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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Active ingredient

Composition

1 tablet contains venlafaxine (as hydrochloride) 75 mg

How to take, the dosage

Velaxin is taken orally, with meals.

The recommended starting dose is 75 mg daily.

Interaction

Incompatible with MAO inhibitors.

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

Accelerates the effect of ethanol on psychomotor reactions.

On oral administration, decreases total clearance of haloperidol by 42%, increases its AUC by 70% and Cmax by 88%.

Cimetidine inhibits the “first pass” metabolism of venlafaxine and has no effect on the pharmacokinetics of O-desmethylvenlafaxine. In most patients, only a slight increase in the overall pharmacological activity of venlafaxine and O-desmethyl-venlafaxine is expected (more pronounced in elderly patients and in patients with hepatic dysfunction).

There is no effect on the pharmacokinetics of imipramine and 2-ON-imipramine, but the AUC, Cmax and Cmin of desipramine are increased by 35% and the AUC of 2-ON-desipramine by 2.5-4.5 times.

Enhances the AUC of risperidone by 32%, but has no significant effect on the total pharmacokinetic profile of the active components, risperidone plus 9-hydroxyrisperidone (the clinical significance of the identified phenomenon is unknown).

It does not interact with lithium drugs as well as drugs metabolized by CYP3A4, CYP1A2 and CYP2C9 systems (including alprazolam, caffeine, carbamazepine, diazepam).

The plasma concentrations of drugs with high degree of binding to proteins are not affected.

Special Instructions

Withdrawal of Velaxin: As with other antidepressants, abrupt discontinuation of therapy with venlafaxine, especially after high doses of the drug, may cause withdrawal symptoms; therefore, it is recommended that the dose of the drug be gradually reduced before withdrawal.

The length of time required to reduce the dose depends on the magnitude of the dose, the duration of therapy, and the individual sensitivity of the patient.

Contraindications

Hypersensitivity, concomitant use of MAO inhibitors, severe renal dysfunction (glomerular filtration rate18 s), age less than 18 years (safety and effectiveness for this age group is not proven), pregnancy or presumed pregnancy, lactation (insufficient data from controlled studies).

Side effects

General symptoms: weakness, increased fatigue.

Gastrointestinal disorders: decreased appetite, constipation, nausea, vomiting, dry mouth, rarely – hepatitis.

Metabolic disorders: increase in serum cholesterol levels, weight loss, sometimes – changes in the results of laboratory tests of liver function, hyponatremia, insufficient secretion of antidiuretic hormone syndrome.

Cardiovascular system disorders: arterial hypertension, hyperemia of the skin, postural hypotension, tachycardia.

CNS disorders: unusual dreams, dizziness, insomnia, increased excitability, paresthesias, stupor, increased muscle tone, tremor, yawning; sometimes – apathy, hallucinations, muscle spasms, serotonin syndrome, rarely – epileptic seizures, manic reactions, as well as symptoms resembling malignant neuroleptic syndrome.

Urogenital system disorders: disorders of ejaculation, erections, anorgasmia, dysuric disorders (mainly – difficulty in the beginning of urination); sometimes – decreased libido, menorrhagia, urinary retention.

Sensory organs: accommodation disorders, mydriasis, visual impairment; infrequently – taste disorders.

Skin disorders: sweating; sometimes – photosensitivity reactions; erythema multiforme, Stevens-Johnson syndrome – rare.

Hematopoietic system: sometimes – haemorrhages of the skin (ecchymosis) and mucous membranes, thrombocytopenia; rarely – prolongation of bleeding time.

Overdose

Symptoms (often occurs with simultaneous administration of ethanol): dizziness, decreased BP, ECG changes (Q-T interval prolongation, Gis bundle leg block, QRS expansion), sinus and ventricular tachycardia or bradycardia, impaired consciousness (from drowsiness to coma), seizures and death.

The treatment is symptomatic; control of ECG and vital organ functions; at risk of aspiration it is not recommended to induce vomiting; flushing (if overdose occurred recently or overdose symptoms persist); activated charcoal. Efficacy of forced diuresis, dialysis, hemoperfusion, and blood transfusion are not proven; specific antidotes are unknown.

Pregnancy use

It is contraindicated during pregnancy and during lactation (breastfeeding).

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

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