Ixel, 50mg capsules, 56pcs

Composition

Active ingredient:

milnacipran hydrochloride 50 mg;

Auxiliary substances:

calcium hydrophosphate dihydrate 101.85 mg;

carmellose calcium 44.3 mg;

povidone K 30 4.2 mg;

colloidal silicon dioxide 1.25 mg;

magnesium stearate 4.2 mg;

talc 4.2 mg

Pharmacological action

Ixel is an antidepressant, a selective monoamine reuptake inhibitor (norepinephrine and serotonin). Ixel does not bind to m-cholinergic receptors, α1-adrenergic receptors, histamine H1-receptors, as well as to dopamine D1-and D2-receptors, benzodiazepine and opioid receptors.

It does not have a sedative effect, but it improves sleep physiologically and does not negatively affect cognitive function. Ixel also has no effect on the cardiac conduction system and blood pressure, which is especially important for elderly patients who are constantly taking cardiotropic drugs.

Pharmacokinetics

Suction

After oral use, milnacipran is well absorbed from the gastrointestinal tract. Bioavailability is about 85% and does not depend on the nature and mode of nutrition. Cmax in blood plasma is reached approximately 2 hours after use.

Distribution

The equilibrium state is reached after 2-3 days of regular intake. Binding to plasma proteins is about 13% and is not accompanied by saturation.

Metabolism

Biotransformed mainly by conjugation with glucuronic acid. The metabolites have no pharmacological activity.

Elimination

T1 / 2 is 8 h. It is mainly excreted by the kidneys – about 90%. Completely eliminated from the body within 2-3 days.

Indications

Depressive disorders of varying severity.

Contraindications

• children and adolescents under 15 years of age (due to the lack of clinical data);
• simultaneous use of non-selective and selective MAO type B inhibitors, sumatriptan;
• hypersensitivity to the components of the drug.
• urinary tract obstruction (mainly with prostatic hyperplasia);
• pregnancy;
• lactation (breastfeeding);
• concomitant use with epinephrine, norepinephrine, clonidine and its derivatives;
• concomitant use of selective MAO inhibitors type A, digoxin.

With caution, the drug should be used for angle-closure glaucoma, epilepsy.

Side effects

From the central nervous system:  perhaps-a feeling of anxiety, dizziness; rarely-tremor, headache.

From the digestive system:  rarely – dry mouth, nausea, vomiting, constipation; in some cases-a moderate increase in transaminase activity without clinical manifestations.

Other services:  possibly-increased sweating, hot flashes, difficulty urinating; rarely-palpitations, rash; in some cases-serotonin syndrome.

Interaction

Simultaneous use is contraindicated Ixel with non-selective MAO inhibitors (iproniazid), with selective MAO type B inhibitors (selegiline), with sumatriptan due to the risk of serotonin syndrome, arterial hypertension, and coronary artery spasm (the minimum interval after the end of treatment with these drugs and the appointment of Ixel is 2 weeks).

Simultaneous use is not recommended Ixel with epinephrine and norepinephrine due to the risk of arterial hypertension and arrhythmia; with clonidine and related compounds due to a decrease in their hypotensive effect; with digoxin (especially with parenteral use) due to the risk of tachycardia and arterial hypertension; with selective MAO inhibitors type A (moclobemide, toloxatone) due to the risk of serotonin syndrome.

With caution, Ixel should be prescribed in combination with epinephrine (epinephrine) and norepinephrine (norepinephrine) (in the case of local anesthesia, doses should not exceed 100 mcg for 10 minutes or 300 mcg for 1 hour), with lithium preparations due to the risk of serotonin syndrome.

How to take, course of use and dosage

Ixel is intended for oral use.

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

The drug should preferably be taken with a meal.

The duration of therapy is set individually.

In patients with renal insufficiency (creatinine clearance 50-10 ml / min) it is recommended to reduce the daily dose depending on the values of creatinine clearance.

Overdose

Symptoms:  if the dose was accidentally increased, nausea, vomiting, sweating, and constipation were observed. When taking the drug in a dose exceeding 800-1000 mg, vomiting, difficulty breathing, tachycardia are possible. After taking an excessively high dose (1900-2800 mg of milnacipran) in combination with other psychotropic drugs (most often benzodiazepines), drowsiness, hypercapnia, and impaired consciousness are added to the symptoms described above. There were no signs of cardiotoxicity or fatal outcome with an overdose of Ixel.

Treatment:  gastric lavage followed by symptomatic therapy. Medical monitoring of the patient’s condition for at least a day is recommended. The specific antidote is unknown.

Special instructions

With caution, the drug is prescribed to patients with a history of convulsive seizures, with arterial hypertension, cardiomyopathy. Ixel can be prescribed no earlier than 14 days after the withdrawal of MAO inhibitors. In addition, at least 7 days should elapse from the moment of discontinuation of Ixel to the start of therapy with MAO inhibitors.

To reduce the severity of side effects, a gradual increase in the dose of the drug is recommended.

When performing local anesthesia with drugs containing epinephrine or norepinephrine against the background of therapy with Ixel, the dose of anesthetics should not exceed 0.1 mg for 10 minutes and 0.3 mg for 1 hour.

Do not drink alcohol during treatment with Ixel.

Influence on the ability to drive and manage mechanisms

During the period of using the drug, you should refrain from engaging in potentially dangerous activities that require increased attention and rapid psychomotor reactions.

Form of production

Capsules

Storage conditions

At a temperature not exceeding 30 °C

Shelf life

3 years

Active ingredient

Milnacipran

Conditions of release from pharmacies

By prescription

Dosage form

Capsules