Benazepril Hydrochloride And Hydrochlorothiazide

Benazepril Hydrochloride And Hydrochlorothiazide

Benazepril Hydrochloride And Hydrochlorothiazide Recall

Get an alert when a recall is issued.

Questions & Answers

Side Effects & Adverse Reactions

There is currently no warning information available for this product. We apologize for any inconvenience.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

1.1 Schizophrenia

Quetiapine fumarate tablet is indicated for the treatment of schizophrenia. The efficacy of quetiapine fumarate tablets 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 fumarate tablets 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 fumarate tablet 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 fumarate tablet 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 adult patients with bipolar I and bipolar II disorder [see Clinical Studies (14.2)].

Quetiapine fumarate tablet is indicated for the maintenance treatment of bipolar I disorder, as an adjunct to lithium or divalproex. Efficacy was established in two maintenance trials in adults. The effectiveness of quetiapine fumarate tablets as monotherapy for the maintenance treatment of bipolar disorder has not been systematically evaluated in controlled clinical trials. [see Clinical Studies (14.2)].

1.3Special 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.

History

There is currently no drug history available for this drug.

Other Information

Quetiapine is a psychotropic agent belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f ] [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 C42H50N6O4S2•C4H4O4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is:

chemstructure

Quetiapine fumarate is a white to off-white crystalline powder which is moderately soluble in water.

Quetiapine fumarate tablet is supplied for oral administration as 25 mg (round, pink), 50 mg (round, white to off white), 100 mg (round, yellow), 200 mg (round, white to off white), 300 mg (capsule-shaped, white), and 400 mg (capsule-shaped, yellow) tablets.

Inactive ingredients are povidone, dibasic calcium phosphate dihydrate, microcrystalline cellulose, sodium starch glycolate, lactose monohydrate, magnesium stearate, hypromellose, polyethylene glycol and titanium dioxide.

The 25 mg tablets contain iron oxide red and iron oxide yellow and the 100 mg and 400 mg tablets contain only iron oxide yellow.

Each 25 mg tablet contains quetiapine fumarate equivalent to 25 mg quetiapine. Each 50 mg tablet contains quetiapine fumarate equivalent to 50 mg quetiapine. Each 100 mg tablet contains quetiapine fumarate equivalent to 100 mg quetiapine. Each 200 mg tablet contains quetiapine fumarate equivalent to 200 mg quetiapine. Each 300 mg tablet contains quetiapine fumarate equivalent to 300 mg quetiapine. Each 400 mg tablet contains quetiapine fumarate equivalent to 400 mg quetiapine.

Benazepril Hydrochloride And Hydrochlorothiazide Manufacturers


  • Golden State Medical Supply, Inc.
    Benazepril Hydrochloride And Hydrochlorothiazide Tablet [Golden State Medical Supply, Inc.]
  • Apotex Corp.
    Benazepril Hydrochloride And Hydrochlorothiazide Tablet [Apotex Corp.]
  • Genharm, L.p.
    Benazepril Hydrochloride And Hydrochlorothiazide (Benazepril Hydrochloride And Hydrochlorothiazide) Tablet [Genharm, L.p.]
  • Andrx Pharmaceuticals, Inc.
    Benazepril Hydrochloride And Hydrochlorothiazide (Benazepril Hydrochloride And Hydrochlorothiazide) Tablet, Film Coated [Andrx Pharmaceuticals, Inc.]
  • Physicians Total Care, Inc.
    Benazepril Hydrochloride And Hydrochlorothiazide Tablet, Film Coated [Physicians Total Care, Inc.]
  • H.j. Harkins Company, Inc.
    Benazepril Hydrochloride And Hydrochlorothiazide Tablet, Film Coated [H.j. Harkins Company, Inc.]
  • Bryant Ranch Prepack
    Benazepril Hydrochloride And Hydrochlorothiazide Tablet, Film Coated [Bryant Ranch Prepack]
  • Mylan Pharmaceuticals Inc.
    Benazepril Hydrochloride And Hydrochlorothiazide Tablet, Film Coated [Mylan Pharmaceuticals Inc.]
  • Bryant Ranch Prepack
    Benazepril Hydrochloride And Hydrochlorothiazide Tablet, Film Coated [Bryant Ranch Prepack]
  • Clinical Solutions Wholesale
    Benazepril Hydrochloride And Hydrochlorothiazide Tablet, Film Coated [Clinical Solutions Wholesale]
  • Ranbaxy Pharmaceuticals Inc.
    Benazepril Hydrochloride And Hydrochlorothiazide Tablet, Coated [Ranbaxy Pharmaceuticals Inc.]
  • Eon Labs, Inc.
    Benazepril Hydrochloride And Hydrochlorothiazide Tablet, Film Coated [Eon Labs, Inc.]
  • Rising Pharmaceuticals, Inc.
    Benazepril Hydrochloride And Hydrochlorothiazide Tablet [Rising Pharmaceuticals, Inc.]
  • Bryant Ranch Prepack
    Benazepril Hydrochloride And Hydrochlorothiazide Tablet, Film Coated [Bryant Ranch Prepack]
  • Medsource Pharmaceuticals
    Benazepril Hydrochloride And Hydrochlorothiazide Tablet, Film Coated [Medsource Pharmaceuticals]

Login To Your Free Account