Omeprazole And Sodium Bicarbonate

2 DOSAGE AND ADMINISTRATION Indication ( 2 ) Recommended Adult Dosage ( 2 ) Omeprazole and Sodium Bicarbonate for oral suspension or Omeprazole and Sodium Bicarbonate capsules ( 2 ) Active Duodenal Ulcer ( 2 ) 20 mg once daily for 4 weeks; some patients may require an additional 4 weeks ( 2 ) Active Benign Gastric Ulcer ( 2 ) 40 mg once daily for 4 to 8 weeks ( 2 ) Treatment of Symptomatic GERD ( 2 ) 20 mg once daily for up to 4 weeks ( 2 ) Treatment of EE due to Acid-Mediated GERD 20 mg once daily for 4 to 8 weeks* ( 2 ) Maintenance of Healing of EE due to Acid-Mediated GERD ( 2 ) 20 mg once daily** ( 2 ) 40 mg Omeprazole and Sodium Bicarbonate for oral suspension ( 2 ) Reduction of Risk of Upper GI Bleeding in Critically Ill Patients ( 2 ) 40 mg initially followed by 40 mg 6 to 8 hours later and 40 mg once daily thereafter for 14 days ( 2 ) *an additional 4 weeks of treatment may be given if no response; if recurrence, additional 4 to 8-week courses may be considered.

( 2 ) **studied for 12 months. 1 Important Administration Instructions Omeprazole and Sodium Bicarbonate is available as a capsule and as a powder for oral suspension in 20 mg and 40 mg strengths of omeprazole for adult use. All recommended doses throughout the labeling are based upon omeprazole.

3) ] : Omeprazole and Sodium Bicarbonate capsule: each 20 mg and 40 mg capsule contains 1,100 mg (13 mEq) of sodium bicarbonate. The total content of sodium in each capsule is 304 mg. Omeprazole and Sodium Bicarbonate for oral suspension: each 20 mg and 40 mg packet of contains 1,680 mg (20 mEq) of sodium bicarbonate.

The total content of sodium in each packet is 460 mg.

Due to the sodium bicarbonate content of Omeprazole and Sodium Bicarbonate:

Do not substitute two packets of 20 mg Omeprazole and Sodium Bicarbonate for oral suspension with one packet of 40 mg Omeprazole and Sodium Bicarbonate for oral suspension. Do not substitute two 20 mg Omeprazole and Sodium Bicarbonate capsules with one 40 mg Omeprazole and Sodium Bicarbonate capsule.

2 Dosage Regimen The recommended dosage regimen by indication in adults of Omeprazole and Sodium Bicarbonate for oral suspension and Omeprazole and Sodium Bicarbonate capsules is summarized in Table 1 . Only 40 mg Omeprazole and Sodium Bicarbonate for oral suspension is indicated for the reduction of risk of upper GI bleeding in critically ill adult patients and the dosage regimen is summarized in Table 2 .

All recommended dosages are based upon omeprazole content.

Table 1:

Recommended Dosage Regimen of Omeprazole and Sodium Bicarbonate for Oral Suspension and Omeprazole and Sodium Bicarbonate Capsules in Adults by Indication Indication Dosage of Omeprazole and Sodium Bicarbonate for oral suspension or Omeprazole and Sodium Bicarbonate capsules Treatment Duration Treatment of Active Duodenal Ulcer 20 mg once daily 4 weeks *† Treatment of Active Benign Gastric Ulcer 40 mg once daily 4 to 8 weeks Treatment of Symptomatic GERD 20 mg once daily Up to 4 weeks Treatment of EE due to Acid-Mediated GERD 20 mg once daily 4 to 8 weeks † Maintenance of Healing of EE due to Acid-Mediated GERD 20 mg once daily Controlled studies do not extend beyond 12 months.

3 Preparation and Administration Omeprazole and Sodium Bicarbonate Capsules Swallow capsules intact with water. Do not open the capsule and do not administer with liquids other than water. 3) ] . Omeprazole and Sodium Bicarbonate for Oral Suspension Omeprazole and Sodium Bicarbonate for oral suspension is intended to be mixed with water and administered orally or via a nasogastric (NG) or orogastric (OG) tube.

If administered orally, take on an empty stomach at least one hour before a meal. If administered via NG or OG tube, suspend enteral feeding approximately 3 hours before and 1 hour after administration of Omeprazole and Sodium Bicarbonate for oral suspension.

Oral Administration Empty the contents of a packet into a small cup containing 5 to 10 mL of water. Do not mix with liquids or foods other than water. Stir well and drink immediately. Refill cup with water and drink immediately. Nasogastric (NG) or Orogastric (OG) Tube Administration

14) ] Most common adverse reactions (≥2%) are: headache, abdominal pain, nausea, diarrhea, vomiting, and flatulence. gov/medwatch. 1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety of Omeprazole and Sodium Bicarbonate has been established, in part, based on oral studies of an oral delayed-release omeprazole product. S. clinical trial population of 465 adult patients, the adverse reactions summarized in Table 3 were reported to occur in 1% or more of patients on therapy with omeprazole.

Table 3:

Adverse Reactions Occurring in 1% or More of Adult Patients in US Clinical Trials of Omeprazole Therapy Omeprazole % (n = 465) Placebo % (n = 64) Ranitidine % (n = 195) Headache 7 6 8 Diarrhea 3 3 2 Abdominal Pain 2 3 3 Nausea 2 3 4 Upper Respiratory Infection (URI) 2 2 3 Dizziness 2 0 3 Vomiting 2 5 2 Rash 2 0 0 Constipation 1 0 0 Cough 1 0 2 Asthenia 1 2 2 Back Pain 1 0 1 Table 4 summarizes the adverse reactions that occurred in 1% or more of omeprazole-treated patients from international double-blind and open-label clinical trials in which 2,631 patients and subjects received omeprazole.

8 Clinical Trial of 40 mg Omeprazole and Sodium Bicarbonate for Oral Suspension Adverse reactions reported in at least 3% of critically ill adult patients in a clinical trial of 40 mg Omeprazole and Sodium Bicarbonate for oral suspension compared to intravenous cimetidine for up to 14 days are presented in Table 5 .

2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of omeprazole and sodium bicarbonate. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Omeprazole Body as a Whole:

Hypersensitivity reactions, including anaphylaxis, anaphylactic shock, angioedema, bronchospasm, urticaria (see also Skin below), fever, pain, fatigue, malaise, and systemic lupus erythematosus.

Cardiovascular:

Chest pain or angina, tachycardia, bradycardia, palpitation, elevated blood pressure, and peripheral edema.

Gastrointestinal:

Pancreatitis (some fatal), anorexia, irritable colon, flatulence, fecal discoloration, esophageal candidiasis, mucosal atrophy of the tongue, dry mouth, stomatitis, abdominal swelling and fundic gland polyps. Gastroduodenal carcinoids have been reported in patients with Zollinger-Ellison syndrome on long-term treatment with omeprazole.

This finding is believed to be a manifestation of the underlying condition, which is known to be associated with such tumors.

Hepatic:

Mild and, rarely, marked elevations of liver function tests [ALT (SGPT), AST (SGOT), ᵞ-glutamyl transpeptidase, alkaline phosphatase, and bilirubin (jaundice)]. In rare instances, overt liver disease has occurred, including hepatocellular, cholestatic, or mixed hepatitis, liver necrosis (some fatal), hepatic failure (some fatal), and hepatic encephalopathy.

Infections and Infestations:

Clostridium difficile -associated diarrhea. 10) ] , hyponatremia, hypoglycemia, and weight gain.

Musculoskeletal:

Muscle cramps, myalgia, muscle weakness, joint pain, bone fracture, and leg pain.

Nervous System/Psychiatric:

Psychic disturbances including depression, agitation, aggression, hallucinations, confusion, insomnia, nervousness, tremors, apathy, somnolence, anxiety, dream abnormalities; vertigo; paresthesia; and hemifacial dysesthesia.

Respiratory:

Epistaxis, pharyngeal pain.

Skin:

Severe generalized skin reactions including TEN (some fatal), SJS, DRESS, AGEP, cutaneous lupus erythematosus and erythema multiforme (some severe); purpura and/or petechiae (some with rechallenge); skin inflammation, urticaria, angioedema, pruritus, photosensitivity, alopecia, dry skin, and hyperhidrosis.

Special Senses:

Tinnitus, taste perversion.

Ocular:

Blurred vision, ocular irritation, dry eye syndrome, optic atrophy, anterior ischemic optic neuropathy, optic neuritis, and double vision.

Urogenital:

Tubulointerstitial nephritis, urinary tract infection, microscopic pyuria, urinary frequency, elevated serum creatinine, proteinuria, hematuria, glycosuria, testicular pain, gynecomastia, and erectile dysfunction.

Hematologic:

Rare instances of pancytopenia, agranulocytosis (some fatal), thrombocytopenia, neutropenia, leukopenia, anemia, leukocytosis, and hemolytic anemia have been reported. Sodium Bicarbonate Metabolic alkalosis, seizures, and tetany.

5 WARNINGS AND PRECAUTIONS Gastric Malignancy : In adults, symptomatic response does not preclude the presence of gastric malignancy. Consider additional follow-up and diagnostic testing. 1 ) Acute Tubulointerstitial Nephritis: Discontinue treatment and evaluate patients.

2 ) Sodium Bicarbonate Buffer Content : Take sodium content into consideration in patients on a sodium-restricted diet. Avoid in patients with Bartter’s syndrome, hypokalemia, hypocalcemia, and problems with acid-base balance. 3 ) Clostridium difficile -Associated Diarrhea : PPI therapy may be associated with increased risk.

4 ) Bone Fracture : Long-term and multiple daily dose PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist, or spine. 5 ) Severe Cutaneous Adverse Reactions: Discontinue at the first signs or symptoms of severe cutaneous adverse reactions or other signs of hypersensitivity and consider further evaluation.

6 ) Cutaneous and Systemic Lupus Erythematosus : Mostly cutaneous; new onset or exacerbation of existing disease; discontinue Omeprazole and Sodium Bicarbonate and refer to specialist for evaluation. 7 ) Interaction with Clopidogrel : Avoid concomitant use of Omeprazole and Sodium Bicarbonate.

, longer than 3 years) may lead to malabsorption or a deficiency of cyanocobalamin. 9 ) Hypomagnesemia and Mineral Metabolism : Reported rarely with prolonged treatment with PPIs. 10 ) Interaction with St.

John’s wort or Rifampin :

Avoid concomitant use of Omeprazole and Sodium Bicarbonate. 11 , 7 ) Interactions with Diagnostic Investigations for Neuroendocrine Tumors : Increased Chromogranin A (CgA) levels may interfere with diagnostic investigations for neuroendocrine tumors; temporarily stop Omeprazole and Sodium Bicarbonate at least 14 days before assessing CgA levels.

12 ) Interaction with Methotrexate : Concomitant use with PPIs may elevate and/or prolong serum concentrations of methotrexate and/or its metabolite, possibly leading to toxicity. With high dose methotrexate administration, consider a temporary withdrawal of Omeprazole and Sodium Bicarbonate.

13 , 7 ) Fundic Gland Polyps : Risk increases with long-term use, especially beyond one year. Use the shortest duration of therapy. 1 Presence of Gastric Malignancy In adults, symptomatic response to therapy with Omeprazole and Sodium Bicarbonate 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 proton pump inhibitor (PPI). In older patients, also consider an endoscopy.

2 Acute Tubulointerstitial Nephritis Acute tubulointerstitial nephritis (TIN) has been observed in patients taking PPIs and may occur at any point during PPI therapy. , malaise, nausea and anorexia). , fever, rash or arthralgia). Discontinue Omeprazole and Sodium Bicarbonate and evaluate patients with suspected acute TIN [ see Contraindications (4) ].

3 Sodium Bicarbonate Buffer Content Each 20 mg and 40 mg Omeprazole and Sodium Bicarbonate capsule contains 1,100 mg (13 mEq) of sodium bicarbonate. The total content of sodium in each capsule is 304 mg. Each 20 mg and 40 mg packet of Omeprazole and Sodium Bicarbonate for oral suspension contains 1,680 mg (20 mEq) of sodium bicarbonate.

The total content of sodium in each packet is 460 mg. Chronic administration of bicarbonate with calcium or milk can cause milk-alkali syndrome. Chronic use of sodium bicarbonate may lead to systemic alkalosis, and increased sodium intake can produce edema and weight gain.

The sodium content of Omeprazole and Sodium Bicarbonate products should be taken into consideration when administering to patients on a sodium-restricted diet or those at risk for developing congestive heart failure. Avoid Omeprazole and Sodium Bicarbonate in patients with Bartter’s syndrome, hypokalemia, hypocalcemia, and problems with acid-base balance.

4 Clostridium difficile -Associated Diarrhea Published observational studies suggest that PPI therapy like Omeprazole and Sodium Bicarbonate may be associated with an increased risk of Clostridium difficile -associated diarrhea, especially in hospitalized patients.

2) ] . Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated. 5 Bone Fracture Several published observational studies suggest that proton pump inhibitor (PPI) therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist, or spine.

The risk of fracture was increased in patients who received high-dose, defined as multiple daily doses, and long-term PPI therapy (a year or longer). Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated.

2) ] . 2)]. Discontinue Omeprazole and Sodium Bicarbonate at the first signs or symptoms of severe cutaneous adverse reactions or other signs of hypersensitivity and consider further evaluation. 7 Cutaneous and Systemic Lupus Erythematosus Cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE) have been reported in patients taking PPIs, including omeprazole.

These events have occurred as both new onset and an exacerbation of existing autoimmune disease. The majority of PPI-induced lupus erythematosus cases were CLE. The most common form of CLE reported in patients treated with PPIs was subacute CLE (SCLE) and occurred within weeks to years after continuous drug therapy in patients ranging from infants to the elderly.

Generally, histological findings were observed without organ involvement. Systemic lupus erythematosus (SLE) is less commonly reported than CLE in patients receiving PPIs. PPI associated SLE is usually milder than non-drug induced SLE.

Onset of SLE typically occurred within days to years after initiating treatment in patients ranging from young adults to the elderly. The majority of patients presented with rash; however, arthralgia and cytopenia were also reported.

Avoid administration of PPIs for longer than medically indicated. If signs or symptoms consistent with CLE or SLE are noted in patients receiving Omeprazole and Sodium Bicarbonate, discontinue the drug and refer the patient to the appropriate specialist for evaluation.

Most patients improve with discontinuation of the PPI alone in 4 to 12 weeks. , ANA) may be positive and elevated serological test results may take longer to resolve than clinical manifestations. 8 Interaction with Clopidogrel Avoid concomitant use of Omeprazole and Sodium Bicarbonate with clopidogrel.

Clopidogrel is a prodrug. Inhibition of platelet aggregation by clopidogrel is entirely due to an active metabolite. The metabolism of clopidogrel to its active metabolite can be impaired by use with concomitant medications, such as omeprazole, that interfere with CYP2C19 activity.

Concomitant use of clopidogrel with 80 mg omeprazole reduces the pharmacological activity of clopidogrel, even when administered 12 hours apart. 3 )]. , longer than 3 years) may lead to malabsorption of cyanocobalamin (vitamin B-12) caused by hypo- or achlorhydria.

Rare reports of cyanocobalamin deficiency occurring with acid-suppressing therapy have been reported in the literature. This diagnosis should be considered if clinical symptoms consistent with cyanocobalamin deficiency are observed in patients treated with Omeprazole and Sodium Bicarbonate.

10 Hypomagnesemia and Mineral Metabolism Hypomagnesemia, symptomatic and asymptomatic, has been reported rarely in patients treated with PPIs for at least three months, in most cases after a year of therapy. Serious adverse events include tetany, arrhythmias, and seizures.

Hypomagnesemia may lead to hypocalcemia and/or hypokalemia and may exacerbate underlying hypocalcemia in at-risk patients. In most patients, treatment of hypomagnesemia required magnesium replacement and discontinuation of the PPI. 2) ].

, hypoparathyroidism). Supplement with magnesium and/or calcium as necessary. If hypocalcemia is refractory to treatment, consider discontinuing the PPI. 11 Interaction with St. John’s wort or Rifampin Drugs which induce CYP2C19 or CYP3A4 (such as St.

John’s wort or rifampin) can substantially decrease omeprazole concentrations [see Drug Interactions (7) ]. Avoid concomitant use of Omeprazole and Sodium Bicarbonate with St. John’s wort or rifampin. 12 Interactions with Investigations for Neuroendocrine Tumors Serum chromogranin A (CgA) levels increase secondary to drug-induced decreases in gastric acidity.

The increased CgA level may cause false positive results in diagnostic investigations for neuroendocrine tumors. Providers should temporarily stop Omeprazole and Sodium Bicarbonate treatment for at least 14 days before assessing CgA levels and consider repeating the test if initial CgA levels are high.

, for monitoring), the same commercial laboratory should be used for testing, as reference ranges between tests may vary [see Drug Interactions (7) ] . 13 Interaction with Methotrexate Literature suggests that concomitant use of PPIs with methotrexate (primarily at high dose) may elevate and prolong serum levels of methotrexate and/or its metabolite, possibly leading to methotrexate toxicities.

In high-dose methotrexate administration, a temporary withdrawal of the PPI may be considered in some patients [see Drug Interactions (7) ]. 14 Fundic Gland Polyps PPI use is associated with an increased risk of fundic gland polyps that increases with long-term use, especially beyond one year.

Most PPIs users who developed fundic gland polyps were asymptomatic and fundic gland polyps were identified incidentally on endoscopy. Use the shortest duration of PPI therapy appropriate to the condition being treated.

4 CONTRAINDICATIONS Omeprazole and Sodium Bicarbonate is contraindicated in patients with known hypersensitivity to substituted benzimidazoles or to any component of the formulation. 2) Error! Hyperlink reference not valid. 2)] . Proton pump inhibitors (PPIs), including Omeprazole and Sodium Bicarbonate, are contraindicated in patients receiving rilpivirine containing products [see Drug Interactions (7) ] .

Known hypersensitivity to any components of the formulation ( 4 ) Patients receiving rilpivirine-containing products ( 4 , 7 )