英文药名: Savella(Milnacipran Tablets)

中文药名: 米那普伦片

药品介绍

Forest与Cypress宣布美国FDA已批准米那普伦盐酸盐(milnacipran Hcl，Savella)用于治疗纤维肌痛。纤维肌痛是一种以全身性疼痛与疲劳为主的疾病。根据美国风湿病学会估计大约有6百万美国人患有纤维肌痛。
虽然对于本品改善纤维肌痛症状的确切机制尚不明确，但一些研究者认为：某些脑部神经递质的异常可能是纤维肌痛的关键所在。本品可能是通过对5-羟色胺与去甲肾上腺素(NE)再摄取的双重抑制(在体外对NE再摄取抑制的选择性更强)来改善纤维肌痛症状。
在美国进行的2项关键性III期临床研究中，共纳入2084例患者，其中1460例患者接受本品治疗，624例患者则使用安慰剂。结果显示：与安慰剂相比，本品(剂量为100mg/天、200mg/天)能同时显著改善疼痛(视觉模拟评分)、患者整体评价(患者对变化的整体印象评分)与生理功能 (Short Form-36 总体生理健康)。预期，本品将于2009年3月上市。
本品的安全性与耐受性良好。最常见的不良反应为恶心。其他常见不良反应包括便秘、潮热、多汗、呕吐、心悸、心率上升、口干与高血压。本品所报道的大多数不良反应为轻微至中等程度。

SAVELLA

Generic Name for SAVELLA

Milnacipran HCl 12.5mg, 25mg, 50mg, 100mg; tabs.

Legal Classification:

Rx

Pharmacological Class for SAVELLA

Serotonin and norepinephrine reuptake inhibitor (SNRI).

Manufacturer of SAVELLA

Forest Laboratories and Cypress Bioscience

Indications for SAVELLA

Fibromyalgia.

Adult dose for SAVELLA

May take with food. Titrate dose. Day 1: 12.5mg once. Days 2–3: 12.5mg twice daily. Days 4–7: 25mg twice daily. After Day 7: 50mg twice daily (recommended dose); max 100mg twice daily. Severe renal impairment (CrCl 5–29mL/min): maintenance 25mg twice daily; max 50mg twice daily. Withdraw gradually.

Children's dosing for SAVELLA

<17yrs: not recommended.

Contraindications for SAVELLA

Allow at least 14 days after MAOI discontinuance before starting milnacipran; allow at least 5 days after discontinuing milnacipran before starting an MAOI. Uncontrolled narrow-angle glaucoma.

Warnings/Precautions for SAVELLA

Substantial alcohol abuse, chronic liver disease, end stage renal disease: not recommended. Hypertension. Heart disease. Arrhythmias. Monitor BP and heart rate; reduce dose or discontinue if elevated BP persists. Controlled narrow-angle glaucoma. Seizure disorder. Suicidal ideation (monitor). Mania. Severe hepatic dysfunction. Discontinue if liver dysfunction develops. Volume depleted. GU obstruction. Risk of bleeding. Reevaluate periodically. Write Rx for smallest practical amount. Pregnancy (Cat.C; see literature for effects on fetus). Labor & delivery, nursing mothers: not recommended.

Interactions for SAVELLA

See Contraindications. Concomitant serotonin precursors (eg, tryptophan), serotonergics (eg, triptans, tramadol): not recommended. Avoid IV digoxin (postural hypotension, tachycardia). May potentiate anticoagulants (eg, aspirin, NSAIDs, coumadin). May antagonize certain antihypertensives (eg, clonidine). Serotonin syndrome with SSRIs, SNRIs, lithium, tramadol, triptans (monitor). Caution with other CNS-active drugs or those that can increase BP. Arrhythmias, hypertension with epinephrine, norepinephrine.

Adverse Reactions for SAVELLA

GI upset, headache, constipation, dizziness, insomnia, hot flush, hyperhidrosis, palpitations, increased heart rate, dry mouth, hypertension; rare: GU effects in men; hyponatremia (esp. in elderly); serotonin syndrome; seizure.

How is SAVELLA supplied?

Tabs 12.5mg—60; 25mg, 50mg, 100mg—60, 180; Titration Pack (4 week supply)—1

Related Disease:

Fibromyalgia

 

Brand Names:Savella
Generic name:milnacipran
Pregnancy Category:C
What is Savella?
Savella (milnacipran HCI) is a prescription drug that is in a class of medications known as selective serotonin and norepinephrine reuptake inhibitors, or SNRIs. Savella is used to increase the amount and effectiveness of neurotransmitters such as serotonin and norepinephrine, which are used to communicate between brain cells. Savella (milnacipran) prescribed by your doctor is a laboratory-synthesized form of these neurotransmitters.

Savella comes in a tablet form that is taken orally, usually twice per day. Milnacipran medications may be taken with or without food; taking the drug with food may reduce the occurrence of common Savella side effects, such as nausea. For best results, always take Savella exactly as directed by your doctor and at the same time each day.

Savella Uses
The Food and Drug Administration approved Savella (milnacipran) for the treatment of fibromyalgia in 2009. Savella works best for fibromyalgia patients age 18 and older; it is not usually recommended for children or young teenagers. In clinical trials completed before the drug received FDA approval, a large number of patients using Savella reported a 30 percent or greater reduction in the severity or occurrence of fibromyalgia-related conditions such as chronic pain, fatigue, muscle stiffness and tiredness, and difficulty falling or staying asleep.

Although the Food and Drug Administration has not approved Savella for the treatment of major depressive disorders, milnacipran has been used to treat depression in French patients since 1996. In fact, milnacipran is used as an antidepressant in more than 45 countries around the world, including Finland, Japan, France, Austria, Bulgaria, Mexico, Portugal and Russia. Only time, and further clinical trials, will tell whether the FDA will approve milnacipran as a treatment for depression and other mood disorders in American patients.

What to Expect
Patients are started on a low dose of Savella, and based on their reactions to the medication, the dose can be increased during the first week of treatment.

Some patients have reported pain reduction in as little as the first week of stable doses; however, it can take several weeks to feel the beneficial effects of Savella. Patients should continue taking the prescribed dose even if they do not experience immediate improvement.

Risk Information
Savella also carries the same risks as antidepressant medications. Savella is not approved for individuals under the age of 18 because of the increased risk of suicidal thoughts or actions in children, teenagers, and young adults.

Patients on Savella should alert their doctor if they experience unusual changes in behavior, suicidal thoughts, anxiety, agitation, panic attacks, difficulty sleeping, irritability, hostility, aggressiveness, impulsivity, restlessness, or extreme hyperactivity.

Before Taking Savella
You should not take Savella if you are currently taking or have recently taken a monoamine oxidase inhibitor (MAOI) or have uncontrolled narrow-angle glaucoma.

Before taking Savella, you should tell your healthcare provider if you have hypertension, heart rhythm problems, any heart diseases, liver problems, substantial alcohol use, kidney problems, manic episodes, seizure disorders, bleeding disorders, or glaucoma. Also tell your doctor if you are taking medication for a psychiatric or neurological condition, NSAID pain relievers, aspirin, warfarin, blood thinners, or diuretics.

Savella is a viable option for any individuals suffering from Fibromyalgia. If you feel that Savella could help relieve your chronic pain, talk to your doctor to see if Savella is right for you.

More information on Savella
Savella Side Effects
Patients who are considering taking Savella, also known as milnacipran, for the treatment of fibromyalgia should be aware of the many side effects and potential drug interactions associated with the use of this drug. Nausea, constipation and increased sweating are the most common Savella side effects; these side effects may fade as your body becomes used to the medication. More serious Savella side effects, such as suicidal thoughts and behaviors, are concerning for some users.

Savella Drug Interactions
Savella is not a suitable treatment option for everyone. Patients who are taking certain other prescription drugs, such as Monoamine Oxidase Inhibitors (MAOIs), may have an increased risk for negative drug interactions.

Savella Dosage
Savella is a drug that is taken orally and is offered only in tablet form. Dosages range from 12.5mg up to 100mg depending on the patient. It is important to talk to your doctor if you feel there is a need to increase the medication or if there are any side effects that develop when increasing the treatment.

规格：25mg  50mg