Levomilnacipran

Levomilnacipran comes as an extended-release (long-acting) capsule to take by mouth. It is usually taken once daily with or without food. Take levomilnacipran at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take levomilnacipran exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the capsules whole; do not open, chew, or crush them.

Your doctor may start you on a low dose of levomilnacipran and gradually increase your dose, not more than once every 2 days.

Levomilnacipran controls depression but does not cure it. It may take several weeks or longer before you feel the full benefit of levomilnacipran. Continue to take levomilnacipran even if you feel well. Do not stop taking levomilnacipran without talking to your doctor. Your doctor will probably decrease your dose gradually. If you suddenly stop taking levomilnacipran, you may experience withdrawal symptoms such as mood changes, agitation, irritability, dizziness, ringing in the ears, shock-like sensations, anxiety, confusion, tiredness, difficulty falling asleep or staying asleep, numbness or tingling in the arms, legs, hands, or feet, headache, increased sweating, seizures, or nausea. Tell your doctor if you experience any of these symptoms when your dose of levomilnacipran is decreased.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from light, excess heat and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

>10%

Nausea (17%)

1-10%

Erectile dysfunction, dose-related (6-10%)

Constipation (9%)

Tachycardia (6%)

Urinary hesitation, dose-related (4-6%)

Palpitations (5%)

Vomiting (5%)

Hyperhidrosis (2%)

Increased heart rate (1%)

Increased blood pressure (1%)

Hot flush (1%)

Hypotension (1%)

Decreased appetite (1%)

<1%

Testicular pain

Ejaculation disorder

Serious side effects have been reported with levomilnacipran including the following:

• High blood pressure. Your healthcare provider should monitor your blood pressure before and while you are taking levomilnacipran. If you have high blood pressure, it should be controlled before you start taking this medication
• Increased heart rate
• Abnormal bleeding: levomilnacipran and other antidepressant medicines may increase your risk of bleeding or bruising, especially if you take blood thinners (eg, warfarin, Coumadin, or Jantoven), a non-steroidal anti-inflammatory drug (NSAID), or aspirin. Tell your healthcare provider right away about any unusual bleeding or bruising.
• Glaucoma (increased eye pressure)
• Trouble urinating
• Hypomania (manic episodes). Tell your doctor if you notice any of the following:
  • greatly increased energy
  • severe trouble sleeping
  • racing thoughts
  • reckless behavior
  • unusually grand ideas
  • excessive happiness or irritability
  • or talking more or faster than usual
• Seizures or convulsions
• Discontinuation symptoms: Do not stop levomilnacipran without first talking to your healthcare provider. Stopping levomilnacipran suddenly may cause serious symptoms, including:
  • anxiety
  • irritability
  • high or low mood
  • feeling restless or sleepy
  • headache
  • sweating
  • nausea
  • dizziness
  • electric shock-like sensations
  • tremor
  • confusion
• Low salt (sodium) levels in the blood. Tell your healthcare provider right away if you have some or all of the following symptoms of low salt (sodium) levels.
  • headache, difficulty concentrating, memory changes, confusion, weakness, and unsteadiness on your feet.
  • Severe or sudden cases may produce hallucinations (seeing or hearing things that are not real), fainting, seizures, and coma.
  • If not treated, severe low sodium levels could cause death.
  • Elderly people may be at greater risk

Levomilnacipran can cause blurred vision. Do not drive or operate heavy machinery until you know how levomilnacipran affects you.

Do not take levomilnacipran if you:

• are allergic to levomilnacipran or to any of its ingredients
• Have taken any drugs known as monoamine oxidase inhibitors (MAOIs) within the last 14 days, including the antibiotic linezolid or intravenous methylene blue
• Have an eye condition called narrow-angle glaucoma that is not being controlled with medical treatment

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• other medical conditions you have
• how you respond to this medication
• your renal function

The recommended dose range of levomilnacipran for the treatment of depression is 40 mg to 120 mg once daily.

For patients with moderate renal impairment, the dose should not exceed 80 mg once daily.

It is very important that your doctor check your progress at regular visits to make sure levomilnacipran is working properly.

Do not take levomilnacipran with a monoamine oxidase (MAO) inhibitor (eg, isocarboxazid [Marplan®], phenelzine [Nardil®], selegiline [Eldepryl®], tranylcypromine [Parnate®]). Do not start taking levomilnacipran during the 2 weeks after you stop a MAO inhibitor. Wait 1 week after stopping levomilnacipran before you start taking a MAO inhibitor. If you take them together or do not wait the proper amount of time, you may develop confusion, agitation, restlessness, stomach or intestinal symptoms, a sudden high body temperature, an extremely high blood pressure, or severe convulsions.

Levomilnacipran may cause some teenagers and young adults to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. Some people may have trouble sleeping, get upset easily, have a big increase in energy, or start to act reckless. If you or your caregiver notice any of these unwanted effects, tell your doctor right away. Let the doctor know if you or anyone in your family has bipolar disorder (manic-depressive) or has tried to commit suicide.

Levomilnacipran may cause a serious condition called serotonin syndrome if taken together with some medicines. Do not use levomilnacipran with buspirone (Buspar®), fentanyl (Abstral®, Duragesic®), linezolid (Zyvox®), lithium (Eskalith®, Lithobid®), methylene blue injection, tryptophan, St. John's wort, amphetamines, or some pain or migraine medicines (eg, rizatriptan, sumatriptan, tramadol, Frova®, Imitrex®, Maxalt®, Relpax®, Ultram®, Zomig®). Check with your doctor first before taking any other medicines with levomilnacipran.

levomilnacipran may increase your risk for bleeding problems. Make sure your doctor knows if you are also taking other medicines that thin the blood, such as aspirin, nonsteroidal antiinflammatory agents, also called NSAIDs (eg, diclofenac, ibuprofen, naproxen, Advil®, Aleve®, Celebrex®, Voltaren®), or warfarin (Coumadin®, Jantoven®).

Do not stop taking levomilnacipran without checking first with your doctor. Your doctor may want you to gradually reduce the amount you are taking before stopping it completely to decrease the chance of withdrawal effects. Some examples of withdrawal effects include agitation, breathing problems, chest pain, confusion, diarrhea, dizziness or lightheadedness, fast heartbeat, headaches, increased sweating, muscle pain, nausea, restlessness, runny nose, trouble sleeping, trembling or shaking, unusual tiredness or weakness, vision changes, or vomiting.

levomilnacipran may cause hyponatremia (low sodium in the blood). This is more common in elderly patients, those who are taking diuretic medicines, or those who have less fluid in the body due to severe diarrhea or vomiting. Check with your doctor right away if you have confusion, a headache, memory problems, trouble concentrating, weakness, or feel unsteady when standing.

levomilnacipran may cause some people to become dizzy, drowsy, or less alert than they are normally. Make sure you know how you react to levomilnacipran before you drive, use machines, or do anything else that could be dangerous if you are not alert.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Use levomilnacipran as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take this medicine at the same time of day.
• Take with or without food.
• Swallow whole. Do not chew, open, or crush.
• To gain the most benefit, do not miss doses.
• Keep taking levomilnacipran as you have been told by your doctor or other health care provider, even if you feel well.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Upset stomach or throwing up.
• Hard stools (constipation).
• Sweating a lot.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

• Fetzima
• Fetzima Titration

Major depressive disorder: Treatment of major depressive disorder (MDD)

Depression: Oral: Initial: 20 mg once daily for 2 days; increase to 40 mg once daily; may then be increased in increments of 40 mg at intervals of 2 or more days; Maintenance: 40-120 mg once daily; Maximum: 120 mg daily

Discontinuation of therapy: Upon discontinuation of antidepressant therapy, gradually taper the dose to minimize the incidence of withdrawal symptoms and allow for the detection of re-emerging symptoms. Evidence supporting ideal taper rates is limited. APA and NICE guidelines suggest tapering therapy over at least several weeks with consideration to the half-life of the antidepressant; antidepressants with a shorter half-life may need to be tapered more conservatively. In addition for long-term treated patients, WFSBP guidelines recommend tapering over 4-6 months. If intolerable withdrawal symptoms occur following a dose reduction, consider resuming the previously prescribed dose and/or decrease dose at a more gradual rate (APA, 2010; Bauer, 2002; Haddad, 2001; NCCMH, 2010; Schatzberg, 2006; Shelton, 2001; Warner, 2006).

MAO inhibitor recommendations:

Switching to or from an MAO inhibitor intended to treat psychiatric disorders:

Allow 14 days to elapse between discontinuing an MAO inhibitor intended to treat psychiatric disorders and initiation of levomilnacipran.

Allow 7 days to elapse between discontinuing levomilnacipran and initiation of an MAO inhibitor intended to treat psychiatric disorders.

Use with other MAO inhibitors (linezolid or IV methylene blue):

Do not initiate levomilnacipran in patients receiving linezolid or IV methylene blue; consider other interventions for psychiatric condition.

If urgent treatment with linezolid or IV methylene blue is required in a patient already receiving levomilnacipran and potential benefits outweigh potential risks, discontinue levomilnacipran promptly and administer linezolid or IV methylene blue. Monitor for serotonin syndrome for 2 weeks or until 24 hours after the last dose of linezolid or IV methylene blue, whichever comes first. May resume levomilnacipran 24 hours after the last dose of linezolid or IV methylene blue.