Duloxetine Delayed-Release 20 mg/1
DULOXETINE HYDROCHLORIDE · CAPSULE, DELAYED RELEASE PELLETS · Bryant Ranch Prepack
Duloxetine Delayed-Release is a capsule, delayed release pellets containing duloxetine hydrochloride at 20 mg/1, taken oral. Manufactured by Bryant Ranch Prepack.
Key Facts
- Brand Name
- Duloxetine Delayed-Release
- Generic Name
- DULOXETINE HYDROCHLORIDE
- NDC Code (Product)
71335-0165- Manufacturer
- Bryant Ranch Prepack
- Strength
- 20 mg/1
- Dosage Form
- CAPSULE, DELAYED RELEASE PELLETS
- Route
- ORAL
- Marketing Status
- Application #
- ANDA203088
- Marketing Start
- 06/11/2014
Recall History
AVKARE Inc.
Failed Impurities/Degradation Specifications: slightly elevated levels of phthalic acid.
Lupin Pharmaceuticals Inc.
Failed Dissolution Specification
Amerisource Health Services LLC
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit
Breckenridge Pharmaceutical, Inc.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above safety assessment limit
Breckenridge Pharmaceutical, Inc
CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Apotex Scientific, Inc
Failed Dissolution Specification: Out of specification dissolution results when testing product stability.
Breckenridge Pharmaceutical, Inc
Presence of Foreign Tablets/Capsules: one foreign capsule identified as omeprazole 10 mg was found in the bottle
Amerisource Health Services LLC
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit
Amerisource Health Services LLC
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit.
Breckenridge Pharmaceutical, Inc.
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Duloxetine delayed-release capsules is indicated for the treatment of: Major depressive disorder in adults Generalized anxiety disorder in adults and pediatric patients 7 years of age and older Diabetic peripheral neuropathic pain in adults Fibromyalgia in adults and pediatric patients 13 years of age and older Chronic musculoskeletal pain in adults Duloxetine delayed-release capsules are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of the following conditions: Major depressive disorder (MDD) in adults ( 1 ) Generalized anxiety disorder (GAD) in adults and pediatric patients 7 years of age and older ( 1 ) Diabetic peripheral neuropathic pain (DPNP) in adults ( 1 ) Fibromyalgia (FM) in adults and pediatric patients 13 years of age and older ( 1 ) Chronic musculoskeletal pain in adults ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Take Duloxetine delayed-release capsules once daily, with or without food. Swallow whole; do not crush, chew, or open capsule ( 2.1 ) Indication Starting Dose Target Dose Maximum Dose MDD ( 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 ( 2.3 ) Adults 60 mg/day 60 mg/day (once daily) 120 mg/day Geriatric 30 mg/day 60 mg/day (once daily) 120 mg/day Pediatrics (7 to 17 years of age) 30 mg/day 30 to 60 mg/day (once daily) 120 mg/day DPNP ( 2.4 ) 60 mg/day 60 mg/day (once daily) 60 mg/day FM ( 2.5 ) Adults and Pediatrics (13 to 17 years of age) 30 mg/day 60 mg/day (once daily) 60 mg/day Chronic Musculoskeletal Pain ( 2.6 ) 30 mg/day 60 mg/day (once daily) 60 mg/day Discontinuing Duloxetine delayed-release capsules: Gradually reduce dosage to avoid discontinuation symptoms ( 2.8 , 5.7 ) 2.1 Important Administration Instructions Administer Duloxetine delayed-release capsules orally (with or without meals) and swallow whole. Do not chew or crush, and do not open the delayed-release capsule and sprinkle its contents on food or mix with …
Contraindications
4 CONTRAINDICATIONS 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 contraindicated [see Dosage and Administration (2.8) and Warnings and Precautions (5.4) ]. 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 [see Dosage and Administration (2.9) and Warnings and Precautions (5.4) ]. Concomitant use of an MAOI antidepressant with Duloxetine delayed-release capsules is contraindicated Use of Duloxetine delayed-release capsules within 14 days of stopping an MAOI antidepressant is contraindicated In linezolid- or intravenous methylene blue-treated patients, initiation of Duloxetine delayed-release capsules is contraindicated ( 4 )
Drug Interactions
7 DRUG INTERACTIONS Both CYP1A2 and CYP2D6 are responsible for duloxetine metabolism. Potent inhibitors of CYP1A2 should be avoided ( 7.1 ) Potent inhibitors of CYP2D6 may increase Duloxetine delayed-release capsules concentrations ( 7.2 ) Duloxetine delayed-release capsules is a moderate inhibitor of CYP2D6 ( 7.9 ) 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) ]. 7.2 Inhibitors of CYP2D6 Concomitant use of duloxetine (40 mg once daily) with paroxetine (20 mg once daily) increased the concentration of duloxetine AUC by about 60%, and greater degrees of inhibition are expected with higher doses of paroxetine. Similar effects would be expected with other potent CYP2D6 inhibitors (e.g., fluoxetine, quinidine) [see Warnings and Precautions (5.12) ]. 7.3 Dual Inhibition of CYP1A2 and CY…
Adverse Reactions
6 ADVERSE REACTIONS The following serious adverse reactions are described below and elsewhere in the labeling: Suicidal Thoughts and Behaviors in Children, Adolescents, and Young Adults [see Boxed Warning and Warnings and Precautions (5.1) ] Hepatotoxicity [see Warnings and Precautions (5.2) ] Orthostatic Hypotension, Falls and Syncope [see Warnings and Precautions (5.3) ] Serotonin Syndrome [see Warnings and Precautions (5.4) ] Increased Risk of Bleeding [see Warnings and Precautions (5.5) ] Severe Skin Reactions [see Warnings and Precautions (5.6) ] Discontinuation Syndrome [see Warnings and Precautions (5.7) ] Activation of Mania/Hypomania [see Warnings and Precautions (5.8) ] Angle-Closure Glaucoma [see Warnings and Precautions (5.9) ] Seizures [see Warnings and Precautions (5.10) ] Increases in Blood Pressure [see Warnings and Precautions (5.11) ] Clinically Important Drug Interactions [see Warnings and Precautions (5.12) ] Hyponatremia [see Warnings and Precautions (5.13) ] Urinary Hesitation and Retention [see Warnings and Precautions (5.15) ] Sexual Dysfunction [see Warnings and Precautions (5.16) ] Most common adverse reactions (≥5% and at least twice the incidence of plac…
Frequently Asked Questions
What is Duloxetine Delayed-Release used for?
Duloxetine Delayed-Release contains DULOXETINE HYDROCHLORIDE. It is a capsule, delayed release pellets taken oral. Consult your doctor for specific uses.
Is Duloxetine Delayed-Release a controlled substance?
Duloxetine Delayed-Release is not classified as a controlled substance by the DEA.
What is the generic name for Duloxetine Delayed-Release?
The generic name for Duloxetine Delayed-Release is DULOXETINE HYDROCHLORIDE. There are 7 other brand versions of DULOXETINE HYDROCHLORIDE.
What is the NDC code for Duloxetine Delayed-Release 20 mg/1?
The NDC (National Drug Code) for Duloxetine Delayed-Release 20 mg/1 is 71335-0165, listed by Bryant Ranch Prepack.