Venlafaxine-DT tablets are indicated for the treatment of major depressive episodes and for the prevention of recurrence of major depressive episodes.
Composition
Active ingredient: venlafaxine;
1 tablet contains venlafaxine hydrochloride equivalent to venlafaxine 75 mg;
Excipients: celactose 80 (a mixture of lactose monohydrate and powdered cellulose (75:25)), sodium starch glycolate (type A), microcrystalline cellulose, magnesium stearate, colloidal silicon dioxide.
Contraindication
Hypersensitivity to venlafaxine or to any of the components of the drug.
Concomitant therapy with irreversible MAO inhibitors (MAOIs) is contraindicated due to the risk of serotonin syndrome, accompanied by symptoms such as agitation, tremor, hyperthermia. Venlafaxine treatment should not be initiated for at least 14 days after discontinuation of irreversible MAO inhibitors.
Method of application
The drug is administered orally.
Venlafaxine immediate-release tablets are recommended to be taken with meals, preferably at the same time.
Application features
Pregnant women
Venlafaxine is prescribed to pregnant women only if the expected benefit to the mother outweighs the possible risk to the fetus/child.
Use in elderly patients. The patient's age does not in itself require a change in dosage. However, caution should be exercised in the treatment of elderly patients (e.g., due to the possibility of impaired renal function, the likelihood of changes in neurotransmitter sensitivity and affinity that occur with age). In such cases, the lowest effective dose should be used, and patients should be monitored closely when the dose is increased.
Children
Do not use.
Drivers
Any psychotropic drug therapy may impair the ability to think or perform motor functions. Therefore, patients taking venlafaxine should exercise caution when driving or operating potentially dangerous machinery.
Overdose
Symptoms: Tachycardia, altered level of consciousness (ranging from drowsiness to coma), mydriasis, convulsions, vomiting, ECG changes (QT prolongation, nerve block, QRS prolongation), ventricular tachycardia and bradycardia, hypotension, vertigo. Possible risk of death.
Treatment. General supportive and symptomatic therapy is recommended; monitoring of heart rate and vital signs is recommended. If there is a risk of aspiration, induction of vomiting is not recommended. If the drug has been taken recently and the patient is conscious, gastric lavage is performed. The appointment of activated charcoal may also reduce the absorption of the active substance. The effectiveness of measures such as forced diuresis, dialysis, hemoperfusion and exchange transfusion is unlikely. The specific antidote to venlafaxine is unknown.
Side effects
Blood and lymphatic system disorders: ecchymoses, gastrointestinal bleeding; mucosal bleeding, prolonged bleeding time, thrombocytopenia, dyscrasia (including agranulocytosis, aplastic anemia, neutropenia, pancytopenia). Immune system disorders: anaphylactic reactions. Endocrine disorders: increased prolactin levels in the blood. Metabolism disorders: increased serum cholesterol levels, weight loss, weight gain, hyponatremia, syndrome of inappropriate ADH secretion (SIADH). Psychiatric disorders: abnormal dreams, decreased libido, insomnia, nervous excitability, sedation, confusion, depersonalization, apathy, hallucinations, anxiety, manic reactions, delirium, suicidal thoughts and behavior*. Nervous system: headache, dizziness, muscle hypertonia, tremor, paresthesia, stupor, yawning, myoclonus, impaired balance and coordination, akathisia, convulsions, neuroleptic malignant syndrome (NMS), serotoninergic syndrome, extrapyramidal reactions (including dystonia and dyskinesia), tardive dyskinesia. Visual system: accommodation disorders, mydriasis, visual impairment, glaucoma. Hearing and balance: tinnitus. Cardiovascular system: palpitations, tachycardia, QT prolongation, ventricular fibrillation, ventricular tachycardia (including torsades de pointes), hypertension, vasodilation (mainly hot flushes), orthostatic hypotension, syncope, hypotension. Respiratory system: yawning, pulmonary eosinophilia. Digestive system: nausea, dry mouth, decreased appetite (anorexia), constipation, vomiting, taste disturbance, bruxism, diarrhea, pancreatitis. Liver and biliary tract: hepatitis, abnormal liver function tests. Skin and skin derivatives: sweating (including night sweats), rash, alopecia, erythema multiforme, toxic epidermal necrolysis, Stevens-Johnson syndrome, itching, urticaria, photosensitivity reactions. Musculoskeletal and connective tissue: rhabdomyolysis. Urinary system: urination disorders (mainly difficulty), pollakiuria, urinary retention. From the reproductive system and mammary glands: pathological ejaculation/orgasm in men, lack of orgasm, erectile dysfunction (impotence), menstrual disorders associated with increased irregular bleeding (e.g., menorrhagia, metrorrhagia), pathological orgasm in women.
Venlafaxine should not be used in combination with irreversible non-selective MAO inhibitors. Venlafaxine should not be started earlier than 14 days after the end of therapy with irreversible non-selective MAO inhibitors. After the cancellation of venlafaxine, at least 7 days should be allowed before starting therapy with irreversible non-selective MAO inhibitors.
Due to the risk of serotonin syndrome, the combination of venlafaxine with reversible selective MAO inhibitors, such as moclobemide, is not recommended. Venlafaxine should not be started until 14 days after discontinuation of reversible MAO inhibitors. After discontinuation of venlafaxine, at least 7 days should be allowed before starting reversible MAO inhibitors.
The decrease in mental and motor activity under the influence of alcohol is not increased after the use of venlafaxine, however, patients should refrain from drinking alcoholic beverages while using the drug.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 °C.
Keep out of reach of children.
Shelf life - 2 years.
