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当前位置:药品说明书与价格首页 >> 神经内科 >> 新药动态 >> FDA批准雷萨吉兰片剂(Rasagiline/Azilect)治疗帕金森病新药

FDA批准雷萨吉兰片剂(Rasagiline/Azilect)治疗帕金森病新药

——FDA批准雷萨吉兰片剂(Rasagiline/Azilect)治疗帕金森病

2006-05-27 11:26:13  作者:新特药房  来源:新特药房药讯  浏览次数:120  文字大小:【】【】【

 日前,美国食品药品管理局(FDA)批准了以色列梯瓦制药工业公司开发的雷萨吉兰(Rasagiline/Azilect)片剂,用于1日1次单药治疗早期帕金森病和作为中、晚期帕金森病左旋多巴(Levodoba)疗法的附加用药。

  3项总计包括1600多例各阶段帕金森病患者的大型、多中心、国际性、双盲、随机、安慰剂对照临床试验证实,雷萨吉兰治疗有益、安全,且能被很好耐受。该药目前还在进行一项大型研究,以考察其能否减缓帕金森病患者的疾病进展。

  雷萨吉兰单药治疗的副反应有关节痛和消化不良等;用作附加用药的副反应包括运动障碍、意外伤害、体重下降、体位性低血压、呕吐、关节痛、恶心、便秘、口干、皮疹和嗜睡等。

  雷萨吉兰先前已于2005年在欧盟和以色列获准上市。

AZILECT (RASAGILINE)

Azilect Information

Azilect is a popular medicine also known under the name of Rasagiline. This medicine belongs to a wide class of drugs also known as monoamine oxidase-B (MAO-B) inhibitors. The purpose of a treatment with Azilect is to reduce and treat some of the Symptoms that come with Parkinson’s disease. This medicine can sometimes be combined with another drug, levodopa, to increase the treatment’s effects. This drug is known to increase the levels in which certain brain chemicals are found in the patient’s body, thus making it an ideal medicine for the treatment of Parkinson’s disease symptoms. 

Azilect Indications

Although this medicine is commonly prescribed to reduce some of Parkinson’s disease’s symptoms, Azilect can also be used for other purposes that have not been mentioned in this guidebook.

Azilect Warnings

You must not start a treatment with Azilect if you are suffering from adrenal gland tumor or any type of liver disorder. You must avoid taking Azilect if you have had a surgery in the past two weeks. If you have recently followed a treatment with any of the drugs that are listed below, you may not be allowed to take this medicine:

  • St. John's wort;
  • tramadol (Ultram);
  • meperidine (Demerol);
  • methadone (Methadose, Dolophine);
  • propoxyphene (Darvon, Darvocet);
  • cyclobenzaprine (Flexeril);
  • over-the-counter cough, allergy or cold medicines that contain pseudoephedrine, dextromethorphan, or phenylephrine;
  • mirtazapine (Remeron);
  • amphetamines (for example ADHD medication), diet pills, stimulants;
  • other MAO inhibitors like selegiline (Eldepryl, Emsam), tranylcypromine (Parnate), isocarboxazid (Marplan) or phenelzine (Nardil).

Some patients who have followed a treatment with this drug developed melanoma (skin cancer). Patients who are suffering from Parkinson’s disease are more prone to developing this illness. Ask your personal physician for further information and advice.

Azilect is a category C FDA pregnancy drug; therefore this medicine can harm a growing fetus if it is taken during pregnancy. You should not start taking this drug without your physician’s consent if you are pregnant or if you are planning to be so soon. It has not been determined whether this medicine can pass into breast milk. However, you should ask your doctor if it is safe to take this drug if you are breastfeeding an infant.

During your treatment with this medicine and 2 weeks after finishing it you are not allowed to drink certain beverages or to eat certain foods that are known to be high in tyramine. Ask your physician for further information regarding this matter.

Azilect Intake Guidelines

Ask your doctor how and when you should take Azilect. You must not disobey any of the instructions that your physician has given you. You can also rely on the instructions that are written on the drug’s label. If you fail to understand some of them, you should ask a doctor, a pharmacist or a nurse. A dose of this drug is regularly accompanied by a glass of water. You must not stop your treatment with this drug without your physician’s consent, even if you start to feel better after a few days.

During your treatment with Azilect you are allowed to eat and drink:

  • fresh meat, fish or poultry;
  • vegetables (this does not include broad bean pods (also known as fava beans);
  • bottled or canned beer;
  • processed cheese, ricotta, mozzarella, cottage cheese;
  • white wine;
  • some types of pizza;
  • yogurt;
  • soy milk;

Azilect Dosage

Ask your physician to calculate the correct dose of Azilect that works best in your case. The dosage of this drug is known to vary from one person to another because it depends on some factors such as age, body weight, general health condition, etc. You must not make any adjustments to the dosage that you have been prescribed without your physician’s consent.

Azilect Overdose

If you suspect that you are suffering from an overdose with this drug you might be in need of immediate medical care. You must contact your local poison control centre as soon as possible and inform your personal physician. The average Azilect overdose symptoms include severe headache, drowsiness, vision problems, feeling irritable or agitated, sweating, uneven or fast heartbeat, clammy or cold skin, fainting, shallow breathing, seizure, etc.

Azilect Missed Dose

If you miss one of your Azilect doses, you should take it as soon as you recall. If it is about time for another scheduled dose, you must skip the one that you have missed and continue your treatment.

Azilect Side Effects

Stop your treatment with this medicine and alert your physician if you experience any of these severe side effects:

  • high blood pressure (confusion, chest pain, blurred vision, nausea, seizure, vomiting);
  • sudden weakness or numbness, balance or speech problems;
  • abnormal behavior or thoughts, extreme agitation, confusion;
  • twitching muscle movements;
  • fever, muscle stiffness, sweating;
  • fainting, light-headedness;
  • blistering skin rash;
  • hallucinations.

You may continue your treatment with Azilect (Rasagiline) but inform your doctor if you experience these common side effects:

  • dizziness;
  • joint pain;
  • hair loss;
  • mild headache, depressed mood;
  • tingly feeling or numbness;
  • loss of appetite;
  • dry mouth;
  • constipation, upset stomach, weight loss, diarrhea, vomiting;
  • impotence, decreased sex drive;
  • flu-like symptoms.

Alert your personal physician if you experience anything bothersome during your treatment with Rasagiline.

Azilect Drug Reactions

Ask for your doctor’s consent before taking any other drugs during a treatment with Azilect.

Buy Azilect

Buy Azilect through our Online Pharmacy Escrow Service or at any Canada Pharmacy selling Online Prescriptions.

In some countries AZILECT may also be known as: Elbrus, Rasagiline

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