Fetzima titration package (oral)

Fetzima titration package (oral)

Fetzima Titration Pack (Oral) Oral Route (Capsule, Extended Release)

Warning: Suicidal thoughts and behavior

Antidepressants increased the risk of suicidal thoughts and behavior in pediatric and young adult patients in short-term studies. Monitor all patients treated with antidepressants closely for clinical deterioration and for the emergence of suicidal thoughts and behavior. Levomilnacipran is not approved for use in pediatric patients.

Used for the Fetzima titration package

This medicine is only available with a doctor's prescription.

Before using the Fetzima Titration Pack

When deciding whether to use a medicine, the risks of taking the medicine must be weighed against the benefits it produces. This is a decision that you and your doctor will make. The following should be noted with this medicine:

Allergies

Tell your doctor if you have ever had an unusual or allergic reaction to this medicine or any other medicines. Also tell your doctor if you have other allergies, such as to foods, dyes, preservatives or animals. For over-the-counter products, read the label or package ingredients carefully.

Pediatrics

No appropriate studies have been conducted on the association with levomilnacipran in children and adolescents. Safety and effectiveness have not been established.

geriatrics

Studies conducted to date have not shown any geriatric-specific problems that would limit the benefit of levomilnacipran in the elderly. However, older patients are at higher risk of hyponatremia (low sodium levels in the blood) and age-related kidney problems, which may require dose adjustments in patients receiving levomilnacipran.

Breastfeeding

There are insufficient studies in women to determine the risk to infants when using this drug while breast-feeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug interactions

Although certain medicines should not be used together at all, in other cases two different medicines can be used together, although interactions may occur. In these cases, your doctor may want to change the dose or other precautions may be necessary. If you are taking this medicine, it is particularly important that your doctor knows whether you are taking any of the medicines listed below. The following interactions were selected for their potential significance and are not necessarily exhaustive.

The use of this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or to change some of the other medications you are taking.

• Isocarboxazid
• Linezolid
• Methylenblau
• Metoclopramid
• Ozanimod
• Phenelzin
• Procarbazin
• Rasagilin
• Safinamid
• Selegilin
• Tranylcypromin

Using this medicine with any of the following medicines is not usually recommended but may be necessary in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both medicines.

• Abciximab
• Aceclofenac
• Acemetacin
• Acenocoumarol
• Alfentanil
• Almotriptan
• Amifampridin
• Amineptin
• Amitriptylin
• Amitriptylinoxid
• Amoxapin
• Amphetamin
• Amtolmetin Guacil
• Anagrelid
• Anileridin
• Apixaban
• Ardeparin
• Argatroban
• Aspirin
• Bemiparin
• Benzhydrocodon
• Benzphetamin
• Betrixaban
• Bivalirudin
• Boceprevir
• Bromfenac
• Brompheniramin
• Bufexamac
• Buprenorphin
• Bupropion
• Buspiron
• Butorphanol
• Cangrelor
• Carbamazepin
• Celecoxib
• Ceritinib
• Certoparin
• Chlorpheniramin
• Cholinsalicylat
• Cilostazol
• Citalopram
• Clarithromycin
• Clomipramin
• Clonixin
• Clopidogrel
• Cobicistat
• Kokain
• Kodein
• Conivaptan
• Cyclobenzaprin
• Dabigatranetexilat
• Dalteparin
• Danaparoid
• Desipramin
• Desirudin
• Desvenlafaxin
• Dexibuprofen
• Dexketoprofen
• Dextroamphetamin
• Dextromethorphan
• Dibenzepin
• Diclofenac
• Difenoxin
• Diflunisal
• Dihydrocodein
• Diphenoxylat
• Dipyridamol
• Dipyron
• Dolasetron
• Donepezil
• Doxepin
• Droxicam
• Duloxetin
• Edoxaban
• Eletriptan
• Enoxaparin
• Epoprostenol
• Eptifibatid
• Escitalopram
• Ethylmorphin
• Etodolac
• Etofenamat
• Etoricoxib
• Felbinac
• Fenfluramin
• Fenoprofen
• Fentanyl
• Fepradinol
• Feprazon
• Floctafenin
• Fluconazol
• Flufenaminsäure
• Fluoxetin
• Flurbiprofen
• Fluvoxamin
• Fondaparinux
• Frovatriptan
• Gepiron
• Granisetron
• Heparin
• Hydrocodon
• Hydromorphon
• Hydroxyamphetamin
• Hydroxytryptophan
• Ibuprofen
• Idelalisib
• Iloprost
• Imipramin
• Indinavir
• Indomethacin
• Iobenguane I 131
• Itraconazol
• Josamycin
• Ketobemidon
• Ketoconazol
• Ketoprofen
• Ketorolac
• Lasmiditan
• Lepirudin
• Levorphanol
• Lisdexamfetamin
• Lithium
• Lofepramin
• Lonafarnib
• Lopinavir
• Lorcaserin
• Lornoxicam
• Loxoprofen
• Lumiracoxib
• Meclofenamat
• Mefenaminsäure
• Melitracen
• Meloxicam
• Meperidin
• Metaxalone
• Methadon
• Methamphetamin
• Mibefradil
• Mifepriston
• Milnacipran
• Mirtazapin
• Morniflumate
• Morphium
• Morphinsulfat-Liposom
• Nabumeton
• Nadroparin
• Nalbuphin
• Naproxen
• Naratriptan
• Nefazodon
• Nelfinavir
• Nepafenac
• Nialamid
• Nicomorphin
• Nifluminsäure
• Nimesulid
• Nimesulid Beta Cyclodextrin
• Nortriptylin
• Ondansetron
• Opipramol
• Opium
• Opiumalkaloide
• Oxaprozin
• Oxycodon
• Oxymorphon
• Oxyphenbutazon
• Palonosetron
• Papaveretum
• Parecoxib
• Paregorisch
• Parnaparin
• Paroxetin
• Pentazocin
• Phenindion
• Phenprocoumon
• Phenylbutazon
• Piketoprofen
• Piritramid
• Piroxicam
• Posaconazol
• Pranoprofen
• Prasugrel
• Proglumetacin
• Propyphenazon
• Proquazone
• Protein C
• Protriptylin
• Remifentanil
• Reviparin
• Ribociclib
• Ritonavir
• Rivaroxaban
• Rizatriptan
• Rofecoxib
• Salicylsäure
• Salsalat
• Saquinavir
• Selexipag
• Sertralin
• Sibutramin
• Simeprevir
• Natriumsalicylat
• Johanniskraut
• Sufentanil
• Sulfinpyrazon
• Sulindac
• Sulodexid
• Sumatriptan
• Tapentadol
• Telaprevir
• Telithromycin
• Tenoxicam
• Tianeptin
• Tiaprofensäure
• Ticagrelor
• Ticlopidin
• Tilidin
• Tinzaparin
• Tirofiban
• Tolfenaminsäure
• Tolmetin
• Tramadol
• Trazodon
• Treprostinil
• Trimipramin
• Troleandomycin
• Tryptophan
• Tucatinib
• Valdecoxib
• Venlafaxin
• Vilazodon
• Vorapaxar
• Voriconazol
• Vortioxetin
• Warfarin
• Ziprasidon
• Zolmitriptan

Interactions with food/tobacco/alcohol

Certain medicines should not be taken during or near food or consumption of certain foods because interactions may occur. Consuming alcohol or tobacco with certain medications can also lead to interactions. The following interactions were selected for their potential significance and are not necessarily exhaustive.

The use of this medicine for any of the following conditions is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or frequency of use of this medication, or give you special instructions about food, alcohol, or tobacco consumption.

• Ethanol
• Grapefruitsaft

Other medical problems

The presence of other medical problems may affect the use of this medicine. Be sure to tell your doctor if you have any other medical problems, especially:

• Bipolare Störung (manisch-depressive Störung) oder Risiko für oder
• Blutungsprobleme bzw
• Glaukom, Winkelblockglaukom oder
• Herz- oder Blutgefäßerkrankung oder
• Herzrhythmusstörungen bzw
• Hypertonie (Bluthochdruck) bzw
• Hyponatriämie (niedriger Natriumspiegel im Blut) oder
• Manie, Geschichte von oder
• Anfälle, Geschichte von oder
• Schlaganfall bzw
• Tachykardie (schneller Herzschlag) oder
• Probleme beim Wasserlassen bzw
• Harnblasenverstopfung – Mit Vorsicht anwenden. Kann diese Bedingungen verschlimmern.

• Nierenerkrankung – Mit Vorsicht verwenden. Die Wirkung kann durch die langsamere Entfernung des Arzneimittels aus dem Körper verstärkt werden.

Proper use of the Fetzima Titration Pack

To improve your condition as much as possible, take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, or take it for longer than your doctor prescribed.

This medicine should be accompanied by 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 result in the capsule contents being released too early.

dosage

The dose of this medicine is different for different patients. Follow your doctor's instructions or the label directions. The following information includes average doses of this medicine only. If your dose is different, do not change it unless your doctor tells you to.

The amount of medicine you take depends on the strength of the medicine. In addition, the number of doses you take each day, the time between doses, and how long you take the medicine depend on the medical problem for which you are using the medicine.

• Für die orale Darreichungsform (Retardkapseln):
  • Bei Depressionen:
    • Erwachsene – zunächst 20 Milligramm (mg) einmal täglich. Nach 2 Tagen wird die Dosis einmal täglich auf 40 mg erhöht. Ihr Arzt kann Ihre Dosis je nach Bedarf anpassen. Allerdings beträgt die Dosis in der Regel nicht mehr als 120 mg pro Tag.
    • Kinder – Die Verwendung wird nicht empfohlen.

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 return to your regular dosing schedule. Do not double the dose.

storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Protect from freezing.

Keep away from children.

Do not keep medications that are outdated or no longer needed.

Ask your doctor how to throw away medicines you don't use.

Precautions when using the Fetzima Titration Pack

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 (e.g. isocarboxazid [Marplan®]phenelzine [Nardil®]selegiline [Eldepryl®]tranylcypromine [Parnate®]). Do not start taking levomilnacipran within two weeks of stopping an MAOI. Wait one week after stopping levomilnacipran before starting an MAOI. Do not use this medicine if you are taking certain MAO inhibitors (e.g., linezolid [Zyvox®], methylene blue injection). Taking them together or not waiting the right time may cause confusion, agitation, agitation, stomach or intestinal distress, sudden high body temperature, extremely high blood pressure, or severe seizures.

Levomilnacipran may cause restlessness, irritability, or other abnormal behavior in some teenagers and young adults. It can also cause some people to have suicidal thoughts and tendencies or become more depressed. Some people may have trouble sleeping, become easily upset, have a large increase in energy, or begin to behave recklessly. If you or your caregiver notice any of these undesirable effects, tell your doctor immediately. Tell the doctor if you or anyone in your family has bipolar disorder (manic-depressive disorder) or has tried to commit suicide.

When levomilnacipran is taken with some medicines, a serious condition called serotonin syndrome can occur. Do not use levomilnacipran with buspirone (Buspar®), fentanyl (Abstral®, Duragesic®), lithium (Eskalith®, Lithobid®), tryptophan, St. John's wort, amphetamines, or some pain or migraine medications (e.g., meperidine, methadone). , Rizatriptan, Sumatriptan, Tramadol, Demerol®, Methadose®, Frova®, Imitrex®, Maxalt®, Relpax®, Ultram®, Zomig®). Consult your doctor first before taking other medicines with levomilnacipran.

This medicine may increase your risk of bleeding problems. Make sure your doctor knows if you are also taking other medicines that thin the blood, including aspirin, nonsteroidal anti-inflammatory drugs also called NSAIDs (e.g., diclofenac, ibuprofen, naproxen, Advil®, Aleve®, Celebrex®, Voltaren®), or warfarin (Coumadin®, Jantoven®).

Do not stop taking this medicine without first consulting your doctor. Your doctor may want you to gradually reduce the amount you take before stopping completely to reduce the risk of withdrawal symptoms. Some examples of withdrawal symptoms include restlessness, difficulty breathing, chest pain, confusion, diarrhea, dizziness or lightheadedness, fast heartbeat, headache, increased sweating, muscle pain, nausea, restlessness, runny nose, trouble sleeping, shaking or shaking, unusual tiredness, weakness, vision problems, or vomiting.

This medicine may cause hyponatremia (low levels of sodium in the blood). This is more common in older patients, those taking diuretic medications, or those whose bodies have reduced fluid levels due to severe diarrhea or vomiting. Contact your doctor immediately if you experience confusion, headache, memory problems, difficulty concentrating, weakness, or feel unsteady when standing.

This medicine may make some people feel dizzy, sleepy, or have less attention than usual. Make sure you know how you react to this medicine before driving, operating machinery, or doing other activities that could be dangerous if you are not alert.

Consult your doctor immediately if you have lost interest in sexual intercourse, have delayed or inability to orgasm in women, are unable to have or maintain an erection in men, or have lost your sexual ability, desire, drive, or performance. These could be symptoms of sexual dysfunction.

Do not take any other medicines unless you have discussed this with your doctor. This includes both prescription and non-prescription (over-the-counter [OTC]) medicines and herbal (e.g. St. John's wort) or vitamin supplements.

Side effects of the Fetzima Titration Pack

In addition to the necessary effects, a medicine may also have some undesirable effects. Although not all of these side effects may occur, medical attention may be required if they occur.

Consult your doctor immediately if any of the following side effects occur:

More common

• Vermindertes Interesse am Geschlechtsverkehr
• schwieriges Wasserlassen
• schneller, hämmernder oder unregelmäßiger Herzschlag oder Puls
• Unfähigkeit, eine Erektion zu haben oder aufrechtzuerhalten
• Verlust der sexuellen Fähigkeiten, des Verlangens, des Antriebs oder der Leistung

Less common

• Angst
• Arm-, Rücken- oder Kieferschmerzen
• verschwommene Sicht
• Brennen, Krabbeln, Jucken, Taubheitsgefühl, Kribbeln, Kribbeln oder Kribbeln
• Brustschmerzen, Unwohlsein, Schweregefühl oder Engegefühl
• trüber Urin
• Verwirrung
• Verringerung der Häufigkeit des Wasserlassens
• Schwierigkeiten beim Wasserlassen (Tröpfeln)
• Schwierigkeiten beim Sprechen
• Schwindel, Ohnmacht oder Benommenheit beim plötzlichen Aufstehen aus einer liegenden oder sitzenden Position
• sabbern
• trockener Mund
• Ohnmacht
• Kopfschmerzen
• Reizbarkeit
• Verlust der Gleichgewichtskontrolle
• Muskelzittern, -zuckungen oder -steifheit
• Brechreiz
• schmerzhaftes Urinieren
• in den Ohren hämmern
• schneller oder unregelmäßiger Herzschlag
• Unruhe
• zittern
• schlurfender Gang
• langsamer Herzschlag
• Steifheit der Gliedmaßen
• Schwitzen
• Atembeschwerden
• Schlafstörungen
• Drehbewegungen des Körpers
• unkontrollierte Bewegungen, insbesondere von Gesicht, Hals und Rücken
• ungewöhnliche Müdigkeit oder Schwäche

Incident not known

• Verzögerter oder fehlender Orgasmus

Some side effects may occur that usually do not require medical attention. These side effects may disappear during treatment as your body gets used to the medicine. Your doctor may also be able to give you ways to prevent or reduce some of these side effects. If any of the following side effects persist or are bothersome, or if you have any questions, contact your doctor:

More common

• Schwierigkeiten beim Stuhlgang (Stuhl)
• vermehrtes Schwitzen
• Erbrechen

Less common

• Völlegefühl oder Völlegefühl
• verminderter Appetit
• trockene Augen
• trockene Haut
• Gefühl von Wärme
• Kopfschmerzen, stark und pochend
• Nesselsucht oder Quaddeln, Juckreiz oder Hautausschlag
• Gas geben
• rotes Auge
• rotes Gesicht, Hals, Arme und gelegentlich auch die obere Brust
• Magenschmerzen
• plötzliches Schwitzen
• Durst
• Gähnen

Incident not known

• Nachlassender Geruch
• Verlust des Geruchssinns

Some patients may also experience other side effects not listed. If you notice other side effects, contact your doctor.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Commonly used brand names

In the USA

• Fetzima
• Fetzima-Titrationspaket

Available dosage forms:

• Kapsel, verlängerte Veröffentlichung

Therapeutic class: Antidepressant

Pharmacological class: Serotonin/norepinephrine reuptake inhibitors

• Verursacht Fetzima Gewichtsverlust oder Gewichtszunahme?
• Verursacht Fetzima Haarausfall?

More information