Duvanta Tablets (Generic Duloxetine Hydrochloride Tablets)

1. Duvanta Tablets (Generic Duloxetine Hydrochloride Tablets) © The Swiss Pharmacy

2. Duvanta Tablets (Generic Duloxetine Hydrochloride Tablets) Duvanta (Generic Duloxetine Hydrochloride Tablets) is used for the symptomatic relief of major depressive disorder (MDD). Duvanta is used for the symptomatic relief of anxiety causing clinically significant distress in patients with generalized anxiety disorder (GAD). This medicine is also used to treat neuropathic pain associated with diabetic peripheral neuropathy, chronic low back pain and osteoarthritis of the knee. © The Swiss Pharmacy

3. Duvanta Tablets (Generic Duloxetine Hydrochloride Tablets) Duvanta Tablets are manufactured by Intas Pharmaceuticals Limited, India in the strengths of 20 mg, 30 mg, 40 mg and 60 mg. © The Swiss Pharmacy

4. Duvanta Tablets (Generic Duloxetine Hydrochloride Tablets) Chemical Structure © The Swiss Pharmacy

5. Duvanta Tablets (Generic Duloxetine Hydrochloride Tablets) The active ingredient contained in Duvanta tablets is Duloxetine Hydrochloride. Each gastro-resistant Duvanta tablet contains Duloxetine Hydrochloride equivalent to 20 mg, 30 mg, 40 mg or 60 mg of Duloxetine. © The Swiss Pharmacy

6. Duvanta Tablets (Generic Duloxetine Hydrochloride Tablets) Uses of Duvanta 20 mg, 30 mg, 40 mg and 60 mg Tablets: Duvanta tablets (Generic Duloxetine Hydrochloride tablets) contain the active substance Duloxetine Hydrochloride. Duvanta increases the levels of serotonin and noradrenaline in the nervous system. Duvanta is used in adult patients to treat: depression and generalised anxiety disorder (chronic feeling of anxiety or nervousness). It is also used for pain caused by nerve damage associated with diabetes called diabetic neuropathic pain (often described as burning, stabbing, stinging, shooting or aching or like an electric shock. There may be loss of feeling in the affected area, or sensations such as touch, heat, cold or pressure may cause pain). Duloxetine is also used to treat fibromyalgia (muscle pain and stiffness) and chronic (long-lasting) pain that is related to muscles and bones. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9654_Duvanta-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9654_Duvanta-Tablets.html © The Swiss Pharmacy

7. Duvanta Tablets (Generic Duloxetine Hydrochloride Tablets) Uses of Duvanta 20 mg, 30 mg, 40 mg and 60 mg Tablets: Duloxetine belongs to a group of medicines known as selective serotonin and norepinephrine reuptake inhibitors (SSNRIs). These medicines are thought to work by increasing the activity of chemicals called serotonin and norepinephrine in the brain. Duvanta starts to work in most people with depression or anxiety within two weeks of starting treatment, but it may take 2 to 4 weeks before you feel better. Inform your doctor if you do not start to feel better after this time. Your doctor may continue to give you Duvanta when you are feeling better to prevent your depression or anxiety from returning. In patients with diabetic neuropathic pain it can take some weeks before you feel better. Talk to your doctor if you do not feel better after 2 months. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9654_Duvanta-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9654_Duvanta-Tablets.html © The Swiss Pharmacy

8. Duvanta Tablets (Generic Duloxetine Hydrochloride Tablets) Recommended Adult Dosage For the treatment of is Major Depressive Disorder Duvanta Tablets Duvanta Tablets (Generic Duloxetine Hydrochloride Tablets) should be administered at a total dose of 40 mg/day (given as 20 mg twice daily) to 60 mg/day (given either once daily or as 30 mg twice daily). For some patients, it may be desirable to start at 30 mg once daily for 1 week, to allow patients to adjust to the medication before increasing to 60 mg once daily. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9654_Duvanta-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9654_Duvanta-Tablets.html © The Swiss Pharmacy

9. Duvanta Tablets (Generic Duloxetine Hydrochloride Tablets) Recommended Adult Dosage Generalized Anxiety Disorder: For most patients, the recommended starting dose for Duvanta tablets is 60 mg administered once daily. For some patients, it may be desirable to start at 30 mg once daily for 1 week, to allow patients to adjust to the medication before increasing to 60 mg once daily. Diabetic Peripheral Neuropathic Pain: The recommended dose for Duvanta tablets is 60 mg administered once daily. There is no evidence that doses higher than 60 mg confer additional significant benefit and the higher dose is clearly less well tolerated. Fibromyalgia: The recommended dose for Duvanta tablets is 60 mg administered once daily. Treatment should begin at 30 mg once daily for 1 week, to allow patients to adjust to the medication before increasing to 60 mg once daily. Some patients may respond to the starting dose. There is no evidence that doses greater than 60 mg/day confer additional benefit. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9654_Duvanta-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9654_Duvanta-Tablets.html © The Swiss Pharmacy

10. Duvanta Tablets (Generic Duloxetine Hydrochloride Tablets) Contraindications ➔Duvanta tablets are contraindicated in patients with a known hypersensitivity to Duloxetine Hydrochloride or any component of the tablet. ➔Monoamine Oxidase Inhibitors: Concomitant use in patients taking Monoamine Oxidase Inhibitors (MAOIs) is contraindicated due to the risk of serious, sometimes fatal, drug interactions with serotonergic drugs. These interactions may include hyperthermia, rigidity, myoclonus, autonomic instability with possible rapid fluctuations of vital signs, and mental status changes that include extreme agitation progressing to delirium and coma. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9654_Duvanta-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9654_Duvanta-Tablets.html © The Swiss Pharmacy

11. Duvanta Tablets (Generic Duloxetine Hydrochloride Tablets) Contraindications ➔Uncontrolled Narrow-Angle Glaucoma: During clinical trials, Duloxetine use was associated with an increased risk of mydriasis; therefore, its use should be avoided in patients with uncontrolled narrow-angle glaucoma. ➔Do not start treatment with Duvanta (Generic Duloxetine Hydrochloride Tablets) in a patient who is being treated ,with Linezolid or intravenous Methylene Blue URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9654_Duvanta-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9654_Duvanta-Tablets.html © The Swiss Pharmacy

12. Duvanta Tablets (Generic Duloxetine Hydrochloride Tablets) Storage Instructions Duvanta Tablets (Generic Duloxetine Hydrochloride Tablets) have to be stored at controlled room temperature i.e. from 20°C to 25°C (68°F to 77°F) with excursions permitted between 15° to 30°C (59° to 86°F). Keep this as well as all other medicines away from children and pets. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9654_Duvanta-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9654_Duvanta-Tablets.html © The Swiss Pharmacy

13. Duvanta Tablets (Generic Duloxetine Hydrochloride Tablets) Warnings Suicidality: Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of Duvanta (Generic Duloxetine tablets) or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Monitor for clinical worsening and suicide risk. Hepatotoxicity: Hepatic failure, sometimes fatal, has been reported in patients treated with Duvanta. Duvanta should be discontinued in patients who develop jaundice or other evidence of clinically significant liver dysfunction and should not be resumed unless another cause can be established. Duvanta should not be prescribed to patients with substantial alcohol use or evidence of chronic liver disease. Orthostatic Hypotension and Syncope: Cases have been reported with Duloxetine therapy. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9654_Duvanta-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9654_Duvanta-Tablets.html © The Swiss Pharmacy

14. Duvanta Tablets (Generic Duloxetine Hydrochloride Tablets) Warnings Serotonin Syndrome, or Neuroleptic Malignant Syndrome (NMS)-like reactions: Serotonin syndrome or NMS-like reactions have been reported with SSRIs and SNRIs. Discontinue Duvanta and initiate supportive treatment. Abnormal Bleeding: Duvanta may increase the risk of bleeding events. Patients should be cautioned about the risk of bleeding associated with the concomitant use of duloxetine and NSAIDs, Aspirin, or other drugs that affect coagulation. Severe Skin Reactions: Severe skin reactions, including erythema multiforme and Stevens-Johnson Syndrome (SJS), can occur with Duvanta (Generic Duloxetine Hydrochloride tablets). Duvanta should be discontinued at the first appearance of blisters, peeling rash, mucosal erosions, or any other sign of hypersensitivity if no other etiology can be identified. Activation of mania or hypomania has occurred. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9654_Duvanta-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9654_Duvanta-Tablets.html © The Swiss Pharmacy

15. Duvanta Tablets (Generic Duloxetine Hydrochloride Tablets) Warnings Discontinuation: May result in symptoms, including dizziness, headache, nausea, diarrhea, paresthesia, irritability, vomiting, insomnia, anxiety, hyperhidrosis, and fatigue. Seizures: Prescribe with care in patients with a history of seizure disorder Blood Pressure: Monitor blood pressure prior to initiating treatment and periodically throughout treatment Inhibitors of CYP1A2 or Thioridazine: Should not administer with Duvanta tablets. Hyponatremia: Cases of hyponatremia have been reported Hepatic Insufficiency and Severe Renal Impairment: Should ordinarily not be administered to these patients Controlled Narrow-Angle Glaucoma: Use cautiously in these patients URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9654_Duvanta-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9654_Duvanta-Tablets.html © The Swiss Pharmacy

16. Duvanta Tablets (Generic Duloxetine Hydrochloride Tablets) Warnings Glucose Control in Diabetes: In diabetic peripheral neuropathic pain patients, small increases in fasting blood glucose, and HbA1c have been observed Conditions that Slow Gastric Emptying: Use cautiously in these patients Urinary Hesitation and Retention URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9654_Duvanta-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9654_Duvanta-Tablets.html © The Swiss Pharmacy

17. Duvanta Tablets (Generic Duloxetine Hydrochloride Tablets) Possible Side Effects Most common Duloxetine Hydrochloride (Duvanta tablets) side effects with an incidence rate of greater than or equal to 5% and at least twice the incidence of placebo patients include nausea, dry mouth, somnolence, constipation, decreased appetite, and hyperhidrosis URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9654_Duvanta-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9654_Duvanta-Tablets.html © The Swiss Pharmacy

18. Duvanta Tablets (Generic Duloxetine Hydrochloride Tablets) Possible Side Effects The other side effects observed during clinical trials include: Cardiac Disorders — Frequent: palpitations; Infrequent: myocardial infarction and tachycardia. Ear and Labyrinth Disorders — Frequent: vertigo; Infrequent: ear pain and tinnitus. Endocrine Disorders — Infrequent: hypothyroidism. Eye Disorders — Frequent: vision blurred; Infrequent: diplopia and visual disturbance. Gastrointestinal Disorders — Frequent: flatulence; Infrequent: eructation, gastritis, halitosis, and stomatitis; Rare: gastric ulcer, hematochezia, and melena. General Disorders and Administration Site Conditions — Frequent: chills/rigors; Infrequent: feeling abnormal, feeling hot and/or cold, malaise, and thirst; Rare: gait disturbance. Infections and Infestations — Infrequent: gastroenteritis and laryngitis. Investigations — Frequent: weight increased; Infrequent: blood cholesterol increased. Metabolism and Nutrition Disorders — Infrequent: dehydration and hyperlipidemia; Rare: dyslipidemia. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9654_Duvanta-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9654_Duvanta-Tablets.html © The Swiss Pharmacy

19. Duvanta Tablets (Generic Duloxetine Hydrochloride Tablets) Possible Side Effects Musculoskeletal and Connective Tissue Disorders — Frequent: musculoskeletal pain; Infrequent: muscle tightness and muscle twitching. Nervous System Disorders — Frequent: dysgeusia, lethargy, and parasthesia / hypoesthesia; Infrequent: disturbance in attention, dyskinesia, myoclonus, and poor quality sleep; Rare: dysarthria. Psychiatric Disorders — Frequent: abnormal dreams and sleep disorder; Infrequent: apathy, bruxism, disorientation/confusional state, irritability, mood swings, and suicide attempt; Rare: completed suicide. Renal and Urinary Disorders — Infrequent: dysuria, micturition urgency, nocturia, polyuria, and urine odor abnormal. Reproductive System and Breast Disorders — Frequent: anorgasmia/orgasm abnormal; Infrequent: menopausal symptoms, and sexual dysfunction. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9654_Duvanta-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9654_Duvanta-Tablets.html © The Swiss Pharmacy

20. Duvanta Tablets (Generic Duloxetine Hydrochloride Tablets) Possible Side Effects Respiratory, Thoracic and Mediastinal Disorders — Frequent: yawning; Infrequent: throat tightness. Skin and Subcutaneous Tissue Disorders — Infrequent: cold sweat, dermatitis contact, erythema, increased tendency to bruise, night sweats, and photosensitivity reaction; Rare: ecchymosis. Vascular Disorders — Frequent: hot flush; Infrequent: flushing, orthostatic hypotension, and peripheral coldness URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9654_Duvanta-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9654_Duvanta-Tablets.html © The Swiss Pharmacy

21. Duvanta Tablets (Generic Duloxetine Hydrochloride Tablets) Duvanta Tablets Overdosage Cases of Duloxetine Hydrochloride (Duvanta tablets) overdoses, alone or in combination with other medicinal products, with Duloxetine doses of 5400 mg were reported. Some fatalities have occurred, primarily with mixed overdoses, but also with Duloxetine alone at a dose of approximately 1000 mg. Signs and symptoms of overdose (Duloxetine alone or in combination with other medicinal products) included somnolence, coma, serotonin syndrome, seizures, vomiting and tachycardia. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9654_Duvanta-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9654_Duvanta-Tablets.html © The Swiss Pharmacy

22. Duvanta Tablets (Generic Duloxetine Hydrochloride Tablets) Treatment of Duvanta Tablets Overdosage No specific antidote is known for Duloxetine Hydrochloride (Duvanta tablets), but if Serotonin syndrome ensues, specific treatment (such as with Cyproheptadine and/or temperature control) may be considered. A free airway should be established. Monitoring of cardiac and vital signs is recommended, along with appropriate symptomatic and supportive measures. Gastric lavage may be indicated if performed soon after ingestion or in symptomatic patients. Activated charcoal may be useful in limiting absorption. Duloxetine has a large volume of distribution and forced diuresis, haemoperfusion, and exchange perfusion are unlikely to be beneficial. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9654_Duvanta-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9654_Duvanta-Tablets.html © The Swiss Pharmacy

23. Duvanta Tablets (Generic Duloxetine Hydrochloride Tablets) Duvanta Tablets During Pregnancy Duloxetine Hydrochloride (Duvanta tablets) has been classified by the US FDA as Pregnancy Category C. During animal reproduction studies, duloxetine has been shown to have adverse effects on embryo/fetal and postnatal development. When Duloxetine was administered orally to pregnant rats during the period of organogenesis, there was no evidence of teratogenicity at doses up to 45 mg/kg/day (7 times the maximum recommended human dose [MRHD, 60 mg/day]) in rat. There are no adequate and well-controlled studies in pregnant women; therefore, Duloxetine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9654_Duvanta-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9654_Duvanta-Tablets.html © The Swiss Pharmacy

24. Duvanta Tablets (Generic Duloxetine Hydrochloride Tablets) Duvanta Tablets Duvanta Tablets (Generic Duloxetine Hydrochloride Tablets) are manufactured by Intas Pharmaceuticals Limited, India. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9654_Duvanta-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9654_Duvanta-Tablets.html © The Swiss Pharmacy