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Desvenlafaxine (Desvenlafaxine)

Trade Name : Desvenlafaxine

West-Ward Pharmaceuticals Corp.

TABLET, FILM COATED, EXTENDED RELEASE

Strength 50 mg/1

DESVENLAFAXINE SUCCINATE Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Desvenlafaxine (Desvenlafaxine) which is also known as Desvenlafaxine and Manufactured by West-Ward Pharmaceuticals Corp.. It is available in strength of 50 mg/1 per ml. Read more

Desvenlafaxine (Desvenlafaxine) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • No data
  • 5.2n- 5.4n- 5.5n- 5.7
  • Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients over age 24; there was a reduction in risk with antidepressant use in patients aged 65 and older .
  • In patients of all ages who are started on antidepressant therapy, monitor closely for worsening, and for emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber .
  • Desvenlafaxine Extended-Release Tablets are not approved for use in pediatric patients .
  • WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
  • See full prescribing information for complete boxed warning.
  • Increased the risk of suicidal thoughts and behaviors in children, adolescents and young adults taking antidepressants ().
  • Closely monitor for clinical worsening and emergence of suicidal thoughts and behaviors ().
  • Desvenlafaxine Extended-Release Tablets are not approved for use in pediatric patients ().
  • Desvenlafaxine is indicated for the treatment of adults with major depressive disorder (MDD) n
  • Desvenlafaxine is a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of adults with major depressive disorder (MDD) ().
  • No data
  • Recommended Dose
  • Discontinuation
  • Moderate Renal Impairment:
  • Severe Renal Impairment and End-stage Renal Disease
  • Moderate to Severe Hepatic Impairment:
  • Desvenlafaxine Extended-Release Tablets are available as 25 mg, 50 mg and 100 mg tablets for oral administration.
  • 25 mg Tablets: Beige film-coated, standard biconvex tablet debossed with u201c54u201d [above] u201c427u201d on one side and plain on the other side.
  • 50 mg Tablets: Peach film-coated, standard biconvex tablet debossed with u201c54u201d [above] u201c716u201d on one side and plain on the other side.
  • 100 mg Tablets: Orange film-coated, standard biconvex tablet debossed with u201c54 [above] 341u201d on one side and plain on the other side.
  • No data
  • Serotonin Syndrome and MAOIs
  • No data
  • Serotonin Syndrome:
  • Elevated Blood Pressure:
  • Increased Risk of Bleeding:
  • Angle Closure Glaucoma:
  • Activation of Mania/Hypomania:
  • Discontinuation Syndrome:
  • Seizure:
  • Hyponatremia:
  • Interstitial Lung Disease and Eosinophilic Pneumonia:
  • The following adverse reactions are discussed in greater detail in other sections of the label.
  • Most common adverse reactions (incidence u2265 5% and twice the rate of placebo in the 50 mg or 100 mg dose groups) were: nausea, dizziness, insomnia, hyperhidrosis, constipation, somnolence, decreased appetite, anxiety, and specific male sexual function disorders ().
  • To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceuticals Corp. at 1-800-962-8364 or FDA at 1-800-FDA-1088 or
  • No data
  • No data
  • Pregnancy
  • Geriatric Use:
  • Desvenlafaxine is not a controlled substance.
  • No data
  • Desvenlafaxine 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 disorder.
  • Desvenlafaxine is designated 4-[2-dimethylamino-1-(1-hydroxycyclohexyl)ethyl]phenol succinate and has the molecular formula of CHNO (free base) and CHNOu2022CHOu2022HO (succinate monohydrate). Desvenlafaxine succinate monohydrate has a molecular weight of 399.48. The structural formula is shown below.
  • Desvenlafaxine succinate is a white to off-white powder that is soluble in water. The solubility of desvenlafaxine succinate is not pH dependent. The solubility in water is about 50 mg per mL.
  • Desvenlafaxine is formulated as an extended-release tablet for once-a-day oral administration containing 38 mg, 76 mg or 152 mg of desvenlafaxine succinate equivalent to 25 mg, 50 mg or 100 mg of desvenlafaxine, respectively.
  • Each tablet contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, povidone and sodium stearyl fumarate. In addition to the ingredients listed above, the 25 mg tablets are film-coated with Opadry II Beige film-coating which contains FD&C Red No. 40, FD&C Yellow No. 6, FD&C Blue No. 1, polyvinyl alcohol, polyethylene glycol, talc, and titanium dioxide. The 50 mg and 100 mg tablets are film-coated with Opadry II Orange film-coating which contains: FD&C Red No. 40, FD&C Yellow No. 6, polyvinyl alcohol, polyethylene glycol, talc, and titanium dioxide.
  • No data
  • Carcinogenesis
  • Desvenlafaxine succinate administered by oral gavage to mice and rats for 2 years did not increase the incidence of tumors in either study.
  • Mice received desvenlafaxine succinate at dosages up to 500/300 mg/kg/day (dosage lowered after 45 weeks of dosing). The AUC exposure at 300 mg/kg/day dose is estimated at 10 times the AUC exposure at an adult human dose of 100 mg per day.
  • Rats received desvenlafaxine succinate at dosages up to 300 mg/kg/day (males) or 500 mg/kg/day (females). The AUC exposure at the highest dose is estimated at 11 (males) or 26 (females) times the AUC exposure at an adult human dose of 100 mg per day.
  • Mutagenesis
  • Desvenlafaxine was not mutagenic in the bacterial mutation assay (Ames test) and was not clastogenic in an chromosome aberration assay in cultured CHO cells, an mouse micronucleus assay, or an chromosome aberration assay in rats. Additionally, desvenlafaxine was not genotoxic in the CHO mammalian cell forward mutation assay and was negative in the BALB/c-3T3 mouse embryo cell transformation assay.
  • Impairment of Fertility
  • When desvenlafaxine succinate was administered orally to male and female rats, fertility was reduced at the high dose of 300 mg/kg/day, which is 10 (males) and 19 (females) times the AUC exposure at an adult human dose of 100 mg per day. There was no effect on fertility at 100 mg/kg/day, which is 3 (males) or 5 (females) times the AUC exposure at an adult human dose of 100 mg per day. These studies did not address reversibility of the effect on fertility. The relevance of these findings to humans is not known.
  • Major Depressive Disorder
  • The efficacy of desvenlafaxine as a treatment for depression was established in four 8-week, randomized, double-blind, placebo-controlled, fixed-dose studies (at doses of 50 mg per day to 400 mg per day) in adult outpatients who met the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for major depressive disorder. In the first study, patients received 100 mg (n = 114), 200 mg (n = 116), or 400 mg (n = 113) of desvenlafaxine once daily, or placebo (n = 118). In a second study, patients received either 200 mg (n = 121) or 400 mg (n = 124) of desvenlafaxine once daily, or placebo (n = 124). In two additional studies, patients received 50 mg (n = 150 and n = 164) or 100 mg (n = 147 and n = 158) of desvenlafaxine once daily, or placebo (n = 150 and n = 161).
  • Desvenlafaxine showed superiority over placebo as measured by improvement in the 17-item Hamilton Rating Scale for Depression (HAM-D) total score in four studies and overall improvement, as measured by the Clinical Global Impressions Scale - Improvement (CGI-I), in three of the four studies. In studies directly comparing 50 mg per day and 100 mg per day there was no suggestion of a greater effect with the higher dose and adverse reactions and discontinuations were more frequent at higher doses .
  • Analyses of the relationships between treatment outcome and age and treatment outcome and gender did not suggest any differential responsiveness on the basis of these patient characteristics. There was insufficient information to determine the effect of race on outcome in these studies.
  • In a longer-term trial (Study 5), adult outpatients meeting DSM-IV criteria for major depressive disorder, who responded to 8 weeks of open-label acute treatment with 50 mg per day desvenlafaxine and subsequently remained stable for 12 weeks on desvenlafaxine, were assigned randomly in a double-blind manner to remain on active treatment or switch to placebo for up to 26 weeks of observation for relapse. Response during the open-label phase was defined as a HAM-D total score of u2264 11 and CGI-I u2264 2 at the day 56 evaluation; stability was defined as HAM-D total score of u2264 11 and CGI-I u2264 2 at week 20 and not having a HAM-D total score of u2265 16 or a CGI-I score u2265 4 at any office visit. Relapse during the double-blind phase was defined as follows: (1) a HAM-D total score of u2265 16 at any office visit, (2) discontinuation for unsatisfactory efficacy response, (3) hospitalized for depression, (4) suicide attempt, or (5) suicide. Patients receiving continued desvenlafaxine treatment experienced statistically significantly longer time to relapse compared with placebo. At 26 weeks, the Kaplan-Meier estimated proportion of relapse was 14% with desvenlafaxine treatment versus 30% with placebo.
  • Figure 4: Estimated Proportion of Relapses vs. Number of Days Since Randomization (Study 5)
  • In another longer-term trial (Study 6), adult outpatients meeting DSM-IV criteria for major depressive disorder and who responded to 12 weeks of acute treatment with desvenlafaxine were assigned randomly to the same dose (200 mg or 400 mg per day) they had received during acute treatment or to placebo for up to 26 weeks of observation for relapse. Response during the open-label phase was defined as a HAM-D total score of u2264 11 at the day 84 evaluation. Relapse during the double-blind phase was defined as follows: (1) a HAM-D total score of 16 at any office visit, (2) a CGI-I score of u2265 6 (versus day 84) at any office visit, or (3) discontinuation from the trial due to unsatisfactory response. Patients receiving continued desvenlafaxine treatment experienced statistically significantly longer time to relapse over the subsequent 26 weeks compared with those receiving placebo. At 26 weeks, the Kaplan-Meier estimated proportion of relapse was 29% with desvenlafaxine treatment versus 49% with placebo.
  • Figure 5: Estimated Proportion of Relapses vs. Number of Days Since Randomization (Study 6)
  • In a postmarketing study, the efficacy of desvenlafaxine at a dose lower than 50 mg per day was evaluated in an 8-week, multicenter, randomized, double-blind, placebo-controlled, fixed-dose study in adult outpatients with Major Depressive Disorder. The treatment arms were 25 mg (n=232), 50 mg (n=236), and placebo (n=231). The 50 mg dose was superior to placebo, as measured by the mean change from baseline on the HAMD-17. The 25 mg dose was not superior to placebo.
  • Desvenlafaxine Extended-Release Tablets
  • 25 mg tablet is supplied as a beige film-coated, standard biconvex tablet debossed with u201c54u201d [above] u201c427u201d on one side and plain on the other side. Each tablet contains 38 mg of desvenlafaxine succinate equivalent to 25 mg of desvenlafaxine.
  • NDC 0054-0603-13: Bottle of 30 Tablets Unit-of-use
  • 50 mg tablet is supplied as a peach film-coated, standard biconvex tablet debossed with u201c54u201d [above] u201c716u201d on one side and plain on the other side. Each tablet contains 76 mg of desvenlafaxine succinate equivalent to 50 mg of desvenlafaxine.
  • NDC 0054-0400-06: Bottle of 14 Tablets Unit-of-useNDC 0054-0400-13: Bottle of 30 Tablets Unit-of-useNDC 0054-0400-22: Bottle of 90 Tablets Unit-of-useNDC 0054-0400-29: Bottle of 500 TabletsNDC 0054-0400-20: Carton of 100 (10x10) Unit-Dose Tablets
  • 100 mg tablets are supplied as orange film-coated, standard biconvex tablet debossed with u201c54 [above] 341u201d on one side and plain on the other side. Each tablet contains 152 mg of desvenlafaxine succinate equivalent to 100 mg of desvenlafaxine.
  • NDC 0054-0401-06: Bottle of 14 Tablets Unit-of-use NDC 0054-0401-13: Bottle of 30 Tablets in Unit-of-use NDC 0054-0401-22: Bottle of 90 Tablets in Unit-of-use NDC 0054-0401-20: Carton of 100 (10x10) Unit-Dose Tablets
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F). [See USP Controlled Room Temperature.]
  • The unit-of-use package is intended to be dispensed as a unit.
  • Advise the patient to read the FDA-approved patient labeling ().
  • Suicidal Thoughts and Behaviors
  • Advise patients and caregivers to look for the emergence of suicidality, especially early during treatment and when the dose is adjusted up or down, and instruct them to report such symptoms to the healthcare provider n .
  • Concomitant Medication
  • Advise patients taking desvenlafaxine not to use concomitantly other products containing desvenlafaxine or venlafaxine. Healthcare professionals should instruct patients not to take desvenlafaxine with an MAOI or within 14 days of stopping an MAOI and to allow 7 days after stopping desvenlafaxine before starting an MAOI .
  • Serotonin Syndrome
  • Caution patients about the risk of serotonin syndrome, particularly with the concomitant use of desvenlafaxine with other serotonergic agents (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, amphetamines, tryptophan, buspirone, and St. John's Wort supplements) .
  • Elevated Blood Pressure
  • Advise patients that they should have regular monitoring of blood pressure when taking desvenlafaxine .
  • Increased Risk of Bleeding
  • Inform patients about the concomitant use of desvenlafaxine with NSAIDs, aspirin, other antiplatelet drugs, warfarin, or other coagulants because the combined use of has been associated with an increased risk of bleeding. Advise patients to inform their health care providers if they are taking or planning to take any prescription or over-the-counter medications that increase the risk of bleeding n
  • Activation of Mania/Hypomania
  • Advise patients, their families, and caregivers to observe for signs of activation of mania/hypomania .
  • Discontinuation
  • Advise patients not to abruptly stop taking desvenlafaxine without talking first with their healthcare professional. Patients should be aware that discontinuation effects may occur when stopping desvenlafaxine, and a dose of 25 mg per day is available for discontinuing therapy n .
  • Switching Patients from Other Antidepressants to Desvenlafaxine Extended-Release Tablets
  • Discontinuation symptoms have been reported when switching patients from other antidepressants, including venlafaxine, to desvenlafaxine. Tapering of the initial antidepressant may be necessary to minimize discontinuation symptoms.
  • Interference with Cognitive and Motor Performance
  • Caution patients about operating hazardous machinery, including automobiles, until they are reasonably certain that desvenlafaxine therapy does not adversely affect their ability to engage in such activities.
  • Alcohol
  • Advise patients to avoid alcohol while taking desvenlafaxine .
  • Allergic Reactions
  • Advise patients to notify their physician if they develop allergic phenomena such as rash, hives, swelling, or difficulty breathing.
  • Pregnancy
  • Advise patients to notify their physician if they become pregnant or intend to become pregnant during therapy. Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to desvenlafaxine during pregnancy .
  • Residual Inert Matrix Tablet
  • Patients receiving desvenlafaxine may notice an inert matrix tablet passing in the stool or via colostomy. Patients should be informed that the active medication has already been absorbed by the time the patient sees the inert matrix tablet.
  • Distr. by: Eatontown, NJ 07724
  • 10008303/04
  • Revised February 2020
  • Distr. by: Eatontown, NJ 07724
  • 10008303/04
  • Revised February 2020
  • Desvenlafaxine Extended-Release Tablets, 25 mg
  • NDC 0054-0603-13, Rx Only
  • Desvenlafaxine Extended-Release Tablets, 50 mg
  • NDC 0054-0400-13, Rx Only
  • Desvenlafaxine Extended-Release Tablets, 100 mg
  • NDC 0054-0401-13, Rx Only

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