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Milnacipran (Oral route)

Pronunciation:

mil-NA-si-pran

Brand Names:

  • Savella

Dosage Forms:

  • Tablet

Warnings:

Oral route(Tablet)

Milnacipran hydrochloride is a selective serotonin and norepinephrine reuptake inhibitor (SNRI) similar to antidepressants and drugs to treat other psychiatric disorders. Antidepressants increased the risk compared with placebo of suicidal thinking and behavior in children, adolescents, and young adults in short-term studies with major depressive disorder (MDD) and other psychiatric disorders. Short term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24 years, and there was a reduction in risk with antidepressants compared to placebo in adults aged 65 or older. This risk must be balanced with the clinical need. Monitor patients closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Milnacipran hydrochloride is not approved for treatment of MDD or for use in pediatric patients .

Classifications:

Therapeutic—

Central Nervous System Agent

Pharmacologic—

Serotonin/Norepinephrine Reuptake Inhibitor

Uses of This Medicine:

Milnacipran is used to treat a condition called fibromyalgia, which causes muscle pain and stiffness.

Milnacipran belongs to a group of medicines known as selective serotonin and norepinephrine reuptake inhibitors (SNRIs). These medicines work by increasing the activity of certain chemicals in the brain called serotonin and norepinephrine.

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:

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.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of milnacipran in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of milnacipran 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 milnacipran.

Pregnancy—

Pregnancy CategoryExplanation
All TrimestersCAnimal 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.

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.

Other 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.

  • Furazolidone
  • Iproniazid
  • Isocarboxazid
  • Linezolid
  • Methylene Blue
  • Moclobemide
  • Phenelzine
  • Procarbazine
  • Rasagiline
  • 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
  • Acrivastine
  • Almotriptan
  • Amisulpride
  • Amitriptyline
  • Amoxapine
  • Amtolmetin Guacil
  • Anagrelide
  • Ancrod
  • Anisindione
  • Antithrombin III Human
  • Apixaban
  • Aripiprazole
  • Aspirin
  • Avitriptan
  • Benperidol
  • Bivalirudin
  • Bromfenac
  • Bufexamac
  • Bupropion
  • Celecoxib
  • Chlorpromazine
  • Choline Salicylate
  • Cilostazol
  • Citalopram
  • Clonixin
  • Clopidogrel
  • Clovoxamine
  • Clozapine
  • Cyclobenzaprine
  • Danaparoid
  • Defibrotide
  • Dermatan Sulfate
  • Desirudin
  • Desvenlafaxine
  • Dexibuprofen
  • Dexketoprofen
  • Dextromethorphan
  • Diclofenac
  • Dicumarol
  • Diflunisal
  • Dipyridamole
  • Dipyrone
  • Dolasetron
  • Duloxetine
  • Eletriptan
  • Epoprostenol
  • Eptifibatide
  • Escitalopram
  • Etodolac
  • Etofenamate
  • Etoricoxib
  • Felbinac
  • Femoxetine
  • Fenoprofen
  • Fentanyl
  • Fepradinol
  • Feprazone
  • Floctafenine
  • Fluconazole
  • Flufenamic Acid
  • Fluoxetine
  • Fluphenazine
  • Flurbiprofen
  • Fluvoxamine
  • Fondaparinux
  • Frovatriptan
  • Granisetron
  • Haloperidol
  • Heparin
  • Ibuprofen
  • Ibuprofen Lysine
  • Iloprost
  • Indomethacin
  • Iobenguane I 123
  • Ketoprofen
  • Ketorolac
  • Lamifiban
  • Levomilnacipran
  • Lexipafant
  • Lithium
  • Lorcaserin
  • Lornoxicam
  • Loxapine
  • Loxoprofen
  • Lumiracoxib
  • Meclofenamate
  • Mefenamic Acid
  • Meloxicam
  • Meperidine
  • Mesoridazine
  • Metoclopramide
  • Mirtazapine
  • Molindone
  • Morniflumate
  • Nabumetone
  • Naproxen
  • Naratriptan
  • Nefazodone
  • Nepafenac
  • Niflumic Acid
  • Nimesulide
  • Olanzapine
  • Oxaprozin
  • Oxyphenbutazone
  • Palonosetron
  • Parecoxib
  • Paroxetine
  • Pentosan Polysulfate Sodium
  • Perphenazine
  • Phenindione
  • Phenprocoumon
  • Phenylbutazone
  • Piketoprofen
  • Pimozide
  • Piroxicam
  • Pranoprofen
  • Proglumetacin
  • Promazine
  • Propyphenazone
  • Proquazone
  • Quetiapine
  • Risperidone
  • Rizatriptan
  • Rofecoxib
  • Salicylic Acid
  • Salsalate
  • Sertraline
  • Sibrafiban
  • Sibutramine
  • Sodium Salicylate
  • Sulfinpyrazone
  • Sulindac
  • Sulodexide
  • Sumatriptan
  • Tapentadol
  • Tenoxicam
  • Thioridazine
  • Thiothixene
  • Tiaprofenic Acid
  • Ticlopidine
  • Tirofiban
  • Tolfenamic Acid
  • Tolmetin
  • Tramadol
  • Trazodone
  • Trifluoperazine
  • Tryptophan
  • Valdecoxib
  • Venlafaxine
  • Vilazodone
  • Vortioxetine
  • Warfarin
  • Xemilofiban
  • Zimeldine
  • Ziprasidone
  • Zolmitriptan

Other interactions—

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

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:

  • Bleeding problems or
  • Depression, history of or
  • Enlarged prostate or
  • Heart disease or
  • Heart rhythm problems or
  • Hypertension (high blood pressure) or
  • Hyponatremia (low sodium in the blood) or
  • Liver disease or
  • Mania, history of or
  • Narrow-angle glaucoma, controlled or
  • Painful or difficult urination, history of or
  • Seizures, history of or
  • Urinary tract 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.
  • Narrow-angle glaucoma, uncontrolled—Should not be used in patients with this condition.

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 these instructions carefully. Ask your doctor if you have any questions.

You may take this medicine with or without food.

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 (tablets):
    • For treatment of fibromyalgia:
      • Adults—
        • Day 1: 12.5 milligram (mg) once.
        • Days 2 to 3: 25 mg per day (12.5 mg two times a day).
        • Days 4 to 7: 50 mg per day (25 mg two times a day).
        • After day 7: 100 mg per day (50 mg two times a day).
        • Your doctor may increase your dose up to 200 mg per day (100 mg two times a day).
      • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, 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.

Precautions While Using This Medicine:

It is important that your doctor check your progress at regular visits to allow for changes in your dose and to help reduce any side effects.

Milnacipran may cause some people 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. If you or your caregiver notice any of these side effects, tell your doctor right away.

Do not take this medicine during the 2 weeks (14 days) after stopping a monoamine oxidase inhibitor (MAOI) (eg, isocarboxazid [Marplan®], linezolid [Zyvox®], methylene blue injection, phenelzine [Nardil®], selegiline [Eldepryl®], or tranylcypromine [Parnate®]). Do not take an MAO inhibitor for at least 5 days after stopping milnacipran. Talk to your doctor about this if you have questions.

Make sure your doctor knows if you are also using aspirin, NSAIDs (eg, ibuprofen, naproxen, Advil®, Aleve®, Celebrex®, Motrin®), or a blood thinner (eg, warfarin, Coumadin®). Milnacipran may increase your risk of bleeding problems when taken together with these medicines.

Make sure your doctor knows about all the other medicines you are using. This medicine may cause a serious condition called serotonin syndrome when taken with certain medicines such as St. John's wort, buspirone, fentanyl, lithium, tryptophan, other medicines to treat depression, or some pain or migraine medicines (eg, rizatriptan [Maxalt®], sumatriptan [Imitrex®], tramadol [Ultram®], or zolmitriptan [Zomig®]. Check with your doctor first before taking any other medicines.

You will also need to have your blood pressure and pulse measured before starting and while you are using this medicine. If you notice any change to your recommended blood pressure or pulse rate, call your doctor right away. If you have questions about this, talk to your doctor.

Liver problems may occur while you are using this medicine. Check with your doctor right away if you are having more than one of these symptoms: abdominal or stomach pain or tenderness, clay-colored stools, dark urine, decreased appetite, fever, headache, itching, loss of appetite, nausea and vomiting, skin rash, swelling of the feet or lower legs, unusual tiredness or weakness, or yellow eyes or skin.

Avoid taking alcohol while you are using this medicine.

This medicine may cause some people to become 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 suddenly stop taking this medicine without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping it completely to decrease the chance of side effects.

Side Effects of This Medicine:

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
Blurred vision
body aches or pain
chills
cough
difficulty with breathing
dizziness
ear congestion
fast, irregular, pounding, or racing heartbeat or pulse
fear or nervousness
fever
headache
increased sweating
loss of voice
nasal congestion
pounding in the ears
runny nose
slow or fast heartbeat
sneezing
sore throat
unusual tiredness or weakness
Less common
Back pain
burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
chest pain or discomfort
chills
decrease in frequency of urination
decrease in urine volume
difficult or painful urination
difficulty in passing urine (dribbling)
frequent urination
groin pain
muscle aches
pain or burning with urination
shakiness in the legs, arms, hands, or feet
swollen, tender prostate
tightness in the chest
Rare
Bladder pain
bloating or swelling of the face, arms, hands, lower legs, or feet
bloody or cloudy urine
bruise
discouragement
fall
feeling sad or empty
frequent urge to urinate
full or bloated feeling
heartburn
increased or decreased weight
irritability
lack of appetite
loss of interest or pleasure
lower back or side pain
pressure in the stomach
rapid weight gain
swelling of the abdominal or stomach area
tingling of the hands or feet
tiredness
trouble concentrating
trouble sleeping
unusual weight gain or loss
vomiting
Incidence not known
Agitation
black, tarry stools
bleeding gums
blistering, peeling, or loosening of the skin
blood in the urine or stools
coma
confusion as to time, place, or person
convulsions
dark-colored urine
decreased urine output
diarrhea
difficulty with swallowing
general tiredness and weakness
high fever
holding false beliefs that cannot be changed by fact
increased sweating
increased thirst
itching
joint or muscle pain
light-colored stools
loss of balance control
loss of consciousness
mask-like face
muscle cramps or spasms
muscle pain or stiffness
overactive reflexes
pinpoint red spots on the skin
poor coordination
red irritated eyes
red skin lesions, often with a purple center
restlessness
seeing, hearing, or feeling things that are not there
seizures
severe muscle stiffness
shuffling walk
slowed movements
slurred speech
sores, ulcers, or white spots on the lips or in the mouth
stiffness of the arms and legs
sweating
swelling of the face, ankles, fingers, or lower legs
swollen glands
talking or acting with excitement you cannot control
tic-like (jerky) movements of the head, face, mouth, and neck
tiredness
trembling and shaking of the fingers and hands
twitching
unusual bleeding or bruising
unusual excitement, nervousness, or restlessness
unusually pale skin
upper right abdominal or stomach pain
weight gain
yellow eyes and skin

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
Feeling of warmth
headache, severe and throbbing
redness of the face, neck, arms, and occasionally, upper chest
sudden sweating
Less common
Abdominal or stomach pain
change or problem with discharge of semen
decreased appetite
decreased interest in sexual intercourse
inability to have or keep an erection
loss in sexual ability, desire, drive, or performance
not able to ejaculate semen
rash
swelling of the testes
Rare
Acid or sour stomach
belching
bloated
change in taste
excess air or gas in the stomach or intestines
full feeling
heartburn
indigestion
irritability
loss of taste
night sweats
passing gas
sleepiness or unusual drowsiness
stomach discomfort, upset, or pain
Incidence not known
Swelling of the breasts or unusual milk production
unexpected or excess milk flow from the breasts

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: 11/4/2014

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