Go PLR Content Marketing Cayman Islands: milnacipran

mil-NA-si-pran

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 to 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, and there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and 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 .

Commonly used brand name(s)

In the U.S.

Savella

Available Dosage Forms:

Tablet

Pharmacologic Class: Serotonin/Norepinephrine Reuptake Inhibitor

Uses For milnacipran

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.

milnacipran is available only with your doctor's prescription.

Before Using milnacipran

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 milnacipran, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to milnacipran 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 age to the effects of milnacipran 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 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 Category	Explanation
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.

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 milnacipran, 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 milnacipran 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.

Brofaromine

Clorgyline

Furazolidone

Iproniazid

Isocarboxazid

Lazabemide

Linezolid

Moclobemide

Nialamide

Pargyline

Phenelzine

Procarbazine

Rasagiline

Selegiline

Toloxatone

Tranylcypromine

Using milnacipran 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

Acenocoumarol

Almotriptan

Amisulpride

Anagrelide

Ancrod

Anisindione

Antithrombin III Human

Aripiprazole

Aspirin

Avitriptan

Benperidol

Bivalirudin

Chlorpromazine

Cilostazol

Citalopram

Clopidogrel

Clovoxamine

Clozapine

Danaparoid

Defibrotide

Dermatan Sulfate

Desirudin

Desvenlafaxine

Dextromethorphan

Dicumarol

Dipyridamole

Duloxetine

Eletriptan

Epoprostenol

Eptifibatide

Escitalopram

Femoxetine

Fluoxetine

Fluphenazine

Fluvoxamine

Fondaparinux

Frovatriptan

Haloperidol

Heparin

Iloprost

Lamifiban

Lexipafant

Lithium

Loxapine

Mesoridazine

Metoclopramide

Molindone

Naratriptan

Nefazodone

Olanzapine

Paroxetine

Pentosan Polysulfate Sodium

Perphenazine

Phenindione

Phenprocoumon

Pimozide

Promazine

Quetiapine

Risperidone

Rizatriptan

Sertraline

Sibrafiban

Sibutramine

Sulfinpyrazone

Sulodexide

Sumatriptan

Tapentadol

Thioridazine

Thiothixene

Ticlopidine

Tirofiban

Tramadol

Trifluoperazine

Tryptophan

Venlafaxine

Vilazodone

Warfarin

Xemilofiban

Zimeldine

Ziprasidone

Zolmitriptan

Using milnacipran with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Aceclofenac

Acemetacin

Alclofenac

Benoxaprofen

Bromfenac

Bufexamac

Carprofen

Celecoxib

Clonixin

Dexketoprofen

Diclofenac

Diflunisal

Dipyrone

Droxicam

Etodolac

Etofenamate

Etoricoxib

Felbinac

Fenbufen

Fenoprofen

Fentiazac

Floctafenine

Flufenamic Acid

Flurbiprofen

Ibuprofen

Indomethacin

Indoprofen

Isoxicam

Ketoprofen

Ketorolac

Lornoxicam

Meclofenamate

Mefenamic Acid

Meloxicam

Morniflumate

Nabumetone

Naproxen

Niflumic Acid

Nimesulide

Oxaprozin

Parecoxib

Phenylbutazone

Pirazolac

Piroxicam

Pirprofen

Propyphenazone

Proquazone

Rofecoxib

Sulindac

Suprofen

Tenidap

Tenoxicam

Tiaprofenic Acid

Tolmetin

Valdecoxib

Zomepirac

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 milnacipran 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 milnacipran, or give you special instructions about the use of food, alcohol, or tobacco.

Ethanol

Proper Use of milnacipran

Take milnacipran 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.

milnacipran should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

You may take milnacipran with or without food.

Dosing

The dose of milnacipran 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 milnacipran. 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 milnacipran, 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.

Precautions While Using milnacipran

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.

It is important to tell your doctor if you become pregnant. Your doctor may want you to join a pregnancy registry for patients taking milnacipran.

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 milnacipran during the 2 weeks (14 days) after stopping a monoamine oxidase inhibitor (MAOI) (e.g., isocarboxazid [Marplan®], phenelzine [Nardil®], selegiline [Eldepryl®], or tranylcypromine [Parnate®]). Do not take an MAO inhibitor for at least 5 days after stopping milnacipran. If you do, you may have serious side effects such as seizures. Talk to your doctor about this if you have questions.

Make sure your doctor knows if you are also using aspirin, NSAIDs (e.g., ibuprofen, naproxen, Advil®, Aleve®, Celebrex®, or Motrin®), or a blood thinner (e.g., warfarin or 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. milnacipran may cause a serious condition called serotonin syndrome or neuroleptic malignant syndrome (NMS)-like reactions when taken with certain medicines such as lithium, tryptophan, or some pain or migraine medicines (e.g., 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 milnacipran. 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 milnacipran. Stop using milnacipran and check with your doctor right away if you are having more than one of these symptoms: abdominal 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 milnacipran.

milnacipran may cause some people to become less alert than they are normally. Make sure you know how you react to milnacipran before you drive, use machines, or do anything else that could be dangerous if you are not alert.

Do not suddenly stop taking milnacipran 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.

milnacipran 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

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 discomfort

chest pain

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

shortness of breath

swollen, tender prostate

tightness in the chest

wheezing

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 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

sleeplessness

sudden sweating

unable to sleep

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.

See also: milnacipran side effects (in more detail)

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More milnacipran resources

Milnacipran Side Effects (in more detail)
Milnacipran Dosage
Milnacipran Use in Pregnancy & Breastfeeding
Milnacipran Drug Interactions
Milnacipran Support Group
206 Reviews for Milnacipran - Add your own review/rating

Milnacipran MedFacts Consumer Leaflet (Wolters Kluwer)

Savella Prescribing Information (FDA)

Savella Consumer Overview

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Go PLR Content Marketing Cayman Islands

Wednesday, September 14, 2016

milnacipran