Aspirin and omeprazole

Name: Aspirin and omeprazole

Aspirin and omeprazole Brand Names

Aspirin and omeprazole may be found in some form under the following brand names:

  • Yosprala

Uses For aspirin and omeprazole

Aspirin and omeprazole combination is used in patients who need aspirin to prevent heart and blood vessel problems (eg, heart attack, stroke) and who are at risk of developing stomach ulcers caused by aspirin.

Aspirin is a salicylate medicine and used to lower risk of heart attack in patients with chronic coronary artery disease, such as patients with history of heart attack or angina (severe chest pain). It is also used to lower risk of recurrent stroke in patients who had an ischemic stroke or transient ischemic attack. Omeprazole is a proton pump inhibitor (PPI). It works by decreasing the amount of acid produced by the stomach.

aspirin and omeprazole is available only with your doctor's prescription.

Proper Use of aspirin and omeprazole

Take aspirin and omeprazole only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

aspirin and omeprazole should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Take aspirin and omeprazole at least 60 minutes before a meal.

Swallow the delayed-release tablet whole with liquid. Do not split, chew, crush, or dissolve it.

Dosing

The dose of aspirin and omeprazole will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of aspirin and omeprazole. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (delayed release tablets):
    • To prevent heart and blood vessel problems and who are at risk of developing stomach ulcers caused by aspirin:
      • Adults—1 tablet once a day. Each tablet contains 81 or 325 milligrams (mg) of aspirin and 40 mg of omeprazole.
      • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of aspirin and omeprazole, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Uses of Aspirin and Omeprazole

  • It is used to lower the chance of heart attack, stroke, and death in some people.
  • It may be given to you for other reasons. Talk with the doctor.

How do I store and/or throw out Aspirin and Omeprazole?

  • Store in the original container at room temperature.
  • Store in a dry place. Do not store in a bathroom.
  • Keep lid tightly closed.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Check with your pharmacist about how to throw out unused drugs.

Pharmacologic Category

  • Analgesic, Nonopioid
  • Antiplatelet Agent
  • Nonsteroidal Anti-inflammatory Drug (NSAID), Oral
  • Proton Pump Inhibitor
  • Salicylate
  • Substituted Benzimidazole

Dosing Adult

Secondary prevention of cardiovascular and cerebrovascular events: Oral: One tablet (aspirin 81 mg/omeprazole 40 mg or aspirin 325 mg/omeprazole 40 mg) once daily. Note: Generally 81 mg of aspirin has been accepted as an effective dose for secondary cardiovascular prevention; refer to current clinical practice guidelines when considering the need for 325 mg of aspirin.

Dosing Renal Impairment

GFR ≥10 mL/minute: No dosage adjustment necessary.

GFR <10 mL/minute: Avoid use.

Warnings/Precautions

Concerns related to adverse effects:

• Atrophic gastritis: Long-term omeprazole therapy has caused atrophic gastritis (identified by biopsy).

• Carcinoma: In long-term (2-year) studies in rats, omeprazole produced a dose-related increase in gastric carcinoid tumors. While available endoscopic evaluations and histologic examinations of biopsy specimens from human stomachs have not detected a risk from short-term exposure to omeprazole, further human data on the effect of sustained hypochlorhydria and hypergastrinemia are needed to rule out the possibility of an increased risk for the development of tumors in humans receiving long-term therapy.

Clostridium difficile-associated diarrhea: Use of proton pump inhibitors (PPIs) may increase risk of Clostridium difficile-associated diarrhea (CDAD), especially in hospitalized patients; consider CDAD diagnosis in patients with persistent diarrhea that does not improve. Use the lowest dose and shortest duration of PPI therapy appropriate for the condition being treated.

• Cutaneous and systemic lupus erythematosus: Has been reported in patients taking PPIs as new onset or exacerbation of existing autoimmune disease; most cases reported were cutaneous lupus erythematosus (CLE) with onset up to 2 years after continuous therapy and occurred primarily in older patients (some cases were reported in patients as young as 7 months of age); complete recovery generally occurred within 12 weeks after discontinuation. Systemic lupus erythematosus (SLE) is less common and typically occurs within 30 days after initiation (some cases were reported days or years) and occurred primarily in older adults (some cases reported in young adults); clinical symptoms generally resolved within 8 weeks. Discontinue therapy if signs or symptoms of CLE or SLE occur and refer to specialist for evaluation.

• Fractures: Increased incidence of osteoporosis-related bone fractures of the hip, spine, or wrist may occur with PPI therapy. Patients on high-dose (multiple daily doses) or long-term (≥1 year) therapy should be monitored. Use the lowest effective dose for the shortest duration of time, use vitamin D and calcium supplementation, and follow appropriate guidelines to reduce risk of fractures in patients at risk.

• GI effects: Aspirin may cause serious GI adverse reactions, including inflammation, bleeding ulceration and perforation. Other adverse reactions include stomach pain, heartburn, nausea, and vomiting. Monitor patients for signs of ulceration and bleeding. Discontinue therapy if active and significant bleeding occurs. Use aspirin with caution in patients with erosive gastritis; avoid use in patients with active peptic ulcer disease.

• Hypomagnesemia: Reported rarely, usually with prolonged PPI use of >3 months (most cases >1 year of therapy). May be symptomatic or asymptomatic; severe cases may cause tetany, seizures, and cardiac arrhythmias. Consider obtaining serum magnesium concentrations prior to beginning long-term therapy, especially if taking concomitant digoxin, diuretics, or other drugs known to cause hypomagnesemia; and periodically thereafter. Hypomagnesemia may be corrected by magnesium supplementation, although discontinuation of omeprazole may be necessary; magnesium levels typically return to normal within 1 week of stopping.

• Interstitial nephritis: Acute interstitial nephritis has been observed in patients taking PPIs; may occur at any time during therapy and is generally due to an idiopathic hypersensitivity reaction. Discontinue if acute interstitial nephritis develops.

• Salicylate sensitivity: Patients with sensitivity to tartrazine dyes, nasal polyps, and asthma may have an increased risk of salicylate sensitivity.

• Tinnitus: Discontinue use if tinnitus or impaired hearing occurs.

• Upper gastrointestinal events (eg, symptomatic or complicated ulcers): Low-dose aspirin for cardioprotective effects is associated with a two- to fourfold increase in upper gastrointestinal (UGI) events. The risks of these events increase with increasing aspirin dose; during the chronic phase of aspirin dosing, doses >81 mg are not recommended unless indicated (Bhatt 2008).

• Vitamin B12 deficiency: Prolonged treatment (>3 years) of PPIs may lead to vitamin B12 malabsorption and subsequent vitamin B12 deficiency. The magnitude of the deficiency is dose-related and the association is stronger in females and those younger in age (<30 years); prevalence is decreased after discontinuation of therapy (Lam 2013).

Disease-related concerns:

• Bleeding disorders: Use aspirin with caution in patients with platelet and bleeding disorders.

• Dehydration: Use aspirin with caution in patients with dehydration.

• Gastric malignancy: Relief of gastric symptoms does not preclude the presence of a gastric malignancy.

• Gastrointestinal infection (eg, Salmonella, Campylobacter): Use of PPIs may increase risk of these infections.

• Hepatic impairment: Avoid use in patients with hepatic impairment.

• Renal impairment: Avoid use in patients with glomerular filtration rate (GFR) <10 mL/minute.

Concurrent drug therapy issues:

• Clopidogrel: PPIs may diminish the therapeutic effect of clopidogrel, thought to be due to reduced formation of the active metabolite of clopidogrel. The manufacturer of clopidogrel recommends either avoidance of both omeprazole (even when scheduled 12 hours apart) and esomeprazole or use of a PPI with comparatively less effect on the active metabolite of clopidogrel (eg, pantoprazole). In contrast to these warnings, others have recommended the continued use of PPIs, regardless of the degree of inhibition, in patients with a history of GI bleeding or multiple risk factors for GI bleeding who are also receiving clopidogrel since no evidence has established clinically meaningful differences in outcome; however, a clinically significant interaction cannot be excluded in those who are poor metabolizers of clopidogrel (Abraham 2010; Levine 2011).

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Special populations:

• Asian ethnicity: Avoid use in Asian patients with unknown CYP2C19 genotype or those who are known to be poor metabolizers.

Dosage form specific issues:

•Interchangeability: Aspirin/omeprazole combination product is not interchangeable with the individual components of aspirin and omeprazole.

Other warnings/precautions:

• Laboratory test interference: Serum chromogranin A (CgA) levels increase secondary to drug-induced decreases in gastric acid; may cause false-positive results in diagnostic investigations for neuroendocrine tumors. Temporarily stop omeprazole treatment at least 14 days before CgA test; if initial CgA levels are high, repeat test to confirm. Use same commercial laboratory for testing to prevent variable results.

Pregnancy Considerations

Use of aspirin in women ≥30 weeks gestation is associated with an increased risk for premature closure of the fetal ductus arteriosus; third trimester use may be also associated with an increased risk of neonatal complications. In addition, use of aspirin during labor may increase the risk for excessive blood loss at delivery. Use of this combination should be avoided in women ≥30 weeks gestation. Refer to individual monographs for additional information.

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience heartburn. Have patient report immediately to prescriber signs of bleeding (vomiting blood or vomit that looks like coffee grounds; coughing up blood; hematuria; black, red, or tarry stools; bleeding from the gums; abnormal vaginal bleeding; bruises without a reason or that get bigger; or any severe or persistent bleeding), signs of low magnesium (mood changes; muscle pain or weakness; muscle cramps or spasms; seizures; tremors; lack of appetite; severe nausea or vomiting; or an abnormal heartbeat), signs of kidney problems (urinary retention, hematuria, change in amount of urine passed, or weight gain), signs of infection, signs of liver problems (dark urine, fatigue, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or jaundice), signs of pancreatitis (severe abdominal pain, severe back pain, severe nausea, or vomiting), signs of lupus (rash on the cheeks or other body parts, sunburn easy, muscle or joint pain, angina or shortness of breath, or swelling in the arms or legs), severe nausea, vomiting, severe abdominal pain, bone pain, edema, severe dizziness, passing out, tinnitus, signs of Clostridium difficile (C. diff)-associated diarrhea (abdominal pain or cramps, severe diarrhea or watery stools, or bloody stools), or signs of Stevens-Johnson syndrome/toxic epidermal necrolysis (red, swollen, blistered, or peeling skin [with or without fever]; red or irritated eyes; or sores in mouth, throat, nose, or eyes) (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

Other Comments

Administration advice:
-Take at least 60 minutes before a meal
-Swallow whole with liquid; do not split, chew, crush, or dissolve the tablet
-If a dose is missed, it may be taken as soon as it is remembered; if it is almost time for the next dose, skip the missed dose and take the next dose at the regular time.
-This drug should not be abruptly stopped as it could increase the risk of heart attack or stroke.

Storage requirements:
-Store in original container with desiccant; keep tightly closed to protect from moisture.
-Dispense in tight container if package is subdivided.

General:
-Use the lowest effective dose based on individual patient treatment goals and to avoid potential dose dependent adverse reactions including bleeding.
-This drug contains a delayed-release formulation of aspirin and is not for use as the initial dose of aspirin therapy during acute coronary syndrome, acute myocardial infarction, or before percutaneous coronary intervention (PCI) for which immediate-release therapy is appropriate.
-This drug has not been shown to reduce the risk of gastrointestinal bleeding due to aspirin.
-This drug is not interchangeable with the individual components of aspirin and omeprazole.

Monitoring:
-Hematologic: Monitor for signs/symptoms of increased bleeding.
-Metabolic: Monitor magnesium levels prior to initiation and periodically throughout treatment in patients receiving long term treatment or concomitant use with medications that may cause hypomagnesemia (e.g., digoxin, diuretics).

Patient advice:
-Consult the patient medication guide for further information

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