盐酸甲基苄肼胶囊procarbazine(Matulane 50Capsules)

产地国家:美国

处方药:是

所属类别: 50毫克/胶囊 100胶囊/盒

包装规格: 50毫克/胶囊 100胶囊/盒

计价单位:盒

生产厂家英文名:SIGMA-TAU PHARMA-BRAND RX

原产地英文商品名:MATULANE 50mg/Capsules 100Capsules/box

原产地英文药品名:PROCARBAZINE HCL

中文参考商品译名:MATULANE 50毫克/胶囊 100胶囊/盒

中文参考药品译名:盐酸甲基苄肼

简介

部份中文盐酸甲基苄肼处方资料(仅供参考)

商品名:Matulane

英文名:Procarbazine Hydrochloride

中文名:盐酸甲基苄肼胶囊

生产商:SIGMA-TAU PHARMA-BRAND RX

药理作用

本品为细胞周期非特异性药物。进入人体后自身氧化形成H2O2和OH-,可引起类似电离幅射作用,特别使鸟嘌呤的第3位和腺嘌呤的第1位上发生甲基化,抑制RNA、DNA及蛋白质的合成。对G1/S期有延缓作用,抑制细胞的有丝分裂,使分裂指数明显下降,G1-G2间期延长。本品与烷化剂、长春新碱、皮质激素类及放射治疗无交叉耐药性。

临床应用:(1)主要用于霍奇金病,有1/3-1/2的病人能获得完全缓解,缓解期为3周-6个月或更长,常联合用药,如MOPP方案。(2)对恶性淋巴瘤、多发性骨髓瘤、肺癌亦有一定疗效。(3)对网织细胞瘤、淋巴肉瘤、原发性及转移性脑瘤、慢性淋巴细胞白血病、恶性黑色素瘤等均有一定疗效。

用法用量:口服,成人每日150-200mg,分3-4次;或每次150-200mg,睡前顿服;总量7~9g为1疗程。静脉注射:每次2-7mg/kg,从较低剂量开始逐渐增加,总量以7~10g为1疗程。

不良反应:(1)骨髓抑制:白细胞下降,血小板减少,贫血等,常见于用药后2~8周内,停药后2~3周可恢复。(2)胃肠道反应:恶心,呕吐,食欲不振,口干,口炎;日剂量超过200mg时,反应较明显。(3)中枢神经毒性:头痛、乏力、眩晕、不安、失眠、神经错乱、脑电图不正常。(4)周围神经毒性:可能出现下肢感觉异常,深反射消失,麻痹等。(5)其他反应:皮下出血、紫癜、鼻衄、黑便、溶血性贫血、脱发、皮炎、色素沉着,偶见肝功能异常。

禁忌:(1)孕妇及严重骨髓抑制、肝肾损害者禁用。(2)糖尿病、感染或用过其他化疗药物的患者慎用。(3)出血、过敏、口腔炎及用过安眠药、麻醉药的患者慎用。

注意事项:(1)本品与中枢神经系统抑制药或抗高血压药联合应用可增加这两种药物的治疗作用。(2)本品有单胺氧化酶抑制作用,避免与麻黄素、苯丙胺、间羟胺、苯丙醇胺等拟交感药以及丙咪嗪、阿米替林合用,以免高血压病患者的血压上升和过度兴奋。用药期间凡含有高酷胺成分的食物,如乳酪、香蕉等均不宜食用,酒类亦宜少用。(3)胰岛素、降糖灵、利他林、硫喷妥钠等可使本品作用延长并增强。(4)本品与氮芥合用可产生神经毒性。(5)少数年轻妇女用药可致闭经,停药后可恢复。

英文版说明书

GENERIC NAME: PROCARBAZINE – ORAL (pro-KAR-buh-zeen)BRAND NAME(S): Matulane, MatulaneUSES: Procarbazine is an alkylating chemotherapy drug used along with other chemotherapy drugs to treat Hodgkin’s disease (also known as Hodgkin’s lymphoma). It works by preventing cancer cells from growing and from creating new cancer cells. Because procarbazine also affects the growth of normal body cells, you will most likely experience side effects while using this drug.Procarbazine also acts as a monoamine oxidase inhibitor. (See also Drug Interactions for cautions regarding use of procarbazine with other drugs and the need to limit the amount of tyramine in your diet.)OTHER This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.This drug may also be used to treat other cancers such as brain tumors.HOW TO USE: This is a strong medication and is used in combination with other medicines.Use them exactly as directed by your doctor.Dosage is based on your medical condition, weight, the otherdrugs used for cancer treatment, and response to treatment.In children, the dosage is based on body size instead of weight.Use this medication regularly to get the most benefit from it. To helpyou remember, take it at the same time(s) each day.Do not stop taking this medication, even if you feel nauseated or experience vomiting. However, if you vomit shortly after a dose, contact your doctor immediately.SIDE EFFECTS: Nausea, vomiting, loss of appetite, constipation, dry mouth, difficulty swallowing, drowsiness, dizziness, headache, trouble sleeping, muscle/joint pain, or darkening of the skin may occur. Nausea and vomiting can be severe. In some cases, drug treatment may be needed to prevent or relieve nausea and vomiting.Not eating before your treatment may help relieve vomiting. Changesin diet and lifestyle, such as eating several small meals and limiting activity, may help lessen some of these effects.If any of these effects continue or worsen, tell your doctor or pharmacist.Temporary hair loss may occur. Normal hair growth should return several months after treatment has ended.Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects.Some people using this medication do not have serious side effects.Tell your doctor immediately if any of these unlikely but serious side effects occur: black/bloody stools, bloody/pink urine, vomit that is bloody or looks like coffee grounds, stomach pain, yellowing eyes/skin, unsteadiness, fainting.Seek immediate medical attention if any of these unlikely but very serious side effects occur: chest pain, vision problems, fast or slow heartbeat, severe headache, seizures, stiff/sore neck, increased sweating (with or without fever), cold/clammy skin, mental/mood changes, tingling/numbness of hands/feet, unusual bleeding/bruising, diarrhea, mouth/lip sores.This medication can lower your body’s ability to fight an infection. Tell your doctor if you develop any signs of an infection such as: fever, sore throat, chills, unusual tiredness, lower back or side pain, difficult urination, cough, breathing difficulty, thick mucus/phlegm.Very rarely, people with cancer who are treated with this type of medication have developed other cancers (e.g., secondary leukemia). Your risk is greater if you have received certain types of chemotherapy or radiation therapy. Consult your doctor for more details.A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.In Canada – Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.PRECAUTIONS: Before taking procarbazine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies.This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: history of alcohol use.Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart/blood vessel problems, recent chickenpox, shingles (Herpes zoster), diabetes, seizures, liver disease, kidney disease, severe/frequent headaches, current infection, overactivethyroid (hyperthyroidism), current or past tobacco use, radiation therapy, blood diseases (e.g., bone marrow depression, low plateletcounts).Avoid alcoholic beverages or alcohol-containing products/foods (e.g., cough and cold syrups, mouthwash, aftershave, sauces, vinegars) while taking this medication. When procarbazine is combined with alcohol, a severe reaction (disulfiram/alcohol-like reaction) may occur, with symptoms such severe nausea, vomiting, flushing, blurred vision, headache, dizziness, severe tiredness, difficulty breathing, fast/pounding heartbeat, increased sweating, or seizures. Contact your doctor immediately if you drink alcohol or have any of the above symptoms while taking procarbazine.Avoid smoking while using this medication.Smoking increases the risk of developing lung cancer while using this drug. Consult your doctor or pharmacist for more details.This drug may make you dizzy or drowsy.Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely.To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.Before having surgery or emergency treatment, tell the doctor or dentist that you have been receiving this medication.This medication may make you more sensitive to the sun.Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors.To lower the chance of getting cut, bruised or injured, use caution with sharp objects like safety razors and nail cutters, and avoid activities such as contact sports.Wash your hands well and often to prevent the spread of infections.Also, avoid touching your eyes or inside your nose without first washing your hands.Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received oral polio vaccine or flu vaccine inhaled through the nose.Caution is advised when using this drug in children becausethey may be more sensitive to its effects, especially the risk ofshaking (tremors), loss of consciousness, or seizures.This medication is not recommended for use during pregnancy. It may harm an unborn baby. It is recommended that men and women use 2 effective forms of birth control (e.g., condoms and birth control pills) while being treated with this medication and for some time afterward.Consult your doctor for more details and to discuss reliable formsof birth control.It is not known whether this drug passes into breast milk. Because this drug may harm a nursing infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.DRUG INTERACTIONS: Your doctor or pharmacist may already be aware ofany possible drug interactions and may be monitoring you for them.Do not start, stop, or change the dosage of any medicine beforechecking with your doctor or pharmacist first.This drug should not be used with the following medications because very serious(possibly fatal) interactions may occur: antidepressants (e.g., TCAs such as amitriptyline/nortriptyline; mirtazapine; nefazodone; SSRIs such as citalopram/fluoxetine/paroxetine/venlafaxine), appetite suppressants (e.g., diethylpropion, sibutramine), drugs for attention deficit disorder-ADD (e.g., atomoxetine, methylphenidate), certain antihistamines (azatadine, carbetapentane, chlorpheniramine), bronchodilators (e.g., albuterol, salmeterol), bupropion, buspirone, carbamazepine, cyclobenzaprine, dextromethorphan, certain drugs for glaucoma (apraclonidine, brimonidine), herbal products (e.g., ephedra/ma huang), certain drugs for high blood pressure (guanethidine, methyldopa), other MAO inhibitors (furazolidone, isocarboxazid, linezolid, moclobemide, phenelzine, rasagiline, selegiline, tranylcypromine), certain narcotic medications (fentanyl, meperidine, morphine), certain drugs for Parkinson’s (entacapone, levodopa, tolcapone), street drugs(e.g., MDMA/”ecstasy,” LSD, mescaline), stimulants (e.g., amphetamines, cocaine, dopamine, epinephrine, phenylalanine), tetrabenazine, “triptan” migraine drugs (e.g., sumatriptan, rizatriptan), tramadol.If you are currently using any of these medications listed above, tell your doctor or pharmacist before starting procarbazine. Do not take these medications within the 2 weeks before, during or after treatment with procarbazine.If you have been taking fluoxetine, wait at least 5 weeks before starting procarbazine. Ask your doctor how much time to wait between starting or stopping any of these drugs and taking procarbazine.Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: bethanidine, drugs for diabetes (e.g., glyburide, insulin), digoxin, other drugs for high blood pressure (e.g., beta blockers such as atenolol, clonidine, rauwolfia alkaloids such as reserpine, “water pills”/diuretics such as hydrochlorothiazide), methotrexate, papaverine, tryptophan.Tell your doctor or pharmacist if you also take drugs that cause drowsiness such as: certain antihistamines(e.g., diphenhydramine), anti-seizure drugs (e.g., phenytoin), medicine for sleep or anxiety (e.g., alprazolam, diazepam,zolpidem), muscle relaxants, narcotic pain relievers (e.g., codeine), psychiatric medicines (e.g., chlorpromazine, lithium, risperidone, trazodone).Check the labels on all your medicines(e.g., allergy, cough-and-cold products, decongestants, diet pills)because they may contain dextromethorphan, decongestants, stimulants, or drowsiness-causing ingredients. Ask your pharmacist about the safe use of those products.To prevent a very serious high blood pressure reaction, it is very important that you follow a special diet recommended by your doctor or dietician in order to limit your intake of tyramine while you are taking this medicine.Avoid foods and beverages that are high in tyramine, including: agedcheeses (e.g., bleu, cheddar, parmesan), dried/aged/fermented meatsand sausages (e.g., salami, liverwurst), preserved fish (e.g., pickled herring), products containing large amounts of yeast (e.g., concentrated yeast extract, bouillon cubes, powdered soup/gravy, homemade or sourdough bread), fermented foods (e.g., sauerkraut, kim chee), most soybean products (e.g., soy sauce, tofu), broad/fava beans, red wine, sherry, tap beers, vermouth. Limit or avoid foodsthat are moderate in tyramine, including: avocados, bananas, eggplant, green beans, raisins, raspberries, red plums, spinach, tomatoes, chocolate, cultured dairy products (e.g., buttermilk, yogurt, sour cream), fish eggs, pate, peanuts, coffee, cola, alcohol-free beer, bottled beer, distilled spirits, port, white wine.Consult your doctor or dietician for more details and a complete list of other tyramine-containing foods you should limit or avoid.Seek immediate medical attention if you notice symptoms of very high blood pressure such as unusually fast/slow heartbeat, vomiting, unexplained sweating, headache, chest pain, sudden vision changes, weakness on one side of the body, slurred speech.This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all theproducts you use. Keep a list of all your medications with you, andshare the list with your doctor and pharmacist.OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include nausea, vomiting, diarrhea, shakiness, severe dizziness, seizures, and loss of consciousness.NOTES: Do not share this medication with others.Keep all medical appointments. Laboratory and/or medical tests (e.g., complete bloodcounts, kidney function, liver function) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.STORAGE: Store at room temperature between 59-86 degrees F (15-30 degrees C) away from light and moisture. Keep below 104 degrees F(40 degrees C). Do not store in the bathroom. Keep all medicines way from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert。

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