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Parlodel(甲磺酸溴隐亭胶囊和片剂)

2010-12-14 14:55:44  作者:新特药房  来源:中国新特药网天津分站  浏览次数:162  文字大小:【】【】【
简介: 【通用名称】甲磺酸溴隐亭 BROMOCRIPTINE说明【适应症】自发性和脑炎后帕金森氏病,可单独使用或合并其它抗帕金森氏病药。治疗与催乳素有关的生殖系统功能异常,分娩后,自发性,肿瘤性、药物引起的闭 ...

【通用名称】甲磺酸溴隐亭

BROMOCRIPTINE说明
【适应症】自发性和脑炎后帕金森氏病,可单独使用或合并其它抗帕金森氏病药。治疗与催乳素有关的生殖系统功能异常,分娩后,自发性,肿瘤性、药物引起的闭经。催乳激素引起的月经紊乱、不孕和继发性闭经,排卵减少。抑制泌乳,预防分娩后和早产后的泌乳。产后的乳房充血,催乳激素引起的特殊的乳房触痛、乳房胀痛和烦躁不安。催乳激素引起的雄性激素低下症,如阳痿和精子减少引起的不育。肢端肥大症的辅助治疗。抗震颤麻痹:本品显效快,持续时间长。

【用法用量】溴隐亭应在用餐中服用。为了得到最佳耐受性,治疗应从低剂量开始,每天1.25毫克(半片)。第一周推荐晚间服药。日剂量可每周增加1.25mg,直至达到最小有效剂量,每日剂量通常分2—3次服用。如果在6—8周内未达到满意的疗效,可尝试每周增加剂量2.5mg/日。在剂量调整阶段,一旦发生不良反应,应减少其每天用量,至少一周。一旦不良反应消失,则应尽快再次加量。对于使用左旋多巴治疗而出现运动障碍的病人,在使用溴隐亭前应减少左旋多巴的用量。当获得满意疗效时,则可逐步减少左旋多巴的剂量。在某些患者中,左旋多巴甚至可以完全停用。溴隐亭于单独或合并其他药物使用时,其剂量通常为每天10—40mg。某些患者可能需要更高剂量。

【不良反应】治疗的最初几天,有些患者可能出现恶心,极少数患者可能出现眩晕、疲乏、呕吐或腹泻,但不致于严重到需要停药。溴隐亭可引起直立性低血压,个别病人会出现虚脱,因此,病人特别是在治疗最初几天应监测血压。如发生此类症状可对症治疗。下列不良反应亦有报道:鼻塞、便秘、嗜睡、头痛,少数病人偶有精神紊乱、精神运动性兴奋、幻觉、运动障碍、口干、下肢痉挛、肌内疼痛、皮肤过敏反应及脱发。这些副作用大多与剂量有关,通常降低剂量即可控制。曾有报道,长期治疗期间少数病人出现感觉障碍,周围动脉障碍(如肢体末稍缺血)以及由寒冷引起的手指,脚趾可逆性苍白,特别是患雷诺氏病的病人。偶有报道发生动脉痉挛和坏疽。曾有报道,使用溴隐亭后出现心绞痛加重,心动过缓及短暂的心律失常(束支传导阻滞)。少数病例在使用溴隐亭抑制分娩后泌乳时发生高血压、心肌梗塞、癫痫发作、中风及精神障碍已有记载,长期治疗(数年)且每日剂量在30mg或以上的患者出现腹膜后和胸膜纤维化,但仅限于接受溴隐亭治疗帕金森氏病的患者。

【禁忌】已知对本品任何成份或其它麦角碱过敏者。控制不满意的高血压、妊娠期(包括子痫。子痫前期及妊娠高血压),分娩后及产褥期高血压状态。冠心病及其他严重的心血管疾病。有严重精神障碍的症状和/或病史的病人。有脑血管意外,动脉阻塞性疾病、Raynaud’s征,尼古丁成瘾病史者。

【注意事项】概况:溴隐亭治疗可能会恢复生育能力,不愿生育的育龄妇女,服用溴隐亭期间须使用可靠的避孕措施。一旦出现血管痉挛或血栓形成的症状,持续头痛或其他中枢神经系统毒性表现,治疗应立即终止。已有胃肠道出血和胃溃疡的报道。发生类似反应时,溴隐亭应停用。对于有活动性溃疡病或溃疡病史的患者,接受溴隐亭治疗过程中,应严密监测。偶有患者在治疗头几天会出现低血压,并可能使精神警觉性下降。因此在驾驶或操作机器时应特别谨慎。分娩后和产褥期使用:已有报道,少数分娩后妇女接受溴隐亭抑制泌乳治疗时出现严重不良事件,包括高血压、心肌梗塞、癫痫发生、中风及精神障碍。其中一些病人在严重头痛或短暂视觉悟障碍后发生癫痫或中风,尽管尚无因果关系的结论性证据,但对这些病人或接受溴隐亭治疗其它适应证的患者进行定期血压监测是必需的。一旦出现高血压,严重的、持续的或逐渐加重的头痛(伴或不伴视觉障碍)或中枢神经系统毒性表现,治疗应立即终止,并即刻对病人病情进行判定。对近期或正在服用可影响血压的药物,例如:血管收缩药(如拟交感神经药)或麦角碱类,包括麦角新碱或甲基麦角新碱的患者。使用溴隐亭时应特别小心。尽管溴隐亭与这些药物间的相互作用没有证据,但不推荐分娩后和产褥期的妇女合并使用。

【贮藏】避光保存在25℃以下。

【-原产地英文商品名-】BROMOCRIPTINE(PARLODEL GENERIC)2.5mg/tab 100tabs/box
【-原产地英文药品名-】BROMOCRIPTINE MESYLATE中文参考商品译名】
【-溴隐亭(PARLODEL仿制药)2.5毫克/片 100片/盒
【-中文参考药品译名-】甲磺酸溴隐亭
【-临床试验期】完成
【-中文适应病症参考-】帕金森氏病
【-中文适应病症参考-】与催乳素有关的生殖系统功能异常

Parlodel
Generic name: Bromocriptine mesylate
Brand names: Parlodel

Why is Parlodel prescribed?
Parlodel inhibits the secretion of the hormone prolactin from the pituitary gland. It also mimics the action of dopamine, a chemical lacking in the brain of someone with Parkinson's disease. It is used to treat a variety of medical conditions, including:
Infertility in some women
Menstrual problems such as the abnormal stoppage or absence of flow, with or without excessive production of milk
Growth hormone overproduction leading to acromegaly, a condition characterized by an abnormally large skull, jaw, hands, and feet
Parkinson's disease
Pituitary gland tumors

Some doctors also prescribe Parlodel to treat cocaine addiction, the eye condition known as glaucoma, erection problems in certain men, restless leg syndrome, and a dangerous reaction to major tranquilizers called neuroleptic malignant syndrome.

Most important fact about Parlodel
Notify your doctor immediately if you develop a severe headache that does not let up or continues to get worse. It could be a warning of the possibility of other dangerous reactions, including seizure, stroke, or heart attack.

How should you take Parlodel?
Parlodel should be taken with food. Take the first dose while lying down. You may faint or become dizzy due to lower blood pressure, especially following the first dose.

You may not feel the full effect of Parlodel for a few weeks. Do not stop taking Parlodel without first checking with your doctor.

--If you miss a dose...
Take it as soon as you remember if it is within 4 hours of the scheduled time. Otherwise, skip the dose you missed and go back to your regular schedule. Do not take 2 doses at once.

--Storage instructions...
information...
Store at room temperature in a tightly closed, light-resistant container.

Parlodel side effects
The number and severity of side effects depend on many factors, including the condition being treated, dosage, and duration of treatment. Side effects cannot be anticipated. If any develop or change in intensity, inform your doctor as soon as possible. Only your doctor can determine if it is safe for you to continue taking Parlodel.

Side effects may include:
Abdominal cramps or discomfort, confusion, constipation, depression, diarrhea, dizziness, drop in blood pressure, drowsiness, dry mouth, fainting, fatigue, hallucinations (particularly in Parkinson's patients), headache, inability to sleep, indigestion, light-headedness, loss of appetite, loss of coordination, nasal congestion, nausea, shortness of breath, uncontrolled body movement, vertigo, visual disturbance, vomiting, weakness

Some of the above side effects are also symptoms of Parkinson's disease.

Why should Parlodel not be prescribed?
You should not be using Parlodel if you have high blood pressure that is not under control or if you are pregnant (unless your doctor finds it medically necessary). You should also not take Parlodel if you are allergic to it or to any other drugs containing ergot alkaloids, such as Bellergal-S and Cafergot.

Women who have severe heart conditions should not use Parlodel after they have had a baby unless it is medically necessary.

Special warnings about Parlodel
Your doctor will check your pituitary gland thoroughly before you are treated with Parlodel.

Since Parlodel can restore fertility and pregnancy can result, women who do not want to become pregnant should use a "barrier" method of contraception during treatment with Parlodel. Do not use the "Pill" or oral contraceptives, as they may prevent Parlodel from working properly.

Notify your doctor immediately if you become pregnant while you are being treated with Parlodel.

If you have kidney or liver disease, consult your doctor before taking Parlodel.

If you are being treated with Parlodel for endocrine problems related to a tumor and stop taking Parlodel, the tumor may grow back rapidly.

Use Parlodel with caution if you have had mental problems, any disease of the heart and circulatory system, peptic ulcer, or bleeding in the stomach and intestines.

If you are being treated for Parkinson's disease, the use of Parlodel alone or Parlodel with levodopa may cause hallucinations, confusion, and low blood pressure. If this happens, notify your doctor immediately.

If you have an abnormal heartbeat rhythm caused by a previous heart attack, consult your doctor before taking Parlodel.

If you experience a persistent watery nasal discharge while taking Parlodel, notify your doctor.

This drug may impair your ability to drive a car or operate potentially dangerous machinery. Do not participate in any activities that require full alertness if you are unsure about your ability to do so.

Your first dose of Parlodel may cause dizziness. If so, check with your doctor.

Possible food and drug interactions when taking Parlodel
Combining alcohol with Parlodel can cause blurred vision, chest pain, pounding heartbeat, throbbing headache, confusion, and other problems. Do not drink alcoholic beverages while taking Parlodel.

Certain drugs used for psychotic conditions, including Thorazine and Haldol, inhibit the action of Parlodel. It is important that you consult your doctor before taking these drugs while on Parlodel therapy.

Other drugs that may interact with Parlodel include:
Blood pressure-lowering drugs such as Aldomet and Catapres
Metoclopramide (Reglan)
Oral contraceptives
Other ergot derivatives such as Hydergine
Pimozide (Orap)

Special information if you are pregnant or breastfeeding
The use of Parlodel during pregnancy should be discussed thoroughly with your doctor. If Parlodel is essential to your treatment, your doctor will carefully monitor you throughout your pregnancy.

You should not take Parlodel while breastfeeding.

Recommended dosage for Parlodel
ADULTS
Parlodel is available as 2.5-milligram tablets and 5-milligram capsules. Dosage information given is for 2.5-milligram tablets.

Excess Prolactin Hormone
If you are being treated for conditions associated with excess prolactin, such as menstrual problems, with or without excessive milk production, infertility, or pituitary gland tumors, the usual starting dose is one-half to 1 tablet daily. Your doctor may add a tablet every 3 to 7 days, until the treatment works. The usual longer term dose is 5 to 7.5 milligrams per day and ranges from 2.5 to 15 milligrams per day.

Growth Hormone Overproduction
Treatment for the overproduction of growth hormones is usually one-half to 1 tablet with food at bedtime for 3 days. Your doctor may add one-half to 1 tablet every 3 to 7 days. The usual treatment dose varies from 20 to 30 milligrams per day. The dose should not exceed 100 milligrams per day. Your doctor will do a monthly re-evaluation.

Parkinson's Disease
Parlodel taken in combination with levodopa may provide additional treatment benefits if you are currently taking high doses of levodopa, are beginning to develop a tolerance to levodopa, or are experiencing "end of dose failure" on levodopa therapy.

The usual starting dose of Parlodel is one-half tablet twice a day with meals. Your dose will be monitored by your doctor at 2-week intervals. If necessary, your doctor may increase the dose every 14 to 28 days by 1 tablet per day.

CHILDREN
The safety and effectiveness of Parlodel have not been established in children.

Overdosage
Any medication taken in excess can have serious consequences. If you suspect an overdose of Parlodel, contact your doctor immediately or seek other medical attention.

Symptoms of Parlodel overdose may include:
Confusion, constipation, delusions, dizziness, drowsiness, feeling unwell, hallucinations, lethargy, nausea, pallor, severely low blood pressure, sweating, vomiting, yawning repeatedly

英文药名: Parlodel (Bromocriptine Mesylate Capsules)

中文药名: 甲磺酸溴隐亭胶囊

【别名】甲磺酸溴隐亭, 麦角克碱, 溴麦角环太, 溴麦亭, 抑乳亭, 溴麦角隐亭
【外文名】Bromocriptine
【商品名】Parlodel
适应症

可用于:
1.分娩后,自发性,肿瘤性、药物引起的闭经。
2.催乳激素引起的月经紊乱、不孕和继发性闭经,排卵减少。
3.抑制泌乳,预防分娩后和早产后的泌乳。
4.产后的乳房充血,催乳激素引起的特殊的乳房触痛、乳房胀痛和烦躁不安。
5.催乳激素引起的雄性激素低下症,如阳萎和精子减少引起的不育。
6.肢端肥症的辅助治疗。
7.抗震颤麻痹:本品显效快,持续时间长。
用法用量

1.乳溢或催乳激素引起的闭经,月经病和低生育力,开始时 1次0.125mg,1日2~3次,如确系剂量不足,可逐渐增至1次0.25mg,1日2~3次,饭后服用。连续治疗至泌乳停止。对于闭经、功能性月经病和低生育力者,治疗要持续到月经恢复正常。如果需要,治疗可延续至几 周期,以防复发。
2.抑制泌乳:1次0.25mg,1日2次,早晚与食物共服,连续用药14日。应在分娩后服用。停药后,偶有少量的乳分泌2~3日,以同样剂量继续服用 日后就可停止。
3.分娩后的乳房充血:轻者可口服1次0.25mg,如需要又没停止泌乳则12小时后可重复1次。
4.催乳激素引起的雄性激素低下症:1日5~10mg。
5.肢端肥大症:开始1日2.5mg,经7~14日后根据临床反应每日可逐渐增至10~20mg,分4次食物同服。
6.震颤麻痹:开始每次1.25mg,1日2次,2周内逐渐增加剂量,从14~28日每日增加2.5mg,以找到最佳疗效的最小剂量。
任何疑问,请遵医嘱!
注意事项

1.如与左旋多巴合用可提高疗效,但应用本品10mg,需减少左旋多巴剂量12.5%。
2.主要不良反应有恶心、头痛、眩晕、疲倦、腹痛、呕吐等,也可出现低血压、多动症、运动障碍及精神症状。不良反应的发生率约为68%。连续用药后可减轻,与食物同服也可减轻。约有3%需中止用药。
3.用于治疗闭经或乳溢,可产生短期疗效,不宜久用。治疗期间可以妊娠,如需计划生育,应使用不含雌激素的避孕药或其他措施。
4.对麦角生物碱过敏者和心脏病、周围血管性疾病、妇女妊娠期禁用。
5.忌与降压药、吩噻嗪类或H2受体阻滞剂合用。
规格

胶囊剂:2.5mg, 5mg。

责任编辑:admin


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