IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
MILNACIPRAN - ORAL
COMMON BRAND NAME(S): Savella
WARNING: Although not used for depression, this medication is in the same class as antidepressant medications. Antidepressant medications are used to treat a variety of conditions, including depression and other mental/mood disorders. These medications can help prevent suicidal thoughts/attempts and provide other important benefits. However, studies have shown that a small number of people (especially people younger than 25) who take antidepressants for any condition may experience worsening depression, other mental/mood symptoms, or suicidal thoughts/attempts. Therefore, it is very important to talk with the doctor about the risks and benefits of antidepressant medication (especially for people younger than 25), even if treatment is not for a mental/mood condition. Tell the doctor immediately if you notice worsening depression/other psychiatric conditions, unusual behavior changes (including possible suicidal thoughts/attempts), or other mental/mood changes (including new/worsening anxiety, panic attacks, trouble sleeping, irritability, hostile/angry feelings, impulsive actions, severe restlessness, very rapid speech). Be especially watchful for these symptoms when a new antidepressant is started or when the dose is changed.
USES: Milnacipran is used to treat pain caused by a condition called fibromyalgia that affects the muscles, tendons, ligaments, and supporting tissues. This medication is a serotonin-norepinephrine reuptake inhibitor (SNRI) that works by helping to restore the balance of certain natural substances in the brain (neurotransmitters).
HOW TO USE: Read the Medication Guide provided by your pharmacist before you start using milnacipran and each time you get a refill. If you have any questions, consult your doctor or pharmacist. Take this medication by mouth with or without food, usually 2 times a day or as directed by your doctor. If you have nausea, it may help to take this medication with food. Dosage is based on your medical condition and response to treatment. To reduce your risk of side effects, your doctor may start you at a low dose and gradually increase your dose. Follow your doctor's instructions carefully. Do not increase your dose or take this medication more often than prescribed. Your condition will not improve any faster, and the risk of serious side effects may be increased. If this medication has been used regularly for a long time, withdrawal symptoms (such as mood swings, headache, tiredness, sleep changes, and brief feelings similar to electric shock) may occur if you suddenly stop using this medication. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details, and report any withdrawal reactions immediately. Tell your doctor if your condition does not improve or if it worsens.
SIDE EFFECTS: See also Warning section. Nausea, vomiting, dry mouth, constipation, loss of appetite, dizziness, increased sweating, headache, or hot flashes (flushing) may occur. If any of these effects persist or worsen, tell your doctor promptly. Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor immediately if any of these unlikely but serious side effects occur: fast/pounding heartbeat, changes in sexual ability, decreased interest in sex, painful/difficult urination. Tell your doctor immediately if any of these rare but very serious side effects occur: seizures, yellowing eyes/skin, dark urine, severe stomach/abdominal pain, black/bloody stools, vomit that looks like coffee grounds, easy bruising/bleeding. This medication may rarely cause a very serious condition called serotonin syndrome. The risk increases when this medication is used with other drugs which increase serotonin (See Drug Interactions section). Before taking this drug, tell your doctor if you take any of those medications. Serotonin syndrome may be more likely when you start or increase the dose of any of those medications. Seek immediate medical attention if you develop some of the following symptoms: hallucinations, unusual restlessness, loss of coordination, fast heartbeat, severe dizziness, unexplained fever, severe nausea/vomiting/diarrhea, twitchy muscles. A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before taking milnacipran, tell your doctor or pharmacist if you are allergic to it, or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, alcohol use, glaucoma (narrow-angle), personal or family history of psychiatric disorders (such as bipolar/manic-depressive disorder), personal or family history of suicide attempts, high blood pressure, heart problems (such as chest pain, heart attack, fast heartbeat), seizure disorder, severe loss of body water (dehydration), stomach/intestinal ulcers, mineral imbalance (low level of sodium in the blood), painful/difficult urination (for example, due to enlarged prostate). This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages. Drinking alcohol can also increase your risk of liver problems. Older adults may be at greater risk for mineral imbalance (low level of sodium in the blood) while using this drug, especially if they are also taking "water pills" (diuretics) with this medication. During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. Babies born to mothers who have used this drug during the last 3 months of pregnancy may infrequently develop withdrawal symptoms such as feeding/breathing difficulties, seizures, muscle stiffness, or constant crying. If you notice any of these symptoms in your newborn, tell the doctor promptly. It is unknown if this medication passes into breast milk. Discuss the risks and benefits with your doctor before breast-feeding.
DRUG INTERACTIONS: The effects of some drugs can change if you take other drugs or herbal products at the same time. This can increase your risk for serious side effects or may cause your medications not to work correctly. These drug interactions are possible, but do not always occur. Your doctor or pharmacist can often prevent or manage interactions by changing how you use your medications or by close monitoring. To help your doctor and pharmacist give you the best care, be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products) before starting treatment with this product. While using this product, do not start, stop, or change the dosage of any other medicines you are using without your doctor's approval. Some products that may interact with this drug include: "water pills" (diuretics such as furosemide), drugs that can cause bleeding/bruising (such as "blood thinners" including warfarin/heparin, anti-platelet drugs including clopidogrel). Avoid taking MAO inhibitors (isocarboxazid, linezolid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, tranylcypromine) for 2 weeks before treatment, during treatment, and at least 5 days after your last dose of milnacipran. In some cases a serious, possibly fatal drug interaction may occur. Consult your doctor or pharmacist for more information. Check all prescription and nonprescription medicine labels carefully since many medications contain pain relievers/fever reducers (nonsteroidal anti-inflammatory drugs-NSAIDs such as aspirin, ibuprofen, naproxen) that may increase your risk for bleeding if taken together with this drug. Low-dose aspirin should be continued if prescribed by your doctor for specific medical reasons such as heart attack or stroke prevention (usually at dosages of 81-325 milligrams per day). Consult your doctor or pharmacist for more details. Also tell your doctor if you take any other drugs that increase serotonin, such as amphetamines (including dextroamphetamine), bromocriptine, buspirone, dextromethorphan, lithium, meperidine, propoxyphene, phentermine, tramadol, tryptophan, sibutramine, St. John's Wort, drugs used to treat migraines (including dihydroergotamine, or "triptans" such as sumatriptan), street drugs such as MDMA/"ecstasy," certain antidepressants including SSRIs (such as citalopram, paroxetine) and other SNRIs (such as duloxetine, venlafaxine). Dextromethorphan is a commonly used cough medication and may interact with milnacipran. Check the labels on all your medicines (such as cough-and-cold products) because they may contain dextromethorphan. Ask your pharmacist about using those products safely. This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.
OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: confusion, severe drowsiness/dizziness.
NOTES: Do not share this medication with others. Laboratory and/or medical tests (such as blood pressure, heart rate, liver function) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.
MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.
STORAGE: Store at room temperature at 77 degrees F (25 degrees C) away from light and moisture. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Do not store in the bathroom. Keep all medicines away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.
Information last revised October 2011. Copyright(c) 2011 First Databank, Inc.