Omeprazole/Sodiium Bicarbonate

What is Omeprazole/Sodiium Bicarbonate?

Omeprazole and Sodium Bicarbonate capsules are 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]-1H-benzimidazole, a racemic mixture of two enantiomers that inhibits gastric acid secretion. Its empirical formula is C17H19N3O3S, with a molecular weight of 345.42. The structural formula is: [STR] Omeprazole is a white to off-white crystalline powder which melts with decomposition at about 155ºC. 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 capsules are supplied as immediate-release capsules. Each capsule contains either 40 mg or 20 mg of omeprazole USP and 1,100 mg of sodium bicarbonate USP with the following excipients: croscarmellose sodium and sodium stearyl fumarate. The black imprinting ink contains black iron oxide, propylene glycol, shellac, and potassium hydro

Uses of Omeprazole/Sodiium Bicarbonate

Established uses

• Omeprazole and Sodium Bicarbonate capsules are indicated in adults for the: short-term treatment of active duodenal ulcer.
• Most patients heal within four weeks.
• Some patients may require an additional four weeks of therapy.
• short-term treatment (4 to 8 weeks) of active benign gastric ulcer.
• treatment of heartburn and other symptoms associated with GERD for up to 4 weeks.
• short-term treatment (4 to 8 weeks) of EE due to acid-mediated GERD which has been diagnosed by endoscopy in adults.

How to take Omeprazole/Sodiium Bicarbonate

2.1 Important Administration Instructions Omeprazole and Sodium Bicarbonate is available as a capsule in 20 mg and 40 mg strengths of omeprazole for adult use. All recommended doses throughout the labeling are based upon omeprazole. The sodium content of Omeprazole and Sodium Bicarbonate capsules should be taken into consideration when prescribing this product [see Warnings and Precautions (5.3)]: 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. Due to the sodium bicarbonate content of Omeprazole and Sodium Bicarbonate capsules: Do not substitute two 20 mg Omeprazole and Sodium Bicarbonate capsules with one 40 mg Omeprazole and Sodium Bicarbonate capsule. 2.2 Dosage Regimen The recommended dosage regimen by indication in adults of Omeprazole and Sodium Bicarbonate capsules is summarized in Table 1. All recommended dosages are based upon omeprazole content. Table 1: Recommended Dosage Regimen of Omeprazole and Sodium Bicarbonate Capsules in Adults by Indication 1. Most patients heal within 4 weeks. Some patients may require an additional 4 weeks of therapy

Dosage

Follow the dose prescribed by your doctor or pharmacist. The ranges below are general information, not a personal prescription.

Adults

2.1 Important Administration Instructions Omeprazole and Sodium Bicarbonate is available as a capsule in 20 mg and 40 mg strengths of omeprazole for adult use. All recommended doses throughout the labeling are based upon omeprazole. The sodium content of Omeprazole and Sodium Bicarbonate capsules should be taken into consideration when prescribing this product [see Warnings and Precautions (5.3)]: 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. Due to the sodium bicarbonate content of Omeprazole and Sodium Bicarbonate capsules: Do not substitute two 20 mg Omeprazole and Sodium Bicarbonate capsules with one 40 mg Omeprazole and Sodium Bicarbonate capsule. 2.2 Dosage Regimen The recommended dosage regimen by indication in adults of Omeprazole and Sodium Bicarbonate capsules is summarized in Table 1. All recommended dosages are based upon omeprazole content. Table 1: Recommended Dosage Regimen of Omeprazole and Sodium Bicarbonate Capsules in Adults by Indication 1. Most patients heal within 4 weeks. Some patients may require an additional 4 weeks of therapy

Side effects of Omeprazole/Sodiium Bicarbonate

Common

• The following serious adverse reactions are described below and elsewhere in labeling: Acute Tubulointerstitial Nephritis [see Warnings and Precautions (5.2)] Clostridium difficile-Associated Diarrhea [see Warnings and Precautions (5.4)] Bone Fracture [see Warnings and Precautions (5.5)] Severe Cutaneous Adverse Reactions [see Warnings and Precautions (5.6)] Cutaneous and Systemic Lupus Erythematosus [see Warnings and Precautions (5.7)] Cyanocobalamin (Vitamin B-12) Deficiency [see Warnings and Precautions (5.9)] Hypomagnesemia and Mineral Metabolism [see Warnings and Precautions (5.10)] Fundic Gland Polyps [see Warnings and Precautions (5.14)] 6.1 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 capsules has been established, in part, based on oral studies of an oral delayed-release omeprazole product.
• Clinical Trials with Omeprazole In the U.S.
• clinical trial population of 465 adult patients, th

Warnings and who should not take it

Who should NOT take Omeprazole/Sodiium Bicarbonate?

• Omeprazole and Sodium Bicarbonate capsules are contraindicated in patients with known hypersensitivity to substituted benzimidazoles or to any components of the formulation.
• Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute tubulointerstitial nephritis, and urticaria [see Warnings and Precautions (5.2), Adverse Reactions (6.2)].
• Proton pump inhibitors (PPIs), including Omeprazole and Sodium Bicarbonate capsules, are contraindicated in patients receiving rilpivirine containing products[see Drug Interactions (7)].

Overdose

If over-exposure occurs, call your Poison Control Center at 1-800-222-1222 for current information on the management of poisoning or overdosage. Omeprazole Reports have been received of overdosage with omeprazole in humans. Doses ranged up to 2,400 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 clinical experience with the recommended dosage [see Adverse Reactions (6)]. 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. Sodium Bicarbonate Overdosage of sodium bicarbonate can cause electrolyte abnormalities (hypocalcemia, hypokalemia, hypernatremia), metabolic alkalosis, and seizures. Institute supportive care and correct electrolyte abnormalities.

Interactions

Medicine and medicine

• Tables 6 and 7 include drugs with clinically important drug interactions and interaction with diagnostics when administered concomitantly with omeprazole and instructions for preventing or managing them.
• Consult the labeling of concomitantly used drugs to obtain further information about interactions with PPIs.
• Table 6: Clinically Relevant Interactions Affecting Drugs Co-Administered with Omeprazole and Interaction with Diagnostics Antiretrovirals Clinical Impact: The effect of PPIs on antiretroviral drugs is variable.
• The clinical importance and the mechanisms behind these interactions are not always known.
• Decreased exposure of some antiretroviral drugs (e.g., rilpivirine, atazanavir and nelfinavir) when used concomitantly with omeprazole may reduce antiviral effect and promote the development of drug resistance [see Clinical Pharmacology (12.3)].
• Increased exposure of other antiretroviral drugs (e.g., saquinavir) when used concomitantly with omeprazole may increase toxicity [see Clinical Pharmacology (12.3)].

Frequently asked questions