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Desvenlafaxine Succinate
Overview
What is Desvenlafaxine Succinate?
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 and has the empirical formula of CHNO (free base) and CHNO•CHO•HO (succinate monohydrate). Desvenlafaxine succinate monohydrate has a molecular weight of 399.48. The structural formula is shown below.
Desvenlafaxine succinate monohydrate is a white to creamish crystalline powder that is soluble in water. The solubility of desvenlafaxine succinate monohydrate is pH dependent. Its octanol: aqueous system (at pH 7.0) partition coefficient is 0.21.
Desvenlafaxine is formulated as an extended-release tablet for once-a-day oral administration.
Each film-coated tablet contains 76 mg or 152 mg of desvenlafaxine succinate monohydrate equivalent to 50 mg or 100 mg of desvenlafaxine, respectively.
Inactive ingredients for the 50 mg tablet consist of colloidal silicon dioxide, hypromellose, iron oxide red, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide.
Inactive ingredients for the 100 mg tablet consist of colloidal silicon dioxide, FD&C yellow #6 aluminum lake, hypromellose, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide.
What does Desvenlafaxine Succinate look like?
What are the available doses of Desvenlafaxine Succinate?
Desvenlafaxine extended-release tablets are available as 50 mg and 100 mg tablets.
50 mg, light pink, biconvex, round shaped film-coated tablets, debossed with "LU" on one side and "S61" on the other side.
100 mg, reddish-orange, biconvex, round shaped film-coated tablets, debossed with "LU" on one side and "S62" on the other side.
What should I talk to my health care provider before I take Desvenlafaxine Succinate?
How should I use Desvenlafaxine Succinate?
Desvenlafaxine extended-release tablet is indicated for the treatment of adults with major depressive disorder (MDD)
The recommended dose for desvenlafaxine extended-release tablets are 50 mg once daily, with or without food. The 50 mg dose is both a starting dose and the therapeutic dose. Desvenlafaxine extended-release tablets should be taken at approximately the same time each day. Tablets must be swallowed whole with fluid and not divided, crushed, chewed, or dissolved.
In clinical studies, doses of 10 mg to 400 mg per day were studied. In clinical studies, doses of 50 mg to 400 mg per day were shown to be effective, although no additional benefit was demonstrated at doses greater than 50 mg per day and adverse reactions and discontinuations were more frequent at higher doses.
The 25 mg per day dose is intended for a gradual reduction in dose when discontinuing treatment. When discontinuing therapy, gradual dose reduction is recommended whenever possible to minimize discontinuation symptoms .
What interacts with Desvenlafaxine Succinate?
Sorry No Records found
What are the warnings of Desvenlafaxine Succinate?
Sorry No Records found
What are the precautions of Desvenlafaxine Succinate?
Sorry No Records found
What are the side effects of Desvenlafaxine Succinate?
Sorry No records found
What should I look out for while using Desvenlafaxine Succinate?
Hypersensitivity to desvenlafaxine succinate, venlafaxine hydrochloride or any excipients in the desvenlafaxine formulation ().
Do not use MAOIs intended to treat psychiatric disorders with desvenlafaxine or within 7 days of stopping treatment with desvenlafaxine. Do not use desvenlafaxine within 14 days of stopping an MAOI intended to treat psychiatric disorders. In addition, do not start desvenlafaxine in a patient who is being treated with linezolid or intravenous methylene blue ().
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
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
]
What might happen if I take too much Desvenlafaxine Succinate?
How should I store and handle Desvenlafaxine Succinate?
Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Preserve in tight, light-resistant containers as defined in the USP.Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Preserve in tight, light-resistant containers as defined in the USP.Desvenlafaxine extended-release tablets are available as follows:50 mg, light pink, biconvex, round shaped film-coated tablets, debossed with "LU" on one side and "S61" on the other side.NDC 68180-592-06, bottle of 30 tablets in unit-of-use packageNDC 68180-592-09, bottle of 90 tablets in unit-of-use packageNDC 68180-592-02, bottle of 500 tablets 100 mg, reddish-orange, biconvex, round shaped film-coated tablets, debossed with "LU" on one side and "S62" on the other side.NDC 68180-593-06, bottle of 30 tablets in unit-of-use packageNDC 68180-593-09, bottle of 90 tablets in unit-of-use packageNDC 68180-593-02, bottle of 500 tablets Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Each tablet contains 76 mg or 152 mg of desvenlafaxine succinate monohydrate equivalent to 50 mg or 100 mg of desvenlafaxine, respectively.Desvenlafaxine extended-release tablets are available as follows:50 mg, light pink, biconvex, round shaped film-coated tablets, debossed with "LU" on one side and "S61" on the other side.NDC 68180-592-06, bottle of 30 tablets in unit-of-use packageNDC 68180-592-09, bottle of 90 tablets in unit-of-use packageNDC 68180-592-02, bottle of 500 tablets 100 mg, reddish-orange, biconvex, round shaped film-coated tablets, debossed with "LU" on one side and "S62" on the other side.NDC 68180-593-06, bottle of 30 tablets in unit-of-use packageNDC 68180-593-09, bottle of 90 tablets in unit-of-use packageNDC 68180-593-02, bottle of 500 tablets Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Each tablet contains 76 mg or 152 mg of desvenlafaxine succinate monohydrate equivalent to 50 mg or 100 mg of desvenlafaxine, respectively.Desvenlafaxine extended-release tablets are available as follows:50 mg, light pink, biconvex, round shaped film-coated tablets, debossed with "LU" on one side and "S61" on the other side.NDC 68180-592-06, bottle of 30 tablets in unit-of-use packageNDC 68180-592-09, bottle of 90 tablets in unit-of-use packageNDC 68180-592-02, bottle of 500 tablets 100 mg, reddish-orange, biconvex, round shaped film-coated tablets, debossed with "LU" on one side and "S62" on the other side.NDC 68180-593-06, bottle of 30 tablets in unit-of-use packageNDC 68180-593-09, bottle of 90 tablets in unit-of-use packageNDC 68180-593-02, bottle of 500 tablets Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Each tablet contains 76 mg or 152 mg of desvenlafaxine succinate monohydrate equivalent to 50 mg or 100 mg of desvenlafaxine, respectively.Desvenlafaxine extended-release tablets are available as follows:50 mg, light pink, biconvex, round shaped film-coated tablets, debossed with "LU" on one side and "S61" on the other side.NDC 68180-592-06, bottle of 30 tablets in unit-of-use packageNDC 68180-592-09, bottle of 90 tablets in unit-of-use packageNDC 68180-592-02, bottle of 500 tablets 100 mg, reddish-orange, biconvex, round shaped film-coated tablets, debossed with "LU" on one side and "S62" on the other side.NDC 68180-593-06, bottle of 30 tablets in unit-of-use packageNDC 68180-593-09, bottle of 90 tablets in unit-of-use packageNDC 68180-593-02, bottle of 500 tablets Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Each tablet contains 76 mg or 152 mg of desvenlafaxine succinate monohydrate equivalent to 50 mg or 100 mg of desvenlafaxine, respectively.Desvenlafaxine extended-release tablets are available as follows:50 mg, light pink, biconvex, round shaped film-coated tablets, debossed with "LU" on one side and "S61" on the other side.NDC 68180-592-06, bottle of 30 tablets in unit-of-use packageNDC 68180-592-09, bottle of 90 tablets in unit-of-use packageNDC 68180-592-02, bottle of 500 tablets 100 mg, reddish-orange, biconvex, round shaped film-coated tablets, debossed with "LU" on one side and "S62" on the other side.NDC 68180-593-06, bottle of 30 tablets in unit-of-use packageNDC 68180-593-09, bottle of 90 tablets in unit-of-use packageNDC 68180-593-02, bottle of 500 tablets Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Each tablet contains 76 mg or 152 mg of desvenlafaxine succinate monohydrate equivalent to 50 mg or 100 mg of desvenlafaxine, respectively.Desvenlafaxine extended-release tablets are available as follows:50 mg, light pink, biconvex, round shaped film-coated tablets, debossed with "LU" on one side and "S61" on the other side.NDC 68180-592-06, bottle of 30 tablets in unit-of-use packageNDC 68180-592-09, bottle of 90 tablets in unit-of-use packageNDC 68180-592-02, bottle of 500 tablets 100 mg, reddish-orange, biconvex, round shaped film-coated tablets, debossed with "LU" on one side and "S62" on the other side.NDC 68180-593-06, bottle of 30 tablets in unit-of-use packageNDC 68180-593-09, bottle of 90 tablets in unit-of-use packageNDC 68180-593-02, bottle of 500 tablets Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Each tablet contains 76 mg or 152 mg of desvenlafaxine succinate monohydrate equivalent to 50 mg or 100 mg of desvenlafaxine, respectively.Desvenlafaxine extended-release tablets are available as follows:50 mg, light pink, biconvex, round shaped film-coated tablets, debossed with "LU" on one side and "S61" on the other side.NDC 68180-592-06, bottle of 30 tablets in unit-of-use packageNDC 68180-592-09, bottle of 90 tablets in unit-of-use packageNDC 68180-592-02, bottle of 500 tablets 100 mg, reddish-orange, biconvex, round shaped film-coated tablets, debossed with "LU" on one side and "S62" on the other side.NDC 68180-593-06, bottle of 30 tablets in unit-of-use packageNDC 68180-593-09, bottle of 90 tablets in unit-of-use packageNDC 68180-593-02, bottle of 500 tablets Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Each tablet contains 76 mg or 152 mg of desvenlafaxine succinate monohydrate equivalent to 50 mg or 100 mg of desvenlafaxine, respectively.Desvenlafaxine extended-release tablets are available as follows:50 mg, light pink, biconvex, round shaped film-coated tablets, debossed with "LU" on one side and "S61" on the other side.NDC 68180-592-06, bottle of 30 tablets in unit-of-use packageNDC 68180-592-09, bottle of 90 tablets in unit-of-use packageNDC 68180-592-02, bottle of 500 tablets 100 mg, reddish-orange, biconvex, round shaped film-coated tablets, debossed with "LU" on one side and "S62" on the other side.NDC 68180-593-06, bottle of 30 tablets in unit-of-use packageNDC 68180-593-09, bottle of 90 tablets in unit-of-use packageNDC 68180-593-02, bottle of 500 tablets Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Each tablet contains 76 mg or 152 mg of desvenlafaxine succinate monohydrate equivalent to 50 mg or 100 mg of desvenlafaxine, respectively.Desvenlafaxine extended-release tablets are available as follows:50 mg, light pink, biconvex, round shaped film-coated tablets, debossed with "LU" on one side and "S61" on the other side.NDC 68180-592-06, bottle of 30 tablets in unit-of-use packageNDC 68180-592-09, bottle of 90 tablets in unit-of-use packageNDC 68180-592-02, bottle of 500 tablets 100 mg, reddish-orange, biconvex, round shaped film-coated tablets, debossed with "LU" on one side and "S62" on the other side.NDC 68180-593-06, bottle of 30 tablets in unit-of-use packageNDC 68180-593-09, bottle of 90 tablets in unit-of-use packageNDC 68180-593-02, bottle of 500 tablets Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Each tablet contains 76 mg or 152 mg of desvenlafaxine succinate monohydrate equivalent to 50 mg or 100 mg of desvenlafaxine, respectively.Desvenlafaxine extended-release tablets are available as follows:50 mg, light pink, biconvex, round shaped film-coated tablets, debossed with "LU" on one side and "S61" on the other side.NDC 68180-592-06, bottle of 30 tablets in unit-of-use packageNDC 68180-592-09, bottle of 90 tablets in unit-of-use packageNDC 68180-592-02, bottle of 500 tablets 100 mg, reddish-orange, biconvex, round shaped film-coated tablets, debossed with "LU" on one side and "S62" on the other side.NDC 68180-593-06, bottle of 30 tablets in unit-of-use packageNDC 68180-593-09, bottle of 90 tablets in unit-of-use packageNDC 68180-593-02, bottle of 500 tablets Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Each tablet contains 76 mg or 152 mg of desvenlafaxine succinate monohydrate equivalent to 50 mg or 100 mg of desvenlafaxine, respectively.Desvenlafaxine extended-release tablets are available as follows:50 mg, light pink, biconvex, round shaped film-coated tablets, debossed with "LU" on one side and "S61" on the other side.NDC 68180-592-06, bottle of 30 tablets in unit-of-use packageNDC 68180-592-09, bottle of 90 tablets in unit-of-use packageNDC 68180-592-02, bottle of 500 tablets 100 mg, reddish-orange, biconvex, round shaped film-coated tablets, debossed with "LU" on one side and "S62" on the other side.NDC 68180-593-06, bottle of 30 tablets in unit-of-use packageNDC 68180-593-09, bottle of 90 tablets in unit-of-use packageNDC 68180-593-02, bottle of 500 tablets Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Each tablet contains 76 mg or 152 mg of desvenlafaxine succinate monohydrate equivalent to 50 mg or 100 mg of desvenlafaxine, respectively.Desvenlafaxine extended-release tablets are available as follows:50 mg, light pink, biconvex, round shaped film-coated tablets, debossed with "LU" on one side and "S61" on the other side.NDC 68180-592-06, bottle of 30 tablets in unit-of-use packageNDC 68180-592-09, bottle of 90 tablets in unit-of-use packageNDC 68180-592-02, bottle of 500 tablets 100 mg, reddish-orange, biconvex, round shaped film-coated tablets, debossed with "LU" on one side and "S62" on the other side.NDC 68180-593-06, bottle of 30 tablets in unit-of-use packageNDC 68180-593-09, bottle of 90 tablets in unit-of-use packageNDC 68180-593-02, bottle of 500 tablets Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Each tablet contains 76 mg or 152 mg of desvenlafaxine succinate monohydrate equivalent to 50 mg or 100 mg of desvenlafaxine, respectively.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
The exact mechanism of the antidepressant action of desvenlafaxine is unknown, but is thought to be related to the potentiation of serotonin and norepinephrine in the central nervous system, through inhibition of their reuptake. Non-clinical studies have shown that desvenlafaxine is a potent and selective serotonin and norepinephrine reuptake inhibitor (SNRI).
Non-Clinical Toxicology
Hypersensitivity to desvenlafaxine succinate, venlafaxine hydrochloride or any excipients in the desvenlafaxine formulation ().Do not use MAOIs intended to treat psychiatric disorders with desvenlafaxine or within 7 days of stopping treatment with desvenlafaxine. Do not use desvenlafaxine within 14 days of stopping an MAOI intended to treat psychiatric disorders. In addition, do not start desvenlafaxine in a patient who is being treated with linezolid or intravenous methylene blue ().
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
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
]
Aminoglutethimide:
Amphotericin B injection and potassium-depleting agents:
Anticholinesterases:
Anticoagulants, oral:
Antidiabetics:
Antitubercular drugs:
Cholestyramine:
Cyclosporine:
Digitalis glycosides:
Estrogens, including oral contraceptives:
Hepatic Enzyme Inducers (e.g., barbiturates, phenytoin, carbamazepine, rifampin):
Hepatic Enzyme Inhibitors (e.g., ketoconazole, macrolide antibiotics such as erythromycin and troleandomycin):
Ketoconazole:
Nonsteroidal anti-inflammatory agents (NSAIDs):
Skin tests:
Patients with 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. Suicide is a known risk of depression and certain other psychiatric disorders, and these disorders themselves are the strongest predictors of suicide. There has been a long-standing concern, however, that antidepressants may have a role in inducing worsening of depression and the emergence of suicidality in certain patients during the early phases of treatment. Pooled analyses of short-term placebo-controlled studies of antidepressant drugs (SSRIs and others) showed that these drugs increase the risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults (ages 18 to 24) with major depressive disorder (MDD) and other psychiatric disorders. 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 with antidepressants compared to placebo in adults aged 65 and older.
The pooled analyses of placebo-controlled studies in children and adolescents with MDD, obsessive compulsive disorder (OCD), or other psychiatric disorders included a total of 24
short-term studies of 9 antidepressant drugs in over 4,400 patients. The pooled analyses of placebo-controlled studies in adults with MDD or other psychiatric disorders included a total of 295 short-term studies (median duration of 2 months) of 11 antidepressant drugs in over 77,000 patients. There was considerable variation in risk of suicidality among drugs, but a tendency toward an increase in the younger patients for almost all drugs studied. There were differences in absolute risk of suicidality across the different indications, with the highest incidence in MDD. The risk differences (drug vs. placebo), however, were relatively stable within age strata and across indications. These risk differences (drug-placebo difference in the number of cases of suicidality per 1,000 patients treated) are provided in Table 1.
No suicides occurred in any of the pediatric studies. There were suicides in the adult studies, but the number was not sufficient to reach any conclusion about drug effect on suicide.
It is unknown whether the suicidality risk extends to longer-term use, i.e., beyond several months. However, there is substantial evidence from placebo-controlled maintenance studies in adults with depression that the use of antidepressants can delay the recurrence of depression.
All patients being treated with antidepressants for any indication should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months of a course of drug therapy, or at times of dose changes, either increases or decreases.
The following symptoms, anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, and mania, have been reported in adult and pediatric patients being treated with antidepressants for major depressive disorder as well as for other indications, both psychiatric and nonpsychiatric. Although a causal link between the emergence of such symptoms and either the worsening of depression and/or the emergence of suicidal impulses has not been established, there is concern that such symptoms may represent precursors to emerging suicidality.
Consideration should be given to changing the therapeutic regimen, including possibly discontinuing the medication, in patients whose depression is persistently worse, or who are experiencing emergent suicidality or symptoms that might be precursors to worsening depression or suicidality, especially if these symptoms are severe, abrupt in onset, or were not part of the patient's presenting symptoms.
If the decision has been made to discontinue treatment, medication should be tapered, as rapidly as is feasible, but with recognition that abrupt discontinuation can be associated with certain symptoms .
Families and caregivers of patients being treated with antidepressants for major depressive disorder or other indications, both psychiatric and nonpsychiatric, should be alerted about the need to monitor patients for the emergence of agitation, irritability, unusual changes in behavior, and the other symptoms described above, as well as the emergence of suicidality, and to report such symptoms immediately to healthcare providers. Such monitoring should include daily observation by families and caregivers.
Prescriptions for desvenlafaxine extended-release tablets should be written for the smallest quantity of tablets consistent with good patient management, in order to reduce the risk of overdose.
A major depressive episode may be the initial presentation of bipolar disorder. It is generally believed (though not established in controlled studies) that treating such an episode with an antidepressant alone may increase the likelihood of precipitation of a mixed/manic episode in patients at risk for bipolar disorder. Whether any of the symptoms described above represent such a conversion is unknown. However, prior to initiating treatment with an antidepressant, patients with depressive symptoms should be adequately screened to determine if they are at risk for bipolar disorder; such screening should include a detailed psychiatric history, including a family history of suicide, bipolar disorder, and depression. It should be noted that desvenlafaxine is not approved for use in treating bipolar depression.
The following adverse reactions are discussed in greater detail in other sections of the label.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72Tips
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