55111-363-05Omeprazole and sodium bicarbonate capsules, 40 mg/1100 mg: Bottles of 30                                                                           NDC 55111-364-30Bottles of 100                                                                         NDC 55111-364-01Bottles of 500                                                                         NDC 55111-364-05Storage Keep container tightly closed. Protect from light and moisture. Omeprazole and sodium bicarbonate capsules, 20 mg/1100 mg: Bottles of 30                                                                           NDC 55111-363-30Bottles of 100                                                                         NDC 55111-363-01Bottles of 500                                                                         NDC 55111-363-05Omeprazole and sodium bicarbonate capsules, 40 mg/1100 mg: Bottles of 30                                                                           NDC 55111-364-30Bottles of 100                                                                         NDC 55111-364-01Bottles of 500                                                                         NDC 55111-364-05Storage Keep container tightly closed. Protect from light and moisture. Omeprazole and sodium bicarbonate capsules, 20 mg/1100 mg: Bottles of 30                                                                           NDC 55111-363-30Bottles of 100                                                                         NDC 55111-363-01Bottles of 500                                                                         NDC 55111-363-05Omeprazole and sodium bicarbonate capsules, 40 mg/1100 mg: Bottles of 30                                                                           NDC 55111-364-30Bottles of 100                                                                         NDC 55111-364-01Bottles of 500                                                                         NDC 55111-364-05Storage Keep container tightly closed. Protect from light and moisture. Omeprazole and sodium bicarbonate capsules, 20 mg/1100 mg: Bottles of 30                                                                           NDC 55111-363-30Bottles of 100                                                                         NDC 55111-363-01Bottles of 500                                                                         NDC 55111-363-05Omeprazole and sodium bicarbonate capsules, 40 mg/1100 mg: Bottles of 30                                                                           NDC 55111-364-30Bottles of 100                                                                         NDC 55111-364-01Bottles of 500                                                                         NDC 55111-364-05Storage Keep container tightly closed. Protect from light and moisture. Omeprazole and sodium bicarbonate capsules, 20 mg/1100 mg: Bottles of 30                                                                           NDC 55111-363-30Bottles of 100                                                                         NDC 55111-363-01Bottles of 500                                                                         NDC 55111-363-05Omeprazole and sodium bicarbonate capsules, 40 mg/1100 mg: Bottles of 30                                                                           NDC 55111-364-30Bottles of 100                                                                         NDC 55111-364-01Bottles of 500                                                                         NDC 55111-364-05Storage Keep container tightly closed. Protect from light and moisture. Omeprazole and sodium bicarbonate capsules, 20 mg/1100 mg: Bottles of 30                                                                           NDC 55111-363-30Bottles of 100                                                                         NDC 55111-363-01Bottles of 500                                                                         NDC 55111-363-05Omeprazole and sodium bicarbonate capsules, 40 mg/1100 mg: Bottles of 30                                                                           NDC 55111-364-30Bottles of 100                                                                         NDC 55111-364-01Bottles of 500                                                                         NDC 55111-364-05Storage Keep container tightly closed. Protect from light and moisture. Omeprazole and sodium bicarbonate capsules, 20 mg/1100 mg: Bottles of 30                                                                           NDC 55111-363-30Bottles of 100                                                                         NDC 55111-363-01Bottles of 500                                                                         NDC 55111-363-05Omeprazole and sodium bicarbonate capsules, 40 mg/1100 mg: Bottles of 30                                                                           NDC 55111-364-30Bottles of 100                                                                         NDC 55111-364-01Bottles of 500                                                                         NDC 55111-364-05Storage Keep container tightly closed. Protect from light and moisture. Omeprazole and sodium bicarbonate capsules, 20 mg/1100 mg: Bottles of 30                                                                           NDC 55111-363-30Bottles of 100                                                                         NDC 55111-363-01Bottles of 500                                                                         NDC 55111-363-05Omeprazole and sodium bicarbonate capsules, 40 mg/1100 mg: Bottles of 30                                                                           NDC 55111-364-30Bottles of 100                                                                         NDC 55111-364-01Bottles of 500                                                                         NDC 55111-364-05Storage Keep container tightly closed. Protect from light and moisture. Omeprazole and sodium bicarbonate capsules, 20 mg/1100 mg: Bottles of 30                                                                           NDC 55111-363-30Bottles of 100                                                                         NDC 55111-363-01Bottles of 500                                                                         NDC 55111-363-05Omeprazole and sodium bicarbonate capsules, 40 mg/1100 mg: Bottles of 30                                                                           NDC 55111-364-30Bottles of 100                                                                         NDC 55111-364-01Bottles of 500                                                                         NDC 55111-364-05Storage Keep container tightly closed. Protect from light and moisture. Omeprazole and sodium bicarbonate capsules, 20 mg/1100 mg: Bottles of 30                                                                           NDC 55111-363-30Bottles of 100                                                                         NDC 55111-363-01Bottles of 500                                                                         NDC 55111-363-05Omeprazole and sodium bicarbonate capsules, 40 mg/1100 mg: Bottles of 30                                                                           NDC 55111-364-30Bottles of 100                                                                         NDC 55111-364-01Bottles of 500                                                                         NDC 55111-364-05Storage Keep container tightly closed. Protect from light and moisture.


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Clinical Information

Chemical Structure

No Image found
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
Omeprazole and sodium bicarbonate is contraindicated in patients with known hypersensitivity to any components of the formulation. Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute interstitial nephritis, and urticaria. [See

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

• Acute Interstitial Nephritis [see Warnings and Precautions ()]

• Clostridium difficile-Associated Diarrhea [see Warnings and Precautions (]

• Bone Fracture [see Warnings and Precautions ()]

• Cutaneous and Systemic Lupus Erythematosus [see Warnings and Precautions ()]

• Cyanocobalamin (Vitamin B-12) Deficiency [see Warnings and Precautions ()]

• Hypomagnesemia [see Warnings and Precautions ()]

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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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Tips

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Interactions

Interactions

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