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TEVA-SPIRONOLACTONE/HCTZ is a brand name for Spironolactone, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Fixed-dose combination drugs are not indicated for initial therapy. Patients should be titrated on the individual drugs. If the fixed combination represents the dosage so determined, its use may be more convenient in patient management. If during maintenance therapy dosage adjustment is necessary, it is advisable to…
Verbatim from this product's HC label. Tap a section to expand.
5 Drug Food Interactions). Dose adjustment may be considered. TEVA-SPIRONOLACTONE/HCTZ Page 6 of 49 Optimal dosage should be established by individual titration of the components. Treatment should be continued for 2 weeks before optimal effectiveness can be assessed.
2 Recommended Dose and Dosage Adjustment Edema in adults: (congestive heart failure, hepatic cirrhosis or nephrotic syndrome): Daily dosage of 2 to 4 tablets of TEVA-SPIRONOLACTONE/HCTZ (25 mg/ 25 mg), or 1 to 2 tablets of TEVA-SPIRONOLACTONE/HCTZ (50 mg/ 50 mg) in single or divided doses should be adequate for most patients, but may range from 2 to 8 tablets daily of TEVA- SPIRONOLACTONE/HCTZ (25 mg/ 25 mg) or 1 to 4 tablets of TEVA-SPIRONOLACTONE/HCTZ (50 mg/ 50 mg) .
3 mg of spironolactone per kilogram of body weight.
Essential hypertension:
In essential hypertension, a daily dosage of 2 to 4 TEVA- SPIRONOLACTONE/HCTZ (25 mg / 25 mg) tablets or 1 to 2 TEVA-SPIRONOLACTONE/HCTZ (50 mg/ 50 mg) tablets in single or divided doses, will be adequate for most patients, but may range from 2 to 8 tablets of TEVA-SPIRONOLACTONE/HCTZ (25 mg/ 25 mg) or 1 to 4 tablets of TEVA-SPIRONOLACTONE/HCTZ (50 mg/ 50 mg).
Since TEVA-SPIRONOLACTONE/HCTZ increases the action of other antihypertensive drugs, especially the ganglionic blocking agents, the dosage of such drugs should be reduced by at least 50% when TEVA-SPIRONOLACTONE/HCTZ is added to the regimen.
4 Adminisrtation TEVA-SPIRONOLACTONE/HCTZ is to be taken orally with or without food. 5 Missed Dose In the event that a dose is missed, skip the missed dose and resume at the next scheduled dose. Do not double dose.
5 Post Market Drug Adverse Reactions). The photosensitizing action of hydrochlorothiazide may be a possible mechanism for N MSC (see 16 NON – CLINICAL TOXICOLOGY, Carcinogenicity – Hydrochlorothiazide). Patients taking hydrochlorothiazide should be informed of the potential risk of NMSC.
They should be advised to regularly check their skin for new lesions as well as changes to existing ones, and to promptly report any suspicious skin lesions. g. a broad spectrum sunscreen with a SPF of 30 or higher, clothing, and a hat) when exposed to sunlight or UV light to minimize the risk of skin cancer.
5 Post Market Adverse Reactions). Cardiovascular TEVA-SPIRONOLACTONE/HCTZ Page 9 of 49 Orthostatic hypotension may occur and may be potentiated by alcohol, barbiturates or narcotics. Driving and Operating Machinery Caution is advised when driving or operating machinery until the response to initial treatment has been determined.
Endocrine and Metabolism Gynecomastia:
Gynecomastia may develop with the use of spironolactone and healthcare professionals should be advised of its possible occurrence. The development of gynecomastia appears to be related to both dosage and duration of therapy and is normally reversible when the drug is discontinued.
If gynecomastia develops, discontinue the drug. In rare instances some breast enlargement may persist.
Hyperchloremic metabolic acidosis:
Reversible hyperchloremic metabolic acidosis, usually in association with hyperkalemia, has been reported to occur in some patients with decompensated hepatic cirrhosis, even in the presence of normal renal function. Caution should be used in treating patients with acute liver impairments, since vigorous diuretic therapy may precipitate hepatic encephalopathy.
– Hepatic/Biliary/Pancreatic and Renal sections). 2 CONTRAINDICATIONS TEVA-SPIRONOLACTONE/HCTZ is contraindicated in: • Patients who are hypersensitive to spironolactone, thiazides, or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS,COMPOSITION AND PACKAGING. • Patients who are allergic to sulfonamide-derived drugs. • Patients with anuria. 2 Breastfeeding) • Combination with eplerenone ( see 7 Warnings and Precautions- Hematologic - Hyperkalemia, 9 Drug Interactions sections) • Combination with heparin, low molecular weight heparin ( see 7 Warnings and Precautions- Hematologic - Hyperkalemia, 9 Drug Interactions sections) • Patients with severe or progressive liver disease.
5 Drug Food Interactions). Dose adjustment may be considered. TEVA-SPIRONOLACTONE/HCTZ Page 6 of 49 Optimal dosage should be established by individual titration of the components. Treatment should be continued for 2 weeks before optimal effectiveness can be assessed.
2 Recommended Dose and Dosage Adjustment Edema in adults: (congestive heart failure, hepatic cirrhosis or nephrotic syndrome): Daily dosage of 2 to 4 tablets of TEVA-SPIRONOLACTONE/HCTZ (25 mg/ 25 mg), or 1 to 2 tablets of TEVA-SPIRONOLACTONE/HCTZ (50 mg/ 50 mg) in single or divided doses should be adequate for most patients, but may range from 2 to 8 tablets daily of TEVA- SPIRONOLACTONE/HCTZ (25 mg/ 25 mg) or 1 to 4 tablets of TEVA-SPIRONOLACTONE/HCTZ (50 mg/ 50 mg) .
3 mg of spironolactone per kilogram of body weight.
Essential hypertension:
In essential hypertension, a daily dosage of 2 to 4 TEVA- SPIRONOLACTONE/HCTZ (25 mg / 25 mg) tablets or 1 to 2 TEVA-SPIRONOLACTONE/HCTZ (50 mg/ 50 mg) tablets in single or divided doses, will be adequate for most patients, but may range from 2 to 8 tablets of TEVA-SPIRONOLACTONE/HCTZ (25 mg/ 25 mg) or 1 to 4 tablets of TEVA-SPIRONOLACTONE/HCTZ (50 mg/ 50 mg).
and 7 WARNINGS AND PRECAUTIONS – Hepatic/Biliary/Pancreatic and Renal sections). 2 CONTRAINDICATIONS TEVA-SPIRONOLACTONE/HCTZ is contraindicated in: • Patients who are hypersensitive to spironolactone, thiazides, or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS,COMPOSITION AND PACKAGING. • Patients who are allergic to sulfonamide-derived drugs. • Patients with anuria. 2 Breastfeeding) • Combination with eplerenone ( see 7 Warnings and Precautions- Hematologic - Hyperkalemia, 9 Drug Interactions sections) • Combination with heparin, low molecular weight heparin ( see 7 Warnings and Precautions- Hematologic - Hyperkalemia, 9 Drug Interactions sections) • Patients with severe or progressive liver disease.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Spironolactone 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.
Acidosis and renal function:
Rare reports of acidosis have been reported with spironolactone and hydrochlorothiazide.
Hypochloremic alkalosis:
Hypochloremic alkalosis occurs infrequently and is rarely severe. Unduly restricted dietary sodium may complicate therapy. A chloride deficit may be corrected by using ammonium chloride (except in renal or hepatic disease) and is largely prevented by a near-normal sodium/chloride intake.
Pathological changes in the parathyroid gland, with resultant hypercalcemia and hypophosphatemia, have been observed in a few patients on prolonged thiazide therapy. Thiazides may increase the concentration of blood uric acid. Caution is necessary in patients with hyperuricemia or a history of gout, because gout may be precipitated by thiazides.
Dosage adjustment of anti-gout medications may be necessary. In diabetic and prediabetic patients, thiazides may increase blood gl ucose concentrations. Dosage adjustments of insulin or hypoglycemic medications may be required.
Hematologic Electrolyte Balance:
Because of the diuretic action of TEVA-SPIRONOLACTONE/HCTZ, patients TEVA-SPIRONOLACTONE/HCTZ Page 10 of 49 should be carefully evaluated for possible disturbance of fluid and electrolyte balance, due to the possibility of hyperkalemia, hypochloremic alkalosis, hyponatremia and possible blood urea nitrogen (BUN) elevation, especially the elderly and/or patients with pre-existing impaired renal or hepatic function.
a) Hyperkalemia Hyperkalemia may occur in patients treated with TEVA-SPIRONOLACTONE/HCTZ, if the potassium intake is excessive. This can cause cardiac irregularities, some of which may be fatal. Hyperkalemia may occur in the absence of excessive potassium intake, particularly in patients with impaired renal function, elderly patients, or patients with diabetes.
Consequently, no potassium supplementation should ordinarily be given with TEVA- SPIRONOLACTONE/HCTZ. TEVA-SPIRONOLACTONE/HCTZ should not be administered concurrently with other potassium-sparing diuretics. Spironolactone and hydrochlorothiazide, when used with angiotensin-converting enzyme (ACE) inhibitors, nonsteroidal anti-inflammatory drugs, angiotensin II antagonists, other aldosterone blockers, even in the presence of a diuretic, has been associated with severe hyperkalemia (see
Since TEVA-SPIRONOLACTONE/HCTZ increases the action of other antihypertensive drugs, especially the ganglionic blocking agents, the dosage of such drugs should be reduced by at least 50% when TEVA-SPIRONOLACTONE/HCTZ is added to the regimen.
4 Adminisrtation TEVA-SPIRONOLACTONE/HCTZ is to be taken orally with or without food. 5 Missed Dose In the event that a dose is missed, skip the missed dose and resume at the next scheduled dose. Do not double dose. 5 OVERDOSAGE Symptoms: There have been no reports of fatal overdose in man (except indirectly through hyperkalemia).
Nausea and vomiting occur, and (much more rarely) drowsiness, dizziness, decreased consciousness, coma, mental confusion, diarrhea, or a maculopapular or erythematous rash. These manifestations disappear promptly on discontinuation of medication.
Hyperkalemia may be exacerbated. Thrombocytopenic purpura and granulocytopenia have occurred with thiazide therapy.
TEVA-SPIRONOLACTONE/HCTZ Page 7 of 49 Treatment:
No specific antidote. No persistent toxicity has occurred or is expected. Spironolactone/hydrochlorothiazide use should be discontinued and potassium intake (including dietary sources) restricted. For management of a suspected drug overdose, contact your regional poison control centre.
6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table 1 – Dosage Forms, Strengths, Composition and Packaging Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients Oral Tablet: 25 mg of spironolactone and 25 mg of hydrochlorothiazide or 50 mg of spironolactone and 50 mg of hydrochlorothiazide colloidal silicon dioxide, lactose monohydrate, magnesium stearate, natural peppermint flavour powder, Sodium lauryl sulfate and sodium starch glycolate, 25 mg of spironolactone and 25 mg of hydrochlorothiazide tablets also contain D&C Yellow #10 AL Lake HT, FD&C Yellow #6 AL Lake HT Availability TEVA-SPIRONOLACTONE/HCTZ 25 mg of spironolactone and 25 mg of hydrochlorothiazide: Each ivory coloured, peppermint odour, round, bi-convex, compressed tablets; 25 over and under scoreline engraved on one side, novo engraved on the reverse contains 25mg of spironolactone and 25mg of hydrochlorothiazide.
Available in bottles of 100 tablets.
TEVA-SPIRONOLACTONE/HCTZ 50 mg of spironolactone and 50 mg of hydrochlorothiazide:
Each white coloured, peppermint odour, round, bi-convex, compressed tablets; 50 over and under scoreline engraved on one side, novo engraved on the reverse contains 50mg of spironolactone and 50mg of hydrochlorothiazide. Available in bottles of 100 tablets.
7 WARNINGS AND PRECAUTIONS TEVA-SPIRONOLACTONE/HCTZ Page 8 of 49 Please see 3 SERIOUS WARNINGS AND PRECAUTIONS BOX.
General Potassium (K+) Supplementation:
The concurrent administration of potassium supplements, a diet rich in potassium, or other K+-sparing diuretics is not recommended as this may induce hyperkalemia.
Somnolence and dizziness:
Somnolence and dizziness have been reported to occur in some patients sometimes leading to falls and fractures.
Carcinogenesis and Mutagenesis Tumorigenicity:
Spironolactone, in chronic toxicity studies, has […]