DULOXETINE HYDROCHLORIDE 20 mg/1

DULOXETINE HYDROCHLORIDE · CAPSULE, DELAYED RELEASE PELLETS · Yaopharma Co., Ltd.

No Recall History

Plain English

Duloxetine hydrochloride is a prescription medication taken by mouth that belongs to a class of antidepressants called serotonin-norepinephrine reuptake inhibitors (SNRIs), and it is used to treat depression, anxiety disorders, and certain pain conditions. Your doctor will determine the appropriate dose and duration of treatment based on your individual condition and medical history.

Key Facts

Brand Name: DULOXETINE HYDROCHLORIDE
Generic Name: DULOXETINE HYDROCHLORIDE
NDC Code (Product): 50771-201
Manufacturer: Yaopharma Co., Ltd.
Strength: 20 mg/1
Dosage Form: CAPSULE, DELAYED RELEASE PELLETS
Route: ORAL
Marketing Status
Application #: ANDA207219
Marketing Start: 01/01/2024

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective5,251 reports

nausea4,954 reports

fatigue4,917 reports

off label use4,206 reports

pain3,783 reports

headache3,765 reports

diarrhoea3,376 reports

dizziness3,117 reports

fall2,860 reports

vomiting2,543 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE Duloxetine delayed-release capsules are 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 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 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 Geriatric Pediatrics (7 to 17 years of age) 60 mg/day 30 mg/day 30 mg/day 60 mg/day (once daily) 60 mg/day (once daily) 30 to 60 mg/day (once daily) 120 mg/day 120 mg/day 120 mg/day DPNP (2.4) 60 mg/day 60 mg/day (once daily) 60 mg/day FM (2.5) Adults 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 capsule 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 liquids because these actions might affect the enteri…

Contraindications

4 CONTRAINDICATIONS The use of MAOIs intended to treat psychiatric disorders with duloxetine delayed-release capsule or within 5 days of stopping treatment with duloxetine delayed-release capsule 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 capsule 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 capsule is contraindicated Use of duloxetine delayed-release capsule within 14 days of stopping an MAOI antidepressant is contraindicated In linezolid-or intravenous methylene blue-treated patients, initiation of duloxetine delayed-release capsule 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 concentrations (7.2). Duloxetine is a moderate inhibitor of CYP2D6 (7.9). 7.1 Inhibitors of CYP1A2 When duloxetine delayed-release capsules 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 delayed-release capsules (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 CYP2D…

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 placebo-treated pat…

Frequently Asked Questions

What is DULOXETINE HYDROCHLORIDE used for?

Is DULOXETINE HYDROCHLORIDE a controlled substance?

DULOXETINE HYDROCHLORIDE is not classified as a controlled substance by the DEA.

What is the generic name for DULOXETINE HYDROCHLORIDE?

The generic name for DULOXETINE HYDROCHLORIDE is DULOXETINE HYDROCHLORIDE. There are 11 other brand versions of DULOXETINE HYDROCHLORIDE.

What is the NDC code for DULOXETINE HYDROCHLORIDE 20 mg/1?

The NDC (National Drug Code) for DULOXETINE HYDROCHLORIDE 20 mg/1 is 50771-201, listed by Yaopharma Co., Ltd..

Product NDC

50771-201

Package NDC

50771-201-01

Other Duloxetine Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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