Duloxetine Hydrochloride (Page 14 of 16)

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

Duloxetine delayed-release capsules, USP 20 mg are size ‘4’ hard gelatin capsules having light blue cap and body, imprinted as ’20 mg’ on the body and ‘1109’ on the cap with black ink, containing off white to reddish brown colored pellets.

Blistercards of 30 NDC 0615-8290-39

Duloxetine delayed-release capsules, USP 30 mg are size ‘3’ hard gelatin capsules having blue cap and milky white body, imprinted as ’30 mg’ on the body with black ink and ‘1110’ on the cap with white ink, containing off white to reddish brown colored pellets.

Duloxetine delayed-release capsules, USP 60 mg are size ‘1’ hard gelatin capsules having opaque blue cap and yellow body, imprinted as ’60 mg’ on the body and ‘1111’ on the cap with white ink, containing off white to reddish brown colored pellets.

16.2 Storage and Handling

Store at 20° to 25°C (68° to 77°); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

17 PATIENT COUNSELING INFORMATION

See FDA-approved patient labeling (Medication Guide).

  • Information on Medication Guide Inform patients, their families, and their caregivers about the benefits and risks associated with treatment with duloxetine delayed-release capsules and counsel them in its appropriate use. A patient Medication Guide is available for duloxetine delayed-release capsules. Instruct patients, their families, and their caregivers to read the Medication Guide before starting duloxetine delayed-release capsules and each time their prescription is renewed, and assist them in understanding its contents. Give patients the opportunity to discuss the contents of the Medication Guide and to obtain answers to any questions they may have. The complete text of the Medication Guide is reprinted at the end of this document.

Advise patients of the following issues and asked to alert their prescriber if these occur while taking duloxetine delayed-release capsules.

  • Suicidal Thoughts and Behaviors Encourage patients, their families, and their caregivers to be alert to the emergence of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, mania, other unusual changes in behavior, worsening of depression, and suicidal ideation, especially early during antidepressant treatment and when the dose is adjusted up or down

Advise families and caregivers of patients to observe for the emergence of such symptoms on a day-to-day basis, since changes may be abrupt. Such symptoms should be reported to the patient’s prescriber or health professional, especially if they are severe, abrupt in onset, or were not part of the patient’s presenting symptoms. Symptoms such as these may be associated with an increased risk for suicidal thinking and behavior and indicate a need for very close monitoring and possibly changes in the medication [see Boxed Warning, and Warnings and Precautions (5.1)].

  • Duloxetine delayed-release 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.
  • Continuing the Therapy Prescribed While patients may notice improvement with duloxetine delayed-release capsule therapy in 1 to 4 weeks, advise patients to continue therapy as directed.
  • 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. For this reason, duloxetine delayed-release capsules should ordinarily 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 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), 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). Patients should be cautioned 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)].
  • 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 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 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 physician 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 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 – Safety and efficacy of duloxetine in patients 7 to 17 years of age have been established for the treatment of GAD. The types of adverse reactions observed with duloxetine in children and adolescents were generally similar to those observed in adults. The safety and effectiveness of duloxetine 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 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.

8067025 Revised January 2018

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