Classification: Serotonin norepinephrine reuptake inhibitor (SNRI).

Common Usage: Venlafaxine is indicated for the adult treatment of major depressive disorder (MDD), generalized anxiety disorder (GAD), social anxiety disorder/social phobia, and panic disorder with or without agoraphobia.

Warnings and Precautions:

Clinical worsening and suicide risk: Antidepressants may increase suicidal thoughts or behavior in some children, adolescents, and young adults, especially during the first few months of treatment or when changing the dose. No increased risk for these events has been shown for adults over 24 years of age, and the risk is decreased for adults over 65 years of age. All patients starting treatment with antidepressants should be monitored and observed closely for new or worsening symptoms of depression, suicidal thoughts or behavior, or unusual changes in behavior.

Bipolar disorder: Before starting antidepressant treatment, patients should be screened for bipolar disorder. Venlafaxine is not approved for treating bipolar depression.

Serotonin syndrome: Potentially life-threatening serotonin syndrome or neuroleptic malignant syndrome (NMS)-like reactions may occur when venlafaxine is taken with other SNRIs or selective serotonin reuptake inhibitors (SSRIs), certain headache or migraine medications (triptans) or tryptophan, and drugs that impair metabolism of serotonin, including monoamine oxidase inhibitors (MAOIs). Your doctor should be notified if you develop one or more of the following: restlessness, hallucinations (seeing, hearing, feeling, or tasting something that is not actually there), loss of coordination, very rapid heartbeat, very high fever, muscle stiffness, increased or irregular blood pressure, diarrhea, nausea, vomiting, confusion, or coma.

Hypertension (high blood pressure): Venlafaxine may raise blood pressure in some patients. Your blood pressure should be under control before starting venlafaxine and should be checked regularly during venlafaxine treatment.

Mydriasis (prolonged dilation of the pupils of the eye): This has occurred in some patients taking venlafaxine. Tell your doctor before starting venlafaxine if you have a history of glaucoma or increased eye pressure.

Hyponatremia: Low sodium levels in the blood can occur when taking SNRIs or SSRIs. Contact your doctor right away if you become severely ill and have any of the following symptoms: headache, feeling weak, confusion, problems concentrating, memory problems, or feeling unsteady. In more severe or acute cases, hallucinations, fainting, seizures, coma, respiratory arrest, or death may occur.

Seizures: Venlafaxine should be used cautiously in patients with a history of seizures and should be discontinued if seizures occur.

Cholesterol levels: Measuring serum cholesterol levels should be considered during long-term venlafaxine treatment.

Cardiac risk: Venlafaxine should be used cautiously in patients with risk factors for a disturbance of the electrical activity of the heart known as QTc prolongation, or in patients concomitantly using other drugs that prolong the QTc interval.

Special Populations:

Pregnancy and nursing: Tell your doctor if you are pregnant, planning pregnancy, breastfeeding, or planning to breastfeed, as the potential benefits of venlafaxine must be weighed against the possible risks to the unborn child or infant.

Geriatrics: Elderly patients may be at greater risk of developing hyponatremia when taking SNRIs, such as venlafaxine, or SSRIs.

Pediatrics: Venlafaxine is not approved for patients younger than 18 years.

Common Side Effects: The most commonly reported side effects in clinical trials include constipation, dizziness, dry mouth, insomnia, loss of appetite, nausea, nervousness, sexual side effects, sleepiness, sweating, and weakness.

This is not a complete list of all known or potential adverse effects. Notify your prescriber or pharmacist of any symptoms that have started since you began taking this medication, changing its dose, or adding or changing other medication or diet. Take care when performing any task (such as driving a car or operating machinery) that requires your attention until you have experience with this drug and are confident you can perform the task safely.

Interactions with Other Medications:

Contraindications: Do not take venlafaxine if you are taking an MAOI, or within at least 14 days after stopping an MAOI. Allow at least 7 days before stopping venlafaxine and starting an MAOI. MAOIs include phenelzine (Nardil), tranylcypromine (Parnate), isocarboxazid (Marplan), selegiline (Eldepryl), and the antibiotic linezolid (Zyvox).

Abnormal bleeding: Taking SNRIs, such as venlafaxine, or SSRIs may increase the risk of abnormal bleeding. Taking aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen (Advil), aspirin, other blood thinners, or drugs that affect blood clotting such as warfarin (Coumadin) at the same time as SNRIs or SSRIs may add to the risk. Patients taking warfarin should be carefully monitored when starting or stopping SNRIs or SSRIs.

Caution is advised when using venlafaxine with triptans such as almotriptan (Axert) or sumatriptan (Imitrex); other SNRIs; SSRIs such as fluoxetine (Prozac); lithium; St. John’s wort; methylene blue; cimetidine (Tagamet); antipsychotics such as haloperidol (Haldol) or risperidone (Risperdal); other central nervous system (CNS) drugs; metoprolol (Lopressor); or ketoconazole (Nizoral). Avoid drinking alcohol while taking venlafaxine.

This is not a complete list of all known or potential drug interactions. To help prevent problems, always make sure that your pharmacist and all prescribers know about all medications you are taking, including over-the-counter drugs; dietary herbal supplements; folk or home remedies; or unusual foods, drinks, or dietary habits.

Common Dosages: Effexor XR should be taken with food in a single dose in the morning or evening at approximately the same time each day. Capsules should be swallowed whole and not divided, crushed, chewed, or placed in water. It can also be taken by carefully opening the capsule and sprinkling the contents on a spoonful of applesauce, and then swallowed immediately without chewing, followed by drinking a glass of water to make sure all the medication is swallowed.

MDD: The recommended starting dose for most patients is 75 mg/day in a single dose. Dose increases should be in increments of up to 75 mg/day, as needed, at intervals of not less than 4 days. Some patients may benefit from a lower starting dose of 37.5 mg/day for 4 to 7 days before increasing the dose to 75 mg/day. The maximum recommended daily dose is approximately 225 mg. It is not known whether higher doses are needed for severely depressed patients, and very little is known about Effexor XR at doses higher than 225 mg/day.

GAD: The recommended starting dose for most patients is 75 mg/day in a single dose. Dose increases should be in increments of up to 75 mg/day, as needed, at intervals of not less than 4 days. Some patients may benefit from a lower starting dose of 37.5 mg/day for 4 to 7 days before increasing the dose to 75 mg/day. The maximum recommended daily dose is approximately 225 mg.

Social anxiety disorder/social phobia: The recommended dose is 75 mg/day in a single dose. There is no evidence that higher doses provide any additional benefit.

Panic disorder: The recommended starting dose is 37.5 mg/day for 7 days. Dose increases should be in increments of up to 75 mg/day at intervals of not less than 7 days, to a maximum of approximately 225 mg/day if needed.

In patients with mild to moderate hepatic (liver) impairment, the total daily dose should be reduced by 50%. In some cases, it may be necessary to reduce the dose by even more than 50%, and individualization may be desirable in some patients. In patients with renal (kidney) impairment, including patients undergoing hemodialysis, it is recommended that the daily dose be reduced by 50%.

Pregnancy: Tapering the dose may be considered during the third trimester.

Geriatrics: No dose adjustments are recommended based solely on age. When individualizing the dose, extra care should be taken when increasing the dose.

Discontinuing venlafaxine should be done gradually, whenever possible. If intolerable symptoms develop during discontinuation, then resuming the previous dose may be considered, followed by gradual discontinuation at a slower rate.

Identification: Effexor XR extended-release capsules are supplied as follows:

  • 37.5 mg: gray cap/peach body with “W” and “Effexor XR” on the cap and “37.5” on the body.
  • 75 mg: peach cap and body with “W” and “Effexor XR” on the cap and “75” on the body.
  • 150 mg: dark orange cap and body with “W” and “Effexor XR” on the cap and “150” on the body.

Storage: Store this medication at controlled room temperature (59°F to 86°F) in a tightly closed, child-, light-, and moisture-resistant container. If you have difficulty opening child-resistant containers, your pharmacist can provide you with a container that is easier to open. Keep the medication out of direct sunlight and avoid storing it in a warm and humid area, such as the bathroom or kitchen, to avoid deterioration. To prevent accidental poisoning, keep all medications out of the reach of children or adults with dementia. Do not take expired medication. Do not transfer medication from one container to another. Carefully discard discontinued medication where children, pets, or adults with dementia cannot find it.

For more information: www.effexor.com