“We use cookies on this website to enhance your user experience and to personalise content. By clicking any link or continuing to use our Website you agree to our cookies as per our Privacy Policy. Read More” Ok, I agree

Quetiapine - Extended Release (Quetiapine)

Trade Name : Quetiapine

ACI Healthcare USA, Inc.

TABLET, FILM COATED, EXTENDED RELEASE

Strength 50 mg/1

QUETIAPINE FUMARATE Atypical Antipsychotic [EPC]

Delivery Process

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.

We’ll Get in Touch

Once we review your request, we’ll send you an estimated price for the medicine within 2-5 days.

Confirmation and Payment

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.

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.

Product information is meant for

Wholesalers Suppliers Exporters Doctors MOH Tender Supplies Hospitals Brand CROs Comparator Supplies Generic Cooperate Sourcing Individual Patients Indian Institutional Buyers

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 - Extended Release (Quetiapine) which is also known as Quetiapine and Manufactured by ACI Healthcare USA, Inc.. It is available in strength of 50 mg/1 per ml. Read more

Quetiapine - Extended Release (Quetiapine) 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.

Inquire directly from our website and get 5% off on any medicine!

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

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
  • No data
  • Warnings and Precautions, Tardive Dyskinesia () 08/2019
  • Arrayn- Increased Mortality in Elderly Patients with Dementia-Related Psychosis
  • Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of deathu00a0. Quetiapine extended-release tablets are not approved for the treatment of patients with dementia-related psychosisu00a0n
  • Arrayn- Suicidal Thoughts and Behavior
  • 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 olderu00a0. 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 prescriberu00a0n
  • Quetiapine extended-release tablets are not approved for use in pediatric patients under ten years of agen
  • WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS; and SUICIDAL THOUGHTS AND BEHAVIORS
  • See full prescribing information for complete boxed warning.
  • Increased Mortality in Elderly Patients with Dementia-Related Psychosis
  • Suicidal Thoughts and Behaviors
  • Quetiapine extended-release tablets are an atypical antipsychotic indicated for the treatment of:
  • Schizophreniau00a0n
  • Bipolar I disorder, manic or mixed episodesu00a0n
  • Bipolar disorder, depressive episodesu00a0n
  • Major depressive disorder, adjunctive therapy with antidepressantsu00a0n
  • No data
  • Swallow tablets whole and do not split, chew or crushu00a0n
  • Take without food or with a light meal (approx. 300 calories)u00a0n
  • Administer once daily, preferably in the eveningu00a0n
  • Geriatric Use
  • Hepatic Impairment
  • Extended-Release Tablets: 50 mg, 150 mg, 200 mg, 300 mg, and 400 mg ()
  • Hypersensitivity to quetiapine or to any excipients in the quetiapine extended-release tablets formulation. Anaphylactic reactions have been reported in patients treated with quetiapine extended-release tablets.
  • Known hypersensitivity to quetiapine extended-release tablets or any components in the formulation. ()
  • No data
  • Cerebrovascular Adverse Reactions:
  • Neuroleptic Malignant Syndrome (NMS):
  • Metabolic Changes:
  • Tardive Dyskinesia:
  • Hypotension:
  • Increased Blood Pressure in Children and Adolescents:
  • Leukopenia, Neutropenia and Agranulocytosisn- :
  • Cataracts:
  • Anticholinergic(antimuscarinic) Effects: Use with caution with other anticholinergic drugs and in patients with urinary retention, prostatic hypertrophy, constipation, or increased intraocular pressure n
  • The following adverse reactions are discussed in more detail in other sections of the labeling:
  • Most common adverse reactions (incidence u22655% and twice placebo): Adults: somnolence, dry mouth, constipation, dizziness, increased appetite, dyspepsia, weight gain, fatigue, dysarthria, and nasal congestion ()
  • Children and Adolescents: somnolence, dizziness, fatigue, increased appetite, nausea, vomiting, dry mouth, tachycardia, weight increased ()
  • To report SUSPECTED ADVERSE REACTIONS, contact ACI Healthcare USA, Inc. at 1-888-802-1213 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
  • 8.1
  • No data
  • No data
  • Quetiapine extended-release tablets are an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [] [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, USP is a white to off-white crystalline powder which is soluble in 0.1Nu00a0u00a0hydrochloric acid, slightly soluble in water, in alcohol, and in methanol.
  • Quetiapine extended-release tablets,USP are supplied for oral administration as 50 mg (peach), 150 mg (white), 200 mg (yellow), 300 mg (pale yellow), and 400 mg (white). All tablets are capsule shaped and film coated.
  • Inactive ingredients for quetiapine extended-release tablets are lactose monohydrate, microcrystalline cellulose, sodium citrate dihydrate, hypromellose, and magnesium stearate. The film coating for all quetiapine extended-release tablets, USP contain hypromellose, polyethylene glycol 400 and titanium dioxide. In addition, yellow iron oxide (50 mg, 200 mg and 300 mg tablets) and red iron oxide (50 mg tablets) are included in the film coating of specific strengths.
  • Each 50 mg tablet contains 57.56 mg of quetiapine fumarate equivalent to 50 mg quetiapine.
  • Each 150 mg tablet contains 172.7 mg of quetiapine fumarate equivalent to 150 mg quetiapine.
  • Each 200 mg tablet contains 230.26 mg of quetiapine fumarate equivalent to 200 mg quetiapine.
  • Each 300 mg tablet contains 345.38 mg of quetiapine fumarate equivalent to 300 mg quetiapine.
  • Each 400 mg tablet contains 460.5 mg of quetiapine fumarate equivalent to 400 mg quetiapine.
  • No data
  • No data
  • No data
  • Store quetiapine extended-release tablets at 25u00baC (77u00baF); excursions permitted to 15 to 30u00baC (59 to 86u00baF) [See USP Controlled Room Temperature].
  • Advise the patient to read the FDA-approved patient labeling (Medication Guide).
  • Patients should be advised of the following issues and asked to alert their prescriber if these occur while taking quetiapine extended-release tablets.
  • Increased Mortality in Elderly Patients with Dementia-Related Psychosis
  • Patients and caregivers should be advised that elderly patients with dementia-related psychoses treated with atypical antipsychotic drugs are at increased risk of death compared with placebo. Quetiapine extended-release tablets are not approved for elderly patients with dementia-related psychosis n
  • Suicidal Thoughts and Behaviors
  • Patients, their families, and their caregivers should be encouraged 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. 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 n
  • 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 n
  • 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 n
  • 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 n
  • Weight Gain
  • Patients should be advised that they may experience weight gain. Patients should have their weight monitored regularly n n
  • Orthostatic Hypotension
  • 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 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 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 extended-release tablets. 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 extended-release tablets to be stopped and/or treatment to be given 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 n
  • Heat Exposure and Dehydration
  • Patients should be advised regarding appropriate care in avoiding overheating and dehydration 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 n
  • Pregnancy
  • Advise pregnant women to notify their healthcare provider if they become pregnant or intend to become pregnant during treatment with quetiapine extended-release tablets Advise patients that quetiapine extended-release tablets may cause extrapyramidal and/or withdrawal symptoms (agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, and feeding disorder) in a neonate. Advise patients that there is a pregnancy registry that monitors pregnancy outcomes in women exposed to quetiapine extended-release tablets during pregnancy .
  • Infertility
  • Advise females of reproductive potential that quetiapine extended-release tablets may impair fertility due to an increase in serum prolactin levels. The effects on fertility are reversible n
  • Need for Comprehensive Treatment Program
  • Quetiapine extended-release tablets are 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 extended-release tablets 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 n
  • Manufactured by:
  • ScieGen Pharmaceuticals, Inc.
  • Hauppauge NY 11788
  • Distributed by:
  • ACI Healthcare USA, Inc.
  • 10100 W. Sample Road, Suite 406
  • Coral Springs, FL 33065
  • Rev: 01/2021
  • Quetiapine (kwe-TYE-a-peen) Extended-Release Tablets
  • Read this Medication Guide before you start taking quetiapine extended-release tablets and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or treatment.
  • What is the most important information I should know about quetiapine extended-release tablets?
  • Quetiapine extended-release tablets may cause serious side effects, including:
  • 1. risk of death in the elderly with dementia:
  • 2. risk of suicidal thoughts or actions (antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions).
  • Talk to your or your family memberu2019s, healthcare provider about:
  • 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 is quetiapine extended-release tablet?
  • Quetiapine extended-release tablet is a prescription medicine used to treat:
  • It is not known if quetiapine extended-release tablet is safe and effective in children under 10 years of age.
  • Who should not take quetiapine extended-release tablets?
  • Do not take quetiapine extended-release tablets if you are allergic to quetiapine or any of the ingredients in quetiapine extended-release tablets.
  • What should I tell my healthcare provider before taking quetiapine extended-release tablets?
  • Before you take quetiapine extended-release 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 extended-release tablets and other medicines may affect each other causing serious side effects. Quetiapine extended-release tablets may affect the way other medicines work, and other medicines may affect how quetiapine extended-release tablets works.
  • Tell your healthcare provider if you are having a urine drug screen because quetiapine extended-release tablets may affect your test results. Tell those giving the test that you are taking quetiapine extended-release tablets.
  • How should I take quetiapine extended-release tablets?
  • What should I avoid while taking quetiapine extended-release tablets?
  • What are possible side effects of quetiapine extended-release tablets?
  • Quetiapine extended-release tablets can cause serious side effects, including:
  • See u201cWhat is the most important information I should know about quetiapine extended-release tablets?u201d
  • Increases in blood sugar can happen in some people who take quetiapine extended-release 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 extended-release tablets and during therapy.
  • Call your healthcare provider if you have any of these symptoms of high blood sugar (hyperglycemia) while taking quetiapine extended-release tablets:
  • The most common side effects of quetiapine extended-release tablets include:
  • Children and Adolescents:
  • These are not all the possible side effects of quetiapine extended-release tablets. For more information, ask your healthcare provider or pharmacist.
  • Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
  • How should I store quetiapine extended-release tablets?
  • General information about the safe and effective use of quetiapine extended-release tablets.
  • Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use quetiapine extended-release tablets for a condition for which it was not prescribed. Do not give quetiapine extended-release 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 extended-release tablets. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about quetiapine extended-release tablets that is written for health professionals.
  • For more information, call 1-888-802-1213.
  • What are the ingredients in quetiapine extended-release tablets?
  • Active ingredient:
  • Inactive ingredients:
  • This Medication Guide has been approved by the U.S. Food and Drug Administration.
  • Manufactured by:
  • ScieGen Pharmaceuticals, Inc.
  • Hauppauge NY 11788
  • Distributed by:
  • ACI Healthcare USA, Inc.
  • 10100 W. Sample Road, Suite 406
  • Coral Springs, FL 33065
  • Rev: 01/2021
  • NDC 71093-135-02
  • NDC 71093-136-02
  • NDC 71093-137-02
  • NDC 71093-138-02
  • NDC 71093-139-02

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Desogestrel And Ethinyl Estradiol (Emoquette)

Manufacturer: REMEDYREPACK INC.

Presentation: KIT

Strength:

Pack Size:

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Manufacturer: REMEDYREPACK INC.

Presentation: TABLET

Strength: 2.5; .025 mg/1; mg/1

Pack Size:

Fluoxetine Hydrochloride (Fluoxetine)

Fluoxetine Hydrochloride (Fluoxetine)

Manufacturer: REMEDYREPACK INC.

Presentation: CAPSULE

Strength: 40 mg/1

Pack Size:

Metoprolol Succinate (Metoprolol Succinate)

Metoprolol Succinate (Metoprolol Succinate)

Manufacturer: REMEDYREPACK INC.

Presentation: TABLET, EXTENDED RELEASE

Strength: 25 mg/1

Pack Size:

Losartan Potassium (Losartan Potassium)

Losartan Potassium (Losartan Potassium)

Manufacturer: REMEDYREPACK INC.

Presentation: TABLET, FILM COATED

Strength: 25 mg/1

Pack Size:

Browse Our Services And Processes

Comparator Sourcing for Clinical Trials

Comparator Sourcing for Clinical Trials

GNH India brings over 10 years of experience in Comparator

Read More

Name Patient Supply

Name Patient Supply

Today, the exact cause for many rare diseases remains unknown

Read More

Validated Cold Chain Shipment

Validated Cold Chain Shipment

With shifting of pharma industry from synthetic molecules to biologic

Read More

Clinical Trials Supply

Clinical Trials Supply

STOP SOURCING..... START SMART SOURCING...... COME STRAIGHT TO THE SOURCE

Read More

Pharmaceutical Contract Manufacturing

Pharmaceutical Contract Manufacturing

GNH Provides Contract Manufacturing services for: Generic Medicines with following

Read More

Pricing

Pricing

PRICING POLICY Terms of sales are typically prepaid, unless otherwise

Read More

Disclaimer

Please see the Legal Notice for detailed terms and disclaimers. The Legal Notice governs the use of this Website and by accessing and using this Website you agree to be bound by and accept the Legal Notice.

Browse from other international pharmaceuticals

General

64020 Products

GNH India Brings to over 64036 Product SKUs from India all at 1 place with easy access and global deliveries.

US NDC

71245 Products

GNH India Brings to over 71252 Product SKUs from India all at 1 place with easy access and global deliveries.

Canadian DIN

51046 Products

GNH India Brings to over 51047 Product SKUs from India all at 1 place with easy access and global deliveries.

Swiss Drugs

150 Products

GNH India Brings to over 150 Product SKUs from India all at 1 place with easy access and global deliveries.

NZ Drugs

13296 Products

GNH Brings to over 13298 Product SKUs from India all at 1 place with easy access and global deliveries.

FAQ

Check out our delivery process

Can’t find what
you’re looking for?

Contact US
Get Price

Are you an existing customer or a vendor of GNH India? Log in here to

View your Transaction
COMPANY
SERVICES
QUICK LINKS
CONTACT US
Registered Office Address:

Unit # G- 14, 15, 16, 17, Ground Floor, Prabhadevi Industrial Estate, Enterprises Industrial Premises, 408, Veer Sawarkar Road, Prabhadevi,
Mumbai 400025 India

US Office Address:

GNH Pharmaceuticals USA LLC,
Suite E # 499, 1235 EAST BLVD,
Charlotte, NC, 28203, U.S.A
TEL: +1 704 557 0412

Pharmexcil
DB
FIEO-2016
SiteLock

Copyright © 2024 GNHIndia .com. All Rights Reserved. Please read Legal Notice for further details.

Disclaimer: Product names, logos, brands and other trademarks featured or referred to are the property of their respective trademark holders.