Zegerid For Oral Suspension

— THERAPEUTIC CATEGORIES —
  • Hyperacidity, GERD, and ulcers

Zegerid For Oral Suspension Generic Name & Formulations

General Description

Omeprazole, sodium bicarbonate; 20mg/1680mg, 40mg/1680mg; per packet; pwd; contains 460mg Na+/packet.

Pharmacological Class

Proton pump inhibitor + antacid.

See Also

How Supplied

Caps—30; Susp—30 packets

Generic Availability

YES

Mechanism of Action

Omeprazole suppresses gastric acid secretion by specific inhibition of the (H+/K+)-ATPase enzyme system on the surface of the gastric parietal cell. Sodium bicarbonate raises the gastric pH and protects omeprazole from acid degradation.

Zegerid For Oral Suspension Indications

Indications

Short-term treatment of active benign gastric ulcer, active duodenal ulcer, erosive esophagitis (EE). Symptomatic GERD. Maintenance of healing of EE. To reduce risk of upper GI bleed in critically ill patients (40mg oral susp only).

Zegerid For Oral Suspension Dosage and Administration

Adult

Take on empty stomach. Caps: swallow whole with water only. Susp: mix in 15–30mL water only; drink immediately; refill cup with water and drink; or, may give via NG/OG tube (see full labeling). Due to sodium bicarbonate component, two 20mg packets or caps are not equivalent to one 40mg packet or cap. ≥18yrs: Active duodenal ulcer: 20mg once daily for 4 weeks; may continue 4 more weeks. Gastric ulcer: 40mg once daily for 4–8 weeks. GERD (no esophageal lesions): 20mg once daily for up to 4 weeks. EE with GERD symptoms: 20mg once daily for 4–8 weeks. Maintenance of healing of EE: 20mg once daily. GI bleed risk reduction: Day 1: initially 40mg susp once then 40mg susp 6–8hrs later, then 40mg susp once daily for up to 14 days.

Children

<18yrs: not established.

Administration

Take on empty stomach. Mix in 15–30mL water only; drink immediately; refill cup with water and drink. Via NG/OG tube: constitute suspension with 20mL of water only; stir well and administer immediately. Use appropriately-sized syringe to instill suspension in the tube; wash suspension through the tube with 20mL of water. For continuous NG/OG tube feeding, enteral feeding should be suspended approximately 3hrs before and 1hr after. Due to sodium bicarbonate component, two 20mg packets are not equivalent to one 40mg packet.

Nursing Considerations

Take on empty stomach. Mix in 15–30mL water only; drink immediately; refill cup with water and drink. Via NG/OG tube: constitute suspension with 20mL of water only; stir well and administer immediately. Use appropriately-sized syringe to instill suspension in the tube; wash suspension through the tube with 20mL of water. For continuous NG/OG tube feeding, enteral feeding should be suspended approximately 3hrs before and 1hr after. Due to sodium bicarbonate component, two 20mg packets are not equivalent to one 40mg packet.

Zegerid For Oral Suspension Contraindications

Contraindications

Concomitant rilpivirine-containing products.

Zegerid For Oral Suspension Boxed Warnings

Not Applicable

Zegerid For Oral Suspension Warnings/Precautions

Warnings/Precautions

Symptomatic response does not preclude gastric malignancy. Discontinue and evaluate if acute tubulointerstitial nephritis, severe cutaneous adverse reactions, or cutaneous/systemic lupus erythematosus occurs. Sodium-restricted diets. CHF. Avoid in Bartter's syndrome, hypokalemia, hypocalcemia, or acid-base balance abnormalities. Long-term therapy (eg, >3yrs) may lead to malabsorption/deficiency of Vit. B12. Monitor magnesium levels during prolonged therapy. Consider monitoring magnesium, calcium levels in those with preexisting risk of hypocalcemia (eg, hypoparathyroidism). Increased risk of fundic gland polyps with long-term use (esp. >1yr) or osteoporosis-related fractures (hip, wrist or spine) with long-term (>1yr) and multiple daily dose PPI therapy. Use lowest dose for shortest duration appropriate to condition. Hepatic impairment or Asian patients: avoid use for maintenance of healing of EE. Pregnancy. Nursing mothers.

Zegerid For Oral Suspension Pharmacokinetics

Distribution

Plasma protein bound: ~95%.

Metabolism

Hepatic (CYP2C19, CYP3A4). 

Elimination

Renal (77%), fecal, biliary.

Zegerid For Oral Suspension Interactions

Interactions

Avoid concomitant clopidogrel, St. John's Wort, rifampin, atazanavir, nelfinavir. May potentiate citalopram, cilostazol, diazepam, digoxin, phenytoin, warfarin (monitor INR/PT), tacrolimus, saquinavir, methotrexate (esp. high-dose); monitor. Potentiated by voriconazole. May alter absorption of pH-dependent drugs (eg, erlotinib, dasatinib, nilotinib, ketoconazole, itraconazole, mycophenolate mofetil, iron salts). Monitor drugs metabolized by CYP450 (eg, cyclosporine, disulfiram). Long-term use of bicarbonate with calcium or milk may cause milk-alkali syndrome. Concomitant digoxin, diuretics may predispose patients to hypomagnesemia. May interfere with neuroendocrine tumor diagnostic investigations, secretin stimulation tests; interrupt therapy for ≥14 days. May result in false (+) urine tests for tetrahydrocannabinol.

Zegerid For Oral Suspension Adverse Reactions

Adverse Reactions

Headache, abdominal pain, nausea, diarrhea, vomiting, flatulence; bone fracture; possible C. difficile associated diarrhea; rare: hypomagnesemia and mineral metabolism.

Zegerid For Oral Suspension Clinical Trials

See Literature

Zegerid For Oral Suspension Note

Not Applicable

Zegerid For Oral Suspension Patient Counseling

See Literature