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Savella 100 Mg Tabs 60 By Allergan Inc.

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Savella 100 Mg Tabs 60 By Allergan Inc.

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Savella 100 Mg Tabs 60 By Allergan Inc. This Item Requires A Valid Order From A Physician Licensed in USA. Item Number.:RXD4220315/RXB10029383/RXA310222
Size : 60
Selling UoM : EA
NDC: 00456-1510-60
UPC Barcode : 304561510603
Supplier: 0050001063 ALLERGAN USA, INC.
Supplier Material : 13189
Generic Code : 065090 MILNACIPRAN HCL ORAL TABLET 100 MG
Fine Line Class : 850085008510 All Rx Products
Product Category : RX Pharmaceuticals
Product Type : BRX Branded RX

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Product Description.:

FL, 100
tablet , film-coated , pink , oval oblong
Debossed

Milnacipran hydrochloride is a selective norepinephrine and serotonin reuptake inhibitor it inhibits norepinephrine uptake with greater potency than serotonin.

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

INDICATIONS

Savella is indicated for the management of fibromyalgia.

Savella is not approved for use in pediatric patients

SIDE EFFECTS
Clinical Trial Data Sources

Savella was evaluated in three double-blind placebo-controlled trials involving 2209 fibromyalgia patients (1557 patients treated with Savella and 652 patients treated with placebo) for a treatment period up to 29 weeks.

The stated frequencies of adverse reactions represent the proportion of individuals who experienced, at least once, a treatment-emergent adverse reaction of the type listed. A reaction was considered treatment emergent if it occurred for the first time or worsened while receiving therapy following baseline evaluation.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Adverse Reactions Leading to Discontinuation

In placebo-controlled trials in patients with fibromyalgia, 23% of patients treated with Savella 100 mg/day, 26% of patients treated with Savella 200 mg/day discontinued prematurely due to adverse reactions, compared to 12% of patients treated with placebo. The adverse reactions that led to withdrawal in ≥ 1% of patients in the Savella treatment group and with an incidence rate greater than that in the placebo treatment group were nausea (milnacipran 6%, placebo 1%), palpitations (milnacipran 3%, placebo 1%), headache (milnacipran 2%, placebo 0%), constipation (milnacipran 1%, placebo 0%), heart rate increased (milnacipran 1%, placebo 0%), and hyperhidrosis (milnacipran 1%, placebo 0%), vomiting (milnacipran 1%, placebo 0%), and dizziness (milnacipran 1% and placebo 0.5%). Discontinuation due to adverse reactions was generally more common among patients treated with Savella 200 mg/day compared to Savella 100 mg/day.