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TEVA-VALSARTAN/HCTZ is a brand name for Valsartan, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Teva-Valsartan/HCTZ (valsartan and hydrochlorothiazide tablets) is indicated for: • the treatment of mild to moderate essential hypertension in patients for whom combination therapy is appropriate. Teva-Valsartan/HCTZ is not indicated for initial therapy (see 4 DOSAGE AND ADMINISTRATION). Patients should be titrated…
Verbatim from this product's HC label. Tap a section to expand.
). Patients should be titrated on individual drugs. If the fixed combination represents the dose and dosing frequency determined by this titration, the use of Teva-Valsartan/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 (< 18 years of age): The safety and efficacy of valsartan and hydrochlorothiazide tablets in children and adolescents (below the age of 18 years) have not been established and use in this age group is not recommended. 2 Geriatrics (> 65 years of age): No overall age-related differences were seen in the adverse effect profile but greater sensitivity in some older individuals cannot be ruled out and appropriate caution is recommended.
2 CONTRAINDICATIONS • Teva-Valsartan/HCTZ is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation or component of the container (see
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. Valsartan and hydrochlorothiazide tablets have been evaluated for safety in more than 7616 patients treated for essential hypertension.
Of these, 4372 were treated with valsartan and hydrochlorothiazide tablets in controlled clinical trials with a mean exposure of 8 weeks. 1% of patients treated with valsartan and hydrochlorothiazide tablets and placebo, respectively.
The most common AEs resulting in discontinuation of therapy with valsartan and hydrochlorothiazide tablets were dizziness and headache. TEVA-VALSARTAN/HCTZ (Valsartan and Hydrochlorothiazide Tablets) Page 17 of 60 The most common serious AEs with valsartan and hydrochlorothiazide tablets were myocardial infarction and chest pain.
5 mg and 25 mg (see 14 CLINICAL TRIALS). The table includes all AEs with an incidence of 1% or greater in either the valsartan and hydrochlorothiazide tablets, valsartan monotherapy, HCT monotherapy, or placebo group, irrespective of causal relationship to study drug.
5 mg and 320 mg/25 mg. 4) Evaluation of the AEs in the total active-, or placebo-controlled safety population, showed that the most common events, regardless of relationship to treatment in patients treated with valsartan 320 mg/HCTZ were, dizziness, nasopharyngitis, headache and fatigue.
7% in patients treated with valsartan 320 mg/HCTZ. The following adverse reactions have been reported in patients treated with thiazide diuretics alone, including hydrochlorothiazide: Very common: mainly at higher doses, hypokalemia, blood lipids increased (total cholesterol and triglycerides).
, Driving and Operating Machinery 12/2023 7 WARNINGS AND PRECAUTIONS, Ophthalmologic 12/2023 7 WARNINGS AND PRECAUTIONS, Respiratory 12/2023 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 (< 18 years of age): ...................................................................................... 2 Geriatrics (> 65 years of age): ......................................................................................
4 2 CONTRAINDICATIONS .................................................................................................... 4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................................... 5 4 DOSAGE AND ADMINISTRATION ...................................................................................
1 Dosing Considerations ................................................................................................. 2 Recommended Dose and Dosage Adjustment ............................................................. 5 Missed Dose .................................................................................................................
7 5 OVERDOSAGE ................................................................................................................ 7 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................................... 7 7 WARNINGS AND PRECAUTIONS.....................................................................................
• Teva-Valsartan/HCTZ is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation or component of the container (see 6 DOSAGE FORMS, STRENGTH, COMPOSITION AND PACKAGING). • Because of the hydrochlorothiazide component, it is also contraindicated in patients with anuria, severe progressive renal disease and if increasing azotemia and oliguria occur during treatment.
• Patients who are hypersensitive to other sulfonamide-derived drugs. 2 Breast-feeding). TEVA-VALSARTAN/HCTZ (Valsartan and Hydrochlorothiazide Tablets) Page 5 of 60 • Thiazide diuretics are contraindicated in patients with hyponatremia, hypercalcemia, symptomatic hyperuricemia, and conditions involving enhanced potassium loss.
4 Drug-Drug Interactions- Dual Blockade of the Renin-Angiotensin-System (RAS) with ARBs, ACEIs, or aliskiren).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Valsartan 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.
TEVA-VALSARTAN/HCTZ (Valsartan and Hydrochlorothiazide Tablets) Page 19 of 60 Common: Hyponatremia, hypomagnesemia, hyperuricemia, urticaria and other forms of rash, decreased appetite, mild nausea and vomiting, orthostatic hypotension, which may be aggravated by alcohol, anaesthetics or sedatives, and impotence.
Rare:
Hypercalcemia, hyperglycemia, glycosuria and worsening of diabetic metabolic state, photosensitivity reaction, abdominal discomfort, constipation, diarrhoea, cholestasis or jaundice, arrhythmias, headache, dizziness, sleep disorders, depression, paresthesia, visual impairment, thrombocytopenia, sometimes with purpura.
Very rare:
Hypochloremic alkalosis, vasculitis necrotising, toxic epidermal necrolysis, cutaneous lupus erythematosus-like reactions, reactivation of cutaneous lupus erythematosus, pancreatitis, leukopenia, agranulocytosis, bone marrow failure, haemolytic anaemia, hypersensitivity reactions, respiratory distress including pneumonitis and pulmonary oedema.
3 Less Common Clinical Trial Adverse Reactions Body as a whole: arthritis, asthenia, […]
1 Special Populations .................................................................................................... 1 Pregnant Women ....................................................................................................
2 Breast-feeding......................................................................................................... 3 Pediatrics ................................................................................................................
4 Geriatrics................................................................................................................. 16 8 ADVERSE REACTIONS ...................................................................................................
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 ................................................................................. 20 9 DRUG INTERACTIONS ..................................................................................................
1 Serious Drug Interactions ........................................................................................... 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 .....................................................................................................
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 Hypertension ...................................................................................................................
2 Comparative Bioavailability Studies ......................................................................... 34 15 MICROBIOLOGY ...........................................................................................................
36 16 NON-CLINICAL TOXICOLOGY ........................................................................................ 37 17 SUPPORTING PRODUCT MONOGRAPH […]