Omeprazole/Sodium Bicarbonate

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Overview

What is Omeprazole/Sodium Bicarbonate?

Omeprazole and Sodium Bicarbonate powder for oral suspension is a combination of omeprazole, a proton-pump inhibitor, and sodium bicarbonate, an antacid. Omeprazole is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3,5-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 155°C. 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 powder for oral suspension are supplied as immediate-release unit-dose packets as powder for oral suspension. Packets of powder for oral suspension contains either 40 mg or 20 mg of omeprazole USP and 1680 mg of sodium bicarbonate USP with the following excipients: xylitol, sucralose, xanthan gum, colloidal silicon dioxide and flavorings.

What does Omeprazole/Sodium Bicarbonate look like?

What are the available doses of Omeprazole/Sodium Bicarbonate?

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

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How should I use Omeprazole/Sodium Bicarbonate?

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

Since both the 20 mg and 40 mg packets contain the same amount of sodium bicarbonate (1680 mg), two packets of 20 mg are equivalent to one packet ofOmeprazole and Sodium Bicarbonate powder for oral suspension 40 mg; therefore, two 20 mg packets ofOmeprazole and Sodium Bicarbonate powder for oral suspension should not be substituted for one packet of Omeprazole and Sodium Bicarbonate powder for oral suspension 40 mg.

Omeprazole and Sodium Bicarbonate powder for oral suspension should be taken on an empty stomach at least one hour before a meal.

For patients receiving continuous Nasogastric (NG)/ Orogastric (OG) tube feeding, enteral feeding should be suspended approximately 3 hours before and 1 hour after administration of Omeprazole and Sodium Bicarbonate Powder for Oral Suspension.

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

Special Populations

Hepatic Insufficiency

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

Preparation and Administration of Suspension

Directions for use: Empty packet contents into a small cup containing 1-2 tablespoons of water. DO NOT USE OTHER LIQUIDS OR FOODS. Stir well and drink immediately. Refill cup with water and drink.

If Omeprazole and Sodium Bicarbonate powder for oral suspension is to be administered through a nasogastric (NG) or orogastric (OG) tube, the suspension should be constituted with approximately 20 mL of water. DO NOT USE OTHER LIQUIDS OR FOODS. Stir well and administer immediately. An appropriately-sized syringe should be used to instill the suspension in the tube. The suspension should be washed through the tube with 20 mL of water.

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?

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°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 Powder for Oral Suspension NDC 27241-029-31 Cartons of 30: 20 mg unit-dose packetsNDC 27241-030-31 Cartons of 30: 40 mg unit-dose packetsStorageStore 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 Powder for Oral Suspension NDC 27241-029-31 Cartons of 30: 20 mg unit-dose packetsNDC 27241-030-31 Cartons of 30: 40 mg unit-dose packetsStorageStore 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 Powder for Oral Suspension NDC 27241-029-31 Cartons of 30: 20 mg unit-dose packetsNDC 27241-030-31 Cartons of 30: 40 mg unit-dose packetsStorageStore 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 Powder for Oral Suspension NDC 27241-029-31 Cartons of 30: 20 mg unit-dose packetsNDC 27241-030-31 Cartons of 30: 40 mg unit-dose packetsStorageStore 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 Powder for Oral Suspension NDC 27241-029-31 Cartons of 30: 20 mg unit-dose packetsNDC 27241-030-31 Cartons of 30: 40 mg unit-dose packetsStorageStore 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 Powder for Oral Suspension NDC 27241-029-31 Cartons of 30: 20 mg unit-dose packetsNDC 27241-030-31 Cartons of 30: 40 mg unit-dose packetsStorageStore 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

Thiazides may add to or potentiate the action of other antihypertensive drugs.

The thiazides may decrease arterial responsiveness to norepinephrine. This diminution is not sufficient to preclude effectiveness of the pressor agent for therapeutic use. Thiazides have also been shown to increase the responsiveness to tubocurarine.

Lithium generally should not be given with diuretics because they reduce its renal clearance and add a high risk of lithium toxicity. Refer to the package insert on lithium before use of such concomitant therapy.

Acute renal failure has been reported in a few patients receiving indomethacin and formulations containing triamterene and hydrochlorothiazide. Caution is therefore advised when administering non-steroidal anti-inflammatory agents with triamterene and hydrochlorothiazide.

Potassium-sparing agents should be used very cautiously, if at all, in conjunction with angiotensin-converting enzyme (ACE) inhibitors due to a greatly increased risk of hyperkalemia. Serum potassium should be monitored frequently.

In adults, symptomatic response to therapy with Omeprazole and Sodium Bicarbonate powder for oral suspension 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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