aspirin and omeprazole

Action and Spectrum

Actions and spectrum: 

aspirin is a NSAID that inhibits the synthesis of prostaglandins, which are involved in pain, inflammation, and fever. It also has antiplatelet effects, which help prevent blood clot formation. The spectrum of aspirin’s action includes relieving pain, reducing inflammation, lowering fever, and preventing blood clot formation. 

omeprazole is the proton pump inhibitor that decreases the production of acid in stomach by inhibiting the enzyme responsible for acid secretion. It helps to treat conditions such as gastroesophageal reflux disease (GERD), peptic ulcers, and certain gastrointestinal disorders. The spectrum of omeprazole’s action is primarily focused on reducing gastric acid secretion and relieving symptoms associated with excessive stomach acid production. 

Drug Interaction

Adverse Reaction

Frequency defined 

1-10% 

Diarrhea (3%) 

Noncardiac chest pain (2%) 

Nausea (3%) 

Gastric polyps (2%)  

>10% 

Gastritis (16%)  

<1% 

Small bowel obstruction 

lower or upper GI bleed  

Post marketing Reports 

aspirin 

CNS: cerebral edema, confusion, headache, intracranial hemorrhage, seizures, Agitation, coma, dizziness, lethargy 

Gastrointestinal: GI bleeding, nausea, Reye syndrome, Dyspepsia, ulceration, vomiting, hepatitis, pancreatitis 

Hypersensitivity: angioedema, bronchospasm, urticaria, Acute anaphylaxis, asthma, laryngeal edema 

Metabolism: hyperglycemia, Hypoglycemia 

Respiratory: pulmonary edema, Hyperpnea, tachypnea 

Urogenital: papillary necrosis, renal failure, Interstitial nephritis, proteinuria 

Whole body: hypothermia, Dysrhythmias, tachycardia, Fever, hypotension 

Fluid and electrolyte: hyperkalemia, respiratory alkalosis, Dehydration, metabolic acidosis 

Hematologic: thrombocytopenia, prothrombin time prolongation, coagulopathy 

Musculoskeletal: Rhabdomyolysis 

Reproductive: stillbirths, antepartum, Prolonged labor and pregnancy, postpartum bleeding 

Special senses: tinnitus, Hearing loss  

omeprazole 

Cardiovascular: tachycardia, palpitations, peripheral edema, Chest pain or angina, bradycardia, elevated blood pressure 

Gastrointestinal: anorexia, fecal discoloration, mucosal atrophy, abdominal swelling, microscopic colitis, Pancreatitis, irritable colon, esophageal candidiasis, stomatitis, dry mouth 

Hepatic: hepatic failure, hepatic encephalopathy, cholestatic disease, jaundice, liver necrosis, hepatocellular disease, mixed hepatitis 

nutritional and metabolism disorders: hypomagnesemia, weight gain, Hypoglycemia, hyponatremia 

psychiatric/ Nervous system: agitation, hallucinations, insomnia, apathy, anxiety, depression, aggression, confusion, nervousness, somnolence 

Ocular: dry eye syndrome, blurred vision, Optic atrophy, optic neuritis, double vision 

Acute tubulointerstitial nephritis 

whole Body: Hypersensitivity reactions, anaphylactic shock, bronchospasm, urticaria, fever, fatigue, anaphylaxis, angioedema, interstitial nephritis, SLE, pain, malaise 

Endocrine: Gynecomastia 

Hematologic: hemolytic anemia, neutropenia, thrombocytopenia, leukocytosis, Agranulocytosis, pancytopenia, anemia, leukopenia 

Musculoskeletal: myalgia, joint pain, bone fracture, Muscle weakness, muscle cramps, leg pain 

Respiratory: pharyngeal pain, Epistaxis 

Special senses: taste perversion, Tinnitus 

Black Box Warning

Black Box Warning: 

aspirin has a black box warning for its increased risk of bleeding, including gastrointestinal bleeding, intracranial haemorrhage, and haemorrhagic stroke. It is especially important to use caution in patients with a history of bleeding disorders or those taking anticoagulant medications. 

omeprazole has a black box warning regarding the increased risk of Clostridium difficile-associated diarrhoea, a potentially severe intestinal infection. 

Contraindication / Caution

Contraindication/Caution: 

Contraindication: 

• Hypersensitivity or allergy to aspirin or other NSAIDs. 
• Active peptic ulcer disease or gastrointestinal bleeding. 
• Severe liver or kidney disease. 
• Bleeding disorders or a history of bleeding problems. 
• Asthma triggered by NSAIDs. 
• Pregnancy, especially in the first and third trimester. 
• Concurrent use of certain medications, such as atazanavir or nelfinavir. 

Caution: 

aspirin 

• History of gastrointestinal ulcers or bleeding. 
• Asthma or nasal polyps, as aspirin may trigger or worsen these conditions. 
• Renal impairment or kidney disease. 
• Liver disease. 
• History of bleeding disorders or coagulation disorders. 
• Use of anticoagulant medications. 
• Concurrent use of other NSAIDs or antiplatelet drugs. 

omeprazole 

• History of liver disease. 
• Hypomagnesemia (low magnesium levels) or electrolyte imbalances. 
• Osteoporosis or increased risk of bone fractures. 
• Concurrent use of certain medications, such as warfarin or clopidogrel. 
• Long-term use, as it may increase the risk of certain infections or nutrient deficiencies.

Comorbidities: 

• Cardiovascular disease: aspirin is commonly used to reduce the risk of heart attack and stroke in individuals with cardiovascular disease. omeprazole may be prescribed to manage gastrointestinal side effects of aspirin therapy. 
• Gastrointestinal disorders: Both aspirin and omeprazole can affect the gastrointestinal system. Individuals with a history of gastrointestinal ulcers, bleeding, or other digestive disorders may require caution and close monitoring when using these medications. 
• Asthma: aspirin is known to cause asthma exacerbations in some individuals with a history of asthma. Close monitoring and cautious use are recommended in such cases. 
• Renal impairment: aspirin and omeprazole can have effects on kidney function. Individuals with pre-existing renal impairment or kidney disease may require dosage adjustments or closer monitoring of kidney function. 
• Liver disease: omeprazole is primarily metabolized in the liver, so individuals with liver disease may require dosage adjustments. aspirin use may also need to be monitored in individuals with liver disease due to the potential for liver toxicity. 

Pregnancy / Lactation

Pregnancy consideration: US FDA pregnancy category: Not assigned. 

Lactation: Excreted into human milk: Yes  

Pregnancy category: 

• Category A: well-controlled and Satisfactory studies show no risk to the fetus in the first or later trimester. 
• Category B: there was no evidence of risk to the fetus in animal studies, and there were not enough studies on pregnant women. 
• Category C: there was evidence of risk of adverse effects in animal reproduction studies, and no adequate evidence in human studies must take care of potential risks in pregnant women.   
• Category D: adequate data with sufficient evidence of human fetal risk from various platforms, but despite the potential risk, and used only in emergency cases for potential benefits. 
• Category X: Drugs listed in this category outweigh the risks over benefits. Hence these categories of drugs need to be avoided by pregnant women. 
• Category N: There is no data available for the drug under this category. 

Pharmacology

Pharmacology: 

aspirin is a nonsteroidal anti-inflammatory drug (NSAID) that inhibits the enzyme cyclooxygenase (COX). It irreversibly acetylates and inhibits both COX-1 and COX-2 enzymes, leading to decreased production of prostaglandins, which are involved in pain, inflammation, and platelet aggregation. 

omeprazole is a proton pump inhibitor (PPI) that inhibits the enzyme H+/K+-ATPase in the stomach’s parietal cells. It reduces gastric acid secretion by suppressing the final step of acid production, leading to an increased gastric pH. 

Pharmacodynamics: 

aspirin: 

• Anti-inflammatory effects: aspirin inhibits the enzyme cyclooxygenase (COX), thereby reducing the production of prostaglandins. Prostaglandins are involved in the inflammatory process, and by inhibiting their synthesis, aspirin exhibits anti-inflammatory effects. 
• Analgesic effects: aspirin’s inhibition of COX also leads to decreased production of prostaglandins involved in pain signalling. This contributes to its analgesic properties. 
• Antipyretic effects: aspirin’s ability to inhibit prostaglandin production helps reduce fever by blocking the pyrogenic effects of prostaglandins on the hypothalamus. 
• Antiplatelet effects: aspirin irreversibly inhibits COX-1 in platelets, reducing the synthesis of thromboxane A2, a potent platelet aggregator. This antiplatelet effect makes aspirin effective in preventing blood clot formation. 

omeprazole: 

• Gastric acid suppression: omeprazole inhibits the enzyme H+/K+-ATPase (proton pump) in the gastric parietal cells. By blocking this enzyme, it reduces the secretion of gastric acid into the stomach. This leads to an increase in gastric pH and a decrease in acid-related symptoms such as heartburn and acid reflux. 
• Suppression of acid-related disorders: omeprazole’s primary pharmacodynamic effect is the reduction of gastric acid secretion. This makes it effective in treating conditions such as gastroesophageal reflux disease (GERD), peptic ulcers, and Zollinger-Ellison syndrome. 

Pharmacokinetics: 

aspirin: 

• Absorption: aspirin is rapidly and well absorbed from the gastrointestinal tract after oral administration. 
• Distribution: aspirin is widely distributed throughout the body and readily crosses cell membranes. It can also cross the placenta and enter breast milk. 
• Metabolism: aspirin undergoes hepatic metabolism, primarily through hydrolysis to salicylic acid. Salicylic acid is the main active metabolite responsible for the pharmacological effects of aspirin. 
• Elimination: Both aspirin and its metabolite, salicylic acid, are eliminated primarily by renal excretion. The elimination half-life of aspirin is relatively short, around 15-20 minutes, but the half-life of salicylic acid is longer, ranging from 2-3 hours. 

omeprazole: 

• Absorption: omeprazole is acid-labile and needs an acidic environment for optimal absorption. It is absorbed from the gastrointestinal tract, with peak plasma concentrations of 1-2 hours after oral administration. 
• Distribution: omeprazole is extensively protein-bound, primarily to albumin. It distributes widely throughout the body, including the gastric parietal cells, where it exerts its pharmacological effects. 
• Metabolism: omeprazole undergoes hepatic metabolism via the cytochrome P450 enzymes, primarily CYP2C19 and CYP3A4. It is metabolized to its active metabolites, which contribute to its pharmacological effects. 
• Elimination: omeprazole and its metabolites are eliminated in the urine, with a small portion excreted in the feces. The elimination half-life of omeprazole is 1-2 hours, but its effects on gastric acid secretion can last up to 24 hours due to the irreversible inhibition of the proton pump. 

Adminstartion

Administration: 

aspirin and omeprazole are typically administered orally. aspirin is available in various forms such as tablets, capsules, and chewable tablets. It is usually taken with water and can be taken with or without food, depending on the specific instructions provided by the healthcare professional. It is important to follow the recommended dosage and frequency of administration. 

omeprazole is also available in the form of capsules or tablets. It is usually taken once a day, preferably in the morning before breakfast, with a glass of water. The capsule or tablet should be administered whole and should not be crushed, chewed, or broken. It is important to take omeprazole consistently at the same time each day for optimal effectiveness. 

Patient Information Leaflet

Patient information leaflet 

Generic Name: aspirin and omeprazole 

Pronounced: (uh-SPY-rin” omeprazole: “oh-MEP-ruh-zole)  

Why do we use aspirin and omeprazole? 

aspirin is commonly used for its analgesic, antipyretic, and anti-inflammatory properties. It is used in mild to moderate pain, reduce fever, and treat various inflammatory conditions. Additionally, aspirin is prescribed for its antiplatelet effects to prevent heart attacks and strokes. 

omeprazole is the proton pump inhibitor that is used to reduce stomach acid production. It is primarily prescribed for the treatment of gastroesophageal reflux disease (GERD), gastric ulcers, and duodenal ulcers. omeprazole is also used in combination with antibiotics to eradicate Helicobacter pylori infection and prevent the recurrence of certain gastric ulcers.