Ixelles

Active material: Milnacipran
When ATH: N06AX17
CCF: Antidepressant
ICD-10 codes (testimony): F31, F32, F33, F41.2
When CSF: 02.02.06
Manufacturer: PIERRE FABRE MEDICAMENT PRODUCTION (France)

PHARMACEUTICAL FORM, COMPOSITION AND PACKAGING

Capsules gelatin, size №4, с крышечкой оранжево-розового цвета с черным оттиском “IXEL” и корпусом оранжево-розового цвета с черным оттиском “25”; содержимое капсул – порошок от белого до почти белого цвета.

Excipients: calcium hydrogen phosphate dihydrate, carmellose calcium, povidone K30 (polyvidone K30), silica colloidal anhydrous, magnesium stearate, talc.

Ingredients of the capsule shell: Titanium dioxide (E171), iron oxide red (E172), iron oxide yellow (E172), gelatin.

14 PC. – блистеры (2) – пачки картонные.
14 PC. – блистеры (4) – пачки картонные.

Capsules gelatin, size №3, с крышечкой оранжево-розового цвета с черным оттиском “IXEL” и корпусом желто-оранжевого цвета (Rust) с черным осевым оттиском “50”; содержимое капсул – порошок от белого до почти белого цвета.

Excipients: calcium hydrogen phosphate dihydrate, carmellose calcium, povidone K30 (polyvidone K30), Colloidal anhydrous silica, magnesium stearate, talc.

Ingredients of the capsule shell: Titanium dioxide (E171), iron oxide red (E172), iron oxide yellow (E172), gelatin.

14 PC. – блистеры (2) – пачки картонные.
14 PC. – блистеры (4) – пачки картонные.

* international non-proprietary name, рекомендованное ВОЗ – мильнаципран.

Pharmacological action

Antidepressant, selective inhibitor of monoamine reuptake (noradrenaline and serotonin). It has no affinity for the m-holinoretseptorami, a₁-adrenoceptor, gistaminovym N₁-Receptor, and the dopamine D₁– и D₂-Receptor, benzodiazepine and opioid receptors.

It does not have a sedative effect, thus physiologically it improves sleep and not have a negative impact on cognitive function. Ixel not affect the conduction system of the heart and blood pressure, which is especially important for elderly patients, constantly taking drugs cardiotropic.

Pharmacokinetics

Absorption

After oral administration of milnacipran is well absorbed from the gastrointestinal tract. Bioavailability is about 85% and does not depend on the nature and diet. FROM_max in plasma is approximately 2 h after administration.

Distribution

The equilibrium state is achieved after 2-3 regular admission days. Plasma protein binding is about 13% and is not accompanied by saturation.

Metabolism

Biotransformiroetsa, mainly, by conjugation with glucuronic acid. Metabolites not possess pharmacological activity.

Deduction

T_1/2 is 8 no. Выводится преимущественно почками – около 90%. Completely eliminated from the body within 2-3 days.

Testimony

- Depressive disorders of varying severity.

Dosage regimen

Ixel for ingestion.

The average daily dose is 100 mg; drug should be taken in 2 receiving in the first half of the day. Depending on the severity of symptoms the dose may be increased to 250 mg / day.

The drug is preferably taken with food.

The duration of therapy is determined individually.

In patients with renal insufficiency (CC 50-10 ml / min) recommended lowering the daily dose depending on the values ​​QC.

Side effect

CNS: возможно – чувство тревоги, dizziness; редко – тремор, headache.

From the digestive system: редко – сухость во рту, nausea, vomiting, constipation; в отдельных случаях – умеренное повышение активности трансаминаз без клинических проявлений.

Other: возможно – усиление потоотделения, tides, strangury; редко – сердцебиение, rash; в отдельных случаях – серотониновый синдром.

Side effects are rare, preferably during the first 2 weeks of therapy, expressed slightly, usually self-cropped as a regression of symptoms of depression, and do not require discontinuation of the drug. Reduce the severity and number of side effects may be by gradually building up the dose during treatment.

Contraindications

Absolute

- Childhood and adolescence up 15 years (due to the lack of clinical data);

- Concomitant use of non-selective and selective inhibitors of MAO-B, sumatriptan;

- Hypersensitivity to the drug.

Relative

- Obstruction of the urinary tract (mainly in benign prostatic hyperplasia);

- Pregnancy;

- Lactation (breast-feeding);

- Simultaneous reception with adrenaline, noradrenaline, clonidine and its derivatives;

- Concomitant use of selective inhibitors of MAO-A, digoksina.

FROM caution use in patients with angle-closure glaucoma, epilepsy.

Pregnancy and lactation

Do not appoint Ixel during pregnancy and lactation.

Cautions

With extreme caution should be used on patients with BPH (benign prostatic hyperplasia) prostate, with a history of seizures, with hypertension, kardiomiopatiej (in connection with a slight increase in heart rate).

Ixel can be administered no earlier than 14 days after discontinuation of MAO inhibitors. Besides, from the time of withdrawal of the drug before Ixel MAO inhibitor therapy should be at least 7 days.

During treatment Ixelles avoid alcohol.

Effects on ability to drive vehicles and management mechanisms

During the period of use of the drug should refrain from activities potentially hazardous activities, requiring increased attention and rapid psychomotor reactions.

Overdose

Symptoms: при случайном увеличении дозы – тошнота, vomiting, Sweating, constipation. Before the drug at a dose of, exceeding 800-1000 mg, -vomiting, difficulty breathing, tachycardia. Upon receiving excessively high dose (1900-2800 mg of milnacipran) in combination with other psychotropic drugs (most benzodiazepines) to the above symptoms added sleepiness, giperkapniя, disturbances of consciousness. Manifestations of cardiotoxicity and death with overdose Ixelles not checked.

Treatment: gastric lavage, followed by symptomatic treatment. Recommended medical monitoring of the patient for at least a day. Spetsificheskiy antidote unknown.

Drug Interactions

Concomitant use Ixelles with non-selective MAO inhibitors (iproniazid), with selective inhibitors of MAO type B (selegiline), with sumatriptan because of the risk of serotonin syndrome, hypertension, coronary artery spasm (минимальный интервал после окончания лечения указанными препаратами и назначением Иксела – 2 of the week).

Not recommended simultaneous application Ixelles with epinephrine and norepinephrine because of the risk of hypertension and arrhythmia; clonidine and related compounds due to reduction of the hypotensive effect of; with digoxin (particularly when administered parenterally) because of the risk of tachycardia and hypertension; with selective inhibitors of MAO-A (moclobemide, toloksaton) due to the risk of serotonin syndrome.

Carefully should be used in combination with Ixel epinephrine and norepinephrine (in case of a local anesthetic dose should not exceed 100 micrograms per 10 min or 300 micrograms per 1 no), with lithium due to the risk of serotonin syndrome.

Conditions of supply of pharmacies

The drug is released under the prescription.

Conditions and terms

The drug should be stored out of reach of children at or above 30 °. Shelf life - 3 year.