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DULOXETINE HYDROCHLORIDE
Overview
What is DULOXETINE DELAYED-RELEASE?
Duloxetine Delayed-release Capsules (duloxetine hydrochloride) are a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) for oral administration. Its chemical designation is (+)-()--methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The empirical formula is CHNOS∙HCl, which corresponds to a molecular weight of 333.88. The structural formula is:
Duloxetine hydrochloride is a white to slightly brownish white solid, which is slightly soluble in water.
Each capsule contains enteric-coated pellets of 22.4, 33.7, or 67.3 mg of duloxetine hydrochloride equivalent to 20, 30, or 60 mg of duloxetine, respectively. These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include ammonium hydroxide, black iron oxide, hypromellose, methacrylic acid copolymer dispersion (methacrylic acid-ethyl acrylate copolymer, polysorbate 80, sodium lauryl sulfate), potassium hydroxide, propylene glycol, shellac, sucrose, sugar spheres (maize starch, sucrose), talc, titanium dioxide, triethylcitrate, and hard gelatin capsules (gelatin, titanium dioxide). The 20 mg hard gelatin capsule colorant is yellow iron oxide. The 30 mg hard gelatin capsule colorants are FD&C Blue No. 1, FD&C Yellow No. 6, and FD&C Yellow No. 10. The 60 mg hard gelatin capsule colorants are FD&C Blue No. 1, FD&C Yellow No. 6, FD&C Yellow No.10, and yellow iron oxide.
What does DULOXETINE DELAYED-RELEASE look like?
What are the available doses of DULOXETINE DELAYED-RELEASE?
20 mg, 30 mg, and 60 mg delayed-release capsules ()
What should I talk to my health care provider before I take DULOXETINE DELAYED-RELEASE?
Pediatric use information for patients ages 7 to 17 years is approved for Eli Lilly and Company, Inc.'s CYMBALTA® (duloxetine) delayed-release capsules. However, due to Eli Lilly and Company, Inc.'s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
How should I use DULOXETINE DELAYED-RELEASE?
Duloxetine Delayed-release Capsules are indicated for the treatment of:
Swallow Duloxetine Delayed-release Capsules whole. Do not chew or crush. Do not open the capsule and sprinkle its contents on food or mix with liquids. All of these might affect the enteric coating. Duloxetine Delayed-release Capsules can be given without regard to meals. If a dose of Duloxetine Delayed-release Capsules is missed, take the missed dose as soon as it is remembered. If it is almost time for the next dose, skip the missed dose and take the next dose at the regular time. Do not take two doses of Duloxetine Delayed-release Capsules at the same time.
What interacts with DULOXETINE DELAYED-RELEASE?
Sorry No Records found
What are the warnings of DULOXETINE DELAYED-RELEASE?
Sorry No Records found
What are the precautions of DULOXETINE DELAYED-RELEASE?
Sorry No Records found
What are the side effects of DULOXETINE DELAYED-RELEASE?
Sorry No records found
What should I look out for while using DULOXETINE DELAYED-RELEASE?
Monoamine Oxidase Inhibitors (MAOIs) — The use of MAOIs intended to treat psychiatric disorders with Duloxetine Delayed-release Capsules or within 5 days of stopping treatment with Duloxetine Delayed-release Capsules is contraindicated because of an increased risk of serotonin syndrome. The use of Duloxetine Delayed-release Capsules within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated .
Starting Duloxetine Delayed-release Capsules 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 .
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 .
What might happen if I take too much DULOXETINE DELAYED-RELEASE?
How should I store and handle DULOXETINE DELAYED-RELEASE?
Protect VISIPAQUE from direct exposure to sunlight.Store VISIPAQUE at controlled room temperature, 20°C-25°C (68°F-77°F); excursions permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature].VISIPAQUE may be stored in a contrast media warmer for up to one month at 37°C (98.6°F).Do not freeze. Discard any product that is inadvertently frozen, as freezing may compromise the closure integrity of the immediate container.Protect VISIPAQUE from direct exposure to sunlight.Store VISIPAQUE at controlled room temperature, 20°C-25°C (68°F-77°F); excursions permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature].VISIPAQUE may be stored in a contrast media warmer for up to one month at 37°C (98.6°F).Do not freeze. Discard any product that is inadvertently frozen, as freezing may compromise the closure integrity of the immediate container.Protect VISIPAQUE from direct exposure to sunlight.Store VISIPAQUE at controlled room temperature, 20°C-25°C (68°F-77°F); excursions permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature].VISIPAQUE may be stored in a contrast media warmer for up to one month at 37°C (98.6°F).Do not freeze. Discard any product that is inadvertently frozen, as freezing may compromise the closure integrity of the immediate container.Protect VISIPAQUE from direct exposure to sunlight.Store VISIPAQUE at controlled room temperature, 20°C-25°C (68°F-77°F); excursions permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature].VISIPAQUE may be stored in a contrast media warmer for up to one month at 37°C (98.6°F).Do not freeze. Discard any product that is inadvertently frozen, as freezing may compromise the closure integrity of the immediate container.Duloxetine Delayed-release Capsules are available as delayed release capsules as Opaque Ochre, Opaque Green capsules, with 'B' on one side and "748" on the other.90 CAPSULE in a BOTTLE (53217-130-90)30 CAPSULE in a BOTTLE (53217-130-30)60 CAPSULE in a BOTTLE (53217-130-60)Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Repackaged by Aidarex Pharmaceuticals, LLCCorona, CA 92880Duloxetine Delayed-release Capsules are available as delayed release capsules as Opaque Ochre, Opaque Green capsules, with 'B' on one side and "748" on the other.90 CAPSULE in a BOTTLE (53217-130-90)30 CAPSULE in a BOTTLE (53217-130-30)60 CAPSULE in a BOTTLE (53217-130-60)Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Repackaged by Aidarex Pharmaceuticals, LLCCorona, CA 92880Duloxetine Delayed-release Capsules are available as delayed release capsules as Opaque Ochre, Opaque Green capsules, with 'B' on one side and "748" on the other.90 CAPSULE in a BOTTLE (53217-130-90)30 CAPSULE in a BOTTLE (53217-130-30)60 CAPSULE in a BOTTLE (53217-130-60)Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Repackaged by Aidarex Pharmaceuticals, LLCCorona, CA 92880Duloxetine Delayed-release Capsules are available as delayed release capsules as Opaque Ochre, Opaque Green capsules, with 'B' on one side and "748" on the other.90 CAPSULE in a BOTTLE (53217-130-90)30 CAPSULE in a BOTTLE (53217-130-30)60 CAPSULE in a BOTTLE (53217-130-60)Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Repackaged by Aidarex Pharmaceuticals, LLCCorona, CA 92880Duloxetine Delayed-release Capsules are available as delayed release capsules as Opaque Ochre, Opaque Green capsules, with 'B' on one side and "748" on the other.90 CAPSULE in a BOTTLE (53217-130-90)30 CAPSULE in a BOTTLE (53217-130-30)60 CAPSULE in a BOTTLE (53217-130-60)Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Repackaged by Aidarex Pharmaceuticals, LLCCorona, CA 92880Duloxetine Delayed-release Capsules are available as delayed release capsules as Opaque Ochre, Opaque Green capsules, with 'B' on one side and "748" on the other.90 CAPSULE in a BOTTLE (53217-130-90)30 CAPSULE in a BOTTLE (53217-130-30)60 CAPSULE in a BOTTLE (53217-130-60)Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Repackaged by Aidarex Pharmaceuticals, LLCCorona, CA 92880Duloxetine Delayed-release Capsules are available as delayed release capsules as Opaque Ochre, Opaque Green capsules, with 'B' on one side and "748" on the other.90 CAPSULE in a BOTTLE (53217-130-90)30 CAPSULE in a BOTTLE (53217-130-30)60 CAPSULE in a BOTTLE (53217-130-60)Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Repackaged by Aidarex Pharmaceuticals, LLCCorona, CA 92880Duloxetine Delayed-release Capsules are available as delayed release capsules as Opaque Ochre, Opaque Green capsules, with 'B' on one side and "748" on the other.90 CAPSULE in a BOTTLE (53217-130-90)30 CAPSULE in a BOTTLE (53217-130-30)60 CAPSULE in a BOTTLE (53217-130-60)Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Repackaged by Aidarex Pharmaceuticals, LLCCorona, CA 92880
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Although the exact mechanisms of the antidepressant, central pain inhibitory and anxiolytic actions of duloxetine in humans are unknown, these actions are believed to be related to its potentiation of serotonergic and noradrenergic activity in the CNS.
Non-Clinical Toxicology
Monoamine Oxidase Inhibitors (MAOIs) — The use of MAOIs intended to treat psychiatric disorders with Duloxetine Delayed-release Capsules or within 5 days of stopping treatment with Duloxetine Delayed-release Capsules is contraindicated because of an increased risk of serotonin syndrome. The use of Duloxetine Delayed-release Capsules within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated .Starting Duloxetine Delayed-release Capsules 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 .
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 .
Serotonergic Drugs
Based on the mechanism of action of SNRIs and SSRIs including citalopram, and the potential for serotonin syndrome, caution is advised when citalopram is coadministered with other drugs that may affect the serotonergic neurotransmitter systems, such as triptans, linezolid (an antibiotic which is a reversible non-selective MAOI), lithium, tramadol, or St. John's Wort (see -Serotonin Syndrome). The concomitant use of citalopram with other SSRIs, SNRIs or tryptophan is not recommended (see - ).
Triptans
There have been rare postmarketing reports of serotonin syndrome with use of an SSRI and a triptan. If concomitant treatment of citalopram with a triptan is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases (see - Serotonin Syndrome).
CNS Drugs
Given the primary CNS effects of citalopram, caution should be used when it is taken in combination with other centrally acting drugs.
Alcohol
Although citalopram did not potentiate the cognitive and motor effects of alcohol in a clinical trial, as with other psychotropic medications, the use of alcohol by depressed patients taking citalopram is not recommended.
Monoamine Oxidase Inhibitors (MAOIs) - See and .
Drugs That Interfere With Hemostasis (NSAIDs, Aspirin, Warfarin, etc.)
Serotonin release by platelets plays an important role in hemostasis. Epidemiological studies of the case-control and cohort design that have demonstrated an association between use of psychotropic drugs that interfere with serotonin reuptake and the occurrence of upper gastrointestinal bleeding have also shown that concurrent use of an NSAID or aspirin may potentiate the risk of bleeding. Altered anticoagulant effects, including increased bleeding, have been reported when SSRIs and SNRIs are coadministered with warfarin. Patients receiving warfarin therapy should be carefully monitored when citaloram is initiated or discontinued.
Cimetidine
In subjects who had received 21 days of 40 mg/day citlaopram, combined administration of 400 mg/day cimetidine for 8 days resulted in an increase in citalopram AUC and C of 43% and 39%, respectively.
Citalopram 20 mg/day is the maximum recommended dose for patients taking concomitant cimetidine because of the risk of QT prolongation (see and ).
Digoxin
In subjects who had received 21 days of 40 mg/day citalopram, combined administration of citalopram and digoxin (single dose of 1 mg) did not significantly affect the pharmacokinetics of either citalopram or digoxin.
Lithium
Coadministration of citalopram (40 mg/day for 10 days) and lithium (30 mmol/day for 5 days) had no significant effect on the pharmacokinetics of citalopram or lithium. Nevertheless, plasma lithium levels should be monitored with appropriate adjustment to the lithium dose in accordance with standard clinical practice. Because lithium may enhance the serotonergic effects of citalopram, caution should be exercised when citalopram and lithium are coadministered.
Pimozide
In a controlled study, a single dose of pimozide 2 mg co-administered with citalopram 40 mg given once daily for 11 days was associated with a mean increase in QTc values of approximately 10 msec compared to pimozide given alone. Citalopram did not alter the mean AUC or C of pimozide. The mechanism of this pharmacodynamic interaction is not known.
Theophylline
Combined administration of citalopram (40 mg/day for 21 days) and the CYP1A2 substrate theophylline (single dose of 300 mg) did not affect the pharmacokinetics of theophylline. The effect of theophylline on the pharmacokinetics of citalopram was not evaluated.
Sumatriptan
There have been rare postmarketing reports describing patients with weakness, hyperreflexia, and incoordination following the use of a SSRI and sumatriptan. If concomitant treatment with sumatriptan and an SSRI (e.g., fluoxetine, fluvoxamine, paroxetine, sertraline, citalopram) is clinically warranted, appropriate observation of the patient is advised.
Warfarin
Administration of 40 mg/day citalopram for 21 days did not affect the pharmacokinetics of warfarin, a CYP3A4 substrate. Prothrombin time was increased by 5%, the clinical significance of which is unknown.
Carbamazepine
Combined administration of citalopram (40 mg/day for 14 days) and carbamazepine (titrated to 400 mg/day for 35 days) did not significantly affect the pharmacokinetics of carbamazepine, a CYP3A4 substrate. Although trough citalopram plasma levels were unaffected, given the enzyme-inducing properties of carbamazepine, the possibility that carbamazepine might increase the clearance of citalopram should be considered if the two drugs are coadministered.
Triazolam
Combined administration of citalopram (titrated to 40 mg/day for 28 days) and the CYP3A4 substrate triazolam (single dose of 0.25 mg) did not significantly affect the pharmacokinetics of either citalopram or triazolam.
Ketoconazole
Combined administration of citalopram (40 mg) and ketoconazole (200 mg) decreased the C and AUC of ketoconazole by 21% and 10%, respectively, and did not significantly affect the pharmacokinetics of citalopram.
CYP2C19 Inhibitors
Citalopram 20 mg/day is the maximum recommended dose for patients taking concomitant CYP2C19 inhibitors because of the risk of QT prolongation (see , , AND ).
Metoprolol
Administration of 40 mg/day citlaopram for 22 days resulted in a two-fold increase in the plasma levels of the beta-adrenergic blocker metoprolol. Increased metoprolol plasma levels have been associated with decreased cardioselectivity. Coadministration of citalopram and metoprolol had no clinically significant effects on blood pressure or heart rate.
Imipramine and Other Tricyclic Antidepressants (TCAs)
In vitro
Electroconvulsive Therapy (ECT)
There are no clinical studies of the combined use of electroconvulsive therapy (ECT) and citalopram.
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 trials 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 18-24) 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 trials in children and adolescents with MDD, obsessive compulsive disorder (OCD), or other psychiatric disorders included a total of 24 short-term trials of 9 antidepressant drugs in over 4400 patients. The pooled analyses of placebo-controlled trials in adults with MDD or other psychiatric disorders included a total of 295 short-term trials (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 of 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 1000 patients treated) are provided in Table 1.
No suicides occurred in any of the pediatric trials. There were suicides in the adult trials, 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 trials 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 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 health care providers. Such monitoring should include daily observation by families and caregivers. Prescriptions for Duloxetine Delayed-release Capsules should be written for the smallest quantity of capsules consistent with good patient management, in order to reduce the risk of overdose.
The following serious adverse reactions are described below and elsewhere in the labeling:
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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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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Interactions
Interactions
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