Duloxetine Hydrochloride (Cymbalta)

Trade Name : Cymbalta

Eli Lilly and Company

CAPSULE, DELAYED RELEASE

Strength 20 mg/1

Storage and handling for Cymbalta

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

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Duloxetine Hydrochloride (Cymbalta) which is also known as Cymbalta and Manufactured by Eli Lilly and Company. It is available in strength of 20 mg/1 per ml. Read more

Duloxetine Hydrochloride (Cymbalta) 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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Packaging and Delivery

Validated Cold Chain Shipment

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.

About GNH

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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 nn- [see Warnings and Precautions ()]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 nn- [see Warnings and Precautions ()]n- .
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
See full prescribing information for complete boxed warning.

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 ()

CYMBALTA is indicated for the treatment of:n
CYMBALTA is a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for:n

Major Depressive Disorder (MDD) ()n
Generalized Anxiety Disorder (GAD) ()n
Diabetic Peripheral Neuropathic Pain (DPNP) ()n
Fibromyalgia (FM) ()n
Chronic Musculoskeletal Pain ()n

Swallow CYMBALTA 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. CYMBALTA can be given without regard to meals. If a dose of CYMBALTA 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 CYMBALTA at the same time.n

CYMBALTA is available as delayed release capsules:n
20u00a0mg opaque green capsules imprinted with u201cLilly 3235 20mgu201dn
30u00a0mg opaque white and blue capsules imprinted with u201cLilly 3240 30mgu201dn
60u00a0mg opaque green and blue capsules imprinted with u201cLilly 3270 60mgu201dn
20 mg, 30 mg, and 60 mg delayed-release capsules ()n

Monoamine Oxidase Inhibitors (MAOIs) u2014 The use of MAOIs intended to treat psychiatric disorders with CYMBALTA or within 5 days of stopping treatment with CYMBALTA is contraindicated because of an increased risk of serotonin syndrome. The use of CYMBALTA within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated .n
Starting CYMBALTA 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 CYMBALTA or within 5 days of stopping treatment with CYMBALTA. Do not use CYMBALTA within 14 days of stopping an MAOI intended to treat psychiatric disorders. In addition, do not start CYMBALTA in a patient who is being treated with linezolid or intravenous methylene blue ()n

No data

Hepatotoxicity: Hepatic failure, sometimes fatal, has been reported in patients treated with CYMBALTA. CYMBALTA 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. CYMBALTA should not be prescribed to patients with substantial alcohol use or evidence of chronic liver disease ()n
Orthostatic Hypotension, Falls and Syncope: Cases have been reported with CYMBALTA therapy ()n
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 CYMBALTA and initiate supportive treatment ()n
Increased Risk of Bleeding: CYMBALTA may increase the risk of bleeding events. Concomitant use of NSAIDs, aspirin, other antiplatelet drugs, warfarin, and anticoagulants may increase this risk (, , )n
Severe Skin Reactions: Severe skin reactions, including erythema multiforme and Stevens-Johnson Syndrome (SJS), can occur with CYMBALTA. CYMBALTA 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 ()n
Discontinuation: Taper dose when possible and monitor for discontinuation symptoms ()n
Activation of mania or hypomania has occurred ()n
Angle-Closure Glaucoma: Angle-closure glaucoma has occurred in patients with untreated anatomically narrow angles treated with antidepressants ()n
Seizures: Prescribe with care in patients with a history of seizure disorder ()n
Blood Pressure: Monitor blood pressure prior to initiating treatment and periodically throughout treatment ()n
Inhibitors of CYP1A2 or Thioridazine: Should not administer with CYMBALTA ()n
Hyponatremia: Can occur in association with SIADH. Cases of hyponatremia have been reported ()n
Glucose Control in Diabetes: In diabetic peripheral neuropathic pain patients, small increases in fasting blood glucose, and HbA have been observed ()n
Conditions that Slow Gastric Emptying: Use cautiously in these patients ()n

The following serious adverse reactions are described below and elsewhere in the labeling:n
To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Most common adverse reactions (u22655% and at least twice the incidence of placebo patients): nausea, dry mouth, somnolence, constipation, decreased appetite, and hyperhidrosis ()n

Both CYP1A2 and CYP2D6 are responsible for duloxetine metabolism.n

Potent inhibitors of CYP1A2 should be avoided ()n
Potent inhibitors of CYP2D6 may increase CYMBALTA concentrations ()n
CYMBALTA is a moderate inhibitor of CYP2D6 ()n

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Pregnancy: Third trimester use may increase risk for symptoms of poor adaptation (respiratory distress, temperature instability, feeding difficulty, hypotonia, tremor, irritability) in the neonate ()n

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CYMBALTA (duloxetine delayed-release capsules) is a selective serotonin and norepinephrine reuptake inhibitor (SNRI) for oral administration. Its chemical designation is (+)-()--methyl-u03b3-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The empirical formula is CHNOSu2022HCl, which corresponds to a molecular weight of 333.88. The structural formula is:n
Duloxetine hydrochloride is a white to slightly brownish white solid, which is slightly soluble in water.n
Each capsule contains enteric-coated pellets of 22.4, 33.7, or 67.3u00a0mg of duloxetine hydrochloride equivalent to 20, 30, or 60u00a0mg 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 FD&C Blue No. 2, gelatin, hypromellose, hydroxypropyl methylcellulose acetate succinate, sodium lauryl sulfate, sucrose, sugar spheres, talc, titanium dioxide, and triethyl citrate. The 20 and 60u00a0mg capsules also contain iron oxide yellow.n

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The efficacy of CYMBALTA has been established in the following adequate and well-controlled trials:n

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Medication Guide
Cymbaltan [sim-BALL-tah] (duloxetine delayed-release capsules)
Read this Medication Guide before you start taking Cymbalta 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.n
Talk to your healthcare provider about:
What is the most important information I should know about antidepressant medicines, depression, other serious mental illnesses, and suicidal thoughts or actions?
1. Cymbalta and other antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, or young adults within the first few months of treatment or when the dose is changed.
2. Depression and other serious mental illnesses are the most important causes of suicidal thoughts or actions. Some people may have a particularly high risk of having suicidal thoughts or actions.
3. How can I watch for and try to prevent suicidal thoughts and 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.
What else do I need to know about antidepressant medicines?
What is Cymbalta?
Cymbalta is a prescription medicine used to treat a certain type of depression called Major Depressive Disorder (MDD). Cymbalta belongs to a class of medicines known as SNRIs (or serotonin-norepinephrine reuptake inhibitors).n
Cymbalta is also used to treat or manage:n
Who should not take Cymbalta?
Do Not take Cymbalta if you:
People who take Cymbalta close in time to an MAOI may have a serious problem called Serotonin Syndrome (see u201cu201d).tttttttntttttttnttttttt
What should I tell my healthcare provider before taking Cymbalta?
Before starting Cymbalta, tell your healthcare provider if you:n
Tell your healthcare provider about all the medicines that you take,
Especially tell your healthcare provider if you take:n
Ask your healthcare provider for a list of these medicines if you are not sure.n
Do not take Cymbalta with any other medicine that contain duloxetine.n
How should I take Cymbalta?
What should I avoid while taking Cymbalta?
What are the possible side effects of Cymbalta?
Cymbalta may cause serious side effects, including: See u201cu201dn
Common possible side effects in people who take Cymbalta include:n
1. liver damage. Symptoms may include:
2. changes in blood pressure and falls.
3. Serotonin Syndrome: This condition can be life-threatening and symptoms may include:
4. abnormal bleeding:
5. severe skin reactions:
6. discontinuation symptoms:
7. manic episodes:
8. visual 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. seizures or convulsions
10. low salt (sodium) levels in the blood.
11. problems with urination. Symptoms may include:
The most common side effects of Cymbalta include:n
Common possible side effects in children and adolescents who take Cymbalta include:n
Side effects in adults may also occur in children and adolescents who take Cymbalta. Children and adolescents should have height and weight monitored during treatment.n
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 Cymbalta. For more information, ask your healthcare provider or pharmacist.n
Call your doctor for medical advice about side effects. You may report side effects to 1-800-FDA-1088.
How should I store Cymbalta?
Store Cymbalta at room temperature between 68u00b0F to 77u00b0F (20u00b0C to 25u00b0C).n
Keep Cymbalta and all medicines out of the reach of children.
General information about the safe and effective use of Cymbalta.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Cymbalta for a condition for which it was not prescribed. Do not give Cymbalta to other people, even if they have the same symptoms that you have. It may harm them.n
This Medication Guide summarizes the most important information about Cymbalta. If you would like more information, talk with your healthcare provider. You may ask your healthcare provider or pharmacist for information about Cymbalta that is written for healthcare professionals.n
For more information, call 1-800-545-5979.n
What are the ingredients in Cymbalta?
Active ingredient: duloxetine hydrochloriden
Inactive ingredients:n
FD&C Blue No. 2, gelatin, hypromellose, hydroxypropyl methylcellulose acetate succinate, sodium lauryl sulfate, sucrose, sugar spheres, talc, titanium dioxide, and triethyl citrate. The 20 and 60 mg capsules also contain iron oxide yellow.n
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Coumadin, Jantoven, and Mellaril are trademarks of their respective owners and not trademarks of Eli Lilly and Company.n
Medication Guide revised: 10/2019n
Marketed by: Lilly USA, LLCIndianapolis, IN 46285, USA
Cymbalta is a registered trademark of Eli Lilly and Company.
Copyright u00a9 2009, 2019, Eli Lilly and Company. All rights reserved.n
CYM-0005-MG-20191004n

PACKAGE LABEL- Cymbalta 20 mg, bottle of 60
NDC 0002-3235-60n
60 capsulesn
PU3235n
Cymbaltan
duloxetinen
delayed release capsulesn
20 mgn
Each capsule contains 22.4 mg of duloxetine hydrochloride equivalent to 20 mg duloxetine.n
Rx onlyn
www.Cymbalta.comn
Lillyn

PACKAGE LABEL- Cymbalta 30 mg, bottle of 30
NDC 0002-3240-30n
30 capsulesn
PU3240n
Cymbaltan
duloxetinen
delayed release capsulesn
30 mgn
Each capsule contains 33.7 mg of duloxetine hydrochloride equivalent to 30 mg duloxetine.n
Rx onlyn
www.Cymbalta.comn
Lillyn

PACKAGE LABEL- Cymbalta 60 mg, bottle of 30
NDC 0002-3270-30n
30 capsulesn
PU3270n
Cymbaltan
duloxetine n
delayed release capsulesn
60 mgn
Each capsule contains 67.3 mg of duloxetine hydrochloride equivalent to 60 mg duloxetine.n
Rx onlyn
www.Cymbalta.comn
Lillyn

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