Duloxetin Hydrochloride
Generic Name: duloxetin hydrochloride
Brand Names:
Duloxetine Hydrochloride
11. DESCRIPTION Duloxetine hydrochloride, USP 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 empirical formula is C 18 H 19 NOS•HCl, which corresponds to a molecular weight of 333.88. The structural formula is: Duloxetine hydrochloride, USP is a white to slightly brownish white solid, which is slightly soluble in water.
Overview
11. DESCRIPTION Duloxetine hydrochloride, USP 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 empirical formula is C 18 H 19 NOS•HCl, which corresponds to a molecular weight of 333.88. The structural formula is: Duloxetine hydrochloride, USP is a white to slightly brownish white solid, which is slightly soluble in water.
Uses
1. INDICATIONS AND USAGE Duloxetine delayed-release capsules, USP are 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) • Chronic Musculoskeletal Pain (1.5) 1.1 Major Depressive Disorder 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)] .
Dosage
2. DOSAGE AND ADMINISTRATION • Duloxetine delayed-release capsules should generally be administered once daily without regard to meals. Duloxetine delayed-release capsules should be swallowed whole and should not be chewed or crushed, nor should the capsule be opened and its contents be sprinkled on food or mixed with liquids (2) Indication Starting Dose Target Dose Maximum Dose MDD (2.1, 2.2) 40 mg/day to 60 mg/day Acute Treatment: 40 mg/day (20 mg twice daily) to 60 mg/day (once daily or as 30 mg twice daily); Maintenance Treatment: 60 mg/day 120 mg/day GAD (2.1) 60 mg/day 60 mg/day (once daily) 120 mg/day DPNP (2.1) 60 mg/day 60 mg/day (once daily) 60 mg/day Chronic Musculoskeletal Pain (2.1) 30 mg/day 60 mg/day (once daily) 60 mg/day • Some patients may benefit from starting at 30 mg o...
Side Effects
6. ADVERSE REACTIONS • Most common adverse reactions (≥5% and at least twice the incidence of placebo patients): nausea, dry mouth, somnolence, constipation, decreased appetite, and hyperhidrosis (6.3). To report SUSPECTED ADVERSE REACTIONS, contact Torrent Pharma Inc. at 1-269-544-2299 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trial Data Sources The data described below reflect exposure to duloxetine in placebo-controlled trials for MDD (N=2489), GAD (N=910), OA (N=239), CLBP (N=600), and DPNP (N=906).The population studied was 17 to 91 years of age; 65.5%, 62.5%, 61.5%, and 42.9% female; and 86.5%, 81.2%, 86.2%, and 74.0% Caucasian for MDD, GAD, OA and CLBP, and DPNP, respectively.
Interactions
7. DRUG INTERACTIONS • Potent inhibitors of CYP1A2 should be avoided (7.1). • Potent inhibitors of CYP2D6 may increase duloxetine concentrations (7.2). • Duloxetine is a moderate inhibitor of CYP2D6 (7.9). Both CYP1A2 and CYP2D6 are responsible for duloxetine metabolism. 7.1 Inhibitors of CYP1A2 When duloxetine 60 mg was co-administered with fluvoxamine 100 mg, a potent CYP1A2 inhibitor, to male subjects (n=14) duloxetine AUC was increased approximately 6-fold, the C max was increased about 2.5-fold, and duloxetine t 1/2 was increased approximately 3-fold. Other drugs that inhibit CYP1A2 metabolism include cimetidine and quinolone antimicrobials such as ciprofloxacin and enoxacin [see Warnings and Precautions (5.12)] .
Warnings
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS WARNING: SUICIDAL THOUGHTS AND BEHAVIORS See full prescribing information for complete boxed warning. • Increased risk of suicidal thinking and behavior in children, adolescents, and young adults taking antidepressants (5.1) • Monitor for worsening and emergence of suicidal thoughts and behaviors (5.1) • Duloxetine delayed-release capsules are not approved for use in pediatric patients (8.4) Antidepressants increased the risk of suicidal thoughts and beha... 5. WARNINGS AND PRECAUTIONS • Suicidality: Monitor for clinical worsening and suicide risk (5.1) • Hepatotoxicity: Hepatic failure, sometimes fatal, has been reported in patients treated with duloxetine delayed-release capsules. Duloxetine delayed-release capsules should be discontinued in patients who develop jaundice or other evidence of clinically significant liver dysfunction and should not be resumed unless another cause can be established. 4. CONTRAINDICATIONS • Serotonin Syndrome and MAOIs: Do not use MAOIs intended to treat psychiatric disorders with duloxetine delayed-release capsules or within 5 days of stopping treatment with duloxetine delayed-release capsules. Do not use duloxetine delayed-release capsules within 14 days of stopping an MAOI intended to treat psychiatric disorders.
Pregnancy
8.1 Pregnancy Teratogenic Effects, Pregnancy Category C — In animal reproduction studies, duloxetine has been shown to have adverse effects on embryo/fetal and postnatal development. When duloxetine was administered orally to pregnant rats and rabbits during the period of organogenesis, there was no evidence of teratogenicity at doses up to 45 mg/kg/day (7 times the maximum recommended human dose [MRHD, 60 mg/day] and 4 times the human dose of 120 mg/day on a mg/m 2 basis, in rat; 15 times the MRHD and 7 times the human dose of 120 mg/day on a mg/m 2 basis in rabbit).
Storage
16. HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied Duloxetine delayed-release capsules, USP 60 mg are size '1' hard gelatin capsules having opaque blue cap and yellow body, imprinted as '60 mg' on the body and '1111' on the cap with white ink, containing off white to reddish brown colored pellets.
Frequently Asked Questions
What is Duloxetin Hydrochloride used for?▼
1. INDICATIONS AND USAGE Duloxetine delayed-release capsules, USP are 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) • Chronic Musculoskeletal Pain (1.5) 1.1 Major Depressive Disorder 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)] .
What are the side effects of Duloxetin Hydrochloride?▼
6. ADVERSE REACTIONS • Most common adverse reactions (≥5% and at least twice the incidence of placebo patients): nausea, dry mouth, somnolence, constipation, decreased appetite, and hyperhidrosis (6.3). To report SUSPECTED ADVERSE REACTIONS, contact Torrent Pharma Inc. at 1-269-544-2299 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trial Data Sources The data described below reflect exposure to duloxetine in placebo-controlled trials for MDD (N=2489), GAD (N=910), OA (N=239), CLBP (N=600), and DPNP (N=906).The population studied was 17 to 91 years of age; 65.5%, 62.5%, 61.5%, and 42.9% female; and 86.5%, 81.2%, 86.2%, and 74.0% Caucasian for MDD, GAD, OA and CLBP, and DPNP, respectively.
Can I take Duloxetin Hydrochloride during pregnancy?▼
8.1 Pregnancy Teratogenic Effects, Pregnancy Category C — In animal reproduction studies, duloxetine has been shown to have adverse effects on embryo/fetal and postnatal development. When duloxetine was administered orally to pregnant rats and rabbits during the period of organogenesis, there was no evidence of teratogenicity at doses up to 45 mg/kg/day (7 times the maximum recommended human dose [MRHD, 60 mg/day] and 4 times the human dose of 120 mg/day on a mg/m 2 basis, in rat; 15 times the MRHD and 7 times the human dose of 120 mg/day on a mg/m 2 basis in rabbit).
What are the important warnings for Duloxetin Hydrochloride?▼
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS WARNING: SUICIDAL THOUGHTS AND BEHAVIORS See full prescribing information for complete boxed warning. • Increased risk of suicidal thinking and behavior in children, adolescents, and young adults taking antidepressants (5.1) • Monitor for worsening and emergence of suicidal thoughts and behaviors (5.1) • Duloxetine delayed-release capsules are not approved for use in pediatric patients (8.4) Antidepressants increased the risk of suicidal thoughts and beha... 5. WARNINGS AND PRECAUTIONS • Suicidality: Monitor for clinical worsening and suicide risk (5.1) • Hepatotoxicity: Hepatic failure, sometimes fatal, has been reported in patients treated with duloxetine delayed-release capsules. Duloxetine delayed-release capsules should be discontinued in patients who develop jaundice or other evidence of clinically significant liver dysfunction and should not be resumed unless another cause can be established. 4. CONTRAINDICATIONS • Serotonin Syndrome and MAOIs: Do not use MAOIs intended to treat psychiatric disorders with duloxetine delayed-release capsules or within 5 days of stopping treatment with duloxetine delayed-release capsules. Do not use duloxetine delayed-release capsules within 14 days of stopping an MAOI intended to treat psychiatric disorders.
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.