Velafax
Frequency: very often - more than 1/10, often - more than 1/100 and less than 1/10, infrequently - 1/1000 and less than 1/100, rarely - more than 1/10000 and less than 1/1000.
From the hematopoietic organs: infrequently - ecchymosis, bleeding from the gastrointestinal tract; frequency unknown - bleeding from the mucous membranes, prolongation of bleeding time, thrombocytopenia, hematopoietic disorders (including agranulocytosis, aplastic anemia, neutropenia, pancytopenia).
Metabolism: often - hypercholesterolemia, weight loss; infrequently - weight gain; frequency unknown - impaired liver function tests, hyponatremia, syndrome of inappropriate ADH secretion, hyperprolactinemia.
From the nervous system: very often - headache (30.3%); often - unusual dreams, decreased libido, dizziness, increased muscle tone, sleep disturbance, nervousness, paresthesia, sedation, tremor, confusion, depersonalization; infrequently - apathy, hallucinations, myoclonus, agitation, loss of coordination and balance; rarely - akathisia, psychomotor restlessness, convulsions, manic reactions; frequency unknown - neuroleptic malignant syndrome, serotonin syndrome, delirium, extrapyramidal disorders (including dystonia, dyskinesia), tardive dyskinesia, suicidal thoughts and behavior.
From the senses: often - disturbance of accommodation, mydriasis, blurred vision; infrequently - taste disturbance, tinnitus; frequency unknown - angle-closure glaucoma.
From the cardiovascular system: often - increased blood pressure, vasodilation (usually in the form of “flushes” of blood), palpitations; uncommon - postural hypotension, fainting, tachycardia; frequency unknown - decreased blood pressure, prolongation of the QT interval, ventricular fibrillation, ventricular tachycardia (including torsade de pointes).
From the respiratory system: often - yawning; frequency unknown - eosinophilic pulmonary infiltrate.
From the digestive system: very often - dryness of the oral mucosa, nausea (20%); often - anorexia, constipation, vomiting; infrequently - bruxism, diarrhea; frequency unknown - hepatitis, pancreatitis.
From the skin: very often - increased sweating (12.2%), including night sweating; uncommon - rash, alopecia; frequency unknown - erythema multiforme, toxic epidermal necrolysis, Stevens-Johnson syndrome, itching, urticaria.
From the musculoskeletal system: frequency unknown - rhabdomyolysis.
From the genitourinary system: often - impaired ejaculation or orgasm (including anorgasmia) in men, erectile dysfunction, impaired urination (usually difficulty urinating), menstruation disorders (including menorrhagia, metrorrhagia), pollakiuria; infrequently - impaired orgasm in women, urinary retention.
Other: often - asthenia, chills; uncommon - photosensitivity; frequency unknown - anaphylaxis.
Venlafaxine
Use during pregnancy and breastfeeding
Venlafaxine should not be prescribed to pregnant and breastfeeding women, because
The safety of the drug during pregnancy and lactation in women has not been sufficiently established, due to the fact that there are no adequately controlled clinical studies on a sufficiently large sample of such patients. This concerns the health of both the mother and, to a greater extent, the fetus/child. Women of childbearing age should be warned about this before starting treatment and should immediately consult a doctor if they become pregnant or plan to become pregnant during treatment with the drug. Venlafaxine and its metabolite (EFV) are excreted into breast milk. If it is necessary to take the drug during lactation, breastfeeding must be stopped.
In practice, there are cases of prescribing venlafaxine to mothers during pregnancy and shortly before childbirth, when in a particular situation the expected benefit to the mother outweighs the potential risk to the fetus. In these cases, newborns often experienced complications that required: increased hospitalization, maintenance of breathing and tube feeding. These complications can develop immediately after childbirth and are also typical when taking other antidepressants from the SNRI group or SSRIs (not containing venlafaxine). In such cases, the following clinical symptoms in newborns have been reported: respiratory disorders, cyanosis, apnea, convulsions, temperature instability, feeding difficulties, vomiting, hypoglycemia, muscle hypertension or hypotonia, hyperreflexia, tremor, trembling, irritability, lethargy, constant crying, drowsiness or insomnia. Such disturbances may indicate the serotonergic effects of the drug Venlafaxine.
If venlafaxine was used during pregnancy and maternal treatment was completed shortly before delivery, the newborn may experience withdrawal symptoms. In such a newborn, the presence of serotonin syndrome or neuroleptic malignant syndrome should be excluded. Epidemiological evidence suggests that use of SSRIs during pregnancy, especially late in pregnancy, may increase the risk of persistent neonatal pulmonary hypertension.
special instructions
Suicide and suicidal behavior
Depression is associated with an increased risk of suicidal ideation, self-harm, and suicide (suicidal behavior). This risk persists until significant remission occurs. Since improvement may not be observed during the first few weeks of therapy or even longer, patients should be closely monitored until such improvement occurs. Based on accumulated clinical experience, the risk of suicide may increase in the early stages of recovery.
Patients with a history of suicide attempts or high levels of suicidal ideation prior to treatment are at greater risk for suicidal ideation or suicide attempts and should be closely monitored. A meta-analysis of placebo-controlled clinical trials of antidepressants in adult patients with mental disorders found that antidepressants were at increased risk of suicidal behavior compared with placebo in patients under 25 years of age. Drug treatment of these patients, and in particular those at high risk of suicide, should be accompanied by careful monitoring, especially early in therapy and during dose adjustment. Patients (and caregivers of such patients) should be warned to monitor for any signs of clinical worsening, suicidal behavior or ideation, or unusual changes in behavior, and to seek immediate medical attention if these symptoms occur.
In a small number of patients taking antidepressants, incl. venlafaxine, aggression may occur during initiation of treatment, dose changes, or discontinuation of treatment.
Clinical studies conducted to date have not revealed tolerance or dependence to venlafaxine. Despite this, as with other drugs that act on the central nervous system, the physician should closely monitor patients for signs of drug abuse, as well as patients with a history of such symptoms.
Special patient groups
Venlafaxine is not approved for use in children.
In patients with a history of aggression, venlafaxine should be used with caution.
In patients with affective disorders, bipolar disorder when treated with antidepressants, incl. venlafaxine, hypomanic and manic states may occur. Like other antidepressants, venlafaxine should be used with caution in patients with a history of mania. Such patients require medical supervision.
Convulsive disorders may occur during therapy with venlafaxine. As with all antidepressants, venlafaxine should be used with caution in patients with a history of seizure disorders and such patients should be closely monitored. Treatment should be discontinued if seizures develop.
Akathisia
The use of venlafaxine has been associated with the development of akathisia, which is characterized by an unpleasant feeling of internal motor restlessness for the patient and manifested in the patient’s inability to sit quietly in one position for a long time or remain motionless for a long time. This condition may occur at the beginning of treatment and during the first weeks of treatment. In patients who develop such symptoms, increasing the dose is not recommended.
Bipolar disorder
Before starting treatment, it is necessary to identify those patients who are at risk for bipolar disorder. Such a check should include a detailed examination of the medical history, incl. family, to identify cases of suicide, bipolar disorder. It should be noted that venlafaxine is not recommended for use in the treatment of bipolar depression.
Use in patients with concomitant diseases
Clinical experience with the use of venlafaxine in patients with concomitant diseases is limited.
It should be used with caution in patients with diseases in which the effect of venlafaxine on hemodynamic parameters and/or metabolism may be significant.
Patients should be warned to immediately consult a doctor if a rash, urticaria or other allergic reactions occur.
Some patients while taking venlafaxine experienced a dose-dependent increase in blood pressure and/or an increase in heart rate, so regular monitoring of blood pressure and ECG is recommended, especially during the period of adjusting or increasing the dosage of venlafaxine. In post-marketing experience with venlafaxine (overdose), fatal cardiac arrhythmias have been reported. Before prescribing venlafaxine to patients at high risk of developing serious cardiac arrhythmias, the ratio of the likely benefit to the possible risk of use should be assessed.
Patients, especially the elderly, should be warned about the possibility of dizziness and impaired balance in order to prevent injury.
While taking venlafaxine, especially in conditions of dehydration or decreased blood volume (including in elderly patients and patients taking diuretics), hyponatremia and/or syndrome of insufficient secretion of antidiuretic hormone may occur.
Venlafaxine has not been studied in patients with recent myocardial infarction and decompensated heart failure. The drug should be prescribed to such patients with caution.
Taking SSRIs or venlafaxine in patients with diabetes may cause changes in plasma glucose levels. Dosage adjustments of insulin and/or antidiabetic medications may be required.
During treatment, it is recommended to refrain from drinking any alcohol-containing drinks.
The safety and effectiveness of venlafaxine in combination with weight loss medications (including phentermine) have not been established. The simultaneous use of venlafaxine and drugs that reduce body weight is not recommended.
Women of childbearing potential should use appropriate contraception while taking venlafaxine.
Explanations of special symptoms and conditions that may occur during treatment with the drug
Dry mouth occurs in 10% of patients receiving venlafaxine. This may increase your risk of developing tooth decay. Patients should practice good oral hygiene.
The use of venlafaxine may cause the development of akathisia, characterized by subjective discomfort or restlessness and the need to move frequently, often accompanied by an inability to sit or stand still. This mostly occurs during the first few weeks of treatment. Increasing the dose in patients who develop these symptoms may cause undesirable effects.
In placebo-controlled clinical trials, a clinically significant increase in serum cholesterol was reported in 5.3% of patients. Cholesterol level control is necessary during long-term treatment.
Withdrawal syndrome
When stopping treatment, withdrawal symptoms are common, especially if it is stopped abruptly. The risk of withdrawal syndrome may depend on several factors, including the duration of treatment, the size of therapeutic doses and the rate of dose reduction. These symptoms are very rarely reported in patients who accidentally missed taking the drug.
Withdrawal symptoms usually occur within the first few days after stopping treatment. These symptoms usually go away within 2 weeks, although in some people they may last 2-3 months or more. It is recommended to gradually reduce the dose of venlafaxine when stopping the drug - over several weeks or months, depending on the severity of the clinical symptoms of the disease.
Serotonin syndrome
Taking venlafaxine, like other serotonergic drugs, can cause serotonin syndrome, a potentially life-threatening condition, especially when used concomitantly with other drugs that can affect the serotonergic neurotransmitter systems such as MAO inhibitors.
Symptoms of serotonin syndrome may include mental status changes (agitation, hallucinations, coma), autonomic instability (tachycardia, blood pressure lability, hyperthermia), neuromuscular disorders (hyperreflexia, incoordination), and/or gastrointestinal symptoms (nausea, vomiting). , diarrhea).
Impact on the ability to drive vehicles and operate machinery
During the treatment period, care should be taken when performing potentially hazardous types of work that require increased concentration and speed of psychomotor reaction (including driving a car and operating machinery).
