Duloxetine (Page 10 of 12)

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

Duloxetine Delayed-Release Capsules USP are available as delayed release capsules in the following strengths, colors, imprints, and presentations:

Features

Strengths

30 mga

Body color

White

Cap color

Blue

Cap imprint

Dulox

Body imprint

30mg

Capsule size

2

Bottles of 6

68788-7828-0

Bottles of 10

68788-7828-1

Bottles of 20

68788-7828-2

Bottles of 30

68788-7828-3

Bottles of 60

Bottles of 90

68788-7828-6

68788-7828-9

a equivalent to duloxetine base

16.2 Storage and Handling

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Medication Guide).
· Suicidal Thoughts and Behaviors — Advise patients, their families, and their caregivers to look for the emergence of suicidal ideation and behavior, especially during treatment and when the dose is adjusted up or down and instruct them to report such symptoms to their healthcare provider [see Boxed Warning and Warnings and Precautions (5.1)].
· Duloxetine capsules should be swallowed whole and should not be chewed or crushed, nor should the capsule be opened and its contents be sprinkled on food or mixed with liquids. All of these might affect the enteric coating.

· Hepatotoxicity — Inform patients that severe liver problems, sometimes fatal, have been reported in patients treated with duloxetine. Instruct patients to talk to their healthcare provider if they develop itching, right upper belly pain, dark urine, or yellow skin/eyes while taking duloxetine, which may be signs of liver problems. Instruct patients to talk to their healthcare provider about their alcohol consumption. Use of duloxetine with heavy alcohol intake may be associated with severe liver injury [see Warnings and Precautions (5.2)].

· Alcohol — Although duloxetine does not increase the impairment of mental and motor skills caused by alcohol, use of duloxetine concomitantly with heavy alcohol intake may be associated with severe liver injury. For this reason, duloxetine should not be prescribed for patients with substantial alcohol use [see Warnings and Precautions (5.2) and Drug Interactions (7.15)] .

· Orthostatic Hypotension, Falls and Syncope — Advise patients of the risk of orthostatic hypotension, falls and syncope, especially during the period of initial use and subsequent dose escalation, and in association with the use of concomitant drugs that might potentiate the orthostatic effect of duloxetine[see Warnings and Precautions (5.3)] .

· Serotonin Syndrome — Caution patients about the risk of serotonin syndrome with the concomitant use of duloxetine and other serotonergic agents including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, buspirone, tryptophan,amphetamines, and St. John’s Wort [see Contraindications (4), Warnings and Precautions (5.4), and Drug Interactions (7.14)]. Advise patients of the signs and symptoms associated with serotonin syndrome that may include mental status changes (e.g., agitation, hallucinations, delirium, and coma), autonomic instability (e.g., tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia), neuromuscular changes (e.g., tremor, rigidity, myoclonus, hyperreflexia, incoordination), seizures, and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). Caution patients to seek medical care immediately if they experience these symptoms.

· Abnormal Bleeding — Caution patients about the concomitant use of duloxetine and NSAIDs, aspirin, warfarin, or other drugs that affect coagulation since combined use of psychotropic drugs that interfere with serotonin reuptake and these agents has been associated with an increased risk of bleeding [see Warnings and Precautions (5.5) and Use in Specific Populations (8.1)].

· Severe Skin Reactions — Caution patients that duloxetine may cause serious skin reactions. This may need to be treated in a hospital and may be life-threatening. Counsel patients to call their doctor right away or get emergency help if they have skin blisters, peeling rash, sores in their mouth, hives, or any other allergic reactions [see Warnings and Precautions (5.6)] .
·Discontinuation of Treatment — Instruct patients that discontinuation of duloxetine may be associated with symptoms such as dizziness, headache, nausea, diarrhea, paresthesia, irritability, vomiting, insomnia, anxiety, hyperhidrosis, and fatigue, and should be advised not to alter their dosing regimen, or stop taking duloxetine without consulting their physician [see Warnings and Precautions (5.7)] .
· Activation of Mania or Hypomania — Adequately screen patients with depressive symptoms for risk of bipolar disorder (e.g. family history of suicide, bipolar disorder, and depression) prior to initiating treatment with duloxetine. Advise patients to report any signs or symptoms of a manic reaction such as greatly increased energy, severe trouble sleeping, racing thoughts, reckless behavior, talking more or faster than usual, unusually grand ideas, and excessive happiness or irritability [see Warnings and Precautions (5.8)] .

· Angle-Closure Glaucoma — Advise patients that taking duloxetine can cause mild pupillary dilation, which in susceptible individuals, can lead to an episode of angle-closure glaucoma. Pre-existing glaucoma is almost always open-angle glaucoma because angle-closure glaucoma, when diagnosed, can be treated definitively with iridectomy. Open-angle glaucoma is not a risk factor for angle-closure glaucoma. Patients may wish to be examined to determine whether they are susceptible to angle-closure, and have a prophylactic procedure (e.g., iridectomy), if they are susceptible. [See Warnings and Precautions (5.9)].

· Seizures — Advise patients to inform their physician if they have a history of seizure disorder [see Warnings and Precautions (5.10)] .

· Effects on Blood Pressure — Caution patients that duloxetine 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. 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 is 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
· Advise pregnant women to notify their healthcare provider if they become pregnant or intend to become pregnant during treatment with duloxetine.
· Advise patients that duloxetine use during the month before delivery may lead to an increased risk for postpartum hemorrhage and may increase the risk of neonatal complications requiring prolonged hospitalization, respiratory support, and tube feeding.
· Advise pregnant women that there is a risk of relapse with discontinuation of antidepressants.
· Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to duloxetine during pregnancy [see Use in Specific Populations (8.1)].
· Lactation ― Advise breastfeeding women using duloxetine to monitor infants for sedation, poor feeding and poor weight gain and to seek medical care if they notice these signs [see Use in Specific Populations (8.2)].
· Pediatric Use Pediatric use information for patients ages 7 to 17 years with GAD is approved for Eli Lilly and Company, Inc.’s 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 duloxetine delayed-release capsules have not been established in pediatric patients less than 18 years of age with other indications. The safety and effectiveness of duloxetine delayed-release capsules have not been established in pediatric patients less than 18 years of age with other indications. [See Use in Specific Populations (8.4)].

· Interference with Psychomotor Performance — Any psychoactive drug may impair judgment, thinking, or motor skills. Although in controlled studies duloxetine has 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.


Manufactured by:
Alkem Laboratories Ltd.
Mumbai — 400 013, INDIA.
Distributed by:
Ascend Laboratories, LLC

Parsippany, NJ 07054

Revised: December, 2019
PT1663-03

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