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LISINOPRIL is a brand name for Lisinopril, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: LISINOPRIL (lisinopril tablets) is indicated in adults for: • Hypertension: in the treatment of essential hypertension and in renovascular hypertension, alone or in combination with thiazide diuretics. A great majority of patients (>80%) with severe hypertension required combination therapy. • Heart Failure: in the…
Verbatim from this product's HC label. Tap a section to expand.
and 10 CLINICAL PHARMACOLOGY). • Acute Myocardial Infarction: in the treatment of hemodynamically stable patients as early as within 24 hours following acute myocardial infarction, to improve survival. Patients should receive, as appropriate, the standard recommended treatments such as thrombolytics, ASA and beta blocker(s).
Therapy with LISINOPRIL should be reassessed after 6 weeks. If there is no evidence of symptomatic or asymptomatic left ventricular dysfunction, treatment with LISINOPRIL can be stopped. LISINOPRIL should not be used if systolic blood pressure is <100 mmHg, if clinically relevant renal failure is present, or if there is a history of bilateral stenosis of the renal arteries (see 7 WARNINGS AND PRECAUTIONS, Cardiovascular, Hypotension Following Acute Myocardial Infarction and Renal, Renal Impairment).
73 m2 has been established. 3 Pediatrics). 3 Pediatrics). 4 Geriatrics). Pharmacokinetic studies indicate that maximum blood levels and area under the plasma concentration time curve (AUC) are doubled in older patients (See 4. DOSAGE AND LISINOPRIL (Lisinopril Tablets) Page 5 of 52 ADMINISTRATION).
2 CONTRAINDICATIONS LISINOPRIL (lisinopril tablets USP) is contraindicated in patients who: • are hypersensitive to the drug or to any ingredient in the formulation. For a complete listing, see
2 Breast-feeding); • are taking sacubitril/valsartan due to an increased risk of angioedema. LISINOPRIL must not be initiated until at least 36 hours have elapsed following discontinuation of salcubitril/valsartan therapy. If treatment with LISINOPRIL is stopped, sacubitril/valsartan therapy must not be initiated until 36 hours after the last dose of LISINOPRIL.
73 m2). 3 SERIOUS WARNINGS AND PRECAUTIONS BOX Serious Warnings and Precautions When used in pregnancy, ACE inhibitors can cause injury or even death of the developing fetus. 1 Pregnant Women). 1 Dosing Considerations • Dosage must be individualized and should be adjusted according to blood pressure response.
2 Recommended Dose and Dosage Adjustment Essential Hypertension In patients with essential hypertension, not on diuretic therapy, the usual recommended starting dose is 10 mg once a day. The usual dosage range is 10 to 40 mg per day, administered in a single daily dose.
The antihypertensive effect may diminish toward the end of the dosing interval regardless of the administered dose, but most commonly with a dose of 10 mg daily. 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, an increase in dose should be considered. The maximum dose used in long-term controlled clinical trials was 80 mg/day. If blood pressure is not controlled with LISINOPRIL alone, a low dose of diuretic may be added. 5 mg has been shown to provide an additive effect.
After the addition of diuretic, it may be possible to reduce the dose of LISINOPRIL. Diuretic Treated Patients In hypertensive patients who are currently being treated with a diuretic, symptomatic hypotension may occur occasionally following the initial dose of LISINOPRIL.
The diuretic should be discontinued, if possible, for 2 to 3 days before beginning therapy with LISINOPRIL to reduce the likelihood of hypotension (see 7 WARNINGS AND PRECAUTIONS). The dosage of LISINOPRIL should be adjusted according to blood pressure response.
09/2024 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 ...................................................................................................
5 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 ............................................................................................................
9 5 OVERDOSAGE ............................................................................................................... 9 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING .................................... 9 7 WARNINGS AND PRECAUTIONS ..................................................................................
09/2024 7 WARNINGS AND PRECAUTIONS 09/2024 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 ...................................................................................................
5
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Lisinopril in Canada.
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If the patient’s blood pressure is not controlled with LISINOPRIL alone, diuretic therapy may be resumed as described above. If the diuretic cannot be discontinued, an initial dose of 5 mg should be used under medical supervision for ≥2 hours and until blood pressure has stabilized for ≥1 additional hour (see 7 WARNINGS AND PRECAUTIONS and
1 Special Populations ............................................................................................... 1 Pregnant Women ..................................................................................................
2 Breast-feeding ....................................................................................................... 3 Pediatrics ...............................................................................................................
4 Geriatrics ............................................................................................................... 16 8 ADVERSE REACTIONS ..................................................................................................
1 Adverse Reaction Overview .................................................................................. 2 Clinical Trial Adverse Reactions............................................................................. 1 Clinical Trial Adverse Reactions – Pediatrics .........................................................
4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data ................................................................................................................ 5 Post-Market Adverse Reactions ............................................................................
21 9 DRUG INTERACTIONS .................................................................................................. 1 Serious Drug Interactions ......................................................................................
4 Drug-Drug Interactions.......................................................................................... 5 Drug-Food Interactions ......................................................................................... 6 Drug-Herb Interactions .........................................................................................
7 Drug-Laboratory Test Interactions ........................................................................ 27 10 CLINICAL PHARMACOLOGY ......................................................................................... 1 Mechanism of Action ............................................................................................
2 Pharmacodynamics ............................................................................................... 3 Pharmacokinetics ..................................................................................................
30 11 STORAGE, STABILITY AND DISPOSAL ........................................................................... 31 12 SPECIAL HANDLING INSTRUCTIONS ............................................................................. 32 PART II: SCIENTIFIC INFORMATION ......................................................................................
33 13 PHARMACEUTICAL INFORMATION .............................................................................. 33 14 CLINICAL TRIALS..........................................................................................................
2 Comparative Bioavailability Studies ...................................................................... 33 15 MICROBIOLOGY ..........................................................................................................
35 16 NON-CLINICAL TOXICOLOGY ....................................................................................... 35 17 SUPPORTING PRODUCT MONOGRAPHS ...................................................................... 44 PATIENT MEDICATION INFORMATION .................................................................................
45 LISINOPRIL (Lisinopril Tablets) Page 4 of 52 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS LISINOPRIL (lisinopril tablets) […]