Quetiapine Fumarate (Quetiapine Fumarate)

Trade Name : Quetiapine Fumarate

Alembic Pharmaceuticals Limited

TABLET, FILM COATED

Strength 25 mg/1

QUETIAPINE FUMARATE Atypical Antipsychotic [EPC]

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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 Alembic Pharmaceuticals Limited. It is available in strength of 25 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

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Warnings and Precautions, Falls (5.8) u00a0u00a0u00a0u00a0u00a0 02/2017

Arrayn- Array
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Quetiapine fumarate is not approved for use in pediatric patients under ten years of age [].
See full prescribing information for complete boxed warning.
Increased Mortality in Elderly Patients with Dementia-Related Psychosis
u00b7u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 u00a0
Suicidal Thoughts and Behaviors
u00b7u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 u00a0
Monitor for worsening and emergence of suicidal thoughts and behaviors (5.2)

u00a0Quetiapine fumarate is an atypical antipsychotic indicated for the treatment of:
u00b7u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 Schizophrenia (1.1)
u00b7u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 Bipolar I disorder manic episodes (1.2)
u00b7u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 Bipolar disorder, depressive episodes (1.2)

u2022u00a0u00a0 Quetiapine fumarate can be taken with or without food (2.1).
u00a0u00a0
u00b7u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 Consider a lower startingu00a0 dose (50 mg/day), slower titration and careful monitoring during the initial u00a0u00a0u00a0 dosing period in the elderly (2.3, 8.5)
u00b7u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 Lower starting dose (25 mg/day) and slower titration may be neededu00a0u00a0u00a0u00a0u00a0u00a0 (2.4, 8.7, 12.3)

25 mg tablets are white to off white, round, biconvex, film coated tablets debossed with u2018224u2019 on one side and u2018Lu2019 on the other side.
50 mg tablets are white to off white, round, biconvex, film coated tablets debossed with u2018225u2019 on one side and u2018Lu2019 on the other side.
100 mg tablets are white to off white, round, biconvex, film coated tablets debossed with u2018226u2019 on one side and u2018Lu2019 on the other side.
200 mg tablets are white to off white, round, biconvex, film coated tablets, debossed with u2018L227u2019 on one side and plain on the other side.
300 mg tablets are white to off white, capsule shaped, biconvex, film coated tablets, debossed with u2018L228u2019 on one side and plain on the other side.
400 mg tablets are white to off white, capsule shaped, biconvex, film coated tablets, debossed with u2018L229u2019 on one side and plain on the other side.n
25 mg, 50 mg, 100 mg, 200 mg, 300 mg, and 400 mg (3)

Hypersensitivity to quetiapine or to any excipients in the quetiapine fumarate formulation. Anaphylactic reactions have been reported in patients treated with quetiapine fumarate.
Known hypersensitivity to quetiapine fumarateu00a0 or any components in the formulation. (4)

u00a0
u00b7u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 Increased incidence of cerebrovascular adverse events (e.g., stroke, transient ischemic attack) hasbeen seen in elderly patients with dementia-related psychoses treated with atypical antipsychotic drugs (5.3)
u00b7u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 Manage with immediate discontinuation and close monitoring (5.4)
u00b7u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 Atypical antipsychotics have been associated with metabolic changes. These metabolic changes include hyperglycemia, dyslipidemia, and weight gain (5.5)
u00b7u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 Hyperglycemia and Diabetes Mellitus: Monitor patients for symptoms of hyperglycemia including polydipsia, polyuria, polyphagia, and weakness. Monitor glucose regularly in patients with diabetes or at risk for diabetes
u00b7u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 Dyslipidemia: Undesirable alterations have been observed in patients treated with atypical antipsychotics. Appropriate clinical monitoring is recommended, including fasting blood lipid testing at the beginning of, and periodically, during treatment
u00b7u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 Weight Gain: Gain in body weight has been observed; clinical monitoring of weight is recommended
u00b7u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 Discontinue if clinically appropriate (5.6)
u00b7u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 Use with caution in patients with known cardiovascular or cerebrovascular disease (5.7)
u00b7u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 Monitor blood pressure at the beginning of, and periodically during treatment in children and adolescents (5.9)
u00b7u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 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 quetiapine fumarate at the first sign of a decline in WBC in absence of other causative factors (5.10)
u00b7u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 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 (5.11)

The following adverse reactions are discussed in more detail in other sections of the labeling:
u00b7u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 Increased mortality in elderly patients with dementia-related psychosis n
u00b7u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 Suicidal thoughts and behaviors in adolescents and young adults n
u00b7u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 Cerebrovascular adverse reactions, including stroke in elderly patients with dementia-related psychosis u00b7u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 Neuroleptic Malignant Syndrome (NMS) []u00b7u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 Metabolic changes (hyperglycemia, dyslipidemia, weight gain) []
u00b7u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 Tardive dyskinesia []u00b7u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 Hypotension [] u2022u00a0Fallsu00a0 u00b7u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 Increases in blood pressure (children and adolescents) []u00b7u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 Leukopenia, neutropenia and agranulocytosis []u00b7u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 Cataractsu00a0[]
u00b7u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 QT Prolongation []u00b7u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 Seizures []u00b7u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 Hypothyroidism []u00b7u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 Hyperprolactinemia[]u00b7u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 Potential for cognitive and motor impairment []u00b7u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 Body temperature regulation[]u00b7u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 Dysphagia []u00b7u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 Discontinuation Syndrome []n
u2022u00a0u00a0 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 (6.1) u2022u00a0u00a0 Children and Adolescents: somnolence, dizziness, fatigue, increased appetite, nausea, vomiting, dry mouth, tachycardia, weight increased (6.1) n n n n n
u00a0

u00b7u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 Reduce quetiapine dose to one sixth when coadministered with strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir) (2.5, 7.1, 12.3)
u00b7u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 Increase quetiapine dose up to 5 fold when used in combination with a chronic treatment (more than 7 to 14 days) of potent CYP3A4 inducers (e.g., phenytoin, rifampin, St. Johnu2019s wort) (2.6, 7.1, 12.3)
u00b7u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 Reduce quetiapine dose by 5 fold within 7 to 14 days of discontinuation of CYP3A4 inducers (2.6, 7.1, 12.3)

u00b7u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 Limited human data. Based on animal data, may cause fetal
u00b7u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 Discontinue drug or nursing, taking into considerationn
u00a0u00a0u00a0u00a0u00a0u00a0u00a0
u00a0

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Quetiapine fumarate is a psychotropic agent 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:u00a0
u00a0
Quetiapine fumarate is a white to cream colored powder which isu00a0practically insoluble in water. Quetiapine fumarate tablets are supplied for oral administration as 25 mg (round, white to off-white), 50 mg (round, white to off-white), 100 mg (round, white to off-white), 200 mg (round, white to off-white), 300 mg (capsule-shaped, white to off-white), and 400 mg (capsule-shaped, white to off-white) tablets.
Inactive ingredients are povidone, dibasic calcium phosphate anhydrous, microcrystalline cellulose, sodium starch glycolate, lactose monohydrate, magnesium stearate, hypromellose, hydroxypropyl cellulose and titanium dioxide.

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Quetiapine Fumarate Tablets are supplied as below:
25 mg: White to off white, round, biconvex, film coated tablets debossed with u2018224u2019 on one side and u2018Lu2019 on the other side.
NDC 46708-134-30u00a0u00a0u00a0 bottle of 30 tablets
NDC 46708-134-31u00a0u00a0u00a0 bottle of 100 tablets
NDC 46708-134-91u00a0u00a0u00a0 bottle of 1000 tablets
NDC 46708-134-10u00a0u00a0u00a0 100 (10 x 10) Tablets Unit dose package
u00a0u00a0
50 mg: White to off white, round, biconvex, film coated tablets debossed with u2018225u2019 on one side and u2018Lu2019 on the other side.
NDC 46708-135-30u00a0u00a0u00a0 bottle of 30 tablets
NDC 46708-135-31u00a0u00a0u00a0 bottle of 100 tablets
NDC 46708-135-91u00a0u00a0u00a0 bottle of 1000 tablets
NDC 46708-135-10u00a0u00a0u00a0 100 (10 x 10) Tablets Unit dose package
u00a0u00a0
100 mg: White to off white, round, biconvex, film coated tablets debossed with u2018226u2019 on one side and u2018Lu2019 on the other side.
NDC 46708-136-30u00a0u00a0u00a0 bottle of 30 tablets
NDC 46708-136-31u00a0u00a0u00a0 bottle of 100 tablets
NDC 46708-136-91u00a0u00a0u00a0 bottle of 1000 tablets
NDC 46708-136-10u00a0u00a0u00a0 100 (10 x 10) Tablets Unit dose package
200 mg: White to off white, round, biconvex, film coated tablets, debossed with u2018L227u2019 on one side and plain on the other side.
NDC 46708-137-30u00a0u00a0u00a0 bottle of 30 tablets
NDC 46708-137-31u00a0u00a0u00a0 bottle of 100 tablets
NDC 46708-137-91u00a0u00a0u00a0 bottle of 1000 tablets
NDC 46708-137-10u00a0u00a0u00a0 100 (10 x 10) Tablets Unit dose package
u00a0u00a0
300 mg: White to off white, capsule shaped, biconvex, film coated tablets, debossed with u2018L228u2019 on one side and plain on the other side.
NDC 46708-138-30u00a0u00a0u00a0 bottle of 30 tablets
NDC 46708-138-60u00a0u00a0u00a0 bottle of 60 tablets
NDC 46708-138-91u00a0u00a0u00a0 bottle of 1000 tablets
NDC 46708-138-10u00a0u00a0u00a0 100 (10 x 10) Tablets Unit dose package
u00a0u00a0
400 mg: White to off white, capsule shaped, biconvex, film coated tablets, debossed with u2018L229u2019 on one side and plain on the other side.
NDC 46708-139-30u00a0u00a0u00a0 bottle of 30 tablets
NDC 46708-139-31u00a0u00a0u00a0 bottle of 100 tablets
NDC 46708-139-71u00a0u00a0u00a0 bottle of 500 tablets
NDC 46708-139-10u00a0u00a0u00a0 100 (10 x 10) Tablets Unit dose package
u00a0u00a0
Store at 25u00baC (77u00baF); excursions permitted to 15u00b0 to 30u00baC (59u00b0 to 86u00baF) [see USP].

See FDA-approved patient labeling (Medication Guide)
Prescribers or other health professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with quetiapine fumarate 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 fumarate. 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.
Patients should be advised of the following issues and asked to alert their prescriber if these occur while taking quetiapine fumarate.
Increased Mortality in Elderly Patients with Dementia-Related Psychosis
Patients 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 .
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
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 .
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 [].
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 fumarate [].
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 [].
Heat Exposure and Dehydration
Patients should be advised regarding appropriate care in avoiding overheating and dehydration [].
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 and Nursing Patients should be advised to notify their physician if they become pregnant or intend to become pregnant during therapy with quetiapine fumarate [].
Need for Comprehensive Treatment Program
Quetiapine fumarate 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 fumarate 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 [].

Quetiapine Fumarate
(kwe-TYE-a-peen FUE-ma-rate) Tablets
Read this Medication Guide before you start taking quetiapine fumarate 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?
quetiapine fumarate may cause serious side effects, including:
1.u00a0u00a0u00a0u00a0u00a0 Quetiapine fumarate is not for treating psychosis in the elderly with dementia.
2.u00a0u00a0u00a0u00a0u00a0 u00a0
u00a0
u00b7u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 :
ou00a0u00a0 all risks and benefits of treatment with antidepressant medicines.
ou00a0u00a0 all treatment choices for depression or other serious mental illness
u00a0
u00b7u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 u00a0
u00b7u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 n These include people who have (or have a family history of) u00a0u00a0u00a0 depression, bipolar illness (also called manic-depressive illness), or suicidal thoughts or actions.
u00b7u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 n n
ou00a0u00a0 Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is very important when an antidepressant medicine is started or when the dose is changed.
ou00a0u00a0 Call the healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings.
ou00a0u00a0 Keep all follow-up visits with the healthcare provider as scheduled. Call the healthcare provider between visits as needed, especially if you have concerns about symptoms.
u00a0
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:
u00b7u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 thoughts about suicide or dying
u00b7u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 attempts to commit suicide
u00b7u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 new or worse depression
u00b7u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 new or worse anxiety
u00b7u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 feeling very agitated or restless
u00b7u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 panic attacks
u00b7u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 trouble sleeping (insomnia)
u00b7u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 new or worse irritability
u00b7u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 acting aggressive, being angry, or violent
u00b7u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 acting on dangerous impulses
u00b7u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 an extreme increase in activity and talking (mania)
u00b7u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 other unusual changes in behavior or mood
What else do I need to know about antidepressant medicines?
u00b7u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 Stopping an antidepressant medicine suddenly can cause other symptoms.
u00b7u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 It is important to discuss all the risks of treating depression and also the risks of not treating it. Patients and their families or other caregivers should discuss all treatment choices with the healthcare provider, not just the use of antidepressants.
u00b7u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 Talk to the healthcare provider about the side effects of the medicine prescribed for you or your family member.
u00b7u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 Know all of the medicines that you or your family member take. Keep a list of all medicines to show the healthcare provider. Do not start new medicines without first checking with your healthcare provider.
u00b7u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 Talk to your childu2019s healthcare provider for more information.
What is quetiapine fumarate?
Quetiapine fumarate is a prescription medicine used to treat:
u00b7u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 schizophrenia in people 13 years of age or older
u00b7u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 bipolar disorder in adults, including:
ou00a0u00a0 depressive episodes associated with bipolar disorder
ou00a0u00a0 manic episodes associated with bipolar I disorder alone or with lithium or divalproex
ou00a0u00a0 long-term treatment of bipolar I disorder with lithium or divalproex
u00b7u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 manic episodes associated with bipolar I disorder in children ages 10 to 17 years old
It is not known if quetiapine fumarate is safe and effective in children under 10 years of age.
u00a0
What should I tell my healthcare provider before taking quetiapine fumarate?
u00a0
Before you take quetiapine fumarate, tell your healthcare provider if you have or have had:
u00b7u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 diabetes or high blood sugar in you or your family. Your healthcare provider should check your blood sugar before you start quetiapine fumarate and also during therapy
u00b7u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 high levels of total cholesterol, triglycerides or LDL-cholesterol or low levels of HDL-cholesterol
u00b7u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 low or high blood pressure
u00b7u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 low white blood cell count
u00b7u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 cataracts
u00b7u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 seizures
u00b7u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 abnormal thyroid tests
u00b7u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 high prolactin levels
u00b7u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 heart problems
u00b7u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 liver problems
u00b7u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 any other medical condition
u00b7u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 pregnancy or plans to become pregnant. It is not known if quetiapine fumarate will harm your unborn baby.
u00b7u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 Breast-feeding or plans to breast-feed. quetiapine fumarate can pass into your breast milk. You and your healthcare provider should decide if you will take quetiapine fumarate or breast-feed. You should not do both.
Tell the healthcare provider about all the medicines that you take or recently have taken
Quetiapine fumarate and other medicines may affect each other causing serious side effects. quetiapine fumarate may affect the way other medicines work, and other medicines may affect how quetiapine fumarate works.
Tell your healthcare provider if you are having a urine drug screen because quetiapine fumarate may affect your test results. Tell those giving the test that you are taking quetiapine fumarate.
How should I take quetiapine fumarate?
u00b7u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 Take quetiapine fumarate exactly as your healthcare provider tells you to take it. Do not change the dose yourself.
u00b7u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 Take quetiapine fumarate by mouth, with or without food.
u00b7u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 . If you suddenly stop taking quetiapine fumarate, you may have side effects such as trouble sleeping or trouble staying asleep (insomnia), nausea, and vomiting.
u00b7u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 If you miss a dose of quetiapine fumarate, take it as soon as you remember. If you are close to your next dose, skip the missed dose. Just take the next dose at your regular time. Do not take 2 doses at the same time unless your healthcare provider tells you to. If you are not sure about your dosing, call your healthcare provider.
What should I avoid while taking quetiapine fumarate?
u00b7u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 Do not drive, operate machinery, or do other dangerous activities until you know how quetiapine fumarate affects you. quetiapine fumarate may make you drowsy.
u00b7u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 Avoid getting overheated or dehydrated.
ou00a0u00a0 Do not over-exercise.
ou00a0u00a0 In hot weather, stay inside in a cool place if possible.
ou00a0u00a0 Stay out of the sun. Do not wear too much or heavy clothing.
ou00a0u00a0 Drink plenty of water.
u00b7u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 Do not drink alcohol while taking quetiapine fumarate. It may make some side effects of quetiapine fumarate worse.
What are possible side effects of quetiapine fumarate?
Quetiapine fumarate can cause serious side effects, including:
u00b7u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 n
u00b7u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 n
u00b7u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NMS is a rare but very serious condition that can happen in people who take antipsychotic medicines, including quetiapine fumarate. NMS can cause death and must be treated in a hospital. Call your healthcare provider right away if you become severely ill and have some or all of these symptoms:
ou00a0u00a0 high fever
ou00a0u00a0 excessive sweating
ou00a0u00a0 rigid muscles
ou00a0u00a0 confusion
ou00a0u00a0 changes in your breathing, heartbeat, and blood pressure u2022u00a0can happen in some people who take quetiapine fumarate. These falls may cause serious injuries.
u00b7u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 High blood sugar can happen if you have diabetes already or if you have never had diabetes. High blood sugar could lead to:
ou00a0u00a0 build up of acid in your blood due to ketones (ketoacidosis)
ou00a0u00a0 coma
ou00a0u00a0 death
Increases in blood sugar can happen in some people who take quetiapine fumarate. 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 and during therapy. Call your healthcare provider if you have any of these symptoms of high blood sugar (hyperglycemia) while taking quetiapine fumarate:
ou00a0u00a0 feel very thirsty
ou00a0u00a0 need to urinate more than usual
ou00a0u00a0 feel very hungry
ou00a0u00a0 feel weak or tired
ou00a0u00a0 feel sick to your stomach
ou00a0u00a0 feel confused, or your breath smells fruity
u00b7u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 High fat levels may happen in people treated with quetiapine fumarate. You may not have any symptoms, so your healthcare provider may decide to check your cholesterol and triglycerides during your treatment with quetiapine fumarate.
u00b7u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 Weight gain is common in people who take quetiapine fumarate so you and your healthcare provider should check your weight regularly. Talk to your healthcare provider about ways to control weight gain, such as eating a healthy, balanced diet, and exercising.
u00b7u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 These may be signs of a serious condition. Tardive dyskinesia may not go away, even if you stop taking quetiapine fumarate. Tardive dyskinesia may also start after you stop taking quetiapine fumarate.
u00b7u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 , including lightheadedness or fainting caused by a sudden change in heart rate and blood pressure when rising too quickly from a sitting or lying position.
u00b7u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 Your healthcare provider should check blood pressure in children and adolescents before starting quetiapine fumarate and during therapy.
u00b7u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 u00a0
u00b7u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 u00a0
u00b7u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 u00a0
u00b7u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 Your healthcare provider may do blood tests to check your thyroid hormone level.
u00b7u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 Your healthcare provider may do blood tests to check your prolactin levels.
u00b7u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 u00a0
u00b7u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 u00a0
u00b7u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 u00a0
u00b7u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 These symptoms usually get better 1 week after you start having them.n
u00a0
The most common side effects of quetiapine fumarateu00a0 include:
u00a0
In Adults:
u00a0
In Children and Adolescents:
These are not all the possible side effects of quetiapine fumarate. For more information, ask your healthcare provider or pharmacist. n 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 fumarate ?
u00b7u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 Store quetiapine fumarate at room temperature, between 68u00b0F to 77u00b0F (20u00b0C to 25u00b0C).
u00b7u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 u00a0
General information about the safe and effective use of quetiapine fumarate.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use quetiapine fumarate for a condition for which it was not prescribed. Do not give quetiapine fumarate 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 fumarate. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about quetiapine fumarate that is written for health professionals.
What are the ingredients in quetiapine fumarate?
Active ingredient:
Inactive ingredients:
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Manufactured by:
Alembic Pharmaceuticals Limited(Formulation Division),
Village Panelav, P. O. Tajpura, Near Baska,
Taluka-Halol, Panchmahal, Gujarat, India.
u00a0n
Revised: 03/2017u00a0

Quetiapine Fumarate Tablets 25 mg (30 Tablets in 1 Bottle)Each coated tablet contains quetiapine fumarate equivalent to 25 mg of quetiapine46708-134-30
u00a0u00a0

Quetiapine Fumarate Tablets 50 mg (30 Tablets in 1 Bottle) Each coated tablet contains quetiapine fumarate equivalent to 50 mg of quetiapine 46708-135-30

Quetiapine Fumarate Tablets 100 mg (30 Tablets in 1 Bottle) Each coated tablet contains quetiapine fumarate equivalent to 100 mg of quetiapine 46708-136-30

Quetiapine Fumarate Tablets 200 mg (30 Tablets in 1 Bottle) Each coated tablet contains quetiapine fumarate equivalent to 200 mg of quetiapine 46708-137-30

Quetiapine Fumarate Tablets 300 mg (30 Tablets in 1 Bottle) Each coated tablet contains quetiapine fumarate equivalent to 300 mg of quetiapine 46708-138-30

Quetiapine Fumarate Tablets 400 mg (30 Tablets in 1 Bottle) Each coated tablet contains quetiapine fumarate equivalent to 400 mg of quetiapine 46708-139-30

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Quetiapine Fumarate (Quetiapine Fumarate)

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Quetiapine Fumarate (Quetiapine Fumarate)

Trade Name : Quetiapine Fumarate

TABLET, FILM COATED

Delivery Process

Product information is meant for

Disclaimer

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

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

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

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

Browse Our Services And Processes

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