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VESANOID Capsule 10mg
2015-01-02 18:55:30 来源: 作者: 【 】 浏览:608次 评论:0
Manufacturer's name : Chugai Pharmaceutical Co., Ltd. 620005101
Revised: 12/2010
 
Brand name : VESANOID Capsule 10mg
 Active ingredient: Tretinoin
 Dosage form: (reddish) yellow/red-brown capsule (major axis: approx. 10.0mm, minor axis: approx. 7.0mm)
 Printings on wrapping:  

Effects of this medicine

This medicine decreases abnormally proliferated promyelocyte by suppressing function of the gene which inhibits differentiation of promyelocyte in the blood. It is usually used to treat acute promyelocytic leukemia.

Before using this medicine, tell your doctor/pharmacist

  • If you ever experienced any allergic reaction (itch, rash etc.) to any medicine.
    If you are a patient with hepatic/renal disorder or hypervitaminosis A.
    If you are predisposed to hypertriglyceridemia. (For example, you have diabetes, obesity, alcoholism or lipid metabolism abnormality.)
  • If you are pregnant or breastfeeding.
  • If you are using any other prescription or nonprescription (OTC) medicine. (It is important to reduce the risk of drug interactions.)

Dosage regimen (proper use of this medicine)

  • Your dosage regimen is:(order of your doctor)
  •  
  • General dosage regimen: For adults, take 6-8 capsules [60-80mg (45mg/m2) of the active ingredient] in 3 divided doses a day, after each meal. It should be adjusted according to your age and symptoms. Strictly follow the instructions of your doctor/pharmacist.
  • Missed dose: Take the missed dose as soon as possible. If it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. DO NOT take double doses to make up for the missed dose.
  • Overdose: If you took too much of the medicine (more than ordered), check with your doctor/pharmacist.
  • Others: Do not stop taking the medicine without the instructions of your doctor.

Precautions while using this medicine

  • The medicine has teratogenic potency (possibility to cause fetal anomaly), and has a high frequency of side effects. So, you and your family need to be informed of the medicine's side effects until everyone fully understands them.
  • If you have a possibility of becoming pregnant, make sure to avoid pregnancy for 1 month before starting the medication, during taking the medicine, and for at least 1 month after discontinuing it.
  • If you have a possibility of pregnancy, you have to wait a few days after your menstruation begins before taking the medicine.
  • A patient who has a possibility of pregnancy may have a pregnancy test periodically.
  • The medicine may cause retinoic acid syndrome (shortness of breath, fever, chest pain, etc.). If you have these symptoms, stop taking the medicine and go to see your doctor.
  • A patient with hypertriglyceridemia tends to have lipid metabolism abnormality. So, your blood triglyceride will be examined.
  • Your liver function will be checked before and 1 month after starting the medication, and also every 3 months during use.
  • When you have joint/bone pain, contact your doctor immediately. If you are supposed to take the medicine for a long period, you may have to take an X-ray examination and etc.
  • Avoid breastfeeding.
  •  

Side effects of this medicine

Common side effects are reported as below. If any of them occurs, check with your doctor/pharmacist: retinoic acid syndrome, fever, etc.Symptoms described below may be the sign of side effects indicated in brackets [ ]. If they occur, stop taking your medicine and check with your doctor immediately.
  • high fever of over 38℃, breathlessness, shortness of breath, chest pain, headache, lassitude[retinoic acid syndrome]
  • fever, feverish, headache, impaired judgment/mind, decreased consciousness, falling asleep in a faint, failing vision, nausea, vomiting, vomiting of blood, bloody phlegm, difficulty speaking, breathlessness, shortness of breath, chest pain, chest constrictive/ oppressive feeling, severe abdominal pain, enlarged feeling of abdomen, lower-back pain, paralysis/numbness in the limbs, one-sided paralysis, partial paralysis, swelling, pain in the legs, skin,lips and nails turning bluish purple, bloody stool, bleeding, sensory numbness[thrombosis (cerebral infarction, pulmonary infarction, arterial thrombosis, venous thrombosis, etc.)]
  • angialgia, purplish bruise, swelling [angiitis]
  • fever, chills, cough, phlegm, shortness of breath, joint pain, muscular pain[infection (pneumonia, sepsis, etc.)]
  • confused consciousness, disturbed consciousness, impaired mind[confusion]
Other side effects not listed here may occur. Check with your doctor/pharmacist if you have any worrisome symptom.

Storage and other information

  • Keep out of the reach of children. Store at room temperature (1-30℃), away from light and moisture.
  • Discard the remainder. Do not store them. Ask the pharmacist how to discard.
For further information, ask your doctor/pharmacist. "Kanjamuke Iyakuhin Guide" and Japanese package insert information (for medical professionals) is available on the website of Pharmaceuticals and Medical Devices Agency. 
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