Quetiapine Fumarate (Quetiapine Fumarate)

Trade Name : Quetiapine fumarate

Dr.Reddy's Laboratories Limited

TABLET, FILM COATED

Strength 50 mg/1

QUETIAPINE FUMARATE Atypical Antipsychotic [EPC]

Delivery Process

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Submit a Request

You can fill in a request for your medicine through the form provided. You can access the form by clicking on the ‘Get Price’ button.

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Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Quetiapine Fumarate (Quetiapine Fumarate) which is also known as Quetiapine fumarate and Manufactured by Dr.Reddy's Laboratories Limited. It is available in strength of 50 mg/1 per ml. Read more

Quetiapine Fumarate (Quetiapine Fumarate) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

Read more
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  • WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIARELATED PSYCHOSIS; and SUICIDAL THOUGHTS AND BEHAVIORSn- u00a0
  • Increased Mortality in Elderly Patients with Dementia-Related Psychosis
  • Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at ann- increased risk of death [see Warnings and Precautions n n- Quetiapine is not approved for the treatment of patients with dementia-related psychosis [see Warnings and Precautions n
  • Arrayn- u00a0n- Array
  • Suicidal Thoughts and Behaviors
  • Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients over age 24; there was a reduction in risk with antidepressant use in patients aged 65 and older [see Warnings and Precautions ].n- u00a0n- In patients of all ages who are started on antidepressant therapy, monitor closely for worsening, and for emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber [see Warnings and Precautions ].n- u00a0n- Array
  • Quetiapine is not approved for use in pediatric patients under ten years of age [see Use in Specific Populations ].
  • WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIAL-RELATED PSYCHOSIS: and SUICIDAL THOUGHTS AND BEHAVIORS
  • See full prescribing information for complete boxed warning.
  • Increased Mortality in Elderly Patients with Dementia-Related Psychosis
  • u2022 Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death, Quetiapine is not approved for elderly patients with dementia-related psychosis ()
  • Suicidal Thoughts and Behaviors
  • u2022 Increased risk of suicidal thoughts and behavior in children, adolescents and young adults taking antidepressants (n
  • u2022 Monitor for worsening and emergence of suicidal thoughts and behaviors ()
  • (5.8)
  • Warnings and Precautions, Leukopenia, Neutropenia and Agranulocytosis u00a0() u00a011/2018
  • Warnings and Precautions, Anticholinergic (antimuscarinic) Effects () 11/2018
  • Quetiapine u00a0is an atypical antipsychotic indicated for the treatment of:
  • Schizophrenia n
  • Bipolar I disorder manic episodes n
  • Bipolar disorder, depressive episodes (n
  • No data
  • Tablets: 25 mg, 50 mg, 100 mg, 150 mg, 200 mg, 300 mg, and 400 mg n
  • Hypersensitivity to quetiapine or to any excipients in the quetiapine formulation. Anaphylacticreactions have been reported in patients treated with quetiapine.
  • Known hypersensitivity to quetiapine or any components in the formulation. n
  • No data
  • Cerebrovascular Adverse Reactions
  • Neuroleptic Malignant Syndrome (NMS)
  • Metabolic Changes
  • Tardive Dyskinesia
  • Hypotension
  • Increased Blood Pressure in Children and Adolescents
  • Leukopenia, Neutropenia and Agranulocytosis
  • Cataracts
  • Anticholinergic (antimuscarinic) Effects
  • The following adverse reactions are discussed in more detail in other sections of the labeling:
  • u2022 Most common adverse reactions (incidence u22655% and twice placebo):Adults: somnolence, dry mouth, dizziness, constipation, asthenia, abdominal pain, postural hypotension, pharyngitis, weight gain, lethargy, ALT increased, dyspepsia n
  • u2022 Children and Adolescents: somnolence, dizziness, fatigue, increased appetite, nausea, vomiting, dry mouth, tachycardia, weight increased n
  • To report SUSPECTED ADVERSE REACTIONS, contact Dr. Reddyu2019s Laboratories Inc., at 1-888-375-3784 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • No data
  • Concomitant use of strong CYP3A4 inhibitors
  • Concomitant use of strong CYP3A4 inducers
  • Discontinuation of strong CYP3A4 inducers
  • No data
  • Pregnancy
  • Nursing Mothers
  • No data
  • No data
  • Quetiapine fumarate is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f] [1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is CHNOSu2022CHO and it has a molecular weight of 883.11 (fumarate salt). The structural formula is:
  • Quetiapine fumarate is a white to off-white crystalline powder soluble in DMF, slightly soluble in methanol.
  • Quetiapine fumarare tablets are supplied for oral administration as 25 mg (round, white), 50 mg (round, white), 100 mg (round, yellow), 150 mg (round, yellow), 200 mg (round, white), 300 mg (capsule-shaped, white), and 400 mg (capsule-shaped, yellow) tablets.
  • Inactive ingredients are colloidal silicon dioxide, dibasic calcium phosphate dehydrate (fine powder), lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate.
  • The 25 mg, 50 mg, 200 mg and 300 mg tablets contain opadry white OY58900 (hypromellose 5 cp, polyethylene glycol 400, titanium dioxide) and 100 mg, 150 mg and 400 mg tablets contains opadry yellow OY52945 (hypromellose 5 cp, iron oxide yellow, polyethylene glycol 400, titanium dioxide).
  • No data
  • No data
  • No data
  • Quetiapine fumarate tablets are available as 25 mg, white, round, biconvex, film coated tablets debossed with u2018Ru2019 on one side and u20181u2019 on other side and they are supplied in bottles of 30u2019s, 60u2019s,100u2019s, 500u2019s and unit dose package of 100 (10 x 10).
  • Bottles of 30 u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 55111-249-30
  • Bottles of 60 u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 55111-249-60
  • Bottles of 100 u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0NDC 55111-249-01
  • Bottles of 500 u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0NDC 55111-249-05
  • Unit dose package of 100 (10 x 10) u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 55111-249-78u00a0
  • Quetiapine fumarate tablets 50 mg are white colored, round, biconvex, film coated tablets, debossed with u2018Ru2019 on one side and u20182u2019 on other side and they are supplied in bottles of 30u2019s, 60u2019s,100u2019s, 500u2019s and unit dose package of 100 (10 x 10).
  • Bottles of 30 u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 55111-169-30
  • Bottles of 60 u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 55111-169-60
  • Bottles of 100 u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0NDC 55111-169-01
  • Bottles of 500 u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0NDC 55111-169-05
  • Unit dose package of 100 (10 x 10) u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 55111-169-78u00a0
  • Quetiapine fumarate tablets 100 mg are yellow colored, round, biconvex, film coated tablets debossed with u2018Ru2019 on one side and u20183u2019 on other side and they are supplied in bottles of 30u2019s, 60u2019s,100u2019s, 500u2019s and unit dose package of 100 (10 x 10).
  • Bottles of 30 u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 55111-186-30
  • Bottles of 60 u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 55111-186-60
  • Bottles of 100 u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0NDC 55111-186-01
  • Bottles of 500 u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0NDC 55111-186-05
  • Unit dose package of 100 (10 x 10) u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 55111-186-78
  • Quetiapine fumarate tablets 150 mg are yellow colored, round, biconvex, film coated tablets debossed with u2018RDYu2019 on one side and u2018188u2019 on other side and they are supplied in bottles of 30u2019s, 60u2019s,100u2019s, 500u2019s and unit dose package of 100 (10 x 10).
  • Bottles of 30 u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 55111-188-30
  • Bottles of 60 u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 55111-188-60
  • Bottles of 100 u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0NDC 55111-188-01
  • Bottles of 500 u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0NDC 55111-188-05
  • Unit dose package of 100 (10 x 10) u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 55111-188-78
  • Quetiapine fumarate tablets 200 mg are white, round, biconvex, film coated tablets debossed with u2018Ru2019 on one side and u20185u2019 on other side and they are supplied in bottles of 30u2019s, 60u2019s,100u2019s, 500u2019s and unit dose package of 100 (10 x 10).
  • Bottles of 30 u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 55111-189-30
  • Bottles of 60 u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 55111-189-60
  • Bottles of 100 u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0NDC 55111-189-01
  • Bottles of 500 u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0NDC 55111-189-05
  • Unit dose package of 100 (10 x 10) u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 55111-189-78
  • Quetiapine fumarate tablets 300 mg are white colored, modified capsule shaped, biconvex, film coated tablets, debossed with u2018Ru2019 on one side and u20186u2019 on other side and they are supplied in bottles of 30u2019s, 60u2019s,100u2019s, 500u2019s and unit dose package of 100 (10 x 10).
  • Bottles of 30 u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 55111-190-30
  • Bottles of 60 u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 55111-190-60
  • Bottles of 100 u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0NDC 55111-190-01
  • Bottles of 500 u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0NDC 55111-190-05
  • Unit dose package of 100 (10 x 10) u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 55111-190-78
  • Quetiapine fumarate tablets 400 mg are yellow colored, capsule shaped, biconvex, film coated tablets, debossed with u2018Ru2019 on one side and u20187u2019 on other side and they are supplied in bottles of 30u2019s, 60u2019s,100u2019s, 500u2019s and unit dose package of 100 (10 x 10).
  • Bottles of 30 u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 55111-606-30
  • Bottles of 60 u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 55111-606-60
  • Bottles of 100 u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0NDC 55111-606-01
  • Bottles of 500 u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0NDC 55111-606-05
  • Unit dose package of 100 (10 x 10) u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 55111-606-78
  • Store at 20u00b0-25u00b0C (68u00b0-77u00b0F); [see USP Controlled Room Temperature]
  • See n
  • Prescribers or other health professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with quetiapine and should counsel them in its appropriate use. A patient Medication Guide about u201cAntidepressant Medicines, Depression and other Serious Mental Illness, and Suicidal Thoughts or Actionsu201d is available for quetiapine. The prescriber or health professional should instruct patients, their families, and their caregivers to read the Medication Guide and should assist them in understanding its contents. Patients should be given 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.
  • Array
  • Increased Mortality in Elderly Patients with Dementia-Related PsychosisPatients and caregivers should be advised that elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at increased risk of death compared with placebo. Quetiapine is not approved for elderly patients with dementia-related psychosis [see ].
  • Suicidal Thoughts and Behaviors
  • Patients, their families, and their caregivers should be encouraged to be alert to the emergence ofanxiety, 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. Families and caregivers of patients should be advised to look 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 ].
  • Neuroleptic Malignant Syndrome (NMS)
  • Patients should be advised to report to their physician any signs or symptoms that may be related to NMS. These may include muscle stiffness and high fever [see ].
  • Hyperglycemia and Diabetes Mellitus
  • Patients should be aware of the symptoms of hyperglycemia (high blood sugar) and diabetes mellitus.
  • Patients who are diagnosed with diabetes, those with risk factors for diabetes, or those that develop these symptoms during treatment should have their blood glucose monitored at the beginning of and periodically during treatment [see ].
  • Hyperlipidemia
  • Patients should be advised that elevations in total cholesterol, LDL-cholesterol and triglycerides and decreases in HDL-cholesterol may occur. Patients should have their lipid profile monitored at the beginning of and periodically during treatment [see ].
  • Weight Gain
  • Patients should be advised that they may experience weight gain. Patients should have their weight monitored regularly [see ].
  • Orthostaticu00a0Hypotension
  • Patients should be advised of the risk of orthostatic hypotension (symptoms include feeling dizzy or lightheaded upon standing, which may lead to falls), especially during the period of initial dose titration, and also at times of re-initiating treatment or increases in dose [see n ].
  • Increased Blood Pressure in Children and Adolescents Children and adolescent patients should have their blood pressure measured at the beginning of, and periodically during, treatment [see n n ].
  • Leukopenia/Neutropenia
  • Patients with a pre-existing low WBC or a history of drug induced leukopenia/neutropenia should be advised that they should have their CBC monitored while taking quetiapine.Patients should be advised to talk to their doctor as soon as possible if they have a fever, flu-like symptoms, sore throat, or any other infection as this could be a result of a very low WBC, which may require quetiapine to be stopped and/or treatment to be given [see n n ].
  • Interference with Cognitive and Motor Performance
  • Patients should be advised of the risk of somnolence or sedation (which may lead to falls), especially during the period of initial dose titration. Patients should be cautioned about performing any activity requiring mental alertness, such as operating a motor vehicle (including automobiles) or operating machinery, until they are reasonably certain quetiapine therapy does not affect them adversely [see n n ].
  • Heat Exposure and Dehydration
  • Patients should be advised regarding appropriate care in avoiding overheating and dehydration [see n n ].
  • Concomitant Medication
  • As with other medications, patients should be advised to notify their physicians if they are taking, or plan to take, any prescription or over-the-counter drugs [see ].
  • Pregnancy and Nursing
  • Patients should be advised to notify their physician if they become pregnant or intend to becomepregnant during therapy with quetiapine [see n and ].
  • Need for Comprehensive Treatment Program
  • Quetiapine is indicated as an integral part of a total treatment program for adolescents with schizophrenia and pediatric bipolar disorder that may include other measures (psychological, educational, and social). Effectiveness and safety of quetiapine have not been established in pediatric patients less than 13 years of age for schizophrenia or less than 10 years of age for bipolar mania. Appropriate educational placement is essential and psychosocial intervention is often helpful.
  • The decision to prescribe atypical antipsychotic medication will depend upon the physicianu2019s assessment of the chronicity and severity of the patientu2019s symptoms [see ].
  • u00a0
  • Medication Guideu00a0
  • Quetiapine Fumarate Tabletsu00a0
  • (kwe tye'a peen)n- Array
  • Read this Medication Guide before you start taking quetiapine fumarate tablets and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.u00a0
  • What is the most important information I should know about quetiapine fumarate tablets?
  • Quetiapine fumarate tablets may cause serious side effects, including
  • 1. risk of death in the elderly with dementia. Medicines like quetiapine fumarate tablets can increase the risk of death in elderly people who have memory loss (dementia).
  • 2. risk of suicidal thoughts or actions (antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions).
  • Call a healthcare provider right away if you or your family member has any of the following symptoms, especially if they are new, worse, or worry you:
  • What else do I need to know about antidepressant medicines?
  • What are quetiapine fumarate tablets?
  • Array
  • It is not known if quetiapine fumarate tablets are safe and effective in children under 10 years of age.u00a0
  • What should I tell my healthcare provider before taking quetiapine fumarate tablets?
  • Before you take quetiapine fumarate tablets, tell your healthcare provider if you have or have had:
  • Tell the healthcare provider about all the medicines that you take or recently have taken
  • Quetiapine fumarate tablets and other medicines may affect each other causing serious side effects. Quetiapine fumarate tablets may affect the way other medicines work, and other medicines may affect how quetiapine fumarate tablets works.u00a0
  • Tell your healthcare provider if you are having a urine drug screen because quetiapine fumarate tablets may affect your test results. Tell those giving the test that you are taking quetiapine fumarate tablets.u00a0
  • How should I take quetiapine fumarate tablets?
  • What should I avoid while taking quetiapine fumarate tablets?
  • What are possible side effects of quetiapine fumarate tablets?
  • Quetiapine fumarate tablets can cause serious side effects, including
  • Increases in blood sugar can happen in some people who take quetiapine fumarate tablets. Extremely high blood sugar can lead to coma or death. If you have diabetes or risk factors for diabetes (such as being overweight or a family history of diabetes) your healthcare provider should check your blood sugar before you start quetiapine fumarate tablets and during therapy.u00a0
  • Call your healthcare provider if you have any of these symptoms of high blood sugar (hyperglycemia) while taking quetiapine fumarate tablets:
  • The most common side effects of quetiapine fumarate tablets include:
  • In Adults:
  • u2022 drowsiness
  • u2022 sudden drop in blood pressure upon standing
  • u2022 weight gain
  • u2022 sluggishness
  • u2022 abnormal liver tests
  • u2022 upset stomach
  • u2022 dry mouth
  • u2022 dizziness
  • u2022 weakness
  • u2022 abdominal pain
  • u2022 constipation
  • u2022 sore throatu00a0
  • In Children and Adolescents:
  • u2022 drowsiness
  • u2022 dizziness
  • u2022 fatigue
  • u2022 nausea
  • u2022 dry mouth
  • u2022 weight gain
  • u2022 increased appetite
  • u2022 vomiting
  • u2022 rapid heart beatu00a0
  • These are not all the possible side effects of quetiapine fumarate tablets. For more information, ask your healthcare provider or pharmacist.u00a0
  • Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.u00a0
  • How should I store quetiapine fumarate tablets?
  • General information about the safe and effective use of quetiapine fumarte tablets.
  • Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use quetiapine fumarte tablets for a condition for which it was not prescribed. Do not give quetiapine fumarte tablets to other people, even if they have the same symptoms you have. It may harm them. This Medication Guide summarizes the most important information about quetiapine fumarte tablets. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about quetiapine fumarte tablets that is written for health professionals.u00a0
  • For more information, call 1-888-375-3784.u00a0
  • What are the ingredients in quetiapine fumarate tablets?
  • Active ingredient:
  • Inactive ingredients
  • u00a0This Medication Guide has been approved by the U.S. Food and Drug Administration.u00a0
  • Ru00a0Onlyu00a0
  • Manufactured by:
  • Dr. Reddyu2019s Laboratories Limited
  • Bachupally u2013 500 090 INDIAu00a0
  • Revised: 1218
  • Dispense with Medication Guide available at:
  • www.drreddys.com/medguide/quetiapinetabs.pdf u00a0
  • Arrayn- Quetiapine fumarate tablets 25 mg : Container label
  • Unvarnished Area Consists of: 2D Barcode, Lot Number, Expiry Date and Serial Number
  • Array
  • Array
  • Arrayn- Quetiapine fumarate tablets 50 mg : Container label
  • Unvarnished Area Consists of: 2D Barcode, Lot Number, Expiry Date and Serial Number
  • Array
  • Array
  • Arrayn- Quetiapine fumarate tablets 100 mg : Container label
  • Unvarnished Area Consists of: 2D Barcode, Lot Number, Expiry Date and Serial Number
  • Array
  • Array
  • Quetiapine fumarate tablets 150 mg : Container label
  • Array
  • Array
  • Quetiapine fumarate tablets 200 mg : Container label
  • Unvarnished Area Consists of: 2D Barcode, Lot Number, Expiry Date and Serial Number
  • Array
  • Array
  • Arrayn- Quetiapine fumarate tablets 300 mg : Container label 60's count
  • Unvarnished Area Consists of: 2D Barcode, Lot Number, Expiry Date and Serial Number
  • Array
  • Array
  • Arrayn- Quetiapine fumarate tablets 400 mg : Container label
  • Unvarnished Area Consists of: 2D Barcode, Lot Number, Expiry Date and Serial Number
  • Array
  • Array
  • Quetiapine Fumarate Tablets, 25 mg - Carton Label
  • Quetiapine Fumarate Tablets, 50 mg - Carton Label
  • Quetiapine Fumarate Tablets,100 mg - Carton Label
  • Quetiapine Fumarate Tablets, 150 mg - Carton Label
  • Quetiapine Fumarate Tablets, 200 mg - Carton Label
  • Quetiapine Fumarate Tablets, 300 mg - Carton Label
  • Quetiapine Fumarate Tablets, 400 mg - Carton label

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