Generic name: levomilnacipran [ LEE-voe-mil-NA-si-pran ]
Brand name: Fetzima
Dosage form: oral capsule, extended release (120 mg; 20 mg; 20 mg-40 mg; 40 mg; 80 mg)
Drug class: Serotonin-norepinephrine reuptake inhibitors
What is levomilnacipran?
Levomilnacipran is a serotonin and norepinephrine reuptake inhibitor antidepressant (SNRI).
Levomilnacipran is used to treat major depressive disorder.
Levomilnacipran may also be used for purposes not listed in this medication guide.
People with depression or mental illness may have thoughts about suicide. Some young people may have increased suicidal thoughts when first starting a medicine to treat depression. Tell your doctor right away if you have any sudden changes in mood or behavior, or thoughts about suicide.
Do not stop using levomilnacipran without first asking your doctor.
Before taking this medicine
You should not use levomilnacipran if you are allergic to levomilnacipran or milnacipran (Savella).
Do not use levomilnacipran within 7 days before or 14 days after you have taken an MAO inhibitor. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, and tranylcypromine.
Tell your doctor if you also use stimulant medicine, opioid medicine, herbal products, or medicine for depression, mental illness, Parkinson's disease, migraine headaches, serious infections, or prevention of nausea and vomiting. An interaction with levomilnacipran could cause a serious condition called serotonin syndrome.
Tell your doctor if you have ever had:
heart problems, high blood pressure;
low levels of sodium in your blood;
bipolar disorder (manic depression);
if there is a history of depression, manic behavior, or suicide in your family; or
if you drink alcohol.
People with depression or mental illness may have thoughts about suicide. Some young people may have increased suicidal thoughts when first starting a medicine to treat depression. Stay alert to changes in your mood or symptoms. Your family or caregivers should also watch for sudden changes in your behavior.
Taking this medicine during pregnancy could harm the baby, but stopping the medicine may not be safe for you. Do not start or stop levomilnacipran without asking your doctor.
If you are pregnant, your name may be listed on a pregnancy registry to track the effects of levomilnacipran on the baby.
If you are breastfeeding, tell your doctor if your baby is agitated or irritable and has feeding problems or trouble gaining weight.
Not approved for use by anyone younger than 18 years old.
How should I take levomilnacipran?
Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.
Take the medicine at the same time each day, with or without food.
Swallow the capsule whole and do not crush, chew, break, or open it.
Your blood pressure and heart rate will need to be checked often.
Tell your doctor if you have any changes in sexual function, such as loss of interest in sex, trouble having an orgasm, or (in men) problems with erections or ejaculation. Some sexual problems can be treated.
Do not stop using levomilnacipran suddenly, or you could have unpleasant symptoms (such as agitation, confusion, tingling or electric shock feelings). Ask your doctor before stopping the medicine.
Store at room temperature away from moisture and heat.
What happens if I miss a dose?
Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while taking levomilnacipran?
Avoid driving or hazardous activity until you know how levomilnacipran will affect you. Your reactions could be impaired.
Ask your doctor before taking a nonsteroidal anti-inflammatory drug (NSAID) such as aspirin, ibuprofen, naproxen, Advil, Aleve, Motrin, and others. Using an NSAID with levomilnacipran may cause you to bruise or bleed easily.
Avoid drinking alcohol. It may raise your blood levels of levomilnacipran.
Levomilnacipran side effects
Tell your doctor right away if you have new or sudden changes in mood or behavior, including new or worse depression or anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, more active or talkative, or have thoughts about suicide or hurting yourself.
Call your doctor at once if you have:
painful or difficult urination;
easy bruising, unusual bleeding, purple or red spots under your skin;
pounding heartbeats or fluttering in your chest;
manic episodes--racing thoughts, increased energy, decreased need for sleep, risk-taking behavior, being agitated or talkative; or
Serious side effects may be more likely in older adults.
Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.
Common side effects may include:
nausea, vomiting, constipation;
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.
Levomilnacipran dosing information
Usual Adult Dose for Depression:
Initial dose: 20 mg orally once a day for 2 days, then increase to 40 mg orally once a day
Maintenance dose: 40 to 120 mg orally once a day
Maximum dose: 120 mg/day
-The dose may be increased in increments of 40 mg at intervals of 2 or more days based on tolerability and efficacy.
-Efficacy was established in trials lasting 5 weeks.
Use: Treatment of major depressive disorder (MDD)
What other drugs will affect levomilnacipran?
Using levomilnacipran with other drugs that make you drowsy can worsen this effect. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.
Tell your doctor about all your other medicines, especially:
any other antidepressant;
tryptophan (sometimes called L-tryptophan);
a diuretic or "water pill";
This list is not complete. Other drugs may affect levomilnacipran, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.
Research has shown that Fetzima has no overall effect on weight and does not cause weight gain or loss in studies that followed people for up to one year. Data pooled from short-term trials show an average overall weight loss of 0.59kg with Fetzima and a weight gain of 0.02kg with placebo. The number of patients who reported a more than 7% increase in their weight was 0.6% with Fetzima and 0.9% with placebo. The number of patients reporting a weight loss of more than 7% was 1.6% with Fetzima and 1% with placebo. In a 1-year, unblinded safety study, an average weight loss of 0.55kg was reported with Fetzima. Generally, there was a trend towards weight loss with Fetzima but this was not considered significant. Continue reading
Hair loss is not a common side effect of Fetzima and is not listed in the product information but post-marketing reports indicate hair loss has been reported in approximately 1.2% of people who reported side effects while taking Fetzima. Hair loss was more likely to occur in women, with 54% of cases documented in those aged 50 to 59. Continue reading
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- Drug class: serotonin-norepinephrine reuptake inhibitors
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Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
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