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Instruction for use: Venlafaxine Organica

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Dosage form: coated tablets

Active substance: Venlafaxine*

ATX

N06AX16 Venlafaxine

Pharmacological groups:

Antidepressant [Antidepressants]

The nosological classification (ICD-10)

F32 Depressive episode: Adynamic subdepression; Astheno-adynamic subdepressive states; Asthenoadressive disorder; Astheno-depressive disorder; Asthenodepressive state; Astheno-depressive state; Major Depressive Disorder; Vyaloapatichesky depression with retardation; Double Depression; Depressive pseudodement; Depressive illness; Depressive mood disorder; Depressive disorder; Depressive mood disorder; Depressive state; Depressive disorders; Depressive syndrome; Depressive syndrome larviated; Depressive syndrome in psychoses; Depressed masks; Depression; Depression Depletion; Depression with the phenomena of inhibition within the framework of cyclothymia; Depression is smiling; Involutional depression; Involutionary melancholy; Involutional depression; Manic-depressive disorder; Masked Depression; Melancholic Attack; Neurotic depression; Neurotic depression; Shallow Depression; Organic depression; Organic depressive syndrome; Simple depression; Simple melancholic syndrome; Psychogenic depression; Reactive depression; Reactive depression with moderate psychopathological symptoms; Reactive depressive states; Reactive depression; Recurrent depression; Seasonal depressive syndrome; Severostatic depression; Senile Depression; Symptomatic Depression; Somatogenic depression; Cyclotymic depression; Exogenous depression; Endogenous depression; Endogenous Depressive Conditions; Endogenous Depression; Endogenous depressive syndrome

F33 Recurrent depressive disorder: Major depressive disorder; Secondary depression; Double Depression; Depressive pseudodement; Depressive mood disorder; Depressive disorder; Depressive mood disorder; Depressive state; Depressive syndrome; Depressed masks; Depression; Depression is smiling; Involutional depression; Involutional depression; Masked Depression; Melancholic Attack; Reactive depression; Reactive depression with moderate psychopathological symptoms; Reactive depressive states; Exogenous depression; Endogenous depression; Endogenous Depressive Conditions; Endogenous Depression; Endogenous depressive syndrome

Composition

Tablets covered with a film membrane 1 tab.

active substance:

venlafaxine 37.5 / 75 mg

auxiliary substances: MCC - 53.03 / 106.06 mg; lactose monohydrate (sugar milk) - 35.1 / 70.2 mg; sodium carboxymethyl starch (primogel) - 15.7 / 31.4 mg; povidone (PVP low molecular weight medical) K17 - 2,65 / 5,3 mg; magnesium stearate 1.1 / 2.2 mg

film sheath: Opadry II (85F28751) white (polyvinyl alcohol - 2/4 mg, titanium dioxide - 1.25 / 2.5 mg, macrogol (polyethylene glycol) - 1.01 / 2.02 mg, talc 0.74 / 1.48 mg) - 5/10 mg

Description of dosage form

Round biconvex tablets covered with a film coat of white or almost white color.

On the cross section, the nucleus is white or almost white in color.

In patients with hepatic and renal insufficiency from medium to severe, venlafaxine metabolism and elimination of EFA is reduced, Cmax of venlafaxine and EFA is increased, and T1 / 2 is lengthened. The decrease in the total clearance of venlafaxine is most pronounced in patients with Cl creatinine below 30 ml / min, as well as in patients on renal dialysis (T1 / 2 increases by 180% for venlafaxine and 142% for EFA, and the clearance of both active substances decreases approximately on 57%). For such patients, especially those on hemodialysis, individual doses of venlafaxine and monitoring of kinetics are necessary, taking into account the duration of treatment with this drug.

Although the data for patients with hepatic insufficiency of severe degree on the Child-Pugh scale are limited, it should be taken into account that individual variations in pharmacokinetics, in particular, clearance of the preparation and its T1 / 2, are very diverse, which should be taken into account when appointing venlafaxine to such patients. In patients with Child-Pugh class A (mild liver function abnormalities) and Child-Pugh class B (mild disabilities), venlafaxine T1 / 2 and EFA are elongated approximately 2-fold compared to those in healthy patients, and the clearance is lowered by more than half.

Indications for the Venlafaxine Organica

Depression (prevention and treatment).

Contraindications

hypersensitivity to venlafaxine or any of the excipients;

simultaneous application with MAO inhibitors (see "Interaction");

severe renal and / or hepatic impairment (GFR <10 mL / min);

pregnancy;

lactation period;

children under the age of 18 years.

With caution: recently transferred myocardial infarction, unstable angina, arterial hypertension, tachycardia, a history of convulsive syndrome, increased IOP, angle-closure glaucoma, manic conditions in the anamnesis, a predisposition to bleeding from the skin and mucous membranes, initially reduced body weight.

Application in pregnancy and lactation

Do not prescribe venlafaxine to pregnant women and breastfeeding women, because the safety of the drug during pregnancy and lactation in a woman is not established sufficiently, because there are no adequately conducted controlled clinical trials on a sufficiently large sample of such patients. This applies to health, both mother and fetus / child. Women of childbearing age should be warned about this before starting treatment, should immediately seek medical attention in the event of pregnancy or planning pregnancy during drug treatment.

Venlafaxine and EFA are excreted in breast milk. If you need to take the drug during lactation, it is necessary to stop breastfeeding.

In practice, there are cases of venlafaxine administered to mothers during pregnancy and shortly before delivery, when in a particular situation the expected benefit to the mother exceeds the potential risk to the fetus. In these cases, neonates often experienced complications that required an increase in the length of hospitalization, maintenance of breathing and feeding through the probe. These complications can develop immediately after birth and are also characteristic in the case of taking other antidepressants from the group of SSRIs or SSRIs. In such cases, the following clinical symptoms were reported in neonates: external respiratory disorders, cyanosis, apnea, convulsions, temperature instability, feeding difficulties, vomiting, hypoglycemia, muscle hypertension or hypotension, hyperreflexia, tremor, tremor, irritability, lethargy, constant crying, drowsiness or insomnia. Similar violations may indicate the serotonergic effects of the drug Venlafaxine.

If venlafaxine was used during pregnancy and the mother's treatment was completed shortly before the birth, a newborn can experience withdrawal symptoms. Such a newborn should be excluded from the presence of a serotonin or malignant neuroleptic syndrome. Epidemiological evidence suggests that the use of SSRIs during pregnancy, especially in later life, may increase the risk of persistent pulmonary hypertension in newborns.

Side effects

Frequency of side effects: very often - ≥1 / 10; often - ≥1 / 100 to <1/10; infrequently - ≥1 / 1000 to <1/100; rarely - ≥1 / 10000 to <1/1000; very rarely - <1/10000; frequency is not established (there is currently no data on the prevalence of adverse reactions).

Common symptoms: often - weakness, increased fatigue, chills; infrequently - Quincke's edema, photosensitivity reaction; frequency not established - anaphylactic reactions.

From the nervous system: very often - dry mouth, headache; often - unusual dreams, decreased libido, dizziness, insomnia, increased excitability, paresthesia, stupor, confusion, depersonalization, increased muscle tone, tremor; infrequently - apathy, agitation, hallucinations, myoclonus, impaired coordination of movements and balance; rarely - akathisia, psychomotor agitation, epileptic seizures, manic reactions; frequency not established - dizziness, malignant neuroleptic syndrome (CNS), serotonin syndrome, delirium, extrapyramidal reactions (including dystonia and dyskinesia), tardive dyskinesia, suicidal thoughts and behavior, aggression.

Co of the gastrointestinal tract: very often - nausea; often - decreased appetite (anorexia), constipation, vomiting; infrequently - bruxism, diarrhea; rarely - hepatitis; frequency not established - pancreatitis.

On the part of the respiratory system: often - yawning, bronchitis, dyspnea; rarely - interstitial lung diseases (ESR) and eosinophilic pneumonia, chest pain.

From the CVS: often - arterial hypertension, hyperemia of the skin; infrequently - postural hypotension, tachycardia, fainting; frequency not established - hypotension, QT interval elongation, ventricular fibrillation, ventricular tachycardia (including bidirectional tachycardia).

From the hemopoietic system: infrequently - hemorrhages in the skin (ecchymosis), gastrointestinal bleeding; frequency not established - hemorrhages in the mucous membranes, prolonged bleeding time, thrombocytopenia, pathological changes in blood (including agranulocytosis, aplastic anemia, neutropenia and pancytopenia).

From the side of metabolism: often - an increase in the level of Xs in the blood serum, a decrease in body weight; infrequently - weight gain; very rarely - an increase in prolactin; frequency is not established - a change in laboratory tests of liver function, hepatitis, hyponatremia, ADH deficiency syndrome.

On the part of the genitourinary system: often - violations of ejaculation / orgasm in men, erectile dysfunction (impotence), anorgasmia, dysuric disorders (mainly - difficulties at the beginning of urination), pollakiuria, menstruation disorders associated with increased bleeding or increased irregular bleeding (menorrhagia, metrorrhagia); infrequently - violations of orgasm in women, urinary retention; rarely - urinary incontinence.

From the sense organs: often - disruption of accommodation, mydriasis, impaired vision; infrequent - a violation of taste, noise or ringing in the ears; frequency not established - angle-closure glaucoma.

From the skin: very often - sweating; infrequently - alopecia, fast-passing rash; frequency is not established - erythema multiforme, toxic epidermal necrolysis, Stevens-Johnson syndrome, pruritus, urticaria.

From the side of the musculoskeletal system: the frequency is not established - rhabdomyolysis.

If you stop taking venlafaxine, a sharp cancellation or a decrease in the dose, you may experience symptoms that refer to the so-called. withdrawal syndrome: increased fatigue, asthenia, headache, dizziness, sleep disturbances (drowsiness or insomnia, difficulty falling asleep, unusual dreams), hypomania, anxiety, agitation (increased nervous excitability and irritability), confusion, paresthesia (including spontaneously arising unpleasant sensation of numbness, tingling, burning, crawling), increased sweating, dry mouth, decreased appetite, nausea, vomiting, diarrhea (most of these reactions are slightly expressed and not tr fuck treatment).

Interaction

Venlafaxine itself, without having an increased bond with plasma proteins, practically does not increase the concentration of concomitantly taken drugs, which are characterized by a high bond with plasma proteins. Clinically significant interaction with antihypertensive (including beta-blockers, ACE inhibitors, diuretics) and antidiabetic drugs was not detected.

Caution should be exercised when concomitant administration with other drugs affecting the central nervous system, since the interaction of venlafaxine with such drugs has not been studied.

MAO inhibitors. Contraindicated concomitant use of venlafaxine with MAO inhibitors, as well as within 14 days after their withdrawal (risk of serious adverse effects up to the lethal outcome is likely). Therapy with MAO inhibitors can be prescribed not less than 7 days after the withdrawal of the drug Venlafaxine. The preparation of the drug Venflaxin should be discontinued at least 7 days before the onset of reversible selective MAO inhibitors (moclobemide). A weakly reversible and nonselective MAO inhibitor, linezolid (antimicrobial drugs) and methylene blue (IV) are also not recommended for simultaneous use with venlafaxine.

Serotonergic agents. Caution should be exercised simultaneously with the use of drugs that affect serotonergic drug delivery, such as triptans (including sumatriptan, zolmitriptan), SSRIs, SSRIs (prolonged seizures), tricyclic antidepressants, lithium, sibutramine or fentanyl (in t his analogues - dextromethorphan, tramadol), as well as an excess of tryptophan sources due to the increased potential risk of the occurrence of serotonin syndrome.

Alcohol. During treatment with venlafaxine, alcohol should be completely ruled out. Alcohol enhances the impairment of psychomotor functions, which can cause venlafaxine.

Lithium. Lithium preparations have no significant effect on the pharmacokinetics of venlafaxine.

Diazepam. There was no effect of oral diazepam on the pharmacokinetics of venlafaxine and EFA, and conversely, venlafaxine did not alter the pharmacokinetics of diazepam and its metabolite, desmethyldiazepam. In addition, the appointment of both these drugs does not impair the psychomotor effects and psychometric indices caused by diazepam.

Cimetidine. Simultaneous administration of cimetidine and venlafaxine resulted in a delay in metabolism during the first passage of venlafaxine through the liver. The venlafaxine clearance for oral administration decreased by 43%, and the AUC and Cmax of the drug increased by 60%. However, such an impact did not manifest itself with regard to EFA. Since the overall activity of venlafaxine and EFA is expected to increase only to a small extent, dose adjustment for most conventional patients will not be required. However, patients with existing (identified) hypertension, elderly patients and those who have a violation of the liver or kidney function, it is possible to adjust the dose of venlafaxine.

Haloperidol. In a study where venlafaxine was prescribed in the Css stage at a dose of 150 mg / day, there was a decrease in total clearance of oral haloperidol by 42% after a dose of 2 mg orally; while AUC increased by 70%, and Cmax - by 88%, while T1 / 2 haloperidol did not change. This should be considered for the correct choice of a dose of haloperidol.

Imipramine. Venlafaxine does not impair the pharmacokinetics of imipramine and 2-hydroxyimipramine. However, AUC, Cmax and Cmin desipramine (an active metabolite of imipramine) increased by approximately 35% with concurrent administration of venlafaxine. It also increases by 2.5 or 4.5 times (depending on the dose of venlafaxine: 37.5 mg or 75 mg twice a day) concentration of 2-hydroxydesipramine, but the clinical significance of this fact is unknown.

Metoprolol. Care should be taken when using metoprolol and venlafaxine concomitantly. due to pharmacokinetic interaction, the concentration of metoprolol in the blood plasma increases by about 30-40%, without changing the concentration of its active metabolite alpha-hydroxymethoprolol. The clinical significance of this interaction has not been studied. Metoprolol does not affect the venlafaxine AUC and EFA.

Risperidone. When used simultaneously with risperidone (despite an increase in risperidone AUC), the pharmacokinetics of a pair of active molecules (risperidone and 9-hydroxyrisperidone) does not change significantly when combined with venlafaxine.

Clozapine. During the post-marketing study of venlafaxine, it was found that with simultaneous use with clozapine, its concentration in the blood plasma increases. This was manifested by an increase in the side effects of clozapine, especially with respect to the incidence of seizures.

Indinavir. With simultaneous use, the pharmacokinetics of indinavir changes (AUC decreases by 28%, and Cmax decreases by 36%). Changes in the pharmacokinetics of venlafaxine are not observed. The clinical significance of this fact is unknown.

Ketoconazole. A study of pharmacokinetics in combination with ketoconazole showed an increase in plasma concentrations of venlafaxine and EFA in subjects in whom the original metabolism involving the CYP2D6 isoenzyme is both good (X-Meth) and poor (P-Meth). In particular, Cmax of venlafaxine increased by 26% in X-Meth and by 48% in P-Meth. Cmax EFA values increased by 14 and 29% in subjects X-Met and P-Meth, respectively. The venlafaxine AUC increased by 21% in X-Meth and by 70% in P-Meth. The AUC EFA values increased by 23 and 33% in the subjects X-Met and P-Meth, respectively.

Means that affect blood clotting and platelet function (NSAIDs of acetylsalicylic acid and other anticoagulants). Serotonin, released by platelets, plays an important role in hemostasis (stopping bleeding). Epidemiological studies demonstrate the relationship between the use of psychotropic drugs that interfere with serotonin reuptake, and the frequency of bleeding from the upper gastrointestinal tract. This relationship is enhanced if NSAIDs are simultaneously used, preparations containing acetylsalicylic acid or other antinecoagulants. The risk of bleeding in the appointment of SSRIs and SSRIs (including venlafaxine) simultaneously with warfarin is increased. Patients assigned to warfarin should be carefully monitored for PV and / or partial thromboplastin time, especially when concomitant use with venlafaxine begins or ends.

Interaction with other drugs at the level of the metabolism studied with cytochrome P450 isoenzymes. The main ways of metabolism of venlafaxine include isozymes CYP2D6 and CYP3A4: the first of them converts venlafaxine to its active metabolite EFA, and the second is less important in the metabolism of venlafaxine compared to CYP2D6 and forms the product N-desmethylvenlafaxine with little pharmacological activity. Preclinical studies have shown, and then it has been clinically confirmed that venlafaxine is a relatively weak inhibitor of CYP2D6. Therefore, even with a prescription with moderately suppressing activity of this enzyme LS (see the example with imipramine above) or in the case of treatment of patients with genetically determined decrease in CYP2D6 function, correction of the dose of venlafaxine is not required. the total concentration of active substance and active metabolite (venlafaxine and EFA) does not change significantly. This positively characterizes venlafaxine when compared with other antidepressants. Caution should be exercised when concomitant administration with such inhibitors of CYP2D6, as quinidine, paroxetine, fluoxetine, haloperidol, perphenazine, levomepromazine, t. in this case venlafaxine can potentially increase the plasma concentration of these substrates CYP2D6. In combination with drugs that inhibit both enzymes (CYP2D6 and CYP3A4), special care must be taken. Such drug interactions have not yet been adequately studied and in this case such a combination of drugs is not recommended. In addition, venlafaxine does not inhibit the activity of the enzymes CYP3A4, CYP1A2 and CYP2C9, so significant interactions are not observed with such drugs as alprazolam, caffeine, carbamazepine, diazepam, tolbutamide, terfenadine.

Interaction with ketoconazole is described above. A similar effect may have such inhibitors 延󕼽 / 4, as itraconazole, ritonavir.

Other interactions with various concomitant therapeutic factors and food. On the background of the use of venlafaxine, special care should be taken with electroconvulsive therapy, because experience with venlafaxine in these conditions is absent. Significant influence of different types of food on the absorption of venlafaxine and its subsequent transformation into EFA was not revealed. Foods (usually high in protein, such as hard cheeses, fish caviar, turkey), as well as dietary supplements and fitness diets that are a source of tryptophan, potentially contribute to a greater production of serotonin in the body, which may increase the side effects of venlafaxine in the serotonergic effects.

Drugs containing St. John's Wort. Unwanted pharmacodynamic interaction may occur when taking venlafaxine simultaneously with a medicinal plant, St. John's wort (grass or various preparations from it), this combination is not recommended.

There are reports of false positive results of an immunochromatographic urine test (test strip) test on phencyclidine and amphetamines in patients taking venlafaxine, even a few days after the withdrawal of venlafaxine. This can be explained by the lack of specificity of this test. To distinguish venlafaxine from phencyclidine and amphetamines can only confirm the test in a specialized anti-doping laboratory.

According to the data available to date, venlafaxine has not proved to be a drug that induces drug abuse or addiction (both in the pre-clinical study of affinity for receptors and in clinical practice).

Dosing and Administration

Inside, with food, preferably at the same time, without chewing and washing down with liquid.

The recommended initial dose is 75 mg in 2 divided doses daily (37.5 mg 2 times a day). Depending on the tolerability and effectiveness, the dose can be gradually increased to 150 mg / day. If necessary, increase the dose to 225 mg / day. An increase in the dose of 75 mg / day can be done at intervals of 2 weeks or more, in case of clinical necessity, in view of the severity of the symptoms, it is possible to increase the dose in shorter periods, but not less than 4 days. Higher doses (up to a maximum daily dose of 375 mg / day in 2-3 doses) require in-patient monitoring of patients. After achieving the necessary therapeutic effect, the daily dose can be gradually reduced to a minimum effective level.

Supportive therapy and prevention of relapse. Supportive treatment can last 6 months or more. The minimum effective doses used in the treatment of a depressive episode are prescribed.

Renal failure. With mild renal failure (GFR> 30 mL / min), correction of the dosing regimen is not required. With moderate renal failure (GFR 10-30 ml / min), the dose should be reduced by 25-50%. In connection with the elongation of venlafaxine T1 / 2 and its active metabolite (EFA), such patients should take the entire dose 1 time per day. It is not recommended to use venlafaxine in severe renal failure (GFR <10 ml / min), as there is no reliable data on such therapy. In hemodialysis, the daily dose should be reduced by 50%, the drug should be taken after the end of the hemodialysis session.

Liver failure. With mild hepatic insufficiency (PV <14 s), correction of the dosing regimen is not required. With moderate hepatic insufficiency (IV 14 to 18 s), the daily dose should be reduced by 50% or more. It is not recommended to use venlafaxine in severe hepatic insufficiency, since there is no reliable data on such therapy.

Elderly patients. The elderly patient's age in the absence of any acute and chronic diseases does not require a dose change, however (as with the appointment of other medications) in the treatment of elderly patients requires caution. Elderly patients should be given the lowest effective dose. When the dose is raised, the patient must be under careful medical supervision.

Abolition of the drug

The discontinuation of taking the drug should be carried out gradually, in order to minimize the risk associated with the withdrawal of the drug. At the course of treatment for 6 weeks or more, the period of gradual withdrawal should be at least 2 weeks and depend on the dose, duration of therapy and individual patient characteristics.

Overdose

Symptoms: impairment of consciousness (from drowsiness to coma), agitation, possible vomiting, diarrhea; tremor, decrease or (weak) increase in blood pressure, dizziness, mydriasis, convulsive conditions, sinus or ventricular tachycardia or bradycardia; changes on the ECG (prolongation of the QT interval, blockade of the bundle of the bundle, expansion of the QRS complex). Postmarketing experience of application indicates that the most frequent overdose of venlafaxine occurred while taking alcohol and / or other psychotropic drugs. There are repeated reports of deaths. Published literature on retrospective studies of venlafaxine overdoses report that such an increased risk of fatal outcomes may be attributable to venlafaxine when compared with available SSRI antidepressants in medical circulation, but this risk is lower than the risk inherent in tricyclic antidepressants. Epidemiological studies have shown that those patients treated with venlafaxine have greater burden with respect to the risk of suicide compared to those treated with SSRIs (other than venlafaxine). However, it remains unclear to what extent such high mortality rates (due to venlafaxine overdose) are due to the toxic properties of the drug itself or the specific characteristics of that group of patients treated with venlafaxine. According to clinical experience, it is recommended that prescriptions for venlafaxine prescribe the minimum possible amount that is sufficient only until the patient's next visit to the doctor, in order to reduce the risk of intentional overdose (see also "Special instructions").

Treatment: symptomatic and supportive therapy is performed. Specific antidotes are unknown. It is recommended continuous monitoring of vital functions (breathing, blood circulation and heart rhythm). When an overdose is recommended, immediate stomach washing, the appointment of activated charcoal to reduce absorption of the drug. It is advisable to induce vomiting at risk of aspiration of vomit. Forced diuresis, dialysis, blood transfusion are ineffective.

Special instructions

Suicide and suicidal behavior. Depression is associated with an increased risk of suicidal thoughts, self-injury and suicide (suicidal behavior). This risk persists until the onset of severe remission. Since there may be no improvement in the first few weeks of therapy or even a longer period of time, careful monitoring of patients is necessary before such an improvement. According to the accumulated clinical experience, the risk of suicide may increase in the early stages of recovery.

Patients with a history of suicide attempts or with a high level of meditation on suicidal topics before starting treatment are more likely to be at risk of suicidal thoughts or suicide attempts, such patients need to be closely monitored. A meta-analysis of placebo-controlled clinical trials of antidepressants with adult patients with mental disorders showed that the risk of suicidal behavior was elevated when taking antidepressants compared with placebo in patients younger than 25 years of age. The medical treatment of these patients, and in particular of patients with a high risk of suicide, should be accompanied by careful monitoring, especially at an early stage of therapy and in dose adjustment. Patients (and caregivers) should be warned about the need to monitor any manifestation of clinical impairment, suicidal behavior or thoughts, and unusual behavioral changes, and seek medical attention immediately if these symptoms appear. A small number of patients taking antidepressants, incl. venlafaxine, at the beginning of treatment with a dose change or discontinuation of treatment, aggression may occur. Clinical studies conducted to date have not revealed a tolerance to, or dependence on, venlafaxine. Despite this, as with other drugs acting on the central nervous system, the physician must establish close monitoring of patients to identify signs of drug abuse, as well as patients who have a history of such symptoms.

Special patient groups

Venlafaxine is not approved for use in children.

In patients with previously observed aggression, venlafaxine should be used with caution. In patients with affective disorders, bipolar disorder in the treatment of antidepressants, including venlafaxine, hypomanic and manic conditions may occur. Like other antidepressants, venlafaxine should be administered with caution to a patient with a history of mania. Such patients need medical supervision.

With venlafaxine therapy, convulsive disorders can occur. Like all antidepressants, venlafaxine should be used with caution in patients with convulsive disorders in the anamnesis, such patients need to be carefully monitored. Treatment should be stopped with the development of seizures.

Akathisia. The use of venlafaxine was associated with the development of akathisia, which is characterized by an unpleasant feeling of motor anxiety for the patient and manifested in the inability of the patient to calmly sit in one position for a long time or remain without movement for a long time. This condition can be observed at the beginning of treatment and during the first weeks of treatment. For patients who have such symptoms, an increase in dose is not recommended.

Bipolar disorder. Before starting treatment, it is necessary to identify those patients who are at risk for having bipolar disorder. Such a check should include a detailed examination of the anamnesis, incl. family, to identify suicides, bipolar disorder. It should be noted that venlafaxine is not recommended for use in the treatment of bipolar depression.

Use in patients with concomitant diseases. The clinical experience of venlafaxine in patients with concomitant diseases is limited. It should be used with caution in patients with those diseases in which the effect of venlafaxine on hemodynamic parameters and / or metabolism may be significant. Patients should be warned about immediate medical attention when rashes, urticaria, or other allergic reactions occur. Some patients with venlafaxine received a dose-related increase in blood pressure and / or increased heart rate, therefore regular monitoring of blood pressure and ECG is recommended, especially during the period of clarifying or increasing the dosage of venlafaxine. During the post-marketing application of venlafaxine (with an overdose), lethal cardiac arrhythmias were recorded. Before appointment of venlafaxine to patients with a high risk of developing serious cardiac arrhythmias, the ratio of likely benefit and possible risk in use should be assessed.

Patients, especially the elderly, should be warned about the possibility of dizziness and imbalance in order to prevent injuries.

During the administration of venlafaxine, especially in conditions of dehydration or reduction of BCC (including in elderly patients and patients taking diuretics), hypotranemia and / or ADH deficiency syndrome may be observed.

The use of venlafaxine has not been studied in patients who have recently undergone myocardial infarction and who suffer from decompensated heart failure. Such patients should be administered with caution.

Taking SSRIs or venlafaxine in patients with diabetes mellitus can cause a change in the level of glucose in the blood plasma. You may need to adjust the dose of insulin and / or anti-diabetic drugs.

During treatment it is recommended to refrain from taking any alcohol-containing drinks.

Safety and effectiveness of venlafaxine in combination with drugs that reduce body weight (including phentermine) have not been established. It is not recommended simultaneous reception of venlafaxine and drugs that reduce body weight.

Women of childbearing age should apply appropriate methods of contraception during the administration of venlafaxine.

Explanation of special symptoms and conditions, the occurrence of which is possible with drug treatment

Dry mouth was noted in 10% of patients receiving venlafaxine. This can increase the risk of developing caries. Patients should carefully observe oral hygiene.

The use of venlafaxine can cause the development of akathisia characterized by subjective unpleasant sensations or motor anxiety and the need to move frequently, which is often accompanied by inability to sit or stand still. This mainly occurs during the first few weeks of treatment. Increasing the dose in patients who develop these symptoms can lead to undesirable consequences.

In placebo-controlled clinical trials, 5.3% of patients had a clinically significant increase in serum cholesterol content. It is necessary to control the level of Xs during long-term treatment.

The withdrawal syndrome. During the cessation of treatment, withdrawal syndrome is common, especially if it is a sudden cessation. The risk of withdrawal may depend on several factors, including the duration of treatment, the amount of therapeutic doses and the rate at which they are reduced. Very rarely reported on these symptoms in patients who accidentally missed the drug. Symptoms of withdrawal syndrome usually occur within the first few days after discontinuation of treatment. Usually these symptoms pass for 2 weeks, although in some people they can last 2-3 months or more. When discontinuing the drug is recommended to gradually reduce the dose of venlafaxine for several weeks or months, depending on the severity of the clinical symptoms of the disease.

Serotonin syndrome. Taking venlafaxine, like other serotonergic drugs, can cause serotonin syndrome, a potentially life-threatening condition, especially when other drugs are used simultaneously, which can affect serotonergic neurotransmitter systems, such as MAO inhibitors (see "Interaction"). Symptoms of serotonin syndrome may include changes in mental status (excitation, hallucinations, coma), autonomic instability (tachycardia, lability of blood pressure, hyperthermia), neuromuscular disorders (hyperreflexia, impaired coordination) and / or gastrointestinal symptoms (nausea, vomiting , diarrhea).

Influence on the ability to drive vehicles, mechanisms. During the treatment period, care should be taken when carrying out potentially dangerous jobs requiring increased concentration of attention and speed of the psychomotor reaction (including driving and controlling the mechanisms).

Release form

Tablets, film-coated, 37.5 mg and 75 mg. For 10 tab. in the outline cell pack. 3 contour mesh packages are placed in a pack of cardboard.

Conditions of leave from pharmacies

On prescription.

Storage conditions for Venlafaxine Organica

In the dark place at a temperature of no higher than 30 C.

Keep out of the reach of children.

Shelf life of Venlafaxine Organica

2 years.

Do not use after the expiry date printed on the package.

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