Ixel
Ixel: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Method of application and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. Application during pregnancy and lactation
- 10. In case of impaired renal function
- 11. For violations of liver function
- 12. Use in the elderly
- 13. Drug interactions
- 14. Analogs
- 15. Terms and conditions of storage
- 16. Terms of dispensing from pharmacies
- 17. Reviews
- 18. Price in pharmacies
Latin name: Ixel
ATX code: N06AX17
Active ingredient: milnacipran (milnacipranum)
Producer: Pierre Fabre Medicament Production (Pierre Fabre Medicament Production), France
Description and photo update: 2018-04-07
Prices in pharmacies: from 1518 rubles.
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Ixel is an antidepressant drug without sedation.
Release form and composition
Dosage form - capsules: hard gelatinous, with an orange-pink cap with a black inscription "IXEL" and a body: size No. 4 - orange-pink color with a black print "25", size No. 3 - yellow-orange color with a black print " 50"; the contents of the capsules are almost white to white powder, the presence of lumps is allowed, turning into a powder with light pressure (14 pieces in blisters, in a cardboard box 2 or 4 blisters).
The active ingredient of Ixela is milnacipran hydrochloride, in 1 capsule - 25 or 50 mg.
Auxiliary components: calcium carmellose, calcium hydrogen phosphate dihydrate, povidone K30, magnesium stearate, colloidal silicon dioxide, talc.
The composition of the capsule shell: gelatin, iron oxide red (E172), titanium dioxide (E171), iron oxide yellow (E172).
Pharmacological properties
Pharmacodynamics
Milnacipran belongs to selective monoamine reuptake inhibitors [norepinephrine and serotonin (5 HT)]. There is no binding of the substance with H 1 -histamine receptors, α 1 -adrenoreceptors, m-cholinergic receptors, as well as D 1 and D 2 -dopaminergic, opioid and benzodiazepine receptors.
Milnacipran has practically no effect on cardiac conduction or repolarization. It also does not alter cognitive function and is mildly sedating.
Milnacipran has been shown to be highly effective in the treatment of patients with depressive sleep disorders. In this case, the total duration of sleep increases, the time to fall asleep is minimized, the time interval before the onset of the rapid phase of sleep increases, and the number of nighttime awakenings decreases.
The effectiveness of the drug is comparable to the effectiveness of tricyclic antidepressants and selective serotonin reuptake inhibitors, but is less than that of clomipramine.
Pharmacokinetics
When taken orally, milnacipran is well absorbed. Its bioavailability reaches 85% and is not determined by the characteristics and diet. The maximum concentration of the substance in the blood plasma is recorded approximately 2 hours after ingestion. When Ixela is taken in a single dose of 50 mg, the maximum blood level of milnacipran is approximately 120 ng / ml. When taking the drug in doses not exceeding 200 mg, a dose-dependent increase in the maximum concentration is observed. After repeated doses of Ixela, the equilibrium concentration is reached within 2-3 days, and it is 70-100% higher than when taking a single dose (the maximum concentration is about 216 ng / ml). Interindividual variability remains low.
Milnacipran binds to blood plasma proteins slightly (by about 13%), and the binding is characterized by unsaturation. The volume of distribution is approximately 5 l / kg with a total clearance of about 40 l / h. Non-renal and renal clearance are the same.
Milnacipran practically does not participate in metabolic processes. An active metabolite was not detected, the substance conjugates with glucuronic acid. The half-life of the active ingredient Ixela is approximately 8 hours. Milnacipran is excreted unchanged, mainly in the urine (approximately 90% of the administered dose) due to tubular secretion.
After the end of the course of treatment, milnacipran is completely excreted from the body within 2-3 days after the drug is discontinued.
Liver dysfunction does not cause significant changes in the pharmacokinetic parameters of milnacipran. The rate of excretion of the substance decreases in proportion to the degree of renal damage in patients with renal insufficiency.
In elderly patients, the pharmacokinetic parameters of milnacipran do not change significantly. However, when choosing a dose, it is necessary to take into account the physiological changes in renal function in elderly patients.
According to information obtained from preclinical studies, with repeated administration of Ixel, the liver is the target organ. Adverse reactions were observed at high doses, approximately 10 times the recommended dose, and were reversible. Preclinical data obtained from studies of reproductive toxicity, genotoxicity and conventional toxicity of milnacipran do not confirm the presence of potential risks to the patient's health. The substance is neither carcinogenic nor mutagenic.
Indications for use
The use of the antidepressant Ixel is indicated in the treatment of depressive disorders of varying severity.
Contraindications
- Concomitant use with sumatriptan, non-selective and selective inhibitors of monoamine oxidase (MAO) type B, selective MAO inhibitors type A, digoxin;
- Age up to 15 years;
- Obstruction of the urinary tract (including against the background of prostatic hyperplasia);
- The period of pregnancy and breastfeeding;
- Concomitant therapy with norepinephrine, epinephrine, clonidine or its derivatives;
- Hypersensitivity to drug components.
Special care should be taken when prescribing Ixel to patients with angle-closure glaucoma, a history of seizures, epilepsy, benign hyperplasia (adenoma) of the prostate gland, renal failure, arterial hypertension, cardiomyopathy.
Instructions for use of Ixela: method and dosage
The capsules should be taken orally, in the morning, preferably with meals.
The dose and duration of therapy is prescribed by the doctor based on the individual severity of the symptoms.
The recommended average daily dose of Ixel is 100 mg, divided into 2 doses.
To achieve a stable therapeutic effect in a severe form of the disease, an increase in the dose is indicated, but not higher than 250 mg per day.
Patients with renal insufficiency with creatinine clearance (CC) 50-10 ml / min, the daily dose is recommended to be reduced taking into account the CC values.
Side effects
- Nervous system: possible - dizziness, anxiety; rarely - headache, tremor;
- Digestive system: rarely - nausea, dry mouth, constipation, vomiting; in some cases - a moderate increase in the activity of liver enzymes without clinical symptoms;
- Others: possibly hot flashes, increased sweating, difficulty urinating; rarely - rash, palpitations; in some cases - serotonin syndrome.
Overdose
In case of an Ixela overdose, the first symptoms of this condition are constipation, excessive sweating, nausea, and vomiting. Taking the drug at a dose of more than 800-1000 mg causes tachycardia, breathing problems, and vomiting. When Ixel is taken in an extremely high dose (1900-2800 mg) in combination with other psychotropic drugs (mainly benzodiazepines), impaired consciousness, hypercapnia, and severe drowsiness are added to the symptoms listed above. Overdose of milnacipran does not lead to the development of manifestations of cardiotoxicity.
In this situation, you should immediately flush the stomach, take activated charcoal and consult a doctor who will prescribe symptomatic therapy. There is no specific antidote for milnacipran. It is recommended to monitor the patient's condition for at least one day.
special instructions
Due to a slight increase in heart rate while taking Ixel, patients with cardiomyopathy, arterial hypertension should use the drug with caution.
The appearance of side effects is rare and does not require the abolition of Ixel. Adverse reactions, as a rule, appear during the first 2 weeks of treatment, are mild and disappear on their own as the symptoms of depression decrease. To reduce the severity and number of side effects, it is recommended to gradually increase the dose during therapy.
It is possible to prescribe the antidepressant Ixel after the withdrawal of MAO inhibitors no earlier than 2 weeks later, and the administration of MAO inhibitors should be started a week after the drug is discontinued.
Alcohol consumption during treatment is contraindicated.
Patients should refrain from driving vehicles and mechanisms during the entire period of therapy.
Application during pregnancy and lactation
Since there is no information regarding the safety and efficacy of taking milnacipran in pregnant women, Ixel should not be prescribed during pregnancy. The active substance penetrates into breast milk, therefore, Ixel should not be taken during breastfeeding.
With impaired renal function
Ixel is unacceptable to prescribe with concomitant obstruction of the urinary tract. Patients with renal insufficiency, as well as patients with a history of indications of problems with urine outflow (especially patients with prostatic hyperplasia and other diseases affecting the urinary tract) should take the drug with caution: a dose reduction associated with prolongation may be required half-life of milnacipran.
For violations of liver function
According to the instructions, Ixel is prescribed with caution to patients with liver cirrhosis.
Use in the elderly
Ixel should be used with caution in elderly patients.
Drug interactions
Since with the simultaneous use of Ixel with sumatriptan, non-selective MAO inhibitors (iproniazid), selective MAO inhibitors of type B (selegilin), it is possible to develop serotonin syndrome, coronary artery spasm, arterial hypertension, it is necessary to strictly observe a break of 2 weeks between the appointment of these drugs.
When combined with norepinephrine and adrenaline, arterial hypertension, arrhythmias may appear; if it is necessary to carry out local anesthesia while taking an antidepressant, their doses should not exceed 0.1 mg in 10 minutes or 0.3 mg in 60 minutes.
It is not recommended to prescribe Ixel simultaneously with digoxin (especially when injected), since this can cause the development of arterial hypertension and tachycardia; clonidine and similar compounds - due to a decrease in their hypotensive effect.
Concomitant therapy with toloxatone, moclobemide and other selective MAO type A inhibitors, lithium preparations poses a threat of serotonin syndrome.
Analogs
There is no information about Ixel's analogues.
Terms and conditions of storage
Store at temperatures up to 30 ° C. Keep out of the reach of children.
The shelf life is 3 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews about Ixel
Many patients leave positive reviews about Ixel. They argue that it helps well with prolonged depression and panic attacks: interest in life appears, anxiety and feelings of weakness disappear, side effects are almost not observed. It can be taken over a long period of time (6 months or more), gradually decreasing the dose.
However, some patients do not like the high cost of the drug and the need to purchase it on order. Also, in isolated cases, there is an insufficient effectiveness of the drug and the manifestation of allergic reactions.
The price of Ixel in pharmacies
The approximate price for Ixel with a dosage of 25 mg in pharmacies is 1199-1946 rubles, and with a dosage of 50 mg - 2338-2724 rubles (for a package containing 56 capsules).
Ixel: prices in online pharmacies
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Drug name Price Pharmacy |
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Ixel 25 mg capsules 56 pcs. RUB 1518 Buy |
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Ixel capsules 25mg 56 pcs. 1614 RUB Buy |
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Ixel 50 mg capsules 56 pcs. 2299 RUB Buy |
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Ixel capsules 50mg 56 pcs. 2628 RUB Buy |
Maria Kulkes Medical journalist About the author
Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
