Fetzima

Fetzima is a prescription medication used to treat depression. Fetzima belongs to a group of drugs called serotonin norepinephrine reuptake inhibitors (SNRIs), which work by increasing serotonin and norepinephrine levels in the brain to maintain mental balance and improve mood.

Do not open, chew, or crush Fetzima capsules. Swallow capsules whole.

Common side effects of Fetzima include nausea or vomiting, constipation, sweating, increased heart rate, erectile dysfunction, and palpitations.

Fetzima can also cause blurred vision and/or dizziness. Do not drive or operate heavy machinery until you know how Fetzima affects you.

Fetzima is a prescription medication used to treat depression.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Forest Pharmaceuticals, Inc.

Serious side effects have been reported with Fetzima. See the “Fetzima Precautions” section.

Common side effects of Fetzima include the following:

• nausea or vomiting
• constipation
• sweating
• increased heart rate
• erectile dysfunction
• palpitations

This is not a complete list of Fetzima side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

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

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• Triptans such as sumatriptan (Imitrex, Treximet), eletriptan (Relpax), almotriptan (Axert), frovatriptan (Frova), naratriptan (Amerge), rizatriptan (Maxalt), and zolmitriptan (Zomig)
• Medications that could lead to serotonin syndrome such as citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), desvenlafaxine (Pristiq), nefazodone (Serzone), paroxetine (Paxil, Pexeva), sertraline (Zoloft), venlafaxine (Effexor), trimipramine (Surmontil), amitriptyline (Elavil), nortriptyline (Pamelor, Aventyl), protriptyline (Vivactil), and clomipramine (Anafranil), and linezolid (Zyvox)
• Monoamine oxidase inhibitors such as isocarboxazid (Marplan), phenelzine (Nardil), tranylcypromine (Parnate), selegiline (Emsam, Eldepryl, Zelapar), rasagiline (Azilect)

• tramadol (Ultram)
• fentanyl (Duragesic)
• Tryptophan 
• St. John's Wort
• Aspirin and other NSAIDs (nonsteroidal anti-inflammatory drugs) such as celecoxib (Celebrex), diclofenac (Cambia, Cataflam, Flector, Voltaren, Zipsor and others), etodolac (Lodine), ibuprofen (Advil, Motrin, Nuprin), indomethacin (Indocin, Indocin SR), ketoprofen (Orudis, Actron, Oruvail), ketorolac (Toradol), meloxicam (Mobic), nabumetone (Relafen), naproxen (Naprosyn), naproxen sodium (Aleve, Anaprox, Naprelan), oxaprozin (Daypro), piroxicam (Feldene)

• Blood thinners such as warfarin (Coumadin, Jantoven)
• Diuretics (water pills) such as acetazolamide (Diamox), amiloride (Midamor), bumetanide (Bumex), chlorothiazide (Diuril), chlorthalidone (Thalitone), ethacrynic acid (Edecrin), furosemide (Lasix), hydrochlorothiazide (Microzide, HCTZ), metolazone (Zaroxolyn), torsemide (Demadex), triamterene (Dyrenium, Dyazide, Maxzide)

This is not a complete list of Fetzima drug interactions. Ask your doctor or pharmacist for more information.

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

• High blood pressure. Your healthcare provider should monitor your blood pressure before and while you are taking Fetzima. If you have high blood pressure, it should be controlled before you start taking this medication
• Increased heart rate
• Abnormal bleeding: Fetzima 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 Fetzima without first talking to your healthcare provider. Stopping Fetzima 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

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

Do not take Fetzima if you:

• are allergic to Fetzima 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

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Fetzima, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Fetzima, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Fetzima or to any of its ingredients
• Have high blood pressure or tend to have a fast heart rate
• Have heart or kidney problems
• Have or had bleeding problems. Fetzima may increase your risk of bleeding or bruising
• Have an eye condition called glaucoma
• Have or had trouble urinating
• Have or had mania, bipolar disorder (manic depression), seizures or convulsions
• Have low salt (sodium) levels in your blood
• Drink alcohol
• Are pregnant, nursing, or are planning to become pregnant or to breastfeed

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Fetzima falls into category C. There are no well-controlled studies that have been done in pregnant women. Fetzima should be used during pregnancy only if the possible benefit outweighs the possible risk to the unborn baby.

It is not known if Fetzima crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Fetzima.

Take Fetzima exactly as prescribed.

Fetzima comes in an extended release capsule form and is taken once a day, with or without food.

Do not open, chew, or crush Fetzima capsules. Swallow capsules whole.

Avoid drinking alcohol while taking drug Fetzima.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Fetzima at the same time.

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 Fetzima 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. For patients with moderate renal impairment, the dose should not exceed 40 mg once daily.

If you take too much Fetzima, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store Fetzima at room temperature 68°F to 77°F (20°C to 25°C).
• Keep this and all medicines out of the reach of children

Suicidality and Antidepressant Drugs

Antidepressants increased the risk of suicidal thoughts and behavior in children, teenagers, and young adults.
In patients of all ages who are started on antidepressant therapy, watch closely for worsening depression and for suicidal thoughts and behaviors. Families and caregivers of patients on antidepressants should talk with the patient's doctor if depression becomes worse.
Fetzima is not approved for use in patients under 18.