Milnacipran (Oral route)
Milnacipran hydrochloride is a selective serotonin and norepinephrine reuptake inhibitor (SNRI), similar to drugs used to treat depression and 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 with placebo in adults beyond age 24 years, and there was a reduction in risk with antidepressants compared with placebo in adults aged 65 or older. This risk must be balanced with clinical need. Monitor patients closely for clinical worsening, suicidality, or unusual changes in behavior. Advise families and caregivers 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 .
Central Nervous System Agent
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:
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.
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.
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.
|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.|
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.
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.
- Methylene Blue
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.
- Amtolmetin Guacil
- Antithrombin III Human
- Choline Salicylate
- Dermatan Sulfate
- Flufenamic Acid
- Iobenguane I 123
- Mefenamic Acid
- Niflumic Acid
- Nimesulide Beta Cyclodextrin
- Pentosan Polysulfate Sodium
- Salicylic Acid
- Sodium Salicylate
- Tiaprofenic Acid
- Tolfenamic Acid
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.
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
- Glaucoma, angle-closure 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
- Painful or difficult urination, history of or
- Seizures, history of or
- Urinary tract blockage Use with caution. May make these conditions worse.
- Kidney disease, moderate or severe Use with caution. The effects may be increased because of slower removal of the medicine from the body.
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.
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:
- 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.
- For treatment of fibromyalgia:
If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
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:
- More common
- Blurred vision
- body aches or pain
- difficulty with breathing
- ear congestion
- fast, irregular, pounding, or racing heartbeat or pulse
- fear or nervousness
- increased sweating
- loss of voice
- nasal congestion
- pounding in the ears
- runny nose
- slow or fast heartbeat
- 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
- 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
- Bladder pain
- bloating or swelling of the face, arms, hands, lower legs, or feet
- bloody or cloudy urine
- feeling sad or empty
- frequent urge to urinate
- full or bloated feeling
- increased or decreased weight
- 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
- trouble concentrating
- trouble sleeping
- unusual weight gain or loss
- Incidence not known
- black, tarry stools
- bleeding gums
- blistering, peeling, or loosening of the skin
- blood in the urine or stools
- confusion as to time, place, or person
- dark-colored urine
- decreased urine output
- difficulty with swallowing
- general tiredness and weakness
- high fever
- holding false beliefs that cannot be changed by fact
- increased sweating
- increased thirst
- 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 skin lesions, often with a purple center
- red, irritated eyes
- seeing, hearing, or feeling things that are not there
- 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
- 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
- trembling and shaking of the fingers and hands
- unusual bleeding or bruising
- unusual excitement, nervousness, or restlessness
- unusually pale skin
- upper right abdominal or stomach pain
- weight gain
- yellow eyes and skin
- 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
- swelling of the testes
- Acid or sour stomach
- change in taste
- excess air or gas in the stomach or intestines
- full feeling
- 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
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:
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:
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: 9/15/2016