Duloxetine hydrochloride

What is Duloxetine hydrochloride?

• Duloxetine hydrochloride (CYMBALTA) is a serotonin and norepinephrine reuptake inhibitor (SNRI) used to treat a certain type of depression called Major Depressive Disorder (MDD).

What are the uses of this medicine?

• This medicine is used to treat a certain type of depression called Major Depressive Disorder (MDD).

Cymbalta is also used to treat or manage:

• Generalized Anxiety Disorder (GAD)
• Diabetic Peripheral Neuropathic Pain (DPNP)
• Fibromyalgia (FM)
• Chronic Musculoskeletal Pain

How does this medicine work?

• Duloxetine hydrochloride increases the amount of certain chemicals in the brain that help relieve depression and pain. It is a type of serotonin and norepinephrine reuptake inhibitor.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• take a Monoamine Oxidase Inhibitor (MAOI)(eg: linezolid; intravenous methylene blue)
• Do not take an MAOI within 5 days of stopping Cymbalta unless directed to do so by your healthcare provider.
• Do not start Cymbalta if you stopped taking an MAOI in the last 14 days unless directed to do so by your healthcare provider.

What drug interactions can this medicine cause?

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

Is this medicine FDA approved?

• Initial U.S. Approval: 2004

How should this medicine be used?

Recommended Dosage: Major Depressive Disorder in Adults:

• The recommended starting dosage in adults with MDD is 40 mg/day (given as 20 mg twice daily) to 60 mg/day (given either once daily or as 30 mg twice daily). For some patients, it may be desirable to start at 30 mg once daily for 1 week, to allow patients to adjust to CYMBALTA before increasing to 60 mg once daily.
• While a 120 mg/day dose was shown to be effective, there is no evidence that doses greater than 60 mg/day confer any additional benefits.

Generalized Anxiety Disorder: Recommended Dosage in Adults Less than 65 Years of Ageː

• For most adults less than 65 years of age with GAD, initiate CYMBALTA 60 mg once daily.
• For some patients, it may be desirable to start at 30 mg once daily for 1 week, to allow patients to adjust to CYMBALTA before increasing to 60 mg once daily.
• While a 120 mg once daily dosage was shown to be effective, there is no evidence that doses greater than 60 mg/day confer additional benefit.

Geriatric Patientsː In geriatric patients with GAD, initiate CYMBALTA at a dosage of 30 mg once daily for 2 weeks before considering an increase to the target dose of 60 mg/day. Thereafter, patients may benefit from doses above 60 mg once daily.

Pediatric Patients 7 to 17 Years of Ageː

• Initiate CYMBALTA in pediatric patients 7 to 17 years of age with GAD at a dosage of 30 mg once daily for 2 weeks before considering an increase to 60 mg once daily.
• The recommended dosage range is 30 to 60 mg once daily.
• Some patients may benefit from dosages above 60 mg once daily.

Diabetic Peripheral Neuropathic Pain in Adults:

• Administer 60 mg once daily in adults with diabetic peripheral neuropathic pain.

Fibromyalgia: Recommended Dosage in Adultsː

• The recommended CYMBALTA dosage is 60 mg once daily in adults with fibromyalgia.
• Begin treatment at 30 mg once daily for 1 week, to allow patients to adjust to CYMBALTA before increasing to 60 mg once daily.

Recommended Dosage in Pediatric Patients 13 to 17 Years of Ageː

• The recommended starting CYMBALTA dosage in pediatric patients 13-17 years of age with fibromyalgia is 30 mg once daily.
• The dosage may be increased to 60 mg once daily based on response and tolerability.

Chronic Musculoskeletal Pain in Adults:

• The recommended CYMBALTA dosage is 60 mg once daily in adults with chronic musculoskeletal pain.
• Begin treatment at 30 mg once daily for one week, to allow patients to adjust to CYMBALTA before increasing to 60 mg once daily.

Patients with Hepatic Impairment or Severe Renal Impairmentː

• Avoid use in patients with chronic liver disease or cirrhosis.
• Avoid use in patients with severe renal impairment, GFR <30 mL/minute.

Administration:

• Take Cymbalta exactly as your healthcare provider tells you to take it. Your healthcare provider may need to change the dose of Cymbalta until it is the right dose for you.
• Swallow Cymbalta whole. Do not chew or crush Cymbalta.
• Do not open the capsule and sprinkle on food or mix with liquids. Opening the capsule may affect how well Cymbalta works.
• Cymbalta may be taken with or without food.
• If you miss a dose of Cymbalta, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Cymbalta at the same time.
• If you take too much Cymbalta, call your healthcare provider or poison control center at 1-800-222-1222 right away, or get emergency treatment.
• When switching from another antidepressant to Cymbalta your healthcare provider may want to lower the dose of the initial antidepressant first to potentially avoid side effects.

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What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Delayed-release capsules: 20 mg, 30 mg, and 60 mg

This medicine is available in fallowing brand namesː

• Cymbalta

What side effects can this medication cause?

The most common side effects of this medicine include:

• nausea
• dry mouth
• sleepiness
• fatigue
• constipation
• loss of appetite
• increased sweating
• dizziness

Common possible side effects in children and adolescents who take Cymbalta include:

• nausea
• decreased weight
• dizziness

Cymbalta may cause serious side effects, including:

• liver damage
• changes in blood pressure and falls
• Serotonin Syndrome
• abnormal bleeding
• severe skin reactions
• discontinuation symptoms
• manic episodes
• visual problems
• seizures or convulsions
• low salt (sodium) levels in the blood
• problems with urination
• sexual problems (dysfunction)

What special precautions should I follow?

• Hepatic failure, sometimes fatal, has been reported. Discontinue CYMBALTA in patients who develop jaundice or other evidence of clinically significant liver dysfunction and should not be resumed unless another cause can be established. Avoid use in patients with substantial alcohol use or evidence of chronic liver disease
• Orthostatic hypotension, falls, and syncope have been reported in patients treated with the recommended CYMBALTA dosages. Consider dosage reduction or discontinuation if these events occur.
• The development of a potentially life-threatening serotonin syndrome has been reported with SNRIs and SSRIs, including CYMBALTA. Increased risk when co-administered with other serotonergic agents (e.g., SSRIs, SNRIs, triptans), but also when taken alone. If it occurs, discontinue CYMBALTA
• Drugs that interfere with serotonin reuptake inhibition, including CYMBALTA, may increase the risk of bleeding events. Concomitant use of antiplatelet drugs and anticoagulants may increase this risk.
• Severe skin reactions, including erythema multiforme and Stevens-Johnson Syndrome (SJS), can occur with CYMBALTA. Discontinue at the first appearance of blisters, peeling rash, mucosal erosions, or any other sign of hypersensitivity if no other etiology can be identified.
• Activation of mania or hypomania has been reported in a small proportion of patients with mood disorders who were treated with other marketed drugs effective in the treatment of major depressive disorder. Prior to initiating, screen patients for personal or family history of bipolar disorder, mania, or hypomania.
• Angle-Closure Glaucoma has occurred in patients with untreated anatomically narrow angles treated with antidepressants.
• CYMBALTA has not been systematically evaluated in patients with a seizure disorder, and such patients were excluded from clinical studies. Prescribe with care in patients with a history of seizure disorder.
• Blood pressure should be measured prior to initiating treatment and periodically measured throughout treatment.
• Hyponatremia may occur as a result of treatment with SSRIs and SNRIs, including CYMBALTA. consider discontinuation.
• CYMBALTA treatment worsened glycemic control in some patients with diabetes. In DPNP patients, increases in fasting blood glucose, and HbA1c have been observed.
• CYMBALTA is in a class of drugs known to affect urethral resistance. If symptoms of urinary hesitation develop during treatment with CYMBALTA, consideration should be given to the possibility that they might be drug-related.
• Use of SNRIs, including CYMBALTA, may cause symptoms of sexual dysfunction.

What to do in case of emergency/overdose?

• Signs and symptoms of overdose (CYMBALTA alone or with mixed drugs) included somnolence, coma, serotonin syndrome, seizures, syncope, tachycardia, hypotension, hypertension, and vomiting.

Management of overdosage:

• There is no specific antidote to a CYMBALTA overdosage, but if serotonin syndrome ensues, specific treatment (such as with cyproheptadine and/or temperature control) may be considered.
• In case of acute overdose with CYMBALTA, treatment should consist of those general measures employed in the management of overdose with any drug, such as assuring an adequate airway, oxygenation, and ventilation and monitoring cardiac rhythm and vital signs.
• Gastric lavage with a large-bore orogastric tube with appropriate airway protection, if needed, may be indicated if performed soon after ingestion or in symptomatic patients.
• Activated charcoal may be useful in limiting absorption of duloxetine from the gastrointestinal tract.
• Consider contacting a poison control center (1-800-222-1222 or www.poison.org) for additional information on the treatment of overdosage.

Can this medicine be used in pregnancy?

• Third trimester use may increase risk for symptoms of poor adaptation (respiratory distress, temperature instability, feeding difficulty, hypotonia, tremor, irritability) in the neonate.
• There is a pregnancy exposure registry that monitors the pregnancy outcomes in women exposed to CYMBALTA during pregnancy. To enroll, contact the CYMBALTA Pregnancy Registry at 1-866-814-6975 or www.cymbaltapregnancyregistry.com.

Can this medicine be used in children?

• The safety and effectiveness of CYMBALTA have been established for treatment of generalized anxiety disorder (GAD) in patients 7 to 17 years of age and for treatment of juvenile fibromyalgia syndrome in patients 13 to 17 years of age.
• The safety and effectiveness of CYMBALTA have not been established in pediatric patients with major depressive disorder (MDD), diabetic peripheral neuropathic pain, or chronic musculoskeletal pain.

What are the active and inactive ingredients in this medicine?

• Active ingredient: duloxetine hydrochloride
• Inactive ingredients:

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.

Who manufactures and distributes this medicine?

• Marketed by: Lilly USA, LLC

Indianapolis, IN 46285, USA

• Cymbalta is a registered trademark of Eli Lilly and Company.

What should I know about storage and disposal of this medication?

• Store Cymbalta at room temperature between 68°F to 77°F (20°C to 25°C).
• Keep Cymbalta and all medicines out of the reach of children.

The following are antidepressant subclasses and drugs

MAO Inhibitors Isocarboxazid, Phenelzine, Tranylcypromine

SNRIs Duloxetine, Levomilnacipran, Venlafaxine

SSRIs Citalopram, Escitalopram, Fluoxetine, Fluvoxamine, Paroxetine, Sertraline, Vilazodone, Vortioxetine

Tricyclics Amitriptyline, Amoxapine, Clomipramine, Desipramine, Doxepin, Imipramine, Nortriptyline, Protriptyline, Trimipramine

Miscellaneous Bupropion, Flibanserin, Mirtazapine, Nefazodone, Trazodone

• Dailymed label info on Duloxetine hydrochloride
• FDA Duloxetine hydrochloride

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