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SAVELLA (MILNACIPRAN): PRESCRIBING INFORMATION
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.
Milnacipran HCl is a white to off-white crystalline powder with a melting point of 179.°C
It is freely soluble in water, ethanol, methanol, 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 povidone, dibasic calcium phosphate, carboxymethylcellulose calcium, magnesium stearate, colloidal silicon dioxide, 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
INDICATIONS AND USAGE
Savella (Milnacipran) is indicated for the management of fibromyalgia.
This medication is not approved for use in pediatric patients.
DOSAGE AND ADMINISTRATION
Savella dosage and administration
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;
25 mg tablets are round, white, "FL" on one side, "25" on the reverse;
50 mg tablets are oval, white, "FL" on one side, "50" on the reverse;
100 mg tablets are oval, pink, "FL" on one side, "100" on the reverse.
Monoamine Oxidase Inhibitors
Concomitant use of Savella (Milnacipran Hydrochloride) in patients taking monoamine oxidase inhibitors (MAOIs) is contraindicated. In patients receiving a serotonin reuptake inhibitor in combination with a monoamine oxidase inhibitor (MAOI), there have been reports of serious, sometimes fatal, reactions including hyperthermia, rigidity, myoclonus, autonomic instability with possible rapid fluctuations of vital signs, and mental status changes that include extreme agitation progressing to delirium and coma. These reactions have also been reported in patients who have recently discontinued serotonin reuptake inhibitors and have been started on an MAOI. Some cases presented with features resembling neuroleptic malignant syndrome. The effects of combined use of Savella and MAOIs have not been evaluated in humans. Therefore, it is recommended that Savella should not be used in combination with an MAOI, or within 14 days of discontinuing treatment with an MAOI. Similarly, at least 5 days should be allowed after stopping Milnacipran (Savella) before starting an MAOI.
Uncontrolled Narrow-Angle Glaucoma
In clinical trials, Milnacipran HCl (Savella) was associated with an increased risk of mydriasis. Mydriasis has been reported with other dual reuptake inhibitors of norepinephrine and serotonin; therefore, do not use Savella in patients with uncontrolled narrow-angle glaucoma.
WARNINGS AND PRECAUTIONS
Savella warnings and precautions
Savella adverse reactions
Savella drug interactions
USE IN SPECIFIC POPULATIONS
Savella use in specific populations
DRUG ABUSE AND DEPENDENCE
Savella (Milnacipran) is not a controlled substance.
Savella (Milnacipran HCl) did not produce behavioral signs indicative of abuse potential in animal or human studies.
Savella (Milnacipran Hydrochloride) produces physical dependence, as evidenced by the emergence of withdrawal symptoms following drug discontinuation, similar to other SNRIs and SSRIs. These withdrawal symptoms can be severe. Thus, Milnacipran (Savella) should be tapered and not abruptly discontinued after extended use.
Savella clinical pharmacology
Savella nonclinical toxicology
Savella clinical studies
HOW SUPPLIED / STORAGE AND HANDLING
12.5-mg tablets: blue, round, film-coated tablets, debossed with "F" on one side and "L" on the reverse; bottles of 60
25-mg tablets: white, round, film-coated tablets, debossed with "FL" on one side and "25" on the reverse; bottles of 60, 180
50-mg tablets: white, oval-shaped, film-coated tablets, debossed with "FL" on one side and "50" on the reverse; bottles of 60, 180
100-mg tablets: pink, oval-shaped film-coated tablets, debossed with "FL" on one side and "100" on the reverse; bottles of 60, 180
Titration Pack: 4-Week Titration Pack; blister package containing 55 tablets: 5 x 12.5-mg tablets, 8 x 25-mg tablets, and 42 x 50 mg tablets.
Store at 25.°C (77.°F); excursions permitted between 15.°C and 30.°C (between 59.°F and 86.°F).
Manufactured and distributed by Forest Pharmaceuticals, Forest Laboratories companies and its divisions.
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