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

What is Savella?

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

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

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

Important information

Do not take Savella 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 Savella. After you stop taking Savella, 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 Savella, 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 while taking Savella. 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 Savella. Savella may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Before taking this medicine

Do not use Savella 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 Savella. You must wait at least 14 days after stopping an MAO inhibitor before you can take Savella. After you stop taking Savella, you must wait at least 5 days before you start taking an MAOI.

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

If you have any of these other conditions, your doctor may need to adjust the dose of Savella or order 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 Savella, 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 Savella 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 Savella without telling your doctor if you are breast-feeding a baby.

See also: Pregnancy and breastfeeding warnings (in more detail)

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

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

How should I take Savella?

Take Savella 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 Savella with food if it upsets your stomach.

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

Do not stop using Savella 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 Savella.

Store Savella 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?

Avoid drinking alcohol. It may increase your risk of liver damage. Savella may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Savella side effects

Get emergency medical help if you have any of these signs of an allergic reaction to Savella: 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 while using Savella:

  • 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 Savella 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)

What other drugs will affect Savella?

Before using Savella, 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 Savella.

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 Savella 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 Savella. 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 Savella.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Savella 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 1996-2014 Cerner Multum, Inc. Version: 3.01. Revision Date: 06/21/2010 3:12:04 PM.

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