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Side Effects & Adverse Reactions
There is currently no warning information available for this product. We apologize for any inconvenience.
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FDA Safety Alerts
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There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Irenka™ is indicated for the treatment of:
- Major Depressive Disorder[see CLINICAL STUDIES 14.1]
- Generalized Anxiety Disorder[see CLINICAL STUDIES 14.2]
- Diabetic Peripheral Neuropathy[see CLINICAL STUDIES 14.3]
- Chronic Musculoskeletal Pain[see CLINICAL STUDIES 14.5]
There is currently no drug history available for this drug.
Irenka™ (duloxetine delayed-release capsules USP) is selective serotonin and norepinephrine reuptake inhibitor (SSNRI) for oral administration. Its chemical designation is (+)-(S)-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The empirical formula is C18H19NOS.HCl, which corresponds to a molecular weight of 333.88. The structural formula is:
Duloxetine hydrochloride is a white to cream colored powder, which is soluble in methanol.
Each capsule contains enteric-coated mini tablets comprising of duloxetine hydrochloride equivalent to 40 of duloxetine. These enteric-coated mini tablets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include ammonia solution, black iron oxide, croscarmellose sodium, gelatin, hypromellose, hypromellose phthalate, lactose monohydrate, magnesium stearate, polysorbate 80, potassium hydroxide, pregelatinized starch, propylene glycol, shellac, talc, titanium dioxide and triethyl citrate.