Levomilnacipran (Oral route)
- Fetzima Titration Pack
- Capsule, Extended Release
Warnings:Oral route(Capsule, Extended Release)
Antidepressants can increase the risk of suicidal thinking and behavior in children, adolescents, and young adults; however, this risk was not observed in patients older than 24 years and risk was reduced in patients 65 years or older. Closely monitor patients of all ages for clinical worsening and for emergence of suicidal thoughts and behaviors. Not approved for use in pediatric patients .
Serotonin/Norepinephrine Reuptake Inhibitor
Uses of This Medicine:
Levomilnacipran is used to treat depression. It belongs to a group of medicines known as serotonin and norepinephrine reuptake inhibitors (SNRIs). These medicines are thought to work by increasing the activity of chemicals called serotonin and norepinephrine in the brain.
This medicine is available only with your doctor's prescription.
Before Using This Medicine:
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Levomilnacipran is not approved for use in children. Safety and efficacy have not been established.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of levomilnacipran in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require an adjustment in the dose for patients receiving levomilnacipran.
|All Trimesters||C||Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.|
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Methylene Blue
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Amtolmetin Guacil
- Choline Salicylate
- Dabigatran Etexilate
- Drotrecogin Alfa
- Flufenamic Acid
- Mefenamic Acid
- Niflumic Acid
- Nimesulide Beta Cyclodextrin
- Propionic Acid
- Protein C
- Salicylic Acid
- Sodium Salicylate
- St John's Wort
- Tiaprofenic Acid
- Tolfenamic Acid
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
- Grapefruit Juice
Other medical problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Bipolar disorder (type of depression), or risk of or
- Bleeding problems or
- Heart disease or
- Hypertension (high blood pressure) or
- Hyponatremia (low sodium in the blood) or
- Mania, history of or
- Narrow-angle glaucoma or
- Seizures, history of or
- Tachycardia (fast heart rate) or
- Trouble urinating or
- Urinary bladder blockage Use with caution. May make these conditions worse.
- Kidney disease Use with caution. The effects may be increased because of slower removal of the medicine from the body.
Proper Use of This Medicine:
Take this medicine only as directed by your doctor to benefit your condition as much as possible. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.
This medicine should come with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.
Take this medicine with or without food, and at the same time every day.
Swallow the extended-release capsule whole. Do not open, crush, or chew it.
Do not take the extended-release capsule with alcohol. This may cause the contents of the capsule to be released too soon.
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For oral dosage form (extended-release capsules):
- For depression:
- Adults At first, 20 milligrams (mg) once a day. After 2 days, the dose will be increased to 40 mg once a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 120 mg per day.
- Children Use is not recommended.
- For depression:
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Precautions While Using This Medicine:
It is very important that your doctor check your progress at regular visits to make sure this medicine 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, 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.
This medicine 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 this medicine 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.
This medicine 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.
This medicine may cause some people to become dizzy, drowsy, or less alert than they are normally. Make sure you know how you react to this medicine 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.
Side Effects of This Medicine:
- More common
- Difficult urination
- fast, pounding, or irregular heartbeat or pulse
- Less common
- arm, back, or jaw pain
- blurred vision
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- chest pain or discomfort
- chest tightness or heaviness
- cloudy urine
- decrease in the frequency of urination
- difficulty in passing urine (dribbling)
- difficulty with speaking
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- dry mouth
- loss of balance control
- muscle trembling, jerking, or stiffness
- painful urination
- pounding in the ears
- rapid or irregular heartbeat
- shortness of breath
- shuffling walk
- slow heartbeat
- stiffness of the limbs
- trouble sleeping
- twisting movements of the body
- uncontrolled movements, especially of the face, neck, and back
- unusual tiredness or weakness
- More common
- Difficulty having a bowel movement (stool)
- increased sweating
- loss in sexual ability, desire, drive, or performance
- Less common
- Abdominal or stomach pain
- bloated or full feeling
- decreased appetite
- dry eyes
- dry skin
- feeling of warmth
- headache, severe and throbbing
- hives or welts, itching, or rash
- passing gas
- red eye
- red face, neck, arms, and occasionally, upper chest
- sudden sweating
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Last Updated: 9/15/2016