Source: FDA, National Drug Code (US) Revision Year: 2017
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: (±)-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. The film coat contains the following additional inactive ingredients:
12.5 mg: FD&C Blue #2 Aluminum Lake, polyvinyl alcohol, polyethylene glycol, titanium dioxide
25 mg: Polyvinyl alcohol, polyethylene glycol, titanium dioxide
50 mg: Polyvinyl alcohol, polyethylene glycol, titanium dioxide
100 mg: FD&C Red #40 Aluminum Lake, polyvinyl alcohol, polyethylene glycol, titanium dioxide
| Dosage Forms and Strengths |
|---|
|
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, blue, “F” on one side, “L” on the reverse; [see Description (11) and How Supplied/Storage and Handling (16)]. |
| How Supplied |
|---|
|
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 10 X 10 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 10 X 10 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 10 X 10 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 10 X 10 Unit Dose: NDC 0456-1510-63 Titration Pack: 4-Week Titration Pack: NDC 0456-1500-55 Blister package containing 55 tablets: 5 × 12.5-mg tablets, 8 × 25-mg tablets, and 42 × 50 mg tablets. |
| Drug | Countries | |
|---|---|---|
| SAVELLA | United States |
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
