Escitalopram-TEVA (escitalopram) coated tablets 20 mg. №28

Description

ESCITALOPRAM-TEVA 20 mg COMPOSITION
active substance: escitalopram

1 tablet contains escitalopram 5 mg, 10 mg, 15 mg, 20 mg

excipients: core: microcrystalline cellulose, colloidal silicon dioxide, croscarmellose sodium, stearic acid, magnesium stearate

shell: hypromellose, titanium dioxide (E 171), polyethylene glycol 400.

ESCITALOPRAM-TEVA 20 mg DOSAGE FORM
Film-coated tablets.

BASIC PHYSICAL AND CHEMICAL PROPERTIES

The division is not intended to break the tablet into two equal doses, but to facilitate swallowing.

ESCITALOPRAM-TEVA 20 mg PHARMACOLOGICAL GROUP
Antidepressants. Selective serotonin reuptake inhibitors. ATX code N06A B10.

PHARMACOLOGICAL PROPERTIES
Pharmacological.

Escitalopram is an antidepressant, selective serotonin reuptake inhibitor (5-HT) with high affinity for the primary binding site. It also binds to the allosteric site of the serotonin transporter with a 1000-fold lower affinity.

Inhibition of 5-HT serotonin reuptake is only a probable mechanism of action and may explain the pharmacological and clinical effects of escitalopram.

Pharmacokinetics.

Absorption is almost complete and does not depend on food intake. The average time to reach the maximum concentration (average T max) is about 4:00. The bioavailability of escitalopram is expected to be 80%.

The kinetics of escitalopram is linear. Equilibrium concentration is achieved in 1 week. The average equilibrium concentration of 50 nmol / L (from 20 to 125 nmol / L) is achieved with a daily dose of 10 mg.

Elderly patients (over 65 years old)

Lack of liver function

In patients with moderate or mild hepatic impairment (according to Child-Pugh criteria – A and B), the half-life of escitalopram almost doubled and the exposure was 60% higher than in those with normal liver function.

Decreased kidney function

In patients with impaired renal function (CLcr 10-53 ml / min), an increase in the half-life of racemic citalopram and a slight increase in exposure were observed. Plasma concentrations of metabolites have not been studied, but an increase can be assumed.

With insufficient activity of the CYP2C19 enzyme, there was a double concentration of the drug in the blood plasma compared with patients with a normal metabolism of escitalopram.

No significant changes in exposure were observed with CYP2D6 enzyme deficiency.

INDICATIONS
treatment:

major depressive episodes
panic disorder with / without agoraphobia
social anxiety disorders (social phobia)
generalized anxiety disorders
obsessive-compulsive disorder.
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any other component of the drug. Concomitant treatment with non-selective irreversible MAO inhibitors (MAO), due to the risk of developing serotonin syndrome, manifested by agitation, tremor, hyperthermia.

Combined treatment with escitalopram and reverse MAO inhibitors type A (eg moclobemide) or reverse non-selective MAO inhibitors (linezolid), due to the risk of serotonin syndrome.

If it is known that a patient has a prolonged QT interval or congenital syndrome of a prolonged QT interval, it is contraindicated to use in conjunction with drugs that prolong the QT interval.

Simultaneous treatment with pimozide.

Interaction with other medicinal products and other types of interactions
pharmacodynamic interactions

Combinations are contraindicated.

Prolongation of the QT interval

Pharmacokinetic and pharmacodynamic studies of escitalopram in combination with other drugs that prolong the QT interval have not been conducted. The general effect of escitalopram and these drugs cannot be ruled out. Therefore, the simultaneous use of escitalopram with drugs that lengthen the QT interval, such as antiarrhythmics of the class IA and ISI, antipsychotics (phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, some antimicrobial drugs (for example, sparfloxicacinom, agents, in particular halofantrine), certain antihistamines (astemizole, mizolastine) are contraindicated.