Ixel is an antidepressant.
Release form and composition
Ixel is produced in the form of hard gelatin capsules (14 pieces in a blister, 2 or 4 blisters per pack).
The active ingredient of the drug is milnacipran hydrochloride, in one capsule it contains 25 or 50 mg.
Excipients: anhydrous colloidal silicon dioxide, carmellose calcium, calcium hydrogen phosphate dihydrate, povidone K30, talc, magnesium stearate.
The composition of the shell: titanium dioxide, gelatin, iron dyes oxide red and yellow.
Indications for use
Ixel is used in the treatment of depressive disorders.
The drug is strictly contraindicated:
- Children and adolescents up to 15 years;
- Simultaneously with selective and non-selective MAO type B inhibitors, lithium preparations and sumatriptan;
- With known hypersensitivity to any component of the drug.
Relative contraindications to the use of Ixel are:
- Obstruction of the urinary tract (mainly with prostatic hyperplasia);
- The simultaneous use of digoxin and selective inhibitors;
- The need to take clonidine or its derivatives, norepinephrine, adrenaline.
With caution, the drug is prescribed for:
- Epilepsy and epileptic seizures;
- Benign prostatic hyperplasia;
- Closed angle glaucoma.
According to the FDA classification, Ixel belongs to category C - drugs that have shown embryotoxic and / or teratogenic effects in animal studies. However, controlled studies in humans have not been conducted, however, there is every reason to believe that drugs in this group may have a reversible damaging effect on the fetus or newborn child, but do not cause congenital anomalies. For this reason, Ixel should be prescribed to pregnant and lactating women only for health reasons and in the case when the expected benefit from the therapy outweighs the potential risks.
Dosing and Administration
The drug is taken orally with meals.
The average daily dose is 100 mg - 50 mg twice a day. In some cases, it can be increased to 250 mg.
For patients with renal insufficiency, the dosage is reduced based on renal function:
- With CC 30-60 - 25 mg twice a day;
- When CC 10-30 - 25 mg once a day.
The effectiveness of Ixel, as in the case of taking any other antidepressant, manifests itself after 1-3 weeks of regular use. In order to avoid recurrence of the disease, treatment is recommended to continue for several months. In each case, the duration of therapy is determined individually, usually it is 6 months.
To prevent the development of withdrawal syndrome, discontinue treatment should be a gradual decrease in dose.
Basically, the drug is well tolerated. If undesirable reactions occur, then, as a rule, during the first 2 weeks of treatment, they are not very pronounced and disappear as the symptoms of depression regress, and therefore do not require the cancellation of Ixel. In addition, to reduce the number and severity of adverse reactions can be a gradual increase in dose.
Possible adverse effects of the drug:
- From the side of the central nervous system: anxiety, dizziness, tremor, headache;
- On the part of the digestive tract: vomiting, dry mouth, constipation, nausea, a moderate increase in liver transaminase activity;
- Other: flushing, difficulty urinating, increased sweating, rapid heartbeat, skin rash.
The most serious side effect of Ixel, which, however, is extremely rare, is serotonin syndrome - a potentially deadly reaction to drugs that increase serotonergic transmission. Its early signs are dyspeptic symptoms, extrapyramidal disorders (restlessness, tremor, muscle hypertonus, dysarthria), myoclonic twitching, hyperreflexia. In more severe cases, a manic-like state occurs, manifested by sleep disturbances, irregular thoughts, confusion, and accelerated blurred speech.
With a slight increase in dosage, excessive sweating, constipation, nausea and / or vomiting are possible, while taking the drug in a dose of more than 800 mg - vomiting, tachycardia, difficulty breathing. In case of a significant excess of the recommended dose (1800-2800 mg), in addition to the symptoms described, impaired consciousness, drowsiness and hypercapnia (signs of carbon dioxide poisoning) are noted. Cases of cardiotoxicity and death in overdose of milnacipran were not registered.
If the patient accidentally or deliberately took a large dose of Ixel, you should do a gastric lavage and consult a doctor. There is no specific antidote for milnacipran. Overdose treatment is symptomatic. At least a day a person must be under medical supervision.
An important advantage of the drug is the absence of a sedative effect and a negative effect on cognitive function, but the ability to physiologically improve sleep. In addition, Ixel does not affect the blood pressure and cardiac conduction system, which is especially important for elderly patients who are constantly taking cardiotropic drugs.
During treatment, it is strictly forbidden to consume alcoholic beverages.
If possible, the combined use of Ixel with should be avoided with:
- adrenaline and norepinephrine - because there is a risk of developing arrhythmias and hypertension;
- selective inhibitors of MAO type A (moccobemide, toloxatone) - due to the likelihood of developing serotonin syndrome;
- digoxin (especially when it is used parenterally) - due to the risk of developing tachycardia and hypertension;
- clonidine and compounds close to it their hypotensive effect decreases.
It is contraindicated to use Ixel at the same time as sumatriptan, non-selective MAO inhibitors, lithium preparations and selective MAO type B inhibitors, since such a combination can lead to arterial hypertension, spasm of the coronary arteries and the development of serotonin syndrome, including fatal. If necessary, the appointment of Ixel should be maintained for at least a 2-week interval after the end of the use of these drugs.
The entire period of treatment is not recommended to get behind the wheel and perform potentially dangerous types of work that require high concentration of attention and / or speed of reactions.
According to belonging to one pharmacological subgroup, Ixel's analogues are Amitriptyline, Apo-Amitriptyline, Vero-Amitriptyline, Anafranil, Anafranil CP, Damilen, Imizin, Klofranil, Clomipramine, Melipramine, Lyudiomil, Saroten Retard.
Terms and conditions of storage
Ixel should be stored in a dark place at temperatures up to 30 ºС. Shelf life of capsules - 3 years.