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Kerledex

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Kerledex

Indications
Dosage
How Supplied

INDICATIONS

Kerledex is indicated in the management of hypertension.

DOSAGE AND ADMINISTRATION

Betaxolol is effective in the treatment of hypertension in once-daily doses of 5-20 mg, while chlorthalidone is effective in doses of 12.5-50 mg. In clinical trials of betaxolol/chlorthalidone combination therapy using betaxolol doses of 5-20 mg and chlorthalidone doses of 12.5-25 mg, the antihypertensive effects increased with increasing doses of either component.

The adverse effects of betaxolol are a mixture of dose-dependent phenomena (principally bradycardia) and dose-independent phenomena (eg, probably skin rash); those of chlorthalidone 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 a combination of betaxolol and chlorthalidone will be associated with both sets of dose-independent adverse effects and to minimize these, it may be appropriate to begin combination therapy only after a patient has failed to achieve the desired effect with monotherapy. On the other hand, regimens that combine low doses of betaxolol and chlorthalidone should produce minimal dose-dependent adverse effects, ie, bradycardia and decreases in serum potassium (see CLINICAL PHARMACOLOGY).

Therapy guided by clinical effect: A patient whose blood pressure is not adequately controlled with monotherapy using either betaxolol (usually 10-20 mg) or chlorthalidone may be switched to Kerledex 5/12.5 mg. Subsequent titration (14-day intervals) could add additional betaxolol, chlorthalidone, or both, using single entity products, Kerledex 5/12.5, or Kerledex 10/12.5 as appropriate.

Initial therapy: Antihypertensive therapy should be initiated with the lowest dose of Kerledex, one 5/12.5 mg tablet once daily. Subsequent titration (14-day intervals) may be carried out with Kerledex tablets up to the maximum recommended dose of 20/25 mg (two 10/12.5 mg tablets) once daily, as appropriate. Alternatively, the single entity products could be used for dose titration.

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

Cessation of therapy: If withdrawal of Kerledex therapy is planned, it should be achieved gradually over a period of about 2 weeks. Patients should be carefully observed.

HOW SUPPLIED

Kerledex 5/12.5 (betaxolol HCl 5 mg and chlorthalidone 12.5 mg) tablets are oval, yellow, film coated, with KERLEDEX debossed on one side and 5221 on the other, supplied as:

NDC Number Size
0025-5221-31 bottle of 100
0025-5221-34 carton of 100 unit dose

Kerledex 10/12.5 (betaxolol HCl 10 mg and chlorthalidone 12.5 mg) tablets are capsule-shaped, yellow, film coated, with KERLEDEX debossed on one side and 5231 on the other, supplied as:

NDC Number Size
0025-5231-31 bottle of 100
0025-5231-34 carton of 100 unit dose

Store below 86°F (30°C) and protect from moisture. Dispense in a tight container.

Caution: Federal law prohibits dispensing without prescription.

Revised: July 2011. Manufactured for: sanofi-aventis U.S. LLC Bridgewater, NJ 08807

Last reviewed on RxList: 9/6/2011
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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