Sprinkledrug info
Sprinkle duloxetine 20 MG Delayed Release Oral Capsule [Drizalma]
What it is used for
DRIZALMA SPRINKLE is indicated for the treatment of:
Major Depressive Disorder in adults
Generalized Anxiety Disorder in adults and pediatric patients 7 years of age and older
Diabetic Peripheral Neuropathy in adults
Fibromyalgia in adults
Chronic Musculoskeletal Pain in adults Additional pediatric use information is approved for Eli Lilly and Company, Inc.’s CYMBALTA (duloxetine delayed-release capsules). However, due to Eli Lilly and Company Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. DRIZALMA SPRINKLE is a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of following conditions:
Major Depressive Disorder (MDD) in adults
Generalized Anxiety Disorder (GAD) in adults and pediatric patients ages 7 years of age and older
Diabetic Peripheral Neuropathic Pain (DPNP) in adults
Fibromyalgia (FM) in adults
Chronic Musculoskeletal Pain in adults
Text above is quoted in full from the FDA-approved drug label published by openFDA, effective May 14, 2024. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.
Description
Duloxetine hydrochloride is a selective serotonin and norepinephrine reuptake inhibitor (SNRI). The chemical name of duloxetine hydrochloride is (+)-( S )- N -methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The molecular formula is C 18 H 19 NOS
HCl, which corresponds to a molecular weight of 333.88. The structural formula is: Duloxetine hydrochloride, USP is a white to off-white powder, which is freely soluble in methanol, soluble in dichloromethane, and slightly soluble in water. The molecular formula of duloxetine free base is C 18 H 19 NOS and its molecular weight is 297.38. Each DRIZALMA SPRINKLE (duloxetine delayed-release capsule) for oral administration contains enteric-coated pellets containing a total of 22.4 mg, 33.6 mg, 44.9 mg or 67.3 mg of duloxetine hydrochloride, equivalent to 20 mg, 30 mg, 40 mg or 60 mg of duloxetine free base, respectively. These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients of the pellets include ascorbic acid, hypromellose, hypromellose phthalate, polyethylene glycol, starch, sucrose, sugar spheres, talc, titanium dioxide, and triethyl citrate. The capsule shell ingredients for 20 mg strength are D&C Yellow 10, FD &C Blue 1, FD &C Red 40, gelatin, sodium lauryl sulfate and titanium dioxide. The capsule shell ingredients for 30 mg strength are FD &C Blue 1, FD &C Red 40 and FD &C Red 3 (present in cap), gelatin, sodium lauryl sulfate and titanium dioxide. The capsule shell ingredients for 40 mg strength are gelatin, sodium lauryl sulfate and titanium dioxide. The capsule shell ingredients for 60 mg strength are D&C Yellow 10 (present in body), FD &C Blue 1, FD &C Red 40, FD &C Red 3 (present in cap), gelatin, sodium lauryl sulfate and titanium dioxide. The imprinting ink for 20 mg, 30 mg, 40 mg, and 60 mg strength capsules was made of ammonia solution, black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol and shellac. DRIZALMA SPRINKLE does not comply with the USP dissolution test. structure-formula
Text above is quoted in full from the FDA-approved drug label published by openFDA, effective May 14, 2024. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.
This page reproduces regulatory text for reference. It is not medical advice, and KenyRx is not a pharmacy or a prescriber. Talk to a doctor or pharmacist about whether a medicine is right for you.
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