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RX ITEM-Quetiapine 100Mg Tab 100 By Accord Healthcare

NDC 16729-0147-01 UPC/GTIN No.3-16729-14701-9 Mfg.Part No.14701BRAND: QUETIAPINE NDC: 16729-0147-01,16729014701 UPC: 3-16729-14701-9,316729147019 Accord Healthcare Inc.Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scopWant to do Research on this Med or need a large quantity? Email Details with quantity required to:sales@AmericanPharmaWholesale.comVisit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.

RX ITEM-Quetiapine 100Mg Tab 100 By Accord Healthcare

$685.75$5.99

item No.:RX178236/A NDC No.16729014701 UPC No.:316729147019 NDC No. 16729-0147-01 UPC/GTIN No. 3-16729-14701-9 MPN 14701 Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,ResearchCo.,Uni.,VA,Vet & Wholesalers in scope of practice can order this RX item. Rx Item No. Rx178236 Quetiapine 100mg Tab 100 by Accord Healthcare Item No. 3178236 NDC No. 16729014701 UPC No. 316729147019 Other Name Seroqu

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QUETIAPINE FUMARATE- quetiapine fumarate tablet, extended release
Accord Healthcare Inc.
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS; and SUICIDAL THOUGHTS AND BEHAVIORS

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 [see Warnings and Precautions (5.1)] . Quetiapine Fumarate Extended-release tablets are not approved for the treatment of patients with dementia-related psychosis [see Warnings and Precautions (5.1)].

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 older [see Warnings and Precautions (5.2)] .

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 (5.2)]

Quetiapine Fumarate Extended-release tablets are not approved for use in pediatric patients under ten years of age [see Use in Specific Populations (8.4)].
1 INDICATIONS AND USAGE
1.1 Schizophrenia

Quetiapine Fumarate Extended-release tablets are indicated for the treatment of schizophrenia. The efficacy of quetiapine fumarate extended-release tablets in schizophrenia was established in one 6-week and one maintenance trial in adults with schizophrenia. Efficacy was supported by three 6-week trials in adults with schizophrenia and one 6-week trial in adolescents with schizophrenia (13 to 17 years) treated with quetiapine tablets [see Clinical Studies (14.1)].
1.2 Bipolar Disorder

Quetiapine Fumarate Extended-release tablets are indicated for the acute treatment of manic or mixed episodes associated with bipolar I disorder, both as monotherapy and as an adjunct to lithium or divalproex. The efficacy of quetiapine fumarate extended-release tablets in manic or mixed episodes of bipolar I disorder was established in one 3-week trial in adults with manic or mixed episodes associated with bipolar I disorder. Efficacy was supported by two 12-week monotherapy trials and one 3-week adjunctive trial in adults with manic episodes associated with bipolar I disorder as well as one 3-week monotherapy trial in children and adolescents (10 to 17 years) with manic episodes associated with bipolar I disorder treated with quetiapine tablets [see Clinical Studies (14.2)].
1.3 Adjunctive Treatment of Major Depressive Disorder (MDD)

Quetiapine Fumarate Extended-release tablets are indicated for use as adjunctive therapy to antidepressants for the treatment of MDD. The efficacy of quetiapine fumarate extended-release tablets as adjunctive therapy to antidepressants in MDD was established in two 6-week trials in adults with MDD who had an inadequate response to antidepressant treatment [see Clinical Studies (14.3)].
1.4 Special Considerations in Treating Pediatric Schizophrenia and Bipolar I Disorder

Pediatric schizophrenia and bipolar I disorder are serious mental disorders, however, diagnosis can be challenging. For pediatric schizophrenia, symptom profiles can be variable, and for bipolar I disorder, patients may have variable patterns of periodicity of manic or mixed symptoms. It is recommended that medication therapy for pediatric schizophrenia and bipolar I disorder be initiated only after a thorough diagnostic evaluation has been performed and careful consideration given to the risks associated with medication treatment. Medication treatment for both pediatric schizophrenia and bipolar I disorder is indicated as part of a total treatment program that often includes psychological, educational and social interventions.
2 DOSAGE AND ADMINISTRATION
2.1 Important Administration Instructions

Quetiapine Fumarate Extended-release tablets should be swallowed whole and not split, chewed or crushed.

It is recommended that quetiapine fumarate extended-release tablets be taken without food or with a light meal (approximately 300 calories) [see Clinical Pharmacology (12.3)].

Quetiapine Fumarate Extended-release tablets should be administered once daily, preferably in the evening.
2.2 Recommended Dosing

The recommended initial dose, titration, dose range and maximum quetiapine fumarate extended-release tablets dose for each approved indication is displayed in Table 1 below. After initial dosing, adjustments can be made upwards or downwards, if necessary, depending upon the clinical response and tolerability of the patient [see Clinical Studies ( 14.1, 14.2 and 14.3)].

NDC 16729-0147-01 UPC/GTIN No.3-16729-14701-9 Mfg.Part No.14701
RX ITEM-Quetiapine 100Mg Tab 100 By Acco
NDC 16729-0147-01 UPC/GTIN No.3-16729-14701-9 Mfg.Part No.14701

BRAND: QUETIAPINE NDC: 16729-0147-01,16729014701 UPC: 3-16729-14701-9,316729147019 Accord Healthcare Inc.
Quetiapine 100Mg Tab 100 By Accord Healt
BRAND: QUETIAPINE NDC: 16729-0147-01,16729014701 UPC: 3-16729-14701-9,316729147019 Accord Healthcare Inc.

Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop
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Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.