MILNACIPRAN - ORAL

MILNACIPRAN - ORAL

PHONETIC PRONUNCIATION: (mil-NA-si-pran)

COMMON BRAND NAME(S): Savella

GENERIC NAME(S): milnacipran HCl

Uses

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 MILNACIPRAN - ORAL

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 right away. Tell your doctor if your condition does not improve or if it worsens.

Side Effects

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. This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high. Tell your doctor right away if you have any serious side effects, including: fast/pounding heartbeat, changes in sexual ability, decreased interest in sex, painful/difficult urination, seizures, yellowing eyes/skin, dark urine, severe stomach/abdominal pain, black/bloody stools, vomit that looks like coffee grounds, easy bruising/bleeding. Get medical help right away if you have any very serious side effects, including: eye pain/swelling/redness, widened pupils, vision changes (such as seeing rainbows around lights at night, blurred vision). This medication may increase serotonin and rarely cause a very serious condition called serotonin syndrome/toxicity. The risk increases if you are also taking other drugs that increase serotonin, so tell your doctor or pharmacist of all the drugs you take (see Drug Interactions section). Get medical help right away if you develop some of the following symptoms: fast heartbeat, hallucinations, loss of coordination, severe dizziness, severe nausea/vomiting/diarrhea, twitching muscles, unexplained fever, unusual agitation/restlessness. A very serious allergic reaction to this drug is rare. However, get medical help right away 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 or at www.fda.gov/medwatch. 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

PRECAUTIONS: Before taking milnacipran, tell your doctor or pharmacist if you are allergic to it; or to levomilnacipran; 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, personal or family history of glaucoma (angle-closure type), 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/irregular 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. Alcohol or marijuana can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana. Drinking alcohol can also increase your risk of liver problems. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). 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 rarely 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. This medication passes into breast milk. Consult your doctor before breast-feeding.

Interactions

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines 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). Taking MAO inhibitors with this medication may cause a serious (possibly fatal) drug interaction. Avoid taking MAO inhibitors (isocarboxazid, linezolid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, safinamide, selegiline, tranylcypromine) during treatment with this medication. Most MAO inhibitors should also not be taken for two weeks before and at least 5 days after treatment with this medication. Ask your doctor when to start or stop taking this medication. 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. The risk of serotonin syndrome/toxicity increases if you are also taking other drugs that increase serotonin. Examples include street drugs such as MDMA/"ecstasy," St. John's wort, certain antidepressants (including SSRIs such as fluoxetine/paroxetine, other SNRIs such as duloxetine/venlafaxine), tryptophan, among others. The risk of serotonin syndrome/toxicity may be more likely when you start or increase the dose of these drugs. Milnacipran is very similar to levomilnacipran. Do not use medications containing levomilnacipran while using milnacipran.

Overdose

OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: confusion, severe drowsiness/dizziness.

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Warning

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 right away 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.


Disclaimer

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.