Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Dipyridamole tablets, USP are available as yellow, round, biconvex, coated tablets debossed tablets of 25 mg, 50 mg and 75 mg coded “181”, ”182” and ”183”, respectively on one side and “O” on the other. They are available in bottles of 100 tablets as indicated below: 25 mg Tablets (NDC 69584-181-10) 50 mg Tablets (NDC 69584-182-10) 75 mg Tablets (NDC 69584-183-10) Store at 20°– 25°C (68°– 77°F) [see USP Controlled Room Temperature]. Keep out of reach of children. Address medical inquiries to: 1-844‑508‑1455, 8:00 AM to 4.30 PM ET, Monday – Friday Manufactured by: OXFORD PHARMACEUTICALS Birmingham, AL 35211 8200025 Rev 00 01/21; PRINCIPAL DISPLAY PANEL NDC 69584-181-10 DIPYRIDAMOLE TABLETS, USP 25 MG Rx only 100 TABLETS EACH TABLETS CONTAINS: Dipyridamole, USP .................... 25 mg DOSAGE: Read accompanying prescribing information. DISPENSE in a tight, light-resistant container. STORE at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature). Keep out of reach of children. MANUFACTURED BY: OXFORD PHARMACEUFTICALS, LLC BIRMINGFHAM, ALABAMA 35211 8000097 Rev. 1/2021 R00 NDC 69584-182-10 DIPYRIDAMOLE TABLETS, USP 50 MG Rx only 100 TABLETS EACH TABLETS CONTAINS: Dipyridamole, USP .................... 50 mg DOSAGE: Read accompanying prescribing information. DISPENSE in a tight, light-resistant container. STORE at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature). Keep out of reach of children. MANUFACTURED BY: OXFORD PHARMACEUFTICALS, LLC BIRMINGFHAM, ALABAMA 35211 8000098 Rev. 1/2021 R00 NDC 69584-183-10 DIPYRIDAMOLE TABLETS, USP 75 MG Rx only 100 TABLETS EACH TABLETS CONTAINS: Dipyridamole, USP .................... 75 mg DOSAGE: Read accompanying prescribing information. DISPENSE in a tight, light-resistant container. STORE at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature). Keep out of reach of children. MANUFACTURED BY: OXFORD PHARMACEUFTICALS, LLC BIRMINGFHAM, ALABAMA 35211 8000099 Rev. 1/2021 R00
- HOW SUPPLIED Dipyridamole tablets, USP are available as yellow, round, biconvex, coated tablets debossed tablets of 25 mg, 50 mg and 75 mg coded “181”, ”182” and ”183”, respectively on one side and “O” on the other. They are available in bottles of 100 tablets as indicated below: 25 mg Tablets (NDC 69584-181-10) 50 mg Tablets (NDC 69584-182-10) 75 mg Tablets (NDC 69584-183-10) Store at 20°– 25°C (68°– 77°F) [see USP Controlled Room Temperature]. Keep out of reach of children. Address medical inquiries to: 1-844‑508‑1455, 8:00 AM to 4.30 PM ET, Monday – Friday Manufactured by: OXFORD PHARMACEUTICALS Birmingham, AL 35211 8200025 Rev 00 01/21
- PRINCIPAL DISPLAY PANEL NDC 69584-181-10 DIPYRIDAMOLE TABLETS, USP 25 MG Rx only 100 TABLETS EACH TABLETS CONTAINS: Dipyridamole, USP .................... 25 mg DOSAGE: Read accompanying prescribing information. DISPENSE in a tight, light-resistant container. STORE at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature). Keep out of reach of children. MANUFACTURED BY: OXFORD PHARMACEUFTICALS, LLC BIRMINGFHAM, ALABAMA 35211 8000097 Rev. 1/2021 R00 NDC 69584-182-10 DIPYRIDAMOLE TABLETS, USP 50 MG Rx only 100 TABLETS EACH TABLETS CONTAINS: Dipyridamole, USP .................... 50 mg DOSAGE: Read accompanying prescribing information. DISPENSE in a tight, light-resistant container. STORE at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature). Keep out of reach of children. MANUFACTURED BY: OXFORD PHARMACEUFTICALS, LLC BIRMINGFHAM, ALABAMA 35211 8000098 Rev. 1/2021 R00 NDC 69584-183-10 DIPYRIDAMOLE TABLETS, USP 75 MG Rx only 100 TABLETS EACH TABLETS CONTAINS: Dipyridamole, USP .................... 75 mg DOSAGE: Read accompanying prescribing information. DISPENSE in a tight, light-resistant container. STORE at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature). Keep out of reach of children. MANUFACTURED BY: OXFORD PHARMACEUFTICALS, LLC BIRMINGFHAM, ALABAMA 35211 8000099 Rev. 1/2021 R00
Overview
Dipyridamole USP is a platelet inhibitor chemically described as 2,2',2'',2'''-[(4,8 Dipiperidinopyrimido[5,4- d ]pyrimidine-2,6-diyl)dinitrilo]-tetraethanol. It has the following structural formula: Dipyridamole is an odorless yellow crystalline powder, having a bitter taste. It is soluble in dilute acids, methanol and chloroform, and practically insoluble in water. Dipyridamole tablets for oral administration contain: Active Ingredient TABLETS 25 mg, 50 mg, and 75 mg : dipyridamole USP 25 mg, 50 mg and 75 mg, respectively. Inactive Ingredients TABLETS 25 mg, 50 mg, and 75 mg : Carnauba wax, D&C yellow no. 10, FD&C yellow no. 6, hydroxypropyl cellulose, hypromellose, lactose, magnesium stearate, methylparaben, microcrystalline cellulose, polyethylene glycol, potassium sorbate, povidone, propylene glycol, propylparaben, silicon dioxide, sodium citrate, sodium starch glycolate, stearic acid, talc, titanium dioxide, and xanthan gum.
Indications & Usage
Dipyridamole tablets are indicated as an adjunct to coumarin anticoagulants in the prevention of postoperative thromboembolic complications of cardiac valve replacement.
Dosage & Administration
Adjunctive Use in Prophylaxis of Thromboembolism after Cardiac Valve Replacement. The recommended dose is 75-100 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.
Warnings & Precautions
No warnings available yet.
Contraindications
Hypersensitivity to dipyridamole and any of the other components.
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/ Warfarin Placebo/ 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 observed. In post-marketing reporting experience, there have been rare reports of hypersensitivity reactions (such as rash, urticaria, severe bronchospasm, and angioedema), larynx edema, fatigue, malaise, myalgia, arthritis, nausea, dyspepsia, paresthesia, hepatitis, thrombocytopenia, alopecia, cholelithiasis, hypotension, palpitation, and tachycardia.
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 A2A-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.
Similar Drugs
Related medications based on brand, generic name, substance, active ingredients.