Велафакс

Велафакс – antidepressant.

Form of release and structure

Dosage form – tablets: yellow or light yellow color, oblong shape, with dividing risky on both sides or round with an engraving of "PLIVA" on one party and risky on another (on 14 pieces in blisters, in a cardboard pack 2 or 4 blisters).

Active ingredient of Velafaks – a venlafaksin a hydrochloride, in 1 tablet – 42,43 mg (that is equivalent to the maintenance of a venlafaksin of 37,5 mg) or 84,86 mg (that is equivalent to the maintenance of a venlafaksin of 75 mg).

Auxiliary components: silicon dioxide colloid, starch corn, cellulose microcrystallic, carboxymethylstarch of sodium, magnesium stearate, dye ferrous oxide yellow (E172), talc.

Indications to use

Velafaks's use is shown at treatment of depressions of various genesis, including with alarm symptoms.

Contraindications

• The expressed abnormal liver functions;
• Heavy renal failures (clearance of creatinine (CC) less than 10 ml/min.);
• Age up to 18 years;
• Simultaneous use of monoamine oxidase inhibitors (MAO);
• Period of pregnancy and breastfeeding;
• Hypersensitivity to drug components.

With care it is necessary to appoint Velafaks the patient with a convulsive syndrome in the anamnesis, arterial hypertension, unstable stenocardia, tachycardia, after recently postponed myocardial infarction, with predisposition to bleeding (from mucous membranes and skin), the increased intraocular pressure, closed-angle glaucoma, a maniacal state in the anamnesis, a hypovolemia, a hyponatremia, dehydration, suicide bents, in combination with diuretics, to patients with initially lost body weight.

Route of administration and dosage

Pill is taken inside, during food, without chewing, washing down with enough liquid.

Drug is recommended to be accepted always in at one time.

The mode of dosing is appointed by the doctor on the basis of clinical indications, taking into account a condition of the patient.

The recommended Velafaks's dosing: an initial dose of 37,5 mg 2 times a day. In the absence of therapeutic effect after several weeks of therapy it is possible to raise a dose to 75 mg 2 times a day. For the patients with heavy depressive frustration who are on hospitalization, the initial dose can make on 75 mg 2 times a day. It is recommended to raise a dose gradually (1 time in 2-3 days) to achievement of desirable clinical effect. The daily dose of drug should not exceed 375 mg.

After stabilization of a condition of the patient the daily dose is recommended to be lowered to a minimal effective dose gradually. For prevention of a recurrence and as a maintenance therapy use of drug can last 6 months and more.

At easy degree of a renal failure (the glomerular filtration rate (GFR) more than 30 ml/min.) the dosing mode does not need correction.

At moderate severity of a renal failure (SKF of 10-30 ml/min.) it is recommended to lower a dose to 3/4 or 1/2 from a usual dose and to accept it in full once.

Patients on a hemodialysis should appoint 1/2 from a usual daily dose after end of a hemodialysis.

At a liver failure of easy degree (the prothrombin time (PT) less than 14 sec.) dose adjustment is not required.

At a liver failure of moderate degree (PV from 14 to 18 sec.) to the patient appoint 1/2 from a usual dose.

It is not required to patients of advanced age of dose adjustment of Velafaks, but at appointment it is necessary to consider a possibility of a renal failure therefore treatment has to take place with use of the smallest effective dose and be followed by careful observation of the doctor at each its increase.

Drug withdrawal should be made by gradual decrease in a daily dose. For example, at reception of 75 mg and above within 7 days and more, cancellation has to last not less than a week, and at patients with a course of treatment a dose it is necessary to reduce more than 6 weeks not less than 2 weeks.

In case of development of symptoms of a recurrence of a depression during drug withdrawal, the patient should appoint an initial dose and to make longer and its gradual decrease.

Side effects

• Nervous system: often – weakness, dizziness, an adynamy, yawning, drowsiness, paresthesias, the increased nervous irritability, sleeplessness, a stupor, a tremor, a hyper tone of muscles, sedation, dreadful dreams; infrequently – apathy, a myoclonus, a syncope, hallucinations; seldom – spasms, disturbance of the speech, an ataxy with frustration of coordination of movement and balance, a hypomania and a mania, epileptic seizures, symptoms similar to a malignant antipsychotic syndrome, a serotoninovy syndrome; in some cases – psychomotor concern or an akathisia, nonsense, extrapyramidal frustration, including dystonia, dyskinesia and late dyskinesia;
• Alimentary system: often – dryness in a mouth, a loss of appetite, nausea, vomiting, a lock, an abdominal pain, dyspepsia; infrequently – a bruxism, increase in activity of liver enzymes; seldom – hepatitis; in some cases – pancreatitis;
• Mental status: frequency is not established – suicide thoughts and behavior during the period and after treatment, a depression;
• Metabolism: often – increase or weight reduction of a body, increase in content of cholesterol in blood serum (is more often against the background of reception of high doses or long therapy); infrequently – a syndrome of insufficient secretion of antidiuretic hormone (ADG), a hyponatremia; in some cases – increase in level of concentration of prolactin in a blood plasma;
• System of a hemopoiesis and lymphatic system: infrequently – thrombocytopenia, hemorrhages in mucous membranes and skin (ecchymomas), a hemorrhagic syndrome, lengthening of a bleeding time; in some cases – aplastic anemia, an agranulocytosis, a pancytopenia, a neutropenia;
• Cardiovascular system: often – a hyperemia of integuments, increase in the arterial pressure (AP); infrequently – postural hypotension, decrease in the ABP, a faint, tachycardia, arrhythmia; very seldom – lengthening of an interval of QT, arrhythmia like "pirouette", fibrillation of ventricles, ventricular tachycardia;
• Respiratory system: infrequently – an asthma; in some cases – a pulmonary eosinophilia;
• Urinary system: often – disturbance of an urination; infrequently – an ischuria;
• Sense bodys: often – a mydriasis, accommodation disturbances, a ring or a sonitus, a vision disorder; infrequently – disturbance of flavoring feelings;
• Reproductive system: often – an anorgazmiya at men, decrease in a libido, disturbance of an ejaculation or erection, a menorrhagia; infrequently – an anorgazmiya at women, disturbance of a menstrual cycle;
• Dermatological reactions: often – the increased perspiration (including at night); infrequently – an alopecia;
• Endocrine system: seldom – a galactorrhoea; in some cases – increase in content of prolactin;
• Musculoskeletal system: often – a mialgiya, an arthralgia; infrequently – spasms of muscles; in some cases – рабдомиолиз;
• Allergic reactions: infrequently – a skin itch, rash, makulopapulezny rash, a small tortoiseshell, a Quincke's disease, a photosensitization; seldom – Stephens-Johnson's syndrome, a mnogoformny exudative erythema; in some cases – anaphylactic reactions;
• Others: at sharp cancellation or a dose decline, it is possible – refusal of food, a headache, drowsiness, increased fatigue, an adynamy, nausea, diarrhea, vomiting, dryness in a mouth, anorexia, dizziness, sleeplessness, backfilling difficulty, unusual dreams, uneasiness, concern, irritability, emotional lability, confusion of consciousness, paresthesia, a disorientation, spasms, a tremor, the increased perspiration, a hypomania, paresthesias, tachycardia, noise or a ring in ears.

It is necessary to reduce gradually Velafaks's dose, especially after use of high doses not to allow development of symptoms of a withdrawal.

Many of the listed side effects have dozozavisimy character, at long therapy the frequency and weight of most of them decreases, without causing the necessity of drug withdrawal.

Special instructions

In the period of a depression at the patient the risk of suicide thoughts and attempts of a suicide which remains before permanent improvement of a state increases. As remission can occur in several weeks of treatment and more, the patient needs during this period constant control. The probability of suicide attempts at the beginning of Velafaks's use and at early stages of recovery, especially at patients with suicide behavior in the anamnesis, at patients of young age (up to 25 years), suicide thoughts, inclined to emergence, prior to therapy is highest.

The persons which are carrying out patient care have to be informed on need of constant observation, and at emergence of the corresponding symptoms to be capable to immediately provide medical care to the patient.

Sharp interruption of administration of drug, especially after use of high doses therefore the dose decline or the termination of therapy need to be made gradually is the reason of a withdrawal. The risk of emergence of symptoms of a withdrawal depends on individual portability of drug, size of a dose and duration of treatment.

At affective frustration against the background of administration of drug at the patient hypomaniacal or maniacal states therefore it is necessary to be careful at Velafaks's appointment at a mania in the anamnesis can develop, treatment of such patients has to be carried out in a hospital.

It is impossible to appoint drug at uncontrollable epilepsy, patients with controlled epilepsy in the anamnesis need observation, and when developing epileptic seizures it is necessary to interrupt therapy.

Against the background of use of a venlafaksin development of psychomotor concern which clinic reminds an akathisia (a syndrome of motive and mental concern) is possible. This state is more often it is observed within the first weeks of therapy, increase in a dose during this period can cause negative effect therefore it is necessary to consider a question of expediency of further administration of drug.

At emergence of rash, small tortoiseshell and other allergic reactions it is necessary to see a doctor.

Use of drug has to take place with regular control of the ABP, especially in an initiation of treatment and at the next increase in a dose.

Because of a possibility of increase in heart rate, patients inclined to tachycardia should take drug with caution.

It is necessary to warn patients, especially at advanced age, about a possibility of disturbance of sense of equilibrium and dizziness.

Seldom reception of a venlafaksin influences change of parameters of the electrocardiogram (lengthening of an interval of PR, lengthening of an interval of QT, expansion of the QRS complex).

Care at treatment of the patients predisposed to hemorrhages in skin and mucous membranes as administration of drug increases risk of these states is necessary.

At decrease in volume of the circulating blood and dehydration the risk of development of a hyponatremia and/or syndrome of insufficient secretion of antidiuretic hormone increases.

During treatment emergence of a mydriasis therefore it is recommended at patients with closed-angle glaucoma is possible or inclined to increase in intraocular pressure to accompany treatment with control of intraocular pressure.

Contraindicated simultaneous use with the phentermine and other means promoting weight reduction of a body.

Treatment by Velafaks has to be carried out in strict observance of the mode of dosing, for an exception of abuse of drug the doctor has to provide control at its reception.

Long therapy demands control of level of concentration of cholesterol in blood serum.

There is no experience of performing electroconvulsive therapy against the background of use of a venlafaksin.

During treatment alcohol intake is contraindicated.

Because of a possibility of development of essential side effects from a nervous system, patients are recommended to be careful during treatment at control of vehicles and mechanisms.

Medicinal interaction

During treatment by Velafaks the attending physician has to define a possibility of simultaneous use of other medicines, considering a clinical condition of the patient and existence of the accompanying pathologies.

Terms and storage conditions

To store at a temperature up to 25 °C. To protect from children.

Period of validity – 3 years.