"The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended the marketing of selexipag (Uptravi, Actelion Registration Ltd) for the treatment of adults with pulmonary arterial hypertension (PAH)./"...
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.
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:
|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:
|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 08807This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 1/11/2017
Additional Kerledex Information
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