Indicated for the treatment of:

Major Depressive Disorder (adults)

Generalized Anxiety Disorder (adults and children and adolescents (7 to 17 years of age) 

Diabetic Peripheral Neuropathy (adults)

Chronic Musculoskeletal Pain (adults)

The safety of doses above 120 mg per day has not been adequately evaluated and doses greater than 60 mg per day for diabetic peripheral neuropathic pain has not been adequately evaluated.

Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. 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.

Avoid use in patients with chronic liver disease or cirrhosis.

Avoid use in patients with severe renal impairment, GFR <30 mL/min.

Irenka is not approved for use in treating bipolar depression.

Irenka should be prescribed with care in patients with a history of a seizure disorder.

Irenka is in a class of drugs known to affect urethral resistance. If symptoms of urinary hesitation develop during treatment with Irenka, consideration should be given to the possibility that they might be drug-related.

Severe skin reactions, including erythema multiforme and Stevens-Johnson Syndrome (SJS), can occur with Irenka.

Discontinuation symptoms have been systematically evaluated in patients taking duloxetine.

Reports of activation of mania or hypomania.

Orthostatic hypotension, falls and syncope have been reported with therapeutic doses of duloxetine. Syncope and orthostatic hypotension tend to occur within the first week of therapy but can occur at any time during Irenka treatment, particularly after dose increases.

In adult placebo-controlled clinical trials duloxetine treatment was associated with mean increases of 0.5 mm Hg in systolic blood pressure and 0.8 mm Hg in diastolic blood pressure.

The pupillary dilation that occurs following use of many antidepressant drugs including Irenka may trigger an angle closure attack in a patient with anatomically narrow angles who does not have a patent iridectomy.

Hyponatremia may occur as a result of treatment with SSRIs and SNRIs, including Irenka. Elderly patients may be at greater risk of developing hyponatremia with SSRIs and SNRIs. Also, patients taking diuretics or who are otherwise volume depleted may be at greater risk.

Caution is advised in using Irenka in patients with conditions that may slow gastric emptying (e.g., some diabetics).

As observed in DPNP trials, duloxetine treatment worsens glycemic control in some patients with diabetes.

Decreased appetite and weight loss have been observed in association with the use of SSRIs and SNRIs. Weight and height should be monitored regularly in children and adolescents treated with Irenka.

The use of MAOIs intended to treat psychiatric disorders with Irenka or within 5 days of stopping treatment with Irenka is contraindicated because of an increased risk of serotonin syndrome. The use of Irenka within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated.

Starting Irenka in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue is contraindicated because of an increased risk of serotonin syndrome.

The development of a potentially life-threatening serotonin syndrome has been reported with SNRIs and SSRIs, including duloxetine, alone but particularly with concomitant use of other serotonergic drugs (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, and St. John’s Wort) and with drugs that impair metabolism of serotonin (in particular, MAOIs, both those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue).

SSRIs and SNRIs, including Irenka, may increase the risk of bleeding events. Concomitant use of aspirin, nonsteroidal anti inflammatory drugs, warfarin, and other anticoagulants may add to this risk.

Use of Irenka concomitantly with heavy alcohol intake may be associated with severe liver injury. For this reason, Irenka should not be prescribed for patients with substantial alcohol use.

Duloxetine bioavailability (AUC) appears to be reduced by about one-third in smokers. Dosage modifications are not recommended for smokers.

Co-administration of Irenka with potent CYP1A2 inhibitors should be avoided.

Because CYP2D6 is involved in Irenka metabolism, concomitant use of duloxetine with potent inhibitors of CYP2D6 would be expected to, and does, result in higher concentrations (on average of 60%) of Irenka.

Co-administration of Irenka with drugs that are extensively metabolized by CYP2D6 and that have a narrow therapeutic index, including certain antidepressants (tricyclic antidepressants [TCAs], such as nortriptyline, amitriptyline, and imipramine), phenothiazines and Type 1C antiarrhythmics (e.g., propafenone, flecainide), should be approached with caution.

There are no adequate and well-controlled studies of duloxetine administration in pregnant women. In animal reproduction studies, duloxetine has been shown to have adverse effects on embryo/fetal and postnatal development.

Neonates exposed during pregnancy to serotonin – norepinephrine reuptake inhibitors (SNRIs) or selective serotonin reuptake inhibitors (SSRIs) have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding which can arise immediately upon delivery. Reported clinical findings have included respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremor, jitteriness, irritability, and constant crying. These features are consistent with either a direct toxic effect of the SNRIs or SSRIs, or possibly, a drug discontinuation syndrome.

Irenka is present in human milk. In a published study, lactating women who were weaning their infants were given duloxetine.

GoToSource

• Use in patients under the age of 7. GoToSource

• Burning mouth syndrome. GoToSource

• Stress urinary incontinence. GoToSource

• Episodic migraines. GoToSource

• Chronic fatigue syndrome. GoToSource

• Adjunctive treatment for chronic prostatitis and chronic pelvic pain syndrome. GoToSource

• Adjunctive treatment for schizophrenia. GoToSource

• Resistant obsessive-compulsive disorder. GoToSource

• Sphincter of oddi dysfunction. GoToSource

• Irritable bowel syndrome. GoToSource

• Binge eating disorder. GoToSource

• Somatoform disorder. GoToSource

• ADHD. GoToSource

• Seasonal affective disorder. GoToSource

• Posttraumatic stress disorder. GoToSource

• Chronic depression (dysthymic disorder). GoToSource 

• Phantom limb pain. GoToSource

• Borderline personality disorder. GoToSource

• Premenstrual dysphoric disorder. GoToSource

• Doses greater than 120 mg per day for major depressive disorder, generalized anxiety disorder and chronic musculoskeletal pain and doses greater than 60 mg per day for diabetic peripheral neuropathy. GoToSource

Dry mouth, constipation, decreased appetite, fatigue, somnolence, increased sweating, paresthesia (abnormal sensation such as burning or prickling), vomiting, irritability, nightmares, mydriasis (dilation of the pupil) and urinary hesitation. GoToSource

Oropharyngeal pain (mouth and pharynx), dizziness, cough and palpitations (irregular heartbeat). GoToSource

Sexual dysfunction. GoToSource

Suicidal thoughts and behaviors. GoToSource

Hyponatremia (low sodium level in the blood). GoToSource 

Liver injury. GoToSource

Orthostatic hypotension (sudden fall in blood pressure after  standing) and falls. GoToSource

Serotonin syndrome (potentially life-threatening drug reaction). GoToSource

Increased risk of bleeding. GoToSource

Discontinuation syndrome. GoToSource

Mania and hypomania (abnormally elevated mood). GoToSource

Angle-closure glaucoma. GoToSource

Seizures. GoToSource

Posterior reversible encephalopathy syndrome (syndrome characterized by headache, confusion, seizures and visual loss). GoToSource

Increased blood pressure. GoToSource

Retrobulbar neuritis (inflammation of the optic nerve). GoToSource

Oral lichenoid reaction (rash inside the mouth). GoToSource

Visual hallucinations. GoToSource

Aggression and panic attacks. GoToSource

Gynecomastia (enlargement of male breasts). GoToSource

Bruxism (teeth grinding). GoToSource

Takotsubo cardiomyopathy (sudden dysfunction of left ventricle of the heart). GoToSource

Tardive dystonia and dyskinesia (movement disorder). GoToSource

Lymphocytic colitis (inflammation of large intestine (colon). GoToSource

Delirium (severe confusion). GoToSource

Restless legs syndrome. GoToSource

Tachycardia (abnormally rapid heart rate). GoToSource

No major injury lawsuits reported.