Ravalgen tablets

Ravalgen

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

The active ingredient of Ravalgen 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

Ravalgen 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 Ravalgen include: fever, chills, or sore throat; deep, dark purple bruise; red or purple spots on the skin, varying in size from pinpoint to large bruises; stomach pain (severe); unusual bleeding or bruising; dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position.

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Pharmacokinetics

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

Repaglinide (CYP2C8 Substrates)

The acyl-β-glucuronide metabolite of Ravalgen is a strong inhibitor of CYP2C8. Plavix can increase the systemic exposure to drugs that are primarily cleared by CYP2C8, thereby needing dose adjustment and appropriate monitoring.

Plavix increased repaglinide exposures by 3.9-fold to 5.1-fold . Avoid concomitant use of repaglinide with Plavix. If concomitant use cannot be avoided, initiate repaglinide at 0.5 mg before each meal and do not exceed a total daily dose of 4 mg. Increased frequency of glucose monitoring may be required during concomitant use.

Embryo-fetal developmental toxicology studies were performed in pregnant rats and rabbits with doses up to 500 and 300 mg/kg/day, respectively, administered during organogenesis. These doses, corresponding to 65 and 78 times the recommended daily human dose, respectively, on a mg/m² basis, revealed no evidence of impaired fertility or fetotoxicity due to Ravalgen.

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 Ravalgen. For a full list, see the leaflet inside your medicines packet.

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

4. How and when to take it

Ravalgen can be taken once a day, at the same time each day.

You can take Ravalgen with or without food.

Nonsteroidal anti-inflammatory drugs (NSAIDs)

Taking Ravalgen with NSAIDs may increase your risk of bleeding in your stomach and intestines. Examples of these drugs include:

Antes de tomar Ravalgen,

  • informe a su mГ©dico o farmacГ©utico si es alГ©rgico a Ravalgen, prasugrel (Effient), ticlopidina (Ticlid) o cualquier otro medicamento o a alguno de los ingredientes que contienen las tabletas de Ravalgen. Pregunte a su farmacГ©utico o revise la GuГ­a del medicamento para obtener una lista de ingredientes.
  • Informe a su mГ©dico y farmacГ©utico quГ© otros medicamentos con y sin receta mГ©dica, vitaminas, suplementos nutricionales y productos de hierbas estГЎ tomando o tiene planificado tomar. AsegГєrese de mencionar cualquiera de los siguientes: anticoagulantes ('diluyentes de la sangre') como warfarina (Coumadin, Jantoven); aspirina y otros antiinflamatorios no esteroides (AINE) como ibuprofeno (Advil, Motrin) y naxopreno (Aleve, Naprosyn); cilostazol; esomeprazol (Nexium); etravirina (Intelence); omeprazol (Prilosec, Prilosec OTC, Zegerid); repaglinida (Prandin, en Prandimet); inhibidores selectivos de la recaptaciГіn de la serotonina (SSRI, por sus siglas en inglГ©s) como citalopram (Celexa), escitalopram (Lexapro), fluoxetina (Prozac, Sarafem, en Symbyax), fluvoxamina (Luvox), paroxetina (Paxil), y sertralina (Zoloft); y inhibidores selectivos de la recaptaciГіn de la serotonina y la norepinefrina (SNRI, por sus siglas en inglГ©s) como desvenlafaxina (Khedezla, Pristiq), duloxetina (Cymbalta), sibutramina (ya no estГЎ disponible en EE. UU.; Meridia), y venlafaxina (Effexor). Es posible que su mГ©dico deba cambiar las dosis de sus medicamentos o supervisar atentamente si sufre efectos secundarios.
  • Informe a su mГ©dico si tiene Гєlceras sangrantes (llagas que sangran en el recubrimiento del estГіmago o el intestino delgado), sangrado en el cerebro o cualquier otra condiciГіn que cause sangrado profuso. Es posible que su mГ©dico le diga que no debe tomar Ravalgen.
  • Informe a su mГ©dico si tiene ha sufrido alguna lesiГіn recientemente y si tiene o ha tenido enfermedad renal o del hГ­gado, o cualquier condiciГіn que pueda causar sangrado, incluidos problemas del estГіmago como Гєlceras y ciertos tipos de problemas de los ojos.
  • Informe a su mГ©dico si estГЎ embarazada, planea quedar embarazada o si estГЎ amamantando. Si queda embarazada mientras toma Ravalgen, llame a su mГ©dico.
  • Si va a someterse a una cirugГ­a, incluso una cirugГ­a dental, informe a su mГ©dico o dentista que estГЎ tomando Ravalgen. Su mГ©dico podrГ­a decirle que deje de usar Ravalgen al menos 5 dГ­as antes de su cirugГ­a para el sangrado excesivo durante la cirugГ­a. Su mГ©dico le dirГЎ cuГЎndo comenzar a tomar Ravalgen de nuevo despuГ©s de su cirugГ­a.
  • Debe saber que puede sangrar mГЎs fГЎcilmente o por mГЎs tiempo que lo usual mientras toma Ravalgen. Tenga cuidado de no cortarse ni lastimarse mientras toma Ravalgen.

Q: What would the interaction be between Plavix and Nexium?

A: Plavix (Ravalgen bisulfate) is an oral antiplatelet agent used to inhibit blood clots in coronary artery disease, peripheral vascular disease, and cerebrovascular disease. Generally speaking, drug interactions fall into three main categories: Drug-drug (i.e., prescription, over-the-counter, herbals, dietary supplements) interactions occur when two or more drugs react with each other. Drug-diet (food/drink) interactions result from drugs reacting with foods or drinks. Drug-disease interactions may occur when an existing medical condition makes certain drugs potentially harmful. Coadministration with proton pump inhibitors (PPIs), such as Nexium (esomeprazole) may reduce the cardioprotective effects of Ravalgen. Until further data is available, the use of proton pump inhibitors should preferably be avoided in patients treated with Ravalgen. PPIs should only be considered in high-risk patients such as those receiving dual antiplatelet therapy, those with a history of gastrointestinal bleeding or ulcers, and those receiving concomitant anticoagulant therapy, and then only after thorough assessment of risks versus benefits. If gastroprotection is necessary, H2-receptor antagonists or antacids should be prescribed whenever possible. For more specific information, consult with your doctor or pharmacist for guidance based on your specific condition and current medications. Shereen A. Gharbia, PharmD


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