Adult Dosing

Thrombotic stroke prevention

• 1 cap bid with or without food
• If intolerable headache during initial therapy switch to 1 capsule hs and low-dose aspirin at am; resume bid dosing within 1 wk

• Not interchangeable with the individual components of aspirin and dipyridamole tablets
• Do not chew

Pediatric Dosing

• Safety and effectiveness in pediatric patients have not been established

[Outline]

• Adult Dosing
• Pediatric Dosing

• Reduces the risk of stroke in patients who have had transient ischemia of the brain or completed ischemic stroke due to thrombosis

• Hypersensitivity to any of the ingredients of the product
• Patients with known allergy to NSAIDs
• Patients with the syndrome of asthma, rhinitis, and nasal polyps
• Active peptic ulcer disease
• GI bleeding
• Aspirin or NSAID-induced asthma or urticaria
• Pregnancy 3rd trimester
• G6PD deficiency
• Aspirin triad
• Uncontrolled hypertension
• Influenza, varicella, or febrile viral infections in patients <20 yrs

• N/A

Renal Dose Adjustment (Based on CrCl)

• <10 mL/min: Avoid use

Hepatic Dose Adjustment

• Hepatic impairment: Dose adjustments not defined

See Supplemental Patient Information

• Therapy may increase risk of bleeding; risk factors include the use of drugs such as anticoagulations, antiplatelet agents, heparin, fibrinolytic therapy, and chronic use of NSAIDs
• GI adverse events such as stomach pain, heartburn, nausea, vomiting, and gross GI bleeding including upper GI symptoms, such as dyspepsia may occur during therapy
• Aspirin should be avoided in patients with a history of active peptic ulcer disease
• Patients who are heavy alcohol users should avoid this therapy due to risk of GI bleeding
• Physicians should remain alert for signs of ulceration and bleeding, even in the absence of previous GI symptoms
• Elevations of hepatic enzymes and hepatic failure have occurred
• Precipitation/aggravation of chest pain may occur in patients with underlying coronary artery disease
• May not provide adequate treatment for the cardiac indications
• Avoid use in patients with severe hepatic/renal impairment/active peptic ulcer disease
• Exacerbation of pre-existing hypotension have occurred
• Induces fetal harm when administered to a pregnant woman, especially in the third trimester
• Aspirin/dipyridamole capsules are not interchangeable with the individual components of aspirin and dipyridamole tablets

Cautions: Use cautiously in:

• Renal impairment
• Hepatic impairment
• Patients taking large amounts of alcohol
• Coronary artery disease
• Hypotension
• Coagulation disorder
• History or risk of abuse
• Thrombocytopenia
• Surgery or trauma
• Intracranial lesion
• ICP increased
• GERD

Supplemental Patient Information

• Advise patients to avoid alcoholic beverages
• Educate patients about the signs and symptoms of GI side effects and measures to take if they occur
• Patients may experience transient headaches upon treatment initiation; if intolerable, contact physician

Pregnancy Category:D

Breastfeeding: Avoid aspirin during breastfeeding, especially with very young infants; although a rare single low dose of aspirin daily is unlikely to cause problems in the infant. The risks with chronic high dose aspirin use are less clear. Monitor infant salicylate serum levels particularly in neonates. Avoid breastfeeding for 1-2 hrs after a dose to minimize antiplatelet effects. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 24 December 2010). Manufacturer advises caution.

• GI: GI ulceration, GI perforation, GI obstruction, GI bleed, hepatotoxicity, nausea, vomiting, dyspepsia, abdominal pain, constipation, diarrhea
• CV: Angioedema, severe hypotension, tachycardia, angina, disseminated intravascular coagulation
• CNS: Intracranial hemorrhage, seizures, drowsiness, dizziness, orthostatic hypotension, ataxia, tremor, headache, irritability
• RESP: Bronchospasm
• HEMA: Pancytopenia, aplastic anemia, agranulocytosis, thrombocytopenia, hypoprothrombinemia
• EENT: Tinnitus, epistaxis, hearing loss
• GU: Acute renal failure, nephrotoxicity, hyperuricemia
• DERM: Purpura, flushing, sweating, pruritus, rash, urticaria, ecchymosis
• MISC: Anaphylactic/anaphylactoid reactions, fever, risk of bleeding

Aspirin

• Antiplatelet; inhibits platelet aggregation by irreversible inhibition of platelet cyclooxygenase and thus inhibits the generation of thromboxane A2
• Hydrolyzed in gut plasma (aspirin) and metabolized by liver (salicylic acid); CYP450: Unknown
• Excreted in urine
• Half life: 20 mins (aspirin), 6 hrs (salicylic acid)

Dipyridamole

• Antiplatelet; inhibits the uptake of adenosine in a dose-dependent manner, increases local concentrations of adenosine thereby stimulates platelet adenylate cyclase and increases platelet cyclic-3',5'-adenosine monophosphate (cAMP) levels; inhibits phosphodiesterase (PDE) in various tissues
• Metabolized by liver; CYP450: Unknown
• Excreted in feces (95%), urine (5%)
• Half life: 13.6 hrs

US Trade Name(s)

• Aggrenox

US Availability

aspirin/dipyridamole (generic)

• ECAPS: 25 mg/200 mg

Aggrenox (aspirin/dipyridamole)

• ECAPS: 25 mg/200 mg

Canadian Trade Name(s)

• Aggrenox

Canadian Availability

Aggrenox (aspirin/dipyridamole)

• ECAPS: 25 mg/200 mg

UK Trade Name(s)

• Asasantin retard

UK Availability

Asasantin retard (aspirin/dipyridamole)

• ECAPS: 25 mg/200 mg

Australian Trade Name(s)

• Asasantin SR

Australian Availability

Asasantin SR (aspirin/dipyridamole)

• ECAPS: 25 mg/200 mg

[Outline]

Hematology/Oncology

Antiplatelet Agents

Platelet Aggregation Inhibitors

Cardiovascular

Antiplatelet Agents

Platelet Aggregation Inhibitors

Neurologic

Antiplatelet Agents

Platelet Aggregation Inhibitors

Pricing data from www.DrugStore.com in U.S.A.

• Aggrenox 25-200 MG CP12 [Bottle] (BOEHRINGER INGELHEIM)
  60 mg = $242.99
  180 mg = $696.98

Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.

Drug Name: Aggrenox (ASA 25 MG / dipyridamole 200 MG) 12HR Extended Release Capsule

Ingredient(s): Aspirin mixture with Dipyridamole

Imprint: BI;01A

Color(s): Red, White

Shape: Capsule

Size (mm): 24.00

Score: 1

Inactive Ingredient(s): acacia / aluminum stearate / silicon dioxide / starch, corn / dimethicone / hypromellose / hypromellose phthalate (31% phthalate, 170 cst) / lactose monohydrate / methacrylic acid - methyl methacrylate copolymer (1:1) / cellulose, microcrystalline / povidone / stearic acid / sucrose / talc / tartaric acid / titanium dioxide / triacetin / gelatin / ferric oxide red / ferric oxide yellow / water

Drug Label Author:
Boehringer Ingelheim Pharmaceuticals, Inc.

DEA Schedule:
Non-Scheduled