البلد: الولايات المتحدة
اللغة: الإنجليزية
المصدر: NLM (National Library of Medicine)
DULOXETINE HYDROCHLORIDE (UNII: 9044SC542W) (DULOXETINE - UNII:O5TNM5N07U)
SUN PHARMACEUTICAL INDUSTRIES, INC.
ORAL
PRESCRIPTION DRUG
DRIZALMA SPRINKLE is indicated for the treatment of: Additional pediatric use information is approved for Eli Lilly and Company, Inc.’s CYMBALTA (duloxetine delayed-release capsules). However, due to Eli Lilly and Company Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. The use of MAOIs intended to treat psychiatric disorders with DRIZALMA SPRINKLE, or within 5 days of stopping treatment with DRIZALMA SPRINKLE, are contraindicated because of an increased risk of serotonin syndrome. The use of DRIZALMA SPRINKLE within 14 days of stopping an MAOI intended to treat psychiatric disorders is contraindicated [see Dosage and Administration (2.10), Warnings and Precautions (5.4), Drug Interactions (7)] . Starting DRIZALMA SPRINKLE in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue is contraindicated because of an increased risk of serotonin syndrome [see Warnings and Precautions (5.4)] . Pregnancy Exposure Registry There i
Features Strengths 20 mg a 30 mg a 40 mg a 60 mg a Body color Green White White Green Cap color Green Blue White Blue Cap imprint RG53 RG54 RL85 RG55 Body imprint RG53 RG54 RL85 RG55 Presentations and NDC Codes Bottles of 30 47335-616-30 47335-617-30 47335-618-30 47335-619-30 Bottles of 60 47335-616-60 47335-617-60 47335-618-60 47335-619-60 Bottles of 90 47335-616-90 47335-617-90 47335-618-90 47335-619-90 Bottles of 1000 47335-616-10 47335-617-10 47335-618-10 47335-619-10 Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Dispense in a tightly closed container. For 30, 60, and 90 count bottles only: This package is child-resistant.
New Drug Application
DRIZALMA SPRINKLE- duloxetine capsule, delayed release SUN PHARMACEUTICAL INDUSTRIES, INC. ---------- Medication Guide DRIZALMA SPRINKLE (dri zal' mah) (duloxetine delayed-release capsules) What is the most important information I should know about DRIZALMA SPRINKLE? DRIZALMA SPRINKLE may cause serious side effects, including: • Increased risk of suicidal thoughts or actions. DRIZALMA SPRINKLE and other antidepressant medicines may increase suicidal thoughts and actions in some people 24 years of age and younger, especially within the first few months of treatment or when the dose is changed. • Depression and other serious mental illnesses are the most important causes of suicidal thoughts or actions. How can I watch for and try to prevent suicidal thoughts and actions? o Pay close attention to any changes in mood, behavior, actions, thoughts, or feelings, especially sudden changes. This is very important when an antidepressant medicine is started or when the dose is changed. o Call your healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings. o Keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you have concerns about symptoms. Call your healthcare provider or get emergency help right away if you or your family member have any of the following symptoms, especially if they are new, worse, or worry you: • attempts to commit suicide • acting on dangerous impulses • acting aggressive, being angry, or violent • thoughts about suicide or dying • new or worse depression • new or worse anxiety • panic attacks • feeling very agitated or restless • new or worse irritability • trouble sleeping • an extreme increase in activity or talking (mania) • other unusual changes in behavior or mood What is DRIZALMA SPRINKLE? DRIZALMA SPRINKLE is prescription medicine used to treat: • A certain type of depression called Major Depressive Disorder (MDD) in adults • Gene اقرأ الوثيقة كاملة
DRIZALMA SPRINKLE- DULOXETINE CAPSULE, DELAYED RELEASE SUN PHARMACEUTICAL INDUSTRIES, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE DRIZALMA SPRINKLE SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR DRIZALMA SPRINKLE. DRIZALMA SPRINKLE™ (DULOXETINE DELAYED-RELEASE CAPSULES), FOR ORAL USE. INITIAL U.S. APPROVAL: 2004 WARNING: SUICIDAL THOUGHTS AND BEHAVIORS _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ • • RECENT MAJOR CHANGES INDICATIONS AND USAGE DRIZALMA SPRINKLE is a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of following conditions: (1) DOSAGE AND ADMINISTRATION • • • INDICATION (2) STARTING DOSE (2) TARGET DOSE (2) MAXIMUM DOSE (2) MDD (2.2) (2) Adults (2) 40 mg/day to (2) 60 mg/day (2) 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 (2) 120 mg/day (2) GAD (2.3) (2) Adults (2) 60 mg/day (2) 60 mg/day (once daily) (2) 120 mg/day (2) Geriatric (2) 30 mg/day (2) 60 mg/day (once daily) (2) 120 mg/day (2) Pediatrics (7 to 17 years of age) (2) 30 mg/day (2) 30 to 60 mg/day (once daily) (2) 120 mg/day (2) DPNP (2.4) (2) 60 mg/day (2) 60 mg/day (once daily) (2) 60 mg/day (2) FM (2.5) (2) 30 mg/day (2) 60 mg/day (once daily) (2) 60 mg/day (2) INCREASED RISK OF SUICIDAL THINKING AND BEHAVIOR IN PEDIATRIC AND YOUNG ADULT PATIENTS TAKING ANTIDEPRESSANTS (5.1) CLOSELY MONITOR ALL ANTIDEPRESSANT-TREATED PATIENTS FOR CLINICAL WORSENING AND EMERGENCE OF SUICIDAL THOUGHTS AND BEHAVIORS (5.1) Indications and Usage; Fibromyalgia (1) 07/2021 Dosage and Administration (2.5, 2.6, 2.12) 07/2021 Warnings and Precautions (5.16) 07/2021 • Major Depressive Disorder (MDD) in adults (1) • Generalized Anxiety Disorder (GAD) in adults and pediatric patients ages 7 years of age and older (1) • Diabetic Peripheral Neuropathic Pain (DPNP) in adults (1) • Fibromyalgia (FM) in adults (1) • Chronic Mu اقرأ الوثيقة كاملة