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HOW AND WHERE TO BUY MILNACIPRAN (SAVELLA, IXEL) 25 MG, 50 MG TABLETS OR CAPSULES ONLINE:

SAVELLA (MILNACIPRAN): PRESCRIBING INFORMATION

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-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.


CONTRAINDICATIONS

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


ADVERSE REACTIONS

Savella adverse reactions


DRUG INTERACTIONS

Savella drug interactions


USE IN SPECIFIC POPULATIONS

Savella use in specific populations


DRUG ABUSE AND DEPENDENCE

Controlled Substance

Savella (Milnacipran) is not a controlled substance.

Abuse

Savella (Milnacipran HCl) did not produce behavioral signs indicative of abuse potential in animal or human studies.

Dependence

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.


OVERDOSAGE

Savella overdosage


CLINICAL PHARMACOLOGY

Savella clinical pharmacology


NONCLINICAL TOXICOLOGY

Savella nonclinical toxicology


CLINICAL STUDIES

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.

    Storage

    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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