EFEKSIVA caps. 75 mg. 30 caps

EFEKSIVA caps. 75 mg. 30 caps
€ 24.00
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Depressive episodes.
  Generalised anxiety disorder (GAD).
  Social anxiety disorder.
  Social phobia with or without agoraphobia.
  panic disorder

EFEKSIVA caps. 75 mg. 30 caps
 

INDICATIONS

 Depressive episodes.
 Generalised anxiety disorder (GAD).
 Social anxiety disorder.
 Social phobia with or without agoraphobia.
 Panic disorder.
 

 DOSAGE AND ADMINISTRATION

 
Application
It is recommended that the capsule be taken with meals.
Each capsule should be swallowed whole with liquid.
The capsule should not be divided, crushed, chewed or dissolved in water.
Venlafaxine extended release (SR and ER forms) should be taken once daily, preferably at the same time every day, morning or evening. Patients treated with venlafaxine formulation of immediate release, may be switched to venlafaxine SR to the nearest equivalent dose (mg / day). May be necessary and individual dose adjustments.
 

Depressive episodes:

 
The effective dose for the treatment of depression is usually between 75 mg and 225 mg. Treatment should be initiated at 75 mg once daily. Some effect is achieved after 2-4 weeks of therapy with standard doses adequate. If the clinical response is inadequate, the dose may be increased to 150 mg, and then to 225 mg. Patients who do not respond to treatment may benefit from higher doses - up to 375 mg. In all cases, high doses should be administered under supervision. Doses should be increased at intervals of two weeks or more with a minimum of 4 days between each dose increase. If there was no response after 3-4 weeks, you will benefit from continued treatment. Usually it is assumed that acute episodes of major depression require continuous treatment for at least 4-6 months. Some patients may require longer treatment courses. Clinicians should periodically reassess the need for continued treatment with venlafaxine.
 

Generalised anxiety disorder:

 
The recommended dose for the treatment of generalized anxiety disorder is 75 mg / day. For patients who do not show an adequate response at a dose of 75 mg / day, the dose may be increased by 75 mg at intervals of at least 4 days between changes in dosage to achieve the maximum dose 225 mg. Generalized anxiety disorder is no evidence of efficacy of continued treatment for more than 8 weeks.
 
Social Anxiety Disorder / Social Phobia:
The recommended dose for the treatment of social anxiety disorder is 75 mg / day. For patients who do not show an adequate response at a dose of 75 mg, this dose may be increased to 75 mg at intervals of at least 4 days between changes in dosage to achieve the maximum dose 225 mg. Efficacy of venlafaxine in the treatment of social anxiety disorder was demonstrated in four 12-week, placebo-controlled studies. No evidence of long-term efficacy.
 

Panic disorders:

 
The recommended dose for the treatment of panic disorder is 75 mg / day. Treatment should be initiated at a dose of 37.5 mg / day for the first 4-7 days, after which the dose was increased to 75 mg / day. For patients who do not show an adequate response to a daily dose of 75 mg / day, the dose may be increased by 75 mg at intervals of about two weeks, but not less than four days between changes in dose to achieve maximum dose of 225 mg.
Patients with panic disorders usually require long-term treatment. There is evidence that venlafaxine is effective for long / 6 months / treatment of panic disorders.
 
Features of dosing:
 
Patients with impaired renal or hepatic function:
Patients with impaired renal or hepatic function should receive lower doses of venlafaxine. These patients may need to start treatment with venlafaxine in the immediate release formulation.
In patients with renal impairment with a glomerular filtration rate of 10 to 70 ml / min, total dose should be reduced by 25-50%. In hemodialysis patients, the total dose should be reduced by half. It is given after dialysis. In patients with mild to moderate hepatic impairment, the total daily dose should be reduced by 50%. The dosage is determined individually for the patient, but some patients may need to be reduced by more than 50%.
There are no data on patients with severe hepatic impairment, but caution is required and should consider reducing the dose by more than 50%. In patients with severe hepatic impairment should consider the risk / benefit during treatment.
 
Use in children and adolescents:
Venlafaxine must not be used to treat children and adolescents under 18 years of age.
 
Elderly:
 
Treatment of elderly patients should be started with the lowest recommended dose. When the dose is determined individually for each patient, with particular attention should be exercised when increasing the dose.
 
Withdrawal symptoms seen on discontinuation of venlafaxine:
You should avoid abrupt discontinuation of the drug. Vnizapnoto discontinuation of the drug leads to serious withdrawal symptoms.
When treatment with venlafaxine was discontinued, the dosage should be reduced very gradually over at least a couple of weeks to reduce the risk of withdrawal reactions. If after a dose reduction or discontinuation symptoms occur, you should consider returning to the previous dosage. At a later stage, the physician may continue decreasing the dose but at a more gradual rate.
 

 CONTRAINDICATIONS

 
Hypersensitivity to venlafaxine or to any of the excipients.
Venlafaxine should not be administered concomitantly with MAO / Monoamine oxidase / inhibitor or within 14 days after discontinuation of MAO inhibitor. It may take seven days after discontinuation of venlafaxine before starting treatment with an MAO inhibitor.
 

 SPECIAL WARNINGS

 
Use in children and adolescents under age 18 golishna
Venlafaxine must not be used in the treatment of children and adolescents under 18 years of age. In clinical trials more frequently observed suicidal behavior / suicide attempt and suicidal thoughts / and hostility / predominantly aggression, oppositional behavior and anger / among children and adolescents treated with antidepressants to those receiving placebo.
If, however, a decision to conduct therapy based on clinical data, the patient should be carefully monitored for the appearance of suicidal symptoms. Moreover, data on long-term safety for children and adolescents concerning growth, maturation and cognitive and behavioral development.
 
Suicide / suicidal thoughts or clinical worsening
Depression is associated with an increased risk of suicidal thoughts, self harm and suicide / suicide-related events /. This risk persists until the significant remission occurs. As the first few weeks of treatment may be no improvement, patients should be closely monitored until the improvement. Clinical experience has shown that the risk of suicide may increase in the early stages of recovery.
 
Other mental conditions for which venlafaxine is prescribed can also be connected with suicide-related events. Moreover, these conditions can occur simultaneously with major depressive disorder. Therefore the same precautions to be observed when treating patients with major depressive disorder should therefore be observed when treating patients with other psychiatric disorders. It is known that patients with a history of suicide-related events or those exhibiting a significant degree of suicidal ideation prior to commencement of treatment are at greater risk of suicidal thoughts or suicide attempts, and should be carefully monitored during treatment.
A meta-analysis of placebo-controlled trials of antidepressant drugs in adult patients with psychiatric disorders showed an increased risk of suicidal behavior in patients on antidepressants compared to placebo patients under the age of 25 years. Patients especially at risk should be closely monitored during drug therapy, especially in the beginning and then changes in dosage. Patients and those who care for them, you should know that it is necessary to monitor for any clinical worsening, suicidal behavior or thoughts and unusual changes in behavior, and immediately seek medical attention if you notice any symptoms.
In all depressed patients should take into account the risk of suicide. Therefore, patients should receive a limited number of capsules to reduce the risk of overdose.
 

Aggressiveness

 
As with other antidepressants during treatment with venlafaxine, dose reduction and at the end of treatment may manifest aggressive behavior. Therefore, venlafaxine should be used with caution in patients with a history of aggressive behavior.
 
Akathisia / psychomotor Twitter
Venlafaxine is associated with the occurrence of akathisia, characterized by a subjectively unpleasant or painful Twitter and need to move often accompanied by an inability of the patient to sit or stand still. This can happen most likely during the first few weeks of treatment. In patients who develop these symptoms, increasing the dose may be detrimental.
 
Mania / hypomania
Mania / hypomania may occur in a small number of patients with mood disorders who were treated with antidepressants, including venlafaxine.
During pre-marketing studies, mania or hypomania was activated in 0.2% of patients treated with venlafaxine for social anxiety disorder. As with other antidepressants, venlafaxine should be used with caution in patients with a history of mania.
When treating depressive phase of manic-depressive psychosis, it can develop into a manic phase.
Rarely convulsions occur. As with other antidepressants, careful dosing, accompanied by regular and close monitoring of the patient's condition is necessary for epileptic patients and / or those with organic brain syndrome. If a convulsion, treatment should be discontinued.
Serotonin syndrome (serotonin toxicity)
Due to the mechanism of action of venlafaxine and the risk of serotonin syndrome, caution is advised when venlafaxine is used in combination with agents that affect the serotonergic neurotransmitter systems, such as triptans, selective MAO inhibitors / moclobemide toloxatone / linezolid, reverse uptake of serotonin or lithium.
As a curative measure very useful can be the application of the serotonin antagonist cyproheptadine.
 
Neuroleptic Malignant Syndrome
As inhibitors of serotonin reuptake, venlafaxine should be used with caution in patients already receiving antipsychotics, since this combination is reported symptoms nevrolertichen malignant syndrome.
 
Mydriasis and narrow-angle glaucoma
Mydriasis has been reported in association with administration of venlafaxine; therefore the condition of patients with raised intraocular pressure or at risk for narrow-angle glaucoma should be monitored closely.
 
Hepatic and renal function
Before starting treatment you should check liver and kidney function. In patients with liver cirrhosis or mild to moderate renal dysfunction, clearance of venlafaxine and its active metabolite is decreased and half-life of these substances - prolonged.
You may need a lower dose of larger spaces. As with all antidepressants, venlafaxine should be used with caution in these patients.
 
Diabetes
For patients with diabetes, treatment with inhibitors of the reuptake of serotonin, SSRI / SNRI may affect control of blood glucose. You may need to adjust the dosage of insulin and / or oral antidiabetics.
Hyponatremia and syndrome of inappropriate antidiuretic hormone / SIADH / The use of antidepressants / including inhibitors of serotonin reuptake / release has cases of hyponatraemia secondary to syndrome transition of inappropriate antidiuretic hormone (S1ADH).
In most cases, this occurs in elderly patients, patients treated with diuretics or suffering from hypovolemia due to other reasons.
 

Elderly

 
Elderly patients are often more sensitive to antidepressants. Particular attention is required when increasing the dosage.
 
Risk of bleeding
The risk of bleeding from the skin and mucous membranes may be increased in patients receiving venlafaxine. As with other agents that inhibit serotonin grip, venlafaxine should be used with caution in patients at increased risk of bleeding in these places.
 
Withdrawal symptoms seen on discontinuation
Upon discontinuation often symptoms of withdrawal, particularly if discontinuation is abrupt.
The risk of withdrawal symptoms depends on several factors, including the duration and dose of therapy and the rate of dose reduction. The most commonly reported effects include dizziness, sensory disturbances / including paresthesia / sleeping / including insomnia and vivid dreams / anxiety, nausea and / or vomiting, tremor and headache. These symptoms are usually mild to moderate, but in some patients they may be severe. They usually occur within the first few days of discontinuing treatment, but rarely reported such symptoms in patients who have accidentally missed a dose. Generally these symptoms resolved spontaneously within 2 weeks, although some patients this time may be longer / 2-3 months or more /. It is therefore recommended discontinuation of venlafaxine therapy should be gradual, over a period of several weeks or months, depending on the needs of the patient / see Withdrawal symptoms seen on discontinuation /.
 
 

 INTERACTIONS

 
MAO inhibitors, adverse reactions / some heavy / has been reported after treatment with venlafaxine began soon after treatment with non-selective MAO inhibitors or in cases where treatment with MAOIs is introduced soon after discontinuation of venlafaxine .
These effects include tremor, myoclonus, sweating, nausea, vomiting, flushing, dizziness, hyperthermia with features resembling nevrolertichen malignant syndrome, serotonin syndrome, in serious cases, convulsions and death.
During concomitant administration of selective inhibitors of serotonin reuptake and MAO inhibitors has been reported following effects: hyperthermia, rigidity, myoclonus, autonomic instability with rapid fluctuations of vital signs, mental status changes / including extreme agitation in passing delirium and coma / and features resembling neuroleptic malignant syndrome.
In light of these events and serious / sometimes fatal / interactions reported during concomitant or as a result of intake immediately after a MAO inhibitor or other antidepressants with pharmacological properties similar to venlafaxine, venlafaxine should not be used concomitantly with MAO inhibitors or within 14 days after discontinuation of MAO inhibitor. It may take at least 7 days after stopping treatment with venlafaxine before starting treatment with an MAO inhibitor.
When introducing treatment with venlafaxine 14 days after MAO inhibitor, it is advisable to start with a dose of 37.5 mg venlafaxine during the first few days.
The above recommendations for specific intervals between discontinuation of an MAO inhibitor and initiation of treatment with venlafaxine are based on data for irreversible MAO inhibitors. The interval between discontinuation of moclobemide / reversible MAO inhibitor / and initiation of treatment with venlafaxine may be less than 14 days. At the risk, however, the side effects / above / associated with MAO inhibitors should have a sufficient washout period when switching patients from moclobenide of venlafaxine. In determining the appropriate washout period should take into account the pharmacological properties of moclobemide, and clinical assessment of the individual patient by the physician.
 
Drugs with risk of serotonin syndrome:
Due to the mechanism of action of venlafaxine and the risk of serotonin syndrome, caution is needed in applying venlafaxine in combination with agents that affect the serotonergic neurotransmitter systems, such as triptans, selective MAO inhibitors (moclobemide, toloxatone) linezolide, dextromethorphan, selective inhibitors reuptake of serotonin or lithium.
 
Drugs with risk of neuroleptic malignant syndrome:
Similarly, inhibitors of serotonin reuptake, venlafaxine should be used with caution in patients already receiving antipsychotics, since this combination have been reported cases of neuroleptic malignant syndrome.
 
Alpha and beta sympathomimetics:
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