Pletaal Tablets 100mg Otsuka tablets treatedia (10 blisters x 10 tablets)

Dosage form Box of 10 blisters x 10 tablets
Specifications Cilostazol

Ingredient

Composition informationContent
Cilostazol100mg

Uses

Indications

Pletaal 100mg drug is indicated in the following case:

  • Treatment of ischemic symptoms including ulcers, pain and colds in chronic artery blockage (Berger disease, arteriosclerosis, peripheral vascular disease due to diabetes).
  • Prevention of recurrent cerebral infarction (except for the heart congestion due to the heart). Disclosure.

    In vitro studies

  • Cilostazol inhibits the end of the human platelet in humans caused by ADP, collagen, arachidonic acid, adrenaline and thrombin. The drug also inhibits the platelet aggregation caused by strong stress.
  • Cilostazol inhibits the initial platelet aggregation caused by ADP and Adrenaline and shows the effect of dispersing platelet capacitors in humans caused by many different collection agents.
  • cilostazol inhibits the formation of thromboxane A2 in platelets that are active.
  • cilostazol inhibits the activity of human platelets.

    • In vivo studies

  • Cilostazol inhibits platelet's convergence caused by ADP and collagen when giving rabbit hunting dogs and pigs.
  • The inhibitory effect of Cilostazol on the platelet aggregation caused by the ADP does not change during the time for the mouse to take the dose repeated.
  • Cilostazol prevents platelet accumulation caused by ADP, Collagen, Arachidonic Acid and Adrenaline when taking orally in patients with chronic artery blockages or cerebral infarction. Cilostazol, because the concentration of the drug in plasma decreases, the platelet's convergence returns to normal levels without an response (does not increase the platelet's convergence).
  • Cilostazol reduces the death rate caused by pulmonary embolism in the mouse experimental by adp intravenous injection or glue. In fake artificial pieces placed into the dog's femoral artery. Human with transient ischemic attacks.
  • cilostazol inhibits the shrinking of the femoral artery, the middle brain artery and the isolated artery in dogs created by KCl and Prostaglandin F2α. Blood into the cerebral cortex in dogs and cats has been anesthetized. Create an increase in skin temperature in limbs and increase blood flow in the skin in patients with chronic artery blockage. Cilostazole increases blood flow in patients with ischemia due to ischemia, as defined by inhalation method.
  • Cilostazol prevents the proliferation of human vascular muscle cells cultured.
  • cilostazol prevents the thickness of the coccidal artery of the rat caused by endothelial lesions.
  • Cilostazole promotes NO production by the cultured endothelial cells.
  • cilostazol prevents the damage of endothelial cells cultured
  • cilostazol prevents the fluid of lactate dehydrogenase from the endothelial cultured endothelial cells activated by Homocystein or Lipopolysaccharide.
  • Experiments on rabbits have shown that cilostazol prevents the release of serotonin from platelets without affecting the reception of serotonin and adenosine of platelets. This drug inhibits the platelet aggregation caused by thromboxane A2 (TXA2).
  • Cilostazol has the effect of inhibiting platelet capacitors and dilating vessels by selecting PDE3 selective (PDE inhibits GMP - CGMP) in platelets and blood vessel smooth muscles.
  • Anti -plateletal effect of cilostazole is increased when there is the presence of blood vascular endothelial cells or prostaglandin E1.
  • Anti -thrombocytopenic effect in Cilostazol's dogs is increased when there is the presence of prostaglandin I2 or adenosine.

    After giving healthy ordinary people fasting a single dose of Cilostazol 100mg, the concentration of cilostazol in plasma quickly increased to the maximum of 763.9ng/ml for 3 hours. The half -life of the drug in plasma is estimated by using a two -stage model of 2.2 hours in α and 18 hours in phase β. Two active metabolites found: OPC-1515 (dehydrated metabolites) and OPC-13213 (metabolites are hydroxylation).

    When taking a single dose of Cilostazol 50mg after eating, the maximum concentration (CMAX) increased by 2-3 times and increased the area under the curve (AUCINF) to 1.4 times higher than when drinking in hunger.

    Metabolic enzymes

    Cilostazol is strongly metabolized by enzymes of Cytochrome P450 in the liver, mainly CYP3A4 and at less, because CYP2D6 and CYP2C19 (In vitro).

    Links to protein

    cilostazol: over 95% (in vitro balancing, 0.1 - 6kg/ml). The metabolites have OPC-1515: 97.4% (Vitro super filter, 1ug/ml). Metabolic substances have OPC-13213: 53.7% (Vitro super filter, 1ng/ml).

    Pharmacokinetics in patients with renal failure (outside Japan)

    In patients with severe kidney failure, repeating the dose of pletaal 100mg/day for 8 days shows that the concentration of cilostazol in plasma decreases (CMAX decreased by 29% and AUC decreased by 39%) and the concentration of metabolites with OPC-13213 activity increased significantly (CMAX increased by 173% and AUC increased by 209%) compared to healthy normal people. However, the concentration of Cilostazol and OPC-13213 in patients with mild to moderate kidney failure is similar to the concentration in healthy normal people.

    Pharmacokinetics in patients with liver failure (outside Japan)

    In patients with mild to medium liver failure, the cilostazol concentration in plasma after taking a single dose of pletaal 100mg is similar to the concentration in healthy normal people (CMAX decreased by 7% and AUC decreased by 8%).

    Drug interaction (outside Japan)

    When used in combination with a single dose of Warfarin 25mg, Pletaal did not inhibit the metabolism or pharmacological effects of R and S-Warfarin. Use a combination of a single dose of Cilostazol 100mg while recalling Erythromycin 500mg, 3 times/day, for 7 days, increasing CMAX of Cilostazol is 47% and AUC is 87% compared to only cilostazol.

    Use a combination of a single ketoconazole 400mg with a single dose of Cilostazol 100mg that increased CMAX of Cilostazol of 94% and AUC was 129% compared to only cilostazol.

    Use a combination of Diltiazem Hydrochloride 180mg with a single dose of Cilostazol 100mg, which increases CMAX of Cilostazol of 34% and AUC is 44% compared to only cilostazol.

    Take a single dose of Cilostazol 100mg with 240ml of grapefruit juice that increases Cilostazol's cmax of 46% and AUC is 14% compared to when using Cilostazol without grapefruit juice.

    Use a combination of a single dose of Cilostazol 100mg while repeating Omeprazole 40mg, 4 times/day, in 7 days, increasing CMAX of Cilostazol is 18% and AUC is 26% compared to only Cilostazol.

    • Before taking Pletaal Tablets 100mg Otsuka tablets treatedia (10 blisters x 10 tablets)

    How to use

    Pletaal 100mg medicine is used orally. The drug is taken at least 30 minutes before eating or 2 hours after breakfast and dinner.

    Dosage

    The common dose for adults of Pletaal 100mg tablets is 1 capsule 2 times/day. Dosage can be adjusted according to the age of the patient and the severity of the symptoms.

    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 to do when using overdose?

    Signs and symptoms that can be anticipated are: severe headaches, diarrhea, fast heartbeat and possibility of arrhythmia.

    Need to monitor patients and support treatment. Need to clean the stomach by causing vomiting or gastric lavage appropriately.

    What to do when you forget a dose? However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Note that it should not be used double the prescribed dose.

    Side Effects

    When using Pletaal 100mg , you may experience unwanted effects (ADR).

    Side reactions, including abnormal laboratory trials, have been reported at 436 (8.92%) out of a total of 4,890 patients who are using Pletaal 100mg (data are the total number of cases that have been reported from the first time of approval until the completion of re -investigation and supplementary approval of Pletaal Tablets 50mg and 100mg).

    The following side effects include the reports that have been reported without information about the frequency that occurs after the drug is put into the market.

    Clinical side effects

  • Hemorrhagic heart failure, myocardial infarction , note pain and ventricular tachycardia (unknown frequency*): Hearing heart failure, myocardial infarction, angina and ventricular tachycardia may occur. If there are any signs of these side effects, the medication must be stopped and taken appropriate treatments. If there is any such sign, it is necessary to stop taking the drug and take appropriate treatments. If there is any such sign, it is necessary to stop taking the drug and take 4 appropriate treatments. Patients should be closely monitored. If there are any signs of these side effects, the medication must be stopped and taken appropriate treatments. If there is any sign of interstitial pneumonia, medication must be stopped and properly treated, including the use of adrenal hormones. can happen. Patients should be closely monitored. If there are signs of liver dysfunction, stop taking the drug and take appropriate treatments. Patients need to be closely monitored, such as doing kidney function tests. If there are signs of kidney failure, stop taking the drug and take appropriate treatments.

    (*) does not record information about the frequency of occurrence because the side effects are reported voluntarily or occur outside Japan.

    Other side effects

    Common, 1/100

  • Stomach - intestines: indigestion.
  • Hypersensitivity: Ban. skin.
  • Hypersensitivity: rash, floating urticaria and itching.
  • liver: increase AST (GOT), ALT (GPT), Alkaline Phosphatase and LDH.

    unknown frequency

  • Hypersensitivity: Light sensitivity. granulocytes, retinal bleeding, nosebleeds.

    • Instructions on how to handle ADR

    Notify the doctor with unwanted effects when using the drug.

    Warnings

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

    Contraindicated

    Pletaal 100mg drug contraindicated in the following cases:

  • Hypersensitivity to cilostazol or any ingredients of the drug.
  • Hemorrhagic heart failure.
  • Pregnant women. There is a long QT range.

    Precautions when using

    Warning

    Patients should be closely monitored on any symptoms of angina (such as chest pain), because the treatment with pletaal 100mg may increase the pulse, which can cause angina. There has been a significant increase in the pulse pacemaker in the drug group that affects the circuit pressure (PRP - Pressure Rate Product) while treating with a long -term pletaal 100mg in a clinical study to evaluate the effectiveness of the drug in preventing recurrent cerebral infarction. Angina is also recorded in some patients treated with pletaal 100mg.

    Precautions

    Be cautious when used (need to be cautious when taking this medication in the following patients)

  • Only use Cilostazol in patients who have taken a way to change lifestyle (exercise, eat and stop smoking) but still do not improve the disease.
  • Not used for patients with serious arrhythmia (tachycardia, arrhythmia), unstable angina, heart attack, patients with coronary artery surgery or patients who are using two anticoagulants or anti -platelets or more platelets such as aspirin and clopidogrel. Aspirin, ticlopidine or clopidogrel sulfate), thrombolytic drugs (such as Uroinase and Alteplase), Prostaglandin E1 or its derivatives (such as Alprostadil and Limaprost Alfadex). Bleeding (if bleeding occurs, the trend of bleeding may increase). malignant blood pressure).

    Be important

  • Do not use Pletaal 100mg for patients with cerebral infarction until the disease is stable. In patients with high blood pressure infarction, it is necessary to fully control blood pressure during treatment with pletaal 100mg. The drug has the effect of inhibiting cyclic nucleotide phosphodiesterase 3 (PDE3). Long -term comparative studies on cardiac aids that inhibit PDE3 (Milrinone and Vesnarinone) in patients with congested heart failure (Group III - IV according to the New York Heart Association (NYHA) are conducted outside Japan have proven the survival in patients using these cardiologists lower than patients with placebo. Pletaal 100mg, has not been identified in patients without congested heart failure.

    Be cautious when used for the elderly

    Physiological, elderly patients are often more sensitive to pletaal than young patients. When prescribing this drug for elderly patients may need to reduce the dose.

    Be cautious when used for children

    Not yet determined the safety of the use of pletaal 100mg in premature babies, newborns, breastfed and children (not clinical experience in these age groups).

    Precautions associated with drug use

    Instruct patients to remove the pill from the compressed blister (PTP) before taking this medication (swallowing PTP blisters has led to serious complications such as perforation of esophagus and mediastinary).

    Other cautions

  • In studies on the repetitive dose of cilostazol in bunny hunting dogs (Beagle), high doses for 13 weeks and 52 weeks, have been recorded with thickness in the heart and coronary artery lesions. The non -toxic dose is 30mg/kg/day for 13 weeks and 12mg/kg/day for 52 weeks. The changes in this heart are not recorded in mice or monkeys. In the studies of toxicity in the heart toxicity repeated when intravenously in a week, the dog has had changes in the pericardium of the left ventricle, the pericardial viscera of the right atria and the coronary artery and has been recorded on monkeys there are mild hemorrhage changes in the pericardium in the heart of the left ventricular heart. In studies on PDE inhibitors and other vasodilators, it has also recorded changes in heart and dogs that are considered highly sensitive in such changes. week). Cong (AUC) of lovastatin is 64% compared to only lovastatin.

    • The ability to drive and operate machinery

    There has been no research on the effect of Pletaal 100mg when driving. A number of patients have been stunned or dizzy while using Pletaal 100mg, such patients need to be cautious when driving or operating machinery.

    Pregnancy

    Do not use Pletaal 100mg for pregnant women or maybe pregnant (studies on the birth of the Biomedo and Studies for birth and after birth on this drug in the mouse shows that the abnormal pregnancy increases, the weight at birth is low and the amount of pregnancy at birth).

    Breastfeeding period

    Breastfeeding women have to stop breastfeeding during the use of this drug. (The studies in mice have shown that pletaal 100mg is distributed into milk in breastfeeding mice).

    Drug interaction

    pletaal is strongly metabolized by enzymes of Cytochrome P450 (CYP) in the liver, mainly CYP3A4 and at less level by CYP2D6 and CYP2C19.

    Precautions when used combined. Be careful when using a combination of pletaal 100mg with the following drugs:

    Drugs

    Signs, symptoms and treatment

    Mechanisms and risk factors

    Prostaglandin E1 or its derivatives

    (like alprostadil and limaprost alfadex).

    If bleeding occurs, the trend of bleeding may increase.

    When Pletaal 100mg combined with these drugs, blood clotting tests or other appropriate monitoring should be conducted to reduce the risk of side effects such as bleeding.

    Because Pletaal 100.g has the effect of inhibiting platelet accumulation, when used with these drugs can increase bleeding trends.

    CYP3A4.

    Macrolide antibiotics (such as Erythromycin), HIV Protease inhibitors (such as Ritonavir), Azole antifungal drugs (such as Itraconazole and miconazole), Cimetidine, Diltiazem hydrochloride and grapefruit juice.

    The effect of pletaal 100mg may increase when used in combination with these drugs. Need to reduce the dose of pletaal 100mg or start with low doses when used in combination with these drugs.

    Patients need to be careful not to drink grapefruit juice while using pletaal 100mg.

    Increasing blood leveling concentration when pletaal 100mg is used in combination with these drugs or the ingredients in grapefruit juice inhibit the enzyme metabolism CYP3A4.

    The effect of pletaal 100mg may increase when used in combination with these drugs. Need to reduce the dose of pletaal 100mg or start with low doses when used in combination with these drugs.

    The blood concentration in the blood increases when Pletaal 100mg is used in combination with these drugs that inhibit the CYP2C19 enzyme.

    Storage

    temperature does not exceed 30ºC.

    Other drugs

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