Dorel tablets

Dorel

  • Active Ingredient: Clopidogrel
  • 75 mg
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What is Dorel?

The active ingredient of Dorel brand is clopidogrel. Clopidogrel helps to prevent platelets in your blood from sticking together and forming a blood clot. Unwanted blood clots can occur with certain heart or blood vessel conditions. Pharmacodynamic and pharmacokinetic parameters measured in these studies showed that the interaction was highest with omeprazole and least with dexlansoprazole. Effect of Clopidogrel on other drugs In vitro studies have shown that the glucuronide metabolite of Clopidogrel is a strong inhibitor of CYP2C8. Concomitant administration of repaglinide with Clopidogrel increased the systemic exposure to repaglinide (AUC0-∞) by 5.1-fold following the loading dose (300 mg) and by 3.9-fold on day 3 of the maintenance dose (75 mg) of Clopidogrel [see Drug Interactions (7.5)].

Used for

Dorel is used to treat diseases such as: Acute Coronary Syndrome, Acute Coronary Syndrome, Prophylaxis, Heart Attack, Ischemic Stroke, Ischemic Stroke, Prophylaxis, Percutaneous Coronary Intervention, Peripheral Arterial Disease, Platelet Aggregation Inhibition, Transient Ischemic Attack.

Side Effect

Possible side effects of Dorel include: cough or hoarseness; dizziness; tightness in the chest; painful or difficult urination; hives; Chest pain; swollen lymph glands.

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How should this medicine be used?

Dorel comes as a tablet to take by mouth. It is usually taken once a day with or without food. Take Dorel at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take Dorel exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Dorel will help prevent serious problems with your heart and blood vessels only as long as you take the medication. Continue to take Dorel even if you feel well. Do not stop taking Dorel without talking to your doctor. If you stop taking Dorel, there is a higher risk that you may have a heart attack or stroke. If you have a stent, there is also a higher risk that you could develop a blood clot in the stent if you stop taking Dorel too soon.

Q: Can Plavix or Aspirin affect healing associated with a tattoo?

A: Plavix (Dorel), which keeps the platelets in your blood from coagulating (clotting) to prevent unwanted blood clots that can occur with certain heart or blood vessel conditions, is used to prevent blood clots after a recent heart attack or stroke, and in people with certain disorders of the heart or blood vessels. The most common side effects with Plavix are pruritus (intense itching sensation), purpura (bleeding under the skin), diarrhea, and rash. Aspirin, one of a group of drugs called salicylates, works by reducing substances in the body that cause pain, fever, and inflammation. Aspirin is used to treat mild to moderate pain, and also to reduce fever or inflammation. Aspirin is sometimes used to treat or prevent heart attacks, strokes, and chest pain (angina). Aspirin should be used for cardiovascular conditions only under the supervision of a doctor. The most common side effects with aspirin are nausea, dyspepsia (upset stomach), tinnitus (ringing or roaring in the ears) with large doses, and dizziness with large doses. The combination of Plavix and aspirin can increase the risk of further bleeding. This is not a complete list of the side effects associated with Plavix or aspirin. Gregory Latham, RPh

How is this medicine (Dorel) best taken?

Use Dorel as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • Take with or without food.
  • Keep taking Dorel as you have been told by your doctor or other health care provider, even if you feel well.

What do I do if I miss a dose?

  • Take a missed dose as soon as you think about it.
  • If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses unless told to do so by your doctor.

Dorel may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

  • excessive tiredness
  • headache
  • dizziness
  • nausea
  • vomiting
  • stomach pain
  • diarrhea
  • nosebleed

What Are Side Effects Associated with Using Dorel?

Side effects associated with use of Dorel, include the following:

Less common side effects of Dorel include:

Postmarketing side effects of Dorel reported include:

  • Blood and lymphatic system disorders: Agranulocytosis, aplastic anemia/pancytopenia, thrombotic thrombocytopenic purpura (TTP), acquiredhemophilia A
  • Eye disorders: Eye (conjunctival, ocular, retinal) bleeding
  • Gastrointestinal disorders: Gastrointestinal and retroperitoneal hemorrhage with fatal outcome, colitis (including ulcerative or lymphocytic colitis), pancreatitis, stomatitis, gastric/duodenal ulcer, diarrhea
  • General disorders and administration site condition: Fever, hemorrhage of operative wound
  • Hepato-biliary disorders: Acute liver failure, hepatitis (non-infectious), abnormal liver function test
  • Immune system disorders: Hypersensitivity reactions, anaphylactoid reactions, serum sickness
  • Musculoskeletal, connective tissue and bone disorders: Musculoskeletal bleeding, muscle pain, joint pain, arthritis
  • Nervous system disorders: Taste disorders, fatal intracranial bleeding, headache
  • Psychiatric disorders: Confusion, hallucinations
  • Respiratory, thoracic and mediastinal disorders: Bronchospasm, interstitial pneumonitis, respiratory tract bleeding, eosinophilic pneumonia
  • Renal and urinary disorders: Increased creatinine levels
  • Skin and subcutaneoustissue disorders: Maculopapular, erythematous, or exfoliative rash, urticaria, bullousdermatitis, eczema, toxic epidermal necrolysis, Stevens-Johnson syndrome, angioedema, drug-induced hypersensitivity syndrome, drug rash with eosinophilia and systemic symptoms (DRESS), erythema multiforme, skin bleeding, lichen planus, generalized itching, acute generalized exanthematous pustulosis (AGEP)
  • Vascular disorders: Vasculitis, hypotension

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

Hypersensitivity

Plavix is contraindicated in patients with hypersensitivity (e.g., anaphylaxis) to Dorel or any component of the product .

Precautions

Before taking Dorel, tell your doctor or pharmacist if you are allergic to it; or to similar antiplatelet drugs (thienopyridines such as prasugrel); 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: bleeding conditions (such as stomach ulcers, bleeding in the brain/eye), recent surgery, serious injury/trauma, liver disease, bleeding disease (such as hemophilia).

To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

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 Dorel for at least 5 days before surgery. Do not stop taking Dorel without talking with your heart doctor (cardiologist) first.

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

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

It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.

Pharmacokinetics

Dorel is a prodrug and is metabolized to a pharmacologically active metabolite and inactive metabolites.

Warning for surgery or procedure

Before having any procedures done, you should tell your doctors or dentists that you’re taking Dorel. You may need to stop taking this drug for a short time before a procedure to prevent bleeding. Your doctor will let you know when to stop taking this medication and when it’s OK to take it again.

What if I take too much?

Accidentally taking 1 or 2 extra tablets is unlikely to harm you.

But the amount of Dorel that can lead to overdose is different from person to person.

Contact your doctor straight away if you have taken some extra tablets and notice any signs of bleeding.

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

Following an oral dose of 14 C-labeled Dorel in humans, approximately 50% of total radioactivity was excreted in urine and approximately 46% in feces over the 5 days post dosing. After a single, oral dose of 75 mg, Dorel has a half-life of approximately 6 hours. The half-life of the active metabolite is about 30 minutes.

Storage

  • Store Dorel at room temperature near 77°F (25°C). It can be stored for a short time at a temperature between 59ºF and 86°F (15ºC and 30°C).
  • Don’t store this medication in moist or damp areas, such as bathrooms.

General Risk Of Bleeding

Thienopyridines, including Plavix, increase the risk of bleeding.

Thienopyridines inhibit platelet aggregation for the lifetime of the platelet (7-10 days). Because the half-life of Dorel’s active metabolite is short, it may be possible to restore hemostasis by administering exogenous platelets; however, platelet transfusions within 4 hours of the loading dose or 2 hours of the maintenance dose may be less effective.

Q: I am taking Plavix. Can I safely eat grapefruit, or will it have an effect on the Plavix?

A: Plavix (Dorel) does not interact with grapefruit. It is generally considered safe to eat grapefruit or drink grapefruit juice while taking Plavix. You may also find helpful information at //www.everydayhealth.com/drugs/plavix. Sarah Lewis, PharmD

More common side effects

The more common side effects that can occur with Dorel include:

If you have itchy skin, it may go away within a few days or a couple of weeks. If it is more severe or doesn’t go away, talk to your doctor or pharmacist.

When to avoid Dorel

Dorel should not be taken if you have:

  • an active (bleeding) peptic ulcer
  • recently had a brain haemorrhage
  • haemophilia or any other bleeding disorder

Dorel must not be given to anyone under 16 years old, unless under specialist advice.

Disease-Associated Maternal And/Or Embryo/Fetal Risk

Myocardial infarction and stroke are medical emergencies. Therapy for the pregnant woman should not be withheld because of potential concerns regarding the effects of Dorel on the fetus.

Labor Or delivery

Dorel use during labor or delivery will increase the risk of maternal bleeding and hemorrhage. Avoid neuraxial blockade during Dorel use because of the risk of spinal hematoma. When possible, discontinue Dorel 5 to 7 days prior to labor, delivery, or neuraxial blockade.

The available data from published case reports over two decades of postmarketing use have not identified an association with Dorel use in pregnancy and major birth defects, miscarriage, or adverse fetal outcomes.


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