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Atacand HCT (Candesartan Cilexetil / Hydrochlorothiazide) - Indications and Dosage

 
 



INDICATIONS AND USAGE

ATACAND HCT is indicated for the treatment of hypertension. This fixed dose combination is not indicated for initial therapy (see DOSAGE AND ADMINISTRATION).

DOSAGE & ADMINISTRATION

The usual recommended starting dose of candesartan cilexetil is 16 mg once daily when it is used as monotherapy in patients who are not volume depleted. ATACAND can be administered once or twice daily with total daily doses ranging from 8 mg to 32 mg. Patients requiring further reduction in blood pressure should be titrated to 32 mg. Doses larger than 32 mg do not appear to have a greater blood pressure lowering effect.

Hydrochlorothiazide is effective in doses of 12.5 to 50 mg once daily.

To minimize dose-independent side effects, it is usually appropriate to begin combination therapy only after a patient has failed to achieve the desired effect with monotherapy.

The side effects (See WARNINGS) of candesartan cilexetil are generally rare and apparently independent of dose; those of hydrochlorothiazide are a mixture of dose-dependent phenomena (primarily hypokalemia) and dose-independent phenomena (eg, pancreatitis), the former much more common than the latter.

Therapy with any combination of candesartan cilexetil and hydrochlorothiazide will be associated with both sets of dose-independent side effects.

Replacement Therapy: The combination may be substituted for the titrated components.

Dose Titration by Clinical Effect: A patient whose blood pressure is not controlled on 25 mg of hydrochlorothiazide once daily can expect an incremental effect from ATACAND HCT 16-12.5 mg. A patient whose blood pressure is controlled on 25 mg of hydrochlorothiazide but is experiencing decreases in serum potassium can expect the same or incremental blood pressure effects from ATACAND HCT 16-12.5 mg and serum potassium may improve.

A patient whose blood pressure is not controlled on 32 mg of ATACAND can expect incremental blood pressure effects from ATACAND HCT 32-12.5 mg and then 32-25 mg. The maximal antihypertensive effect of any dose of ATACAND HCT can be expected within 4 weeks of initiating that dose.

Patients with Renal Impairment: The usual regimens of therapy with ATACAND HCT may be followed as long as the patient’s creatinine clearance is > 30 mL/min. In patients with more severe renal impairment, loop diuretics are preferred to thiazides, so ATACAND HCT is not recommended.

Patients with Hepatic Impairment: The usual regimens of therapy with ATACAND HCT may be followed in patients with mild hepatic impairment. In patients with moderate hepatic impairment, consideration should be given to initiation of ATACAND at a lower dose, such as 8 mg. If a lower starting dose is selected for candesartan cilexetil, ATACAND HCT is not recommended for initial titration because the appropriate initial starting dose of candesartan cilexetil cannot be given. (See CLINICAL PHARMACOLOGY, Special Populations, Hepatic Insufficiency).

Thiazide diuretics should be used with caution in patients with hepatic impairment; therefore, care should be exercised with dosing of ATACAND HCT.

ATACAND HCT may be administered with other antihypertensive agents.

ATACAND HCT may be administered with or without food.

HOW SUPPLIED

No. 3825 — Tablets ATACAND HCT 16-12.5, are peach, oval, biconvex, non-film-coated tablets, scored on both sides and coded with ACS on one side. They are supplied as follows:

Bottles of 30
NDC 54868-4729-0

No. 3826 — Tablets ATACAND HCT 32-12.5, are yellow, oval, biconvex, non-film-coated tablets, scored on both sides and coded with ACJ on one side. They are supplied as follows:

Bottles of 30
NDC 54868-4869-0


Storage:

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Keep container tightly closed.

ATACAND HCT is a trademark of the AstraZeneca group of companies

©AstraZeneca 2008

Manufactured under the license from Takeda Pharmaceutical Company, Ltd.

by: AstraZeneca AB, S-151 85 Södertälje, Sweden

for: AstraZeneca LP, Wilmington, DE 19850

Made in Sweden

Rev. 04/11



Relabeling and Repackaging by:
Physicians Total Care, Inc.
Tulsa, Oklahoma     74146

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