Curantyl tablets

Curantyl

  • Active Ingredient: Dipyridamole
  • 100 mg, 25 mg
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What is Curantyl?

The active ingredient of Curantyl brand is dipyridamole. Dipyridamole helps to prevent platelets in your blood from sticking together and forming a blood clot on or around an artificial heart valve. C24H40N8O4 M.W. 504.63 Dipyridamole, USP is an odorless yellow crystalline powder, having a bitter taste. It is soluble in dilute acids, methanol and chloroform, and practically insoluble in water. Each Dipyridamole tablet USP, for oral administration, contains 25 mg, 50 mg, or 75 mg Dipyridamole, USP and contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, propylene glycol, stearic acid, sodium starch glycolate, and titanium dioxide.

Used for

Curantyl is used to treat diseases such as: Prosthetic Heart Valves - Thrombosis Prophylaxis, Radionuclide Myocardial Perfusion Study.

Side Effect

Possible side effects of Curantyl include: yellow eyes or skin; weakness; General discomfort and/or unusual tiredness or weakness; gallstones; runny nose; dizziness or lightheadedness.

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What if I take too much?

Accidentally taking 1 or 2 extra doses is unlikely to harm you. However, the amount of Curantyl that can lead to overdose is different from person to person.

Contact your doctor straight away if you've taken some extra medicine and you get side effects such as:

  • a faster heart rate or pain in your chest - these can be signs of a heart problem
  • feeling dizzy or lightheaded, especially when you stand up or sit up quickly
  • shortness of breath, wheezing and tightening of the chest

Like all medicines, Curantyl can cause side effects, although not everyone gets them.

SIDE EFFECTS

Adverse reactions at therapeutic doses are usually minimal and transient. On long-term use of Persantine (Curantyl USP) tablets initial side effects usually disappear. The following reactions in Table 1 were reported in two heart valve replacement trials comparing Persantine (Curantyl) E tablets and warfarin therapy to either warfarin alone or warfarin and placebo:

Table 1: Adverse Reactions Reported in 2 Heart Valve Replacement Trials

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 (Curantyl) 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 (Curantyl)

What are the possible side effects of Curantyl (Persantine)?

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • a light-headed feeling, like you might pass out;
  • chest pain; or
  • liver problems--nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Older adults may be more likely to feel light-headed while taking Curantyl.

Common side effects may include:

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

DESCRIPTION

Persantine (Curantyl USP) is a platelet inhibitor chemically described as 2,2',2'',2'''-pyrimidine-2,6-diyl)dinitrilo]-tetraethanol. It has the following structural formula:

Curantyl 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 (Curantyl) tablets for oral administration contain:

Active Ingredient TABLETS 25 mg, 50 mg, and 75 mg: Curantyl 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.

Immediate action required: Call 999 or go to A&E if:

  • you get a skin rash that may include itchy, red, swollen, blistered or peeling skin
  • you're wheezing
  • you get tightness in the chest or throat
  • you have trouble breathing or talking
  • your mouth, face, lips, tongue or throat start swelling

You could be having a serious allergic reaction and may need immediate treatment in hospital.

These are not all the side effects of Curantyl. For a full list, see the leaflet inside your medicines packet.

You can report any suspected side effect to the UK safety scheme.

Precautions

Before taking Curantyl, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: other heart problems (such as severe coronary artery disease, recent heart attack), low blood pressure (hypotension), liver disease, a certain muscle problem (myasthenia gravis).

This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the side effects of this drug, especially dizziness and bleeding.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

This medication passes into breast milk. Consult your doctor before breast-feeding.

What if I forget to take it?

If you forget to take Curantyl, take it as soon as you remember. If it's nearly time for your next dose, skip the missed dose.

Don't take a double dose to make up for a forgotten dose.

If you often forget doses, it may help to set an alarm to remind you. You could also ask your pharmacist for advice on other ways to remember to take your medicines.

Taking Curantyl with everyday painkillers

Your doctor may prescribe daily low dose aspirin (75mg tablets) to take together with Curantyl. Or your doctor may prescribe Curantyl instead of daily low dose aspirin if you have problems with aspirin.

Do not take aspirin for pain relief (300mg tablets) or ibuprofen while you're taking Curantyl unless a doctor has said it's OK to. They increase the chance of bleeding.

You can take paracetamol together with Curantyl.

Adverse Reactions

Adverse reactions at therapeutic doses are usually minimal and transient. On long-term use of Dipyr >Table 1 were reported in two heart valve replacement trials comparing Curantyl tablets and warfarin therapy to either warfarin alone or warfarin and placebo:

What to do about:

  • feeling sick (nausea) - try taking your tablets with or after a meal or snack. It may also help if you don't eat rich or spicy food.
  • diarrhoea and being sick (vomiting) - drink plenty of water in small, frequent sips. Speak to a pharmacist if you have signs of dehydration, such as peeing less than usual or having dark, strong-smelling pee. Don't take any other medicines to treat diarrhoea or vomiting without speaking to a pharmacist or doctor.
  • headaches - make sure you rest and drink plenty of fluids. Don't drink too much alcohol. Ask your pharmacist to recommend a painkiller. Talk to your doctor if the headaches are severe or last longer than a week.
  • feeling dizzy - if Curantyl makes you feel dizzy when you stand up, try getting up very slowly or stay sitting down until you feel better. If you begin to feel dizzy, lie down so that you don't faint, then sit until you feel better. Don't drive or use tools or machines if you feel dizzy or a bit shaky.
  • feeling hot and flushed - try cutting down on coffee, tea and alcohol. It might help to keep the room cool and use a fan. You could also spray your face with cool water or sip cold or iced drinks. The flushing should go away after a few days. If it doesn't, or if it's causing you problems, contact your doctor.

Early clinical trials questioned the efficacy of Curantyl , alone or in combination with ASA, probably because of variability in bioavailability. Recent studies have suggested significant benefit with the new formulation. Addition of modified-release Curantyl 200 mg twice daily to ASA 25 mg twice daily was associated with a 22% relative risk reduction of major vascular events compared with ASA alone. 45 In a study of ASA (30–325 mg/day) with or without Curantyl (200 mg twice daily) in patients within 6 months of a transient ischemic attack (TIA) or minor stroke showed 20% reduction of a composite of major vascular events by the combined treatment. 46 The fixed combination of modified-release Curantyl and low-dose ASA has been approved for stroke prevention.

Important: The information below refers to products available in the United States that contain Curantyl.

Precautions

Before taking this medication, tell your doctor if you are allergic to Curantyl; or to aspirin; or to other salicylates (such as choline salicylate); or to NSAIDs (such as ibuprofen, naproxen); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: aspirin-sensitive asthma (a history of worsening breathing with runny/stuffy nose after taking aspirin or other NSAIDs), bleeding problems (such as hemophilia, vitamin K deficiency, low platelets), low blood pressure (hypotension), heart problems (such as angina, heart attack), stomach problems (such as ulcers, heartburn), kidney disease, liver disease, a certain muscle problem (myasthenia gravis), growths in the nose (nasal polyps), bleeding in the brain.

This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Talk to your doctor if you are using marijuana (cannabis).

This medicine may cause stomach bleeding. Daily use of alcohol and tobacco while using this medicine may increase your risk for stomach bleeding. Limit alcohol and stop smoking. Ask your doctor or pharmacist about how much alcohol you may safely drink.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Your doctor may instruct you to stop aspirin/Curantyl 10 days before surgery. Do not stop taking this medication without first talking with the doctor who prescribed it.

The amount of aspirin in this medication may not be enough to prevent heart attack. If you need aspirin to prevent heart attack, consult your doctor or pharmacist for more information.

This drug contains aspirin. Children and teenagers younger than 18 should not take aspirin if they have chickenpox, flu, or any undiagnosed illness or if they have recently received a vaccine. In these cases, taking aspirin increases the risk of Reye's syndrome, a rare but serious illness.

Older adults may be more sensitive to the side effects of this drug, especially dizziness and bleeding.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

This medication passes into breast milk. Consult your doctor before breast-feeding.

Pharmacokinetics and Metabolism

Following an oral dose of Curantyl tablets, the average time to peak concentration is about 75 minutes. The decline in plasma concentration following a dose of Curantyl tablets fits a two-compartment model. The alpha half-life (the initial decline following peak concentration) is approximately 40 minutes. The beta half-life (the terminal decline in plasma concentration) is approximately 10 hours. Curantyl is highly bound to plasma proteins. It is metabolized in the liver where it is conjugated as a glucuronide and excreted with the bile.

Curantyl

Pharmacologic class: Platelet adhesion inhibitor

Therapeutic class: Antiplatelet agent, diagnostic agent (coronary vasodilator)

Pregnancy risk category B

8. Cautions with other medicines

Some medicines interfere with the way Curantyl works.

Tell your doctor if you're taking these medicines before you start taking Curantyl:

  • medicines to thin blood or prevent blood clots, such as aspirin, warfarin, rivaroxaban or apixaban
  • medicines for high blood pressure, such as bisoprolol, ramipril or furosemide
  • indigestion medicines, such as ranitidine, proton pump inhibitors like omeprazole, or antacids that contain magnesium or aluminium
  • digoxin for heart problems
  • medicines used to treat myasthenia gravis

Pregnancy

Teratogenic Effects: PREGNANCY CATEGORY B

Reproduction studies have been performed in mice, rabbits and rats at oral Curantyl doses of up to 125 mg/kg, 40 mg/kg and 1000 mg/kg, respectively (about 1 ½, 2 and 25 times the maximum recommended daily human oral dose, respectively, on a mg/m 2 basis) and have revealed no evidence of harm to the fetus due to Curantyl. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, Persantine (Curantyl) should be used during pregnancy only if clearly needed.


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