Savella

DRUG DESCRIPTION

Milnacipran hydrochloride is a selective norepinephrine and serotonin reuptake inhibitor; it inhibits norepinephrine uptake with greater potency than serotonin. It is a racemic mixture with the chemical name: (±)-[1R(S),2S(R)]-2-(aminomethyl)-N,N-diethyl-1phenylcyclopropanecarboxamide hydrochloride. The structural formula is:

SAVELLAź (milnacipran HCl) Structural Formula Illustration

Milnacipran hydrochloride is a white to off-white crystalline powder with a melting point of 179°C. It is freely soluble in water, methanol, ethanol, chloroform, and methylene chloride and sparingly soluble in diethyl ether. It has an empirical formula of C15H23ClN2O and a molecular weight of 282.8 g/mol.

Savella is available for oral administration as film-coated tablets containing 12.5 mg, 25 mg, 50 mg, and 100 mg milnacipran hydrochloride. Each tablet also contains dibasic calcium phosphate, povidone, carboxymethylcellulose calcium, colloidal silicon dioxide, magnesium stearate, and talc as inactive ingredients. Additionally, the following inactive ingredients are also present as components of the film coat:

12.5 mg:
FD&C Blue #2 Aluminum Lake, hypromellose, polyethylene glycol, titanium dioxide

25 mg:
Hypromellose, polyethylene glycol, titanium dioxide

50 mg:
Hypromellose, polyethylene glycol, titanium dioxide

100 mg:
FD&C Red #40 Aluminum Lake, hypromellose, polyethylene glycol, titanium dioxide

What are the possible side effects of milnacipran (Savella)?

Get emergency medical help if you have any of these signs of an allergic reaction: skin rash or hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have...

Read All Potential Side Effects and See Pictures of Savella »

What are the precautions when taking milnacipran hcl tablets (Savella)?

Before taking milnacipran, tell your doctor or pharmacist if you are allergic to it, or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, alcohol use, glaucoma (narrow-angle), personal or family history of psychiatric disorders (such as bipolar/manic-depressive disorder), personal or family history of suicide attempts, high blood pressure, heart problems (such as chest pain, heart attack, fast heartbeat), seizure disorder, severe loss of body water (dehydration), stomach/intestinal ulcers, mineral imbalance (low level of sodium...

Read All Potential Precautions of Savella »


Savella Consumer (continued)

SIDE EFFECTS: See also Warning section.

Nausea, vomiting, dry mouth, constipation, loss of appetite, dizziness, increased sweating, headache, or hot flashes (flushing) may occur. If any of these effects persist or worsen, tell your doctor promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: fast/pounding heartbeat, changes in sexual ability, decreased interest in sex, painful/difficult urination.

Tell your doctor immediately if any of these rare but very serious side effects occur: seizures, yellowing eyes/skin, dark urine, severe stomach/abdominal pain, black/bloody stools, vomit that looks like coffee grounds, easy bruising/bleeding.

This medication may rarely cause a very serious condition called serotonin syndrome. The risk increases when this medication is used with other drugs which increase serotonin (See Drug Interactions section). Before taking this drug, tell your doctor if you take any of those medications. Serotonin syndrome may be more likely when you start or increase the dose of any of those medications. Seek immediate medical attention if you develop some of the following symptoms: hallucinations, unusual restlessness, loss of coordination, fast heartbeat, severe dizziness, unexplained fever, severe nausea/vomiting/diarrhea, twitchy muscles.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking milnacipran, tell your doctor or pharmacist if you are allergic to it, or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, alcohol use, glaucoma (narrow-angle), personal or family history of psychiatric disorders (such as bipolar/manic-depressive disorder), personal or family history of suicide attempts, high blood pressure, heart problems (such as chest pain, heart attack, fast heartbeat), seizure disorder, severe loss of body water (dehydration), stomach/intestinal ulcers, mineral imbalance (low level of sodium in the blood), painful/difficult urination (for example, due to enlarged prostate).

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages. Drinking alcohol can also increase your risk of liver problems.

Older adults may be at greater risk for mineral imbalance (low level of sodium in the blood) while using this drug, especially if they are also taking "water pills" (diuretics) with this medication.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. Babies born to mothers who have used this drug during the last 3 months of pregnancy may infrequently develop withdrawal symptoms such as feeding/breathing difficulties, seizures, muscle stiffness, or constant crying. If you notice any of these symptoms in your newborn, tell the doctor promptly.

It is unknown if this medication passes into breast milk. Discuss the risks and benefits with your doctor before breast-feeding.


Savella Patient Information Including Side Effects

Brand Names: Savella

Generic Name: milnacipran (Pronunciation: mil NA si pran)

  • What is milnacipran (Savella)?
  • What are the possible side effects of milnacipran (Savella)?
  • What is the most important information I should know about milnacipran (Savella)?
  • What should I discuss with my healthcare provider before taking milnacipran (Savella)?
  • How should I take milnacipran (Savella)?
  • What happens if I miss a dose (Savella)?
  • What happens if I overdose (Savella)?
  • What should I avoid while taking milnacipran (Savella)?
  • What other drugs will affect milnacipran (Savella)?
  • Where can I get more information?

What is milnacipran (Savella)?

Milnacipran affects certain chemicals in the brain called neurotransmitters. An abnormality in these chemicals is thought to be related to fibromyalgia. Milnacipran is not used to treat depression but how it works in the body is similar to how some antidepressants work.

Milnacipran is used to treat a chronic pain disorder called fibromyalgia.

Milnacipran may also be used for other purposes not listed in this medication guide.

What are the possible side effects of milnacipran (Savella)?

Get emergency medical help if you have any of these signs of an allergic reaction: skin rash or hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have any of these serious side effects:

  • fast or pounding heartbeats;
  • painful or difficult urination;
  • easy bruising or bleeding, nosebleeds, bloody or tarry stools, coughing up blood;
  • confusion, hallucinations, severe weakness, seizure (convulsions);
  • high fever, sweating, chills or goose bumps, memory problems, trouble concentrating, loss of coordination, overactive reflexes, vomiting, diarrhea;
  • high blood pressure (severe headache, blurred vision, buzzing in your ears, chest pain, shortness of breath, uneven heartbeats); or
  • stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

  • constipation;
  • dry mouth, nausea, stomach pain, heartburn, bloating;
  • dizziness, drowsiness, headache, tired feeling;
  • stuffy nose, sneezing, or other cold symptoms;
  • sleep problems (insomnia);
  • swelling in your hands or feet;
  • hot flashes, sweating, itching, mild skin rash;
  • numbness or tingling;
  • blurred vision; or
  • decreased sex drive, impotence, or difficulty having an orgasm.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about milnacipran (Savella)?

Do not take milnacipran together with thioridazine (Mellaril), or a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate). You must wait at least 14 days after stopping an MAOI before you can take milnacipran. After you stop taking milnacipran, you must wait at least 5 days before you start taking an MAOI.

You may have thoughts about suicide when you first start taking this medication, especially if you are younger than 24 years old. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.

Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Avoid drinking alcohol while taking milnacipran. Alcohol may increase the risk of damage to your liver.

Cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety can add to sleepiness caused by milnacipran. Tell your doctor if you regularly use any of these other medicines.

Milnacipran can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

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