Pronunciation:

AS-pir-in, dye-pir-ID-a-mole

Brand Names:

• Aggrenox

Dosage Forms:

• Capsule, Extended Release

Classifications:

Therapeutic—

Platelet Aggregation Inhibitor, Phosphodiesterase Inhibitor/Salicylate, Aspirin Combination

Pharmacologic—

NSAID

Chemical—

Salicylate, Aspirin

Uses of This Medicine:

Aspirin and dipyridamole combination is used to prevent you from having a stroke. Strokes occur when a blood vessel in the brain is blocked by blood clots. This medicine will thin the blood and help prevent blood clots from forming. It is only given when there is a high risk that these problems may occur.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

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.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of aspirin and dipyridamole combination in the pediatric population. Because of aspirin's toxicity, use in children and teenagers is not recommended.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of aspirin and dipyridamole combination in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

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
• Riociguat

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.

• Abciximab
• Acarbose
• Aceclofenac
• Acemetacin
• Acenocoumarol
• Acetazolamide
• Alclometasone
• Aldosterone
• Alipogene Tiparvovec
• Alteplase, Recombinant
• Amcinonide
• Amikacin
• Amiloride
• Amineptine
• Amitriptyline
• Amitriptylinoxide
• Amoxapine
• Amphotericin B
• Amtolmetin Guacil
• Anagrelide
• Anisindione
• Apixaban
• Ardeparin
• Argatroban
• Bacitracin
• Beclomethasone
• Bemetizide
• Bemiparin
• Benazepril
• Bendroflumethiazide
• Benzthiazide
• Betamethasone
• Betrixaban
• Bivalirudin
• Brinzolamide
• Bromfenac
• Budesonide
• Bufexamac
• Bumetanide
• Caplacizumab-yhdp
• Capreomycin
• Captopril
• Celecoxib
• Certoparin
• Chlorothiazide
• Chlorpropamide
• Chlorthalidone
• Choline Salicylate
• Ciclesonide
• Cilostazol
• Cisplatin
• Citalopram
• Clobetasol
• Clobetasone
• Clocortolone
• Clomipramine
• Clonixin
• Clopamide
• Clopidogrel
• Cortisone
• Curcumin
• Cyclopenthiazide
• Cyclosporine
• Cyclothiazide
• Dabigatran Etexilate
• Dalteparin
• Danaparoid
• Deflazacort
• Desipramine
• Desirudin
• Desmopressin
• Desonide
• Desoximetasone
• Desvenlafaxine
• Dexamethasone
• Dexibuprofen
• Dexketoprofen
• Diazoxide
• Dibenzepin
• Diclofenac
• Dicumarol
• Diflorasone
• Diflucortolone
• Diflunisal
• Difluprednate
• Digoxin
• Dipyrone
• Dorzolamide
• Dothiepin
• Doxepin
• Droxicam
• Duloxetine
• Edoxaban
• Emtricitabine
• Enalapril
• Enalaprilat
• Enoxaparin
• Eplerenone
• Eptifibatide
• Escitalopram
• Ethacrynic Acid
• Etodolac
• Etofenamate
• Etoricoxib
• Etozolin
• Felbinac
• Fenoprofen
• Fepradinol
• Feprazone
• Feverfew
• Floctafenine
• Flucloronide
• Fludrocortisone
• Flufenamic Acid
• Flumethasone
• Flunisolide
• Fluocinolone
• Fluocinonide
• Fluocortin
• Fluocortolone
• Fluorometholone
• Fluoxetine
• Flurandrenolide
• Flurbiprofen
• Fluticasone
• Fluvoxamine
• Fondaparinux
• Foscarnet
• Fosinopril
• Fosphenytoin
• Furosemide
• Gentamicin
• Ginkgo
• Glimepiride
• Glipizide
• Glyburide
• Gossypol
• Halcinonide
• Halobetasol
• Heparin
• Hydrochlorothiazide
• Hydrocortisone
• Hydroflumethiazide
• Ibrutinib
• Ibuprofen
• Imipramine
• Indapamide
• Indomethacin
• Inotersen
• Kanamycin
• Ketoprofen
• Ketorolac
• Lepirudin
• Levomilnacipran
• Lisinopril
• Lithium
• Lofepramine
• Lornoxicam
• Loteprednol
• Loxoprofen
• Lumiracoxib
• Macimorelin
• Meclofenamate
• Medrysone
• Mefenamic Acid
• Melitracen
• Meloxicam
• Melphalan
• Metformin
• Methazolamide
• Methotrexate
• Methyclothiazide
• Methylprednisolone
• Metolazone
• Milnacipran
• Moexipril
• Mometasone
• Morniflumate
• Nabumetone
• Nadroparin
• Naproxen
• Nateglinide
• Nefazodone
• Neomycin
• Nepafenac
• Netilmicin
• Nicorandil
• Niflumic Acid
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Nortriptyline
• Opipramol
• Oxaprozin
• Oxyphenbutazone
• Paramethasone
• Parecoxib
• Parnaparin
• Paromomycin
• Paroxetine
• Pemetrexed
• Pentosan Polysulfate Sodium
• Pentoxifylline
• Perindopril
• Phenindione
• Phenprocoumon
• Phenylbutazone
• Phenytoin
• Piketoprofen
• Piracetam
• Piretanide
• Piroxicam
• Plazomicin
• Polythiazide
• Potassium Citrate
• Pranoprofen
• Prasugrel
• Prednicarbate
• Prednisolone
• Prednisone
• Proglumetacin
• Propyphenazone
• Proquazone
• Protein C
• Protriptyline
• Quinapril
• Quinethazone
• Ramipril
• Repaglinide
• Reteplase, Recombinant
• Reviparin
• Rimexolone
• Rivaroxaban
• Rofecoxib
• Salicylic Acid
• Salsalate
• Selumetinib
• Sertraline
• Sodium Salicylate
• Spectinomycin
• Spirapril
• Spironolactone
• Streptokinase
• Streptomycin
• Sulfinpyrazone
• Sulindac
• Sulodexide
• Tacrolimus
• Tenecteplase
• Tenofovir Alafenamide
• Tenofovir Disoproxil Fumarate
• Tenoxicam
• Tianeptine
• Tiaprofenic Acid
• Ticagrelor
• Ticlopidine
• Tinzaparin
• Tirofiban
• Tobramycin
• Tolazamide
• Tolbutamide
• Tolfenamic Acid
• Tolmetin
• Torsemide
• Trandolapril
• Trazodone
• Treprostinil
• Triamcinolone
• Triamterene
• Trichlormethiazide
• Trimipramine
• Turmeric
• Valdecoxib
• Valproic Acid
• Vancomycin
• Varicella Virus Vaccine, Live
• Venlafaxine
• Vilazodone
• Vortioxetine
• Warfarin
• Xipamide

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
• Adenosine
• Atenolol
• Betaxolol
• Bisoprolol
• Carteolol
• Carvedilol
• Celiprolol
• Delapril
• Esmolol
• Imidapril
• Labetalol
• Levobunolol
• Metipranolol
• Metoprolol
• Nadolol
• Nebivolol
• Nitroglycerin
• Oxprenolol
• Penbutolol
• Pindolol
• Probenecid
• Propranolol
• Sotalol
• Streptokinase
• Tamarind
• Temocapril
• Tenecteplase
• Timolol

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.

• 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 use (3 or more drinks per day) or
• Bleeding problems or
• Liver disease, severe or
• Stomach ulcer, history of—May cause side effects to become worse.

• Angina (severe chest pain), unstable or
• Heart attack, recent or
• Heart disease (e.g., coronary artery disease) or
• Hypotension (low blood pressure) or
• Kidney disease, severe or
• Myasthenia gravis (severe muscle weakness)—Use with caution. May make these conditions worse.

• Asthma with nasal polyps and rhinitis, history of or
• Nonsteroidal antiinflammatory drug (NSAID) allergy (e.g., diclofenac, ibuprofen, naproxen, Advil®, Aleve®, Celebrex®, Voltaren®) or
• Reye's syndrome (metabolic disorder)—Should not be used in patients with these conditions.

Proper Use of This Medicine:

Take this medicine exactly as directed by your doctor. Do not take more of it and do not take it more often than your doctor ordered. This medicine works best if there is a constant amount in the blood. To keep blood levels constant, take this medicine at the same time each day and do not miss any doses.

This medicine comes with a patient information leaflet. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Swallow the capsules whole. Do not break, crush, or chew them.

You may take this medicine with or without food.

If you have a severe headache after taking this medicine, tell your doctor right away. Your doctor may temporarily change your dose.

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 (capsules):
  • For preventing stroke:
    • Adults—One capsule two times a day, taken once in the morning and once in the evening.
    • Children—Use is not recommended.

Missed dose—

If you miss a dose of this medicine, 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 While Using This Medicine:

It is very important that your doctor check your progress at regular visits, to make sure this medicine is working properly and to decide if you should continue to take it. Blood tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.

Aspirin and dipyridamole combination provide better protection against the formation of blood clots than either of the medicines used alone. However, the risk of bleeding may also be increased. To reduce the risk of bleeding:

• Do not take aspirin, or any combination medicine that contains aspirin, in addition to this medicine unless the same doctor who ordered it tells you to.
• If you need a medicine to relieve pain or a fever, your doctor may not want you to take extra aspirin. It is a good idea to discuss this with your doctor, so you will know ahead of time what medicine to take.

Dizziness, lightheadedness, or fainting may occur, especially when you get up from a lying or sitting position suddenly. Getting up slowly may help. If this problem continues or gets worse, check with your doctor.

Avoid drinking alcohol while you are taking this medicine.

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 or vitamin supplements.

Side Effects of This Medicine:

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

Abdominal or stomach pain

vomiting

Less common

Bleeding from the rectum

bloody mucous or unexplained nosebleeds

bloody or black, tarry stools

confusion

convulsions (seizures)

difficulty with breathing

difficulty with speaking

double vision

inability to move the arms, legs, or facial muscles

inability to speak

memory loss

pale skin

purple or red spots on skin

slow speech

tightness in the chest

troubled breathing (exertional)

unusual bleeding or bruising

vomiting of blood or material that looks like coffee grounds

Rare

Abdominal or stomach fullness

blood in the urine

chills

clay-colored stools

collection of blood under the skin

cough

deep, dark purple bruise

gaseous abdominal or stomach pain

itching, pain, redness, or swelling of the eye or eyelid

loss of appetite

nausea

noisy breathing

recurrent fever

skin rash or hives (severe)

watering of the eyes

yellow eyes or skin

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

Blurred vision

continuing ringing or buzzing or other unexplained noise in the ears

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

fast or irregular heartbeat

flushes

hearing loss

restlessness

sweating

unusual tiredness or weakness

warm feeling

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:

More common

Acid or sour stomach

belching

diarrhea

difficulty with moving

headache

heartburn

indigestion

muscle pain or stiffness

pain, swelling, or redness in the joints

stomach discomfort or upset

Less common or rare

Back pain

burning feeling in the chest or stomach

loss of strength or energy

rectal pain or swelling

sleepiness or unusual drowsiness

taste loss

tenderness in the stomach area

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.