dilation that occurs following use of SNRI drugs including milnacipran may trigger angle closure attack in patients with anatomically narrow angles who do not have a patent iridectomy; for patients who have not had an iridectomy for narrow-angle glaucoma risk factors, consider performing evaluation Patietns with history of obstructive uropathies may experience higher rates of genitourinary adverse drug reactions (ADRs) ESRD: Use not recommended Development of SIADH and hyponatremia reported with SSRIs and SNRIs, predominantly in the elderly; volume depletion and/or concurrent use of diuretics may increase risk May cause urinary hesitance; advise patients to report urinary symptoms or difficulties; use caution in patients with history of lower urinary tract disorders, including benign prostatic hyperplasia or prostatitis May worsen psychosis in patients with mood disorders; a shift to mania or hypomania reported with bipolar disorder; avoid monotherapy in patients with bipolar disorder; screen prospective patients for bipolar disorder when presenting with depressive symptoms Sexual dysfunction In female patients, SSRI/SNRI use may result in decreased libido and delayed or absent orgasm Important for prescribers to inquire about sexual function prior to initiation of therapy and to inquire specifically about changes in sexual function during treatment, because sexual function may not be spontaneously reported When evaluating changes in sexual function, obtaining a detailed history (including timing of symptom onset) is important because sexual symptoms may have other causes, including underlying psychiatric disorder Discuss potential management strategies to support patients in making informed decisions about treatment Pregnancy category: C Lactation: Drug is excreted in human milk; peak breast milk concentration is observed within 4 hours after maternal dose, and estimated infant exposure is 5% of maternal dose; limited data are available regarding infant exposure, but caution is advisedPregnancy Categories A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk. B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available. Mechanism of Action SNRI; has no affinity for other neurotransmitter receptors (including gamma-aminobutyric acid [GABA], beta-adrenergic, opiate, histaminergic, and benzodiazepine receptors) and has no MAOI activity Absorption Bioavailability: 85-90% Peak plasma time: 2-4 hr Distribution Protein bound: 13% Vd: 400 L Metabolism Metabolized to several metabolites Elimination Half-life: L-isomer, 6-8 hr; D-isomer, 8-10 hr Excretion: Urine (55%) BRAND FORM. UNIT PRICE PILL IMAGE Savella oral- 12.5 mg tabletSavella oral- 100 mg tabletSavella oral- 12.5 mg (5)-25 mg(8)-50 mg(42) tabletSavella oral- 25 mg tabletSavella oral- 50 mg tabletCopyright © 2010 First DataBank, Inc.Print Patient Educationmilnacipran oral MILNACIPRAN - ORAL (mil-NA-si-pran) 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. 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. 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 as directed by your doctor, usually 2 times a day. 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 you suddenly stop using this medication, you may have withdrawal symptoms (such as mood swings, headache, tiredness, sleep changes, brief feelings similar to electric shock). To help prevent withdrawal, your doctor may lower your dose slowly. Withdrawal is more likely if you have used milnacipran for a long time or in high doses. Tell your doctor or pharmacist right away if you have withdrawal.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 last or get worse, tell your doctor promptly.Remember that this medication has been prescribed because your doctor 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, easy bleeding/bruising.Get medical help right away if you have any very serious side effects, including: black stools, vomit that looks like coffee grounds, 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: 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, dehydration, intestinal ulcers/bleeding (peptic ulcer disease), 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 (cannabis) 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 (cannabis). 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 more sensitive to the side effects of this drug, especially bleeding. Older adults may also 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. 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 are: "water pills" (diuretics such as furosemide), other drugs that can cause bleeding/bruising (including antiplatelet drugs such as clopidogrel, NSAIDs such as ibuprofen/naproxen, "blood thinners" such as dabigatran/warfarin).Taking MAO inhibitors with this medication may cause a serious (possibly fatal) drug interaction. Avoid taking MAO inhibitors (isocarboxazid, linezolid, metaxalone, 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.Aspirin can increase the risk of bleeding when used with this medication. However, if your doctor has directed you to take low-dose aspirin for heart attack or stroke prevention (usually 81-162 milligrams a day), you should continue taking it unless your doctor instructs you otherwise. Ask 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: 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. NOTES: Do not share this medication with others.Lab and/or medical tests (such as blood pressure, heart rate, liver function) should be done while you are taking this medication. Keep all medical and lab appointments. 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. Take your next dose at the regular time. Do not double the dose to catch up. STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications 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.