部分中文RISPERDAL M-TAB处方信息(仅供参考) 通用名称:利培酮 英文名称:Risperidone 规格 利培酮口服液:1mg/ml。 利培酮片:0.25mg;0.5mg;1mg;2mg;3mg;4mg。 利培酮口腔崩解片(生产厂家: Janssen-Ortho):0.5mg;1mg;2mg。 药物特点 1.疗效显著,能有效治疗精神分裂症阳性症状和阴性症状患者。 本品对于有幻觉、妄想、思维障碍的精神分裂症阳性症状的患者,疗效尤为显著;对于情感退缩、情感迟钝、言语缺乏的精神分裂症阴性症状的治疗也有较好的效果。 Joseph等关于513例精神分裂症患者用利培酮、氟哌啶醇和安慰剂组治疗疗效的比较研究。 结果显示利培酮和氟哌啶醇组疗效均超过安慰剂组,两者治疗阳性症状效果相当;对阴性症状的患者,用利培酮有显著疗效,而用氟哌啶醇疗效不明显。而且用利培酮治疗的病人,起效时间大多在前2周内,较氟哌啶醇快。 2.适应症广,对其他精神性疾病也有较好效果。 利培酮对5-HT2和D2受体均有较高的亲和力。以前的研究显示利培酮主要用于精神分裂症治疗,但根据它的药理作用和安全性,其治疗范围有可能进一步扩大。最近经多项相关临床试验发现,应用利培酮治疗情感性障碍、少年儿童抽动秽语综合征(Tourette 综合征)、精神发育迟滞的行为紊乱和迟发性运动障碍(TD)有较好疗效。 3.作用维持时间长。 主要代谢物为9- 羟基利培酮,同样具有药理活性。本品及活性代谢物在体内的代谢周期长,t1/2β分别为2.8和24.6小时,因此可以长期发挥作用。 4.副作用小,耐受性好。 利培酮的锥体外系副作用比传统的抗精神病药物氟哌啶醇等要小得多,锥体外系副反应和粒细胞缺乏症少见,耐药性比氟哌啶醇等药物好。其他研究显示,在体重增加、体位性高血压等不良反应均较其他抗精神病药物低。长期使用时,迟发性运动障碍也比经典的神经阻断剂明显降低。 技术优势: 独家的口腔崩解片剂型,服用置于舌上,遇唾液几借助舌与上颚的摩擦可迅速溶解或崩解,不需用水也无需咀嚼,而且溶解吸收迅速服后就无法吐出。因此更适合于幼儿、老年人、卧床不能改变体位者及服药不配合的精神病患者。 适应症 用于治疗精神分裂症并延缓其复发。 用法用量 用药时将片剂置舌上用水或不饮水(崩解片)让其完全溶解。 本品的用法为一天两次或一天一次。常用剂量:首剂1mg (一片),一天两次,如果能够耐受的话,第二天和第三天以每次1mg ,一天两次的频率增加。第三天达到目标剂量:每次3mg ,一天两次。 有些患者可能需要缓慢加量。每次8mg,每天一次的疗法也是安全和有效的。 调整剂量的时间不应少于一周,每次增减 1-2mg 。 任何疑问,请遵医嘱! DIN (Drug Identification Number) 50458-0395-28 RISPERDAL M-TAB 0.5MG
50458-0315-28 RISPERDAL M-TAB 1MG
50458-0325-28 RISPERDAL M-TAB 2MG 50458-0335-28 RISPERDAL M-TAB 3MG
50458-355-28 RISPERDAL M-TAB 4MG
Risperdal M-Tab orally disintegrating tablets
RISPERDAL M-TABS Rx Risperdal M-Tab orally disintegrating tablets Risperdal M-Tab orally disintegrating tablets are used for: Treating schizophrenia or bipolar disorder. It is used to treat irritability caused by autistic disorder. It may also be used for other conditions as determined by your doctor. Risperdal M-Tab orally disintegrating tablets are an atypical antipsychotic. It works by affecting certain substances in the brain. Do NOT use Risperdal M-Tab orally disintegrating tablets if: •you are allergic to any ingredient in Risperdal M-Tab orally disintegrating tablets •you are taking metoclopramide Contact your doctor or health care provider right away if any of these apply to you. Before using Risperdal M-Tab orally disintegrating tablets: Some medical conditions may interact with Risperdal M-Tab orally disintegrating tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you: •if you are pregnant, planning to become pregnant, or are breast-feeding •if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement •if you have allergies to medicines, foods, or other substances •if you have a history of seizures, heart problems (eg, heart failure, slow or irregular heartbeat), abnormal electrocardiogram (ECG), heart attack, stroke, blood vessel problems, high or low blood pressure, high cholesterol or triglyceride levels, or low white blood cell levels •if you have a history of kidney or liver problems, stomach or bowel problems (eg, narrowing, blockage), neuroleptic malignant syndrome (NMS), suicidal thoughts or attempts, or alcohol abuse or dependence •if you have diabetes or are very overweight, or if a family member has had diabetes •if you have Alzheimer disease, dementia, phenylketonuria, Parkinson disease, or esophagus problems (eg, trouble swallowing) •if you have had high blood prolactin levels or a history of certain types of cancer (eg, breast, pancreas, pituitary, brain), or if you are at risk for breast cancer •if you are dehydrated, have low blood volume, drink alcohol, or will be exposed to very high or very low temperatures Some MEDICINES MAY INTERACT with Risperdal M-Tab orally disintegrating tablets. Tell your health care provider if you are taking any other medicines, especially any of the following: •Alpha-blockers (eg, doxazosin) or medicine for high blood pressure because the risk of low blood pressure and fainting may be increased •Anticholinergics (eg, scopolamine) because the risk of overheating may be increased •Tramadol because the risk of seizures may be increased •Abiraterone, clozapine, metoclopramide, or selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine, paroxetine) because they may increase the risk of Risperdal M-Tab orally disintegrating tablets's side effects •Carbamazepine, phenobarbital, phenytoin, or rifampin because they may decrease Risperdal M-Tab orally disintegrating tablets's effectiveness •Dopamine receptor agonists (eg, pramipexole) or levodopa because their effectiveness may be decreased by Risperdal M-Tab orally disintegrating tablets This may not be a complete list of all interactions that may occur. Ask your health care provider if Risperdal M-Tab orally disintegrating tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine. How to use Risperdal M-Tab orally disintegrating tablets: Use Risperdal M-Tab orally disintegrating tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions. •Take Risperdal M-Tab orally disintegrating tablets by mouth with or without food. •Do not remove the blister from the outer pouch until you are ready to take Risperdal M-Tab orally disintegrating tablets. Make sure that your hands are dry when you open the blister pack. Do not push the tablet through the foil. Peel back the foil on the blister pack, place the tablet on your tongue, and allow it to dissolve. The tablet dissolves quickly and can be swallowed with saliva. Risperdal M-Tab orally disintegrating tablets may be taken with or without water. Take the tablet immediately after opening the blister pack. Do not store the removed tablet for future use. •Do not break, chew, or swallow the tablet whole. •Take Risperdal M-Tab orally disintegrating tablets on a regular schedule to get the most benefit from it. Taking Risperdal M-Tab orally disintegrating tablets at the same time each day will help you remember to take it. •Continue to take Risperdal M-Tab orally disintegrating tablets even if you feel well. Do not miss any doses. •If you miss a dose of Risperdal M-Tab orally disintegrating tablets, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once. Ask your health care provider any questions you may have about how to use Risperdal M-Tab orally disintegrating tablets. Important safety information: •Risperdal M-Tab orally disintegrating tablets may cause drowsiness, dizziness, light-headedness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Risperdal M-Tab orally disintegrating tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it. •Do not drink alcohol while you are taking Risperdal M-Tab orally disintegrating tablets. •Check with your doctor before taking medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Risperdal M-Tab orally disintegrating tablets; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness. •Risperdal M-Tab orally disintegrating tablets may cause dizziness, light-headedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects. •Do not become overheated in hot weather or while you are being active; heatstroke may occur. •Patients who have bipolar (manic-depressive) illness, or if their family members have had it, may be at increased risk for suicidal thoughts or actions. Watch patients who take Risperdal M-Tab orally disintegrating tablets closely. Contact the doctor at once if new, worsened, or sudden symptoms such as anxious, restless, or irritable behavior; depressed mood; panic attacks; or any unusual change in mood or behavior occur. Contact the doctor right away if any signs of suicidal thoughts or actions occur. •Risperdal M-Tab orally disintegrating tablets may raise your blood sugar. High blood sugar may make you feel confused, drowsy, or thirsty. It can also make you flush, breathe faster, or have a fruit-like breath odor. If these symptoms occur, tell your doctor right away. •Diabetes patients - Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine. •Risperdal M-Tab orally disintegrating tablets may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills. •NMS is a possibly fatal syndrome that can be caused by Risperdal M-Tab orally disintegrating tablets. Symptoms may include fever; stiff muscles; confusion; abnormal thinking; fast or irregular heartbeat; or sweating. Contact your doctor at once if you have any of these symptoms. •Risperdal M-Tab orally disintegrating tablets contains phenylalanine. If you must have a diet that is low in phenylalanine, check with your doctor before using Risperdal M-Tab orally disintegrating tablets. •Some patients who take Risperdal M-Tab orally disintegrating tablets may develop muscle movements that they cannot control. This is more likely to happen in elderly patients, especially women. The chance that this will happen or that it will become permanent is greater in those who take Risperdal M-Tab orally disintegrating tablets in higher doses or for a long time. Muscle problems may also occur after short-term treatment with low doses. Tell your doctor at once if you have muscle problems with your arms; legs; or your tongue, face, mouth, or jaw (eg, tongue sticking out, puffing of cheeks, mouth puckering, chewing movements) while taking Risperdal M-Tab orally disintegrating tablets. •Risperdal M-Tab orally disintegrating tablets may increase the amount of a certain hormone (prolactin) in your blood. Symptoms may include enlarged breasts, missed menstrual period, decreased sexual ability, or nipple discharge. Contact your doctor right away if you experience any of these symptoms. •Risperdal M-Tab orally disintegrating tablets may rarely cause a prolonged, painful erection. This could happen even when you are not having sex. If this is not treated right away, it could lead to permanent sexual problems such as impotence. Contact your doctor right away if this happens. •Lab tests, including fasting blood glucose and complete blood cell counts, may be performed while you use Risperdal M-Tab orally disintegrating tablets. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments. •Risperdal M-Tab orally disintegrating tablets may cause weight gain. Your weight may need to be monitored while you take Risperdal M-Tab orally disintegrating tablets. •Use Risperdal M-Tab orally disintegrating tablets with caution in the ELDERLY; they may be more sensitive to its effects, especially dizziness when standing or uncontrolled muscle movements. •Risperdal M-Tab orally disintegrating tablets should be used with extreme caution in CHILDREN younger than 5 years old; safety and effectiveness in these children have not been confirmed. •PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of taking Risperdal M-Tab orally disintegrating tablets while you are pregnant. Using Risperdal M-Tab orally disintegrating tablets during the third trimester may result in uncontrolled muscle movements or withdrawal symptoms in the newborn. Discuss any questions or concerns with your doctor. Risperdal M-Tab orally disintegrating tablets are found in breast milk. Do not breast-feed while taking Risperdal M-Tab orally disintegrating tablets. Possible side effects of Risperdal M-Tab orally disintegrating tablets: All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome: Anxiety; back pain; blurred vision; constipation; cough; diarrhea; dizziness; drowsiness; dry mouth; fatigue; headache; increased appetite; increased saliva production; indigestion; light-headedness; mild sore throat; nausea; restlessness; runny or stuffy nose; stomach pain or upset; trouble sleeping; vomiting; weight gain. Seek medical attention right away if any of these SEVERE side effects occur: Severe allergic reactions (rash; hives; itching; difficulty breathing or swallowing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); abnormal thoughts; confusion; drooling; fainting; fast, slow, or irregular heartbeat; fever, chills, or persistent sore throat; inability to control urination; increased sweating; new or worsening mental or mood changes (eg, aggression, agitation, depression, severe anxiety); one-sided weakness; seizures; severe dizziness; stiff or rigid muscles; suicidal thoughts or attempts; symptoms of high blood sugar (eg, increased thirst, hunger, or urination; unusual weakness); tremor; trouble concentrating, speaking, or swallowing; trouble sitting still; trouble walking or standing; uncontrolled muscle movements (eg, arm or leg movements, twitching of the face or tongue, jerking or twisting); unusual bruising; vision changes. This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the https://dailymed.nlm.nih.gov/dailymed/archives/fdaDrugInfo.cfm?archiveid=6666
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