Savella (milnacipran) affects certain chemicals in the brain called neurotransmitters. An abnormality in these chemicals is thought to be related to fibromyalgia (a medical condition that causes chronic pain in the muscles and joints). Savella is not used to treat depression but it works similarly to how some antidepressants work.
Savella is used to treat the chronic pain caused by fibromyalgia.
Important information
Do not use Savella if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others. After you stop taking Savella, you must wait at least 5 days before you start taking an MAOI.
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 milnacipran. 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. Milnacipran may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.
Savella is not approved for use by anyone younger than 18 years old.
Before taking this medicine
You should not use Savella if you are allergic to milnacipran.
Do not use Savella if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others. After you stop taking Savella, you must wait at least 5 days before you start taking an MAOI.
To make sure Savella is safe for you, tell your doctor if you have:
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glaucoma;
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liver disease;
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kidney disease;
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high blood pressure;
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seizures or epilepsy;
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bipolar disorder (manic depression);
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a bleeding or blood clotting disorder such as hemophilia;
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low levels of sodium in your blood;
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problems with urination;
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if you take a blood thinner such as warfarin (Coumadin, Jantoven); or
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if you drink alcohol.
Some young people have thoughts about suicide when first taking Savella. Your doctor should check your progress at regular visits. Your family or other caregivers should also be alert to changes in your mood or symptoms.
Taking Savella during pregnancy may cause serious lung problems or other complications in the baby. However, you may have a relapse of your symptoms if you stop taking Savella. Tell your doctor right away if you become pregnant. Do not start or stop taking this medicine during pregnancy without your doctor"s advice.
If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of Savella on the baby.
Milnacipran can pass into breast milk and may harm a nursing baby. Tell your doctor if you are breast-feeding a baby.
Savella should not be given to a child younger than 18 years old.
How should I take Savella?
Take Savella exactly as prescribed by your doctor. Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not use this medicine in larger or smaller amounts or for longer than recommended.
You may take Savella with or without food, but food may help you tolerate the medicine better.
Your blood pressure and heart rate will need to be checked often.
Do not stop using Savella suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using this medicine.
Tell your doctor if the medicine seems to stop working as well in relieving your fibromyalgia pain.
Store at room temperature away from moisture and heat.
Savella dosing information
Usual Adult Dose for Fibromyalgia:
Maintenance dose: 50 mg orally twice a day
Maximum dose: 100 mg orally twice a day (200 mg orally per day)
Comments:
-Dosing may be titrated according to the following schedule:
-Initial dose on day 1: 12.5 mg orally once
-Days 2 and 3: 12.5 mg orally twice a day
-Days 4 through 7: 25 mg orally twice a day
-After day 7: 50 mg orally twice a day
Use: Management of fibromyalgia
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 Savella?
Avoid drinking alcohol.
Ask your doctor before taking a nonsteroidal anti-inflammatory drug (NSAID) for pain, arthritis, fever, or swelling. This includes aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib (Celebrex), diclofenac, indomethacin, meloxicam, and others. Using an NSAID with Savella may cause you to bruise or bleed easily.
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 signs of an allergic reaction to Savella: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, depression, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself.
Call your doctor at once if you have:
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a light-headed feeling, like you might pass out;
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pounding heartbeats or fluttering in your chest;
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blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
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little or no urinating;
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seizure (convulsions);
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easy bruising or bleeding (nosebleeds), or signs of stomach bleeding (bloody or tarry stools, coughing up blood);
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manic episodes--racing thoughts, increased energy, unusual risk-taking behavior, extreme happiness, being irritable or talkative;
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high levels of serotonin in the body--agitation, hallucinations, fever, fast heart rate, overactive reflexes, nausea, vomiting, diarrhea, loss of coordination, fainting;
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low levels of sodium in the body--headache, confusion, slurred speech, severe weakness, vomiting, loss of coordination, feeling unsteady;
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liver problems--nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
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dangerously high blood pressure--severe headache, blurred vision, pounding in your neck or ears, nosebleed, anxiety, confusion, severe chest pain, shortness of breath, irregular heartbeats.
Some side effects may be more likely in older adults.
Common Savella side effects may include:
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nausea, vomiting, constipation;
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dry mouth;
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increased sweating, flushing (warmth, redness, or tingly feeling);
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headache, dizziness;
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sleep problems (insomnia); or
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high blood pressure, pounding heartbeat.
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?
Taking this medicine with other drugs that make you sleepy can worsen this effect. Ask your doctor before taking Savella with a sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.
Other drugs may interact with milnacipran, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.
