Omeprazole / Sodium Bicarbonate

Trade Names:Zegerid- Capsules omeprazole 20 mg/sodium bicarbonate 1,100 mg- Capsules omeprazole 40 mg/sodium bicarbonate 1,100 mg- Powder for oral suspension omeprazole 20 mg/sodium bicarbonate 1,680 mg- Powder for oral suspension omeprazole 40 mg/sodium bicarbonate 1,680 mg

Indications and Usage

Short-term treatment of active duodenal ulcer; short-term treatment of active benign gastric ulcer; treatment of heartburn and other symptoms associated with gastroesophageal reflux disease (GERD); short-term treatment of erosive esophagitis; maintain healing of erosive esophagitis; reduction of risk of upper GI bleeding in critically ill patients (oral suspension).

Contraindications

Standard considerations.

Dosage and Administration

PO 20 mg once daily for 4 wk. May require additional 4 wk of therapy.

PO 40 mg once daily for 4 to 8 wk.

PO 20 mg once daily for up to 4 wk.

PO 20 mg once daily for 4 to 8 wk.

PO 20 mg once daily.

PO Oral suspension 40 mg initially followed by 40 mg 6 to 8 h later and 40 mg daily thereafter for 14 days.

General Advice

• Empty powder for oral suspension packet into a small cup containing 1 to 2 Tbsp of water. Do not use other liquids or food. Stir well and drink immediately. Refill cup with water and drink.
• Swallow capsules whole with water. Do not take with other liquids or open capsule and sprinkle onto food.
• Take on an empty stomach at least 1 h before meals.
• Because of the amount of sodium bicarbonate in each capsule, do not substitute 2 capsules of 20 mg for 1 capsule of 40 mg.
• If administered through a nasogastric tube, reconstitute suspension with approximately 20 mL of water. Do not use food or other liquids. Stir the suspension well and administer immediately. Wash the suspension through the tube with 20 mL of water.

Storage/Stability

Store at 59° to 86°F.

Drug Interactions

Atazanavir plasma concentrations may be reduced, decreasing the efficacy.

May need to adjust dose of these drugs.

Serum concentrations of these agents may be elevated by omeprazole, increasing the risk of adverse reactions.

Omeprazole and clarithromycin plasma concentrations may be elevated.

Absorption of these agents may be reduced.

Elimination of these agents may be prolonged.

Hydantoin Cl may be decreased while the t _½ is increased.

Omeprazole plasma concentrations may be reduced, decreasing the efficacy.

Increased INR and PT, which may lead to abnormal bleeding and increase the risk of death.

Laboratory Test Interactions

None well documented.

Adverse Reactions

Cardiovascular

Hypotension (10%); hypertension (8%); atrial fibrillation (6%); ventricular tachycardia (5%); bradycardia (4%); supraventricular tachycardia, tachycardia (3%).

CNS

Agitation (3%); seizures, tetany (sodium bicarbonate).

Dermatologic

Rash (6%); decubitus ulcer (3%).

GI

Constipation (5%); diarrhea, oral candidiasis (4%); gastric hypomotility (2%).

Genitourinary

UTI (2%).

Hematologic

Thrombocytopenia (10%); anemia (8%).

Metabolic-Nutritional

Hypokalemia (12%); hyperglycemia (11%); hypomagnesemia (10%); hypocalcemia, hypophosphatemia (6%); fluid overload (5%); hyponatremia (4%); hypoglycemia (3%); hyperkalemia, hypernatremia, LFTs abnormal (2%); metabolic alkalosis (sodium bicarbonate).

Respiratory

Nosocomial pneumonia (11%); acute respiratory distress syndrome (3%); respiratory failure (2%); pneumothorax (1%).

Miscellaneous

Pyrexia (20%); hyperpyrexia, sepsis (5%); edema (3%); candidal infection (2%).

Precautions

Pregnancy

Category C .

Lactation

Excreted.

Children

Safety and efficacy not established.

Special Risk Patients

Sodium bicarbonate is contraindicated in patients with metabolic acidosis and hypocalcemia; use with caution in patients with Bartter syndrome, hypokalemia, respiratory alkalosis, and problems with acid-base balance. Long-term use of bicarbonate with calcium or milk can cause milk-alkali syndrome.

Atrophic gastritis

Has been reported in gastric corpus biopsies in patients treated with long-term omeprazole.

Sodium content

Consider sodium content in patients on a sodium-restricted diet.

Overdosage

Symptoms

Blurred vision, confusion, diaphoresis, drowsiness, dry mouth, flushing, headache, nausea, tachycardia, vomiting.

Patient Information

• Advise patient to take on an empty stomach at least 1 h before meals.
• Advise patient to take capsule whole with water and not to use other liquids or to open capsule and sprinkle onto food.
• Advise patient to empty contents of powder for oral suspension into a small cup containing 1 to 2 Tbsp of water and not to mix with other liquids or food.
• Advise patient to stir the reconstituted powder for oral suspension well and to drink immediately, refilling the cup with water and drinking that as well.

Copyright © 2009 Wolters Kluwer Health.