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KHEDEZLA

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Overview

What is KHEDEZLA?

KHEDEZLA Extended-release Tablets for oral administration contains desvenlafaxine, 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 C H NO . Desvenlafaxine has a molecular weight of 263.38. The structural formula is shown below.

Desvenlafaxine is a white to off-white crystalline powder that is sparingly soluble in dimethyl sulfoxide. The solubility of desvenlafaxine is pH dependent.

KHEDEZLA is formulated as an extended-release tablet for once-a-day oral administration.

Each 50 mg or 100 mg extended-release tablet contains 50 or 100 mg of desvenlafaxine, respectively.

Inactive ingredients for the 50 mg tablet consist of citric acid monohydrate, hypromellose, microcrystalline cellulose, talc, magnesium stearate and colloidal silicon dioxide, and film coating, which consist of titanium dioxide, polyethylene glycol, talc, polyvinyl alcohol and iron oxides.

Inactive ingredients for the 100 mg tablet consist of citric acid monohydrate, hypromellose, microcrystalline cellulose, talc, magnesium stearate and colloidal silicon dioxide, and film coating, which consist of hypromellose, titanium dioxide, polyethylene glycol, talc, polyvinyl alcohol, iron oxides, and FD&C yellow #6.



What does KHEDEZLA look like?



What are the available doses of KHEDEZLA?

KHEDEZLA (desvenlafaxine) Extended-release Tablets are available as 50 and 100 mg tablets.

What should I talk to my health care provider before I take KHEDEZLA?

How should I use KHEDEZLA?

KHEDEZLA, a serotonin and norepinephrine reuptake inhibitor (SNRI), is indicated for the treatment of major depressive disorder (MDD) . The efficacy of desvenlafaxine has been established in four short-term (8-week, placebo-controlled studies) in adult outpatients who met DSM-IV criteria for major depressive disorder.

The recommended dose for KHEDEZLA is 50 mg once daily, with or without food.

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.

When discontinuing therapy, gradual dose reduction is recommended whenever possible to minimize discontinuation symptoms .

KHEDEZLA should be taken at approximately the same time each day. Tablets must be swallowed whole with fluid and not divided, crushed, chewed, or dissolved.


What interacts with KHEDEZLA?

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What are the warnings of KHEDEZLA?

Sorry No Records found


What are the precautions of KHEDEZLA?

Sorry No Records found


What are the side effects of KHEDEZLA?

Sorry No records found


What should I look out for while using KHEDEZLA?

Starting KHEDEZLA in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome and .

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 .

KHEDEZLA is not approved for use in pediatric patients .


What might happen if I take too much KHEDEZLA?


How should I store and handle KHEDEZLA?

Storage ConditionsStore refrigerated between 2° and 8°C (36° and 46°F).Storage of Doxorubicin Hydrochloride Injection under refrigerated conditions can result in the formation of a gelled product. Place gelled product at room temperature [15º to 30ºC (59º to 86ºF)] for 2 to 4 hours to return the product to a slightly viscous, mobile solution. Storage ConditionsStore refrigerated between 2° and 8°C (36° and 46°F).Storage of Doxorubicin Hydrochloride Injection under refrigerated conditions can result in the formation of a gelled product. Place gelled product at room temperature [15º to 30ºC (59º to 86ºF)] for 2 to 4 hours to return the product to a slightly viscous, mobile solution. Storage ConditionsStore refrigerated between 2° and 8°C (36° and 46°F).Storage of Doxorubicin Hydrochloride Injection under refrigerated conditions can result in the formation of a gelled product. Place gelled product at room temperature [15º to 30ºC (59º to 86ºF)] for 2 to 4 hours to return the product to a slightly viscous, mobile solution. KHEDEZLA (desvenlafaxine) Extended-release Tablets are available as follows: 50 mg, pink, round tablet debossed with "OS" on one side and "231" on the other NDC 65224-880-31, bottle of 30 tablets in unit-of-use package NDC 65224-880-90, bottle of 90 tablets in unit-of-use package 100 mg, brown, round tablet debossed with “OS” on one side and "232" on the other NDC 65224-890-31, bottle of 30 tablets in unit-of-use package NDC65224-890-90, bottle of 90 tablets in unit-of-use package Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) . Each 50 mg or 100 mg KHEDEZLA Extended-release Tablet contains 50 or 100 mg of desvenlafaxine, respectively.KHEDEZLA (desvenlafaxine) Extended-release Tablets are available as follows: 50 mg, pink, round tablet debossed with "OS" on one side and "231" on the other NDC 65224-880-31, bottle of 30 tablets in unit-of-use package NDC 65224-880-90, bottle of 90 tablets in unit-of-use package 100 mg, brown, round tablet debossed with “OS” on one side and "232" on the other NDC 65224-890-31, bottle of 30 tablets in unit-of-use package NDC65224-890-90, bottle of 90 tablets in unit-of-use package Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) . Each 50 mg or 100 mg KHEDEZLA Extended-release Tablet contains 50 or 100 mg of desvenlafaxine, respectively.KHEDEZLA (desvenlafaxine) Extended-release Tablets are available as follows: 50 mg, pink, round tablet debossed with "OS" on one side and "231" on the other NDC 65224-880-31, bottle of 30 tablets in unit-of-use package NDC 65224-880-90, bottle of 90 tablets in unit-of-use package 100 mg, brown, round tablet debossed with “OS” on one side and "232" on the other NDC 65224-890-31, bottle of 30 tablets in unit-of-use package NDC65224-890-90, bottle of 90 tablets in unit-of-use package Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) . Each 50 mg or 100 mg KHEDEZLA Extended-release Tablet contains 50 or 100 mg of desvenlafaxine, respectively.KHEDEZLA (desvenlafaxine) Extended-release Tablets are available as follows: 50 mg, pink, round tablet debossed with "OS" on one side and "231" on the other NDC 65224-880-31, bottle of 30 tablets in unit-of-use package NDC 65224-880-90, bottle of 90 tablets in unit-of-use package 100 mg, brown, round tablet debossed with “OS” on one side and "232" on the other NDC 65224-890-31, bottle of 30 tablets in unit-of-use package NDC65224-890-90, bottle of 90 tablets in unit-of-use package Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) . Each 50 mg or 100 mg KHEDEZLA Extended-release Tablet contains 50 or 100 mg of desvenlafaxine, respectively.KHEDEZLA (desvenlafaxine) Extended-release Tablets are available as follows: 50 mg, pink, round tablet debossed with "OS" on one side and "231" on the other NDC 65224-880-31, bottle of 30 tablets in unit-of-use package NDC 65224-880-90, bottle of 90 tablets in unit-of-use package 100 mg, brown, round tablet debossed with “OS” on one side and "232" on the other NDC 65224-890-31, bottle of 30 tablets in unit-of-use package NDC65224-890-90, bottle of 90 tablets in unit-of-use package Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) . Each 50 mg or 100 mg KHEDEZLA Extended-release Tablet contains 50 or 100 mg of desvenlafaxine, respectively.KHEDEZLA (desvenlafaxine) Extended-release Tablets are available as follows: 50 mg, pink, round tablet debossed with "OS" on one side and "231" on the other NDC 65224-880-31, bottle of 30 tablets in unit-of-use package NDC 65224-880-90, bottle of 90 tablets in unit-of-use package 100 mg, brown, round tablet debossed with “OS” on one side and "232" on the other NDC 65224-890-31, bottle of 30 tablets in unit-of-use package NDC65224-890-90, bottle of 90 tablets in unit-of-use package Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) . Each 50 mg or 100 mg KHEDEZLA Extended-release Tablet contains 50 or 100 mg of desvenlafaxine, respectively.KHEDEZLA (desvenlafaxine) Extended-release Tablets are available as follows: 50 mg, pink, round tablet debossed with "OS" on one side and "231" on the other NDC 65224-880-31, bottle of 30 tablets in unit-of-use package NDC 65224-880-90, bottle of 90 tablets in unit-of-use package 100 mg, brown, round tablet debossed with “OS” on one side and "232" on the other NDC 65224-890-31, bottle of 30 tablets in unit-of-use package NDC65224-890-90, bottle of 90 tablets in unit-of-use package Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) . Each 50 mg or 100 mg KHEDEZLA Extended-release Tablet contains 50 or 100 mg of desvenlafaxine, respectively.KHEDEZLA (desvenlafaxine) Extended-release Tablets are available as follows: 50 mg, pink, round tablet debossed with "OS" on one side and "231" on the other NDC 65224-880-31, bottle of 30 tablets in unit-of-use package NDC 65224-880-90, bottle of 90 tablets in unit-of-use package 100 mg, brown, round tablet debossed with “OS” on one side and "232" on the other NDC 65224-890-31, bottle of 30 tablets in unit-of-use package NDC65224-890-90, bottle of 90 tablets in unit-of-use package Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) . Each 50 mg or 100 mg KHEDEZLA Extended-release Tablet contains 50 or 100 mg of desvenlafaxine, respectively.KHEDEZLA (desvenlafaxine) Extended-release Tablets are available as follows: 50 mg, pink, round tablet debossed with "OS" on one side and "231" on the other NDC 65224-880-31, bottle of 30 tablets in unit-of-use package NDC 65224-880-90, bottle of 90 tablets in unit-of-use package 100 mg, brown, round tablet debossed with “OS” on one side and "232" on the other NDC 65224-890-31, bottle of 30 tablets in unit-of-use package NDC65224-890-90, bottle of 90 tablets in unit-of-use package Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) . Each 50 mg or 100 mg KHEDEZLA Extended-release Tablet contains 50 or 100 mg of desvenlafaxine, respectively.


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

The exact mechanism of the antidepressant action of KHEDEZLA 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
Starting KHEDEZLA in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome and .

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 .

KHEDEZLA is not approved for use in pediatric patients .

Clinically meaningful drug interactions have occurred with concomitant medications and include, but are not limited to the following:

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. 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.

                                                          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 KHEDEZLA should be written for the smallest quantity of tablets consistent with good patient management, in order to reduce the risk of overdose.

The following adverse reactions are discussed in greater detail in other sections of the label.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

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. 315.72
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Interactions

Interactions

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