• Home News Sun Pharma Launches Drizalma Sprinkle now the U.S.

Sun Pharma Launches Drizalma Sprinkle now the U.S.

Posted 16 Oct-2019 11:36 AM by Vinita | 101


MUMBAI, India & PRINCETON, N.J.--(Press Release Power)--Sun Pharmaceutical Productions Ltd. (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUN PHARMA, BSE: 524715, “Sun Pharma” excluding its and/or associate companies) today announced that one of its absolutely owned branches has launched Drizalma Sprinkle™ (duloxetine delayed-release capsules) in the U.S. for oral use. Drizalma Sprinkle is a serotonin and norepinephrine reuptake inhibitor (SNRI) designed for the treatment of various neuropsychiatric and pain illnesses in patients who have difficulty swallowing – a problem that is expected to affect approximately 30-35% of long-term care residents. The U.S. Food and Drug Administration (FDA) appropriate Drizalma Sprinkle on July 19, 2019.

“The launch of Drizalma Sprinkle is an important milestone for people with difficulty swallowing, as this formulation of duloxetine can facilitate treatment of common neuropsychiatric disorders while preserving the quality of the medicine”

The availability of Drizalma Sprinkle expands Sun Pharma’s assortment of alternative formulation products designed for beings with swallowing difficulties, the risk of which increases with age and exposure to age-related diseases and conditions - including depression, anxiety, and pain disorders.1-2 Drizalma Sprinkle joins Ezallor Sprinkle™ (Rosuvastatin) and Kapspargo Sprinkle™ (metoprolol succinate) extended-release capsules as the third product in Sun Pharma’s US portfolio designed for individuals in long-term care. It is common practice in long-term care facilities to crush medications to ease administration, but crushing tablets introduces additional risks into the administration process.3 The Joint Commission International Accreditation Standards for Long Term Care urges facilities to dispense medications in forms that require minimal manipulation.4

“The launch of Drizalma Sprinkle is an important milestone for people with difficulty swallowing, as this formulation of duloxetine can facilitate treatment of common neuropsychiatric disorders while preserving the quality of the medicine,” said Abhay Gandhi, CEO, North America, Sun Pharma. ”This launch further underscores our commitment to providing a portfolio of alternative formulation products to treat common diseases – especially in long-term care, where 30-35% of individuals have difficulty swallowing. These patients often encounter medication errors and challenges with medication administration.”

Drizalma Sprinkle is indicated for the treatment of the major depressive disorder (MDD) in adults, generalized anxiety disorder (GAD) in adults and pediatric patients 7-17 years old, diabetic peripheral neuropathic pain (DPNP) in adults, and chronic musculoskeletal pain in adults. It is available in four dosage strengths (20mg, 30mg, 40mg, and 60mg). Drizalma Sprinkle is the first and only FDA-approved formulation of duloxetine that can be swallowed whole, sprinkled on applesauce or administered via nasogastric tube.

Drizalma Sprinkle carries a boxed warning for suicidal thoughts and behaviours. In clinical trials of Drizalma Sprinkle, the most common adverse reactions (in at least 5% of participants and at least twice the incidence of placebo) were nausea, dry mouth, somnolence, constipation, decreased appetite, and hyperhidrosis.


INDICATIONS AND USAGE

Drizalma Sprinkle (duloxetine delayed-release capsules) for oral use is indicated for the treatment of major depressive disorder in adults; generalized anxiety disorder in adults and pediatric patients aged 7 to 17 years; diabetic peripheral neuropathy in adults, and chronic musculoskeletal pain in adults.

IMPORTANT SAFETY INFORMATION

WARNING: SUICIDAL THOUGHTS AND BEHAVIORS: Antidepressants increased the risk of suicidal thoughts and behaviour in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening and for the emergence of suicidal thoughts and behaviors.

Contraindications

Serotonin syndrome and MAOIs: Do not use MAOIs intended to treat psychiatric disorders with Drizalma Sprinkle or inside 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.

WARNINGS AND PRECAUTIONS

Hepatotoxicity: Hepatic failure, sometimes fatal, has been reported in patients treated with duloxetine delayed-release capsules. Duloxetine delayed-release capsules should be discontinued in patients who develop jaundice or other evidence of clinically significant liver dysfunction and should not be resumed unless another cause can be established. Drizalma Sprinkle should not be prescribed to patients with substantial alcohol use or evidence of chronic liver disease.

Orthostatic Hypotension, Falls, and Syncope: Cases have been reported with duloxetine delayed-release capsules therapy. Syncope and orthostatic hypotension tend to occur within the first week of therapy but can occur at any time during treatment, particularly after dose increases.

Serotonin Syndrome: There is increased risk when coadministered with other serotonergic agents (eg, SSRIs, SNRIs, triptans), but also when taken alone. The concomitant use of Drizalma Sprinkle with MAOIs is contraindicated. Do not initiate Drizalma Sprinkle in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue. Monitor all patients taking Drizalma Sprinkle™ for the emergence of serotonin syndrome. If it occurs, discontinue Drizalma Sprinkle and initiate supportive treatment.

Increased Risk of Bleeding: Duloxetine may increase the risk of bleeding events. Concomitant use of NSAIDs, aspirin, other antiplatelet drugs, warfarin, and anticoagulants may increase this risk.

Severe Skin Reactions: Severe skin reactions, including erythema multiforme and Stevens-Johnson Syndrome, can occur with duloxetine. Drizalma Sprinkle should be discontinued at the first appearance of blisters, peeling rash, mucosal erosions, or any other sign of hypersensitivity if no other aetiology can be identified.

Discontinuation Syndrome: Adverse reactions after discontinuation of serotonergic antidepressants, particularly after abrupt discontinuation, include nausea, sweating, dysphoric mood, irritability, agitation, dizziness, sensory disturbances (e.g., paresthesias, such as electric shock sensations), tremor, anxiety, confusion, headache, lethargy, emotional lability, insomnia, hypomania, tinnitus, and seizures. A gradual reduction in dosage rather than abrupt cessation is recommended whenever possible.

Activation of Mania or Hypomania: In patients with bipolar disorder, treating a depressive episode with duloxetine delayed-release capsules or another antidepressant may precipitate a mixed/manic episode. Use cautiously in patients with bipolar disorder. Prior to initiating treatment with Drizalma Sprinkle, screen patients for any personal or family history of bipolar disorder, mania, or hypomania.

Angle-Closure Glaucoma: Duloxetine may trigger an angle-closure attack in patients with anatomically narrow angles who do not have a patent iridectomy. Avoid the use of antidepressants, including Drizalma Sprinkle, in patients with anatomically narrow angles.

Seizures: Drizalma Sprinkle should be prescribed with care in patients with a history of seizure disorder.

Blood Pressure: Monitor blood pressure prior to initiating treatment and periodically throughout treatment.

Hyponatremia: Can occur in association with SIADH. Cases of hyponatremia have been reported.

Glucose Control in Diabetes: In diabetic peripheral neuropathic pain patients, small increases in fasting blood glucose and HbA1c have been observed.

ADVERSE REACTIONS

The most common adverse reactions (≥5% and at least twice the incidence of placebo patients) were nausea, dry mouth, somnolence, constipation, decreased appetite, and hyperhidrosis.

DOSING AND ADMINISTRATION

Drizalma Sprinkle may be taken with or without food. Drizalma Sprinkle may be swallowed whole (do not crush or chew capsule); opened and sprinkled over applesauce; or administered via nasogastric tube.

DRUG INTERACTIONS

Avoid concomitant use with potent CYP1A2 inhibitors.
Consider dose reduction with concomitant use with CYP2D6 substrates.
USE IN SPECIFIC POPULATIONS

Hepatic Impairment: Avoid use in patients with mild, moderate, or severe hepatic impairment.

Renal Impairment: Avoid use in patients with severe renal impairment.

Pregnancy: Advise patients to notify their healthcare provider if they become pregnant or intend to become pregnant during treatment with Drizalma Sprinkle. Third-trimester use may increase the risk of symptoms of poor adaptation (respiratory distress, temperature instability, feeding difficulty, hypotonia, tremor, irritability) in the neonate.

Please see Full Prescribing Information by clicking here.

References:
1. Zis, P, Daskalaki, A, Bountouni, I, Sykioti, P, Varrassi, G, Paladini, A. Depression and chronic pain in the elderly: links and management challenges. Clinical Interventions in Aging. 2017;12:709–720. DOI: 10.2147/CIA.S113576.

2. Wolitzky-Taylor KB, Castriotta N, Lenze EJ, Stanley MA, Craske MG. Anxiety disorders in older adults: a comprehensive review. Depression and Anxiety. 2010;27(2):190-211. doi:10.1002/da.20653.

3. Hughes, PJ, Freeman, MK, Slaton, RM. Common Issues in the medication use processes in nursing homes: a review of medication use quality improvement strategies. Journal of Nursing Education and Practice. 2016;6(7):81-90. DOI: 10.5430/jnep.v6n7p81

4. Joint Commission International. Joint Commission International Endorsement Standards for Long Term Care. 1st ed. Oak Brook, IL: Joint Commission International; 2012.

Contacts
Media:
Vinita Alexander
Tel: 609-720-8197

Reba Auslander
Tel Direct 917-836-9308

For more information about Drizalma Sprinkle, visit DrizalmaSprinkle.com



Company Information

Company Name Contact Person Contact Number Email Id Website
Sun Pharma Vinita Alexander 6097208197 [email protected] http://stage.drizalmasprinkle.com/

Latest News

New Gong Cha Bubble Tea Store Opening In Friendswood, TX - Buy 1 Get 1 For Free Excluive

New York, USA - Gong Cha, one of the most popular bubble tea manufacturers in the U.S and all over the world, is set to open a new franchise in Friend...Read More


UGE Signs Agreement to Develop, Build, and Finance Community Solar Project in New York City Excluive

New York, NY, January 24, 2020 -- UGE International Ltd. (TSXV: UGE, OTCQB: UGEID) (the “Company” or “UGE”), a leader in commercial and commun...Read More


Playa Del Carmen Mexico real estate agency celebrates new website service Excluive

In a strategic and bold marketing move Playa Del Carmen Real Estate, Mexico real estate agency "BuyPlaya Real Estate Advisors" will be celebrating t...Read More


Icoclone ventures into Security Token Offering Services for their global clients Excluive

Icoclone, one of the top-notch Fundraising solution provider has ventured into a new phase of delivering STO Development Services. “We are exci...Read More


Los Angeles Technology Insurance Brokers Discuss Cyber Liability Insurance Excluive

Los Angeles, California (pressreleasepower) January 21, 2020 - The Los Angeles technology insurance brokers at MFE Insurance recently releas...Read More


Virginia Employee Benefit Consultants Discuss Self Funded Insurance Plans Excluive

Fairfax, Virginia (pressreleasepower) January 23, 2020 - The Northern VA employee benefits consultants at BBG Broker recently released a blog educatin...Read More


Andrew Jones' first-ever Collections Curated by Designers of Distinction auction will be held February 23 in Los Angeles Excluive

The Sunday auction will be held online and in the gallery at 2221 South Main Street in downtown Los Angeles, California at 10:30 am Pacific time.Downt...Read More


New York Commercial HVAC Company Educates On Commercial Heating Systems Excluive

Manhattan, New York (pressreleasepower) January 22, 2020 - Cool Works, a New York commercial HVAC company, recently released a blog educating readers ...Read More


A1 Steam Way Creating Milestone With Its Quality Carpet Cleaning Services Excluive

Littleton (22th January 2020) : Due to the busy life, people find it hard to clean their carpet properly. Also, your unclean carpet can lead to other...Read More


DC Pool Removal Contractor Lists Pros & Cons Of Buying A Home With A Pool Excluive

Annandale, Virginia (pressreleasepower) January 22, 2020 - A DC pool removal contractor at Dirt Connections recently released a blog listing the pros ...Read More


Fairfax Roofing Company Answers Questions About Roof Replacement In Winter Excluive

Chantilly, Virginia (pressreleasepower) January 21, 2020 - Beyond Exteriors, a Fairfax roofing company, recently released a blog answering the questio...Read More


Picnic People Doubles Catering Capacity with New Corporate Kitchen Excluive

San Diego, California (pressreleasepower) January 20, 2020 - Catering and special events company, Picnic People, has expanded their corporate cateri...Read More


Global In Vitro Fertilization Market Excluive

Global in Vitro Fertilization market is expected to reach USD 847.8 Bn by 2026 at a CAGR of XX % during the forecast period.The Global in Vitro Fertil...Read More


Avail Luxurious, Economic and Punctual Taxi Services with Blisscars247 Excluive

@page { margin: 2cm } p { margin-bottom: 0.25cm; direction: ltr; color: #00000a; line-height: 120%; text-align: left; orphans: 2; widows: 2 } ...Read More


Sanrai shop is introducing two new pain management Techniques for a Healthier New Year Excluive

A new year has dawned. Most of us are together with our families to celebrate a whole year of prosperity and good health! With the hopes of warmth com...Read More


Ori'Zaba’s to Highlight Investment Opportunities at The Franchise Show - Phoenix Excluive

Prospective franchisees can meet reps from the expanding Mexican restaurant chain face to face.PHOENIX – Calling all investors ready to make their n...Read More


Logicspice provide online exam Software At Competitive Cost Excluive

LogicSpice is a mobile app development company that designs and develops high impact mobile apps and websites for worldwide clients. We provide next-g...Read More


Tangled Hair Techs Helps Women with Depression Come Alive through Detangling Tangled Matted Hair Excluive

Jan 14, 2020 -- Depression is a tricky illness with many unintended side effects. It can make the simple act of getting out of bed and leaving the hou...Read More


Global Auto Instrumentation Market Excluive

Global Auto Instrumentation Market was valued at US$ XX Mn 2017 and is expected to reach US$ XX Mn by 2026, at a CAGR of XXX% during a forecast period...Read More


Increasing Spending on Recreational Activity to Fuel the Emergency Light Sticks Market Excluive

“Emergency Light Sticks Market – Global Industry Dynamics 2018-19, Trends and Forecast, 2020–2027” is an upcoming market research report add...Read More


Innovapptive Announces 77 New Mobile Apps Built on SAP HANA® Cloud Platform Mobile Services Excluive

Innovapptive Inc., a leading provider of mobile solutions, today unveiled 77 new mobile apps leveraging SAP HANA® Cloud Platform mobile services. The...Read More


Recent Releases