What is a Generic Drug?
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.
The only differences between generics and their brand-name counterparts is that generics are less expensive and may look slightly different (eg. different shape or color), as trademarks laws prevent a generic from looking exactly like the brand-name drug.
Generics are less expensive because generic manufacturers don't have to invest large sums of money to develop a drug. When the brand-name patent expires, generic companies can manufacture a copy of the brand-name and sell it at a substantial discount.
Drizalma Sprinkle (Duloxetine)
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Product Details
Description
Drizalma Sprinkle (duloxetine delayed-release) is classified as a serotonin and norepinephrine reuptake inhibitor (SNRI) used for the treatment of major depressive disorder (MDD) in adults, generalized anxiety disorder (GAD) in adults and pediatric patients between 7 years old and 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 20 mg, 30 mg, 40 mg, and 60 mg delayed-release capsules. The capsules can be taken with or without food. Do not crush or chew the capsule. You may swallow the capsule whole or open it to sprinkle over applesauce or administered by nasogastric tube.
If you miss a dose, take it as soon as you remember. Do not take two doses at the same time.
Drizalma Sprinkle Dosing
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
Duloxetine hydrochloride is the active ingredient contained in Drizalma Sprinkle capsules.
Contraindications
Do not take monoamine oxidase inhibitors (MAOIs) for treating psychiatric disorders with Drizalma Sprinkle or within 5 days of stopping Drizalma Sprinkle.
Do not take Drizalma Sprinkle within 2 weeks of stopping an MAOI for the treatment of psychiatric disorders.
Do not start taking Drizalma Sprinkle if you are taking 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
- Talk to your doctor about your allergies.
- Tell your doctor about all the medications you take, including prescription, over-the-counter, vitamins, and supplements.
- Tell your doctor if you have liver problems. Drizalma Sprinkle may cause liver failure or death. Tell your doctor right away if you develop yellowing of your eyes or skin or any other symptoms.
- Tell your doctor if you drink alcohol or have chronic liver disease.
- Tell your doctor if you have blood pressure problems. Drizalma Sprinkle may cause your blood pressure to suddenly drop upon standing from sitting or lying down.
- Your risk for serotonin syndrome is increased if you take Drizalma Sprinkle by itself or with other serotonergic medications (SSRI, SNRI, triptans). Stop taking Drizalma Sprinkle and seek medical care right away if you experience agitation, restlessness, trouble sleeping, confusion, fast heart rate, blood pressure problems, dilated pupils, muscle twitches, muscle rigidity, sweating, diarrhea, headache, or shivering.
- Drizalma Sprinkle may increase your risk for bleeding, especially if you are taking NSAIDs, aspirin, warfarin, or other antiplatelets or anticoagulants. Tell your doctor right away if you notice signs of bleeding, including bleeding from your gums, bleeding from your nose, or blood in your stool.
- Drizalma Sprinkle can cause severe skin reactions. Stop taking Drizalma Sprinkle if you develop blisters, peeling rash, or mucosal erosions.
- Do not stop taking Drizalma Sprinkle suddenly due to the risk of discontinuation syndrome. You should gradually be tapered off.
- Caution should be used if you have bipolar disorder.
- Tell your doctor if you have eye problems such as glaucoma.
- Tell your doctor if you have seizures.
- Tell your doctor if you have blood pressure problems.
- Drizalma Sprinkle can cause low sodium levels. Tell your doctor right away if you experience nausea, vomiting, headache, confusion, drowsiness, weakness, tiredness, muscle weakness, muscle spasms or cramps, restlessness, irritability, or seizures.
- Tell your doctor if you have diabetes.
Side Effects
Tell your doctor if you develop side effects that are bothersome or won't go away. The most common side effects of Drizalma Sprinkle include dry mouth, nausea, drowsiness, constipation, decreased appetite, and excessive sweating.
References:
- Drizalma Sprinkle Prescribing Information. Cranbury, NJ: Sun Pharmaceutical Industries, Inc.; 2019.
- Serotonin syndrome. Mayo Clinic. January 22, 2022. Accessed January 27, 2022.
- 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.Product Code : 13575
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