Velaksin, tablets 75 mg 28 pcs.

Depressed mood, Depression

• Depression (with or without symptoms of anxiety) in both outpatient and inpatient settings.
• Prevention of relapse of depression (with a positive therapeutic effect).

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Indications

Depression (with or without anxiety symptoms) both in outpatient and inpatient settings.
Prevention of relapse of depression (with a positive therapeutic effect).

Pharmacological effect

Velaxin has an antidepressant effect.

Special instructions

Discontinuation of the drug Velaxin: as with the treatment of other antidepressants, abrupt cessation of venlafaxine therapy, especially after high doses of the drug, may cause withdrawal symptoms, and therefore it is recommended to gradually reduce its dose before discontinuing the drug.

The length of the period required to reduce the dose depends on the dose size, duration of therapy, as well as the individual sensitivity of the patient.

Active ingredient

Venlafaxine

Composition

1 tablet contains venlafaxine (as hydrochloride) 75 mg

Pregnancy

Contraindicated during pregnancy and lactation (breastfeeding).

If venlafaxine was used immediately before or shortly before the birth of a child, the possibility of withdrawal syndrome in the newborn must be taken into account.

Contraindications

Hypersensitivity, concomitant use of MAO inhibitors, severe renal impairment (glomerular filtration rate 18 s), age under 18 years (safety and effectiveness for this age group have not been proven), pregnancy or suspected pregnancy, lactation (there is insufficient data from controlled studies).

Side Effects

General symptoms: weakness, increased fatigue.

From the gastrointestinal tract: loss of appetite, constipation, nausea, vomiting, dry mouth, rarely – hepatitis.

From the metabolic side: increased cholesterol levels in the blood serum, decreased body weight, sometimes – changes in the results of laboratory tests of liver function, hyponatremia, syndrome of insufficient secretion of antidiuretic hormone.

From the cardiovascular system: arterial hypertension, skin hyperemia, postural hypotension, tachycardia.

From the side of the central nervous system: unusual dreams, dizziness, insomnia, increased excitability, paresthesia, stupor, increased muscle tone, tremor, yawning; sometimes – apathy, hallucinations, muscle spasms, serotonin syndrome, rarely – epileptic seizures, manic reactions, as well as symptoms reminiscent of neuroleptic malignant syndrome.

From the genitourinary system: disorders of ejaculation, erection, anorgasmia, dysuric disorders (mainly difficulties at the beginning of urination); sometimes – decreased libido, menorrhagia, urinary retention.

From the senses: disturbances of accommodation, mydriasis, visual impairment; infrequently – disturbance of taste.

From the skin: sweating; sometimes – photosensitivity reactions; rarely – erythema multiforme, Stevens-Johnson syndrome.

From the hematopoietic system: sometimes – hemorrhages in the skin (ecchymosis) and mucous membranes, thrombocytopenia; rarely – prolongation of bleeding time.

Interaction

Incompatible with MAO inhibitors.

Reduces the AUC of indinavir by 28% and its Cmax by 36% (the clinical significance of the established phenomenon is unknown).
Increases the anticoagulant effect of warfarin.

Strengthens the effect of ethanol on psychomotor reactions.

When taken orally, it reduces the total clearance of haloperidol by 42%, increases its AUC by 70% and Cmax by 88%.

Cimetidine suppresses 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 with impaired liver function).

It has no effect on the pharmacokinetics of imipramine and 2-OH-imipramine, however, the AUC, Cmax and Cmin of desipramine increase by 35%, and the AUC of 2-OH-desipramine by 2.5-4.5 times.

Increases the AUC of risperidone by 32%, but does not have a significant effect on the total pharmacokinetic profile of the active components – risperidone plus 9-hydroxyrisperidone (the clinical significance of the identified phenomenon is unknown).

Does not interact with lithium preparations or with drugs metabolized by the CYP3A4, CYP1A2 and CYP2C9 systems (including alprazolam, caffeine, carbamazepine, diazepam).

Does not affect the plasma concentration of drugs with a high degree of protein binding.

Overdose

Symptoms (often occurs with concomitant use of ethanol): dizziness, decreased blood pressure, ECG changes (prolongation of the Q-T interval, bundle branch block, widening of the QRS), sinus and ventricular tachycardia or bradycardia, impaired consciousness (from drowsiness to coma), convulsions and death.

Treatment is symptomatic; monitoring of ECG and functions of vital organs; if there is a risk of aspiration, inducing vomiting is not recommended; rinsing (if the overdose has occurred recently, or symptoms of overdose persist); activated carbon. The effectiveness of forced diuresis, dialysis, hemoperfusion and blood transfusion has not been proven; specific antidotes are unknown.

Storage conditions

In a dry place, at temperatures below 30°C

Shelf life

5 years

Manufacturer

EGIS, Hungary