Loading…
TEVA-OLMESARTAN / HCTZ 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: ACT OLMESARTAN HCT ( olmesartan medoxomil and hydrochlorothiazide tablet) is indicated for the treatment of mild to moderate essential hypertension in patients for whom combination therapy is appropriate. ACT OLMESARTAN HCT is not indicated for initial therapy (see DOSAGE AND ADMINISTRATION). 1.1 Pediatrics Pediatrics…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations ACT OLMESARTAN HCT (olmesartan medoxomil and hydrochlorothiazide) is not for initial therapy. The dosage must be individualized. To minimize dose-independent side effects, it is usually appropriate to begin combination therapy only after a patient has failed to achieve the desired effect with monotherapy.
The dose of ACT OLMESARTAN HCT should be determined by the titration of the individual components. 2 Recommended Dose and Dosage Adjustment Replacement Therapy Once the patient has been stabilized on the individual components as described below, ACT OLMESARTAN H C T may be substituted if the doses on which the patient was stabilized are the same as those in the fixed combination.
5 mg and 40 mg/25 mg. A patient whose blood pressure is inadequately controlled by olmesartan medoxomil or hydrochlorothiazide alone may be switched to once daily ACT OLMESARTAN HCT. Dosage should be individualized. Depending on the blood pressure response, the dose may be titrated at intervals of 2-4 weeks.
5 mg to 40 mg/25 mg (see ACTION AND CLINICAL PHARMACOLOGY). The dose of ACT OLMESARTAN HCT is one tablet once daily. More than one tablet daily is not recommended.
Elderly:
No adjustment of dose is generally required in elderly patients (see below for dose recommendation in patients with renal impairment). If up-titration to the maximum dose of 40 mg/25 mg daily is required, blood pressure should be closely monitored (see ACTION AND CLINICAL PHARMACOLOGY, Special Populations).
Hepatic Impairment:
No adjustment of dosage is required for patients with mild hepatic impairment. 5 mg olmesartan medoxomil- hydrochlorothiazide daily should not be exceeded. Care should be exercised in patients with liver disease, especially in ACT OLMESARTAN HCT Page 6 of 39 those patients with biliary obstructive disorders, as the majority of olmesartan is eliminated in the bile.
No information is available in patients with severe liver disease; therefore, use of olmesartan medoxomil in this group of patients is not recommended (see ACTION AND CLINICAL PHARMACOLOGY, Pharmacokinetics). 5 mg once daily. The use of olmesartan medoxomil in patients with severe renal impairment is not recommended, since there is only limited experience in this patient group.
1 Adverse Reaction Overview Olmesartan medoxomil-hydrochlorothiazide Olmesartan medoxomil-hydrochlorothiazide has been evaluated for safety in 1243 patients treated for essential hypertension. Treatment with olmesartan medoxomil-hydrochlorothiazide was well tolerated, with an incidence of adverse events similar to placebo.
Events generally were mild, transient and had no relationship to the dose of olmesartan medoxomil- hydrochlorothiazide. In the clinical trials, the overall frequency of adverse events was not dose-related. Analysis of gender, age and race groups demonstrated no differences between olmesartan medoxomil- hydrochlorothiazide and placebo-treated patients.
0% (7/342) of patients treated with placebo. The following potentially serious adverse reactions have been reported with olmesartan medoxomil / olmesartan medoxomil-hydrochlorothiazide in controlled trials: syncope, hypotension. 2 Clinical Trial Adverse Reactions Because clinical trials are conducted under very specific conditions the adverse reaction rates observed in the clinical trials 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 is useful for identifying drug-related adverse events and for approximating rates. In a placebo-controlled clinical trial, the following adverse events were reported with olmesartan medoxomil-hydrochlorothiazide in >1% of patients (Table 1).
2%) a Adverse events reported in >1% of patients in the Total Olmesartan Medoxomil + HCTZ treatment group. 0%, whether or not attributed to treatment, in the more than 1200 hypertensive patients treated with olmesartan medoxomil-hydrochlorothiazide in controlled or open-label trials are listed below.
Gastrointestinal disorders: abdominal pain, dyspepsia, diarrhea. General disorders and administration site conditions: chest pain, edema peripheral. Infections and infestations: gastroenteritis. Investigations: alanine aminotransferase increased, aspartate aminotransferase increased, creatine phosphokinase increased, gamma-glutamyltransferase increased.
16 9 DRUG INTERACTIONS ..................................................................................................... 22 10 ACTION AND CLINICAL PHARMACOLOGY ................................................................. 23 11 STORAGE, STABILITY AND DISPOSAL .......................................................................
25 12 SPECIAL HANDLING INSTRUCTIONS .......................................................................... 25 PART II: SCIENTIFIC INFORMATION ........................................................................................
26 13 PHARMACEUTICAL INFORMATION .............................................................................. 26 14 CLINICAL TRIALS ...............................................................................................................
29 15 MICROBIOLOGY ................................................................................................................ 30 16 NON-CLINICAL TOXICOLOGY ........................................................................................
30 17 SUPPORTING PRODUCT MONOGRAPHS .................................................................. 32 PATIENT MEDICATION INFORMATION ................................................................................... 33 ACT OLMESARTAN HCT Page 4 of 39 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS ACT OLMESARTAN HCT ( olmesartan medoxomil and hydrochlorothiazide tablet) is indicated for the treatment of mild to moderate essential hypertension in patients for whom combination therapy is appropriate.
ACT OLMESARTAN HCT is not indicated for initial therapy (see DOSAGE AND ADMINISTRATION). 1 Pediatrics Pediatrics (<18 years of age): No data are available to Health Cana da; therefore, Health Canada has not authorized an indication for pediatric use.
2 Geriatrics Geriatrics (≥65 years of age): Reported clinical experience has not identified differences in responses between elderly and younger patients, however, greater sensitivity of some older individuals cannot be ruled out (see DOSAGE AND ADMINISTRATION).
16 9 DRUG INTERACTIONS ..................................................................................................... 22 10 ACTION AND CLINICAL PHARMACOLOGY ................................................................. 23 11 STORAGE, STABILITY AND DISPOSAL .......................................................................
25 12 SPECIAL HANDLING INSTRUCTIONS .......................................................................... 25 PART II: SCIENTIFIC INFORMATION ........................................................................................
26 13 PHARMACEUTICAL INFORMATION .............................................................................. 26 14 CLINICAL TRIALS ...............................................................................................................
29 15 MICROBIOLOGY ................................................................................................................ 30 16 NON-CLINICAL TOXICOLOGY ........................................................................................
30 17 SUPPORTING PRODUCT MONOGRAPHS .................................................................. 32 PATIENT MEDICATION INFORMATION ................................................................................... 33 ACT OLMESARTAN HCT Page 4 of 39 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS ACT OLMESARTAN HCT ( olmesartan medoxomil and hydrochlorothiazide tablet) is indicated for the treatment of mild to moderate essential hypertension in patients for whom combination therapy is appropriate.
ACT OLMESARTAN HCT is not indicated for initial therapy (see DOSAGE AND ADMINISTRATION). 1 Pediatrics Pediatrics (<18 years of age): No data are available to Health Cana da; therefore, Health Canada has not authorized an indication for pediatric use.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Hydrochlorothiazide in Canada.
Know a brand we are missing in Canada? Suggest a brand →
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.
In patients with more severe renal impairment, loop diuretics are preferred to thiazides, so ACT OLMESARTAN HCT is not recommended. , patients treated with diuretics, particularly those with impaired renal function), ACT OLMESARTAN HCT should be initiated under close medical supervision and consideration should be given to use of a lower starting dose (see WARNINGS AND PRECAUTIONS, Renal).
The side effects (see WARNINGS AND PRECAUTIONS) of olmesartan medoxomil are generally rare and independent of dose; those of hydrochlorothiazide are most typically dose- dependent (primarily hypokalemia). , pancreatitis) do occur with hydrochlorothiazide.
Therapy with any combination of olmesartan medoxomil and hydrochlorothiazide will be associated with both sets of dose-independent side effects. To minimize dose-independent side effects, it is usually appropriate to begin combination therapy only after a patient has failed to achieve the desired effect with monotherapy.
Olmesartan Medoxomil Monotherapy The usual recommended starting dose of olmesartan medoxomil monotherapy is 20 mg once daily in patients who are not volume-contracted. For patients requiring further reduction in blood pressure after 2 weeks of therapy, the dose may be increased to 40 mg.
Doses above 40 mg do not appear to have greater effect. Twice-daily dosing offers no advantage over the same total dose given once daily. Elderly: No adjustment of dose is generally required in elderly patients (see below for dose recommendation in patients with renal impairment).
If up-titration to the maximum dose of 40 mg daily is required, blood pressure should be closely monitored (see ACTION AND CLINICAL PHARMACOLOGY, Special Populations). Hepatic Impairment: No adjustment of dosage is required for patients with mild hepatic impairment.
5 mg olmesartan medoxomil-hydrochlorothiazide daily should not be exceeded. Care should be exercised in patients with liver disease, especially in those patients with biliary obstructive disorders, as the majority of olmesartan is eliminated in the bile.
No information is available in patients with severe liver disease; therefore, use of olmesartan medoxomil in this group of patients is not recommended (see ACTION AND CLINICAL PHARMACOLOGY, Pharmacokinetics). Renal Impairment: Owing to the limited experience of higher dosages in this patient group, the maximum dose in patients with mild to moderate renal impairment is 20 mg olmesartan medoxomil once daily.
The use of olmesartan medoxomil in patients with severe ACT OLMESARTAN HCT Page 7 of 39 renal impairment is not recommended, since there is only limited experience in this patient group. , patients treated with diuretics, particularly those with impaired renal […]
Musculoskeletal and connective tissue disorders: arthritis, arthralgia, back pain, myalgia. Nervous system disorders: vertigo. Renal and urinary disorders: hematuria. Respiratory, thoracic and mediastinal disorders: cough. Skin and subcutaneous tissue disorders: rash.
3 Less Common Clinical Trial Adverse Reactions (<1%) Facial edema was reported in 2/1243 patients receiving olmesartan medoxomil- hydrochlorothiazide. Angioedema has been reported with angiotensin II receptor antagonists. 4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data In controlled clinical trials, clinically important changes in standard laboratory parameters were rarely associated with administration of olmesartan medoxomil-hydrochlorothiazide.
Liver Functions Tests: elevations of liver enzymes and/or serum bilirubin were observed infrequently. 4%) 1 […]
2 CONTRAINDICATIONS ACT OLMESARTAN HCT ( olmesartan medoxomil and hydrochlorothiazide) is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
For a complete listing, see DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. Because of the hydrochlorothiazide component, ACT OLMESARTAN HCT (olmesartan medoxomil and hydrochlorothiazide) is contraindicated in patients with anuria, and in patients who are hypersensitive to other sulfonamide-derived drugs.
73 m2) is contraindicated (see WARNINGS and PRECAUTIONS, Dual Blockade of the Renin-Angiotensin System (RAS) and Renal, and DRUG INTERACTIONS, Dual Blockade of the Renin-Angiotensin-System (RAS) with ARBs, ACE inhibitors or aliskiren-containing drugs).
Pregnant women (see WARNINGS AND PRECAUTIONS, Special Populations, Pregnant Women) Breast-feeding women (see WARNINGS AND PRECAUTIONS, Special Populations, Breastfeeding) ACT OLMESARTAN HCT Page 5 of 39 3 SERIOUS WARNINGS AND PRECAUTIONS BOX Serious Warnings […]
2 Geriatrics Geriatrics (≥65 years of age): Reported clinical experience has not identified differences in responses between elderly and younger patients, however, greater sensitivity of some older individuals cannot be ruled out (see DOSAGE AND ADMINISTRATION).
2 CONTRAINDICATIONS ACT OLMESARTAN HCT ( olmesartan medoxomil and hydrochlorothiazide) is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
For a complete listing, see DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. Because of the hydrochlorothiazide component, ACT OLMESARTAN HCT (olmesartan medoxomil and hydrochlorothiazide) is contraindicated in patients with anuria, and in patients who are hypersensitive to other sulfonamide-derived drugs.
73 m2) is contraindicated (see WARNINGS and PRECAUTIONS, Dual Blockade of the Renin-Angiotensin System (RAS) and Renal, and DRUG INTERACTIONS, Dual Blockade of the Renin-Angiotensin-System (RAS) with ARBs, ACE inhibitors or aliskiren-containing drugs).
Pregnant women (see WARNINGS AND PRECAUTIONS, Special Populations, Pregnant Women) Breast-feeding women (see WARNINGS AND PRECAUTIONS, Special Populations, Breastfeeding) ACT OLMESARTAN […]
+8 more