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Drizalma Sprinkle (Duloxetine)

Prescription medicineOnly Available By Prescription
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20mg
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30mg
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Strength
40mg
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Strength
60mg
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A generic drug is a copy of the brand-name drug with the same dosage, safety, strength, quality, consumption method, performance, and intended use. Before generics become available on the market, the generic company must prove it has the same active ingredients as the brand-name drug and works in the same way and in the same amount of time in the body.

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Description

Drizalma Sprinkle (duloxetine delayed-release) is a serotonin and norepinephrine reuptake inhibitor (SNRI) used to treat major depressive disorder (MDD) in adults, generalized anxiety disorder (GAD) in adults and pediatric patients (7 to 17 years old), diabetic peripheral neuropathic pain (DPNP) in adults, and chronic musculoskeletal pain in adults.


Fact Table

Formula

C18H19NOS

License

US FDA, US DailyMed, EU EMA

Bioavailability

32% to 80%

Legal status

Rx-Only

Chemical Name

Duloxetine

Elimination half-life

12 hours

Dosage (Strength)

20mg, 30mg, 40mg, 60mg

Pregnancy

Consult Doctor

Brands

Drizalma Sprinkle

Protein binding

95%

PubChem CID

60835

MedlinePlus

a604030

ChEBI

36795

ATC code

N06AX21

DrugBank

DB00476

KEGG

D07880

Routes of administration

By mouth (tablets)

Directions

Drizalma Sprinkle is available in delayed-release capsules of 20 mg, 30 mg, 40 mg, and 60 mg strengths. Drizalma Sprinkle may be taken with or without food. Avoid crushing or chewing the capsule. The capsule may be swallowed whole or opened to be sprinkled over applesauce or given by nasogastric tube.

If you forget to take a dose, take it as soon as you remember. Do not take two doses at once.

Dosing for Drizalma Sprinkle

MDD

Starting Dose

Target Dose

Maximum Dose




40 mg/day to 60 mg/day

Acute treatment: 40 mg/day (20 mg twice daily) to 60 mg/day (60 mg once daily or 30 mg twice daily)


Maintenance treatment: 60 mg/day




120 mg/day

GAD

Starting Dose

Target Dose

Maximum Dose

Adults

60 mg/day

60 mg once daily

120 mg/day

Elderly

30 mg/day

60 mg once daily

120 mg/day

Children and Adolescents (7 to 17 years of age)


30 mg/day


30 mg to 60 mg once daily


120 mg/day

DPNP

Starting Dose

Target Dose

Maximum Dose

60 mg/day

60 mg once daily

60 mg/day

Chronic Musculoskeletal Pain

Starting Dose

Target Dose

Maximum Dose

30 mg/day

60 mg once daily

60 mg/day

Ingredients

The active ingredient in Drizalma Sprinkle capsules is duloxetine hydrochloride

Contraindications

You should not take monoamine oxidase inhibitors (MAOIs) for treating psychiatric problems with Drizalma Sprinkle or within 5 days of discontinuing Drizalma Sprinkle. 

You should not take Drizalma Sprinkle within 2 weeks of discontinuing an MAOI for the treatment of psychiatric problems. 

You should not begin treatment with Drizalma Sprinkle if you are being treated with linezolid or intravenous methylene blue.

Cautions

WARNING: SUICIDAL THOUGHTS AND BEHAVIORS

See full prescribing information for complete boxed warning.

  • Increased risk of suicidal thinking and behavior in pediatric and young adult patients taking antidepressants 
  • Closely monitor all antidepressant-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors
  • Discuss your allergies with your doctor.
  • Discuss all the medications you take with your doctor. These include prescription, over-the-counter, vitamins, and herbal supplements.
  • Let your doctor know if you have liver issues. Drizalma Sprinkle may cause liver failure that can be fatal. Contact your doctor immediately if you develop yellowing of your eyes or skin or any other symptoms of liver problems.
  • Let your doctor know if you drink alcohol or have chronic liver disease.
  • Let your doctor know if you have blood pressure problems. Drizalma Sprinkle may cause a sudden drop in your blood pressure when standing from sitting or lying down.
  • The risk for serotonin syndrome is increased with the use of Drizalma Sprinkle by itself or with concomitant use of Drizalma Sprinkle and other serotonergic medications (SSRI, SNRI, triptans). Stop taking Drizalma Sprinkle and seek medical attention immediately if you experience agitation, confusion, dilated pupils, diarrhea, headache, excessive sweating, shivering, rapid heart rate, restlessness, trouble sleeping, problems with your blood pressure problems, muscle twitches, or muscle rigidity. 
  • Your risk for bleeding may be increased while taking Drizalma Sprinkle, especially if you take NSAIDs, aspirin, warfarin, or other antiplatelets or anticoagulants. Contact your doctor immediately if you experience signs of bleeding such as bleeding from your gums, bleeding from your nose, or blood in your stool.
  • Severe skin reactions can occur with the use of Drizalma Sprinkle. Stop taking Drizalma Sprinkle and seek medical care immediately if you develop blisters, peeling rash, or mucosal erosions.
  • Do not suddenly stop taking Drizalma Sprinkle due to the risk of discontinuation syndrome. 
  • If you have bipolar disorder, use caution while taking Drizalma Sprinkle. 
  • Let your doctor know if you have glaucoma or other eye problems.
  • Let your doctor know if you have seizures.
  • Let your doctor know if you have blood pressure problems.
  • Drizalma Sprinkle can cause low sodium levels. Let your doctor know immediately if you have nausea, vomiting, headache, confusion, drowsiness, weakness, tiredness, muscle weakness, muscle spasms or cramps, restlessness, irritability, or seizures. 
  • Let your doctor know if you have diabetes.

Side Effects

Let your doctor know if you develop any side effects while taking Drizalma Sprinkle. The most common side effects include dry mouth, nausea, drowsiness, constipation, decreased appetite, and excessive sweating. 

References:

  1. Drizalma Sprinkle Prescribing Information. Cranbury, NJ: Sun Pharmaceutical Industries, Inc.; 2019.
  2. Serotonin syndrome. Mayo Clinic. January 22, 2022. Accessed January 27, 2022.
  3. Hyponatremia. Mayo Clinic. May 23, 2020. Accessed January 27, 2022.


IMPORTANT NOTE: The above information is intended to increase awareness of health information and does not suggest treatment or diagnosis. This information is not a substitute for individual medical attention and should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. See your health care professional for medical advice and treatment.

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