Rx Item-Aggrenox 25mg 200mg Cap 60 By Boehringer Ingelheim

Clinical Information
Gen. Code and Des.
40303 aspirin/dipyridamole ORAL CPMP 12HR 25MG-200MG
GCN and Des.
95347 aspirin/dipyridamole ORAL CPMP 12HR 25MG-200MG
Strength
200MG ER
Dose Form
CAPSULE,EXTENDED RELEASE MULTIPHASE 12HR
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family

AHFS Class
24129200 VASODILATING AGENTS, MISCELLANEOUS
28080424 SALICYLATES
20121800 PLATELET-AGGREGATION INHIBITORS
Active Ingredients
1587 aspirin 50782
691 dipyridamole 58322
Item info.
These highlights do not include all the info. needed to use
AGGRENOX safely and effectively. See full prescribing info. for
AGGRENOX.
AGGRENOX? (aspirin/extended-release dipyridamole) Capsules
Initial U.S. Approval: 1999 INDICATIONS AND USAGE

?
AGGRENOX is combination antiplatelet agent indicated to reduce the
risk of stroke in patients who have had transient ischemia of the brain or
completed ischemic stroke due to thrombosis --DOSAGE AND ADMINISTRATION

?
One capsule twice daily (morning and evening) with or without food
?
In case of intolerable headaches during initial treatment, switch to one
capsule at bedtime and low-dose aspirin in the morning; resume BID
dosing within one week
?
Do not chew capsule
?
Not interchangeable with the individual components of aspirin and
dipyridamole tablets

?
Dispense in this unit-
of-use container (16) -DOSAGE FORMS AND STRENGTHS
--
?
Capsule: 25 mg aspirin/200 mg extended-release dipyridamole CONTRAINDICATIONS

?
Hypersensitivity to any product ingredients
?
Patients with known allergy to NSAIDs
?
Patients with the syndrome of asthma, rhinitis, and nasal polyps WARNINGS AND PRECAUTIONS
--
?
AGGRENOX increases the risk
of bleeding
?
Avoid use in patients with severe hepatic or renal insufficiency (5.2, 5.3)
?
Can cause fetal harm when administered to pregnant woman,
especially in the third trimester -ADVERSE REACTIONS

?
The most frequently reported adverse reactions (>10% and greater than
placebo) were headache, dyspepsia, abdominal pain, nausea, and
diarrhea
To report SUSPECTED ADVERSE REACTIONS, contact Boehringer
Ingelheim Pharmaceuticals, Inc. at (800) 542-6257 or (800) 459-9906 TTY
or FDA at 1-800-FDA-1088 or
www.fda.gov/medwatch
. DRUG INTERACTIONS
-
?
Co-administration with anticoagulants, antiplatelets, or NSAIDs can
increase risk of bleeding
?
Decreased renal function can occur with co-administration with NSAIDs
USE IN SPECIFIC POPULATIONS
--
?
Pregnancy Category
See 17 for PATIENT COUNSELING info. and FDA-
approved patient labeling.
Revised:
11/2015

Rx Item-Aggrenox 25mg 200mg Cap 60 By Bo
NDC No.00597-0001-60 UPC/GTIN No.3-05970-00160-7 MPN No. 160 Only Lic.-Physician, Pharmacy, Dentist, Drug Mfg, Dist., Gov, Hospital, Lic.Lab, Naturalist, Naturopath, NP, Optometrist, Pharmacist, PA, P

Aggrenox 25mg 200mg Cap 60 by
Boehringer Ingelheim Aggrenox 25mg 200mg Cap 60 by Boehringer Ingelheim

ASPIRIN/DIPYRIDAMOLE ORAL
Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop

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