Fetzima Titration Pack

Generic name: Levomilnacipran
Drug class: Serotonin-norepinephrine reuptake inhibitors

Usage of Fetzima Titration Pack

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.

Fetzima Titration Pack side effects

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:

More common

Decreased interest in sexual intercourse

difficult urination

fast, pounding, or irregular heartbeat or pulse

inability to have or keep an erection

loss in sexual ability, desire, drive, or performance

Less common

Anxiety

arm, back, or jaw pain

blurred vision

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

chest pain, discomfort, heaviness, or tightness

cloudy urine

confusion

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

drooling

dry mouth

fainting

headache

irritability

loss of balance control

muscle trembling, jerking, or stiffness

nausea

painful urination

pounding in the ears

rapid or irregular heartbeat

restlessness

shaking

shuffling walk

slow heartbeat

stiffness of the limbs

sweating

trouble breathing

trouble sleeping

twisting movements of the body

uncontrolled movements, especially of the face, neck, and back

unusual tiredness or weakness

Incidence not known

Delayed or inability to have an orgasm

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:

More common

Difficulty having a bowel movement (stool)

increased sweating

vomiting

Less common

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

stomach pain

sudden sweating

thirst

yawning

Incidence not known

Decrease in smell

loss of sense of smell

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.

Before taking Fetzima Titration Pack

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:

Allergies

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.

Pediatric

Appropriate studies have not been performed on the relationship of levomilnacipran in the pediatric population. Safety and efficacy have not been established.

Geriatric

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 hyponatremia (low sodium in the blood) and age-related kidney problems, which may require an adjustment in the dose for patients receiving levomilnacipran.

Breast Feeding

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.

Interactions with Medicines

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.

Isocarboxazid

Linezolid

Methylene Blue

Metoclopramide

Ozanimod

Phenelzine

Procarbazine

Rasagiline

Safinamide

Selegiline

Tranylcypromine

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.

Abciximab

Aceclofenac

Acemetacin

Acenocoumarol

Alfentanil

Almotriptan

Amifampridine

Amineptine

Amitriptyline

Amitriptylinoxide

Amoxapine

Amphetamine

Amtolmetin Guacil

Anagrelide

Anileridine

Apixaban

Ardeparin

Argatroban

Aspirin

Bemiparin

Benzhydrocodone

Benzphetamine

Betrixaban

Bivalirudin

Boceprevir

Bromfenac

Brompheniramine

Bufexamac

Buprenorphine

Bupropion

Buspirone

Butorphanol

Cangrelor

Carbamazepine

Celecoxib

Ceritinib

Certoparin

Chlorpheniramine

Choline Salicylate

Cilostazol

Citalopram

Clarithromycin

Clomipramine

Clonixin

Clopidogrel

Cobicistat

Cocaine

Codeine

Conivaptan

Cyclobenzaprine

Dabigatran Etexilate

Dalteparin

Danaparoid

Desipramine

Desirudin

Desvenlafaxine

Dexibuprofen

Dexketoprofen

Dextroamphetamine

Dextromethorphan

Dibenzepin

Diclofenac

Difenoxin

Diflunisal

Dihydrocodeine

Diphenoxylate

Dipyridamole

Dipyrone

Dolasetron

Donepezil

Doxepin

Droxicam

Duloxetine

Edoxaban

Eletriptan

Enoxaparin

Epoprostenol

Eptifibatide

Escitalopram

Ethylmorphine

Etodolac

Etofenamate

Etoricoxib

Felbinac

Fenfluramine

Fenoprofen

Fentanyl

Fepradinol

Feprazone

Floctafenine

Fluconazole

Flufenamic Acid

Fluoxetine

Flurbiprofen

Fluvoxamine

Fondaparinux

Frovatriptan

Gepirone

Granisetron

Heparin

Hydrocodone

Hydromorphone

Hydroxyamphetamine

Hydroxytryptophan

Ibuprofen

Idelalisib

Iloprost

Imipramine

Indinavir

Indomethacin

Iobenguane I 131

Itraconazole

Josamycin

Ketobemidone

Ketoconazole

Ketoprofen

Ketorolac

Lasmiditan

Lepirudin

Levorphanol

Lisdexamfetamine

Lithium

Lofepramine

Lonafarnib

Lopinavir

Lorcaserin

Lornoxicam

Loxoprofen

Lumiracoxib

Meclofenamate

Mefenamic acid

Melitracen

Meloxicam

Meperidine

Metaxalone

Methadone

Methamphetamine

Mibefradil

Mifepristone

Milnacipran

Mirtazapine

Morniflumate

Morphine

Morphine Sulfate Liposome

Nabumetone

Nadroparin

Nalbuphine

Naproxen

Naratriptan

Nefazodone

Nelfinavir

Nepafenac

Nialamide

Nicomorphine

Niflumic Acid

Nimesulide

Nimesulide Beta Cyclodextrin

Nortriptyline

Ondansetron

Opipramol

Opium

Opium Alkaloids

Oxaprozin

Oxycodone

Oxymorphone

Oxyphenbutazone

Palonosetron

Papaveretum

Parecoxib

Paregoric

Parnaparin

Paroxetine

Pentazocine

Phenindione

Phenprocoumon

Phenylbutazone

Piketoprofen

Piritramide

Piroxicam

Posaconazole

Pranoprofen

Prasugrel

Proglumetacin

Propyphenazone

Proquazone

Protein C

Protriptyline

Remifentanil

Reviparin

Ribociclib

Ritonavir

Rivaroxaban

Rizatriptan

Rofecoxib

Salicylic Acid

Salsalate

Saquinavir

Selexipag

Sertraline

Sibutramine

Simeprevir

Sodium Salicylate

St John's Wort

Sufentanil

Sulfinpyrazone

Sulindac

Sulodexide

Sumatriptan

Tapentadol

Telaprevir

Telithromycin

Tenoxicam

Tianeptine

Tiaprofenic Acid

Ticagrelor

Ticlopidine

Tilidine

Tinzaparin

Tirofiban

Tolfenamic Acid

Tolmetin

Tramadol

Trazodone

Treprostinil

Trimipramine

Troleandomycin

Tryptophan

Tucatinib

Valdecoxib

Venlafaxine

Vilazodone

Vorapaxar

Voriconazole

Vortioxetine

Warfarin

Ziprasidone

Zolmitriptan

Interactions with Food/Tobacco/Alcohol

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.

Ethanol

Grapefruit Juice

Relate drugs

How to use Fetzima Titration Pack

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.

Dosing

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.

Missed Dose

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.

Storage

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.

Warnings

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. Do not use this medicine if you are using certain MAOI (eg, linezolid [Zyvox®], methylene blue injection). 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 seizures.

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®), lithium (Eskalith®, Lithobid®), tryptophan, St. John's wort, amphetamines, or some pain or migraine medicines (eg, meperidine, methadone, rizatriptan, sumatriptan, tramadol, Demerol®, Methadose®, 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, including 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.

Check with your doctor right away if you have decreased interest in sexual intercourse, delayed or inability to have an orgasm in women, inability to have or keep an erection in men, or loss in sexual ability, desire, drive, or performance. These could be symptoms of sexual dysfunction.

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 (eg, St. John's wort) or vitamin supplements.

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