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Duloxetine (Duloxetine)

Trade Name : Duloxetine

Bryant Ranch Prepack

CAPSULE, DELAYED RELEASE

Strength 60 mg/1

DULOXETINE HYDROCHLORIDE Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Duloxetine (Duloxetine) which is also known as Duloxetine and Manufactured by Bryant Ranch Prepack. It is available in strength of 60 mg/1 per ml. Read more

Duloxetine (Duloxetine) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • Warnings and Precautions ()u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 10/2019
  • Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients over age 24; there was a reduction in risk with antidepressant use in patients aged 65 and older n n . In patients of all ages who are started on antidepressant therapy, monitor closely for worsening, and for emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber n n .n
  • WARNING: SUICIDAL THOUGHTS AND BEHAVIORSn n
  • Increased risk of suicidal thinking and behavior in children, adolescents, and young adults taking antidepressants ()
  • Monitor for worsening and emergence of suicidal thoughts and behaviors ()
  • Duloxetine delayed-release capsules are indicated for the treatment of:
  • Duloxetine delayed-release capsules are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for:
  • Major Depressive Disorder (MDD) ()
  • Generalized Anxiety Disorder (GAD) ()
  • Diabetic Peripheral Neuropathic Pain (DPNP) ()
  • Chronic Musculoskeletal Pain ()
  • u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 Swallow duloxetine delayed-release capsules whole. Do not chew or crush. Do not open the capsule and sprinkle its contents on food or mix with liquids. All of these might affect the enteric coating. Duloxetine delayed-release capsules can be given without regard to meals. If a dose of duloxetine delayed-release capsules is missed, take the missed dose as soon as it is remembered. If it is almost time for the next dose, skip the missed dose and take the next dose at the regular time. Do not take two doses of duloxetine delayed-release capsules at the same time.
  • Duloxetine delayed-release capsules are available as:
  • 20 mg white and blue capsules imprinted with u201cap DLX20u201d
  • 30 mg blue and blue capsules imprinted with u201cap DLX30u201d
  • 40 mg pink and blue capsules imprinted with u201cap DLX40u201d
  • 60 mg white and blue capsules imprinted with u201cap DLX60u201d
  • 20 mg, 30 mg, 40u00a0mgu00a0and 60 mg delayed-release capsules ()
  • u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 Monoamine Oxidase Inhibitors (MAOIs) - The use of MAOIs intended to treat psychiatric disorders with duloxetine or within 5 days of stopping treatment with duloxetine is contraindicated because of an increased risk of serotonin syndrome. The use of duloxetine within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated n n
  • u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 Starting duloxetine in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome n
  • Serotonin Syndrome and MAOIs: Do not use MAOIs intended to treat psychiatric disorders with duloxetine or within 5 days of stopping treatment with duloxetine. Do not use duloxetine within 14 days of stopping an MAOI intended to treat psychiatric disorders. In addition, do not start duloxetineu00a0 in a patient who is being treated with linezolid or intravenous methylene blue ()
  • No data
  • Hepatotoxicity: Hepatic failure, sometimes fatal, has been reported in patients treated with duloxetine. Duloxetine 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. Duloxetine 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 therapy ()
  • Serotonin Syndrome: Increased risk when co-administered with other serotonergic agents (e.g., SSRIs, SNRIs, triptans), but also when taken alone. If it occurs, discontinue duloxetine and initiate supportive treatment ()
  • Increased Risk of Bleeding: Duloxetine may increase in risk of bleeding events. Concomitant use of NSAIDs, aspirin, other antiplatelet drugs, warfarin, and anticoagulants may increase the risk (,, )
  • Severe Skin Reactions: Severe skin reactions, including erythema multiforme and Stevens-Johnson Syndrome (SJS), can occur with duloxetine. Duloxetine should be discontinued at the first appearance of blisters, peeling rash, mucosal erosions, or any other sign of hypersensitivity if no other etiology can be identified. ()
  • Discontinuation: Taper dose when possible and monitor for discontinuation symptoms ().
  • Activation of mania or hypomania has occurred ()
  • Angle-Closure Glaucoma: Angle-closure glaucoma has occurred in patients with untreated anatomically narrow angles treated with antidepressants. ()
  • Seizures: Prescribe with care in patients with a history of seizure disorder ()
  • Blood Pressure: Monitor blood pressure prior to initiating treatment and periodically throughout treatment ()
  • Inhibitors of CYP1A2 or Thioridazine: Should not administer with duloxetine ()
  • 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 HbA have been observed ()
  • Conditions that Slow Gastric Emptying: Use cautiously in these patients ()
  • The following serious adverse reactions are described below and elsewhere in the labeling:
  • To report SUSPECTED ADVERSE REACTIONS, contact Ajanta Pharma USA Inc. at 1-855-664-7744 or FDA at 1-800-FDA-1088 or
  • Most common adverse reactions (u22655% and at least twice the incidence of placebo patients): nausea, dry mouth, somnolence, constipation, decreased appetite, and hyperhidrosis ().
  • u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 Both CYP1A2 and CYP2D6 are responsible for duloxetine metabolism.
  • Potent inhibitors of CYP1A2 should be avoided ().
  • Potent inhibitors of CYP2D6 may increase duloxetine concentrations ().
  • Duloxetine is a moderate inhibitor of CYP2D6 ().
  • No data
  • Pregnancy: Third trimester use may increase risk for symptoms of poor adaptation (respiratory distress, temperature instability, feeding difficulty, hypotonia, tremor, irritability) in the neonate ()
  • No data
  • No data
  • u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 Duloxetine hydrochloride USP is a selective serotonin and norepinephrine reuptake inhibitor (SNRI) for oral administration. Its chemical designation is (+)-()--methyl-u03b3-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The molecular formula is CHNOSu2022HCl, which corresponds to a molecular weight of 333.88. The structural formula is:
  • u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 Duloxetine hydrochloride USP is a white to brownish-white solid, which is slightly soluble in water.
  • u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 Each capsule contains enteric-coated pellets of 22.4, 33.7, 44.9 or 67.3 mg of duloxetine hydrochloride USP equivalent to 20, 30, 40,u00a0or 60 mg of duloxetine, respectively. These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include sugar spheres, hypromellose, sucrose, talc, methacrylic acid copolymer dispersion, and triethyl citrate.
  • The capsule shell contains gelatin, FD&C Red No. 3 (40 mg), FD&C Blue No. 1 (40 mg), FD&C Blue No. 2 (20 mg, 30 mg, 60 mg), titanium dioxide, and sodium lauryl sulfate.
  • For 20 mg, 30 mg, 40 mgu00a0 (body & cap) and 60 mg (body only) strengths, imprinting black ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide and purified water.
  • For 60 mg (cap only) strength, imprinting white ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, purified water, potassium hydroxide, and titanium dioxide.
  • USP Assay & Organic Impurities test pending.
  • No data
  • Carcinogenesis
  • In female mice receiving duloxetine at 140 mg/kg/day (3 times the maximum recommended human dose (MRHD) of 120 mg/day on a mg/mbasis), there was an increased incidence of hepatocellular adenomas and carcinomas. The no-effect dose was 50 mg/kg/day (1 times the MRHD given to children). Tumor incidence was not increased in male mice receiving duloxetine at doses up to 100 mg/kg/day (2 times the MRHD given to children).
  • In rats, dietary doses of duloxetine up to 27 mg/kg/day in females (1 times the MRHD given to children) and up to 36 mg/kg/day in males (1.4 times the MRHD given to children) did not increase the incidence of tumors.
  • Mutagenesis
  • in vitro
  • in vivo
  • in vitro
  • in vitro
  • in vivo
  • Impairment of Fertility
  • The efficacy of duloxetine has been established in the following adequate and well-controlled trials:
  • Product: 71335-0402
  • NDC: 71335-0402-1 30 CAPSULE, DELAYED RELEASE in a BOTTLE
  • NDC: 71335-0402-2 28 CAPSULE, DELAYED RELEASE in a BOTTLE
  • NDC: 71335-0402-3 60 CAPSULE, DELAYED RELEASE in a BOTTLE
  • NDC: 71335-0402-4 90 CAPSULE, DELAYED RELEASE in a BOTTLE
  • NDC: 71335-0402-5 180 CAPSULE, DELAYED RELEASE in a BOTTLE
  • NDC: 71335-0402-6 120 CAPSULE, DELAYED RELEASE in a BOTTLE
  • Advise the patient to read the FDA-approved patient labeling (Medication Guide).-n
  • Advise patients, their families, and their caregivers to look for the emergence of suicidal ideation and behavior, especially during treatment and when the dose is adjusted up or down and instruct them to report such symptoms to their healthcare provider .
  • Advise patients of the signs and symptoms associated with serotonin syndrome that may include mental status changes (e.g., agitation, hallucinations, delirium, and coma), autonomic instability (e.g., tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia), neuromuscular changes (e.g., tremor, rigidity, myoclonus, hyperreflexia, incoordination), seizures, and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). Caution patients to seek medical care immediately if they experience these symptoms.
  • Literature revised 11/2019n
  • Marketed by:
  • Ajanta Pharma USA Inc.
  • Bridgewater, NJ 08807.
  • Made in INDIA.
  • Duloxetine Delayed-Release Capsules
  • (doo loxu2019 e teen)
  • Read this Medication Guide before you start taking duloxetine delayed-release capsules and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment.
  • Talk to your healthcare provider about:
  • What is the most important information I should know aboutn- antidepressant medicines, depression, other serious mental illnesses, and suicidal thoughts or actions?
  • Call your healthcare provider right away if you have any of the following symptoms or feelings, especially if they are new, worse, or worry you. In an emergency, call 911.n- Array
  • Array
  • What else do I need to know about antidepressant medicines?
  • What are duloxetine delayed-release capsules?n- Array
  • Duloxetine delayed-release capsules are a prescription medicine used to treat a certain type of depression called Major Depressive Disorder (MDD). Duloxetine delayed-release capsules belongs to a class of medicines known as SNRIs (or serotonin-norepinephrine reuptake inhibitors).
  • Duloxetine delayed-release capsules are also used to treat or manage:
  • Who should not take n- duloxetine delayed-release capsules?
  • Do Not take n- duloxetine delayed-release capsules if you:
  • People who take n- duloxetine delayed-release capsules close in time to an MAOI may have a serious problem called Serotonin Syndrome (see u201cWhat are the possible side effects of dn- uloxetine delayed-release capsules?u201d).
  • What should I tell my healthcare provider before taking dn- uloxetine delayed-release capsules?
  • Before starting duloxetine delayed-release capsules, tell your healthcare provider if you:
  • Tell your healthcare provider about all the medicines that you take,
  • Especially tell your healthcare provider if you take:
  • u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 Ask your healthcare provider for a list of these medicines if you are not sure.
  • Do not take duloxetine delayed-release capsules with any other medicine that contain duloxetine.
  • How should I take n- duloxetine delayed-release capsules?
  • What should I avoid while taking n- duloxetine delayed-release capsules?
  • What are the possible side effects of n- duloxetine delayed-release capsules?
  • Duloxetine delayed-release capsules may cause serious side effects, including: See u201cWhat is the most important information I should know about duloxetine delayed-release capsules?u201d
  • Common possible side effects in people who take duloxetine delayed-release capsules include:
  • 1. liver damage. Symptoms may include:
  • u00a0Monitor your blood pressure before starting and throughout treatment. Duloxetine delayed-release capsules may:
  • u00a0n
  • 4.u00a0u00a0 abnormal bleeding:u00a0
  • 5.u00a0 severe skin reactions:
  • 6.u00a0 discontinuation symptoms:
  • 7. u00a0u00a0manic episodes:
  • 8n- .u00a0u00a0 n- isual problems:
  • Only some people are at risk for these problems. You may want to undergo an eye examination to see if you are at risk and receive preventative treatment if you are.
  • 9.u00a0u00a0 seizures or convulsions
  • u00a0
  • 10. low salt (sodium) levels in the blood.
  • u00a0u00a0u00a0u00a0u00a0
  • 11. problems with urination. Symptoms may include:
  • The most common side effects of duloxetine delayed-release capsulesu00a0include:
  • Common possible side effects in children and adolescents who take duloxetine delayed-release capsulesu00a0include:
  • Side effects in adults may also occur in children and adolescents who take duloxetine delayed-release capsules. Children and adolescents should have height and weight monitored during treatment.
  • Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
  • These are not all the possible side effects of duloxetine delayed-release capsules. For more information, ask your healthcare provider or pharmacist.
  • Call your doctor for medical advice about side effects. You may report side effects to 1-800-FDA-1088.n- Array
  • How should I store n- duloxetine delayed-release capsules?
  • Store duloxetine delayed-release capsules at 25u00b0C (77u00b0F); excursions permitted to 15u00b0 to 30u00b0C (59u00b0 to 86u00b0F) [USP Controlled Room Temperature].
  • Keep n- duloxetine delayed-release capsules and all medicines out of the reach of children.
  • General information about the safe and effective use ofn- duloxetine delayed-release capsules
  • u00a0
  • Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use duloxetine delayed-release capsules for a condition for which it was not prescribed. Do not give duloxetine delayed-release capsules to other people, even if they have the same symptoms that you have. It may harm them.
  • This Medication Guide summarizes the most important information about duloxetine delayed-release capsules. If you would like more information, talk with your healthcare provider. You may ask your healthcare provider or pharmacist for information about duloxetine delayed-release capsules that is written for healthcare professionals.
  • For more information, call 1-855-664-7744.
  • What are the ingredients in n- duloxetine delayed-release capsules?
  • Active ingredient: duloxetine hydrochloride, USP
  • Inactive ingredients:
  • sugar spheres, hypromellose,u00a0 sucrose, talc, methacrylic acid copolymer dispersion, and triethyl citrate.
  • The capsule shell contains gelatin, FD&C Red No. 3 (40 mg), FD&C Blue No. 1 (40 mg), FD&C Blue No. 2 (20 mg, 30 mg, 60 mg), titanium dioxide, and sodium lauryl sulfate.
  • For 20 mg, 30 mg, 40 mgu00a0 (body & cap) and 60 mg (body only) strengths, imprinting black ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide, and purified water.
  • For 60 mg (cap only) strength, imprinting white ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, purified water, potassium hydroxide, and titanium dioxide.u00a0
  • This Medication Guide has been approved by the U.S. Food and Drug Administration
  • All trademarks are the properties of their respective owners.
  • Medication Guide revised: 11/2019
  • Array
  • Marketed by:
  • Ajanta Pharma USA Inc.
  • Bridgewater, NJ 08807.
  • Made un INDIA.
  • No data

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