omeprazole and sodium bicarbonate

(redirected from Zegerid OTC)

omeprazole and sodium bicarbonate

Zegerid, Zegerid OTC

Pharmacologic class: Proton pump inhibitor

Therapeutic class: Antiulcer drug

Pregnancy risk category C

Action

Reduces gastric acid secretion and increases gastric mucus and bicarbonate production, creating protective coating on gastric mucosa and easing discomfort from excess gastric acid

Availability

Capsules (delayed-release): 10 mg, 20 mg, 40 mg

Powder for oral suspension (delayed-release): 2.5 mg, 10 mg in packets

Tablets (delayed-release): 20 mg

Indications and dosages

Gastroesophageal reflux disease

Adults: 20 mg P.O. (capsules, powder) daily for 4 weeks

Erosive esophagitis

Adults: 20 mg P.O. (capsules, powder) daily for 4 to 8 weeks

Short-term treatment of active duodenal ulcer

Adults: 20 mg P.O. (capsules, powder) daily for 4 weeks. Some patients may need 4 additional weeks of therapy.

To reduce risk of duodenal ulcers caused by Helicobacter pylori

Adults: 40 mg P.O. (capsules) daily in morning, given with clarithromycin t.i.d. for 2 weeks; then 20 mg daily for 2 weeks

Gastric ulcers

Adults: 40 mg P.O. (capsules) daily for 4 to 8 weeks

Pathologic hypersecretory conditions, including Zollinger-Ellison syndrome

Adults: Initially, 60 mg P.O. (capsules) daily; may increase up to 120 mg t.i.d. Divide daily dosages above 80 mg.

Frequent heartburn (two or more episodes a week)

Adults ages 18 and older: 20 mg P.O. (OTC tablets, capsules, or powder) daily for 14 days

Off-label uses

• Posterior laryngitis
• To enhance pancreatin efficacy in treating steatorrhea in cystic fibrosis patients

Contraindications

• Hypersensitivity to drug or its components

Precautions

Use cautiously in:
• hepatic disease
• hypomagnesemia
• concurrent use of clopidogrel (avoid use)
• pregnant or breastfeeding patients
• children (safety not established).

Administration

• Give 30 to 60 minutes before a meal, preferably in morning.
• If desired, give concurrently with antacids.
• Know that if patient has ulcer at start of therapy, treatment may be extended.
• When giving through nasogastric tube, use powder for oral suspension, or separate capsule and mix pellets with water. Agitate syringe while injecting. After administration, flush with 30 to 60 ml of water.
• Don't crush capsules.
• Be aware that symptomatic response doesn't rule out gastric cancer.

Adverse reactions

CNS: dizziness, headache, asthenia

GI: nausea, vomiting, diarrhea, constipation, abdominal pain

Metabolic: hypomagnesemia

Musculoskeletal: back pain; fractures of hip, wrist, spine (with long-term daily use)

Respiratory: cough, upper respiratory tract infection

Skin: rash

Interactions

Drug-drug.Ampicillin, cyanocobalamin, iron salts, ketoconazole: reduced absorption of these drugs

Clarithromycin: increased omeprazole blood level

Clopidogrel: diminished antiplatelet activity

Diazepam, phenytoin, warfarin: prolonged elimination and increased effects of these drugs

Digoxin: increased digoxin absorption and blood level, possible digoxin toxicity

Drugs metabolized by CYP450 system: competitive metabolism

Methotrexate: increased methotrexate serum level

Penicillins: serious and occasionally fatal hypersensitivity reactions including anaphylaxis

Rifampin: substantially decreased omeprazole concentrations

Drug-diagnostic tests.Alanine phosphatase, alkaline aminotransferase, aspartate aminotransferase, bilirubin: increased levels

Gastrin: increased level during first 1 to 2 weeks of therapy

Serum chromogranin A: increased level may cause false-positive results in diagnostic investigations for neuroendocrine tumors

Serum magnesium: decreased level

Drug-herbs.St John's wort: substantially decreased omeprazole concentration

Patient monitoring

• Assess vital signs.
• Check for abdominal pain, emesis, diarrhea, or constipation.
• Evaluate fluid intake and output.
• Watch for elevated liver function test results (rare).
• Monitor magnesium level before starting drug and periodically thereafter in patients expected to be on long-term treatment or who take proton pump inhibitors with other drugs such as digoxin or drugs that may cause hypomagnesemia.

Patient teaching

• Tell patient to take 30 to 60 minutes before a meal, preferably in morning.
• Instruct patient to swallow capsules or tablets whole and not to chew or crush them. If he can't swallow capsule, tell him he may open it, carefully sprinkle and mix entire contents into 1 tbsp of cool applesauce, and swallow immediately with glass of water.
• Instruct patient on how to use delayed-release oral suspension: Empty contents of a 2.5-mg packet of powder into a container with 5 ml of water or 10-mg packet of powder into a container with 15 ml of water; don't use other liquids or foods. Stir and allow drug to thicken for 2 to 3 minutes. Stir well and drink within 30 minutes. If any drug remains after drinking, add more water to container, stir, and drink immediately.
• Inform patient taking OTC delayedrelease tablets for heartburn that full effect may take 1 to 4 days. Advise him not to take tablets for more than 14 days without consulting health care professional.
• Advise patient to avoid St John's wort while taking this drug.
• Caution patient to avoid driving and other hazardous activities until he knows how drug affects concentration and alertness.
• As appropriate, review all other significant adverse reactions and interactions, especially those related to the drugs and tests mentioned above.

References in periodicals archive ?
The Dublin-based company gained approval from the Food and Drug Administration for what it says is the equivalent to Bayer's Zegerid OTC capsules.
M2 EQUITYBITES-July 19, 2016-Perrigo passes US FDA final approval for store brand equivalent to Zegerid OTC Capsules for frequent heartburn
M2 PHARMA-July 19, 2016-Perrigo passes US FDA final approval for store brand equivalent to Zegerid OTC Capsules for frequent heartburn
Among these drugs are Prilosec OTC, Zegerid OTC and Prevacid 24HR, and the prescription PPIs Nexium, Dexiland, Prilosec, Zegerid, Prevacid, Protonix, Aciphex and Vimovo.
If you are taking a PPI, even an over-the-counter one such as Prilosec OTC, Zegerid OTC, or Prevacid 24HR, be sure to inform your doctor.
According to Perrigo, its OTC version of Omeprazole and Sodium Bicarbonate Capsules is the store brand equivalent to Merck & Co's Zegerid OTC, a proton pump inhibitor indicated to relieve frequent heartburn, which over the last 12 months recorded sales of about USD42m through food, drug and mass merchandisers.
28 September 2010 - US Perrigo Company (NASDAQ: PRGO) said last Friday it has submitted an Abbreviated New Drug Application (ANDA) to the US Food and Drug Administration (FDA) for omeprazole 20mg/sodium bicarbonate 1100mg, the generic equivalent of Zegerid OTC.
Drug Stores * Brand Manufacturer Dollar Sales Total Sales $149,669,700 Private Label 63,180,490 Prilosec OTC Procter & Gamble 25,308,030 Zantac 150 Boehringer Ingelheim 8,876,420 Prevacid 24HR Novartis Consumer Health 7,675,225 Gas-X Novartis Consumer Health 5,273,307 Pepcid AC Johnson & Johnson-Merck 4,786,785 Turns GIaxoSmithKline 4,243,102 Turns Ultra GIaxoSmithKline 3,515,024 LactaidFast Act McNeilConsumer Products 3,079,330 Zegerid OTC Merck 2,948,154 % Change Dollar % Change Brand vs.
Specialty biopharmaceutical company Santarus Inc (NASDAQ:SNTS) declared on Tuesday the receipt of the USD20m milestone payment for the US Food and Drug Administration's (FDA) approval of ZEGERID OTC (omeprazole 20 mg/sodium bicarbonate 1100 mg capsules) for OTC treatment of frequent heartburn.
99m) milestone payment previously announced on 1 December 2009 relating to the FDA approval of ZEGERID OTC under its over-the-counter (OTC) licensing agreement with Schering-Plough HealthCare Products Inc.
2 December 2009 - US pharmaceutical company Merck & Co Inc (NYSE: MRK) said yesterday that the US Food and Drug Administration (FDA) has approved ZEGERID OTC (omeprazole 20 mg/sodium bicarbonate 1100 mg capsules), for over-the-counter treatment of frequent heartburn.