1 Dosing Considerations Dosage must be individualized. The fixed combination is not for initial therapy. The dose of INHIBACE PLUS (cilazapril and hydrochlorothiazide) should be determined by titration of the individual components.
Once the patient has been successfully titrated and stabilized with the individual components, INHIBACE PLUS may be substituted if the titrated doses and dosing schedule can be achieved by the fixed combination (see 1 INDICATIONS and 7 WARNINGS AND PRECAUTIONS).
In some patients a twice daily administration may be required. Patients at risk for hypotension should start treatment with careful titration and low doses of individual components and also INHIBACE PLUS. Similar caution should be taken for patients with angina pectoris or cerebrovascular disease, in whom hypotension can cause myocardial or cerebral ischemia.
5 mg once daily. Dosage should be adjusted according to the blood pressure response, generally at intervals of at least two weeks. 5 to 5 mg once daily. Minimal additional blood pressure lowering effects were achieved with a dose of 10 mg daily.
A dose of 10 mg should not be exceeded. In most patients, the antihypertensive effect of INHIBACE is maintained with a once daily dosing regimen. In some patients treated once daily, the antihypertensive effect may diminish toward the end of the dosing interval.
This can be evaluated by measuring blood pressure just prior to dosing to determine whether satisfactory control is being maintained for 24 hours. If it is not, either twice daily administration with the same total daily dose, or an increase in dose should be considered.
If blood pressure is not adequately controlled with INHIBACE alone a non-potassium-sparing diuretic may be administered concomitantly. After the addition of a diuretic, it may be possible to reduce the dose of INHIBACE.
Concomitant Diuretic Therapy:
In patients receiving diuretics, INHIBACE therapy should be initiated with caution, since they are usually volume depleted and more likely to experience hypotension following ACE inhibition. Whenever possible, all diuretics should be discontinued two to three days prior to the administration of INHIBACE to reduce the likelihood of hypotension (see 7 WARNINGS AND PRECAUTIONS).
5 mg once daily and the blood pressure closely monitored after the first dose until stabilized. Thereafter, the dose should be adjusted according to individual response. 5 mg tablet) once daily or less, depending on the patient’s volume status and general condition.
Thereafter, the dose of INHIBACE must be adjusted according to individual response.
Dosage Adjustment in Renal Impairment:
See Error! Reference source not found. 5 mg once daily < 10 mL/min Not recommended. When concomitant diuretic therapy is required in patients with severe renal impairment a loop diuretic rather than a thiazide diuretic is preferred for use with cilazapril.
Therefore, for patients with severe renal dysfunction (creatinine clearance < 10 mL/min) INHIBACE PLUS is not recommended. 5 mg once daily or less as significant hypotension may occur (see 7 WARNINGS AND PRECAUTIONS). PrINHIBACE PLUS®, cilazapril and hydrochlorothiazide Page 7 of 71 Drug Discontinuation INHIBACE PLUS should be promptly discontinued and appropriate therapy instituted without delay if angioedema occurs.
Patients receiving cilazapril who develop jaundice or marked elevations of hepatic enzymes should discontinue cilazapril and receive appropriate medical follow-up. If increasing azotemia and oliguria occur during treatment of severe progressive renal disease the diuretic should be discontinued.
If renal failure occurs, treatment should be discontinued. INHIBACE PLUS should be withdrawn and appropriate treatment given if diagnosis of Acute Respiratory Distress Syndrome (ARDS) is suspected. Angioneurotic edema has been reported in patients receiving cilazapril.
INHIBACE PLUS should be discontinued and appropriate therapy instituted without delay when involvement of the face, lips, tongue, glottis and/or larynx occurs. 4 Administration The tablets must not be chewed or crushed and should always be swallowed with a glass of water.
They should be taken at the same time each day, preferably in the morning. 3 Pharmacokinetics). 5 Missed Dose Missed doses should not be replaced by double doses and medication should be resumed at the usual time.