Velafax pills 37.5mg №28

Packaging

28 pcs.

Mechanism of action

Velafax has antidepressant effects.

Indications

Depression of various etiologies, treatment and prevention.

Contraindications

• Hypersensitivity.
• Simultaneous administration of MAO inhibitors (see also section “Interaction”).
• Severe renal and / or liver dysfunction (glomerular filtration rate (GFR) less than 10 ml / min).
• Age up to 18 years (safety and efficacy for this age group have not been proven).
• Established or suspected pregnancy.
• Lactation period.

The safety of venlafaxine in pregnancy has not been proven, therefore, use during pregnancy (or presumptive pregnancy) is possible only if the potential benefit to the mother outweighs the possible risk to the fetus.Women of childbearing age should be warned about this before starting treatment and should immediately consult a doctor if pregnancy occurs or pregnancy planning during the period of drug treatment. Venlafaxine and its metabolite (EFA) are excreted in breast milk. The safety of these substances for newborns is not proven, therefore, taking venlafaxine during breastfeeding is not recommended. If necessary, taking the drug during lactation should decide on the termination of breastfeeding. If the mother’s treatment was completed shortly before delivery, the newborn may experience withdrawal symptoms.

Dosage and administration

Velafax pills are recommended to be taken with meals.
The recommended starting dose is 75 mg in two doses (37.5 mg each) daily.
If after several weeks of treatment there is no significant improvement, the daily dose can be increased to 150 mg (2 × 75 mg per day). If, according to the doctor, a higher dose is necessary (severe depressive disorder or other conditions requiring inpatient treatment), 150 mg can be immediately administered in two doses (2 × 75 mg per day). After that, the daily dose can be increased by 75 mg every 2-3 days until the desired therapeutic effect is achieved. The maximum daily dose of Velafax is 375 mg. After achieving the desired therapeutic effect, the daily dose can be gradually reduced to the minimum effective level. Supportive care and relapse prevention:
Supportive treatment may last b months or more.Assigned to the minimum effective dose used in the treatment of a depressive episode. Renal failure: in case of mild renal insufficiency (glomerular filtration rate (GFR) of more than 30 ml / min), no dosage regimen correction is required. With moderate renal failure. (GFR 10-30 ml / min) the dose should be reduced by 25-50%. In connection with the prolongation of the half-life of venlafaxine and its active metabolite (EFA), such patients should take the entire dose once a day. It is not recommended to use venlafaxine in severe renal failure (GFR less than 10 ml / min), since there is no reliable data on such therapy. Patients on hemodialysis can receive 50% of the usual daily dose of venlafaxine after completion of hemodialysis.
Liver failure: in case of mild liver failure (prothrombin time (PT) less than 14 sec), the dosage regimen correction is not required. With moderate liver failure (PF from 14 to 18 seconds), the dose should be reduced by 50%. It is not recommended to use venlafaxine in case of severe hepatic failure, since there is no reliable data on such therapy.
Elderly patients: By itself, the elderly patient does not require a dose change, but (as with the appointment of other drugs), the treatment of elderly patients requires caution, for example, in connection with the possibility of impaired renal function. The smallest effective dose should be applied.At higher doses, the patient must be under close medical supervision.

Adverse reactions

Most of the side effects listed below are dose dependent. With prolonged treatment, the severity and frequency of most of these effects is reduced, and there is no need to cancel therapy.
In order of decreasing frequency: frequent> 1%, infrequent> 0.1% - <1%, rare> 0.01% - <0.1%, very rare <0.01%.
Common symptoms: weakness, fatigue,
From the gastrointestinal tract: loss of appetite, constipation, nausea, vomiting, dry mouth, rarely hepatitis.
Metabolism: increased serum cholesterol, weight loss; infrequent: changes in laboratory tests of liver function, hyponatremia, syndrome of insufficient secretion of antidiuretic hormone.
Cardiovascular: arterial hypertension, hyperemia of the skin; infrequent: postural hypotension, tachycardia,
Nervous system: unusual dreams, dizziness, insomnia, irritability, paresthesias, stupor, increased muscle tone, tremor, yawning; unclean: apathy, hallucinations, muscle spasms, serotonin syndrome; rare: epileptic seizures, manic reactions, as well as symptoms resembling neuroleptic malignant syndrome (MNS).
From the genitourinary system: disturbances of ejaculation, erection, anorgasmia, dysuric disorders (mainly - difficulty at the beginning of urination); infrequent: decreased libido, menorrhagia, urinary retention.
Special senses: accommodation disturbances, mydriasis, visual disturbances; infrequent: violation of taste sensations.
From the skin: sweating; infrequent: photosensitivity reactions; rare: erythema multiforme, Stevens-Johnson syndrome.
Hemic and lymphatic: infrequent: hemorrhages into the skin (ecchymosis) and mucous membranes, thrombocytopenia; rare; lengthening bleeding time.
Hypersensitivity Reactions: infrequent: skin rash; very rare: Anaphylactic reactions.
After abrupt cancellation of venlafaxine or reduction of its dose, there may be observed: fatigue, drowsiness, headache, nausea, vomiting, anorexia, dry mouth, dizziness, diarrhea, insomnia, anxiety, increased irritability, disorientation, hypomania, paresthesia, sweating. These symptoms are usually mild and go away without treatment. Due to the likelihood of these symptoms, it is very important to gradually reduce the dose of the drug.

Special notes

As with other antidepressants, abrupt cessation of venlafaxine therapy — especially after high doses of the drug — can cause withdrawal symptoms, and therefore it is recommended that the drug be gradually reduced before the drug is withdrawn. The duration of the period required to reduce the dose depends on the dose, the duration of therapy, as well as the individual sensitivity of the patient.

When prescribing Velafax tablets, patients with lactose intolerance should take into account the lactose content (56.62 mg in each pill 25 mg; 84.93 mg in each pill 37.5 mg; 113.24 mg in each pill 50 mg,169.86 mg in each pill 75 mg).
In patients with depressive disorders, the likelihood of suicidal attempts should be considered before starting any drug therapy. Therefore, to reduce the risk of overdose, the initial dose of the drug should be as low as possible, and the patient should be under close medical supervision.
Patients with affective disorders in the treatment of antidepressants, including venlafaxine, may experience hypomania or mania.
Like other antidepressants, venlafaxine should be administered with caution to patients with a history of mania. Such patients need medical supervision.
Like other antidepressants, venlafaxine should be administered with caution to patients with a history of epileptic seizures. Treatment with venlafaxine should be interrupted when epileptic seizures occur.
Patients should be warned about the need to immediately consult a doctor if a rash, urtikarnyh elements or other allergic reactions occur.
In some patients, while taking venlafaxine, a dose-dependent increase in blood pressure was observed, and therefore regular monitoring of blood pressure is recommended, especially during the period of refining or increasing the dosage.
An increase in heart rate may occur, especially during high doses. Caution is advised in tachyarrhythmias.
Patients, especially the elderly, should be warned about the possibility of dizziness and imbalance.
Like other serotonin reuptake inhibitors, venlafaxine may increase the risk of hemorrhages in the skin and mucous membranes. Caution is needed in treating patients prone to such conditions.
While taking venlafaxine. especially in conditions of dehydration or reduction in blood volume (including in elderly patients and patients taking diuretics), hyponatremia and / or syndrome of insufficient secretion of antidiuretic hormone can be observed.
While taking the drug, mydriasis can be observed, and therefore it is recommended that intraocular pressure be monitored in patients prone to elevated or suffering from angle-closure glaucoma.
Venlafaxine has not been studied in patients with recent myocardial infarction and suffering from decompensated heart failure. Such patients should be prescribed with caution.

Simultaneous usemonoamine oxidase inhibitors (MAO) and venlafaxine contraindicated. Reception of the drug Velafax can begin no less than 14 days after the end of therapy with MAO inhibitors. If a reversible MAO inhibitor (moccobemide) was used, this interval may be shorter (24 hours). Therapy with MAO inhibitors can begin no less than 7 days after discontinuation of the drug Velafax.
Venlafaxine does not affect pharmacokineticslithium. 
When applied simultaneously withimipramine The pharmacokinetics of venlafaxine and its metabolite O-desmethylvenlafaxine (EFA) does not change.
Haloperidol: the effect of the latter may increase due to increased levels of the drug in the blood when used together.
When applied simultaneously withdiazepam pharmacokinetics of drugs and their major metabolites are not significantly changed. No effect on the psychomotor and psychometric effects of diazepam was found.
When applied simultaneously withclozapine there may be an increase in its plasma level and the development of side effects (for example, epileptic seizures).
When applied simultaneously withrisperidone (despite the increase in Risperidone AUC), the pharmacokinetics of the sum of the active components (risperidone and its active metabolite) did not change significantly.
Strengthens the effect of alcohol on psychomotor reactions.
When taking venlafaxine, particular care should be taken whenelectroconvulsive therapy, as experience with venlafaxine in these conditions is absent.
Drugs metabolized by cytochrome P 450 isoenzymes: 
The cytochrome P 450 enzyme CYP2D6 converts venlafaxine to the active metabolite O-desmethyl venlafaxine (OD V). Unlike many other antidepressants, the dose of venlafaxine can not be reduced with simultaneous administration with drugs that suppress CYP2D6 activity, or in patients with a genetically determined decrease in CYP2D6 activity, since the total concentration of the active substance and metabolite (venlafaxine and EFA) does not change.
The main route of elimination of venlafaxine involves metabolism involving CYP2D6 and CYP3A4 ; Therefore, special care should be taken when prescribing venlafaxine in combination with drugs that inhibit both these enzymes. Such drug interactions have not yet been investigated.
Venlafaxine is a relatively weak inhibitor of CYP2D6 and does not inhibit the activity of CYP1A2, CYP2C9 and CYP3A4 isoenzymes; therefore, one should not expect its interaction with other drugs, in the metabolism of which these liver enzymes are involved.
Cimetidine inhibits the first pass metabolism of venlafaxine and does not affect the pharmacokinetics of O-desmethylvenlafaxine. In most patients, only a slight increase in the overall pharmacological activity of venlafaxine and O-desmethylvenlafaxine is expected (more pronounced in elderly patients and in violation of liver function).
Clinically significant interactions with venlafaxineantihypertensives (including beta-blockers, ACE inhibitors and diuretics) and antidiabetic drugs not detected.
Drugs associated with plasma proteins : Plasma protein binding is 27% for venlafaxine and 30% for EFA. Therefore, it does not affect the concentration of drugs in the blood plasma, which has a high degree of protein binding.
When taken simultaneously withwarfarin, the anticoagulant effect of the latter may increase.
When taken simultaneously withindinavir the pharmacokinetics of indinavir changes (with a 28% decrease in the area under the AUC curve and a 36% decrease in the maximum concentration of Cmax), and the pharmacokinetics of venlafaxine and EFA do not change. However, the clinical significance of this effect is unknown.

Symptoms: ECG changes (prolongation of the QT interval, blockade of the bundle of the His bundle, expansion of the QRS complex), sinus or ventricular tachycardia, bradycardia, hypotension, convulsive states, altered consciousness (decreased wakefulness). With an overdose of venlafaxine, while taking it with alcohol and / or other psychotropic drugs, fatalities were reported.

Treatment: conducting symptomatic therapy. Specific antidotes are unknown. Continuous monitoring of vital functions (respiration and circulation) is recommended. The appointment of Activated carbon to reduce the absorption of the drug. Do not induce vomiting due to the risk of aspiration. Venlafaxine and EFA are not displayed during dialysis.

At a temperature not higher than 30 ° C.
Keep out of the reach of children.

2 years.