QUETIAPINE 200 mg/1
quetiapine · TABLET · Solco Healthcare US, LLC
QUETIAPINE is a tablet containing quetiapine at 200 mg/1, taken oral. Manufactured by Solco Healthcare US, LLC.
Key Facts
- Brand Name
- QUETIAPINE
- Generic Name
- quetiapine
- NDC Code (Product)
43547-521- Manufacturer
- Solco Healthcare US, LLC
- Strength
- 200 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- ANDA206954
- Marketing Start
- 04/12/2022
Recall History
Attix Pharmaceuticals
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Aidapak Services, LLC
Labeling:Label Mixup; QUEtiapine FUMARATE, Tablet, 25 mg may be potentially mislabeled as chlordiazePOXIDE HCl, Capsule, 25 mg, NDC 00555015902, Pedigree: AD49426_1, EXP: 5/16/2014.
Aidapak Services, LLC
Labeling: Label Mixup; QUETIAPINE FUMARATE Tablet, 12.5 mg (1/2 of 25 mg) may be potentially mislabeled as SIMVASTATIN, Tablet, 40 mg, NDC 00093715598, Pedigree: AD22845_4, EXP: 5/2/2014.
The Harvard Drug Group
Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets.
The Harvard Drug Group
Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets.
Aidapak Services, LLC
Labeling:Label Mixup; QUEtiapine FUMARATE Tablet, 100 mg may be potentially mislabeled as DOCUSATE CALCIUM, Capsule, 240 mg, NDC 00536375501, Pedigree: W002776, EXP: 6/6/2014; NICOTINE POLACRILEX, Lozenge, 2 mg, NDC 37205098769, Pedigree: W003823, EXP: 6/27/2014; DOCUSATE SODIUM, Capsule, 250 mg, NDC 00536375710, Pedigree: AD60578_5, EXP: 5/29/2014.
Aidapak Services, LLC
Labeling:Label Mixup; QUEtiapine FUMARATE, Tablet, 25 mg may be potentially mislabeled as MULTIVITAMIN/MULTIMINERAL, Chew Tablet, NDC 58914001460, Pedigree: AD32325_1, EXP: 5/9/2014; ASPIRIN DR EC, Tablet, 81 mg, NDC 00182106105, Pedigree: W003094, EXP: 6/13/2014.
The Harvard Drug Group
Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets.
American Health Packaging
Failed Dissolution Test Requirements: During analysis of long term stability studies at 3 months time point, an OOS was reported for Quetiapine Fumarate Tablets, 25 mg.
Dr. Reddy's Laboratories, Inc.
Failed USP Dissolution Test Requirements: During analysis of long term stability studies at 3 months time point, an OOS was reported for Quetiapine Fumarate Tablets, 25 mg.
Full Prescribing Information
Indications & Usage
1 INDICATIONS & USAGE Quetiapine is an atypical antipsychotic indicated for the treatment of: Schizophrenia ( 1.1 ) Bipolar I disorder manic episodes ( 1.2 ) Bipolar disorder, depressive episodes ( 1.2 ) 1.1 Schizophrenia Quetiapine is indicated for the treatment of schizophrenia. The efficacy of quetiapine in schizophrenia was established in three 6-week trials in adults and one 6-week trial in adolescents (13 to 17 years). The effectiveness of quetiapine for the maintenance treatment of schizophrenia has not been systematically evaluated in controlled clinical trials [ see Clinical Studies (14.1) ]. 1.2 Bipolar Disorder Quetiapine is indicated for the acute treatment of manic episodes associated with bipolar I disorder, both as monotherapy and as an adjunct to lithium or divalproex. Efficacy was established in two 12-week monotherapy trials in adults, in one 3-week adjunctive trial in adults, and in one 3-week monotherapy trial in pediatric patients (10 to 17 years) [ see Clinical Studies (14.2) ]. Quetiapine is indicated as monotherapy for the acute treatment of depressive episodes associated with bipolar disorder. Efficacy was established in two 8-week monotherapy trials in adu…
Dosage & Administration
2 DOSAGE & ADMINISTRATION · Quetiapine tablets, USP can be taken with or without food ( 2.1 ) Indication Initial Dose Recommended Dose Maximum Dose Schizophrenia-Adults (2.2) 25 mg twice daily 150 to 750 mg/day 750 mg/day Schizophrenia-Adolescents (13 to 17 years) (2.2) 25 mg twice daily 400 to 800 mg/day 800 mg/day Bipolar Mania- Adults Monotherapy or as an adjunct to lithium or divalproex (2.2) 50 mg twice daily 400 to 800 mg/day 800 mg/day Bipolar Mania- Children and Adolescents (10 to 17 years), Monotherapy (2.2) 25 mg twice daily 400 to 600 mg/day 600 mg/day Bipolar Depression-Adults (2.2) 50 mg once daily at bedtime 300 mg/day 300 mg/day Geriatric Use: Consider a lower starting dose (50 mg/day), slower titration and careful monitoring during the initial dosing period in the elderly ( 2.3 , 8.5 ) Hepatic Impairment: Lower starting dose (25 mg/day) and slower titration may be needed ( 2.4 , 8.7 , 12.3 ) 2.1 Important Administration Instructions Quetiapine tablets, USP can be taken with or without food. 2.2 Recommended Dosing The recommended initial dose, titration, dose range and maximum quetiapine dose for each approved indication is displayed in Table 1. After initial dosing,…
Contraindications
4 CONTRAINDICATIONS Hypersensitivity to quetiapine or to any excipients in the quetiapine formulation. Anaphylactic reactions have been reported in patients treated with quetiapine. Known hypersensitivity to quetiapine or any components in the formulation. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS Concomitant use of strong CYP3A4 inhibitors: Reduce quetiapine dose to one sixth when coadministered with strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir) ( 2.5 , 7.1 , 12.3 ) Concomitant use of strong CYP3A4 inducers: Increase quetiapine dose up to 5 fold when used in combination with a chronic treatment (more than 7-14 days) of potent CYP3A4 inducers (e.g., phenytoin, rifampin, St. John’s wort) ( 2.6 , 7.1 , 12.3 ) Discontinuation of strong CYP3A4 inducers: Reduce quetiapine dose by 5-fold within 7-14 days of discontinuation of CYP3A4 inducers ( 2.6 , 7.1 , 12.3 ) 7.1 Effect of Other Drugs on Quetiapine The risks of using quetiapine in combination with other drugs have not been extensively evaluated in systematic studies. Given the primary CNS effects of quetiapine, caution should be used when it is taken in combination with other centrally acting drugs. Quetiapine potentiated the cognitive and motor effects of alcohol in a clinical trial in subjects with selected psychotic disorders, and alcoholic beverages should be limited while taking quetiapine. Quetiapine exposure is increased by the prototype CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, …
Adverse Reactions
6 ADVERSE REACTIONS The following adverse reactions are discussed in more detail in other sections of the labeling: Increased mortality in elderly patients with dementia-related psychosis [see Warnings and Precautions (5.1) ] Suicidal thoughts and behaviors in adolescents and young adults [see Warnings and Precautions (5.2) ] Cerebrovascular adverse reactions, including stroke in elderly patients with dementia-related psychosis [see Warnings and Precautions (5.3 )] Neuroleptic Malignant Syndrome (NMS) [see Warnings and Precautions (5.4 )] Metabolic changes (hyperglycemia, dyslipidemia, weight gain) [see Warnings and Precautions (5.5 )] Tardive dyskinesia [see Warnings and Precautions (5.6 )] Hypotension [see Warnings and Precautions (5.7 )] Falls [ see Warnings and Precautions (5.8) ] Increases in blood pressure (children and adolescents) [see Warnings and Precautions ( 5.9 )] Leukopenia, neutropenia and agranulocytosis [see Warnings and Precautions ( 5.10 )] Cataracts [see Warnings and Precautions ( 5.11 )] QT Prolongation [see Warnings and Precautions ( 5.12 )] Seizures [see Warnings and Precautions ( 5.13 )] Hypothyroidism [see Warnings and Precautions ( 5.14 )] Hyperprolactinem…
Frequently Asked Questions
What is QUETIAPINE used for?
QUETIAPINE contains quetiapine. It is a tablet taken oral. Consult your doctor for specific uses.
Is QUETIAPINE a controlled substance?
QUETIAPINE is not classified as a controlled substance by the DEA.
What is the generic name for QUETIAPINE?
The generic name for QUETIAPINE is quetiapine. There are 12 other brand versions of quetiapine.
What is the NDC code for QUETIAPINE 200 mg/1?
The NDC (National Drug Code) for QUETIAPINE 200 mg/1 is 43547-521, listed by Solco Healthcare US, LLC.
Other Quetiapine Brands
See all →- Quetiapine Fumarate ER400 mg/172189-483
- Quetiapine50 mg/172789-266
- Quetiapine200 mg/176420-518
- QUETIAPINE FUMARATE400 mg/116729-097
- Quetiapine fumarate100 mg/133342-101
- Quetiapine fumarate200 mg/133342-103
- Quetiapine Fumarate200 mg/134908-637
- Quetiapine Fumarate200 mg/150090-7471
- Quetiapine Extended Release300 mg/150228-383
- Quetiapine Fumarate300 mg/150268-634
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)