Rx Item-Anagrelide 0.5mg Cap 100 by Teva Pharma

1
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

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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

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One capsule twice daily (morning and evening) with or without food
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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
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Do not chew capsule
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Not interchangeable with the individual components of aspirin and
dipyridamole tablets

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

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

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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
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Co-administration with anticoagulants, antiplatelets, or NSAIDs can
increase risk of bleeding
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Decreased renal function can occur with co-administration with NSAIDs
USE IN SPECIFIC POPULATIONS
--
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Pregnancy Category
See 17 for PATIENT COUNSELING info. and FDA-
approved patient labeling.
Revised:
11/201

Anagrelide 0.5mg Cap 100 by Teva Pharma
gray, white, oblong, NDC No.00172-5241-60 0172-5241-60 0172524160 172524160 00172524160 UPC/GTIN No.3-01725-24160-1 301725-241601 301725241601 MPN 524160

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Teva Pharmaceuticals USA

ANAGRELIDE HCL ORAL CAPSU
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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