Savella (Milnacipran HCl Tablets) Drug Information: Description, User Reviews, Drug Side Effects, Interactions

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May 26, 2012

Savella

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SAVELLA®
(milnacipran HCl)

WARNING

SUICIDALITY AND ANTIDEPRESSANT DRUGS

Savella is a selective serotonin and norepinephrine reuptake inhibitor (SNRI), similar to some drugs used for the treatment of depression and other psychiatric disorders. Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of such drugs in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on Savella should be monitored appropriately and observed 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. Savella is not approved for use in the treatment of major depressive disorder. Savella is not approved for use in pediatric patients [see WARNINGS AND PRECAUTIONS, Use in Specific Populations].

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:

SAVELLA® (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 »

Last reviewed on RxList: 11/18/2011
This monograph has been modified to include the generic and brand name in many instances.