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PMS-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: pms-RAMIPRIL-HCTZ (ramipril/hydrochlorothiazide) is indicated for the treatment of essential hypertension in patients for whom this combination therapy is appropriate. pms-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 pms-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.
Pediatrics Pediatrics (< 18 years of age):
The safety and effectiveness of ramipril and hydrochlorothiazide in pediatric patients have not been established. Therefore, pms-RAMIPRIL-HCTZ is not indicated in this patient population. 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
1%). 2%). 2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use. 0 *: Patients taking ramipril and hydrochlorothiazide tablets or ramipril + hydrochlorothiazide in combination.
3 Less Common Clinical Trial Adverse Reactions Cardiac disorders: angina pectoris, palpitation, peripheral edema, tachycardia. Ear and labyrinth disorders: hearing loss, tinnitus Eye disorders: conjunctivitis, visual disturbances (including blurred vision).
Gastrointestinal disorders: abdominal pain (sometimes with enzyme changes suggesting pancreatitis), aphthous stomatitis, constipation, dry mouth, dyspepsia, dysphagia, gastroenteritis, gastritis, gastrointestinal pain, gingivitis, increased salivation, nausea, upper abdominal pain General disorders and administration site conditions: chest pain, fever, shock Hepatobiliary disorders: increased hepatic enzymes and/or conjugated bilirubin, cholestatic or cytolytic hepatitis.
Calculous cholecystitis (due to hydrochlorothiazide) Immune system disorders: allergic reactions Metabolism and nutrition disorders: anorexia, decreased appetite, excessive thirst, gout, hyperglycemia, hyperuricemia, hypokalemia, weight gain (related to ramipril).
Musculoskeletal and connective tissue disorders: arthralgia, arthritis, myalgia. Nervous system disorders: burning sensation (mainly to the skin of face or extremities), disorders of balance, neuropathy, paresthesia, polyneuritis, taste loss, tremor, vertigo.
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 pms-RAMIPRIL-HCTZ until at least 36 hours have elapsed following the last dose of sacubitril/valsartan. In the case of a switch from pms-RAMIPRIL-HCTZ to sacubitril/valsartan, do not start sacubitril/valsartan until at least 36 hours have elapsed following the last dose of pms-RAMIPRIL-HCTZ.
73m2), o hyperkalemia(> 5mMol/L) or o congestive heart failure who are hypotensive (see 7 WARNINGS ANDPRECAUTIONS, 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.
, polyacrylonitril) membranes and low-density lipoprotein apheresis with dextran sulfate (see 7 WARNINGS AND PRECAUTIONS, Immune). 1Pregnant Women). 1 Pregnant Women). 1 Dosing Considerations • Dosage should be individualized. • pms-RAMIPRIL-HCTZ (ramipril/hydrochlorothiazide) is not for initial therapy.
• The dose of pms-RAMIPRIL-HCTZ should be determined by the titration of the individual components. • Special attention for dialysis patients. 2 Recommended Dose and Dosage Adjustment Once the patient has been successfully titrated with the individual components as described below, pms-RAMIPRIL-HCTZ may be substituted if the titrated dose and dosing schedule can be achieved by the fixed combination (see 1 INDICATIONS, and 7 WARNINGS AND PRECAUTIONS).
5 mg hydrochlorothiazide daily. Generally, it is recommended that the daily dose be administered in the morning as a single dose. Due to the risk of angioedema when used concomitantly with sacubitril/valsartan, pms- RAMIPRIL-HCTZ must not be started until 36 hours has passed following the last dose of sacubitril/valsartan (see 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 6 DOSAGE FORMS, COMPOSITION AND PACKAGING.
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 pms-RAMIPRIL-HCTZ until at least 36 hours have elapsed following the last dose of sacubitril/valsartan. In the case of a switch from pms-RAMIPRIL-HCTZ to sacubitril/valsartan, do not start sacubitril/valsartan until at least 36 hours have elapsed following the last dose of pms-RAMIPRIL-HCTZ.
73m2), o hyperkalemia(> 5mMol/L) or o congestive heart failure who are hypotensive (see 7 WARNINGS ANDPRECAUTIONS, 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.
, polyacrylonitril) membranes and low-density lipoprotein apheresis with dextran sulfate (see 7 WARNINGS AND PRECAUTIONS, Immune). , hypokalemia, hyponatremia or hypercalcemia)
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.
Psychiatric disorders: anxiety, apathy, depression, insomnia, nervousness, sleep disorder, somnolence. Renal and urinary disorders: abnormal kidney function, increase in urinary output (in connection with an improvement in cardiac performance), renal failure.
Reproductive system and breast disorders: impotence Respiratory, thoracic and mediastinal disorders: dyspnea, sinusitis. pms-RAMIPRIL-HCTZ (ramipril/hydrochlorothiazide) Page 21 of 67 Skin and subcutaneous tissue disorders: alopecia, angioedema, erythroderma, maculopapular rash, maculopapular exanthema, pruritus, psoriasis, purpura, rash, sweating.
Non-melanoma skin cancer Some pharmacoepidemiological studies have suggested a higher risk of squamous cell carcinoma (SCC) and basal cell carcinoma (BCC) of the skin with increasing use of hydrochlorothiazide. Noting substantial uncertainty, a systematic review and meta-analysis undertaken by Health Canada suggested that the use of hydrochlorothiazide for several years (>3 years) could lead to: • 122 additional cases (95% CI, from 112 to 133 additional cases) of SCC per 1000 treated patients compared with non-use of hydrochlorothiazide (meta-analysis of 3 observational studies); • 31 additional cases (95% CI, from 24 to 37 additional cases) of BCC per 1000 treated patients compared with non-use of hydrochlorothiazide (meta-analysis of 2 observational studies).
4 Abnormal Hematologic and Clinical Chemistry Findings Hematologic: decrease in red blood cell count, hemoglobin or hematocrit, leucocytosis. Hydrochlorothiazide Renal function test: increased serum concentrations of uric acid. Cholesterol: increase in serum cholesterol and triglycerides.
Glucose: lower tolerance to glucose. In patients with diabetes mellitus, this may lead to a deterioration of the metabolic control. 5 Post-Market Adverse Reactions Blood and lymphatic system disorders: Agranulocytosis, bone marrow depression, eosinophilia, hemolytic anemia, reduction in the white blood cell or blood platelet count, neutropenia, pancytopenia.
Hemoconcentration in the context of fluid depletion (see 7 WARNINGS AND PRECAUTIONS, Hematologic; and
Titration will be based on physician’s judgment according to severity of hypertension and other associated risk factors. Maximum daily dose: 10 mg ramipril and 50 mg hydrochlorothiazide. Dosage in elderly patients Initial doses should be lower and subsequent dose titration should be more gradual because of greater chance of undesirable effects especially in very old and frail patients (see 7 WARNINGS AND PRECAUTIONS).
25 mg. ). ). 5 mg and pms-RAMIPRIL- HCTZ 10 mg/25 mg MUST NOT be used in these patients. 73 m2) and in dialysis patients (see 2 CONTRAINDICATIONS). ). 5 mg and 10 mg/25 mg MUST NOT be used in these patients. pms-RAMIPRIL-HCTZ is contraindicated in patients with severe hepatic impairment (see 2 CONTRAINDICATIONS).
pms-RAMIPRIL-HCTZ (ramipril/hydrochlorothiazide) Page 7 of 67 Dosing in patients pre-treated with diuretics In patients pre-treated with a diuretic, consideration must be given to discontinuing the diuretic≥2- 3 days (depending on the duration of action of the diuretic) before starting treatment with pms-RAMIPRIL-HCTZ or at least to reducing the diuretic dose.
Should discontinuation not be possible, it is recommended that treatment be initiated with the smallest […]