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PMS-PERINDOPRIL-AMLODIPINE is a brand name for Amlodipine, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: pms-PERINDOPRIL-AMLODIPINE (perindopril arginine and amlodipine) is indicated for: • The treatment of mild to moderate essential hypertension in patients for whom combination therapy is appropriate. • pms-PERINDOPRIL-AMLODIPINE 3.5 mg/2.5 mg is indicated for initial therapy in patients with mild to moderate essential…
Verbatim from this product's HC label. Tap a section to expand.
section). 1 Pediatrics (<18 years of age) pms-PERINDOPRIL-AMLODIPINE is not indicated in pediatric patients <18 years of age. The efficacy and safety have not been studied in this population. 2 Geriatrics (> 65 years of age) pms-PERINDOPRIL-AMLODIPINE is not indicated for the initiation of treatment in elderly patients.
There is no sufficient clinical experience to justify the use in the elderly (> 65 years). 2 CONTRAINDICATIONS pms-PERINDOPRIL-AMLODIPINE (perindopril arginine and amlodipine) is contraindicated in: • Patients who are hypersensitive to the active ingredients of this drug, to any ingredient in the formulation or component of the container, to any other angiotensin converting enzyme inhibitor (ACE-inhibitor), or to any other dihydropyridine derivatives.
For a complete listing, see
1 Adverse Reaction Overview The following adverse reactions were the most frequently reported during clinical trials: cough, dizziness, headache, and oedema. The most serious adverse reactions reported during clinical trials were: hypotension, lip swelling, and renal failure acute.
The adverse drug reactions most frequently resulting in clinical intervention (discontinuation of perindopril arginine and amlodipine) were due to cough, erythema, fatigue, and peripheral oedema. 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.
9) Aml: Amlodipine; Per: Perindopril PATH study The most frequent emergent adverse events (EAEs) during the 6-week active controlled PATH study are presented in Table 3. 4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data The following were observed in patients treated with perindopril: - Abnormal liver function test - Hyperkalemia - Increases in blood creatinine, BUN, serum cholesterol and plasma glucose.
- Decreases in hematocrit and hemoglobin. 5 Post-Market Adverse Reactions The most commonly reported adverse reactions with perindopril and amlodipine given separately are: abdominal pain, change of bowel habits, dysgeusia, dyspepsia, dyspnea, exanthema, joint swelling (ankle swelling), palpitations, paraesthesia, prurit, somnolence, tinnitus, vertigo, visual impairment (including diplopia).
The other adverse drug reactions previously reported during clinical trials and/or post-marketing experience with one of the individual components of perindopril arginine and amlodipine are listed below since they may occur […]
, Renal). • Patients with a history of hereditary/idiopathic angioedema, or angioedema related to previous treatment with an ACE-inhibitor (see 7 WARNINGS AND PRECAUTIONS, Immune). • Women who are pregnant, intend to become pregnant, or of childbearing potential who are not using adequate contraception.
(see 7 WARNINGS AND PRECAUTIONS, Special Populations, Pregnant women) • Nursing women (see 7 WARNINGS AND PRECAUTIONS, Special Populations, Breast-feeding). g. aortic stenosis, hypertrophic cardiomyopathy). • Patients with heart failure.
• Combination with sacubitril/valsartan due to an increased risk of angioedema. pms-PERINDOPRIL- AMLODIPINE must not be initiated earlier than 36 hours after the last dose of sacubitril/valsartan. 73m2) (see 7 WARNINGS AND PRECAUTIONS, Dual Blockade of the Renin-Angiotensin System (RAS) and Renal and 9 DRUG pms-PERINDOPRIL-AMLODIPINE page 5 of 56 INTERACTIONS, Dual Blockade of the Renin-Angiotensin System (RAS) with ACE inhibitors, ARBs or aliskiren-containing drugs).
• Patients with extracorporeal treatments leading to contact of blood with negatively charged surfaces (see 9 DRUG INTERACTIONS). • Patients with bilateral renal artery stenosis or renal artery stenosis in a single functioning kidney (see 7 WARNINGS AND PRECAUTIONS, Renal).
5 mg, 7 mg/5 mg, and 14 mg/10 mg. Dosages of the perindopril arginine in pms-PERINDOPRIL-AMLODIPINE are not marketed individually. Patients cannot be titrated with the individual drugs currently on the market prior to the initiation of pms-PERINDOPRIL-AMLODIPINE, since dosages of perindopril arginine in pms-PERINDOPRIL- AMLODIPINE are not equivalent to those marketed individually (perindopril as erbumine or arginine salt).
5 mg once daily in hypertensive patients for whom combination therapy is appropriate. After 4 weeks of treatment, the dose may be increased to 7 mg/5 mg once daily in adult patients whose blood pressure is not at appropriate target.
pms-PERINDOPRIL-AMLODIPINE (perindopril arginine and amlodipine) is contraindicated in: • Patients who are hypersensitive to the active ingredients of this drug, to any ingredient in the formulation or component of the container, to any other angiotensin converting enzyme inhibitor (ACE-inhibitor), or to any other dihydropyridine derivatives.
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING • Patients with renal impairment (creatinine clearance < 60 ml/min) (see 7 WARNINGS AND PRECAUTIONS, Renal). • Patients with a history of hereditary/idiopathic angioedema, or angioedema related to previous treatment with an ACE-inhibitor (see 7 WARNINGS AND PRECAUTIONS, Immune).
• Women who are pregnant, intend to become pregnant, or of childbearing potential who are not using adequate contraception. (see 7 WARNINGS AND PRECAUTIONS, Special Populations, Pregnant women) • Nursing women (see 7 WARNINGS AND PRECAUTIONS, Special Populations, Breast-feeding).
g. aortic stenosis, hypertrophic cardiomyopathy). • Patients with heart failure. • Combination with sacubitril/valsartan due to an increased risk of angioedema. pms-PERINDOPRIL- AMLODIPINE must not be initiated earlier than 36 hours after the last dose of sacubitril/valsartan.
73m2) (see 7 WARNINGS AND PRECAUTIONS, Dual Blockade of the Renin-Angiotensin System (RAS) and Renal and 9 DRUG pms-PERINDOPRIL-AMLODIPINE page 5 of 56 INTERACTIONS, Dual Blockade of the Renin-Angiotensin System (RAS) with ACE inhibitors, ARBs or aliskiren-containing drugs).
• Patients with extracorporeal treatments leading to contact of blood with negatively charged surfaces (see 9 DRUG INTERACTIONS). • Patients with bilateral renal artery stenosis or renal artery stenosis in a single functioning kidney (see 7 WARNINGS AND PRECAUTIONS, Renal).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Amlodipine 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.
If necessary, titration to 14 mg/10 mg once daily may be considered in adult patients insufficiently controlled after 4 weeks of treatment with 7 mg/5 mg.
Pediatrics (<18 years of age):
Health Canada has not authorized an indication for pediatric use.
Elderly (> 65 years of age):
Serious Warnings and Precautions • When used in pregnancy, angiotensin converting enzyme (ACE) inhibitors can cause injury or even death of the developing fetus. • When pregnancy is detected, pms-PERINDOPRIL-AMLODIPINE should be discontinued as soon as possible.
pms-PERINDOPRIL-AMLODIPINE page 6 of 56 pms-PERINDOPRIL-AMLODIPINE is not indicated for the initiation of treatment in elderly patients (> 65 years of age). Hepatic Impairment: pms-PERINDOPRIL-AMLODIPINE is not recommended in patients with hepatic impairment (see 7 WARNINGS AND PRECAUTIONS).
Renal Impairment: pms-PERINDOPRIL-AMLODIPINE is contraindicated in patients with renal impairment (creatinine clearance <60 ml/min) (see 2 CONTRAINDICATIONS).
Use with Diuretics:
In patients who are currently being treated with a diuretic, symptomatic hypotension can occur following the initial dose of pms-PERINDOPRIL-AMLODIPINE. Consider reducing the dose of diuretic prior to starting pms-PERINDOPRIL-AMLODIPINE (see 9 DRUG INTERACTIONS, Drug-Drug Interactions).
4 Administration pms-PERINDOPRIL-AMLODIPINE should be taken as a single dose, preferably in the morning and before a meal. 5 Missed Dose If a dose is missed, a double dose should not be taken, but just carry on with the next dose at the normal time.
5 OVERDOSAGE There is no experience of overdose with perindopril arginine and amlodipine. For perindopril, limited data are available for overdosage in humans. The most likely clinical manifestation would be symptoms attributable to severe hypotension.
The recommended treatment of overdosage is intravenous infusion of normal saline solution. If available, treatment with angiotensin II infusion and/or intravenous catecholamines may also be considered. Perindopril can be removed from the systemic circulation by haemodialysis (see 10 CLINICAL PHARMACOLOGY – Special Populations, Renal insufficiency).
Vital signs, serum electrolytes and creatinine concentrations should be monitored continuously. For amlodipine, experience with overdosage in humans is limited. Symptoms: available data suggest that overdosage could result in excessive peripheral vasodilatation with marked and probably prolonged hypotension and possibly reflex tachycardia.
Shock and fatal outcome have been reported. Non-cardiogenic pulmonary oedema has rarely been reported as a consequence of amlodipine overdose that may manifest with a delayed onset (24-48 hours post-ingestion) and require ventilatory support.
Early resuscitative measures (including fluid overload) to maintain perfusion and cardiac output may be precipitating factors. Treatment: clinically significant hypotension due to amlodipine overdosage calls for active cardiovascular pms-PERINDOPRIL-AMLODIPINE page 7 of 56 support including frequent monitoring of cardiac and respiratory function, elevation of extremities and attention to circulating fluid volume and urine output.
A vasoconstrictor may be helpful in restoring vascular tone and blood pressure, provided that there is no contraindication to its use. Intravenous […]
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