Efexor xr 150 mg 28 capsules include venlafaxine

4.2. Posology and application form

Posology / application frequency and duration:

The recommended initial dose for major depression is 75 mg EFEXOR XR per day. Patients who do not respond to an initial daily dose of 75 mg may benefit from doses of up to 375 mg per day. The recommended initial dose for generalized anxiety disorder is 75 mg EFEXOR XR per day. Patients who do not respond to an initial daily dose of 75 mg may benefit from a maximum dose of 225 mg per day. The recommended dose of social phobia is 75 mg EFEXOR XR daily. There is no evidence that higher doses provide additional benefit. However, in patients who do not respond to an initial daily dose of 75 mg, the dose may be increased to a maximum of 225 mg per day. The recommended dose for panic disorder is 7 days, once daily 37.5 mg EFEXOR. The dose should then be increased to 75 mg per day. Patients who do not respond to 75 mg daily doza may benefit from a maximum dose of 225 mg per day.

Dose increments should be made at intervals of about 2 weeks or more, but not at shorter intervals of 4 days.

Method of Application:

EFEXOR XR is recommended to be taken with meals. Each capsule should be swallowed whole as liquid. The capsule should not be divided, crushed, chewed or mixed with water. EFEXOR XR should be taken once a day and roughly the same hours (morning or evening).

Additional information on special populations

Kidney / liver failure

Patients with renal and / or hepatic insufficiency should receive low doses of venlafaxine.

In patients with a glomerular filtration rate of 10-70 ml / min, total daily dose of venlafaxine should be reduced by 25-50%. The total daily dose of venlafaxine in hemodialysis patients should be reduced by 50%. Because clearance can change from sick person to patient, dose adjustment may be necessary according to the person.

4.4. Special use warnings and precautions

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Geriatric Population

In elderly patients, it is not advisable to adjust in usual doses only because of their age.

Continuation therapy

The dose needed to recall depression and prevent new episodes is 75 mg EFEXOR XR once daily, as in the initial treatment.

The physician should periodically evaluate the benefit of long-term venlafaxine treatment in each patient. It is generally accepted that cases of acute major depression require pharmacological treatment for several months or longer. Venlafaxine has been shown to be effective in the long-term (up to 12 months) treatment of depression. Anxiety, Social Phobia and Panic Disorder have been shown to be effective for up to 6 months.

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4.3. contraindications

EFEXOR XR is contraindicated in patients known to have hypersensitivity to either venlafaxine or any of the ingredients in the formulation.
4.4. Special use warnings and precautions

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In short-term clinical trials in children and adolescents with Major Depression and other psychiatric disorders, antidepressants increased the risk of suicidal thoughts and behaviors (suicide tendency). When considering the use of EFEXOR or any other antidepressant in children or adolescents, the defined risk and clinical need should be balanced. See the warning about suicide.

The use of antidepressants in children and young people up to the age of 24 is likely to increase suicidal thoughts or behavior. For this reason, it is necessary for the patient to be followed closely by the family, either the family or the caregivers, especially for the beginning and the first months of treatment, the unexpected change of behavior such as uneasiness the patient may show during the period of increasing / decreasing or discontinuing treatment, extreme mobility, or the possibility of suicide.

EFEXOR XR is not approved for use in pediatric patients (under the age of 18).

Some serious adverse reactions have been reported with the introduction of EFEXOR XR immediately following discontinuation of MAO inhibitors and the onset of use of MAO inhibitors immediately following the discontinuation of EFEXOR XR. Hyperthermia, seizures and death similar to tremor, nausea, vomiting, myoclonus, excessive sweating, redness, dizziness, neuroleptic malignant syndrome have been reported with MAO inhibitors and other antidepressants which are similar to venlafaxine PHARMACOLOGICAL PROPERTIES. Therefore, EFEXOR XR should not be used in conjunction with MAOI or within 14 days of discontinuation of MAOI treatment. After an EFEXOR XR has been discontinued, a MAOI must be at least 7
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The above-mentioned suggestions regarding the time interval between discontinuation of the use of MAO inhibitors and initiation of EFEXOR treatment were made by considering irreversible MAO inhibitors. The time interval between the discontinuation of the use of the reversible MAO inhibitor moclobemide and the initiation of EFEXOR treatment may be less than 14 days. However, due to the risk of the above-mentioned adverse reactions to MAO inhibitors, a sufficient time interval should be provided when switching to moclobemide EFEXOR therapy. MICROBEMIDINE A PHARMACOLOGICAL PROPERTIES and an appropriate period of decontamination should be applied considering the patient's personal assessment.

Similar interaction and adverse reactions have been reported with the combination of MAOI and selective serotonin reuptake inhibitors or tricyclic antidepressants.
8.4. Undesirable effects

Suicide is a known risk of depression and certain psychiatric disorders, and these disorders are a reporter of self-suicidal tendencies. Collective analyzes of short-term placebo-controlled trials of antidepressant drugs (SSRI and others) have shown that these drugs increase the risk of suicidal tendency in children, adolescents and young adults (18-24 years) with major depression and other psychiatric disorders. Short-term studies did not show an increased risk of suicide with antidepressants when compared with placebo in adults over 24 years of age; Compared with placebo in adults aged 65 years and older, there was a reduction in the risk of suicide by antidepressants.

Epidemiologic studies have shown an increased risk of bone marrow in patients using serotonin reuptake inhibitors, including venlafaxine. The mechanism leading to this risk has not been fully understood.

4.6. Pregnancy and lactation

General advice Pregnancy Category: C

There is not enough data on the use of venlafaxine in pregnant women.

Studies on animals have shown that reproductive toxicity exists (see section 5.3). The potential risk for humans is unknown.

Women with childbearing potential / Birth control

The reliability of venlafaxine has not been proven in the past. Venlafaxine should only be given to pregnant women if it is more than their potential risk of harm.

Pregnancy period

If venlafaxine is used as early as birth or shortly before birth, the indication for discontinuation of the newborn baby can be seen. Some infants who have been exposed to venlafaxine towards the end of the third trimester have complications that require tube feeding, respiratory support, or longer hospital stay. Such complications may occur immediately after birth.

Lactation period

Venlafaxine and O-desmethylvenlafaxine are passed on to the mother so either breastfeeding should cease or venlafaxine treatment should be discontinued. In post-marketing experiences, crying, irritability and sleep-disorder disorders have been reported in infant feeders. Symptoms continued with the cessation of venlafaxine treatment following cessation of the breastfeeding.

Reproductive ability (fertility)

Reproductive and fertility studies in rats have shown that there is no effect on male and female fertility up to 8 times the recommended daily maximum human dose based on the mg / m2 calculation, or up to 2 times oral doses.