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Drug Catalog - Product Detail

DULOXETINE HCL DR CP 20MG 60

NDC Mfr Size Str Form
47335-0381-86 SUN PHARMACEUTICALS 60 20MG CAPSULE
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Description
Description Section Duloxetine hydrochloride is a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) for oral administration. Its chemical designation is (+)-( S )- N -methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The molecular formula is C 18 H 19 NOS•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 mg, 33.7 mg, or 67.3 mg of duloxetine hydrochloride USP equivalent to 20 mg, 30 mg, 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 sugar spheres, maize starch, hypromellose, mannitol, talc, sucrose, methacrylic acid co-polymer dispersion, triethyl citrate and sodium hydroxide. The capsule shells contain gelatin, sodium lauryl sulfate, titanium dioxide, FD & C Blue No. 2, and iron oxide yellow (20 mg and 60 mg). For 20 mg & 30 mg strengths, imprinting black ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide, and purified water. For 60 mg strength, imprinting white ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, titanium dioxide, potassium hydroxide, and purified water. MM1
How Supplied
How Supplied Section Duloxetine delayed-release capsules USP are available in the following strengths, colors, imprints, and presentations: Features Strengths 20 mg 30 mg 60 mg Body color Green White Green Cap color Green Blue Blue Cap imprint 381 382 383 Body imprint 381 382 383 Capsule size 4 3 1 Presentations and NDC Codes Bottles of 30 CRC 47335-381-83 47335-382-83 47335-383-83 Bottles of 60 CRC 47335-381-86 - - Bottles of 90 CRC - 47335-382-81 - Bottles of 100 CRC 47335-381-88 47335-382-88 47335-383-88 Bottles of 100 NCRC 47335-381-08 47335-382-08 47335-383-08 Bottles of 1000 NCRC 47335-381-18 47335-382-18 47335-383-18 Unit dose blisters of 100 47335-381-61 47335-382-61 47335-383-61 Store duloxetine delayed-release capsules USP at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature]. Dispense in a tightly closed container.
Indications & Usage
Indications & Usage Section Duloxetine is a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for: Major Depressive Disorder (MDD) ( 1.1 ) Generalized Anxiety Disorder (GAD) ( 1.2 ) Diabetic Peripheral Neuropathic Pain (DPNP) ( 1.3 ) Duloxetine delayed-release capsules USP are indicated for the treatment of major depressive disorder (MDD). The efficacy of duloxetine delayed-release capsules USP was established in four short-term and one maintenance trial in adults [see Clinical Studies ( 14.1 )] . A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least 5 of the following 9 symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, or a suicide attempt or suicidal ideation. Duloxetine delayed-release capsules USP are indicated for the treatment of generalized anxiety disorder (GAD). The efficacy of duloxetine delayed-release capsules USP was established in three short-term trials and one maintenance trial in adults [see Clinical Studies ( 14.2 )] . Generalized anxiety disorder is defined by the DSM-IV as excessive anxiety and worry, present more days than not, for at least 6 months. The excessive anxiety and worry must be difficult to control and must cause significant distress or impairment in normal functioning. It must be associated with at least 3 of the following 6 symptoms: restlessness or feeling keyed up or on edge, being easily fatigued, difficulty concentrating or mind going blank, irritability, muscle tension, and/or sleep disturbance. Duloxetine delayed-release capsules USP are indicated for the management of neuropathic pain (DPNP) associated with diabetic peripheral neuropathy [see Clinical Studies ( 14.3 )] .
Dosage and Administration
Dosage & Administration Section Duloxetine delayed-release capsules should be swallowed whole and should not be chewed or crushed, nor should the capsule be opened and its contents sprinkled on food or mixed with liquids. All of these might affect the enteric coating. Duloxetine delayed-release capsules can be given without regard to meals. Major Depressive Disorder - Duloxetine delayed-release capsules should be administered at a total dose of 40 mg/day (given as 20 mg twice daily) to 60 mg/day (given either once daily or as 30 mg twice daily). For some patients, it may be desirable to start at 30 mg once daily for 1 week, to allow patients to adjust to the medication before increasing to 60 mg once daily. While a 120 mg/day dose was shown to be effective, there is no evidence that doses greater than 60 mg/day confer any additional benefits. The safety of doses above 120 mg/day has not been adequately evaluated [see Clinical Studies ( 14.1 )] . Generalized Anxiety Disorder - For most patients, the recommended starting dose for duloxetine delayed-release capsules is 60 mg administered once daily. For some patients, it may be desirable to start at 30 mg once daily for 1 week, to allow patients to adjust to the medication before increasing to 60 mg once daily. While a 120 mg once daily dose was shown to be effective, there is no evidence that doses greater than 60 mg/day confer additional benefit. Nevertheless, if a decision is made to increase the dose beyond 60 mg once daily, dose increases should be in increments of 30 mg once daily. The safety of doses above 120 mg once daily has not been adequately evaluated [see Clinical Studies ( 14.2 )] . Diabetic Peripheral Neuropathic Pain - The recommended dose for duloxetine delayed-release capsules is 60 mg administered once daily. There is no evidence that doses higher than 60 mg confer additional significant benefit and the higher dose is clearly less well tolerated [see Clinical Studies ( 14.3 )] . For patients for whom tolerability is a concern, a lower starting dose may be considered. Since diabetes is frequently complicated by renal disease, a lower starting dose and gradual increase in dose should be considered for patients with renal impairment [see Dosage and Administration ( 2.3 ), Use in Specific Populations ( 8.10 ), and Clinical Pharmacology ( 12.3 )]. Major Depressive Disorder - It is generally agreed that acute episodes of major depression require several months or longer of sustained pharmacologic therapy. Maintenance of efficacy in MDD was demonstrated with duloxetine delayed-release capsules as monotherapy. Duloxetine delayed-release capsules should be administered at a total dose of 60 mg once daily. Patients should be periodically reassessed to determine the need for maintenance treatment and the appropriate dose for such treatment [see Clinical Studies ( 14.1 )] . Generalized Anxiety Disorder - It is generally agreed that episodes of generalized anxiety disorder require several months or longer of sustained pharmacological therapy. Maintenance of efficacy in GAD was demonstrated with duloxetine delayed-release capsules as monotherapy. Duloxetine delayed-release capsules should be administered in a dose range of 60 to 120 mg once daily. Patients should be periodically reassessed to determine the continued need for maintenance treatment and the appropriate dose for such treatment [see Clinical Studies ( 14.2 )] . Diabetic Peripheral Neuropathic Pain - As the progression of diabetic peripheral neuropathy is highly variable and management of pain is empirical, the effectiveness of duloxetine delayed-release capsules must be assessed individually. Efficacy beyond 12 weeks has not been systematically studied in placebo-controlled trials. Hepatic Insufficiency - It is recommended that duloxetine delayed-release capsules should ordinarily not be administered to patients with any hepatic insufficiency [see Warnings and Precautions ( 5.13 ) and Use in Specific Populations ( 8.9 )] . Severe Renal Impairment - Duloxetine delayed-release capsules are not recommended for patients with end-stage renal disease or severe renal impairment (estimated creatinine clearance <30 mL/min) [see Warnings and Precautions ( 5.13 ) and Use in Specific Populations ( 8.10 )] . Elderly Patients - No dose adjustment is recommended for elderly patients on the basis of age. As with any drug, caution should be exercised in treating the elderly. When individualizing the dosage in elderly patients, extra care should be taken when increasing the dose [see Use in Specific Populations ( 8.5 )] . Pregnant Women - There are no adequate and well-controlled studies in pregnant women; therefore, duloxetine delayed-release capsules should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus [see Use in Specific Populations ( 8.1 )] . Nursing Mothers - Because the safety of duloxetine in infants is not known, nursing while on duloxetine delayed-release capsules are not recommended [see Use in Specific Populations ( 8.3 )] . Symptoms associated with discontinuation of duloxetine delayed-release capsules and other SSRIs and SNRIs have been reported. A gradual reduction in the dose rather than abrupt cessation is recommended whenever possible [see Warnings and Precautions ( 5.7 )] . At least 14 days should elapse between discontinuation of an MAOI intended to treat psychiatric disorders and initiation of therapy with duloxetine delayed-release capsules. Conversely, at least 5 days should be allowed after stopping duloxetine delayed-release capsules before starting an MAOI intended to treat psychiatric disorders [see Contraindications ( 4.1 )]. Do not start duloxetine delayed-release capsules in a patient who is being treated with linezolid or intravenous methylene blue because there is an increased risk of serotonin syndrome. In a patient who requires more urgent treatment of a psychiatric condition, other interventions, including hospitalization, should be considered [see Contraindications ( 4.1 )]. In some cases, a patient already receiving duloxetine delayed-release capsules therapy may require urgent treatment with linezolid or intravenous methylene blue. If acceptable alternatives to linezolid or intravenous methylene blue treatment are not available and the potential benefits of linezolid or intravenous methylene blue treatment are judged to outweigh the risks of serotonin syndrome in a particular patient, duloxetine delayed-release capsules should be stopped promptly, and linezolid or intravenous methylene blue can be administered. The patient should be monitored for symptoms of serotonin syndrome for 5 days or until 24 hours after the last dose of linezolid or intravenous methylene blue, whichever comes first. Therapy with duloxetine delayed-release capsules may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue [see Warnings and Precautions ( 5.4 )]. The risk of administering methylene blue by non-intravenous routes (such as oral tablets or by local injection) or in intravenous doses much lower than 1 mg/kg with duloxetine delayed-release capsules is unclear. The clinician should, nevertheless, be aware of the possibility of emergent symptoms of serotonin syndrome with such use [see Warnings and Precautions ( 5.4 )] .