Ixel 50mg №56 capsules
Composition1 capsule contains: miltsipran hydrochloride 50 mg.
Excipients: calcium hydrophosphate dihydrate, calcium carmellose, povidone K30 (polyvidone K30), colloidal anhydrous silicon, magnesium stearate, talc.
The composition of the shell of the capsules: titanium dioxide (E171), iron oxide red (E172), iron oxide yellow (E172), gelatin.
PackagingIn the blister 14 capsules. In packing 4 blisters.
pharmachologic effectIxel is an antidepressant, a selective inhibitor of the reuptake of monoamines (norepinephrine and serotonin).
It has no affinity for m-cholinergic receptors, A 1 -adrenoreceptors, histamine H 1 receptors, as well as dopamine D 1 and D 2 receptors, benzodiazepine and opioid receptors.
It does not have a sedative effect, while physiologically improving sleep and does not adversely affect the cognitive function. Ixel also does not affect the conducting system of the heart and blood pressure, which is especially important for elderly patients who are constantly taking cardiotropic drugs.
IndicationsDepressive disorders of varying severity.
- Children and adolescents up to 15 years (due to the lack of clinical data).
- Simultaneous use of non-selective and selective inhibitors of MAO type B, sumatriptan.
- Hypersensitivity to the drug.
- Obstruction of the urinary tract (mainly in benign prostatic hyperplasia).
- Lactation (breastfeeding).
- Simultaneous reception with adrenaline, norepinephrine, clonidine and its derivatives.
- Simultaneous use of selective inhibitors of MAO type A, digoxin.
Carefully:- angle-closure glaucoma.
Use during pregnancy and lactationIt is not recommended to prescribe Ixel during pregnancy and lactation.
Dosage and administrationIxel is intended for ingestion.
The average daily dose is 100 mg; The drug should be taken in 2 divided doses in the morning. Depending on the severity of symptoms, the dose may be increased to 250 mg / day. The drug is preferably taken with meals. The duration of therapy is determined individually.
In patients with renal insufficiency (creatinine clearance (CK) 50-10 ml / min), a decrease in the daily dose is recommended depending on the CC values.
Side effectsSide effects are rare, mainly during the first 2 weeks of therapy, are mild, usually stop themselves as the depression symptoms regress and do not require discontinuation of the drug.
From the side of the central nervous system: possible - anxiety, dizziness; rarely - tremor, headache.
On the part of the digestive system: rarely - dry mouth, nausea, vomiting, constipation; in some cases, a moderate increase in transaminase activity without clinical manifestations.
Other: possible - increased sweating, flushing, difficulty urinating; rarely - palpitations, rash; in some cases - serotonin syndrome.
special instructionsWith extreme caution should use the drug for benign prostatic hyperplasia (adenoma), with convulsive seizures in history, with arterial hypertension, cardiopathy (due to a slight increase in heart rate).
Ixel can be administered no earlier than 14 days after discontinuation of MAO inhibitors. In addition, from the moment of discontinuation of the drug Ixel before the start of therapy with MAO inhibitors should take at least 7 days.
During the period of treatment Ixel not to allow alcohol.
During the period of use of the drug should refrain from engaging in potentially hazardous activities that require increased attention and quick psychomotor reactions.
Drug interactionThe simultaneous use of Ixel with non-selective MAO inhibitors (iproniazid), with selective MAO type B inhibitors (selegilin), with sumatriptan due to the risk of developing serotonin syndrome, hypertension, spasm of the coronary arteries (the minimum interval after the end of treatment with these drugs and the appointment of Ixel - 2 weeks is contraindicated. ).
The simultaneous use of Ixel with adrenaline and noradrenaline is not recommended due to the risk of arterial hypertension and arrhythmia; with clonidine and related compounds due to the reduction of their hypotensive effect; with digoxin (especially when administered parenterally) because of the risk of developing tachycardia and hypertension; with selective MAO type A inhibitors (moccobemide, toloxaton) due to the risk of developing serotonin syndrome.
With caution, Ixel should be prescribed in combination with epinephrine and norepinephrine (in case of local anesthesia, the doses should not exceed 100 μg for 10 min or 300 μg for 1 h), with lithium preparations due to the risk of developing serotonin syndrome.
OverdoseSymptoms: with an accidental increase in dose - nausea, vomiting, sweating, constipation. When taking the drug in a dose exceeding 800-1000 mg, vomiting, difficulty breathing, tachycardia. After taking in 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. Manifestations of cardiotoxicity and death in overdose of Ixel is not observed.
Treatment: gastric lavage followed by symptomatic therapy. Recommended medical monitoring of the patient for at least a day. The specific antidote is unknown.
Storage conditionsStore at a temperature not higher than 30 ° C.
Shelf life3 years.
It is a pharmaceutical drug. Use only as directed by your doctor.