Dipyridamole 50 mg/1
Dipyridamole · TABLET, FILM COATED · Zydus Lifesciences Limited
Dipyridamole is a tablet, film coated containing dipyridamole at 50 mg/1, taken oral. Manufactured by Zydus Lifesciences Limited.
Key Facts
- Brand Name
- Dipyridamole
- Generic Name
- Dipyridamole
- NDC Code (Product)
65841-663- Manufacturer
- Zydus Lifesciences Limited
- Strength
- 50 mg/1
- Dosage Form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing Status
- Application #
- ANDA040874
- Drug Class
- Platelet Aggregation Inhibitor [EPC]
- Marketing Start
- 05/22/2008
Recall History
Boehringer Ingelheim Pharmaceuticals, Inc.
Presence of foreign tablets/capsules: 50 mg Persantine tablets were found in a 75 mg Persantine 100-count bottle and 50 mg Persantine tablet was found in a 100 count bottle of 75 mg Dipyridamole.
Glenmark Pharmaceuticals Inc., USA
Failed Tablet/Capsule Specification : Capsule breakage
Gyma Laboratories Of Amer,Inc
cGMP Deviations: GYMA laboratories Inc. has recalled multiple Active Pharmaceutical Ingredients manufactured in Italy upon receipt of a Rapid Alert Notification issued by The Italian Medicines Agency due to lack of good manufacturing practices.
Boehringer Ingelheim Pharmaceuticals, Inc.
Presence of foreign tablets/capsules: 50 mg Persantine tablets were found in a 75 mg Persantine 100-count bottle and 50 mg Persantine tablet was found in a 100 count bottle of 75 mg Dipyridamole.
American Health Packaging
Failed Impurities/Degradation Specifications; out of specification result for an unknown impurity in stability samples.
Aidapak Services, LLC
Labeling: Label Mixup: ASPIRIN/ER DIPYRIDAMOLE, Capsule, 25 mg/200 mg may have potentially been mislabeled as the following drug: THIAMINE HCL, Tablet, 100 mg, NDC 00904054460, Pedigree: AD70639_1, EXP: 5/29/2014; LEVOTHYROXINE SODIUM, Tablet, 88 mcg, NDC 00781518392, Pedigree: W003439, EXP: 6/20/2014; ZINC SULFATE, Capsule, 220 mg, NDC 60258013101, Pedigree: W003641, EXP: 6/25/2014.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Dipyridamole tablets are indicated as an adjunct to coumarin anticoagulants in the prevention of postoperative thromboembolic complications of cardiac valve replacement.
Dosage & Administration
DOSAGE AND ADMINISTRATION Adjunctive Use in Prophylaxis of Thromboembolism after Cardiac Valve Replacement The recommended dose is 75 to 100 mg four times daily as an adjunct to the usual warfarin therapy. Please note that aspirin is not to be administered concomitantly with coumarin anticoagulants.
Contraindications
CONTRAINDICATIONS Hypersensitivity to dipyridamole and any of the other components.
Drug Interactions
Drug Interactions No pharmacokinetic drug-drug interaction studies were conducted with dipyridamole tablets. The following information was obtained from the literature. Adenosinergic agents (e.g., adenosine, regadenoson) Dipyridamole has been reported to increase the plasma levels and cardiovascular effects of adenosine. Adjustment of adenosine dosage may be necessary. Dipyridamole also increases the cardiovascular effects of regadenoson, an adenosine A 2A -receptor agonist. The potential risk of cardiovascular side effects with intravenous adenosinergic agents may be increased during the testing period when dipyridamole is not held 48 hours prior to stress testing. Cholinesterase Inhibitors Dipyridamole may counteract the anticholinesterase effect of cholinesterase inhibitors, thereby potentially aggravating myasthenia gravis.
Adverse Reactions
ADVERSE REACTIONS Adverse reactions at therapeutic doses are usually minimal and transient. On long-term use of dipyridamole tablets initial side effects usually disappear. The following reactions in Table 1 were reported in two heart valve replacement trials comparing dipyridamole tablets and warfarin therapy to either warfarin alone or warfarin and placebo: Table 1 Adverse Reactions Reported in 2 Heart Valve Replacement Trials Adverse Reaction Dipyridamole Tablets/ Placebo/ Warfarin Warfarin Number of patients 147 170 Dizziness 13.6% 8.2% Abdominal distress 6. 1% 3.5% Headache 2.3% 0.0% Rash 2.3% 1.1% Other reactions from uncontrolled studies include diarrhea, vomiting, flushing and pruritus. In addition, angina pectoris has been reported rarely and there have been rare reports of liver dysfunction. On those uncommon occasions when adverse reactions have been persistent or intolerable, they have ceased on withdrawal of the medication. When dipyridamole tablets were administered concomitantly with warfarin, bleeding was no greater in frequency or severity than that observed when warfarin was administered alone. In rare cases, increased bleeding during or after surgery has been obs…
Frequently Asked Questions
What is Dipyridamole used for?
Dipyridamole contains Dipyridamole. It is a tablet, film coated taken oral. Consult your doctor for specific uses.
Is Dipyridamole a controlled substance?
Dipyridamole is not classified as a controlled substance by the DEA.
What is the generic name for Dipyridamole?
The generic name for Dipyridamole is Dipyridamole. There are 1 other brand versions of Dipyridamole.
What is the NDC code for Dipyridamole 50 mg/1?
The NDC (National Drug Code) for Dipyridamole 50 mg/1 is 65841-663, listed by Zydus Lifesciences Limited.