Venlafaxine

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{{drugbox| IUPAC_name = 1- (4-methoxyphenyl)- ethylcyclohexan-1-ol| image = Venlafaxine-2D-skeletal.png| image2 = Venlafaxine-3D-balls.png| CAS_number = 93413-69-5| ATC_prefix = N06| ATC_suffix = AX16| ATC_supplemental =| PubChem = 5656| DrugBank = APRD00125| smiles = O1(CCCCC1)C(CN(C)C)c2ccc(OC)cc2| C=17 | H=27 | N=1 | O=2| molecular_weight = 277.402 g/mol| bioavailability = 45%| protein_bound = 27%| metabolism = Hepatic of the [serotonin-norepinephrine reuptake inhibitor (SNRI) class first introduced by Wyeth in 1993. It is prescribed for the treatment of clinical depression and anxiety disorders. Due to the pronounced side effects and suspicions that venlafaxine may significantly increase the risk of suicide it is not recommended as a first line treatment of depression. However, it is often effective for depression not responding to Selective serotonin reuptake inhibitors. Venlafaxine was the sixth most widely-used antidepressant based on the amount of retail prescriptions in the US (17.1 million) in 2006.

Indications Approved Venlafaxine is used primarily for the treatment of clinical depression, generalized anxiety disorder, social anxiety disorder, and panic disorder in adults.

Depression Venlafaxine was shown to be effective for depression in multiple double blind studies. Venlafaxine is similar in efficacy to trazodone and tricyclic antidepressants amitriptiline (Elavil) and imipramine and it was better tolerated than amitriptiline. Venlafaxine appears to have efficacy similar or somewhat better than sertraline (Zoloft) and fluoxetine (Prozac) depending on the criteria and rating scales used. In particular, higher doses of venlafaxine are more effective, and more patients achieved remission or were "very much improved". At the same time the efficacy was similar if the number of patients who achieved "response" or were "improved" was considered. A meta-analysis comparing venlafaxine and combined groups of SSRI or tricyclic antidepressants indicated superiority of venlafaxine. Based on the same set of criteria, venlafaxine was similar in efficacy to an atypical antidepressant bupropion (Wellbutrin); however, the remission rate was significantly lower for venlafaxine. Venlafaxine was also marginally inferior in efficacy to a newer SSRI escitalopram (Lexapro) and had twice higher frequency of the side effects, in particular, nausea, ejaculation disorder, somnolence and sweating.

Interestingly, a popular magazine Consumer Reports, which originally rated venlafaxine as the most effective among six commonly prescribed antidepressants, no longer recommends it. Fluoxetine, citalopram and bupropion have been chosen as Consumer Reports Best Buy drugs in the updated version of their guide, based upon effectiveness, safety, side effects, and cost.

Off-label / investigational uses Many doctors are starting to prescribe venlafaxine "off label" for the treatment of diabetic neuropathy (in a similar manner to duloxetine) and migraine prophylaxis (in some people, however, venlafaxine can exacerbate or cause migraines). Studies have shown venlafaxine's effectiveness for these conditions.It has also been found to reduce the severity of 'hot-flashes' in menopause women.

Substantial weight loss in patients with major depression, generalized anxiety disorder, and social phobia has been noted, but the manufacturer does not recommend use as an anorectic either alone or in combination with phentermine or other amphetamine-like drugs. Venlafaxine hydrochloride is in the phenylthylamine class of modern chemicals, which includes amphetamine, methylendioxymethamphetamine (MDMA), and methamphetamine. This chemical structure likely lends to its activating properties, however some patients find Venlafaxine highly sedating despite its more common stimulatory effects.

Venlafaxine is not approved for the treatment of depressive phases of bipolar disorder; this has some potential danger as venlafaxine can induce mania, mixed state (psychology), rapid cycling and/or psychosis in some bipolar patients, particularly if they are not also being treated with a mood stabilizer. Venlafaxine is perhaps one of the most likely of all modern antidepressants to trigger manic and hypomania states.

Due to its action on both the serotoninergic and adrenergic systems, Venlafaxine is also used as a treatment to reduce episodes of Cataplexy, a form of muscle weakness, in patients with the sleep disorder Narcolepsy. {{cite web | last = | first = | authorlink = | coauthors = | title =Medications | work = | publisher =Stanford University School of Medicine, Center for Narcolepsy | date =Revised 02/07/2003 | url =http://med.stanford.edu/school/Psychiatry/narcolepsy/medications.html | format = | doi = | accessdate =09/03/2007 -->

Contraindications Venlafaxine is not recommended in patients Hypersensitivity to venlafaxine. It should not be taken by anyone who is allergic to the inactive ingredients, which include gelatin, cellulose, ethylcellulose, iron oxide, titanium dioxide and hypromellose. It should never be used in conjunction with a monoamine oxidase inhibitor (MAOI), due to the potential to develop a potentially deadly condition known as serotonin syndrome. Caution should also be used in those with a seizure disorder. Venlafaxine is not approved for use in children or adolescents. However, Wyeth does provide information on precautions if venlafaxine is prescribed to this age group for the treatment of non-approved conditions. Studies in these age groups have not established its efficacy or safety.

Liver, Kidney and Thyroid Disorders The prescribed dosage of venlafaxine may have to be adjusted for those with liver, thyroid or kidney problems. It is crucial to inform a doctor of any such disorders before taking venlafaxine.

Glaucoma Venlafaxine can increase eye pressure, so those with glaucoma should inform their doctors before taking venlafaxine. More frequent eye checks may be necessary.

Pregnancy, labor, and delivery There are no adequate and well controlled studies with venlafaxine in pregnant women. Therefore, venlafaxine should only be used during pregnancy if clearly needed. Prospective studies have not shown any statistically significant Congenital disorder. There have, however, been some reports of self-limiting effects on newborn infants. As with other Serotonin Reuptake Inhibitors, these effects are generally short, lasting only 3 to 5 days and rarely resulting in severe complications. Use of Venlafaxine in pregnancy (like other Serotonin Reuptake Inhibitors) should be considered on a case-by-case basis.

Heart Disease and Hypertension The FDA has asked the sponsors of all SNRIs to include the potential risk for persistent pulmonary hypertension(PPHN) in prescribing data as of July 19, 2006. Medications containing Venlafaxine caused a mean heart rate increase of 4 b.p.m in clinical trials, along with a sustained increase in blood pressure in some.

Serotonin Syndrome The development of a potentially life-threatening serotonin syndrome may occur with Effexor XR treatment, particularly with concomitant use of serotonergic drugs (including SSRIs, SNRIs, and triptans) and with drugs that impair metabolism of serotonin (including MAOIs). Serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile blood pressure, hyperthermia), neuromuscular aberrations (e.g., hyperreflexia, incoordination) and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea).

Adverse effects As with most antidepressants, lack of sexual desire is a common side effect. In trials, delayed ejaculation and delayed orgasm occurred in 8-16% of men. Interestingly, delayed orgasm occurred in only 2-8% of women in trials. Venlafaxine can raise blood pressure at high doses, so it is usually not the drug of choice for persons with hypertension.

It has a higher rate of treatment emergent mania than many modern antidepressants, and many people find it to be a more activating medication (one that increases energy or wakefulness) than other antidepressants. Paradoxically, some users find it highly sedating and find that it must be taken in the evening.

There have been false positive phencyclidine (PCP) results caused by Venlafaxine with certain on-site routine urine-based drug tests.. Positive on-site results should always be sent to a qualified drug testing laboratory for confirmation before any action is taken against the employee.

Suicide Ideation/Risk The FDA requires all antidepressants, including venlafaxine, to carry a black box with a generic warning about a possible suicide risk. In addition, the most recent research indicated that patients taking venlafaxine are at increased risk of suicide.

A study conducted in Finland followed more than 15,000 patients for 3.4 years. Venlafaxine increased suicide risk 1.6-fold (statistically significant), as compared to no treatment. At the same time, fluoxetine (Prozac) halved the suicide risk.

In another study, the data on more than 200,000 cases was obtained from the UK general practice research database. The patients taking venlafaxine had significantly higher risk of completed suicide than the ones on fluoxetine (Prozac) (2.8 times) or citalopram (Celexa) (2.4 times). Even after taking into consideration the fact that venlafaxine was generally prescribed for more severe depression, venlafaxine was associated with 1.6-1.7 times more suicides than fluoxetine or citalopram. This difference was no longer statistically significant due to the rarity of completed suicides. However, for the attempted suicides (more frequent event) the 1.2-1.3 times higher risk for venlafaxine still stayed statistically significant after the adjustment.

An analysis of clinical trials by the FDA statisticians showed the incidence of suicidal behavior among the adults on venlafaxine to be not significantly different from fluoxetine or placebo. A possible explanation for this discrepancy is that suicidal patients are generally excluded from clinical trials, and so clinical trials are not quite representative of the real population of patients.

Venlafaxine is contraindicated to children, adolescents and young adults. According to the FDA analysis of clinical trials venlafaxine caused a 5-fold increase (statistically significant) of suicidal ideation and behavior in subjects younger than 25. In another analysis, venlafaxine was no better than placebo among children (7-11 years old) and improved the depression in adolescents (12-17 years old). However, in both groups hostility and suicidal behavior were increased in comparison to the placebo treatment.

Serotonin Syndrome Another risk is serotonin syndrome. This is a rare but serious side effect that can be caused by interactions with other central nervous system depressant drugs, and is potentially fatal. This risk necessitates clear information to patients and proper medical history. For example, the drug abuse by at-risk patients of certain non-prescription drugs can cause this serious effect, and emphasizes the importance of good medical history sharing between general practitioners and psychiatrists, as both may prescribe venlafaxine. Involvement of family in awareness of risk factors is highlighted in Wyeth information sheets on Effexor.

Common side effects NOTE: The percentage of occurrences for each side effect listed comes from clinical trial data provided by Wyeth Pharmaceuticals Inc. The percentages indicate the percentage of people that experienced the side effect in clinical trials.

Nausea (21-35%)
Headache (34%)
Apathy
Constipation
Ongoing Irritable Bowel Syndrome
Dizziness (11-20%)
Fatigue (physical)
Insomnia (15-23%)
Vertigo (medical)
Dry mouth (12-16%)
Sexual dysfunction (14-34%)
Sweating (10-14%)
Vivid dreams (3-7%)
Impulsive Actions
Increased blood pressure
Decreased Appetite (8-20%)
Electric shock-like sensations also called "Brain zaps"
Increased anxiety at the start of treatment
Akathisia (Agitation) (3-4%)
Memory Loss

Less common to rare side-effects Note 'Rare' adverse effects occur in fewer than 1 in 1000 patients. 'Infrequent' adverse effects occur in 1 in 100 to 1 in 1000 patients.

Cardiac arrhythmia
Increased serum cholesterol
Gas or stomach pain
Abnormal vision
Akathisia
Panic Attacks
Depressed feelings
suicidal ideation
Confusion
Neuroleptic malignant syndrome
Loss of appetite
Tremor
Drowsiness
Allergic skin reactions
External bleeding
Serious bone marrow damage (thrombocytopenia, agranulocytosis)
Hepatitis
Pancreatitis
Seizure
Tardive dyskinesia
Difficulty swallowing
Psychosis
Hair Loss
Hostility
Activation of mania/hypomania.
Weight Loss (of concern when treating patients suffering from anorexia nervosa)
Weight gain (effect not clear, but of concern when treating people who may have Body Dysmorphic Disorder).
Homicidal Thoughts
Aggression
Depersonalization
Visual Hallucinations
Swollen and/or bleeding gums

Dose dependency of adverse events A comparison of adverse event rates in a fixed-dose study comparing venlafaxine 75, 225, and 375 mg/day with placebo revealed a dose dependency for some of the more common adverse events associated with venlafaxine use. The rule for including events was to enumerate those that occurred at an incidence of 5% or more for at least one of the venlafaxine groups and for which the incidence was at least twice the placebo incidence for at least one venlafaxine group. Tests for potential dose relationships for these events (Cochran-Armitage Test, with a criterion of exact 2-sided p-value

Venlafaxine ( Effexor, Efexor )
Pharmacological effects of venlafaxine, given repeatedly, on the alpha 1-adrenergic, dopamine and serotonin systems.

Venlafaxine ( Effexor )
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Venlafaxine - Wikipedia, the free encyclopedia
Venlafaxine (Effexor, Efexor) is an antidepressant of the serotonin-norepinephrine reuptake inhibitor (SNRI) class first introduced by Wyeth in 1993.

Venlafaxine
Venlafaxine - Type of medicine Antidepressants Used for Depression Also called Efexor Available as Tablets and modified release capsules

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Efexor XL capsules contain the active ingredient venlafaxine hydrochloride, which is a type of antidepressant known as a serotonin and noradrenaline reuptake inhibitor (SNRI).

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