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APO-CILAZAPRIL/HCTZ is a brand name for Cilazapril, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: APO-CILAZAPRIL/HCTZ (cilazapril and hydrochlorothiazide tablets) is indicated for • treatment of mild to moderate essential hypertension in patients for whom combination therapy with both cilazapril and hydrochlorothiazide is appropriate. APO-CILAZAPRIL/HCTZ is not indicated for initial therapy. Patients should be…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations • Dosage must be individualized. The fixed combination is not for initial therapy. The dose of APO-CILAZAPRIL/HCTZ (Cilazapril and Hydrochlorothiazide Tablets) Page 6 of 79 APO-CILAZAPRIL/HCTZ (cilazapril and hydrochlorothiazide tablets) should be determined by titration of the individual components.
• Once the patient has been successfully titrated and stabilized with the individual components, APO-CILAZAPRIL/HCTZ 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 APO-CILAZAPRIL/HCTZ. 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 cilazapril 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 cilazapril 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 cilazapril.
Concomitant Diuretic Therapy:
In patients receiving diuretics, cilazapril 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 cilazapril to reduce the likelihood of hypotension (see 7 WARNINGS AND PRECAUTIONS).
). 2 Breast-feeding). 4 Drug- Drug Interactions). , sacubitril/valsartan). Do not administer APO-CILAZAPRIL/HCTZ within 36 hours of switching to or from sacubitril/valsartan, a drug product containing a neprilysin inhibitor (see 7 WARNINGS AND PRECAUTIONS and
08/2023 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES ..........................................................................................
2 TABLE OF CONTENTS ............................................................................................................ 2 PART I: HEALTH PROFESSIONAL INFORMATION ....................................................................
4 1 INDICATIONS ............................................................................................................ 1 Pediatrics ................................................................................................................
2 Geriatrics ................................................................................................................ 4 2 CONTRAINDICATIONS ................................................................................................
4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ........................................................... 5 4 DOSAGE AND ADMINISTRATION................................................................................ 1 Dosing Considerations ............................................................................................
2 Recommended Dose and Dosage Adjustment ...................................................... 4 Administration ........................................................................................................ 5 Missed Dose ...........................................................................................................
8 5 OVERDOSAGE............................................................................................................ 8 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................................ 8 7 WARNINGS AND PRECAUTIONS .................................................................................
APO-CILAZAPRIL/HCTZ (cilazapril and hydrochlorothiazide tablets) is contraindicated in: • Patients who are hypersensitive to this drug or to any ingredient in the formulation or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
• Patients with hereditary/idiopathic angioedema or a history of angioedema related to previous treatment with an angiotensin-converting enzyme (ACE) inhibitor (see 7 WARNINGS AND PRECAUTIONS). • Patients with ascites. APO-CILAZAPRIL/HCTZ (Cilazapril and Hydrochlorothiazide Tablets) Page 5 of 79 • Patients hypersensitive to thiazides and other sulfonamide-derived drugs, because of the hydrochlorothiazide component.
• Patients with anuria. • Women who are pregnant, intend to become pregnant, or of childbearing potential who are not using adequate contraception (see
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Cilazapril in Canada.
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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 cilazapril must be adjusted according to individual response. APO-CILAZAPRIL/HCTZ (Cilazapril and Hydrochlorothiazide Tablets) Page 7 of 79 Dosage Adjustment in Renal Impairment: See Table 1 for dose schedules recommended in patients with renal impairment.
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) APO- CILAZAPRIL/HCTZ is not recommended.
5 mg once daily or less as significant hypotension may occur (see 7 WARNINGS AND PRECAUTIONS). Drug Discontinuation • APO-CILAZAPRIL/HCTZ 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. • APO-CILAZAPRIL/HCTZ 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.
APO- CILAZAPRIL/HCTZ 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.
1 Special Populations .............................................................................................. 1 Pregnant Women .......................................................................................... 2 Breast-feeding...............................................................................................
3 Pediatrics ...................................................................................................... 4 Geriatrics .......................................................................................................
18 APO-CILAZAPRIL/HCTZ (Cilazapril and Hydrochlorothiazide Tablets) Page 3 of 79 8 ADVERSE REACTIONS............................................................................................... 1 Adverse Reaction Overview .................................................................................
2 Clinical Trial Adverse Reactions............................................................................ 3 Less Common Clinical Trial Adverse Reactions .................................................... 4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data .................................................................................................
5 Post-Market Adverse Reactions ........................................................................... 23 9 DRUG INTERACTIONS .............................................................................................. 1 Serious Drug Interactions .....................................................................................
2 Drug Interactions Overview ................................................................................. 3 Drug-Behavioural Interactions ............................................................................. 4 Drug-Drug Interactions.........................................................................................
26 10 CLINICAL PHARMACOLOGY ...................................................................................... 1 Mechanism of Action ........................................................................................... 2 Pharmacodynamics ..............................................................................................
3 Pharmacokinetics ................................................................................................. 38 11 STORAGE, STABILITY AND DISPOSAL ........................................................................ 41 12 SPECIAL HANDLING INSTRUCTIONS..........................................................................
41 PART II: SCIENTIFIC INFORMATION ..................................................................................... 42 13 PHARMACEUTICAL INFORMATION .......................................................................... 42 14 CLINICAL TRIALS ......................................................................................................
2 Comparative Bioavailability Studies ..................................................................... 43 15 MICROBIOLOGY ...................................................................................................... 45 16 NON-CLINICAL TOXICOLOGY ....................................................................................
45 17 SUPPORTING PRODUCT MONOGRAPHS ................................................................... 69 PATIENT MEDICATION INFORMATION ................................................................................ 70 APO-CILAZAPRIL/HCTZ (Cilazapril and Hydrochlorothiazide Tablets) Page 4 of 79 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS APO-CILAZAPRIL/HCTZ (cilazapril and hydrochlorothiazide tablets) is indicated for • treatment of mild to moderate essential hypertension in patients for whom combination therapy with both cilazapril and hydrochlorothiazide is […]