ents that duloxetine delayed-release capsules may cause an increase in blood pressure[see Warnings and Precautions (5.11)].
Concomitant Medications – Advise patients to inform their physicians if they are taking, or plan to take, any prescription or over-the-counter medications, since there is a potential for interactions[see Dosage and Administration (2.8, 2.9), Contraindications (4), Warnings and Precautions (5.4, 5.12), and Drug Interactions (7)].
Hyponatremia – Advise patients that hyponatremia has been reported as a result of treatment with SNRIs and SSRIs, including duloxetine delayed-release capsules. Advise patients of the signs and symptoms of hyponatremia[see Warnings and Precautions (5.13)].
Concomitant Illnesses – Advise patients to inform their physicians about all of their medical conditions[see Warnings and Precautions (5.14)].
Duloxetine delayed-release capsules are in a class of medicines that may affect urination. Instruct patients to consult with their healthcare provider if they develop any problems with urine flow[see Warnings and Precautions (5.15)].
Pregnancy and Nursing Mothers
Advise patients to notify their physician if they
become pregnant during therapy
intend to become pregnant during therapy
are nursing [see Use in Specific Populations (8.1, 8.3)].
Pediatric Use –
Pediatric use information for patients ages 7 to 17 years with GAD 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. The safety and effectiveness of CYMBALTA have not been established in pediatric patients less than 18 years of age with other indications.
[See Use in Specific Populations (8.4)].
The safety and effectiveness of duloxetine have not been established in pediatric patients less than 18 years of age with other indications.
Interference with Psychomotor Performance – Any psychoactive drug may impair judgment, thinking, or motor skills. Although in controlled studies duloxetine delayed-release capsules have not been shown to impair psychomotor performance, cognitive function, or memory, it may be associated with sedation and dizziness. Therefore, caution patients about operating hazardous machinery including automobiles, until they are reasonably certain that duloxetine therapy does not affect their ability to engage in such activities.
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Manufactured by:
TORRENT PHARMACEUTICALS LTD., Indrad-382 721, Dist. Mehsana, INDIA.
For:
TORRENT PHARMA INC., 150 Allen Road, Suite 102, Basking Ridge, NJ 07920.
8063354 Revised February 2017
Medication Guide
Duloxetine (doo-LOX-e-teen) Delayed-Release Capsules, USP
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