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SAVELLA

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Overview

What is SAVELLA?

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-1-phenylcyclopropanecarboxamide hydrochloride. The structural formula is:

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 Red #40 Aluminum Lake dye, hypromellose, polyethylene glycol, titanium dioxide

25 mg:

Hypromellose, polyethylene glycol, titanium dioxide

50 mg:

FD&C Blue #1, Blue #2, and Yellow #5 Aluminum Lake dyes; hypromellose; polyethylene glycol; titanium dioxide

100 mg:

FD&C Blue #1 Aluminum Lake dye, hypromellose, polyethylene glycol, titanium dioxide



What does SAVELLA look like?



What are the available doses of SAVELLA?

Film-coated, immediate release tablets in four strengths: 12.5 mg, 25 mg, 50 mg, and 100 mg of milnacipran hydrochloride.

12.5 mg tablets are round, pink, "F" on one side, "L" on the reverse;

25 mg tablets are round, white, "FL" on one side, "25" on the reverse;

50 mg tablets are oval, green, "FL" on one side, "50" on the reverse;

100 mg tablets are oval, blue, "FL" on one side, "100" on the reverse

[ () ].

What should I talk to my health care provider before I take SAVELLA?

How should I use SAVELLA?

Savella is indicated for the management of fibromyalgia.

Savella is not approved for use in pediatric patients [].

Savella is given orally with or without food.

Taking Savella with food may improve the tolerability of the drug.


What interacts with SAVELLA?

Sorry No Records found


What are the warnings of SAVELLA?

Sorry No Records found


What are the precautions of SAVELLA?

Sorry No Records found


What are the side effects of SAVELLA?

Sorry No records found


What should I look out for while using SAVELLA?

Use of monoamine oxidase inhibitors concomitantly or in close temporal proximity ()

Use in patients with uncontrolled narrow-angle glaucoma ()

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 ()

]


What might happen if I take too much SAVELLA?

There is limited clinical experience with Savella overdose in humans. In clinical trials, cases of acute ingestions up to 1000 mg, alone or in combination with other drugs, were reported with none being fatal.

In postmarketing experience, fatal outcomes have been reported for acute overdoses primarily involving multiple drugs but also with Savella only. The most common signs and symptoms included increased blood pressure, cardio-respiratory arrest, changes in the level of consciousness (ranging from somnolence to coma), confusional state, dizziness, and increased hepatic enzymes.


How should I store and handle SAVELLA?

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:12.5-mg tablets:Blue, round, film-coated tablets, debossed with “F” on one side and “L” on the reverse Bottles of 60:               NDC 0456-1512-60 10X10 Unit Dose:      NDC 0456-1512-63 25-mg tablets:White, round, film-coated tablets, debossed with “FL” on one side and “25” on the reverse Bottles of 60:              NDC 0456-1525-60 Bottles of 180:            NDC 0456-1525-01 10X10 Unit Dose:      NDC 0456-1525-63 50-mg tablets:White, oval-shaped, film-coated tablets, debossed with “FL” on one side and “50” on the reverse Bottles of 60:              NDC 0456-1550-60 Bottles of 180:            NDC 0456-1550-01 10X10 Unit Dose:      NDC 0456-1550-63 100-mg tablets:Pink, oval-shaped film-coated tablets, debossed with “FL” on one side and “100” on the reverse Bottles of 60:              NDC 0456-1510-60 Bottles of 180:            NDC 0456-1510-01 10X10 Unit Dose:      NDC 0456-1510-63 Titration Pack:4-Week Titration Pack: NDC 0456-1500-55 Blister package containing 55 tablets: 5 x 12.5-mg tablets, 8 x 25-mg tablets, and 42 x 50 mg tablets. 12.5-mg tablets:Blue, round, film-coated tablets, debossed with “F” on one side and “L” on the reverse Bottles of 60:               NDC 0456-1512-60 10X10 Unit Dose:      NDC 0456-1512-63 25-mg tablets:White, round, film-coated tablets, debossed with “FL” on one side and “25” on the reverse Bottles of 60:              NDC 0456-1525-60 Bottles of 180:            NDC 0456-1525-01 10X10 Unit Dose:      NDC 0456-1525-63 50-mg tablets:White, oval-shaped, film-coated tablets, debossed with “FL” on one side and “50” on the reverse Bottles of 60:              NDC 0456-1550-60 Bottles of 180:            NDC 0456-1550-01 10X10 Unit Dose:      NDC 0456-1550-63 100-mg tablets:Pink, oval-shaped film-coated tablets, debossed with “FL” on one side and “100” on the reverse Bottles of 60:              NDC 0456-1510-60 Bottles of 180:            NDC 0456-1510-01 10X10 Unit Dose:      NDC 0456-1510-63 Titration Pack:4-Week Titration Pack: NDC 0456-1500-55 Blister package containing 55 tablets: 5 x 12.5-mg tablets, 8 x 25-mg tablets, and 42 x 50 mg tablets. 12.5-mg tablets:Blue, round, film-coated tablets, debossed with “F” on one side and “L” on the reverse Bottles of 60:               NDC 0456-1512-60 10X10 Unit Dose:      NDC 0456-1512-63 25-mg tablets:White, round, film-coated tablets, debossed with “FL” on one side and “25” on the reverse Bottles of 60:              NDC 0456-1525-60 Bottles of 180:            NDC 0456-1525-01 10X10 Unit Dose:      NDC 0456-1525-63 50-mg tablets:White, oval-shaped, film-coated tablets, debossed with “FL” on one side and “50” on the reverse Bottles of 60:              NDC 0456-1550-60 Bottles of 180:            NDC 0456-1550-01 10X10 Unit Dose:      NDC 0456-1550-63 100-mg tablets:Pink, oval-shaped film-coated tablets, debossed with “FL” on one side and “100” on the reverse Bottles of 60:              NDC 0456-1510-60 Bottles of 180:            NDC 0456-1510-01 10X10 Unit Dose:      NDC 0456-1510-63 Titration Pack:4-Week Titration Pack: NDC 0456-1500-55 Blister package containing 55 tablets: 5 x 12.5-mg tablets, 8 x 25-mg tablets, and 42 x 50 mg tablets. 12.5-mg tablets:Blue, round, film-coated tablets, debossed with “F” on one side and “L” on the reverse Bottles of 60:               NDC 0456-1512-60 10X10 Unit Dose:      NDC 0456-1512-63 25-mg tablets:White, round, film-coated tablets, debossed with “FL” on one side and “25” on the reverse Bottles of 60:              NDC 0456-1525-60 Bottles of 180:            NDC 0456-1525-01 10X10 Unit Dose:      NDC 0456-1525-63 50-mg tablets:White, oval-shaped, film-coated tablets, debossed with “FL” on one side and “50” on the reverse Bottles of 60:              NDC 0456-1550-60 Bottles of 180:            NDC 0456-1550-01 10X10 Unit Dose:      NDC 0456-1550-63 100-mg tablets:Pink, oval-shaped film-coated tablets, debossed with “FL” on one side and “100” on the reverse Bottles of 60:              NDC 0456-1510-60 Bottles of 180:            NDC 0456-1510-01 10X10 Unit Dose:      NDC 0456-1510-63 Titration Pack:4-Week Titration Pack: NDC 0456-1500-55 Blister package containing 55 tablets: 5 x 12.5-mg tablets, 8 x 25-mg tablets, and 42 x 50 mg tablets. 12.5-mg tablets:Blue, round, film-coated tablets, debossed with “F” on one side and “L” on the reverse Bottles of 60:               NDC 0456-1512-60 10X10 Unit Dose:      NDC 0456-1512-63 25-mg tablets:White, round, film-coated tablets, debossed with “FL” on one side and “25” on the reverse Bottles of 60:              NDC 0456-1525-60 Bottles of 180:            NDC 0456-1525-01 10X10 Unit Dose:      NDC 0456-1525-63 50-mg tablets:White, oval-shaped, film-coated tablets, debossed with “FL” on one side and “50” on the reverse Bottles of 60:              NDC 0456-1550-60 Bottles of 180:            NDC 0456-1550-01 10X10 Unit Dose:      NDC 0456-1550-63 100-mg tablets:Pink, oval-shaped film-coated tablets, debossed with “FL” on one side and “100” on the reverse Bottles of 60:              NDC 0456-1510-60 Bottles of 180:            NDC 0456-1510-01 10X10 Unit Dose:      NDC 0456-1510-63 Titration Pack:4-Week Titration Pack: NDC 0456-1500-55 Blister package containing 55 tablets: 5 x 12.5-mg tablets, 8 x 25-mg tablets, and 42 x 50 mg tablets. 12.5-mg tablets:Blue, round, film-coated tablets, debossed with “F” on one side and “L” on the reverse Bottles of 60:               NDC 0456-1512-60 10X10 Unit Dose:      NDC 0456-1512-63 25-mg tablets:White, round, film-coated tablets, debossed with “FL” on one side and “25” on the reverse Bottles of 60:              NDC 0456-1525-60 Bottles of 180:            NDC 0456-1525-01 10X10 Unit Dose:      NDC 0456-1525-63 50-mg tablets:White, oval-shaped, film-coated tablets, debossed with “FL” on one side and “50” on the reverse Bottles of 60:              NDC 0456-1550-60 Bottles of 180:            NDC 0456-1550-01 10X10 Unit Dose:      NDC 0456-1550-63 100-mg tablets:Pink, oval-shaped film-coated tablets, debossed with “FL” on one side and “100” on the reverse Bottles of 60:              NDC 0456-1510-60 Bottles of 180:            NDC 0456-1510-01 10X10 Unit Dose:      NDC 0456-1510-63 Titration Pack:4-Week Titration Pack: NDC 0456-1500-55 Blister package containing 55 tablets: 5 x 12.5-mg tablets, 8 x 25-mg tablets, and 42 x 50 mg tablets. 12.5-mg tablets:Blue, round, film-coated tablets, debossed with “F” on one side and “L” on the reverse Bottles of 60:               NDC 0456-1512-60 10X10 Unit Dose:      NDC 0456-1512-63 25-mg tablets:White, round, film-coated tablets, debossed with “FL” on one side and “25” on the reverse Bottles of 60:              NDC 0456-1525-60 Bottles of 180:            NDC 0456-1525-01 10X10 Unit Dose:      NDC 0456-1525-63 50-mg tablets:White, oval-shaped, film-coated tablets, debossed with “FL” on one side and “50” on the reverse Bottles of 60:              NDC 0456-1550-60 Bottles of 180:            NDC 0456-1550-01 10X10 Unit Dose:      NDC 0456-1550-63 100-mg tablets:Pink, oval-shaped film-coated tablets, debossed with “FL” on one side and “100” on the reverse Bottles of 60:              NDC 0456-1510-60 Bottles of 180:            NDC 0456-1510-01 10X10 Unit Dose:      NDC 0456-1510-63 Titration Pack:4-Week Titration Pack: NDC 0456-1500-55 Blister package containing 55 tablets: 5 x 12.5-mg tablets, 8 x 25-mg tablets, and 42 x 50 mg tablets. 12.5-mg tablets:Blue, round, film-coated tablets, debossed with “F” on one side and “L” on the reverse Bottles of 60:               NDC 0456-1512-60 10X10 Unit Dose:      NDC 0456-1512-63 25-mg tablets:White, round, film-coated tablets, debossed with “FL” on one side and “25” on the reverse Bottles of 60:              NDC 0456-1525-60 Bottles of 180:            NDC 0456-1525-01 10X10 Unit Dose:      NDC 0456-1525-63 50-mg tablets:White, oval-shaped, film-coated tablets, debossed with “FL” on one side and “50” on the reverse Bottles of 60:              NDC 0456-1550-60 Bottles of 180:            NDC 0456-1550-01 10X10 Unit Dose:      NDC 0456-1550-63 100-mg tablets:Pink, oval-shaped film-coated tablets, debossed with “FL” on one side and “100” on the reverse Bottles of 60:              NDC 0456-1510-60 Bottles of 180:            NDC 0456-1510-01 10X10 Unit Dose:      NDC 0456-1510-63 Titration Pack:4-Week Titration Pack: NDC 0456-1500-55 Blister package containing 55 tablets: 5 x 12.5-mg tablets, 8 x 25-mg tablets, and 42 x 50 mg tablets. 12.5-mg tablets:Blue, round, film-coated tablets, debossed with “F” on one side and “L” on the reverse Bottles of 60:               NDC 0456-1512-60 10X10 Unit Dose:      NDC 0456-1512-63 25-mg tablets:White, round, film-coated tablets, debossed with “FL” on one side and “25” on the reverse Bottles of 60:              NDC 0456-1525-60 Bottles of 180:            NDC 0456-1525-01 10X10 Unit Dose:      NDC 0456-1525-63 50-mg tablets:White, oval-shaped, film-coated tablets, debossed with “FL” on one side and “50” on the reverse Bottles of 60:              NDC 0456-1550-60 Bottles of 180:            NDC 0456-1550-01 10X10 Unit Dose:      NDC 0456-1550-63 100-mg tablets:Pink, oval-shaped film-coated tablets, debossed with “FL” on one side and “100” on the reverse Bottles of 60:              NDC 0456-1510-60 Bottles of 180:            NDC 0456-1510-01 10X10 Unit Dose:      NDC 0456-1510-63 Titration Pack:4-Week Titration Pack: NDC 0456-1500-55 Blister package containing 55 tablets: 5 x 12.5-mg tablets, 8 x 25-mg tablets, and 42 x 50 mg tablets. 12.5-mg tablets:Blue, round, film-coated tablets, debossed with “F” on one side and “L” on the reverse Bottles of 60:               NDC 0456-1512-60 10X10 Unit Dose:      NDC 0456-1512-63 25-mg tablets:White, round, film-coated tablets, debossed with “FL” on one side and “25” on the reverse Bottles of 60:              NDC 0456-1525-60 Bottles of 180:            NDC 0456-1525-01 10X10 Unit Dose:      NDC 0456-1525-63 50-mg tablets:White, oval-shaped, film-coated tablets, debossed with “FL” on one side and “50” on the reverse Bottles of 60:              NDC 0456-1550-60 Bottles of 180:            NDC 0456-1550-01 10X10 Unit Dose:      NDC 0456-1550-63 100-mg tablets:Pink, oval-shaped film-coated tablets, debossed with “FL” on one side and “100” on the reverse Bottles of 60:              NDC 0456-1510-60 Bottles of 180:            NDC 0456-1510-01 10X10 Unit Dose:      NDC 0456-1510-63 Titration Pack:4-Week Titration Pack: NDC 0456-1500-55 Blister package containing 55 tablets: 5 x 12.5-mg tablets, 8 x 25-mg tablets, and 42 x 50 mg tablets. 12.5-mg tablets:Blue, round, film-coated tablets, debossed with “F” on one side and “L” on the reverse Bottles of 60:               NDC 0456-1512-60 10X10 Unit Dose:      NDC 0456-1512-63 25-mg tablets:White, round, film-coated tablets, debossed with “FL” on one side and “25” on the reverse Bottles of 60:              NDC 0456-1525-60 Bottles of 180:            NDC 0456-1525-01 10X10 Unit Dose:      NDC 0456-1525-63 50-mg tablets:White, oval-shaped, film-coated tablets, debossed with “FL” on one side and “50” on the reverse Bottles of 60:              NDC 0456-1550-60 Bottles of 180:            NDC 0456-1550-01 10X10 Unit Dose:      NDC 0456-1550-63 100-mg tablets:Pink, oval-shaped film-coated tablets, debossed with “FL” on one side and “100” on the reverse Bottles of 60:              NDC 0456-1510-60 Bottles of 180:            NDC 0456-1510-01 10X10 Unit Dose:      NDC 0456-1510-63 Titration Pack:4-Week Titration Pack: NDC 0456-1500-55 Blister package containing 55 tablets: 5 x 12.5-mg tablets, 8 x 25-mg tablets, and 42 x 50 mg tablets. 12.5-mg tablets:Blue, round, film-coated tablets, debossed with “F” on one side and “L” on the reverse Bottles of 60:               NDC 0456-1512-60 10X10 Unit Dose:      NDC 0456-1512-63 25-mg tablets:White, round, film-coated tablets, debossed with “FL” on one side and “25” on the reverse Bottles of 60:              NDC 0456-1525-60 Bottles of 180:            NDC 0456-1525-01 10X10 Unit Dose:      NDC 0456-1525-63 50-mg tablets:White, oval-shaped, film-coated tablets, debossed with “FL” on one side and “50” on the reverse Bottles of 60:              NDC 0456-1550-60 Bottles of 180:            NDC 0456-1550-01 10X10 Unit Dose:      NDC 0456-1550-63 100-mg tablets:Pink, oval-shaped film-coated tablets, debossed with “FL” on one side and “100” on the reverse Bottles of 60:              NDC 0456-1510-60 Bottles of 180:            NDC 0456-1510-01 10X10 Unit Dose:      NDC 0456-1510-63 Titration Pack:4-Week Titration Pack: NDC 0456-1500-55 Blister package containing 55 tablets: 5 x 12.5-mg tablets, 8 x 25-mg tablets, and 42 x 50 mg tablets. 12.5-mg tablets:Blue, round, film-coated tablets, debossed with “F” on one side and “L” on the reverse Bottles of 60:               NDC 0456-1512-60 10X10 Unit Dose:      NDC 0456-1512-63 25-mg tablets:White, round, film-coated tablets, debossed with “FL” on one side and “25” on the reverse Bottles of 60:              NDC 0456-1525-60 Bottles of 180:            NDC 0456-1525-01 10X10 Unit Dose:      NDC 0456-1525-63 50-mg tablets:White, oval-shaped, film-coated tablets, debossed with “FL” on one side and “50” on the reverse Bottles of 60:              NDC 0456-1550-60 Bottles of 180:            NDC 0456-1550-01 10X10 Unit Dose:      NDC 0456-1550-63 100-mg tablets:Pink, oval-shaped film-coated tablets, debossed with “FL” on one side and “100” on the reverse Bottles of 60:              NDC 0456-1510-60 Bottles of 180:            NDC 0456-1510-01 10X10 Unit Dose:      NDC 0456-1510-63 Titration Pack:4-Week Titration Pack: NDC 0456-1500-55 Blister package containing 55 tablets: 5 x 12.5-mg tablets, 8 x 25-mg tablets, and 42 x 50 mg tablets. 12.5-mg tablets:Blue, round, film-coated tablets, debossed with “F” on one side and “L” on the reverse Bottles of 60:               NDC 0456-1512-60 10X10 Unit Dose:      NDC 0456-1512-63 25-mg tablets:White, round, film-coated tablets, debossed with “FL” on one side and “25” on the reverse Bottles of 60:              NDC 0456-1525-60 Bottles of 180:            NDC 0456-1525-01 10X10 Unit Dose:      NDC 0456-1525-63 50-mg tablets:White, oval-shaped, film-coated tablets, debossed with “FL” on one side and “50” on the reverse Bottles of 60:              NDC 0456-1550-60 Bottles of 180:            NDC 0456-1550-01 10X10 Unit Dose:      NDC 0456-1550-63 100-mg tablets:Pink, oval-shaped film-coated tablets, debossed with “FL” on one side and “100” on the reverse Bottles of 60:              NDC 0456-1510-60 Bottles of 180:            NDC 0456-1510-01 10X10 Unit Dose:      NDC 0456-1510-63 Titration Pack:4-Week Titration Pack: NDC 0456-1500-55 Blister package containing 55 tablets: 5 x 12.5-mg tablets, 8 x 25-mg tablets, and 42 x 50 mg tablets. 12.5-mg tablets:Blue, round, film-coated tablets, debossed with “F” on one side and “L” on the reverse Bottles of 60:               NDC 0456-1512-60 10X10 Unit Dose:      NDC 0456-1512-63 25-mg tablets:White, round, film-coated tablets, debossed with “FL” on one side and “25” on the reverse Bottles of 60:              NDC 0456-1525-60 Bottles of 180:            NDC 0456-1525-01 10X10 Unit Dose:      NDC 0456-1525-63 50-mg tablets:White, oval-shaped, film-coated tablets, debossed with “FL” on one side and “50” on the reverse Bottles of 60:              NDC 0456-1550-60 Bottles of 180:            NDC 0456-1550-01 10X10 Unit Dose:      NDC 0456-1550-63 100-mg tablets:Pink, oval-shaped film-coated tablets, debossed with “FL” on one side and “100” on the reverse Bottles of 60:              NDC 0456-1510-60 Bottles of 180:            NDC 0456-1510-01 10X10 Unit Dose:      NDC 0456-1510-63 Titration Pack:4-Week Titration Pack: NDC 0456-1500-55 Blister package containing 55 tablets: 5 x 12.5-mg tablets, 8 x 25-mg tablets, and 42 x 50 mg tablets. 12.5-mg tablets:Blue, round, film-coated tablets, debossed with “F” on one side and “L” on the reverse Bottles of 60:               NDC 0456-1512-60 10X10 Unit Dose:      NDC 0456-1512-63 25-mg tablets:White, round, film-coated tablets, debossed with “FL” on one side and “25” on the reverse Bottles of 60:              NDC 0456-1525-60 Bottles of 180:            NDC 0456-1525-01 10X10 Unit Dose:      NDC 0456-1525-63 50-mg tablets:White, oval-shaped, film-coated tablets, debossed with “FL” on one side and “50” on the reverse Bottles of 60:              NDC 0456-1550-60 Bottles of 180:            NDC 0456-1550-01 10X10 Unit Dose:      NDC 0456-1550-63 100-mg tablets:Pink, oval-shaped film-coated tablets, debossed with “FL” on one side and “100” on the reverse Bottles of 60:              NDC 0456-1510-60 Bottles of 180:            NDC 0456-1510-01 10X10 Unit Dose:      NDC 0456-1510-63 Titration Pack:4-Week Titration Pack: NDC 0456-1500-55 Blister package containing 55 tablets: 5 x 12.5-mg tablets, 8 x 25-mg tablets, and 42 x 50 mg tablets. 12.5-mg tablets:Blue, round, film-coated tablets, debossed with “F” on one side and “L” on the reverse Bottles of 60:               NDC 0456-1512-60 10X10 Unit Dose:      NDC 0456-1512-63 25-mg tablets:White, round, film-coated tablets, debossed with “FL” on one side and “25” on the reverse Bottles of 60:              NDC 0456-1525-60 Bottles of 180:            NDC 0456-1525-01 10X10 Unit Dose:      NDC 0456-1525-63 50-mg tablets:White, oval-shaped, film-coated tablets, debossed with “FL” on one side and “50” on the reverse Bottles of 60:              NDC 0456-1550-60 Bottles of 180:            NDC 0456-1550-01 10X10 Unit Dose:      NDC 0456-1550-63 100-mg tablets:Pink, oval-shaped film-coated tablets, debossed with “FL” on one side and “100” on the reverse Bottles of 60:              NDC 0456-1510-60 Bottles of 180:            NDC 0456-1510-01 10X10 Unit Dose:      NDC 0456-1510-63 Titration Pack:4-Week Titration Pack: NDC 0456-1500-55 Blister package containing 55 tablets: 5 x 12.5-mg tablets, 8 x 25-mg tablets, and 42 x 50 mg tablets. 12.5-mg tablets:Blue, round, film-coated tablets, debossed with “F” on one side and “L” on the reverse Bottles of 60:               NDC 0456-1512-60 10X10 Unit Dose:      NDC 0456-1512-63 25-mg tablets:White, round, film-coated tablets, debossed with “FL” on one side and “25” on the reverse Bottles of 60:              NDC 0456-1525-60 Bottles of 180:            NDC 0456-1525-01 10X10 Unit Dose:      NDC 0456-1525-63 50-mg tablets:White, oval-shaped, film-coated tablets, debossed with “FL” on one side and “50” on the reverse Bottles of 60:              NDC 0456-1550-60 Bottles of 180:            NDC 0456-1550-01 10X10 Unit Dose:      NDC 0456-1550-63 100-mg tablets:Pink, oval-shaped film-coated tablets, debossed with “FL” on one side and “100” on the reverse Bottles of 60:              NDC 0456-1510-60 Bottles of 180:            NDC 0456-1510-01 10X10 Unit Dose:      NDC 0456-1510-63 Titration Pack:4-Week Titration Pack: NDC 0456-1500-55 Blister package containing 55 tablets: 5 x 12.5-mg tablets, 8 x 25-mg tablets, and 42 x 50 mg tablets. 12.5-mg tablets:Blue, round, film-coated tablets, debossed with “F” on one side and “L” on the reverse Bottles of 60:               NDC 0456-1512-60 10X10 Unit Dose:      NDC 0456-1512-63 25-mg tablets:White, round, film-coated tablets, debossed with “FL” on one side and “25” on the reverse Bottles of 60:              NDC 0456-1525-60 Bottles of 180:            NDC 0456-1525-01 10X10 Unit Dose:      NDC 0456-1525-63 50-mg tablets:White, oval-shaped, film-coated tablets, debossed with “FL” on one side and “50” on the reverse Bottles of 60:              NDC 0456-1550-60 Bottles of 180:            NDC 0456-1550-01 10X10 Unit Dose:      NDC 0456-1550-63 100-mg tablets:Pink, oval-shaped film-coated tablets, debossed with “FL” on one side and “100” on the reverse Bottles of 60:              NDC 0456-1510-60 Bottles of 180:            NDC 0456-1510-01 10X10 Unit Dose:      NDC 0456-1510-63 Titration Pack:4-Week Titration Pack: NDC 0456-1500-55 Blister package containing 55 tablets: 5 x 12.5-mg tablets, 8 x 25-mg tablets, and 42 x 50 mg tablets. 12.5-mg tablets:Blue, round, film-coated tablets, debossed with “F” on one side and “L” on the reverse Bottles of 60:               NDC 0456-1512-60 10X10 Unit Dose:      NDC 0456-1512-63 25-mg tablets:White, round, film-coated tablets, debossed with “FL” on one side and “25” on the reverse Bottles of 60:              NDC 0456-1525-60 Bottles of 180:            NDC 0456-1525-01 10X10 Unit Dose:      NDC 0456-1525-63 50-mg tablets:White, oval-shaped, film-coated tablets, debossed with “FL” on one side and “50” on the reverse Bottles of 60:              NDC 0456-1550-60 Bottles of 180:            NDC 0456-1550-01 10X10 Unit Dose:      NDC 0456-1550-63 100-mg tablets:Pink, oval-shaped film-coated tablets, debossed with “FL” on one side and “100” on the reverse Bottles of 60:              NDC 0456-1510-60 Bottles of 180:            NDC 0456-1510-01 10X10 Unit Dose:      NDC 0456-1510-63 Titration Pack:4-Week Titration Pack: NDC 0456-1500-55 Blister package containing 55 tablets: 5 x 12.5-mg tablets, 8 x 25-mg tablets, and 42 x 50 mg tablets. 12.5-mg tablets:Blue, round, film-coated tablets, debossed with “F” on one side and “L” on the reverse Bottles of 60:               NDC 0456-1512-60 10X10 Unit Dose:      NDC 0456-1512-63 25-mg tablets:White, round, film-coated tablets, debossed with “FL” on one side and “25” on the reverse Bottles of 60:              NDC 0456-1525-60 Bottles of 180:            NDC 0456-1525-01 10X10 Unit Dose:      NDC 0456-1525-63 50-mg tablets:White, oval-shaped, film-coated tablets, debossed with “FL” on one side and “50” on the reverse Bottles of 60:              NDC 0456-1550-60 Bottles of 180:            NDC 0456-1550-01 10X10 Unit Dose:      NDC 0456-1550-63 100-mg tablets:Pink, oval-shaped film-coated tablets, debossed with “FL” on one side and “100” on the reverse Bottles of 60:              NDC 0456-1510-60 Bottles of 180:            NDC 0456-1510-01 10X10 Unit Dose:      NDC 0456-1510-63 Titration Pack:4-Week Titration Pack: NDC 0456-1500-55 Blister package containing 55 tablets: 5 x 12.5-mg tablets, 8 x 25-mg tablets, and 42 x 50 mg tablets. 12.5-mg tablets:Blue, round, film-coated tablets, debossed with “F” on one side and “L” on the reverse Bottles of 60:               NDC 0456-1512-60 10X10 Unit Dose:      NDC 0456-1512-63 25-mg tablets:White, round, film-coated tablets, debossed with “FL” on one side and “25” on the reverse Bottles of 60:              NDC 0456-1525-60 Bottles of 180:            NDC 0456-1525-01 10X10 Unit Dose:      NDC 0456-1525-63 50-mg tablets:White, oval-shaped, film-coated tablets, debossed with “FL” on one side and “50” on the reverse Bottles of 60:              NDC 0456-1550-60 Bottles of 180:            NDC 0456-1550-01 10X10 Unit Dose:      NDC 0456-1550-63 100-mg tablets:Pink, oval-shaped film-coated tablets, debossed with “FL” on one side and “100” on the reverse Bottles of 60:              NDC 0456-1510-60 Bottles of 180:            NDC 0456-1510-01 10X10 Unit Dose:      NDC 0456-1510-63 Titration Pack:4-Week Titration Pack: NDC 0456-1500-55 Blister package containing 55 tablets: 5 x 12.5-mg tablets, 8 x 25-mg tablets, and 42 x 50 mg tablets.


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Clinical Information

Chemical Structure

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Clinical Pharmacology

The exact mechanism of the central pain inhibitory action of milnacipran and its ability to improve the symptoms of fibromyalgia in humans are unknown. Preclinical studies have shown that milnacipran is a potent inhibitor of neuronal norepinephrine and serotonin reuptake; milnacipran inhibits norepinephrine uptake with approximately 3-fold higher potency in vitro than serotonin without directly affecting the uptake of dopamine or other neurotransmitters. Milnacipran has no significant affinity for serotonergic (5-HT1-7), α- and β-adrenergic, muscarinic (M1-5), histamine (H1-4), dopamine (D1-5), opiate, benzodiazepine, and γ-aminobutyric acid (GABA) receptors in vitro. Pharmacologic activity at these receptors is hypothesized to be associated with the various anticholinergic, sedative, and cardiovascular effects seen with other psychotropic drugs. Milnacipran has no significant affinity for Ca++, K+, Na+ and Cl– channels and does not inhibit the activity of human monoamine oxidases (MAO-A and MAO-B) or acetylcholinesterase.

Non-Clinical Toxicology
Use of monoamine oxidase inhibitors concomitantly or in close temporal proximity ()

Use in patients with uncontrolled narrow-angle glaucoma ()

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 Interactions

The use of MAO inhibitors or tricyclic antidepressants with hydrocodone preparations may increase the effect of either the antidepressant or hydrocodone.

Savella is a selective serotonin and norepinephrine re-uptake inhibitor (SNRI), similar to some drugs used for the treatment of depression and other psychiatric disorders.

Patients, both adult and pediatric, with depression or other psychiatric disorders may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior, whether or not they are taking these medications, and this risk may persist until significant remission occurs. Suicide is a known risk of depression and certain other psychiatric disorders, and these disorders themselves are the strongest predictors of suicide. There has been a long-standing concern, however, that antidepressants, including drugs that inhibit the reuptake of norepinephrine and/or serotonin, may have a role in inducing worsening of depression and the emergence of suicidality in certain patients during the early phases of treatment.

In the placebo-controlled clinical trials of adults with fibromyalgia, among the patients who had a history of depression at treatment initiation, the incidence of suicidal ideation was 0.5% in patients treated with placebo, 0% in patients treated with Savella 100 mg/day, and 1.3% in patients treated with Savella 200 mg/day. No suicides occurred in the short-term or longer-term (up to 1 year) fibromyalgia trials.

Pooled analyses of short-term placebo-controlled trials of drugs used to treat depression (SSRIs and others) showed that these drugs increase the risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults (ages 18-24) with major depressive disorder (MDD) and other psychiatric disorders. Short-term studies did not show an increase in the risk of suicidality with these drugs compared to placebo in adults beyond age 24; there was a reduction in suicidality risk with antidepressants compared to placebo in adults age 65 and older.

The pooled analyses of placebo-controlled trials in children and adolescents with MDD, obsessive compulsive disorder (OCD), or other psychiatric disorders included a total of 24 short-term trials of 9 drugs used to treat depression in over 4400 patients. The pooled analyses of placebo-controlled trials in adults with MDD or other psychiatric disorders included a total of 295 short-term trials (median duration of 2 months) of 11 antidepressant drugs in over 77,000 patients. There was considerable variation in risk of suicidality among drugs, but a tendency toward an increase in the younger patients for almost all drugs studied. There were differences in absolute risk of suicidality across the different indications, with the highest incidence in MDD. The risk of differences (drug versus placebo), however, were relatively stable within age strata and across indications. These risk differences (drug-placebo difference in the number of cases of suicidality per 1000 patients treated) are provided in .

No suicides occurred in any of the pediatric trials. There were suicides in the adult trials, but the number was not sufficient to reach any conclusion about drug effect on suicide.

It is unknown whether the suicidality risk extends to longer-term use, i.e., beyond several months. However, there is substantial evidence from placebo-controlled maintenance trials in adults with depression that the use of antidepressants can delay the recurrence of depression.

All patients being treated with drugs inhibiting the reuptake of norepinephrine and/or serotonin for any indication should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months of a course of drug therapy, or at times of dose changes, either increases or decreases.

The following symptoms, anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, mania, have been reported in adult and pediatric patients being treated with drugs inhibiting the reuptake of norepinephrine and/or serotonin for major depressive disorder as well as for other indications, both psychiatric and nonpsychiatric. Although a causal link between the emergence of such symptoms and either the worsening of depression and/or the emergence of suicidal impulses has not been established, there is concern that such symptoms may represent precursors to emerging suicidality.

Consideration should be given to changing the therapeutic regimen, including possibly discontinuing the medication, in patients who may experience worsening depressive symptoms, or who are experiencing emergent suicidality or symptoms that might be precursors to worsening depression or suicidality, especially if these symptoms are severe or abrupt in onset, or were not part of the patient's presenting symptoms.

If the decision has been made to discontinue treatment due to worsening depressive symptoms or emergent suicidality, medication should be tapered, as rapidly as is feasible, but with recognition that abrupt discontinuation can produce withdrawal symptoms ), and

Families and caregivers of patients being treated with drugs inhibiting the reuptake of norepinephrine and/or serotonin for major depressive disorder or other indications, both psychiatric and nonpsychiatric, should be alerted about the need to monitor patients for the emergence of agitation, irritability, unusual changes in behavior, and the other symptoms described above, as well as the emergence of suicidality, and to report such symptoms immediately to health care providers. Such monitoring should include daily observation by families and caregivers. Prescriptions for Savella should be written for the smallest quantity of tablets consistent with good patient management, in order to reduce the risk of overdose.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Interactions

Interactions

A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).