Desvenlafaxine

What is Desvenlafaxine?

• Desvenlafaxine (Pristiq) a selective serotonin and norepinephrine reuptake inhibitor (SNRI) used for the treatment of major depressive disorder.

Desvenlafaxine

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What are the uses of this medicine?

• Desvenlafaxine (Pristiq) is a prescription medicine used to treat depression. PRISTIQ belongs to a class of medicines known as SNRIs (or serotonin-norepinephrine reuptake inhibitors).

How does this medicine work?

• Desvenlafaxine is a selective reuptake inhibitor of serotonin and norepinephrine due to its high binding affinities to the pre-synaptic serotonin and norepinephrine transporters.
• By blocking both transporters, this agent prolongs neurotransmitter activities of both serotonin and norepinephrine, thereby alleviating depressive state.

Who Should Not Use this medicine ?

This medicine cannot be used in patients:

• are allergic to desvenlafaxine, venlafaxine or any of the ingredients in PRISTIQ.
• currently take or have taken within the last 14 days, any medicine known as an MAOI. Taking an MAOI with certain other medicines, including PRISTIQ, can cause serious or even life-threatening side effects. Also, you must wait at least 7 days after you stop taking PRISTIQ before you take any MAOI.

What drug interactions can this medicine cause?

• PRISTIQ contains the medicine desvenlafaxine. Do not take PRISTIQ with other medicines containing venlafaxine or desvenlafaxine.
• Rare, but potentially life-threatening, conditions called serotonin syndrome or Neuroleptic Malignant Syndrome (NMS)-like reactions can happen when medicines such as PRISTIQ are taken with certain other medicines. Serotonin syndrome or NMS-like reactions can cause serious changes in how your brain, muscles, heart and blood vessels, and digestive system work.

Especially tell your healthcare provider if you take the following:

• medicines to treat migraine headaches known as triptans
• medicines used to treat mood, anxiety, psychotic, or thought disorders, including tricyclics, lithium, selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), antipsychotic drugs, or other dopamine antagonists, such as metoclopramide
• silbutramine
• tramadol
• St. John's Wort
• MAOIs (including linezolid, an antibiotic)
• tryptophan supplements

Is this medicine FDA approved?

• Desvenlafaxine was approved for medical use in the United States in 2008.

How should this medicine be used?

Recommended dosage:

• 50 mg once daily with or without food.
• There was no evidence that doses greater than 50 mg/day confer any additional benefit.
• When discontinuing treatment, gradual dose reduction is recommended whenever possible.

Renal Impairment:

• The recommended dose in patients with moderate renal impairment is 50 mg/day.
• The recommended dose in patients with severe renal impairment and end-stage renal disease (ESRD) is 50 mg every other day.
• The dose should not be escalated in patients with moderate or severe renal impairment or ESRD.

Hepatic Impairment:

• Dose escalation above 100 mg/day is not recommended.

Administration:

• Take PRISTIQ at about the same time each day.
• PRISTIQ may be taken either with or without food.
• Swallow PRISTIQ tablets whole, with fluid. Do not crush, cut, chew, or dissolve PRISTIQ tablets because the tablets are time-released.
• When you take PRISTIQ, you may see something in your stool that looks like a tablet. This is the empty shell from the tablet after the medicine has been absorbed by your body.
• It is common for antidepressant medicines such as PRISTIQ to take several weeks before you start to feel better. Do not stop taking PRISTIQ if you do not feel results right away.
• Do not stop taking or change the dose of PRISTIQ without talking with your healthcare provider, even if you feel better.
• Talk with your healthcare provider about how long you should use PRISTIQ. Take PRISTIQ for as long as your healthcare provider tells you to.
• If you miss a dose of PRISTIQ, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose. Do not try to “make up” for the missed dose by taking two doses at the same time.
• Do not take more PRISTIQ than prescribed by your healthcare provider. If you take more PRISTIQ than the amount prescribed, contact your healthcare provider right away.
• In case of an overdose of PRISTIQ, call your healthcare provider or poison control center, or go to the emergency room right away.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As 50 and 100 mg tablets containing 76 mg or 152 mg of desvenlafaxine succinate equivalent to 50 mg or 100 mg of desvenlafaxine.

This medicine is available in fallowing brand namesː

• PRISTIQ

What side effects can this medication cause?

The most common side effects of this medicine include:

• nausea
• tiredness
• headache
• diarrhea
• dry mouth
• vomiting
• sweating
• anxiety
• dizziness
• tremor
• insomnia
• dilated pupils
• constipation
• decreased sex drive
• loss of appetite
• delayed orgasm and ejaculation
• sleepiness
• feeling that your surroundings are spinning or moving

PRISTIQ may also cause other serious side effects, including:

• hypertension
• Abnormal bleeding or bruising
• Glaucoma
• Increased cholesterol and triglyceride levels in your blood
• Symptoms when stopping PRISTIQ (discontinuation symptoms)
• Seizures (convulsions)
• Low sodium levels in your blood
• Allergic reactions

What special precautions should I follow?

• Patients with major depressive disorder (MDD), both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior, whether or not they are taking antidepressant medications, and this risk may persist until significant remission occurs. Monitor for clinical worsening and suicide risk.
• The development of a potentially life-threatening serotonin syndrome or Neuroleptic Malignant Syndrome (NMS)-like reactions have been reported with SNRIs and SSRIs alone, including PRISTIQ. Discontinue PRISTIQ and initiate supportive treatment.
• Patients receiving PRISTIQ should have regular monitoring of blood pressure since increases in blood pressure. Hypertension should be controlled before initiating treatment. Monitor blood pressure regularly during treatment.
• SSRIs and SNRIs, including PRISTIQ, may increase the risk of bleeding events. Patients should be cautioned about the risk of bleeding associated with the concomitant use of PRISTIQ and NSAIDs, aspirin, or other drugs that affect coagulation.
• Mydriasis has occurred with PRISTIQ. Patients with raised intraocular pressure or those at risk of angle-closure glaucoma should be monitored.
• Use cautiously in patients with Bipolar Disorder. Caution patients about the risk of activation of mania/hypomania.
• Use cautiously in patients with cardiovascular or cerebrovascular disease.
• Dose-related elevations in fasting serum total cholesterol, LDL (low density lipoprotein) cholesterol, and triglycerides were observed in the controlled studies. Use cautiously in patients with lipid metabolism disorders. Consider monitoring serum cholesterol and triglyceride.
• Discontinuation symptoms have been systematically and prospectively evaluated in patients treated with PRISTIQ. Taper the dose when possible and monitor for discontinuation symptoms.
• In patients with moderate or severe renal impairment or end-stage renal disease (ESRD) the clearance of PRISTIQ was decreased, thus prolonging the elimination half-life of the drug. Dosage adjustment is necessary in severe and ESRD. In moderate renal impairment, the dose should not exceed 50 mg/day.
• Cases of seizure have been reported in pre-marketing clinical studies with PRISTIQ. Use cautiously in patients with seizure disorder.
• Hyponatremia may occur as a result of treatment with SSRIs and SNRIs, including PRISTIQ.
• Products containing desvenlafaxine and products containing venlafaxine should not be used concomitantly with PRISTIQ.
• Interstitial lung disease and eosinophilic pneumonia associated with venlafaxine (the parent drug of PRISTIQ) therapy have been rarely reported. Such patients should undergo a prompt medical evaluation, and discontinuation of PRISTIQ should be considered.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• headache, vomiting, agitation, dizziness, nausea, constipation, diarrhea, dry mouth, paresthesia, and tachycardia

Treatment of overdosage:

• In case of overdosage, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions or effects and appropriate symptomatic treatment instituted immediately.

Can this medicine be used in pregnancy?

• It is not known if PRISTIQ will harm your unborn baby.
• There are no adequate and well-controlled studies of PRISTIQ in pregnant women.
• Therefore, PRISTIQ should be used during pregnancy only if the potential benefits justify the potential risks.

Can this medicine be used in children?

• Safety and effectiveness in the pediatric population have not been established.

What are the active and inactive ingredients in this medicine?

• Active ingredient: desvenlafaxine
• Inactive ingredients: For the 50 mg tablet, hypromellose, microcrystalline cellulose, talc, magnesium stearate and film coating, which consists of polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, and iron oxides.
• For the 100 mg tablet, hypromellose, microcrystalline cellulose, talc, magnesium stearate, a film coating which consists of polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, iron oxide and FD&C yellow #6.

Who manufactures and distributes this medicine?

Distributed by:

• Physicians Total Care, Inc.
• Tulsa, Oklahoma

What should I know about storage and disposal of this medication?

• Store PRISTIQ at 68° to 77°F (20° to 25°C).
• Do not use PRISTIQ after the expiration date (EXP), which is on the container. The expiration date refers to the last day of that month.
• Keep PRISTIQ and all medicines out of the reach of children.

• Dailymed label info on Desvenlafaxine
• FDA Desvenlafaxine

Desvenlafaxine Resources
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The following are antidepressant subclasses and drugs

MAO Inhibitors Isocarboxazid, Phenelzine, Tranylcypromine

SNRIs Duloxetine, Levomilnacipran, Venlafaxine

SSRIs Citalopram, Escitalopram, Fluoxetine, Fluvoxamine, Paroxetine, Sertraline, Vilazodone, Vortioxetine

Tricyclics Amitriptyline, Amoxapine, Clomipramine, Desipramine, Doxepin, Imipramine, Nortriptyline, Protriptyline, Trimipramine

Miscellaneous Bupropion, Flibanserin, Mirtazapine, Nefazodone, Trazodone