Exforge Hct label

Exforge Hct

Exforge Hct Recall

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Uses

Exforge HCT (amlodipine, valsartan, hydrochlorothiazide) is indicated for the treatment of hypertension.

This fixed combination drug is not indicated for the initial therapy of hypertension [see Dosage and Administration (2)].

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History

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Other Information

Exforge HCT is a fixed combination of amlodipine, valsartan and hydrochlorothiazide.

Exforge HCT contains the besylate salt of amlodipine, a dihydropyridine calcium channel blocker (CCB). Amlodipine besylate, USP is a white to pale yellow crystalline powder, slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate’s chemical name is 3-Ethyl 5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(o-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulfonate ; its structural formula is

amlodipine structural formula

Its empirical formula is C20H25ClN2O5•C6H6O3S and its molecular weight is 567.1.

Valsartan, USP is a nonpeptide, orally active, and specific angiotensin II antagonist acting on the AT1 receptor subtype. Valsartan is a white to practically white fine powder, soluble in ethanol and methanol and slightly soluble in water. Valsartan’s chemical name is N-(1-oxopentyl)-N-[[2′-(1H-tetrazol-5-yl) [1,1′-biphenyl]-4-yl]methyl]-L-valine; its structural formula is

Valsartan structural formula

Its empirical formula is C24H29N5O3 and its molecular weight is 435.5.

Hydrochlorothiazide, USP is a white, or practically white, practically odorless, crystalline powder. It is slightly soluble in water; freely soluble in sodium hydroxide solution, in n-butylamine, and in dimethylformamide; sparingly soluble in methanol; and insoluble in ether, in chloroform, and in dilute mineral acids. Hydrochlorothiazide is chemically described as 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7- sulfonamide 1,1-dioxide.

Hydrochlorothiazide is a thiazide diuretic. Its empirical formula is C7H8ClN3O4S2, its molecular weight is 297.73, and its structural formula is

Hydrochlorothiazide structural formula

Exforge HCT film-coated tablets are formulated in five strengths for oral administration with a combination of amlodipine besylate, valsartan and hydrochlorothiazide, providing for the following available combinations: 5/160/12.5 mg, 10/160/12.5 mg, 5/160/25 mg, 10/160/25 mg and 10/320/25 mg amlodipine besylate/valsartan/hydrochlorothiazide. The inactive ingredients for all strengths of the tablets include microcrystalline cellulose; crospovidone; colloidal anhydrous silica; magnesium stearate; hypromellose, macrogol 4000 and talc. Additionally, the 5/160/12.5 mg strength contains titanium dioxide; the 10/160/12.5 mg strength contains titanium dioxide and yellow and red iron oxides; the 5/160/25 mg strength contains titanium dioxide and yellow iron oxide and the 10/160/25 mg and 10/320/25 mg strengths both contain yellow iron oxide.

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Exforge Hct Manufacturers

  • Physicians Total Care, Inc.
    Exforge Hct | Physicians Total Care, Inc.
    No Recall

    Exforge Hct | Physicians Total Care, Inc.

    Exforge Hct | Physicians Total Care, Inc.
    2.1 General Considerations

    Dose once-daily. The dosage may be increased after two weeks of therapy. The full blood pressure lowering effect was achieved 2 weeks after being on the maximal dose of Exforge HCT. The maximum recommended dose of Exforge HCT is 10/320/25 mg.

    Exforge HCT may be administered with or without food.

    No initial dosage adjustment is required for elderly patients.

    Renal impairment: The usual regimens of therapy with Exforge HCT may be followed if the patient’s creatinine clearance is >30 mL/min. In patients with more severe renal impairment, loop diuretics are preferred to thiazides, so avoid use of Exforge HCT [see Impaired Renal Function (5.5)].

    Hepatic impairment: Avoid Exforge HCT in patients with severe hepatic impairment. In patients with lesser degrees of hepatic impairment, monitor for worsening of hepatic or renal function and adverse reactions [see Impaired Hepatic Function (5.4)].

    2.2 Add-on / Switch Therapy

    Exforge HCT may be used for patients not adequately controlled on any two of the following antihypertensive classes: calcium channel blockers, angiotensin receptor blockers, and diuretics.

    A patient who experiences dose-limiting adverse reactions to an individual component while on any dual combination of the components of Exforge HCT may be switched to Exforge HCT containing a lower dose of that component to achieve similar blood pressure reductions.

    2.3 Replacement Therapy

    Exforge HCT may be substituted for the individually titrated components.

  • Remedyrepack Inc.
    Exforge Hct | Remedyrepack Inc.
    No Recall

    Exforge Hct | Remedyrepack Inc.

    Exforge Hct | Remedyrepack Inc.

    Dose once-daily. Titrate up to a maximum dose of 10/320/25 mg
    Exforge HCT may be used as add-on/switch therapy for patients not adequately controlled on any two of the following antihypertensive classes: calcium channel blockers, angiotensin receptor blockers, and diuretics.
    Exforge HCT may be substituted for its individually titrated components (2).

     

    Dose once-daily. The dosage may be increased after 2 weeks of therapy. The full blood pressure lowering effect was achieved 2 weeks after being on the maximal dose of Exforge HCT. The maximum recommended dose of Exforge HCT is 10/320/25 mg.

     

    Exforge HCT may be used for patients not adequately controlled on any 2 of the following antihypertensive classes: calcium channel blockers, angiotensin receptor blockers, and diuretics.

    A patient who experiences dose-limiting adverse reactions to an individual component while on any dual combination of the components of Exforge HCT may be switched to Exforge HCT containing a lower dose of that component to achieve similar blood pressure reductions.

     

    Exforge HCT may be substituted for the individually titrated components.

     

    Exforge HCT may be administered with other antihypertensive agents.

     

  • Novartis Pharmaceuticals Corporation
    Exforge Hct | Novartis Pharmaceuticals Corporation
    No Recall

    Exforge Hct | Novartis Pharmaceuticals Corporation

    Exforge Hct | Novartis Pharmaceuticals Corporation
    2.1     General Considerations

    Dose once-daily. The dosage may be increased after 2 weeks of therapy. The full blood pressure lowering effect was achieved 2 weeks after being on the maximal dose of Exforge HCT. The maximum recommended dose of Exforge HCT is 10/320/25 mg.

    2.2     Add-on / Switch Therapy

    Exforge HCT may be used for patients not adequately controlled on any 2 of the following antihypertensive classes: calcium channel blockers, angiotensin receptor blockers, and diuretics.

    A patient who experiences dose-limiting adverse reactions to an individual component while on any dual combination of the components of Exforge HCT may be switched to Exforge HCT containing a lower dose of that component to achieve similar blood pressure reductions.

    2.3     Replacement Therapy

    Exforge HCT may be substituted for the individually titrated components.

    2.4     Use with Other Antihypertensive Drugs

    Exforge HCT may be administered with other antihypertensive agents.

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