Pristiq (Desvenlafaxine Extended-Release Tablets) Drug Information: Description, User Reviews, Drug Side Effects, Interactions

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January 1, 2012

Pristiq

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Depressive disorders have been with mankind since the beginning of recorded history. In the Bible, King David, as well as Job, suffered from this affliction. Hippocrates referred to depression as melancholia, which literally means black bile. Black bile, along with blood, phlegm, and yellow bile were the four humors (fluids) that described the basic medical physiology theory of that time. Depression, also referred to as clinical depression, has been portrayed in literature and the arts for hundreds of years, but what do we mean today when we refer to a depressive disorder? In the 19th century, depression was seen as an inherited weakness of temperament. In the first half of the 20th century, Freud linked the development of depression to guilt and conflict. John Cheever, the author and a modern sufferer of depressive disorder, wrote of conflict and experiences with his parents as influencing his development of depression.

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Pristiq

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PRISTIQ®
(desvenlafaxine) Extended-Release Tablets, oral

WARNING: SUICIDALITY AND ANTIDEPRESSANT DRUGS

Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of Major Depressive Disorder (MDD) and other psychiatric disorders. Anyone considering the use of PRISTIQ® (desvenlafaxine extended-release tablets) or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and 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. PRISTIQ (desvenlafaxine extended-release tablets) is not approved for use in pediatric patients [see WARNINGS AND PRECAUTIONS, Use in Specific Populations, and PATIENT INFORMATION].

DRUG DESCRIPTION

PRISTIQ is an extended-release tablet for oral administration that contains desvenlafaxine succinate, a structurally novel SNRI for the treatment of MDD. Desvenlafaxine (O-desmethylvenlafaxine) is the major active metabolite of the antidepressant venlafaxine, a medication used to treat major depressive, generalized anxiety, social anxiety and panic disorders.

Desvenlafaxine is designated RS-4-[2-dimethylamino-1 -(1 -hydroxycyclohexyl) ethyl] phenol and has the empirical formula of C₁₆H₂₅NO₂ (free base) and C₁₆H₂₅NO₂•C₄H₆O₄•H₂O (succinate monohydrate). Desvenlafaxine succinate monohydrate has a molecular weight of 399.48. The structural formula is shown below.

PRISTIQ®
(desvenlafaxine) Structural Formula Illustration

Desvenlafaxine succinate is a white to off-white powder that is soluble in water. The solubility of desvenlafaxine succinate is pH dependent. Its octanol: aqueous system (at pH 7.0) partition coefficient is 0.21.

PRISTIQ (desvenlafaxine extended-release tablets) is formulated as an extended-release tablet for once-a-day oral administration.

Each tablet contains 76 or 152 mg of desvenlafaxine succinate equivalent to 50 or 100 mg of desvenlafaxine, respectively.

Inactive ingredients for the 50 mg tablet consist of hypromellose, microcrystalline cellulose, talc, magnesium stearate and film coating, which consists of polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, and iron oxides.

Inactive ingredients for the 100 mg tablet consist of hypromellose, microcrystalline cellulose, talc, magnesium stearate and film coating, which consists of polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, iron oxide and FD&C yellow #6.

What are the possible side effects of desvenlafaxine (Pristiq)?

Get emergency medical help if you have any of these signs of an allergic reaction: skin rash or hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Contact your doctor promptly if you have any of the following side effects, especially if they are new symptoms or if they get worse: mood changes, anxiety, panic attacks, trouble sleeping, irritability, agitation, aggressiveness, severe restlessness, mania (mental and/or physical hyperactivity), thoughts of suicide or hurting yourself.

Call your doctor at once...

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What are the precautions when taking desvenlafaxine extended-release tablets (Pristiq)?

Before taking desvenlafaxine, tell your doctor or pharmacist if you are allergic to it; or to venlafaxine; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: personal or family history of psychiatric disorders (e.g., bipolar/manic-depressive disorder), personal or family history of suicide attempts, bleeding problems, glaucoma, high blood pressure, heart problems (such as chest pain, heart failure, heart attack), history of stroke, high cholesterol, kidney disease, liver disease, seizure disorder, low sodium in the blood (hyponatremia).

This drug may...

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Last reviewed on RxList: 4/29/2011
This monograph has been modified to include the generic and brand name in many instances.