Description
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 used to lower the risk of heart attacks 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 the 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.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Tablet, Delayed Release
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of aspirin and omeprazole combination in the pediatric population. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of aspirin and omeprazole combination in the elderly. However, elderly patients are more sensitive to the effects of this medicine than younger adults.
Breastfeeding
Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Abrocitinib
- Defibrotide
- Dichlorphenamide
- Influenza Virus Vaccine, Live
- Ketorolac
- Mavacamten
- Rilpivirine
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Abametapir
- Acalabrutinib
- Acarbose
- Aceclofenac
- Acemetacin
- Acenocoumarol
- Acetazolamide
- Alclometasone
- Aldosterone
- Alipogene Tiparvovec
- Alteplase, Recombinant
- Amcinonide
- Amikacin
- Amiloride
- Amineptine
- Amitriptyline
- Amitriptylinoxide
- Amoxapine
- Amphetamine
- Amphotericin B
- Amtolmetin Guacil
- Anagrelide
- Anisindione
- Apixaban
- Ardeparin
- Argatroban
- Atazanavir
- Atezolizumab
- Avacopan
- Bacitracin
- Beclomethasone
- Belumosudil
- Belzutifan
- Bemetizide
- Bemiparin
- Benazepril
- Bendroflumethiazide
- Benzphetamine
- Benzthiazide
- Betamethasone
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Acebutolol
- Apalutamide
- Armodafinil
- Atenolol
- Betaxolol
- Bisoprolol
- Carteolol
- Carvedilol
- Celiprolol
- Cyanocobalamin
- Delapril
- Disulfiram
- Esmolol
- Garlic
- Ginkgo Biloba
- Imidapril
- Iron
- Labetalol
- Levobunolol
- Levothyroxine
- Metipranolol
- Metoprolol
- Nadolol
- Nebivolol
- Nitroglycerin
- Oxprenolol
- Penbutolol
- Pindolol
- Probenecid
- Propranolol
- Raltegravir
- Sotalol
- Streptokinase
- Tamarind
- Temocapril
- Tenecteplase
- Timolol
- Tipranavir
- Triazolam
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
- Cranberry
- Ethanol
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Alcohol abuse or history of or
- Bleeding problems (eg, hemophilia) or
- Cutaneous lupus erythematosus or
- Diarrhea or
- Hypomagnesemia (low magnesium in the blood), history of or
- Kidney disease or
- Osteoporosis (bone problem) or
- Stomach ulcers or bleeding, history of or
- Systemic lupus erythematosus (SLE)—Use with caution. May make these conditions worse.
- Aspirin-sensitive asthma or
- Aspirin sensitivity, history of or
- Kidney disease (eg, kidney failure), severe or
- Liver disease or
- Viral infections in children, suspected—Should not be used in patients with these conditions.
Proper Use
Take this medicine 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.
This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.
Take this medicine 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 this medicine 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 this medicine. 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.
- To prevent heart and blood vessel problems and who are at risk of developing stomach ulcers caused by aspirin:
Missed Dose
If you miss a dose of this medicine, 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.
Precautions
It is important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood, urine, and other laboratory tests may be needed to check for unwanted effects.
Do not use this medicine if you are also using medicines containing rilpivirine (Edurant®, Complera®, Odefsey®). Using these medicines together may cause unwanted side effects.
Tell your doctor if you are of Asian descent, such as Filipino, Chinese, Japanese, Korean, or Taiwanese. You may need a lower dose of this medicine.
Serious stomach conditions may occur while using this medicine. Check with your doctor immediately if you have stomach cramps, bloated feeling, watery and severe diarrhea which may also be bloody sometimes, fever, nausea or vomiting, or unusual tiredness or weakness.
Check with your doctor right away if you have a bloody urine, change in frequency of urination or amount of urine, a fever, joint pain, loss of appetite, skin rash, swelling of the body, feet, or ankles, unusual tiredness or weakness, or unusual weight gain after using this medicine. These may be symptoms of a serious kidney problem called acute tubulointerstitial nephritis.
This medicine may increase your risk of having fractures of the hip, wrist, and spine. This is more likely if you are 50 years of age and older, if you receive high doses of this medicine, or use it for one year or more.
Cutaneous or systemic lupus erythematosus may occur or gets worse in lupus patients and are taking PPI. Call your doctor right away if you have a joint pain or skin rash on your cheeks or arms that gets worse when exposed in the sun.
Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.
Drinking alcohol while using this medicine may increase your risk of liver damage. If you drink 3 or more alcoholic drinks every day, tell your doctor.
Taking this medicine for a long time may make it harder for your body to absorb vitamin B12. Tell your doctor if you have concerns about vitamin B12 deficiency.
This medicine may cause hypomagnesemia (low magnesium in the blood). This is more likely to occur if you are taking this medicine for more than one year, or if you are taking this medicine together with digoxin (Lanoxin®) or certain diuretics or "water pills". Check with your doctor right away if you have convulsions (seizures), fast, racing, or uneven heartbeat, muscle spasms (tetany), tremors, or unusual tiredness or weakness.
This medicine may increase your risk for fundic gland polyps (abnormal tissue growth in the upper part of your stomach). This is more likely if you are receiving this medicine for more than 1 year. Talk to your doctor if you have concerns.
Do not stop using this medicine suddenly without asking your doctor. You may need to slowly decrease your dose before stopping it completely.
Using this medicine during the later part of pregnancy can harm your unborn baby. If you think you have become pregnant while using this medicine, tell your doctor right away.
This medicine may cause a delay in ovulation for women and may affect their ability to have children. If you plan to have children, talk with your doctor before using this medicine.
This medicine may cause serious skin reactions, including exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, fixed drug eruption (FDE), and generalized bullous fixed drug eruption (GBFDE). Check with your doctor right away if you have blistering, peeling, or loosening of the skin, chills, cough, diarrhea, itching, joint or muscle pain, red irritated eyes, red skin lesions, often with a purple center, sore throat, sores, ulcers, or white spots in the mouth or on the lips, or unusual tiredness or weakness.
Check with your doctor right away if you have black, tarry stools, chest pain, chills, cough, fever, painful or difficult urination, sore throat, sores, ulcers, or white spots on the lips or in the mouth, swollen glands, trouble breathing, unusual bleeding or bruising, or unusual tiredness or weakness. These may be symptoms of serious skin reaction including drug reaction with eosinophilia and systemic symptoms (DRESS).
Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine several days before you have medical tests.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
More common
- Burning feeling in the chest or stomach
- indigestion
- stomach upset or tenderness
Less common
- Black, tarry stools
- chest pain
- diarrhea
- vomiting of blood or material that looks like coffee grounds
Incidence not known
- Blistering, peeling, or loosening of the skin
- bloating or swelling of the face, arms, hands, lower legs, or feet
- bloody or cloudy urine
- blurred vision
- chest tightness
- chills
- confusion
- constipation
- continuing vomiting
- cough
- darkened urine
- decreased frequency or amount of urine
- difficulty breathing
- difficulty swallowing
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- fast, pounding, or irregular heartbeat or pulse
- fever
- general feeling of discomfort or illness
- hair loss
- headache
- heartburn
- hives, itching, skin rash
- increased thirst
- indigestion
- joint or muscle pain
- loss of appetite
- lower back or side pain
- mood or mental changes
- muscle or joint pain
- muscle spasms (tetany) or twitching
- nausea
- nervousness
- nosebleed
- numbness or tingling in the hands, feet, or lips
- pain or swelling in the arms or legs without any injury
- painful or difficult urination
- pains in the stomach, side, or abdomen, possibly radiating to the back
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- rapid weight gain
- red skin lesions, often with a purple center
- red, irritated eyes
- seizures
- severe stomach cramps and pain
- slow heartbeat
- sore throat
- sores, ulcers, or white spots in the mouth or on the lips
- stomach pain, cramping, tenderness, or burning
- swelling of the face, fingers, or lower legs
- swollen glands
- trembling
- trouble breathing
- unusual bleeding or bruising
- unusual tiredness or weakness
- unusual weight gain or loss
- vomiting
- watery and severe diarrhea, which may also be bloody
- weakness or heaviness of the legs
- weight gain
- yellow eyes or skin
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Incidence not known
- Bad unusual or unpleasant (after) taste
- belching
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- change in taste
- decreased interest in sexual intercourse
- double vision
- heartburn
- inability to have or keep an erection
- increased sensitivity of the skin to sunlight
- loss in sexual ability, desire, drive, or performance
- loss or thinning of the hair
- redness or discoloration of the skin
- severe sunburn
- swelling of the breasts or breast soreness in both females and males
- swelling or inflammation of the mouth
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
DRG-20312492
