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Effexor® is NOT approved for use in pediatric patients.

Also see:  Celexa  Elavil  Fluoxetine  Lexapro  Paxil  Paxil CR  Prozac  Remeron   Zoloft   Cymbalta

Drug Uses
Effexor XR is a potent inhibitor of the reuptake of serotonin and norepinephrine-two neurotransmitters thought to play important roles in the pathophysiology of depression. Correcting the imbalance of these two chemicals may help relieve symptoms of depression.

How Taken
Effexor XR comes as a capsule to take by mouth. It is usually taken once a day and should be taken with food. Each capsule should be swallowed whole with fluid and not divided, crushed, chewed, or placed in water, or it may be administered by carefully opening the capsule and sprinkling the entire contents on a spoonful of applesauce. This drug/food mixture should be swallowed immediately without chewing and followed with a glass of water to ensure complete swallowing of the pellets.

Warnings/Precautions
Before starting Effexor XR, tell your doctor about any medicines you're taking, including over-the-counter drugs and herbal supplements. If you take MAOIs you should not take Effexor XR. If you are taking antidepressants you should be watched closely for signs that your condition is getting worse or that you are becoming suicidal, especially when you first start therapy, or when your dose is increased or decreased. You should also be watched for becoming agitated, irritable, hostile, impulsive, or restless. Such symptoms should be reported to your doctor right away. Effexor XR may raise blood pressure in some patients, so blood pressure should be monitored regularly. When you suddenly stop using or quickly lower your daily dose of Effexor XR, discontinuation symptoms may occur. Talk to your doctor before discontinuing or reducing your dose of Effexor XR. Pregnant or nursing women shouldn't take any antidepressant without consulting their doctor. Until you see how Effexor XR affects you, be careful doing such activities as driving a car or operating machinery. Avoid drinking alcohol while taking Effexor XR.

Missed Dose
Take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and take only the next one as directed. Do not take a double dose of this medication.

Possible Side Effects
If you experience any of the following serious side effects, stop taking Effexor XR and contact your doctor immediately or seek emergency medical treatment: an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives); seizures; or an irregular heartbeat or severely high blood pressure (blurred vision, headache). Other, less serious side effects may be more likely to occur. Continue to take Effexor XR and talk to your doctor if you experience nausea, vomiting, upset stomach, abdominal pain, or loss of appetite or weight; dry mouth; drowsiness or dizziness; mild tremor, anxiety, or agitation; insomnia; abnormal dreams; sexual problems such as impotence, abnormal ejaculation, difficulty reaching orgasm, or decreased libido; sweating; yawning; or increase in blood cholesterol levels (detected by blood tests); Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

Storage
Store Effexor XR at room temperature (68F to 77F or 20C to 25C). Keep Effexor XR away from children.

Overdose
Seek emergency medical attention if an overdose is suspected. Symptoms of an Effexor XR overdose may include dizziness, drowsiness, numbness, nausea, irregular heartbeats, seizures, and unconsciousness.

More Information
Use caution when driving, operating machinery, or performing other hazardous activities. Effexor XR may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities. Use alcohol cautiously. Alcohol may increase drowsiness, dizziness, and confusion Do not stop taking Effexor XR without first talking to your doctor. Your doctor may need to gradually reduce the dose before stopping the medication completely. Stopping the medication suddenly may cause unpleasant side effects to occur.

Effexor XR is an extended-release capsule for oral administration that contains venlafaxine hydrochloride, a structurally novel antidepressant. It is designated

(R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or

(±)-1-[α- [(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride

and has the empirical formula of C17H27NO2HCl. Its molecular weight is 313.87.

Venlafaxine hydrochloride is a white to off-white crystalline solid with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43.

Effexor XR is formulated as an extended-release capsule for once-a-day oral administration. Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH dependent. Capsules contain venlafaxine hydrochloride equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of cellulose, ethylcellulose, gelatin, hypromellose, iron oxide, and titanium dioxide.
 

Suicidality in Children and Adolescents

Antidepressants increased the risk of suicidal thinking and behavior (suicidality) in short-term studies in children and adolescents with Major Depressive Disorder (MDD) and other psychiatric disorders. Anyone considering the use of Effexor XR or any other antidepressant in a child or adolescent must balance this risk with the clinical need. Patients who are started on therapy should be observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Effexor XR is not approved for use in pediatric patients. (See WARNINGS and PRECAUTIONS, Pediatric Use.)

Pooled analyses of short-term (4 to 16 weeks) placebo-controlled trials of 9 antidepressant drugs (SSRIs and others) in children and adolescents with major depressive disorder (MDD, obsessive compulsive disorder (OCD), or other psychiatric disorders (a total of 24 trials involving over 4400 patients) have revealed a greater risk of adverse events representing suicidal thinking or behavior (suicidality) during the first few months of treatment in those receiving antidepressants. The average risk of such events in patients receiving antidepressants was 4%, twice the placebo risk of 2%. No suicides occurred in these trials.