Active substanceVenlafaxineVenlafaxine
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  • Dosage form: & nbspmodified release capsules
    Composition:

    1 modified-release capsule contains:

    active substance: venlafaxine hydrochloride (corresponding to 37.5 mg, 75 mg and 150 mg venlafaxine in the form of pellets);

    pellet auxiliaries: sugar grits, giprolose, povidone, ethylcellulose, dibutyl sebacate;

    Excipients: talc.

    Gelatin Capsules

    Capsule shell composition 37.5 mg (N3): Capsule body: titanium dioxide, gelatin; capsule cap: iron dye oxide red (E172), titanium dioxide, gelatin.

    Capsule shell composition: 75 mg (№1) and 150 mg (№0): Capsule body: iron dye oxide red (E172), titanium dioxide, iron oxide yellow oxide (E172), gelatin; capsule cap: dye iron oxide red (E172), titanium dioxide, iron oxide dye yellow (E172), gelatin.

    Description:

    Capsules 37.5 mg: hard gelatin capsules: capsule body white, cap capsules brownish-pink. Contents of capsules: pellets of white or almost white color.

    Capsules 75 mg: Hard gelatin capsules: body and lid of light pink color. Contents of capsules: pellets of white or almost white color.

    Capsules 150 mg: Hard gelatin capsules: body and cap capsules of a brownish-orange color. Contents of capsules: pellets of white or almost white color.

    Pharmacotherapeutic group:antidepressant
    ATX: & nbsp

    N.06.A.X.16   Venlafaxine

    N.06.A.X   Other antidepressants

    Pharmacodynamics:

    Venlafaxine is a new antidepressant that differs from known antidepressants. The preparation is a racemic mixture of two active enantomers.The mechanism of action of venlafaxine is associated with increased activity of neurotransmitters in the central nervous system. Venlafaxine and its main metabolite, O-desmethylvenlafaxine (EFA) - powerful inhibitors of the reuptake of serotonin and norepinephrine. Venlafaxine also slightly suppresses the capture of dopamine.

    Venlafaxine and EFA weaken the beta-adrenergic response both after a single administration, and with prolonged administration. Venlafaxine and EFA have similar activity with respect to the reuptake of neurotransmitters. Venlafaxine does not have an affinity for muscarinic cholinergic, histamine (H1) or α1-adrenoceptors of rat brain in vitro. The pharmacological effect on these types of receptors can cause the development of various side effects, such as anticholinergic, sedative and cardiovascular reactions, observed with the reception of other antidepressants. Venlafaxine does not suppress the activity of monoamine oxidase (MAO).

    Pharmacokinetics:

    Suction: at a single oral intake, no less than 92% of the venlafaxine dose is absorbed. The absolute bioavailability of venlafaxine is 45%. After taking the event® maximum concentrations of venlafaxine and EFA (TCmax) in plasma are achieved in 6.0 ± 1.5 and 8.8 ± 2.2 hours, respectively. The rate of suction of venlafaxine from capsules of Alventa® lower than the rate of its removal. In connection with this, the half-life of venlafaxine after taking capsules of Alventa® (15 ± 6 hours) is almost half the dose, and not the actual half-life (5 ± 2 hours) of venlafaxine observed after taking immediate-release tablets. Capsules of Alventa® have a lower suction rate, but the same degree of suction (ie, the same AUC) as venlafaxine with immediate release.

    Distribution: venlafaxine and EFA by 27% and 30% are respectively associated with plasma proteins.

    Metabolism: venlafaxine predominantly metabolized in the liver by isoenzyme CYP2D6 with the formation of O-desmethylvenlafaxine (EFA) and the CYP isoenzyme3A3/4 before N- desmethylvenlafaxine and other less important metabolites.

    Excretion: venlafaxine and its metabolites are excreted mainly by the kidneys. 87% of the dose of venlafaxine received is detected in the urine within 48 hours in the form of unchanged form, unconjugated EFA, conjugated EFA and other metabolites.The sex and age of patients do not affect the pharmacokinetics of venlafaxine. With prolonged use of the drug in healthy individuals, there was no accumulation.

    Reception of Alventa® with food does not affect the absorption of venlafaxine or the subsequent formation of EFA.

    Indications:

    Depression (treatment and prevention).

    Contraindications:

    - Hypersensitivity to venlafaxine or any component of the drug;

    - simultaneous therapy with MAO inhibitors or within 14 days after their cancellation. Before starting taking MAO inhibitors after Alventa® has been canceled, it must be at least 7 days;

    - Children and adolescents younger than 18 years.

    Carefully:

    Recent myocardial infarction, unstable angina, hypertension, tachycardia, cramps in history, ocular hypertension, angle-closure glaucoma, manic state history, hyponatremia, hypovolemia, dehydration, simultaneous diuretics, suicidal predisposition to bleeding from the skin and mucous membranes shells, renal / hepatic insufficiency.

    Pregnancy and lactation:Alvento® Do not use during pregnancy without a proven need.
    If venlafaxine is used before delivery or immediately before childbirth, it should be borne in mind the possible effects in the newborn caused by the rapid cancellation of the drug.
    When appointing the Alventa® should resolve the issue of ending breastfeeding.
    Dosing and Administration:

    Alvento® take inside, with food. Capsules must be swallowed whole. The drug is taken once a day, approximately at the same time, in the morning or in the evening.

    Treatment of depression:

    Doses of Alventa® for the treatment of all types of depression from 75 to 375 mg at one time. The recommended starting dose is 75 mg once a day. If after 2-4 weeks of therapy there is no improvement, the daily dose is increased to 150 mg once a day. If necessary, the dose of the drug can be increased to 225 or 375 mg per 1 reception per day. An increase in the dose of the drug should be carried out at intervals of 2 weeks or more, but not shorter than 4 days. In the prevention of exacerbations, the physician should periodically evaluate the dosage and duration of application of the Alventa® for each patient.

    Impaired liver or kidney function: in patients with impaired liver or kidney function, the dose of venlafaxine should be reduced. Treatment is started with short-acting venlafaxine tablets to select the required dose. In patients with a glomerular filtration rate (GFR) of 10-70 ml / min, the dose of venlafaxine is reduced by 25-50%. In patients on hemodialysis, the dose of the drug is reduced by 50%. Alvento® can not be used during dialysis.

    In patients with moderate dysfunction of the liver, the dose of the drug is reduced by 50%, with more severe disorders, a greater dose reduction is required. For such patients, the use of short-acting venlafaxine tablets is more justified.

    Aged people: In elderly patients, therapy is recommended starting with minimal effective doses. If it is necessary to increase the dose, the patient should be under close medical supervision.

    Discontinuation of therapy:

    To reduce the risk of withdrawal symptoms, Alventoy's therapy® it is necessary to stop gradually if it lasted more than 1 week. If the reception of the Alventa® was 6 weeks, the drug was canceled, gradually reducing the dose for another 2 weeks.The time required for complete withdrawal of the drug may vary depending on the duration of treatment and the dose used.

    Side effects:

    From the side of the blood and lymphatic system:

    - infrequently: hemorrhages in the skin (ecchymosis), bleeding of the mucous membranes;

    - rarely: increased bleeding time, thrombocytopenia;

    - very rarely: blood dyscrasia (agranulocytosis, aplastic anemia, neutropenia and pancytopenia).

    From the immune system:

    - very rarely: anaphylactic reactions.

    From the side of metabolism:

    - often: increased serum cholesterol levels (especially with prolonged treatment and, possibly, high doses), weight loss;

    - infrequently: hyponatremia, weight gain;

    - rarely: syndrome of inadequate production of antidiuretic hormone;

    - very rare: increased prolactin levels in the blood.

    From the side of the central nervous system and the peripheral nervous system:

    - often: insomnia, increased nervous excitability, anorgasmia, unusual dreams, decreased libido, dizziness, decreased muscle tone, paresthesia, sedation, tremor;

    - infrequently: apathy, hallucinations, violations of orgasm in women, convulsive disorders;

    - rarely: manic disorders, serotonin syndrome, neuroleptic malignant syndrome;

    - very rarely: delirium, psychomotor agitation, extrapyramidal reactions (dystonia and dyskinesia), tinnitus.

    From the sense organs:

    - often: disorders of accommodation, mydriasis, visual impairment;

    - very rarely: angle-closure glaucoma.

    On the part of the respiratory and mediastinal organs:

    - often: yawning.

    From the cardiovascular system:

    - often: arterial hypertension, sensation of "hot flashes" to the skin of the face;

    - infrequently: tachycardia, hypotension, postural hypotension, collapse;

    - very rarely: lengthening of the interval QT, ventricular fibrillation, ventricular tachycardia (including ventricular fibrillation).

    From the digestive system:

    - often: decreased appetite, constipation, nausea, vomiting;

    - infrequently: bruxism (involuntary gnashing of teeth), changes in taste sensations, changes in liver function parameters;

    - rarely: hepatitis;

    - very rarely: diarrhea.

    From the skin and subcutaneous tissue:

    - often: sweating (including nocturnal);

    - infrequently: dermatitis, alopecia, photosensitivity reactions;

    - very rarely: erythema multiforme, Stevens-Johnson syndrome, itchy skin.

    From the side of skeletal-muscular and connective tissues:

    - very rarely: rhabdomyolysis.

    From the side of the kidneys and the urinary tract:

    - often: disorders of urination (most often intermittent urination);

    - infrequently: urinary retention.

    From the organs of the reproductive system, breast and milk glands:

    - often: erectile dysfunction and ejaculation;

    - infrequently: menometrorrhagia.

    General violations and changes in the place of introduction:

    - often: weakness.

    The "cancellation" syndrome of the Alventa®: anxiety, agitation, confusion, diarrhea, dizziness, dry mouth, weakness, headache, noise in the head, insomnia, nausea, paresthesia, sleep disorders, sweating and vomiting is associated with a sudden discontinuation of the drug or a decrease in its dose. The incidence of the syndrome increases with higher doses and with a longer duration of use. These symptoms usually pass on their own, although they can persist for several weeks. Recommended when canceling the event® gradually reduce the dose and leave the patient under medical supervision. The time required for the complete cancellation of the Alventa® depends on the doses used, the duration of treatment and the individual characteristics of the patient.

    Overdose:

    Symptoms: changes in the ECG (increase in the QT interval, blockade of the bundle branches, enlargement of the QRS complex), sinus or ventricular tachycardia, bradycardia, lowering of blood pressure, inhibition of consciousness (from inhibition to coma) and convulsive seizures. There is evidence of fatal outcomes with an accidental overdose of venlafaxine along with alcohol and / or other drugs.

    Treatment: provide airway patency, oxygenation and ventilation of the lungs, gastric lavage, activated charcoal and symptomatic therapy. It is recommended to monitor the ECG and other vital functions. It is not recommended to induce vomiting. there is a risk of aspiration. The effectiveness of forced diuresis, dialysis, hemoperfusion or blood transfusion is not known. Specific antidotes are unknown.

    Interaction:

    Alvento® It can not be taken concomitantly with MAO inhibitors or within 14 days after their cancellation. Before the beginning of taking MAO inhibitors after the cancellation of the Alventa® must pass at least 7 days.

    Venlafaxine does not affect the pharmacokinetics lithium.

    The pharmacokinetic parameters of venlafaxine and O-desmethylvenlafaxine did not change whensimultaneous admission diazepam. Venlafaxine does not affect the psychomotor or psychometric effects of diazepam.

    Simultaneous oral administration haloperidol with an equilibrium state of venlafaxine led to a decrease in total renal clearance of haloperidol, its AUC and maximum serum concentrations. Half-life time (T1/2) of haloperidol remained unchanged. The mechanism of this interaction is unknown.

    Venlafaxine did not change the metabolism imipramine and its metabolite 2-OH-imipramine, despite the decrease in renal clearance of 2-hydroxydesipramine and an increase AUC and FROMmOh desipramine by about 35%.

    Cimetidine suppressed the metabolism of venlafaxine during the "first passage" through the liver, but did not have a significant effect on the formation or excretion of O-desmethylvenlafaxine, which circulates in the blood in much larger quantities. Therefore, with simultaneous administration of cimetidine and Alvents® no dose changes are required. In patients with impaired liver function and in the elderly, this interaction may be more pronounced, so they need to remain under observation while taking thesepreparations.

    With simultaneous application venlafaxine strengthens the ethanol on psychomotor reactions. During the treatment of Alventa® should avoid drinking alcohol.

    When venlafaxine is administered to patients receiving warfarin, there was an increase in prothrombin time and partial thromboplastin time.

    With simultaneous application with risperidone: the pharmacokinetics did not change significantly.

    Venlafaxine is mainly metabolized in the liver by isoenzyme CYP2D6 with the formation of O-desmethylvenlafaxine (EFA) and isoenzyme FROMYR3A3/4 before N-desmethylvenlafaxine. It is impossible to exclude the potential interaction between venlafaxine and drugs inhibiting the activity of the isoenzyme CYP2D6- Care should be taken when assigning the Alventa® with such drugs (for example, quinidine, paroxetine, fluoxetine, fluvoxamine, perphenazine, haloperidol, levomepromazine).

    When prescribing venlafaxine, remember the isomorphism polymorphism CYP2D6. In patients with slow CYP2D6 metabolism (about 7% of the European population), higher concentrations of venlafaxinein blood. Elevated levels of venlafaxine can also be observed with concurrent administration of CYP inhibitors3A3/4 (for example, ketoconazole, erythromycin, verapamil and cimetidine).

    Venlafaxine is a relatively weak inhibitor CYP2D6. It does not suppress activity. CYP1A2, CYP2C9 or FROMYR3A3/4.

    Special instructions:

    One should remember the risk of suicidal attempts in the treatment of patients with depression.

    To reduce the risk of drug overdose, treatment should begin with the lowest possible dose.

    In a small number of patients with emotional instability with venlafaxine, there have been cases of mania / hypomania. Like other antidepressants, Alvento® should be used with caution in patients with a history of mania.

    Seizures develop very rarely. Particular attention should be given to patients with epilepsy or organic brain damage syndrome. If necessary, a neurologist is required.

    Caution is necessary and with the simultaneous appointment of the Alventa® and electroconvulsive therapy.

    In patients with cirrhosis of the liver, with moderate and severe impairment of kidney function, the renal clearance of venlafaxine and its active metabolites is reduced and the half-life of the drug is increased from the plasma. In such patients, Alvento® use with caution, in smaller doses or with increased intervals between doses.

    Against the background of treatment with antidepressants, including from the group of selective serotonin drugs, occasionally hyponatremia may develop. Greater attention should be given to older people, patients taking diuretics, or signs of dehydration. When receiving venlafaxine, rare cases of hyponatremia are noted, especially in the elderly; the patient's condition improved after the drug was discontinued.

    In the following cases, regular monitoring of the patients' condition is necessary:

    - with violations of urination (for example, with hypertrophy of the prostate); with a closed-angle form of glaucoma;

    - with high or low blood pressure;

    - in cardiovascular diseases, such as conduction disorders, stress angina and recently transferred myocardial infarction.

    Care should be taken when using several drugs at the same time.

    In some patients, venlafaxine therapy is accompanied by an increase in blood pressure, which can persist with prolonged use of the drug.In patients who have recently undergone myocardial infarction, stroke, suffering from diabetes, strict control of blood pressure during treatment with venlafaxine is necessary. Control of blood pressure is recommended for every patient who receives venlafaxine. With an increase in diastolic pressure above 100 mm Hg. Art. it is necessary to stop taking venlafaxine.

    When taking venlafaxine, especially in high doses, the heart rate may increase. Caution should be exercised in appointing venlafaxine to patients with tachyarrhythmias.

    If long-term therapy with venlafaxine is necessary, it is necessary to regularly monitor the content of cholesterol in the blood. With the development of hypercholesterolemia, the need to continue therapy with Alvento® or to replace it with another antidepressant.

    In the treatment of the depressive phase of manic-depressive psychosis, there can be a transition to a manic state, which requires a rapid reassessment of the patient's condition and ongoing therapy.

    Carefully venlafaxine is prescribed for patients who have recently undergone a myocardial infarction and / or with unstable angina and hypertension.

    When taking venlafaxine may increase the risk of bleeding skin and mucous membranes. In patients with a tendency to such bleeding, Alvento® should be used with caution.

    The efficacy and safety of venlafaxine when taken concomitantly with weight loss drugs, including phentermine, has not been studied. Simultaneous administration of venlafaxine with such drugs is not recommended. Venlafaxine It is not indicated for weight loss, either alone or in combination with other drugs.

    When skin rashes, urticaria, or other allergic reactions appear, treatment should be stopped by Alvento®.

    During treatment it is recommended to refrain from drinking alcohol.

    Effect on the ability to drive transp. cf. and fur:

    Influences psychophysical abilities. It can also weaken reactions in some patients. This should be taken into account when driving a car and performing tasks that require special attention.

    Form release / dosage:

    Capsules with modified release, 37.5 mg, 75 mg and 150 mg.

    Packaging:

    For 14 capsules in a blister (contour cell packaging).

    1, 2 or 4 blisters (contour squares) together with the instruction for use are placed in a pack of cardboard.

    Storage conditions:

    Store at a temperature not exceeding 30 ° C.

    Keep out of the reach of children.

    Shelf life:

    2 years.

    Do not use after the expiration date.

    Terms of leave from pharmacies:On prescription
    Registration number:LSR-004693/08
    Date of registration:20.06.2008 / 13.04.2016
    Expiration Date:Unlimited
    The owner of the registration certificate:KRKA-RUS, LLC KRKA-RUS, LLC Russia
    Manufacturer: & nbsp
    KRKA, d.d. Slovenia
    Representation: & nbspKRKA KRKA Slovenia
    Information update date: & nbsp14.12.2015
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