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APO-RAMIPRIL/HCTZ is a brand name for Ramipril, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: APO-RAMIPRIL/HCTZ (ramipril/hydrochlorothiazide) is indicated for the treatment of essential hypertension in patients for whom this combination therapy is appropriate. APO-RAMIPRIL/HCTZ is not indicated for initial therapy (see 4 DOSAGE AND ADMINISTRATION). Patients in whom ramipril and diuretic are initiated…
Verbatim from this product's HC label. Tap a section to expand.
). Patients in whom ramipril and diuretic are initiated simultaneously can develop symptomatic hypotension. Patients should be titrated on individual drugs. If the fixed combination represents the dose and dosing frequency determined by this titration, the use of APO-RAMIPRIL/HCTZ may be more convenient in the management of patients.
If during maintenance therapy dosage adjustment is necessary, it is advisable to use the individual drugs. 1 Pediatrics Pediatrics (< 18 years of age): The safety and effectiveness of ramipril/hydrochlorothiazide in children have not been established.
Therefore, APO-RAMIPRIL/HCTZ is not indicated in this patient population. 2 Geriatrics Geriatrics (> 65 years of age): There is limited clinical experience with Ramipril-Hydrochlorothiazide in the elderly (> 65 years) (see 7 WARNINGS AND PRECAUTIONS, 7.
4 Geriatrics). 2 CONTRAINDICATIONS Patients who are hypersensitive to this drug, any other angiotensin converting enzyme inhibitor (ACE inhibitor), other thiazide diuretics, sulfonamides or any ingredient in the formulation or component of the container.
For a complete listing of ingredients, see
2 Clinical Trials Adverse Reactions). g. g. operating a vehicle or machinery). 73m2). Therefore, the use of APO-RAMIPRIL/HCTZ in combination with aliskiren-containing drugs is contraindicated in these patients (see 2 CONTRAINDICATIONS).
The use of APO-RAMIPRIL/HCTZ, in combination with an ARB is contraindicated in patients with diabetic nephropathy (see 2 CONTRAINDICATIONS). Further, co-administration of ACE inhibitors, including the ramipril component of APO- RAMIPRIL/HCTZ, with other agents blocking the RAS, such as ARBs or aliskiren-containing drugs, is PrAPO-RAMIPRIL/HCTZ, ramipril/hydrochlorothiazide Page 10 of 62 generally not recommended in other patients, since such treatment has been associated with an increased incidence of severe hypotension, renal failure, and hyperkalemia (see
BOX ......................................................................................... 5 4 DOSAGE AND ADMINISTRATION............................................................................................... 1 Dosing Considerations........................................................................................................
2 Recommended Dose and Dosage Adjustment........................................................................ 4 Administration ..................................................................................................................
5 Missed Dose ...................................................................................................................... 7 5 OVERDOSAGE.........................................................................................................................
7 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING................................................... 8 7 WARNINGS AND PRECAUTIONS................................................................................................ 1 Special Populations ...........................................................................................................
1 Pregnant Women ....................................................................................................... 2 Breast-feeding ..........................................................................................................
3 Pediatrics.................................................................................................................. 4 Geriatrics..................................................................................................................
1 Adverse Reaction Overview ............................................................................................. 2 Clinical Trial Adverse Reactions ........................................................................................
Patients who are hypersensitive to this drug, any other angiotensin converting enzyme inhibitor (ACE inhibitor), other thiazide diuretics, sulfonamides or any ingredient in the formulation or component of the container. For a complete listing of ingredients, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING section of the product monograph.
2 Breast-feeding ) Patients with hemodynamically relevant bilateral renal artery stenosis, or unilateral in the single kidney (see 7 WARNINGS AND PRECAUTIONS, Renal, Renal impairment) Patients with hypotensive states or hemodynamically unstable states Concomitant use with sacubitril/valsartan due to an increased risk of angioedema.
Do not initiate APO-RAMIPRIL/HCTZ until at least 36 hours have elapsed following the last dose of PrAPO-RAMIPRIL/HCTZ, ramipril/hydrochlorothiazide Page 5 of 62 sacubitril/valsartan. In the case of a switch from APO-RAMIPRIL/HCTZ to sacubitril/valsartan, do not start sacubitril/valsartan until at least 36 hours have elapsed following the last dose of APO-RAMIPRIL/HCTZ.
73m2), hyperkalemia (> 5mMol/L) or congestive heart failure who are hypotensive (see 7 WARNINGS AND PRECAUTIONS, Dual Blockade of the Renin-Angiotensin System (RAS) and 9 DRUG INTERACTIONS, Dual Blockade of the Renin-Angiotensin-System (RAS)) Combination with extracorporeal treatments leading to contact of blood with negatively charged surfaces since such use may lead to anaphylactoid reactions.
g. polyacrylonitril) membranes and low-density lipoprotein apheresis with dextran sulfate (see 7 WARNINGS AND PRECAUTIONS, Immune). g. 1 Pregnant Women). 1 Pregnant Women).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Ramipril in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
3 Less Common Clinical Trial Adverse Reactions .................................................................... 4 Abnormal Hematologic and Clinical Chemistry Findings ....................................................... 5 Post-Market Adverse Reactions .......................................................................................
4 Drug-Drug Interactions .................................................................................................... 5 Drug-Food Interactions....................................................................................................
6 Drug-Herb Interactions .................................................................................................... 7 Drug-Laboratory Test Interactions......................................................................................
1 Mechanism of Action ...................................................................................................... 2 Pharmacodynamics.........................................................................................................
3 Pharmacokinetics........................................................................................................... 1 Trial Design and Study Demographics ...............................................................................
2 Study Result .................................................................................................................. 3 Comparative Bioavailability Studies ..................................................................................
49 PrAPO-RAMIPRIL/HCTZ, ramipril/hydrochlorothiazide Page 4 of 62 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS APO-RAMIPRIL/HCTZ (ramipril/hydrochlorothiazide) is indicated for the treatment of essential hypertension in patients for whom this combination therapy is appropriate.
APO-RAMIPRIL/HCTZ is not indicated for initial therapy (see 4 DOSAGE AND ADMINISTRATION). Patients in whom ramipril and diuretic are initiated simultaneously can develop symptomatic hypotension. Patients should be titrated on individual drugs.
If the fixed combination represents the dose and dosing frequency determined by this titration, the use of APO-RAMIPRIL/HCTZ may be more convenient in the […]