Duloxetine 60 mg/1
Duloxetine · CAPSULE, DELAYED RELEASE · Bryant Ranch Prepack
Duloxetine is an oral prescription medication used to treat depression, anxiety, and certain types of chronic pain conditions. It comes as a delayed-release capsule that you swallow by mouth.
Key Facts
- Brand Name
- Duloxetine
- Generic Name
- Duloxetine
- NDC Code (Product)
71335-2625- Manufacturer
- Bryant Ranch Prepack
- Strength
- 60 mg/1
- Dosage Form
- CAPSULE, DELAYED RELEASE
- Route
- ORAL
- Marketing Status
- Application #
- ANDA090694
- Marketing Start
- 12/11/2013
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.
American Pharmaceutical Ingredients LLC
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Direct Rx
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed 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
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 used for?
Duloxetine is an oral prescription medication used to treat depression, anxiety, and certain types of chronic pain conditions. It comes as a delayed-release capsule that you swallow by mouth.
Is Duloxetine a controlled substance?
Duloxetine is not classified as a controlled substance by the DEA.
What is the generic name for Duloxetine?
The generic name for Duloxetine is Duloxetine. There are 8 other brand versions of Duloxetine.
What is the NDC code for Duloxetine 60 mg/1?
The NDC (National Drug Code) for Duloxetine 60 mg/1 is 71335-2625, listed by Bryant Ranch Prepack.