Clopias USP medicine prevents blood frequency events (3 blisters x 10 tablets)

Dosage form Box of 3 blisters x 10 tablets
Specifications Clopidogrel, acetylsalicylic acid (aspirin)
Ingredient USP

Ingredient

Composition informationContent
Clopidogrel75mg
Acetylsalicylic acid (aspirin)100mg

Uses

indications

Clopias are indicated in the following cases:

Prevention of thrombus atherosclerosis in adult patients used both clopidogrel and aspirin. Clopias is a fixed combination medicine to continue treatment in:

  • Acute coronary artery syndrome (unstable angina or myocardial infarction without Q wave), including patients who have intervened coronary artery by a stent in the skin.
  • Acute myocardial infarction with st differentia in patients who are eligible for fiber pepper treatment.

    • Pharmacology

    Aspirin:

    Aspirin is not inhibited with cyclooxygenase, thus inhibiting prostaglandin synthesis. Cells have the ability to synthesize the new cyclooxygenase will be able to continue synthesizing prostaglandin, after salicylic acid levels decrease. Aspirin changes the balance between TXA (Thromboxan A, platelet aggregation) and PGI, (Prostaglandin, platelet aggregation inhibitors). Platelets are non -nuclei cells, incapable of synthesizing new cyclooxygenase, so cyclooxygenase is inhibited as inhibited until platelets are newly formed, so it reduces the synthesis of both threads in platelets and pgi in endothelial blood vessel. Thus, Aspirin inhibits unfavorable platelet collection, until platelets are created.

    Aspirin also inhibits prostaglandin production in the kidneys. Prostaglandin production in the kidneys is less physiologically important to patients with normal kidneys, but plays a very important role in maintaining blood circulation through the kidneys in people with chronic renal failure, heart failure, liver failure, or have plasma volume disorders. In these patients, prostaglandin synthesis effects in the kidneys of aspirin can lead to acute renal failure, water retention and acute heart failure.

    clopidogrel:

    Clopidogrel is a precursor, one of its metabolites is platelet supply inhibitors, Clopidogrel must be metabolized by CYP450 enzymes to form a metabolic substance that inhibits platelets.

    The active metabolites of clopidogrel selectively inhibit the cohesion of adenosine diphosphate (ADP) with its receptor on platelets and thereby inhibit the activity of Glycoprotein GPII-IIIA complex through ADP intermediaries, thus inhibiting platelet aggregation.

    Because the cohesion cannot be reversed, these platelets are affected for the rest of their lives (about 7-10 days) and the normal platelet function recovery occurs at a speed that is suitable for platelet movement. The platelet collection caused by non -ADP -owned subjects is also inhibited by the blocking effect of platelet activity caused by ADP.

    Because the metabolites are active formed by CYP450 enzymes, some of which have polymorphic activity or objects that are inhibited by other drugs, not all patients have adequate platelet inhibition.

    Platelet inhibition depends on the dose may occur after 2 hours of taking the medication. The dose of 75 mg daily, repeated many times causes a clear inhibition for the platelet aggregation caused by ADP from the first day, this effect increases and reaches a stable state from 3 to 7. In a stable state, the average inhibitor is noticeable at a dose of 75 mg/day at about 40% to 60%. Platelet's collection and bleeding time gradually returning to the initial value within 5 days after treatment.

    pharmacokinetics

    clopidogrel:

    absorption:

    After the single doses and repeat 75 mg/day, Clopidogrel is quickly absorbed. The average peak concentration in the plasma of Clopidogrel does not change (about 2.2 - 2.5 ng/ml after taking a single dose of 75 mg) occurs about 45 minutes after drinking. The absorption rate is at least 50%, based on the excretion of the metabolites of clopidogrel in the urine.

    Distribution:

    Clopidogrel and the main metabolite in the blood (inactive) in vitro cohesion can be reversed with human plasma proteins (in order of 98% and 94%). In Vitro unsaturated cohesion occurs with a wide range of concentration.

    Metabolism:

  • Clopidogrel is widely metabolized in the liver. In vitro and in vivo, clopidogrel are metabolized in two main metabolic lines: one through the intermediary of the esterase and leads to the hydrophilic award into the carboxylic acid that is not active (85% of the amount of metabolic substance in the blood), and an intermediary with multiple cytochrome p450. The next metabolism of intermediate metabolites 2-olo-clopidogrel leads to the formation of active metabolites, a thiol derivative of clopidogrel. The thiol metabolites are active, have been isolated in vitro, quickly unable to reverse the platelet platelet receptor, thereby inhibiting platelets.
  • On humans, after taking a dose of Clopidogrel was marked with 14C, about 50% was excreted in the urine and about 46% was excreted in the part of the period of 120 hours after drinking. The semi -exhaust time of the main metabolites in the blood (inactive) is 8 hours after the single dose and the repeat dose.

    absorption:

    After absorbing, aspirin in clopias is awarded into salicylic acid and reaches the peak concentration of plasma within 1 hour after drinking, Aspirin concentration in plasma is basically no longer detected after taking the medicine 1.5-3 hours.

    Distribution:

    Aspirin is less attached to plasma proteins and an apparent distribution (10: 1). Its metabolites, salicylic acid, have a high ratio of plasma proteins, but the binding is dependent on concentration (non -linear). At low concentrations ( Metabolism and elimination:

    Aspirin in Clopias is quickly solved in plasma into salicylic acid, with a half -life from 0.3 to 0.4 hours for aspirin doses from 75 to 100 mg. Salicylic acid is mainly reacted in the liver to form salicylunic acid, a glucuronid phenol, a salicylic glucuronid, and a secondary metabolic. Eliminating the kidneys mainly in the form of free salicylic acid and conjugate metabolites.

    • Before taking Clopias USP medicine prevents blood frequency events (3 blisters x 10 tablets)

    How to use

    Take the pills with a glass of water.

    Dosage

    Adults and the elderly: Take 1 capsule daily.

  • Acute coronary syndrome does not differ (unstable angina or myocardial infarction without Q wave): The optimal treatment time has not been officially established. Clinical test data used up to 12 months, and maximum benefits have been noticed for 3 months. If the patient is stopped using Clopias, the patient still has the benefit if he continues to use a plateletic anti -collection drug.

    • Acute myocardial infarction has a difference: The treatment must be started as soon as possible after the symptoms appear and continue for at least 4 weeks. The benefits of combining clopidogrel with aspirin outside 4 weeks have not been studied. If the patient's Clopias is stopped, the patient still has the benefit if he continues to use a plateletic anti -platelet.

    Children: The safety and effectiveness of Clopias in children and teenagers under 18 years old have not been determined. Clopias is not recommended for this object.

    Patients with renal failure: Clopias must not be used in patients with severe renal impairment. The treatment is limited to patients with mild and medium renal failure. Therefore, Clopias should be used cautiously in these patients.

    Patients with liver failure: Clopias must not be used in patients with severe liver failure. The treatment is limited in patients with hepatic impairment that has had organs. Therefore, Clopias should be used cautiously in these patients.

    Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.What do

    do when overdose?

    Overdose Clopidogrel: Research on animal, single dose Clopidogrel ≥ 1500 mg/kg leads to necrosis - gastrointestinal bleeding, esophagitis and bowelitis in rats, monkeys. Nephrotoroma and interstitial renal tubular inflammation are also observed in the mouse. Clopidogrel overdose often leads to increased risk of bleeding and bleeding complications. So, see a doctor or emergency department of the nearest hospital if you observe bleeding.

    Overdose Aspirin: Symptoms are average: Tinnitus, hearing loss, dizziness, headache, confusion, digestive symptoms (nausea, vomiting, stomach pain). Serious symptoms: fever, rapid breathing, increased keratoma in the blood, respiratory alkaline infection, metabolic acidosis, coma, cardiovascular traceability, respiratory failure, hemorrhage, heavy hypoglycemia.

    In case of serious overdose, the following measures should be intervened:

    hospitalized, clean the stomach by causing vomiting (pay attention to not inhale) or gastric lavage, drinking activated carbon. Carry out peritoneal, hemorrhage, blood transfusion if necessary. Monitor and support the necessary functions for life. High fever treatment, infusion, electrolyte, acid -base balance; treatment of ceton accumulation; Keep the compatible blood glucose level.

    In addition, it is necessary to monitor for a long time if it is overdose, as the absorption may last; If the test is performed before drinking 6 hours does not show the Salicylate poisoning concentration, it is necessary to repeat the test.

    Causes the urinary chemical urine to increase salicylate excretion. However, oral bicarbonate should not be used, because it can increase the absorption of salicylat. If acetazolamid is used, it is necessary to carefully consider the risk of serious metabolic acid infection and salicylate poisoning (caused by increased salicylate penetration into the brain due to metabolic acid infection).

    Monitor pulmonary edema and seizures and perform appropriate therapy if needed.

    Blood transfusion or vitamin K if needed to treat bleeding.

    If there is any overdose symptom related to Clopias, stop taking the drug immediately and immediately notify the doctor.

    What to do when you forget 1 dose? If you forget to take medicine for more than 12 hours: Just take the next dose at the usual time and should not double the dose to compensate for the dose to forget to take.

    Side Effects

    When using Clopias, you may experience unwanted effects (ADR).

    Common, ADR> 1/100

  • Hematology: Bleeding, bleeding can occur in the form of bleeding in the stomach or in the intestine, bruising, hematoma (abnormal bleeding or bruising under the skin), nosebleeds, bleeding. In a few cases, bleeding in the eyes, in the skull or in the joints has also been reported;
    • digestive system: diarrhea, nausea, vomiting, heartburn, stomach pain, stomach ulcer;

    Central nervous system: tired; skin: ban, urticaria; Other: Anaphylaxis.

    Uncommon, 1/1000

  • Central nervous system: headache, restlessness, irritability, dizziness;

    • Digestive system: vomiting, nausea, constipation, flatulence in the stomach or intestine; liver: Having liver toxic; Hematology: leukopenia, thrombocytopenia, anemia, prolonged bleeding time;

    Automatic system: Bronchospasm.

    Instructions on how to handle ADR

    When experiencing side effects of the drug, it is necessary to stop using and notify the doctor or go to the nearest medical facility for timely treatment.

    Warnings

    Before using the drug you need to read the instructions carefully and refer to the information below.

    Contraindicated

    Clopias drugs are contraindicated in the following cases:

  • Patients with clopidogrel, aspirin or other ingredients of the drug.
  • Patients with non -steroid anti -inflammatory drugs (NSAID).
  • Patients with accompanying diseases include asthma, nasal flow, nasal polyps (a type of tumor in the nose).

    • Stomach ulcer, bleeding in the brain, severe liver disease, severe kidney disease.

  • Pregnant women: The last 3 months of pregnancy.

    • Be cautious when using

    clopidogrel:

    Blood disorders and hematology: Clopidogrel should be carefully used in patients at high risk of bleeding due to trauma, surgery or other diseases and in patients treated with aspirin, heparin, glycoprotein ilb / Illa inhibitors or anti-inflammatory drugs (NSAIDs) including COX-2 inhibitors, or Serotonin-selective re-inhibitors Bleeding like pentoxifyllin. Clopidogrel should not be used simultaneously with anticoagulant drugs as it can increase the risk of bleeding.

    Be cautious for patients at risk of bleeding such as:

  • Stomach ulcer;
  • Bleeding inside tissues, organs or joints in the body;

    • Recent serious injury;

  • Recently surgical (including tooth extraction);
  • Coming to surgery (including tooth extraction) within the next 7 days.

    • Blood thrombocytopenia:

    Be cautious in the case of thrombocytopenic hemorrhage (TTP), hemophilia suffered, transient cerebral vascular accident, cross -reaction between Thienopyridin.

    haemhiliopa.

    Clopidogrel extends blood clotting time. In case the patient has a blood clot in the cerebral artery (cerebral emulsion), it should be discontinued.

    Cross reaction between Thienopyridines.

    Patients with hypersensitivity to Thienopridin (such as clopidogrel, ticlopidin, prasugrel) due to the cross -reaction between ThienPridin. Thyopyridine may cause mild or severe allergic reactions such as rash, angioedema, or hematurian diagnostic reactions such as platelets and neutropenia.

    Be careful in patients treated simultaneously with clopidogrel and metabolic products through Cytochrom P450 2019 (CYP2C19) and CYP2C8.

    Patients with liver failure, renal failure.

    aspirin:

    Products containing aspirin should be careful in people with a history of asthma, gout, and G6PD deficiency.

    Acetylsalicylic Acid can contribute to Reye syndrome in some children. Use carefully in the case of hypertension and when the patient has a history of stomach, duodenal and hemorrhoids from bleeding or being treated with anticoagulants.

    Acetylsalicylic acid should be used carefully in patients with renal impairment or moderate liver function (contraindicated if severe) or in patients with dehydration due to NSAIDs can impair kidney function. Liver function tests should be done regularly in patients with mild or medium liver failure.

    Acetylsalicylic acid can promote bronchospasm and asthma or other hypersensitivity reactions. Risk factors are asthma, hay fever, nasal polyps or chronic respiratory diseases. The same thing applies to patients who also have allergic reactions to other substances (for example, skin reactions, itching or urticaria).

    Should stop using when the initial manifestation of the skin rash, mucosal damage, or any signs of hypersensitivity.

    Elderly patients are particularly sensitive to the adverse effects of NSAIDs, including acetylsalicylic acid such as stomach bleeding and ulcers that can be fatal. In case of prolonged treatment, patients should be checked regularly.

    Be careful when taking the drug at the same time such as oral corticosteroids, selective Serotonin reabsorption inhibitors and deferasinox may increase the risk of stomach ulcers. Low -dose acetylsalicylic acid reduces uric acid secretion. Therefore, patients are at risk of increasing gout attacks.

    The risk of hypoglycemia with sulfonylirros and insulin may increase when taking higher doses of aspirin.

    Do not use for patients with galactose intolerance, lactase deficiency, Glucose - Galactose absorption disorders.

    The ability to drive and operate machinery

    In a few cases of drugs that can cause headaches, dizziness, so it should be noted when driving and operating machinery.

    Pregnancy

    Aspirin inhibits cyclooxygenase and prostaglandin production, which is important for arteriosclerary closing. Aspirin also inhibits uterine contractions, thus causing labor delays. Prostaglandin production effects can lead to early closing of the ductus artery in the uterus, with a serious risk of hypertension of pulmonary artery and neonatal respiratory failure.

    The risk of bleeding increases in both mother and fetus, because aspirin inhibits platelet aggregation in the mother and fetus. Therefore, do not use Clopias in the last 3 months of pregnancy.

    Clopidogrel studies on mice and rabbits, at a dose of 500 mg and 300 mg/kg/day (equivalent to 65 and 78 times compared to the basic dose on mg/m2 of skin), evidence shows that there is no impact on the reproduction of clopidogrel. However, there is no adequate and controlled research on pregnant women, should not use Clopias during pregnancy.

    The period of breastfeeding

    aspirin into breast milk, but with normal treatment, there is very little risk of harmful effects in breastfed babies. Mouse research shows that Clopidogrel is allocated in mouse milk, but it is not known whether the drug is excreted through human milk. Therefore, Clopias should not be used or stop breastfeeding during medication because of the serious risk of reactions to children.

    Interactive drug

    Some drugs may affect the use of Clopias or vice versa:

    Salicylate concentration in plasma is less affected by other drugs, but simultaneous use with aspirin reduces the concentration of indomethacin, naproxen, and fenoprofen.

    Aspirin's interaction with warfarin increases the risk of bleeding.

    With methotrexate, sulphonylurea blood gelhat, phenytoin, valproic acid increases the concentration of this drug in serum and increases toxicity.

    Other Aspirin's other interactions include antagonism with sodium di by spironolacton and positive transportation of penicillin from brain fluid - marrow into the bloodstream. Aspirin reduces the effect of urinary uric acid such as Probenecid and Sulphinpyrazol.

    Clopidogrel affects the metabolism of liver enzymes. The inhibition of ISOENZYM CYP2C9 on in vitro at high concentrations. Convert into metabolites that are active by CYP2C19. Pharmacokinetic potential (reducing the concentration of metabolic activity) and pharmacological energy (reducing plateletic resistance) interacting with CYP2C19 inhibitors, so avoid using Clopias with CYP2C19 inhibitors (Omeprazol).

    Studies show that proton pump inhibitors may have a disadvantage of platelosis activity of clopidogrel. All proton pump inhibitors are metabolized through CYP2C19 with a change level. Omeprazol reduces the anti -demand effect of Clopidogrel when used first. Other proton pump inhibitors like Rabeprazol and Lansoprazol may affect Clopidogrel's platelet resistance. Data on pantoprazol and esomeprazol shows neutral effects. Pantoprazol is the weakest inhibitor with CYP2C19 and shows no clear interaction with clopidogrel. Based on the current data, Pantoprazol may be the best option in patients using Clopidogrel, which needs to use Proton pump inhibitors.

    Other drugs affecting platelet resistance of clopidogrel such as: cilostazol, cimetidine.

    Simultaneous use Clopidogrel with nonsteroidal anti -inflammatory drugs, warfarin, will increase the risk of bleeding.

    Storage

    Store drugs in a dry place, temperatures below 30 ° C, avoiding light.

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