Persantine

Name: Persantine

Adverse Effects

>10%

Chest pain (20%)

Angina exacerbation, IV (19.7%)

Abnormal ECG (15.9%)

Headache, IV (12.2%)

Dizziness (12%)

1-10%

ST-T changes (7.5%)

Abdominal discomfort, oral (6.1%)

Extrasystole (5%)

Nausea, IV (4.6%)

Hypotension, IV (4.6%)

Flushing (3.4%)

Generalized pain (2.6%)

Headache, oral (2.3%)

Frequency Not Defined

Myocardial infarction (rare)

Ventricular arrhythmia (rare)

Bronchospasm (rare)

Dyspnea

Description

Persantine (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.

Persantine (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: acacia, carnauba wax, corn starch, edible white ink, lactose monohydrate, magnesium stearate, D&C yellow #10 aluminum lake, D&C red #30, helendon aluminum pink lake, sodium benzoate, methylparaben, propylparaben, polyethylene glycol, povidone, sucrose, talc, titanium dioxide, and white wax.

Overdose

In case of real or suspected overdose, seek medical attention or contact a Poison Control Center immediately. Careful medical management is essential. Based upon the known hemodynamic effects of dipyridamole, symptoms such as warm feeling, flushes, sweating, restlessness, feeling of weakness and dizziness may occur. A drop in blood pressure and tachycardia might also be observed.

Symptomatic treatment is recommended, possibly including a vasopressor drug. Gastric lavage should be considered. Administration of xanthine derivatives (e.g., aminophylline) may reverse the hemodynamic effects of dipyridamole overdose. Since dipyridamole is highly protein bound, dialysis is not likely to be of benefit.

Side effects

Adverse reactions at therapeutic doses are usually minimal and transient. On long-term use of Persantine (dipyridamole USP) tablets initial side effects usually disappear. The following reactions in Table 1 were reported in two heart valve replacement trials comparing Persantine (dipyridamole) E 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 PERSANTINE
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 Persantine (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.

Read the entire FDA prescribing information for Persantine (Dipyridamole)

Read More »

Uses of Persantine

Persantine is a prescription medication used to reduce the risk of blood clots after heart valve replacement. 

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Persantine Food Interactions

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Persantine, there are no specific foods that you must exclude from your diet when receiving this medication.

Persantine and Pregnancy

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Persantine falls into category B. There are no well-done studies that have been done in humans with Persantine. In animal studies, pregnant animals were given this medication, and the babies did not show any medical issues related to this medication. Because animal reproduction studies are not always predictive of human response, Persantine should be used during pregnancy only if clearly needed.

Persantine Usage

Take Persantine exactly as prescribed.

Persantine comes in tablet form and is typically taken four times daily.

Continue to take Persantine even if you feel well. Do not stop taking Persantine without talking to your doctor.

What is Persantine (dipyridamole)?

Dipyridamole helps to prevent platelets in your blood from sticking together and forming a blood clot on or around an artificial heart valve.

Dipyridamole is used to prevent blood clots after heart valve replacement surgery.

Dipyridamole may also be used for other purposes not listed in this medication guide.

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Dipyridamole

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Tablets

25 mg*

Dipyridamole Tablets

Persantine

Boehringer Ingelheim

50 mg*

Dipyridamole Tablets

Persantine

Boehringer Ingelheim

75 mg*

Dipyridamole Tablets

Persantine

Boehringer Ingelheim

Parenteral

Injection, for IV use

5 mg/mL*

Dipyridamole Injection

Dipyridamole Combinations

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Capsules, extended-release (containing dipyridamole pellets and 25 mg immediate-release aspirin tablet)

200 mg with Aspirin 25 mg

Aggrenox

Boehringer Ingelheim

If OVERDOSE is suspected

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Adverse Reactions

Adverse reactions at therapeutic doses are usually minimal and transient. On long-term use of Persantine tablets initial side effects usually disappear. The following reactions in Table 1 were reported in two heart valve replacement trials comparing Persantine 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 Persantine
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 Persantine® (dipyridamole USP) 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.

Persantine Dosage and 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.

(web3)