Milnacipran

Milnacipran is a prescription medication used to treat fibromyalgia. Milnacipran belongs to a group of drugs called serotonin and norepinephrine reuptake inhibitors (SNRIs), which work by stopping the movement of pain signals in the brain.

This medication comes in tablet form and is usually taken 2 times a day, with or without food.

Common side effects include nausea, constipation, and headache. Milnacipran can also cause dizziness or drowsiness. Do not drive or operate heavy machinery until you know how milnacipran affects you.

Milnacipran is a prescription medication used to treat fibromyalgia.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Milnacipran may be found in some form under the following brand names:

• Savella

Serious side effects have been reported with milnacipran. See the “Drug Precautions” section.

Common side effects include the following:

• nausea
• headache
• constipation
• dizziness
• insomnia
• hot flush
• sweating
• vomiting
• palpitations
• increased heart rate
• dry mouth
• high blood pressure

This is not a complete list of milnacipran side effects. Ask your doctor or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• alcohol
• medications that block the enzyme CYP3A4 such as some macrolide antibiotics (clarithromycin, telithromycin), some HIV protease inhibitors (indinavir, nelfinavir, ritonavir, saquinavir), some HCV protease inhibitors (boceprevir, telaprevir), some azole antifungals (ketoconazole, itraconazole, posaconazole, voriconazole), conivaptan (Vaprisol), delavirdine (Rescriptor), and nefazodone (Serzone)
• monoamine oxidase inhibitors such as tranylcypromine (Parnate), phenelzine (Nardil), selegiline (Eldepryl, Zelapar), isocarboxazid (Marplan), and rasagiline (Azilect)
• triptans such as sumatriptan (Imitrex, Treximet), eletriptan (Relpax), almotriptan (Axert), frovatriptan (Frova), naratriptan (Amerge), rizatriptan (Maxalt), and zolmitriptan (Zomig)
• aspirin and other NSAIDs (non-steroidal anti-inflammatory drugs) such as
  • celecoxib (Celebrex)
  • diclofenac (Cambia, Cataflam, Flector, Voltaren, Zipsor and others)
  • etodolac (Lodine)
  • ibuprofen (Advil, Motrin, Nuprin)
  • indomethacin (Indocin, Indocin SR)
  • ketoprofen (Orudis, Actron, Oruvail)
  • ketorolac (Toradol)
  • meloxicam (Mobic)
  • nabumetone (Relafen)
  • naproxen (Naprosyn)
  • naproxen sodium (Aleve, Anaprox, Naprelan)
  • oxaprozin (Daypro)
  • piroxicam (Feldene)
• antidepressants such as citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), desvenlafaxine (Pristiq), nefazodone (Serzone), paroxetine (Paxil, Pexeva), sertraline (Zoloft), venlafaxine (Effexor)
• tricyclic antidepressants such as trimipramine (Surmontil), amitriptyline (Elavil), nortriptyline (Pamelor, Aventyl), protriptyline (Vivactil), and clomipramine (Anafranil)
• warfarin (Jantoven, Coumadin)
• linezolid (Zyvox)
• tramadol (Ultram)
• digoxin (Lanoxin)
• clonidine (Catapres)
• fentanyl (Actiq, Fentora, Abstral, Onsolis)
• sibutramine (Meridia)
• methylene blue
• norepinephrine
• epinephrine
• St. John’s wort

This is not a complete list of milnacipran drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with milnacipran including the following:

• behavioral changes. All patients being treated with milnacipran should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the first few months of treatment and when increasing or decreasing the dose. Consider changing the therapeutic regimen, including possibly discontinuing the medication, in patients who show symptoms of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia, hypomania, mania, or suicidality that are severe, or abrupt in onset. Families and caregivers of patients should be alerted about the need to monitor patients daily. In addition,
  • pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is very important when an antidepressant medicine is started or when the dose is changed.
  • call the healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings.
  • keep all follow-up visits with the healthcare provider as scheduled. Call the healthcare provider between visits as needed, especially if you have concerns about symptoms.
• serotonin syndrome. The development of a potentially life-threatening serotonin syndrome has been reported with SNRIs and SSRIs both when taken alone, but especially when co-administered with other serotonergic agents (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, and St. John’s wort) and with drugs that impair metabolism of serotonin (in particular, MAOIs, both those intended to treat psychiatric disorders and also others, such as linezolid and methylene blue). Symptoms of serotonin syndrome may include mental status changes (agitation, hallucinations, delirium, and coma), autonomic instability (tachycardia, labile blood pressure, diaphoresis, flushing, hyperthermia), neuromuscular symptoms (tremor, rigidity, myoclonus, hyperreflexia, incoordination), seizures, and/or gastrointestinal symptoms. If symptoms of serotonin syndrome occur, discontinue milnacipran and initiate supportive treatment. If concomitant use of milnacipran with other serotonergic drugs is clinically warranted, patients should be aware of a potential increased risk for serotonin syndrome, particularly during treatment initiation and dose increases.
• discontinuation symptoms. Do not stop milnacipran without first talking to your healthcare provider. Stopping milnacipran suddenly may cause serious symptoms including:
  • anxiety
  • irritability
  • high or low mood
  • feeling restless or sleepy
  • headache
  • sweating
  • nausea
  • dizziness
  • electric shock-like sensations
  • tremor
  • confusion
• increased blood pressure. SNRIs, including milnacipran, have been associated with increases in blood pressure. Blood pressure should be measured prior to initiating treatment and periodically throughout milnacipran treatment. Pre-existing hypertension should be controlled before initiating treatment with milnacipran. For patients who experience a sustained increase in blood pressure, discontinuation or other appropriate medical intervention should be considered.
• abnormal bleeding or bruising. Milnacipran may increase your risk of bleeding or bruising, especially if you take the blood thinner warfarin (Coumadin, Jantoven), a nonsteroidal anti-inflammatory drug (NSAID), or aspirin.
• glaucoma. This is a condition of increased eye pressure.
• urinary retention and hesitation. This is a condition where you have difficulty urinating or are unable to urinate.
• seizures or convulsions. Reports have been noted with milnacipran therapy. Use milnacipran with caution if you have a history of seizure disorder.
• hypomania (manic episodes). Symptoms of manic episodes include:
  • greatly increased energy
  • severe problems sleeping
  • racing thoughts
  • reckless behavior
  • unusually grand ideas
  • excessive happiness or irritability
  • talking more or faster than usual
• discontinuation symptoms. Do not stop milnacipran without first talking to your healthcare provider. Stopping milnacipran suddenly may cause serious symptoms including:
  • anxiety
  • irritability
  • high or low mood
  • feeling restless or sleepy
  • headache
  • sweating
  • nausea
  • dizziness
  • electric shock-like sensations
  • tremor
  • confusion
• low levels of salt (sodium) in your blood. Symptoms of this may include: headache, difficulty concentrating, memory changes, confusion, weakness, and unsteadiness on your feet. Symptoms of severe or sudden cases of low salt levels in your blood may include: hallucinations (seeing or hearing things that are not real), fainting, seizures, and coma. If not treated, severe low sodium levels could cause death.

Do not take milnacipran if you:

• are allergic to milnacipran or to any of its ingredients
• if you are taking an MAOIs
• if you are about to start taking an MAOI
• are within 14 days of stopping an MAOI and wish to start taking milnacipran
• are taking linezolid (Zyvox) or methylene blue
• have uncontrolled narrow-angle glaucoma

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of milnacipran, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking milnacipran, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to milnacipran or to any of its ingredients
• have high blood pressure
• have heart problems
• have or had bleeding problems
• have glaucoma
• have or had urinary retention or problems urinating
• have mania or bipolar disorder (manic depression)
• have or had seizures or convulsions
• have low salt (sodium) levels in your blood
• have kidney problems
• drink alcohol
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Milnacipran falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. There are no well-controlled studies that have been done in humans with milnacipran, though. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your doctor if you are breastfeeding or plan to breastfeed.

Milnacipran has been detected in human breast milk. Because of the possibility for adverse reactions in nursing infants from milnacipran, a choice should be made whether to stop nursing or to stop use of this medication. The importance of the drug to the mother should be considered.

• Take milnacipran exactly as your healthcare provider tells you to take it.
• Take milnacipran at about the same time each day.
• Your healthcare provider may need to change the dose of milnacipran until it is the right dose for you.
• Do not start or stop taking milnacipran without talking to your healthcare provider first. Stopping milnacipran suddenly can cause side effects. Milnacipran may be taken with or without food.
• Alcohol may intensify some of the side effects of this medication.
• If you miss a dose of milnacipran, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of milnacipran at the same time.

Take milnacipran exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The milnacipran dose your doctor recommends will be based on the following:

• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your kidney function

The recommended dose range for milnacipran is 100 mg per day (split into 50 mg doses taken twice daily) to 200 mg per day (split into 100 mg doses taken twice daily). Your doctor may want to start you out on a lower dose and increase it to achieve a desired response.

If you take too much milnacipran, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store milnacipran between 15°C and 30°C (between 59°F and 86°F).
• Keep this and all medicines out of the reach of children.

Increased risk of suicidal ideation, thinking, and behavior in children, adolescents, and young adults taking antidepressants for major depressive disorder (MDD) and other psychiatric disorders. Milnacipran is not approved for use in pediatric patients.