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What is Quetiapine Fumarate?
Quetiapine Fumarate Extended-release Tablets is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [,] [1,4] thiazepin11-yl-1-piperazinyl)ethoxy]-ethanol hemifumarate (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 CHNOS.½CHO and it has a molecular weight of 441.54 (fumarate salt). The structural formula is:
Quetiapine fumarate is a white to off-white crystalline powder which is practically insoluble in water.
Quetiapine Fumarate Extended-release Tablets are supplied for oral administration as 50 mg (maroon), 150 mg (white), 200 mg (yellow), 300 mg (pale yellow) and 400 mg (white). All tablets are film coated.
Inactive ingredients: The following are common in all 5 tablet strengths: microcrystalline cellulose, hypromellose, magnesium stearate, povidone, polyethylene glycol, and titanium dioxide. Additional inactive ingredients include: 50mg - Polyvinyl alcohol, Talc, Iron oxide yellow and Iron oxide red;150 mg - Polydextrose, Hypromellose, and Triacetin; 200 mg - Polyvinyl alcohol, Talc, Lecithin (soya), D&C yellow #10 Aluminum Lake, FD&C yellow #6 Aluminum Lake and FD&C blue #2 Aluminum Lake; 300 mg - Polyvinyl alcohol, Talc, Lecithin (soya), Iron oxide yellow and Iron oxide black; 400 mg - Polydextrose, Hypromellose, and Triacetin.
Each 50 mg tablet contains 58 mg of quetiapine fumarate equivalent to 50 mg quetiapine. Each 150 mg tablet contains 173 mg of quetiapine fumarate equivalent to 150 mg quetiapine. Each 200 mg tablet contains 230 mg of quetiapine fumarate equivalent to 200 mg quetiapine. Each 300 mg tablet contains 345 mg of quetiapine fumarate equivalent to 300 mg quetiapine. Each 400 mg tablet contains 461 mg of quetiapine fumarate equivalent to 400 mg quetiapine.
USP Dissolution Test Pending.
What does Quetiapine Fumarate look like?
What are the available doses of Quetiapine Fumarate?
Extended-Release Tablets: 50 mg, 150 mg, 200 mg, 300 mg, and 400 mg
What should I talk to my health care provider before I take Quetiapine Fumarate?
How should I use Quetiapine Fumarate?
Quetiapine Fumarate Extended-release Tablets is 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 (13-17 years) treated with quetiapine fumarate tablets
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)
Quetiapine Fumarate Extended-release Tablets should be administered once daily, preferably in the evening.
What interacts with Quetiapine Fumarate?
Sorry No Records found
What are the warnings of Quetiapine Fumarate?
Sorry No Records found
What are the precautions of Quetiapine Fumarate?
Sorry No Records found
What are the side effects of Quetiapine Fumarate?
Sorry No records found
What should I look out for while using Quetiapine Fumarate?
Known hypersensitivity to Quetiapine Fumarate Extended-release Tablets or any components in the formulation.
What might happen if I take too much Quetiapine Fumarate?
How should I store and handle Quetiapine Fumarate?
Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Keep tightly closed (protect from moisture). Protect from light. Store quetiapine fumarate extended-release tablets at 25 (77 H); excursions permitted to 15-30 (59-86 H) [See USP].
Chemical StructureNo Image found
The mechanism of action of Quetiapine Fumarate Extended-release Tablets in the treatment of schizophrenia, bipolar disorder and major depressive disorder (MDD), is unknown. However, its efficacy in schizophrenia could be mediated through a combination of dopamine type 2 (D) and serotonin type 2A (5HT) antagonism. The active metabolite, N-desalkyl quetiapine (norquetiapine), has similar activity at D, but greater activity at 5HT receptors, than the parent drug (quetiapine). Quetiapine's efficacy in bipolar depression and MDD may partly be explained by the high affinity and potent inhibitory effects that norquetiapine exhibits for the norepinephrine transporter.
Antagonism at receptors other than dopamine and serotonin with similar or greater affinities may explain some of the other effects of quetiapine and norquetiapine: antagonism at histamine H receptors may explain the somnolence, antagonism at adrenergic b receptors may explain the orthostatic hypotension, and antagonism at muscarinic M receptors may explain the anticholinergic effects.
Non-Clinical ToxicologyKnown hypersensitivity to Quetiapine Fumarate Extended-release Tablets or any components in the formulation.
Nifedipine is mainly eliminated by metabolism and is a substrate of CYP3A. Inhibitors and inducers of CYP3A can impact the exposure to nifedipine and consequently its desirable and undesirable effects. and data indicate that nifedipine can inhibit the metabolism of drugs that are substrates of CYP3A, thereby increasing the exposure to other drugs. Nifedipine is a vasodilator, and coadministration of other drugs affecting blood pressure may result in pharmacodynamic interactions.
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analysis of 17 placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. Quetiapine Fumarate Extended-release Tablets is not approved for the treatment of patients with dementia-related psychosis
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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