Desvenlafaxine Succinate Er (desvenlafaxine succinate)

Dosage of desvenlafaxine succinate is expressed in terms of desvenlafaxine.

Desvenlafaxine and desvenlafaxine succinate are administered orally and are available as extended-release tablets.

Administer desvenlafaxine and desvenlafaxine succinate with or without food at approximately the same time each day. Extended-release tablets should be swallowed whole with fluid and should not be divided, crushed, chewed, or dissolved.

Store at 20-25oC (excursions permitted between 15-30oC).

No dosing information is available for this tab.

No dosing information is available for this tab.

Desvenlafaxine is principally metabolized by uridine diphosphoglucuronosyltransferase (UGT) isoenzymes and, to a lesser extent, by cytochrome P-450 (CYP) 3A4 isoenzyme. The drug does not inhibit CYP1A2, 2A6, 2C8, 2C9, 2C19, or 2D6 isoenzymes. Desvenlafaxine is not an inhibitor or inducer of CYP3A4.

Desvenlafaxine is not a substrate or an inhibitor of the P-glycoprotein transporter in vitro.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

*Known hypersensitivity to desvenlafaxine, venlafaxine hydrochloride, or any ingredient in the formulation.

*Concurrent or recent (i.e., within 14 days) therapy with a monoamine oxidase inhibitor (MAOI) intended to treat psychiatric disorders. Use of an MAOI intended to treat psychiatric disorders within 7 days of desvenlafaxine discontinuance.

*Initiation of desvenlafaxine therapy in patients receiving MAOIs such as linezolid or IV methylene blue.

There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

There are no moderate contraindications for this drug.

Adverse effects reported in at least 5% of patients with major depressive disorder receiving desvenlafaxine (50 or 100 mg daily) and at an incidence of at least twice that reported with placebo in short-term clinical studies include nausea, dizziness, insomnia, hyperhidrosis, constipation, somnolence, decreased appetite, anxiety, and sexual function disorders in males.

There are no severe adverse reactions for this drug.

There are no less severe adverse reactions for this drug.

No enhanced messaging available.

Safety and effectiveness of desvenlafaxine for major depressive disorder in pediatric patients younger than 18 years of age have not been established. Desvenlafaxine failed to demonstrate efficacy for major depressive disorder in patients 7-17 years of age in 2 randomized studies conducted over an 8-week period.

A greater risk of suicidal thinking or behavior (suicidality) is associated with antidepressant treatment in children and adolescents with major depressive disorder. Decreases in body weight were also observed in short-term pediatric clinical trials of desvenlafaxine, with a >=3.5% weight loss from baseline occurring in 22% and 14% of patients receiving low dose and high dose desvenlafaxine, respectively, compared to 7% of patients receiving placebo. Six-month extension studies of desvenlafaxine in pediatric patients 7-17 years of age with major depressive disorder demonstrated mean changes in weight similar to the expected changes in pediatric patients based on age and sex.

Desvenlafaxine exposure was approximately 30% higher in pediatric patients 7-11 years of age compared to adult patients receiving the same dose. Desvenlafaxine exposure was similar in adolescents 12-17 years of age and adult patients.

The National Pregnancy Registry for Antidepressants monitors pregnancy outcomes in women exposed to desvenlafaxine during pregnancy. Clinicians are encouraged to register patients by calling the National Pregnancy Registry for Antidepressants at 1-844-405-6185.

No published studies are available on desvenlafaxine use in pregnancy; however, available epidemiologic data with venlafaxine (parent compound) in pregnant women have not found a clear association between venlafaxine and adverse developmental outcomes.

There are risks associated with both untreated depression and exposure to SNRIs or SSRIs during pregnancy. A longitudinal study of women with a history of major depression who discontinued antidepressants during pregnancy found that these women were more likely to experience a relapse of major depression compared to women who continued treatment.

The risk of preeclampsia may be increased with desvenlafaxine exposure in mid to late pregnancy. Observational data indicate that exposure to SNRIs, particularly during the month before delivery, has been associated with a less than 2-fold increase in the risk of postpartum hemorrhage.

Some neonates exposed to SNRIs or SSRIs late in the third trimester of pregnancy have developed complications that have sometimes been severe and required prolonged hospitalization, respiratory support, and tube feeding. Such complications may arise immediately upon delivery. Clinical findings reported to date in neonates have included respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremor, jitteriness, irritability, and constant crying. These clinical features appear to be consistent with either a direct toxic effect of the SNRI or SSRI or, possibly, a drug withdrawal syndrome. It should be noted that, in some cases, the clinical picture was consistent with serotonin syndrome. Neonates exposed to desvenlafaxine during the third trimester of pregnancy should be monitored for discontinuation syndrome.

Desvenlafaxine is excreted into human milk at low levels, and adverse reactions have not been detected in breast-fed infants exposed to desvenlafaxine through breast milk. It is not known if desvenlafaxine affects milk production. Consider the developmental and health benefits of breastfeeding, the mother's clinical need for the drug, and the potential for adverse effects on the breast-fed infant from exposure to desvenlafaxine or the underlying maternal condition.

Although there are no specific dosage recommendations for desvenlafaxine in geriatric patients, the possibility of reduced renal clearance of the drug should be considered when determining dosage.

In clinical studies of desvenlafaxine, 6% of patients were >=65 years of age. Although no overall differences in safety or efficacy were observed between geriatric and younger patients in these studies, a higher incidence of systolic orthostatic hypotension was reported in patients >=65 years of age compared with younger patients who received desvenlafaxine. Consider possible reduced renal clearance of the drug in geriatric patients when determining dosage.

SSRIs and SNRIs, including desvenlafaxine, have been associated with clinically important hyponatremia in geriatric patients, who may be at greater risk for this adverse effect.