Elifor (desvenlafaxine succinate) tablets with prolonged release 50 mg. №28

Description

Elifor Storage
active substance: desvenlafaxine succinate;

1 prolonged-release tablet contains desvenlafaxine succinate in an amount equivalent to 50 mg or 100 mg of desvenlafaxine;

excipients: microcrystalline cellulose (Avicel PH102), microcrystalline cellulose (Avicel PH105), talc, magnesium stearate, hypromellose 2208, 100000 CR; for tablets of 100 mg: Opadry® II, 85F94527 (polyvinyl alcohol, macrogol, titanium dioxide (E 171), talc, FD&C Yellow # 6 / Sunset Yellow FCF Aluminum Lake (E 110), iron oxide red (E 172)); for tablets of 50 mg: Opadry® II, 85F94487 (polyvinyl alcohol, macrogol, titanium dioxide (E 171), talc, iron oxide yellow (E 172), iron oxide red (E 172)).

Elifor Dosage form
Prolonged-release tablets.

Basic physical and chemical properties:

50 mg tablets: light pink square film-coated tablets, embossed “W” over “50” on the flat side and in the form of a pyramid on the other side;

100 mg tablets: reddish-orange, film-coated tablets, embossed “W” over “100” on the flat side and in the form of a pyramid on the other side.

Elifor Pharmacotherapeutic group
Antidepressants. ATX code N06A X23.

Pharmacological properties

Pharmacodynamics.

The exact mechanism of antidepressant action of desvenlafaxine is unknown, but it has been suggested that it is potentiated by potentiation of serotonin and norepinephrine in the central nervous system by inhibiting their reuptake. Preclinical studies have shown that desvenlafaxine is a potent and selective inhibitor of serotonin and norepinephrine reuptake (CNS).

Desvenlafaxine did not show a pronounced affinity for many receptors, including muscarinic-cholinergic, H1-histaminergic or α1-adrenergic receptors in vitro. Desvenlafaxine also did not show pronounced activity as a monoamine oxidase inhibitor (MAO).

Pharmacokinetics.

The pharmacokinetics of a single dose of desvenlafaxine are linear and dose-dependent in the dose range from 50 mg to 600 mg (which is 1-12 times more than the recommended approved dose) per day. When administered once daily, steady-state plasma concentrations are reached within approximately 4–5 days. At steady state, the accumulation of multiple doses of desvenlafaxine is linear and predictable, given the pharmacokinetic profile of a single dose.

Indication
Treatment of major depressive disorder (ADD) in adults.

Contraindication
Hypersensitivity to desvenlafaxine succinate, venlafaxine hydrochloride or to any of the excipients in Elifor.
Concomitant use of MAO inhibitors for the treatment of mental disorders, or their use within 7 days after stopping treatment with Elifor. Use of Elifor within 14 days after discontinuation of MAO inhibitors for the treatment of mental disorders.
Concomitant treatment with MAO inhibitors, such as linezolid, or intravenous methylene blue therapy.