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VASERETIC is a brand name for Hydrochlorothiazide, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: , 1.1 Pediatrics 06/2021 1 INDICATIONS, 1.2 Geriatrics 06/2021 4 DOSAGE AND ADMINISTRATION, 4.4 Administration 06/2021 4 DOSAGE AND ADMINISTRATION, 4.5 Missed dose 06/2021 7 WARNINGS AND PRECAUTIONS 11/2022 TABLE OF CONTENTS RECENT MAJOR LABEL…
Verbatim from this product's HC label. Tap a section to expand.
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). In most cases the changes were reversed on discontinuation of the drug. Should the patient receiving VASERETIC® experience any unexplained symptoms (see PATIENT MEDICATION INFORMATION), particularly during the first weeks or months of treatment, it is VASERETIC® (enalapril and hydrochlorothiazide tablets) Page 12 of 60 recommended that a full set of liver function tests and any other necessary inves tigation be carried out.
Discontinuation of VASERETIC® should be considered when appropriate. There are no adequate studies in patients with cirrhosis and/or liver dysfunction. VASERETIC® should be used with particular caution in patients with pre -existing liver abnormalities.
In such patients baseline liver function tests should be obtained before administration of the drug and close monitoring of response and metabolic effects should apply. Thiazides should be used with caution in patients with impaired hepatic function or progressive liver disease, since minor alterations of fluid and electrolyte balance may precipitate hepatic coma.
4 DRUG-DRUG INTERACTIONS). Ophthalmologic Choroidal effusion, Acute Myopia and Secondary Angle-Closure Glaucoma: Hydrochlorothiazide, a sulphonamide, can cause an idiosyncratic reaction, resulting in choroidal effusion, acute transient myopia and/or secondary acute angle-closure glaucoma.
Symptoms include acute onset of decreased visual acuity, blurred vision or ocular pain and typically occur within hours to weeks of drug initiation. Untreated acute angle -closure glaucoma can lead to permanent vision loss. The primary treatment is to discontinue hydrochlorothiazide as rapidly as possible.
Prompt medical or surgical treatments may need to be considered if the intraocular pressure remains uncontrolled. Risk factors for developing acute angle -closure glaucoma may include a history of sulphonamide or penicillin allergy.
1 Special Populations ............................................................................................ 15 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..........................................................................
18 9 DRUG INTERACTIONS.................................................................................................. 1 Serious Drug Interactions ...................................................................................
2 Drug Interactions Overview................................................................................ 4 Drug-Drug Interactions ...................................................................................... 5 Drug-Food Interactions ......................................................................................
6 Drug-Herb Interactions ...................................................................................... 7 Drug-Laboratory Test Interactions ...................................................................... 28 10 CLINICAL PHARMACOLOGY .........................................................................................
1 Mechanism of Action.................................................................................... 2 Pharmacodynamics ...................................................................................... 3 Pharmacokinetics.........................................................................................
VASERETIC® is contraindicated in: Patients who are hypersensitive to this product or to any ingredient in the formulation. For a complete listing, see the 6 DOSAGE FORMS, COMPOSITION AND PACKAGING section of the product monograph.
Patients with a history of angioneurotic edema relating to previous treatment with an angiotensin converting enzyme inhibitor. Patients with hereditary or idiopathic angioedema. 4 DRUG-DRUG INTERACTIONS). g. , sacubitril). Do not administer VASERETIC® within 36 hours of switching to or from sacubitril/valsartan, a product containing a neprilysin inhibitor.
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Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Hydrochlorothiazide 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.
Peri-Operative Considerations Surgery/Anesthesia:
In patients undergoing major surgery or during anesthesia with agents that produce hypotension, enalapril blocks angiotensin II formation, secondary to compensatory renin release. If hypotension occurs and is considered to be due to this mechanism, it can be corrected by volume expansion.
Thiazides may increase the responsiveness to tubocurarine.
Renal Renal Impairment:
As a consequence of inhibiting the renin-angiotensin-aldosterone system, changes in renal function have been seen in susceptible individuals. In patients whose renal function may depend on the activity of the renin-angiotensin-aldosterone system, such as patients with bilateral renal artery stenosis, unilateral renal artery stenosis to a solitary kidney, or severe congestive heart failure, treatment with agents that inhibit this system has been VASERETIC® (enalapril and hydrochlorothiazide tablets) Page 13 of 60 associated with oliguria, progressive azotemia, and rarely, acute renal failure and/or death.
In susceptible patients, concomitant diuretic use may further increase risk. 73 m2). 4 DRUG-DRUG INTERACTIONS). Use of VASERETIC® should include appropriate assessment of renal function. , moderate or severe renal insufficiency).
Azotemia:
Azotemia may be precipitated or increased by hydrochlorothiazide. Cumulative effects of the drug may develop in patients with impaired renal function. 7 mEq/L) was observed in approximately one percent of hypertensive patients in clinical trials with enalapril alone.
In most cases these were isolated values which resolved despite continued therapy. 28% of hypertensive patients. , trimethoprim-containing products). The use of potassium supplements, potassium-sparing diuretics, potassium-containing salt substitutes or other drugs that may increase serum potassium particularly in patients with impaired renal function should be given only for documented hypokalemia and with caution and frequent monitoring of serum potassium since they may lead to a significant increase in serum potassium.
Hyperkalemia can cause serious, sometimes fatal, arrhythmias. 4 DRUG-DRUG INTERACTIONS). Respiratory Very rare severe cases of acute respiratory distress including pneumonitis and pulmonary edema have been reported after taking hydrochlorothiazide.
5 Post-market adverse reactions). Pulmonary oedema typically develops within minutes to hours after hydrochlorothiazide intake. At the onset, symptoms include dyspnoea, fever, pulmonary deterioration and hypotension. Hydrochlorothiazide should not be administered to patients who previously experienced ARDS following hydrochlorothiazide intake.
VASERETIC® (enalapril and hydrochlorothiazide tablets) Page 14 of 60 Sensitivity/Resistance Hypersensitivity […]
30 11 STORAGE, STABILITY AND DISPOSAL ........................................................................... 32 12 SPECIAL HANDLING INSTRUCTIONS............................................................................. 32 PART II: SCIENTIFIC INFORMATION ........................................................................................
33 13 PHARMACEUTICAL INFORMATION.............................................................................. 33 14 CLINICAL TRIALS..........................................................................................................
1 Clinical Trials by Indication............................................................................ 34 15 MICROBIOLOGY ..........................................................................................................
35 16 NON-CLINICAL TOXICOLOGY ....................................................................................... 35 PATIENT MEDICATION INFORMATION ...................................................................................
48 VASERETIC® (enalapril and hydrochlorothiazide tablets) Page 4 of 60 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS VASERETIC® (enalapril and hydrochlorothiazide) is indicated for: Treatment of essential hypertension in patients for whom this combination therapy with enalapril and hydrochlorothiazide is appropriate.
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