Pristiq

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...

Read All Potential Side Effects and See Pictures of Pristiq »

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...

Read All Potential Precautions of Pristiq »


Pristiq Consumer (continued)

SIDE EFFECTS: See also Warning section.

Drowsiness, dizziness, nausea, dry mouth, constipation, loss of appetite, weight loss, blurred vision, nervousness, trouble sleeping, or excessive sweating may occur. If any of these effects persist or worsen, tell your doctor promptly.

Desvenlafaxine may increase blood pressure. Your blood pressure should be checked regularly while you are taking this medication.

An empty tablet shell may appear in your stool. This is harmless.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: severe/pounding headache, shakiness (tremor), decreased interest in sex, changes in sexual ability.

Tell your doctor immediately if any of these rare but very serious side effects occur: chest pain, persistent cough, shortness of breath, black/tarry stools, vomit that looks like coffee grounds, easy bruising/bleeding, seizures, change in the amount of urine.

This medication may rarely cause a very serious condition called serotonin syndrome. The risk increases when this medication is used with certain other drugs such as "triptans" used to treat migraine headaches (e.g., sumatriptan, eletriptan), certain antidepressants including SSRIs (e.g., citalopram, paroxetine) and other SNRIs (e.g., duloxetine), lithium, tramadol, tryptophan, or a certain drug to treat obesity (sibutramine). See also Drug Interactions section. Before taking this drug, tell your doctor if you take any of these medications. Serotonin syndrome may be more likely when you start or increase the dose of any of these medications. Seek immediate medical attention if you develop some of the following symptoms: hallucinations, restlessness, loss of coordination, fast heartbeat, severe dizziness, unexplained fever, severe nausea/vomiting/diarrhea, twitchy muscles.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: 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 make you dizzy or drowsy or cause blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Avoid alcoholic beverages.

Kidney function declines as you grow older. This medication is removed by the kidneys. Therefore, older adults may be at greater risk for side effects (e.g., bleeding) while using this drug. The elderly are more likely to lose too much salt (hyponatremia), especially if they are also taking "water pills" (diuretics) with this medication.

Based on information for a similar drug (venlafaxine), this drug may affect growth rate in children. Therefore, caution is advised if this drug is used in children. Monitor your child's height and growth rate. Consult your doctor or pharmacist for more details.

Use this medication only when clearly needed during pregnancy. It may harm an unborn baby. Also, babies born to mothers who have used this drug during the last 3 months of pregnancy may infrequently develop withdrawal symptoms such as feeding/breathing difficulties, seizures, muscle stiffness, or constant crying. If you notice any of these symptoms in your newborn, tell the doctor promptly.

Since untreated depression can be a serious condition, do not stop taking this medication unless directed by your doctor. If you are planning pregnancy, become pregnant, or think you may be pregnant, immediately discuss the benefits and risks of using this medication during pregnancy with your doctor.

This drug passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.


Pristiq Patient Information Including Side Effects

Brand Names: Pristiq

Generic Name: desvenlafaxine (Pronunciation: des VEN la FAX een)

  • What is desvenlafaxine (Pristiq)?
  • What are the possible side effects of desvenlafaxine (Pristiq)?
  • What is the most important information I should know about desvenlafaxine (Pristiq)?
  • What should I discuss with my healthcare provider before taking desvenlafaxine (Pristiq)?
  • How should I take desvenlafaxine (Pristiq)?
  • What happens if I miss a dose (Pristiq)?
  • What happens if I overdose (Pristiq)?
  • What should I avoid while taking desvenlafaxine (Pristiq)?
  • What other drugs will affect desvenlafaxine (Pristiq)?
  • Where can I get more information?

What is desvenlafaxine (Pristiq)?

Desvenlafaxine is an antidepressant in a group of drugs called selective serotonin and norepinephrine reuptake inhibitors (SNRIs). Desvenlafaxine affects chemicals in the brain that may become unbalanced and cause depression.

Desvenlafaxine is used to treat major depressive disorder.

Desvenlafaxine may also be used for other purposes not listed in this medication guide.

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 if you have any of these serious side effects:

  • seizure (convulsions);
  • very stiff (rigid) muscles, high fever, sweating, fast or uneven heartbeats, tremors, overactive reflexes;
  • restlessness, nausea, vomiting, diarrhea, loss of coordination;
  • blurred vision, eye pain, or seeing halos around lights;
  • cough, chest tightness, trouble breathing;
  • easy bruising or bleeding (nosebleeds, bleeding gums), coughing up blood; or
  • headache, trouble concentrating, memory problems, weakness, confusion, hallucinations, fainting, seizure, shallow breathing or breathing that stops.

Less serious side effects may include:

  • dizziness, drowsiness, tired feeling;
  • dry mouth, loss of appetite;
  • constipation;
  • sleep problems (insomnia);
  • mild headache; or
  • decreased sex drive, impotence, or difficulty having an orgasm.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about desvenlafaxine (Pristiq)?

Do not take this medication if you are allergic to desvenlafaxine or venlafaxine (Effexor), or if you are also using a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate). You must wait at least 14 days after stopping an MAOI before you can take desvenlafaxine. After you stop taking desvenlafaxine, you must wait at least 7 days before you start taking an MAOI.

You should not take desvenlafaxine together with venlafaxine (Effexor).

You may have thoughts about suicide when you first start taking an antidepressant, especially if you are younger than 24 years old. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.

Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Avoid drinking alcohol, which can increase some of the side effects of desvenlafaxine.

It may take several weeks or more for your symptoms to improve. For best results, keep using the medication as directed. Do not stop using desvenlafaxine without first talking to your doctor. You may have unpleasant side effects if you stop taking this medication suddenly.

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