milnacipran

Generic Name: milnacipran (mil NA si pran)
Brand Name: Savella

What is milnacipran?

Milnacipran affects certain chemicals in the brain called neurotransmitters. An abnormality in these chemicals is thought to be related to fibromyalgia. Milnacipran is not used to treat depression but how it works in the body is similar to how some antidepressants work.

Milnacipran is used to treat a chronic pain disorder called fibromyalgia.

Milnacipran may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about milnacipran?

Do not take milnacipran together with thioridazine (Mellaril), or a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate). You must wait at least 14 days after stopping an MAOI before you can take milnacipran. After you stop taking milnacipran, you must wait at least 5 days before you start taking an MAOI.

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You may have thoughts about suicide when you first start taking this medication, especially if you are younger than 24 years old. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Avoid drinking alcohol. It may increase your risk of liver damage.

Tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by milnacipran.

Milnacipran may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

What should I discuss with my healthcare provider before taking milnacipran?

Do not use milnacipran together with thioridazine (Mellaril), or an MAO inhibitor such as isocarboxazid (Marplan), tranylcypromine (Parnate), phenelzine (Nardil), rasagiline (Azilect), or selegiline (Eldepryl, Emsam). Serious and sometimes fatal reactions can occur when these medicines are taken with milnacipran. You must wait at least 14 days after stopping an MAO inhibitor before you can take milnacipran. After you stop taking milnacipran, you must wait at least 5 days before you start taking an MAOI.

You should not use this medication if you are allergic to milnacipran, or if you have untreated or uncontrolled narrow-angle glaucoma.

If you have any of these other conditions, you may need a dose adjustment or special tests:

  • liver or kidney disease;

  • heart disease, high blood pressure, heart rhythm disorder;

  • seizures or epilepsy;

  • glaucoma;

  • a bleeding or blood clotting disorder such as hemophilia;

  • enlarged prostate, urination problems;

  • bipolar disorder (manic depression);

  • a history of heavy alcohol use;

  • a history of suicidal thoughts or actions; or

  • if you are allergic to aspirin or yellow food dye.

You may have thoughts about suicide while taking this medication, especially if you are younger than 24 years old. Tell your doctor if you have new or worsening depression or suicidal thoughts during the first several weeks of treatment, or whenever your dose is changed.

Your family or other caregivers should also be alert to changes in your mood or symptoms. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.

FDA pregnancy category C. It is not known whether milnacipran will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether milnacipran passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Older adults may be more sensitive to the side effects of this medication.

Do not give milnacipran to anyone younger than 17 years old without the advice of a doctor.

How should I take milnacipran?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results.

Take the medicine with food if it upsets your stomach.

Your blood pressure will need to be checked often. Visit your doctor regularly.

Do not stop using milnacipran suddenly, or you could have unpleasant withdrawal symptoms such as dizziness, anxiety, feeling irritable, confusion, headache, ringing in your ears, and sleep problems. Talk to your doctor about how to avoid withdrawal symptoms when you stop using milnacipran.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include extreme drowsiness, slow heart rate, weak pulse, fainting, and slow breathing (breathing may stop).

What should I avoid while taking milnacipran?

Avoid drinking alcohol. It may increase your risk of liver damage.

Milnacipran may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Milnacipran side effects

Get emergency medical help if you have any of these signs of an allergic reaction: skin rash or hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have any of these serious side effects:

  • pounding heartbeats or fluttering in your chest;

  • painful or difficult urination;

  • easy bruising or bleeding, nosebleeds, bloody or tarry stools, coughing up blood;

  • severe weakness, seizure (convulsions);

  • chills or goose bumps, memory problems, trouble concentrating,

  • agitation, hallucinations, fast heart rate, overactive reflexes, nausea, vomiting, diarrhea, loss of coordination, fainting;

  • very stiff (rigid) muscles, high fever, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out;

  • high blood pressure (severe headache, blurred vision, buzzing in your ears, chest pain, shortness of breath, uneven heartbeats); or

  • stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

  • headache;

  • dizziness, drowsiness, tired feeling;

  • swelling in your hands or feet;

  • constipation, upset stomach, bloating;

  • dry mouth;

  • sleep problems (insomnia);

  • hot flashes, sweating;

  • weight changes; or

  • decreased sex drive, impotence, or difficulty having an orgasm.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

Milnacipran dosing information

Usual Adult Dose for Fibromyalgia:

Dosing should be titrated according to the following schedule:
Initial dose on day 1: 12.5 mg once
Days 2 and 3: 12.5 mg twice daily
Days 4 through 7: 25 mg twice daily
After day 7: 50 mg twice daily

Recommended maintenance dose: 50 mg twice daily

Based on individual patient response, the dose may be increased to 100 mg twice daily. Doses above 200 mg/day have not been studied.

Milnacipran should be tapered and not abruptly discontinued after extended use.

Milnacipran may be given orally with or without food. However, taking milnacipran with food may improve the tolerability of the drug.

Usual Pediatric Dose for Fibromyalgia:

17 years and older:
Dosing should be titrated according to the following schedule:
Initial dose on day 1: 12.5 mg once
Days 2 and 3: 12.5 mg twice daily
Days 4 through 7: 25 mg twice daily
After day 7: 50 mg twice daily

Recommended maintenance dose: 50 mg twice daily

Based on individual patient response, the dose may be increased to 100 mg twice daily. Doses above 200 mg/day have not been studied.

Milnacipran should be tapered and not abruptly discontinued after extended use.

Milnacipran may be given orally with or without food. However, taking milnacipran with food may improve the tolerability of the drug.

What other drugs will affect milnacipran?

Before using milnacipran, tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by milnacipran.

Ask your doctor before taking any medicine for pain, arthritis, fever, or swelling. This includes aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn), diclofenac (Voltaren), indomethacin, piroxicam (Feldene), nabumetone (Relafen), etodolac (Lodine), and others. Taking any of these drugs with milnacipran may cause you to bruise or bleed easily.

Tell your doctor about all other medications you use, especially:

  • a blood thinner such as warfarin (Coumadin);

  • clonidine (Catapres, Clorpres);

  • a diuretic (water pill);

  • digoxin (digitalis, Lanoxin);

  • epinephrine (Epi-Pen);

  • lithium (Lithobid, Eskalith);

  • tramadol (Ultram);

  • tryptophan (sometimes called L-tryptophan);

  • medicine to treat a psychiatric disorder;

  • medicines to treat Parkinson's disease, restless leg syndrome, or pituitary gland tumor (prolactinoma);

  • migraine headache medicine such as almotriptan (Axert), frovatriptan (Frova), naratriptan (Amerge), rizatriptan (Maxalt), sumatriptan (Imitrex, Treximet), or zolmitriptan (Zomig); or

  • an antidepressant such as citalopram (Celexa), duloxetine (Cymbalta), desvenlafaxine (Pristiq), fluoxetine (Prozac, Sarafem, Symbyax), paroxetine (Paxil), sertraline (Zoloft), or venlafaxine (Effexor).

This list is not complete and other drugs may interact with milnacipran. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

  • Your pharmacist can provide more information about milnacipran.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 3.02. Revision Date: 2010-12-15, 5:01:39 PM.

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