Qutan Tablets (Generic Quetiapine Fumarate Tablets)

1. Qutan Tablets (Generic Quetiapine Fumarate Tablets) © The Swiss Pharmacy

2. Qutan Tablets (Generic Quetiapine Fumarate Tablets) Qutan (Generic Quetiapine Fumarate Tablets) is used alone or together with other medicines for treating schizophrenia, bipolar disorder (depressive and manic episodes), recurrent major depressive disorder (MDD) and generalised anxiety disorder (GAD). Quetiapine extended-release tablet is also used together with other antidepressants to treat major depressive disorder. This medicine should not be used to treat behavioral problems in older adult patients who have dementia or Alzheimer disease. Quetiapine is an antipsychotic medicine that works in the brain. © The Swiss Pharmacy

3. Qutan Tablets (Generic Quetiapine Fumarate Tablets) Qutan Tablets are manufactured by Intas Pharmaceuticals Limited, India in the strengths of 25 mg, 50 mg, 100 mg, 200 mg and 300 mg. Qutan tablets are also available as Extended Release (XR or XL) or Sustained Release (SR) version in strengths of SR 50 mg, SR 100 mg, SR 200 mg, SR 300 mg and SR 400 mg. © The Swiss Pharmacy

4. Qutan Tablets (Generic Quetiapine Fumarate Tablets) Chemical Structure © The Swiss Pharmacy

5. Qutan Tablets (Generic Quetiapine Fumarate Tablets) The active ingredient contained in Qutan tablets is Quetiapine Fumarate. Each film-coated Qutan tablet contains Quetiapine Fumarate equivalent to 25 mg, 50 mg, 100 mg, 200 mg or 400 mg of Quetiapine. Each film-coated sustained release Qutan tablet contains Quetiapine Fumarate equivalent to 50 mg, 100 mg, 200 mg, 300 mg or 400 mg of Quetiapine. © The Swiss Pharmacy

6. Qutan Tablets (Generic Quetiapine Fumarate Tablets) Uses of Qutan Tablets: Qutan (Generic Quetiapine Fumarate tablets) is used to treat certain mental/mood conditions (such as schizophrenia, bipolar disorder, sudden episodes of mania or depression associated with bipolar disorder). Quetiapine is known as an anti-psychotic drug (atypical type). It works by helping to restore the balance of certain natural substances (neurotransmitters) in the brain. This medication can decrease hallucinations and improve your concentration. It helps you to think more clearly and positively about yourself, feel less nervous, and take a more active part in everyday life. It may also improve your mood, sleep, appetite, and energy level. Quetiapine can help prevent severe mood swings or decrease how often mood swings occur. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9601_Quetiapine-Fumarate-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9601_Quetiapine-Fumarate-Tablets.html © The Swiss Pharmacy

7. Qutan Tablets (Generic Quetiapine Fumarate Tablets) Recommended Adult Dosage For most adult patients, the starting dose of Qutan tablets (Generic Quetiapine tablets) for treatment of Schizophrenia is 25 mg taken twice daily on day 1. Increase in increments of 25 mg to 50 mg divided two or three times on Days 2 and 3 to range of 300 to 400 mg by Day 4. Further adjustments can be made in increments of 25 to 50 mg twice a day, in intervals of not less than 2 days. The recommended dose is 150 mg to 750 mg/day and the maximum dose is 750 mg/day. Qutan tablets URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9601_Quetiapine-Fumarate-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9601_Quetiapine-Fumarate-Tablets.html © The Swiss Pharmacy

8. Qutan Tablets (Generic Quetiapine Fumarate Tablets) Recommended Adult Dosage Treatment of Bipolar Mania in Adults (Monotherapy or as an Treatment of Bipolar Mania in Adults (Monotherapy or as an Adjunct to Lithium or Divalproex): Adjunct to Lithium or Divalproex): Day 1: Twice daily dosing totaling 100 mg. Day 2: Twice daily dosing totaling 200 mg.Day 3: Twice daily dosing totaling 300 mg.Day 4: Twice daily dosing totaling 400 mg. Further dosage adjustments up to 800 mg/day by Day 6 should be in increments of no greater than 200 mg/day. The recommended dose is 400 mg to 800 mg/day and the maximum dose is 800 mg/day. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9601_Quetiapine-Fumarate-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9601_Quetiapine-Fumarate-Tablets.html © The Swiss Pharmacy

9. Qutan Tablets (Generic Quetiapine Fumarate Tablets) Recommended Adult Dosage Treatment of Bipolar Depression in Adults: Treatment of Bipolar Depression in Adults: Qutan (Generic Quetiapine Fumarate tablets) has to be administered once daily at bedtime as given below: Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg and Day 4: 300 mg The recommended dose is 300 mg and the maximum dose is 300 mg/day. © The Swiss Pharmacy

10. Qutan Tablets (Generic Quetiapine Fumarate Tablets) Contraindications ➔Qutan is contraindicated in patients with a known hypersensitivity to Quetiapine Fumarate or any component of the tablet. Anaphylactic reactions have been reported in patients treated with Quetiapine Fumarate. © The Swiss Pharmacy

11. Qutan Tablets (Generic Quetiapine Fumarate Tablets) Storage Instructions Qutan tablets (Generic Quetiapine Fumarate 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=p9601_Quetiapine-Fumarate-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9601_Quetiapine-Fumarate-Tablets.html © The Swiss Pharmacy

12. Qutan Tablets (Generic Quetiapine Fumarate Tablets) Warnings Increased Mortality in Elderly Patients with Dementia-Related Psychosis: Elderly patients with dementia-related psychosis treated with anti-psychotic drugs are at an increased risk of death. Quetiapine Fumarate tablets are not approved for elderly patients with dementia-related psychosis. Suicidal Thoughts and Behaviors: Increased risk of suicidal thoughts and behavior in children, adolescents and young adults taking antidepressants. Monitor for worsening and emergence of suicidal thoughts and behaviors. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9601_Quetiapine-Fumarate-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9601_Quetiapine-Fumarate-Tablets.html © The Swiss Pharmacy

13. Qutan Tablets (Generic Quetiapine Fumarate Tablets) Warnings Cerebrovascular Adverse Reactions: Increased incidence of cerebrovascular adverse reactions (e.g., stroke, transient ischemic attack) has been seen in elderly patients with dementia-related psychoses treated with atypical antipsychotic medications. Neuroleptic Malignant Syndrome (NMS): Manage with immediate discontinuation and close monitoring Metabolic Changes: Atypical anti-psychotics have been associated with metabolic changes. These metabolic changes include hyperglycemia, dyslipidemia, and weight gain. Tardive Dyskinesia: Discontinue if clinically appropriate. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9601_Quetiapine-Fumarate-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9601_Quetiapine-Fumarate-Tablets.html © The Swiss Pharmacy

14. Qutan Tablets (Generic Quetiapine Fumarate Tablets) Warnings Hypotension: Use with caution in patients with known cardiovascular or cerebrovascular disease. Increased Blood Pressure in Children and Adolescents: Monitor blood pressure at the beginning of, and periodically during treatment in children and adolescents. Leukopenia, Neutropenia and Agranulocytosis: Monitor complete blood count frequently during the first few months of treatment in patients with a pre-existing low white cell count or a history of leukopenia/neutropenia and discontinue Qutan tablets at the first sign of a decline in WBC in absence of other causative factors. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9601_Quetiapine-Fumarate-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9601_Quetiapine-Fumarate-Tablets.html © The Swiss Pharmacy

15. Qutan Tablets (Generic Quetiapine Fumarate Tablets) Warnings Cataracts: Lens changes have been observed in patients during long-term quetiapine treatment. Lens examination is recommended when starting treatment and at 6-month intervals during chronic treatment. Anticholinergic (antimuscarinic) Effects: Use with caution with other anticholinergic drugs and in patients with urinaryretention, prostatic hypertrophy, constipation, or increased intraocular pressure. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9601_Quetiapine-Fumarate-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9601_Quetiapine-Fumarate-Tablets.html © The Swiss Pharmacy

16. Qutan Tablets (Generic Quetiapine Fumarate Tablets) Possible Side Effects Most common Quetiapine Fumarate (Qutan tablets) side effects with an incidence rate of greater than or equal to 5% observed in adults include somnolence, dry mouth, constipation, dizziness, increased appetite, dyspepsia, weight gain, fatigue, dysarthria, and nasal congestion. © The Swiss Pharmacy

17. Qutan Tablets (Generic Quetiapine Fumarate Tablets) Possible Side Effects The following Qutan (Generic Quetiapine Fumarate Tablets) side effects have also been reported with Quetiapine: nightmares, hypersensitivity and elevations in serum creatine phosphokinase (not associated with NMS), galactorrhea, bradycardia (which may occur at or near initiation of treatment and be associated with hypotension and/ or syncope) decreased platelets, somnambulism (and other related events), elevations in gamma-GT levels, hypothermia, and priapism. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9601_Quetiapine-Fumarate-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9601_Quetiapine-Fumarate-Tablets.html © The Swiss Pharmacy

18. Qutan Tablets (Generic Quetiapine Fumarate Tablets) Overdosage During clinical trials, survival has been reported in acute overdoses of up to 30 grams of Quetiapine. Most patients who overdosed experienced no adverse reactions or recovered fully from the reported events. Death has been reported in a clinical trial following an overdose of 13.6 grams of Quetiapine alone. In general, reported signs and symptoms were those resulting from an exaggeration of the medicine’s known pharmacological effects, i.e., drowsiness, sedation, tachycardia, hypotension, and anti-cholinergic toxicity including coma and delirium. Patients with pre-existing severe cardiovascular disease may be at an increased risk of the effects of overdose. One case, involving an estimated overdose of 9600 mg, was associated with hypokalemia and first degree heart block. In post-marketing experience, there were cases reported of QT prolongation with Quetiapine overdose. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9601_Quetiapine-Fumarate-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9601_Quetiapine-Fumarate-Tablets.html © The Swiss Pharmacy

19. Qutan Tablets (Generic Quetiapine Fumarate Tablets) Treatment of Qutan Tablets Overdosage Establish and maintain an airway and ensure adequate oxygenation and ventilation. In cases of severe intoxication, the possibility of multiple drug involvement should be considered, and intensive care procedures are recommended, including establishing and maintaining a patent airway, ensuring adequate oxygenation and ventilation, and monitoring and support of the cardiovascular system. In cases of Quetiapine overdose, refractory hypotension should be treated with appropriate measures such as intravenous fluids and/or sympathomimetic agents (adrenaline and dopamine should be avoided, since beta stimulation may worsen hypotension in the setting of quetiapine- induced alpha blockade). Appropriate supportive measures are the mainstay of Qutan (Generic Quetiapine Fumarate Tablets) overdose management. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9601_Quetiapine-Fumarate-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9601_Quetiapine-Fumarate-Tablets.html © The Swiss Pharmacy

20. Qutan Tablets (Generic Quetiapine Fumarate Tablets) Qutan Tablets During Pregnancy Quetiapine Fumarate (Qutan tablets) has been classified by the US FDA as Pregnancy Category C. Neonates exposed to antipsychotic medicines during the third trimester of pregnancy are at risk of experiencing extrapyramidal neurological disturbances and/or withdrawal symptoms following delivery. There have been post-market reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, and feeding disorder in these neonates. Following some pregnancies in which Quetiapine was used, neonatal withdrawal symptoms have been reported. There are no adequate and well-controlled studies in pregnant women and Quetiapine Fumarate (Qutan tablets) 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=p9601_Quetiapine-Fumarate-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9601_Quetiapine-Fumarate-Tablets.html © The Swiss Pharmacy

21. Qutan Tablets (Generic Quetiapine Fumarate Tablets) Qutan Tablets Qutan Tablets (Generic Quetiapine Fumarate Tablets) are manufactured by Intas Pharmaceuticals Limited, India. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9601_Quetiapine-Fumarate-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9601_Quetiapine-Fumarate-Tablets.html © The Swiss Pharmacy