DRIZALMA SPRINKLE 30 mg/1

Duloxetine · CAPSULE, DELAYED RELEASE · SUN PHARMACEUTICAL INDUSTRIES, INC.

No Recall History

Plain English

Drizalma Sprinkle is a delayed-release capsule containing duloxetine, an antidepressant medication used to treat depression, anxiety, and chronic pain conditions. The capsule can be opened and sprinkled on food for patients who have difficulty swallowing whole capsules.

Key Facts

Brand Name: DRIZALMA SPRINKLE
Generic Name: Duloxetine
NDC Code (Product): 47335-617
Manufacturer: SUN PHARMACEUTICAL INDUSTRIES, INC.
Strength: 30 mg/1
Dosage Form: CAPSULE, DELAYED RELEASE
Route: ORAL
Marketing Status
Application #: NDA212516
Marketing Start: 06/10/2024

Recall History

No Recall History

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE DRIZALMA SPRINKLE 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 Neuropathy in adults • Fibromyalgia in adults • Chronic Musculoskeletal Pain in adults 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. DRIZALMA SPRINKLE is a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of following conditions: • 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 Musculoskeletal Pain in adults (1)

Dosage & Administration

2 DOSAGE AND ADMINISTRATION • Take DRIZALMA SPRINKLE with or without food (2.1) • DRIZALMA SPRINKLE may be: swallowed whole (do not crush or chew capsule); opened and sprinkled over applesauce; or administered via nasogastric tube (2.1) • Take a missed dose as soon as it is remembered. Do not take two doses of DRIZALMA SPRINKLE at the same time (2.1) Indication Starting Dose Target Dose Maximum Dose MDD (2.2) Adults 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 30 mg/day 60 mg/day (once daily) 60 mg/day Chronic Musculoskeletal Pain (2.6) Adults 30 mg/day 60 mg/day (once daily) 60 mg/day • There is no evidence that doses greater than 60 mg/day confers additional benefit, while some adverse reactions were observed to be dose-dependent (2) • Discontinuing DRIZALMA SPRINKLE: Gradually reduce dosage to avo…

Contraindications

4 CONTRAINDICATIONS 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)] . Serotonin Syndrome and MAOIs : Do not use MAOIs intended to treat psychiatric disorders with DRIZALMA SPRINKLE or within 5 days of stopping treatment with DRIZALMA SPRINKLE. Do not use DRIZALMA SPRINKLE within 14 days of stopping an MAOI intended to treat psychiatric disorders. In addition, do not start DRIZALMA SPRINKLE in a patient who is being treated with linezolid or intravenous methylene blue (4)

Drug Interactions

7 DRUG INTERACTIONS • Potent CYP1A2 Inhibitors: Avoid concomitant use (2.6, 7) • CYP2D6 Substrates: Consider dose reduction with concomitant use (7) 7.1 Drugs Having Clinically Important Interactions with DRIZALMA SPRINKLE Table 7: Clinically Important Drug Interactions Monoamine Oxidase Inhibitors (MAOIs) Clinical Impact Concomitant use of SSRIs and SNRIs including duloxetine with MAOIs increases the risk of serotonin syndrome. Intervention •The use of MAOIs intended to treat psychiatric disorders with duloxetine or within 5 days of stopping treatment with duloxetine is contraindicated [see Contraindications (4) and Warnings and Precautions (5.4)] .•The use of duloxetine delayed-release capsules within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated [see Contraindications (4) and Warnings and Precautions (5.4)] .•Starting duloxetine in a patient who is being treated with MAOIs is also contraindicated [see Dosage and Administration (2.10), Contraindications (4), Warnings and Precautions (5.4)] . Examples Selegiline, tranylcypromine, isocarboxazid, phenelzine, linezolid, intravenous methylene blue Other Serotonergic Drugs Clinical Impact C…

Adverse Reactions

6 ADVERSE REACTIONS The following adverse reactions are discussed in more detail in other sections of the labeling: Suicidal Thoughts and Behaviors in 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 patients)…

Frequently Asked Questions

What is DRIZALMA SPRINKLE used for?

Is DRIZALMA SPRINKLE a controlled substance?

DRIZALMA SPRINKLE is not classified as a controlled substance by the DEA.

What is the generic name for DRIZALMA SPRINKLE?

The generic name for DRIZALMA SPRINKLE is Duloxetine. There are 12 other brand versions of Duloxetine.

What is the NDC code for DRIZALMA SPRINKLE 30 mg/1?

The NDC (National Drug Code) for DRIZALMA SPRINKLE 30 mg/1 is 47335-617, listed by SUN PHARMACEUTICAL INDUSTRIES, INC..

Product NDC

47335-617

Package NDC

47335-617-10

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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