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Quetiapine - Extended Release (Quetiapine)

Trade Name : Quetiapine

Marlex Pharmaceuticals Inc

TABLET, FILM COATED, EXTENDED RELEASE

Strength 150 mg/1

QUETIAPINE FUMARATE Atypical Antipsychotic [EPC]

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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 Marlex Pharmaceuticals Inc. It is available in strength of 150 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

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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.

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  • No data
  • Warnings and Pre cautions,u00a0Fallsu00a0()nttu00a0u00a0u00a0u00a0u00a0nt02/2017
  • 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 death n- [see Warnings and Precautions (n- Arrayn- )]n- . Quetiapine extended-release tablets are not approved for the treatment of patients with dementia-related psychosis n- [see Warnings and Precautions (n- Arrayn- )].
  • Suicidal Thoughts and Behavior
  • Antidepressn- an- nts increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. Thesen- u00a0n- 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 usn- en- in patients aged 65 and older n- [see Warnings and Precautions (n- Arrayn- )].n- 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 n- [see Warnings and Precautions (n- Arrayn- )]
  • Quetiapine extended-release tablets are not approved for us e in pediatric patients under ten years of age n- [see Use in Specific Populations (n- Arrayn- )].
  • 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 indicate d for the treatment of:
  • Schizophrenia ()n
  • Bipolaru00a0Iu00a0disorder,u00a0manicu00a0oru00a0mixedu00a0episodeu00a0su00a0()n
  • Bipolaru00a0disorder,u00a0depressiveu00a0episodeu00a0su00a0()n
  • Majoru00a0depressiveu00a0disorder,u00a0adjunctiveu00a0therapyu00a0withu00a0antidepressantsu00a0()
  • No data
  • Swallowu00a0tabletsu00a0wholeu00a0and do notu00a0split,u00a0chewu00a0or crush ()n
  • Takeu00a0withoutu00a0food oru00a0withu00a0au00a0lightu00a0mealu00a0(approx.u00a0300u00a0calorieu00a0s)u00a0()n
  • Administeru00a0onceu00a0daily,u00a0preferablyu00a0in theu00a0evening ()n
  • Geriatric Use:
  • Hepaticn- Impairment:n- u00a0
  • 2.4n- 8.7n- 12.3
  • 150 mg extended-release tablets are white, film coated, capsule-shaped, biconvex embossed tablet with on one side and plain on the other
  • 200 mg extended-release tablets are yellow, film coated, capsule-shaped, biconvex embossed tabletu00a0with on one side and plain on the other
  • 300 mg extended-release tablets are pale yellow, film coated, capsule-shaped, biconvex embossed tablet with on one side and plain on the other
  • 400 mg extended-release tablets are white, film coated, capsule-shaped, biconvex embossed tablet with on one side and plain on the other
  • Extended-Release Tablets: 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
  • Cerebrovascularn- u00a0n- Adverse n- Reactions:n- u00a0
  • Neuroleptic n- Malignant n- Syndrome n- (NMS):
  • Metabolicn- Changes:n- u00a0n- Hyperglycemia and Diabetes Mellitus:n- Dyslipidemia:n- Weight Gain:
  • Arrayn- Arrayn- Arrayn- Array
  • Tardive Dyskinesia:
  • Hypotension:n- u00a0
  • Increased n- Blood n- Pressure n- in n- Children n- and n- Adolescents:
  • Leukopenia, Neutropenia n- and n- Agranulocytosis:
  • Cataracts:n- u00a0
  • 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 ()
  • No data
  • Concomitant n- use n- of n- strong n- CYP3A4 n- inhibitors:
  • 2.5n- 7.1n- 12.3
  • Concomitant n- use n- of n- strong n- CYP3A4 n- inducers:
  • 2.6n- 7.1n- 12.3
  • Discontinuation of n- strong n- CYP3A4 n- inducers:
  • 2.6n- 7.1n- 12.3
  • No data
  • Pregnancy:n- u00a0
  • Nursing Mothers:
  • 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 CHNOSu2022CHOand 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 0.1N hydrochloric acid, slightly soluble in water, in alcohol, and in methanol.
  • Quetiapine extended-release tablets,USP are supplied for oral administration as 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 (200 mg and 300 mg tablets) are included in the film coating of specific strengths.
  • Each 150 mg tablet contains 172.7 mg of quetiapine fumarate equivalent to 150 mgu00a0quetiapine. 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 mgu00a0quetiapine.
  • 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].
  • See FDA-approved patient labeling ()
  • Prescribers or other health professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with quetiapine extended-release tabletsu00a0and 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 extended-release tablets. 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 thisu00a0document.
  • 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 is not approved for elderly patients with dementia-related psychosis n n 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 symptomsu00a0should 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 n n n n 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 n n n n 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 ofu00a0and periodically during treatment n n 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 n n
  • Weight Gain
  • Patients should be advised that they may experience weight gain. Patients should have their weight monitored regularly n 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 n n n n 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 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 extended-release tablets n 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 n n n
  • Heat Exposure and Dehydration
  • Patients should be advised regarding appropriate care in avoiding overheating and dehydration n 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 n n n n n n n
  • Pregnancy and Nursing
  • Patients should be advised to notify their physician if they become pregnant or intend to become pregnant during therapy with quetiapine extended-release tablets n n n n n n n n
  • Need for Comprehensive Treatment Program
  • Quetiapine extended-release tablets 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 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 n n n n
  • u00a0u00a0
  • Manufactured for & Distributed by: Marlex Pharmaceuticals, Inc.New Castle, DE 19720 Rev. 05/18AP
  • Tablets
  • MEDICATION GUIDE
  • Quetiapine (n- kwe-TYE-a-peen) Extended-Releasn- e
  • 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 oru00a0treatment.
  • 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. n- risn- k n- of n- death n- in n- the elderly with n- dementia:
  • 2. n- risn- k n- of n- suicidal n- thoughts n- or n- actions (antidepressant n- medicines n- , n- depresn- sn- ion n- and n- other n- sn- eriousn- u00a0n- mentaln- u00a0n- illnessn- esn- u00a0n- ,n- u00a0n- andn- u00a0n- suicidaln- u00a0n- thoughtsn- u00a0n- orn- actionsn- u00a0n- ).
  • Talk to your or your family memberu2019s, healthcare provider about:
  • Call a healthcare n- provider n- right away n- if n- you n- or n- your n- family n- member n- has any n- of n- the following sn- ymptomsn- ,n- u00a0n- esn- peciallyn- u00a0n- ifn- u00a0n- theyn- u00a0n- aren- u00a0n- new,n- u00a0n- worsn- e,n- u00a0n- orn- u00a0n- worry you:
  • What else do I need to know about antidepressant medicines?
  • Stopping an antidepressant medicine suddenly can cause other symptoms.
  • 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 orn- u00a0n- 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-releasn- e tabletsn- ?
  • 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:
  • These are not all the possible side effects of quetiapine extended-release tablets. For more information, ask your healthcare provider oru00a0pharmacist.
  • 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 harmu00a0them.
  • 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.
  • 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 for & Distributed by: Marlex Pharmaceuticals, Inc.New Castle, DE 19720Revised: 05/18AP
  • PRINCIPAL DISPLAY PANELn- Quetiapine n- Arrayn- Arrayn- abletsn- , USP
  • PRINCIPAL DISPLAY PANELn- Quetiapine n- Arrayn- Arrayn- abletsn- , USP
  • PRINCIPAL DISPLAY PANELn- Quetiapine n- Arrayn- Arrayn- abletsn- , USP
  • PRINCIPAL DISPLAY PANELn- Quetiapine n- Arrayn- Arrayn- abletsn- , USP

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