DEPREXOR 37.5 mg. 60 tablets

COMPOSITION:
Each tablet contains venlafaxine hydrochloride eq. 37.5 mg or 75 mg venlafaxine.
 
INDICATIONS:
- Treatment of major depressive disorder, depression combined with anxiety
- Preventing recurrence of a depressive episode or occurrence of new depressive episodes.
 
DOSAGE:
Adults:
The recommended starting dose is 75 mg daily in 2 divided doses (37.5 mg in 2 times a day). If necessary, after a two-week course of treatment, the dose may be increased to 150 mg daily in 2 divided doses (75 mg 2 times a day). The dose is increased by 75 mg daily at intervals of not less than 4 days.
In particularly serious cases of depression or in hospitalized patients the initial dose of 150 mg daily. If necessary, can be gradually increased (75 mg daily), at intervals of about two weeks or more, but not less than four days. The maximum daily dose is 375 mg. Upon reaching the desired therapeutic response, the dose is gradually reduced.
Children:
venlafaxine in children under 18 years of age is contraindicated.
 
Patients with impaired hepatic function:
Reduction is recommended by 50% of the daily dose in patients with moderate or severe hepatic impairment.
 
Patients with impaired renal function:
In patients with glomerular filtration rate <30 mL / min. treatment should be carried out with ½ of the recommended dose. In hemodialysis patients recommended dose reduction by 50% and daily doses after hemodialysis.
 
Patients over 65 years:
usually not required dose reduction.
 
Duration of treatment:
Treatment continues for months. Patients should be monitored periodically and after evaluation of the clinical picture to decide on the need to continue maintenance treatment or discontinuation of therapy.
 
CONTRAINDICATIONS:
- Hypersensitivity to the active or the excipients
- Co-administration of venlafaxine with MAO inhibitors
- Acute liver or kidney disease
- Pregnancy and lactation
- Children and adolescents under 18 years of age
 
Special warnings:
- In patients with depression have an increased risk of suicide and self-harm of treatment to onset of remission. In order to reduce the risk of intentional overdose, venlafaxine should be used in the minimum effective dose under periodic medical supervision.
- Venlafaxine can cause exacerbation of mania or hypomania.
- Upon discontinuation of venlafaxine risk of acts of aggression, particularly in patients with a history of aggressive behavior.
- Venlafaxine administered with caution in patients who had recently experienced a myocardial infarction or decompensated heart failure.
- In patients with tachyarrhythmias venlafaxine is administered with caution due to possible increased tahiartimiyata.
- Venlafaxine may be dose-dependent increase in blood pressure.
- The use of venlafaxine has the potential risk of seizures.
- For long-term treatment with venlafaxine may have an increased level of serum cholesterol.
- Venlafaxine can cause mydriasis, and therefore be used with caution in patients with glaucoma.
- Venlafaxine may increase the risk of bleeding in the skin and mucous membranes, and therefore should be used with caution in patients predisposed to bleeding.
- With venlafaxine dehydrated and patients taking diuretics may be observed cases of hyponatremia and / or syndrome of inappropriate secretion of hormone antidiuetichniya.
- Although venlafaxine did not affect psychomotor and cognitive functions may impair mental processes and execution of motor functions.
- Stopping treatment with venlafaxine may lead to the occurrence of withdrawal symptoms - weakness, restlessness, headache, nausea or vomiting, dizziness, dry mouth, diarrhea, insomnia, nervousness, numbness, sweating, impaired coordination. Discontinuation of treatment should be to gradually reduce the dose.
 
DRUG INTERACTIONS:
- Co-administration of venlafaxine and MAO inhibitors is contraindicated. If necessary, can pass by MAO inhibitor venlafaxine after an interval of at least two weeks of stopping the MAO inhibitor; and vice versa, requires an interval of one week after stopping venlafaxine to initiation of therapy with MAO inhibitor.
- When concomitant use of venlafaxine and warfarin increases the anticoagulant effect of warfarin.
- Due to the risk of serotonin syndrome, venlafaxine should not be used concomitantly with drugs that affect the serotonergic system: Hypericum perforatum, serotonin receptor agonists for the treatment of migraine, sibutramine, dextromethorphan, lithium.
- Concomitant use of venlafaxine and clozapine likelihood of adverse effects including seizures increases.
- Co-administration of venlafaxine and haloperidol may lead to an increase in the maximum plasma concentration of haloperidol.
- Co-administration of venlafaxine and ketoconazole can lead to elevated plasma concentrations of venlafksin and O-desmethylvenlafaxine.
- The concomitant use of venlafaxine and zolpidem may cause disorientation, hallucinations and mania.
- Medicinal products that are metabolized by cytochrome P450 isoenzymes may interact with the pharmacokinetics of venlafaxine.
- Co-administration of venlafaxine and metoprolol may lead to an increase in the plasma concentration of metoprolol. Metoprolol did not alter the pharmacokinetic profile of venlafaxine and its active metabolite.
- Although venlafaxine reinforce adverse reactions to the use of alcohol, patients should be advised to avoid alcohol consumption during treatment with him.
 
Pregnancy and lactation:
Not recommended venlafaxine during pregnancy and lactation.
 
SIDE EFFECTS:
 
Blood and lymphatic system:
Uncommon: ecchymosis, mucosal bleeding.
Rare: prolonged kravene, haemorrhage, thrombocytopenia.
 
Cardiovascular system:
Common: hypertension, vasodilation, palpitation.
Uncommon: hypotension, syncope, Artymata.
Very rare: Torsade de Pointes, prolongation of the QT-interval, ventricular tachycardia, ventricular fibrillation.
 
Gastrointestinal tract:
Very common: constipation, nausea.
Common: anorexia, decreased appetite, diarrhea, dyspepsia, vomiting.
 
General disorders:
Very common: asthenia, headache.
Common: abdominal pain, chills, pyrexia.
Rare: anaphylaxis.
 
Metabolism:
Common: increases in serum cholesterol, loss or weight gain.
Uncommon: hyponatremia, syndrome of inappropriate antidiuretic hormone hepatic dysfunction.
 
Musculoskeletal system:
Common: arthralgia, myalgia.
Uncommon: muscle karmpi.
 
Nervous system:
Very common: dizziness, dry mouth, insomnia, nervousness, somnolence.
Common: abnormal dreams, trevozhost, anxiety, confusion, tremor, paresthesia.
Uncommon: apathy, hallucinations, myoclonus.
Rare: akathisia, ataxia, impaired balance and coordination, speech disorders - dysarthria, mania, hypomania, neuroleptic malignant syndrome, seizures, serotonergic syndrome.
Very rare: delirium, extrapyramidal disorders - dyskinesia, dystonia, tardive dyskinesia.
 
Renal and urinary disorders:
Uncommon: urinary retention.
 
Reproductive system and breast disorders:
Very common: abnormal ejaculation in men, lack of orgasm, abnormal erection.
Common: decreased libido, menstrual disorders.
Rare: menorrhagia, galactorrhoea.
 
Respiratory, thoracic and mediastinal disorders:
Common: dyspnoea, yawning.
 
Skin and subcutaneous tissue disorders:
Very common: sweating.
Common: rash, itching. Uncommon: angioedema, macular-Papoulia eruption, urticaria, photosensitivity, alopecia.