Duloxetine (Page 12 of 14)

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

Duloxetine Delayed-Release Capsules USP, 20 mg: Opaque green/opaque green size ‘4’ hard gelatin capsule filled with white to off-white-spherical enteric coated pellets and imprinted ‘RDY608′ on opaque green cap and ’20 mg’ on opaque green body with black ink.

Bottles of 60 NDC 25000-608-06

Duloxetine Delayed-Release Capsules USP, 30 mg: Opaque blue/opaque white size ‘3’ hard gelatin capsule filled with white to off-white-spherical enteric coated pellets and imprinted ‘RDY609′ on opaque blue cap and ’30 mg’ on opaque white body with golden yellow ink.

Bottles of 30 NDC 25000-609-03
Bottles of 90 NDC 25000-609-07

Duloxetine Delayed-Release Capsules USP, 60 mg: Opaque blue/opaque green size ‘1’ hard gelatin capsule filled with white to off-white spherical enteric coated pellets and imprinted ‘RDY610′ on opaque blue cap and ’60 mg’ on opaque green body with white ink.

Bottles of 30 NDC 25000-610-03
Bottles of 90 NDC 25000-610-07

16.2 Storage and Handling

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 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)].
• Administration — Advise patients to swallow duloxetine delayed-release capsules whole and to not chew, crush, or open the capsule (do not sprinkle contents on food or mixed with liquids) because these actions might affect the enteric coating.
• Hepatotoxicity – Inform patients that severe liver problems, sometimes fatal, have been reported in patients treated with duloxetine delayed-release capsules. 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 delayed-release capsules, which may be signs of liver problems. Instruct patients to talk to their healthcare provider about their alcohol consumption. Use of duloxetine delayed-release capsules with heavy alcohol intake may be associated with severe liver injury [see Warnings and Precautions (5.2)].
• Alcohol – Although duloxetine delayed-release capsules do not increase the impairment of mental and motor skills caused by alcohol, use of duloxetine delayed-release capsules concomitantly with heavy alcohol intake may be associated with severe liver injury [see Warnings and Precautions (5.2) andDrug 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 delayed-release capsules [see Warnings and Precautions (5.3)].
• Serotonin Syndrome — Caution patients about the risk of serotonin syndrome with the concomitant use of duloxetine delayed-release capsules 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), andDrug 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.
• Increased Risk of Bleeding -Caution patients about the concomitant use of duloxetine delayed-release capsules 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) andUse in Specific Populations (8.1)].
• Severe Skin Reactions -Caution patients that duloxetine delayed-release capsules 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 delayed-release capsules 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 delayed-release capsules without consulting their healthcare provider [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 delayed-release capsules. 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 delayed-release capsules 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 healthcare provider if they have a history of seizure disorder [see Warnings and Precautions (5.10)].
• Effects on Blood Pressure – Caution patients 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 healthcare provider 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 (2.9,2.10),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 healthcare provider about all of their medical conditions [see Warnings and Precautions (5.14)].
• Urinary Hesitation and Retention — 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)].

• Sexual Dysfunction – Advise patients that use of duloxetine delayed-release capsules may cause symptoms of sexual dysfunction in both male and female patients. Inform patients that they should discuss any changes in sexual function and potential management strategies with their healthcare provider [see Warnings and Precautions (5.16)].
• Pregnancy
• Advise women to notify their healthcare provider if they become pregnant or intend to become pregnant during treatment with duloxetine delayed-release capsules.
• Advise pregnant women or patients who intend to become pregnant that duloxetine delayed-release capsules 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 delayed-release capsules 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)].
• Interference with Psychomotor Performance — Duloxetine delayed-release capsules may be associated with sedation and dizziness. Therefore, caution patients about operating hazardous machinery including automobiles, until they are reasonably certain that duloxetine delayed-release capsules therapy does not affect their ability to engage in such activities.

Rx only

Manufactured for:
Time-Cap Labs, lnc.
7 Michael Avenue, Farmingdale,
NY 11735, USA

Manufactured by:
Marksans Pharma Ltd.
Plot No. L-82, L-83 Verna Indl. Estate
Verna, Goa-403722, India

Revised: 02/2022