Omeprazole and Sodium Bicarbonate Combination: Indication, Pharmacology, Warnings, and Precautions

Overview:

Omeprazole and Sodium bicarbonate are two separate medicines with their therapeutic values and effects. The drug formulation containing specific Omeprazole and Sodium bicarbonates demonstrates appreciable healing of a gastrointestinal condition called active benign gastric ulcers, where small sores thrive over the stomach's inner lining cells. The drug regulatory authority of the United States, the Food and Drug Administration (FDA), endorsed the use of formulations containing a blend of Omeprazole and Sodium bicarbonate for resolving stomach ulcers in the year 2004. It is marketed in different formulations under diverse brand names. This specific combination integrates the efficacy and potency of both medicines, which enhances ulcer healing and recovery.

Drug Group:

Omeprazole and Sodium bicarbonate formulations combine two separate medicines from two different drug groups. Omeprazole belongs to the category of proton pump inhibitor, whereas Sodium bicarbonate holds its position in the antacid drug class. Both medicines together synergize in bringing down the stomach's acidic level. Both medicines complement and enhance each other's potency and efficacy.

Available Doses and Dosage Forms:

Dosage Forms: Omeprazole and Sodium bicarbonate formulations are marketed in two distinct forms. One is the capsule form, and the second is the powder form. Both the dosage forms are intended for oral intake.

Available Doses: The capsule formulations of Omeprazole and Sodium bicarbonate combinations are marketed in 20 milligram/1100 milligram and 40 milligram/1100 milligram (mg) dosages. The powder form is intended for the formulation of oral suspension.

• 20 mg/1100 mg Capsule of Omeprazole and Sodium Bicarbonate: 20 mg Omeprazole and 1100 mg Sodium bicarbonate.

• 40 mg/1100 mg Capsule of Omeprazole and Sodium Bicarbonate: 40 mg Omeprazole and 1100 mg Sodium bicarbonate.

• 20 mg/1680 mg Powder Form: 1680 mg Sodium bicarbonate and 20 mg Omeprazole.

• 40 mg/1680 mg Powder Form: 1680 mg Sodium bicarbonate and 40 mg Omeprazole.

In capsule and powder form, the dose of Sodium bicarbonate does not vary with the Omeprazole concentration.

For Patients:

What Are Gastric Ulcers?

Just like the sores over the skin surface, the gut’s inner layer is also susceptible to the emergence of open sores. Sores that emerge over the stomach lining are medically categorized as gastric ulcers. A healthy stomach is quite resistant to ulcers as the mucus layer shields it. This mucus layer safeguards the gut cells from getting direct exposure to the acidic content and acts as a protective interface.

Once the protective mucus layer diminishes, the acidic content can establish direct contact with the gut cells. The acidity of the stomach content corrodes the lining cells in the stomach, creating open sores. Gastric ulcers do develop as a consequence of depleted mucus layer thickness or enhanced gastric acidity. Helicobacter pylori infection has a close connection with the emergence of gastric ulcers, as the bacteria can gear up stomach acidity by enhancing the acid secretion.

Stomach pain, flaming sensation, burping, darkly stained vomit, and stool are some of the frequently encountered manifestations associated with gastric ulcers. Compromised hunger, collapsed body weight, stomach fullness, and nausea are other associated manifestations.

How Does Omeprazole and Sodium Bicarbonate Combination Work?

Formulations of Omeprazole and Sodium bicarbonate work by eliciting their actions in the body. Sodium bicarbonate primarily complements the actions of Omeprazole by making the environment apt for Omeprazole to work upon. Omeprazole, being a proton pump inhibitor, checks the activity of the proton pumps expressed on the stomach lining cells. Once these pumps are checked under Omeprazole’s influence, the gastric acid production gears down. Sodium bicarbonate, being an antacid, neutralizes the stomach acidity, thereby enhancing the stomach pH. In an elevated pH environment, Omeprazole remains more efficient and active. The Omeprazole drug molecule does not exhibit tolerance to a highly acidic environment. The acidity impacts the stability of the drug molecule, depreciating its efficacy. Therefore, Omeprazole and Sodium bicarbonate work hand in hand to resolve gastric ulcers.

What Is the Dosage of Omeprazole and Sodium Bicarbonate Combination?

A single dose of 40 mg/1100 mg capsule formulation of Omeprazole and Sodium bicarbonate is the most advised daily adult dosage for tackling active benign gastric ulcers. The treatment course usually extends to four to eight weeks. However, the dosage, as well as the treatment duration, is largely determined by the condition for which the combination formulation is prescribed.

How Effective Is Omeprazole and Sodium Bicarbonate Combination?

Omeprazole with Sodium bicarbonate is proven to be effective in dealing with various acid-related gut issues, including stomach ulcers. Proton pump inhibitors (PPI) work great for stomach ulcers by mitigating acid production. However, in a low pH (acidic) environment, PPIs fail to elicit their actions, and this property is denoted as acid lability. This property of Omeprazole necessitates the incorporation of certain neutralizing or antacid agents. To get over this limitation, Omeprazole capsules were designed with an enteric covering. The additional coating gives rise to a setback in the absorption rate. It finally led to the development of Omeprazole and Sodium bicarbonate combination formulation, in which the Sodium bicarbonate alters and enhances the pH, making it favorable for the Omeprazole to elicit its actions effectively.

What Are the Things to Inform the Doctor Before Taking the Drug?

Before commencing any pharmacological therapy, it is imperative to have a thorough discussion with the concerned doctors. There is a set of information that the doctor should be made aware of before initiating the therapy.

• Any prior allergic or exaggerated reactivity encounter with either Omeprazole, Sodium bicarbonate, or other medicines belonging to the class of PPI or antacid needs to be discussed with the doctor. In such cases, an alternate choice of therapy can be considered if there is potential for an allergic reaction.

• The doctor should be provided with a comprehensive medical history of the patient. It enables the medical professional to understand the patient’s general health condition and other underlying ailments they would have otherwise missed. Details of past medical interventions or surgeries should also be provided so that the doctor can analyze whether the therapy interferes with the success of the intervention.

• Likewise, the patient's drug history also holds greater significance, and hence, the doctor should be informed about it beforehand. Drug history should encompass all the current and past medications, be it supplementary pills, herbal medicines, or over-the-counter medications. Knowing accurate drug history helps the concerned doctor to check for the possibility of adverse effects resulting from unintentional drug-to-drug associations.

• It is imperative to keep the doctor aware of the patient's pregnancy and lactating status. Even if the patient is planning for conception in the near future, the doctor should be informed so that the doctor can make an appropriate choice of medication, taking into account the risk of conception.

How Is Omeprazole and Sodium Bicarbonate Combination Administered?

Capsule and powder forms are FDA-authorized formulations of Omeprazole and Sodium bicarbonate combination. Both these formulations are intended to be taken by mouth. The capsule form needs to be swallowed as a whole with a glass full of water, while the powder form needs to be mixed with a minimal quantity of water (not more than two tablespoons) to form a suspension, which can be introduced orally. Omeprazole and Sodium bicarbonate combination is advised to be administered on an empty stomach. Food intake should be halted for another one hour following medicine administration. For bedridden patients or hospitalized patients who are instituted with tube feeding, withdrawal of the feeding tube is advised for three hours before medicine administration. The tube feeding should be reinstated only after one hour following medicine intake.

What Are the Side Effects of Omeprazole and Sodium Bicarbonate Combination?

The specific combination of Omeprazole and Sodium bicarbonate medicine tends to elicit certain side effects. Some of the frequently encountered adverse effects include the following:

• Headache, diarrhea, stomach pain, vomiting, and bloating (gas) are the routinely reported side effects precipitated by the use of combination formulations of Omeprazole with Sodium bicarbonate.

• Skin rashes, skin bumps, facial puffiness, confusion, dizziness, muscle spasms, tingling sensation in arms and legs, fatigue, heart racing, puffy legs, tremors, and chest discomfort are less frequently encountered but potentially alarming side effects. In such reactions, immediate medical attention is entailed, as it can endanger the patient’s life if left unattended.

Dietary Considerations:

Since the primary action of the Omeprazole and Sodium bicarbonate combination is in the gut, an empty stomach is desired for administration. The subsequent food intake should be held for a minimum of one hour following administration, which provides sufficient time for the combination formulation to work upon. The presence of food interrupts and depreciates the efficacy of Omeprazole.

Missed Dose:

The medicines are supposed to be taken at the specified time to ensure prompt action of the drugs. But at times, the patient may unintentionally forget to take the pill. In such scenarios, the patients can consume the medication once they become aware. If the patient recalls the overlooked dose at the time of the subsequent dose, then the overlooked dose needs to be ignored and can go ahead with the upcoming dose. It is strictly warned not to administer more than the stipulated dosage to balance the overlooked dose. Self-alteration of the medicine dosage can bring in overdose issues, and hence, it is not appreciated.

Overdose:

Overdose issues are precipitated upon administration of appreciably higher doses of Omeprazole and Sodium bicarbonate combinations. The overdose manifestations encompass visual disturbances, excessive sweating, facial redness, dry mouth, sleepiness, raised heart rate, vomiting, headache, and unexplainable warmth. Supportive therapy is advised for dealing with overdose issues.

Storage:

15 to 30 degrees Celsius (59 to 86 degrees Fahrenheit) is the safe storage temperature range for Omeprazole and Sodium bicarbonate combination pills. These are often available in blister packaging and medicine bottles and should keep the formulation in them until consumption. These drug formulations are reactive to extreme temperatures and can alter their effectiveness upon exposure to heat. Special care should be exercised in keeping the medicine safe and inaccessible to small children to check inadvertent medicine consumption.

For Doctors:

Indications:

• Active benign gastric ulcer (short-term therapy).

• Gastroesophageal reflux disease (GERD).

• Active duodenal ulcer (short-term therapy).

• Upper gastrointestinal bleeding (prophylactic therapy for terminally ill patients).

• Erosive esophagitis (treatment therapy and maintenance therapy).

Dose:

The dose of Omeprazole with Sodium bicarbonate is determined by considering the condition and purpose for which the therapy is being advised.

• Active Benign Gastric Ulcer: A daily single dose of 40 mg/1100 mg formulation of Omeprazole and Sodium bicarbonate is the preferred dosage for dealing with active benign gastric ulcer. The therapy regimen is for a period of four to eight weeks.

• Gastroesophageal Reflux Disease: A daily single dose of 20 mg/1100 mg combination of Omeprazole with Sodium bicarbonate is advised for gastroesophageal reflux disease with noticeable manifestation. The therapy is indicated for four weeks.

• Active Duodenal Ulcer: For tackling active duodenal ulcers, a daily single dose of 20 mg/1100 mg is indicated for four to eight weeks.

• Upper Gastrointestinal Bleeding: The oral suspension form of 40 mg/1680 mg is the preferred dosage for prophylactic therapy in terminally ill patients.

• Erosive Esophagitis: For treatment and maintenance therapy, the dose and dosage frequency should be 20 mg/1100 mg at a daily frequency of one time. However, the duration of the therapy differs by the condition’s severity. For treating erosive esophagitis, the therapy regimen ranges between four to eight weeks, while for maintenance therapy, the duration is at the doctor's discretion and varies on an individual basis.

Dosing Considerations:

Administering two tablets containing 20 mg of Omeprazole is not advised for substituting a single pill containing 40 mg. By doing so, the consumed dose of Sodium bicarbonate will be unintentionally doubled. In both 20 mg and 40 mg formulations, the Sodium bicarbonate concentration remains unaltered. Hence, it is always instructed to stick to the prescribed dosage formulation.

What Are the Pharmacological Aspects of Omeprazole and Sodium Bicarbonate Combination?

• Mechanism: The combined formulation of Omeprazole and Sodium bicarbonate utilizes the effectiveness of both drugs. This combination augments the efficacy of Omeprazole and complements each other's actions and effects. Omeprazole elicits its function by checking the proton pumps expressed on the parietal cells' surface. Once the proton pumps are checked, they hinder the acid production and thereby mitigate the gastric acid release. The collapsed gastric acid release favors the healing of the open sores called gastric ulcers. However, the potency of Omeprazole gets significantly curbed by the acidic gut pH. In low pH, Omeprazole loses its stability, which compromises its effectiveness. There comes the role of Sodium bicarbonate; being an antacid, Sodium bicarbonate enhances the gut pH by neutralizing the acidic content. It creates an environment that enables Omeprazole to work efficiently.

• Pharmacodynamics: The pharmacodynamic studies revealed an upsurge in the gastrin level during the initiation of therapy, particularly lasting for one or two weeks, following which no appreciable elevation was reported. In addition, cellular changes like hyperplasia were observed in enterochromaffin-like cells. The mechanism with which Omeprazole masks the proton pump is irreversible, resulting in a persistent effect of the drug.

• Pharmacokinetics: An empty stomach encourages the uptake of the combination formulation. Within 30 minutes, the concentration of the drugs attains its peak value. If it is taken following food intake, there is a substantial decline in the utmost concentration achieved. About 95 percent of the administered Omeprazole component attaches to the plasma protein. Liver enzymes are responsible for the extensive breakdown of the drug molecules, which convert the active molecules into various metabolites. These metabolites lack antisecretory effects and have no beneficial therapeutic values. The elimination of the drug molecules and their metabolites is carried out primarily through the urinary route, almost 77 percent. The remaining elimination is driven through the fecal route.

Toxicity:

Numerous animal toxicology studies were conducted to demonstrate the toxicity potential for Omeprazole and Sodium bicarbonate. Incidences of gastric carcinoid tumors were reported following exposure to a significantly higher concentration of the combination drugs for two years. Appreciable hyperplastic alterations were evident in the enterochromaffin-like cells of the rats exposed to this specific drug combination. Brain astrocytomas were a rare occurrence in association with Omeprazole and Sodium bicarbonate therapy. In vitro studies on human lymphocytes precipitated clastogenic changes, but animal studies failed to provide conclusive outcomes concerning clastogenic properties. Toxicities were reported in pregnant rabbits, potentially impacting the fetus and precipitating complications, while teratogenic effects were not evident in clinical trials on rats. Reproductive health remains unhindered with Omeprazole and Sodium bicarbonate therapy.

Clinical Studies:

Clinical studies and trials have been conducted on patients detected with gastric ulcers, GERD, duodenal ulcers, and upper gastrointestinal bleeding to assess and analyze the potency of the drug combination in dealing with each of these conditions. Randomized and multi-centric clinical trials were conducted across the United States in patients with active benign gastric ulcers. The double blinding ensures the accuracy of the study result by checking all means of bias. For smaller-sized gastric ulcers, the therapeutic effects remained the same irrespective of the concentration of the drugs and course of therapy. However, in the case of larger gastric ulcers, there were dose and duration-dependent appreciation in the healing rate of the active gastric ulcers.

What Are the Contraindications of Omeprazole and Sodium Bicarbonate Combination?

Patients who have had previous allergic experiences with either Omeprazole or Sodium bicarbonate or any other medicine belonging to the class of proton pump inhibitors or antacids are not supposed to take this drug combination. Likewise, suppose the patient is hyper-reactive to any components included in the capsule or powder form of Omeprazole and Sodium bicarbonate therapy. In that case, such patients are more likely to elicit an allergic reaction upon intake of the combination formulation.

Warnings and Precautions:

• Underlying Gastric Malignancy: At times, the gastric ulcer may be a manifestation of underlying gut cancer. The treatment therapy using Omeprazole and Sodium bicarbonate may occasionally bring noticeable relief upon therapy initiation, even for stomach cancers, which may hold up the detection of underlying cancer. Hence, positive responses towards the combination therapy using Omeprazole and Sodium bicarbonate never rule out the possibility of carcinogenic association.

• Presence of Sodium Bicarbonate: As the drug is a blend of Omeprazole and Sodium bicarbonate, there is a specific concentration of Sodium bicarbonate incorporated within the formulation. Therefore, it carries the risk of eliciting electrolyte imbalance issues in the body, particularly in patients with preexisting conditions like hypocalcemia, hypokalemia, and Bartter's syndrome. Administering this drug combination to patients adhering to a sodium-restricted diet can interfere with the sodium balance in their body; they need to be watchful over it.

• Atrophic Gastritis: Persistent therapy using Omeprazole is reported to precipitate atrophic gastritis. Hence, periodic risk assessment is indispensable in patients undergoing Omeprazole and Sodium bicarbonate therapy over a longer duration.

• Acute Interstitial Nephritis: Patients undergoing therapy using Omeprazole with Sodium bicarbonate are susceptible to acute nephritis. At any point in the therapy course, acute interstitial nephritis can be precipitated. The patient should be cautioned about the initial signs of the condition to encourage close monitoring.

• Clostridium Difficile-Associated Diarrhea: Therapy using Omeprazole enhances the likelihood of Clostridium difficile-associated diarrhea (CDAD). Hence, patients should be informed about this beforehand and need to seek immediate medical assistance once non-resolving diarrhea is encountered while on the therapy.

• Compromised Cyanocobalamin Absorption: Studies have concluded the potential of antisecretory drugs in collapsing the uptake of Cyanocobalamin. However, the frequency of clinical reports suggesting the same is relatively rare.

• Osteoporotic Changes: Proton pump inhibitors impair the bone strength and gear up the susceptibility for osteoporotic changes. Enhanced fracture risk is evident with prolonged therapy of proton pump inhibitor drugs, particularly with multiple doses.

• Interference to Diagnostic Tests: Omeprazole and Sodium bicarbonate formulation triggered a collapse in stomach acidity, reinforcing the level of serum chromogranin. This abnormal hike in serum chromogranin may interfere with the diagnostic interventions employed for neuroendocrine tumors, giving rise to false positive outcomes.

• Hypomagnesemia: Year-long therapy using proton pump inhibitors can precipitate discrepancies in the electrolyte homeostasis. Impaired magnesium ion concentration in the body is one of the electrolyte imbalance issues precipitated by Omeprazole. Periodic assessment of the electrolyte balance is hence advised to keep track of approaching electrolyte disparities.

What Are the Drug Interactions of Omeprazole and Sodium Bicarbonate Combination?

The combination formulation accommodating Omeprazole and Sodium bicarbonate tends to elicit interactions with other medicines. Some interactions can impair the effectiveness of either or both medicines. Some of the potential drug-to-drug associations include the following:

• Since Omeprazole and Sodium bicarbonate mitigate gastric acidity, they impair the uptake of certain drugs that require optimum gut pH for absorption. Simultaneous intake with Atazanavir, Erlotinib, or Ketoconazole can depreciate the uptake of these medicines.

• Concurrent intake of Omeprazole and Digoxin amplifies the uptake of Digoxin, which entails necessary dose modification to keep the Digoxin concentration at the required level. Similar effects are also elicited with Tacrolimus and Methotrexate.

• Simultaneous intake of Omeprazole with Phenytoin, Warfarin, or Diazepam can hold up the elimination of these drugs. Prolonged exposure to these drugs may bring in certain potential complications like exaggerated bleeding.

• Concurrent intake with certain antiretroviral medicines depletes the serum concentration of the antiretroviral drugs, thus collapsing their pharmacological properties and effects.

• Interaction of Clarithromycin with Omeprazole and Sodium bicarbonate combination can bring in certain undesirable effects in the body, and hence it is not preferred.

• Omeprazole curbs the conversion of inactive Clopidogrel to its pharmacologically active forms. Therefore, when taken simultaneously, Clopidogrel’s effectivity will be dramatically depleted.

Specific Considerations:

• Pregnancy: Considering the outcomes of animal studies, this drug combination is likely to precipitate fetal harm. However, it lacks validating evidence from clinical trials concerning teratogenicity. To be on the safer side, it is advised not to indulge in Omeprazole and Sodium bicarbonate therapy during conception.

• Breastfeeding: Omeprazole can potentially pass through the mother’s breast milk and gain access to the baby’s body. Hence, this drug combination is generally not preferred for lactating women. However, the decision is often made by the concerned doctor after considering the maternal need for the medicine.

• Pediatric Population: No reliable data is available concerning the therapeutic effects of Omeprazole and Sodium bicarbonate in the pediatric population, which restricts the usage of the medicine in children.