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APO-CHLORTHALIDONE is a brand name for Chlorthalidone, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: APO-CHLORTHALIDONE (chlorthalidone) is indicated for: • Treatment of hypertension. It may be used alone or in association with other antihypertensive agents. • Adjunctive therapy of edema associated with: renal disease, congestive heart failure of mild to moderate degree (functional class II, III), glomerular…
Verbatim from this product's HC label. Tap a section to expand.
, determine the minimum effective maintenance dose for each patient). A single dose daily or every other day given in the morning with food is recommended. 2 Recommended Dose and Dosage Adjustment Hypertension: Usual adult dose is 25 to 50 mg daily.
The clinically useful dosage range is 25 to 50 mg daily. Doses greater than 50 mg per day increase metabolic complications and are rarely of therapeutic benefit. For a given dose, the full effect is reached after 3 to 4 weeks. For long- term therapy, the lowest possible dosage sufficient to maintain an optimal effect should be employed; this applies particularly to elderly patients.
If the decrease in blood pressure obtained using doses of 25 or 50 mg/day proves inadequate, combined treatment with other antihypertensive drugs (such as beta-blockers) is recommended. Edema of Specific Origin.
See 1 INDICATIONS:
The lowest effective dose is to be identified by titration. Maintenance doses should not exceed 50 mg/day and should be administered over limited periods only. The dosage should be individually adapted to the clinical picture and patient's response The therapeutic effect of chlorthalidone occurs even without salt restriction and is well sustained during continued use.
Pediatrics:
Health Canada has not authorized an indication for pediatric use. 5 Missed Dose If the patient misses a dose, instruct the patient to take the dose as soon as they remember. If it is almost time for the next dose, inform the patient to skip the missed dose and continue the regular dosing schedule.
1 Adverse Reaction Overview Serious adverse reactions: Serious adverse reactions include cardiac arrhythmia, dyspnea, aplastic anemia and agranulocytosis. Most frequent adverse reactions (≥10%): The most frequent adverse reactions include hypokalemia, hyperuricemia, and hyperlipidemia.
Other adverse reactions are listed below by system organ class and frequency. 01%.
Blood and lymphatic system disorders:
Rare: thrombocytopenia, leukopenia and eosinophilia.
Eye disorders:
Rare: disturbances of vision.
Not known:
Choroidal effusion, acute myopia and acute angle-closure glaucoma (Cases of APO-CHLORTHALIDONE (Chlorthalidone) Page 12 of 30 choroidal effusion with visual field defect have been reported after the use of thiazide and thiazide-like diuretics).
Gastrointestinal disorders:
Common: minor gastrointestinal distress. Rare: mild nausea and vomiting, gastric pain, constipation, and diarrhea. Very rare: pancreatitis.
Hepatobiliary disorders:
Rare: intrahepatic cholestasis or jaundice.
Investigations:
Common: decreased reaction time.
Metabolism and nutrition disorders:
Common: hyponatremia, hypomagnesemia, hyperglycemia and loss of appetite. Uncommon: gout. Rare: hypercalcemia, worsening of diabetic metabolic state. Very rare: hypochloremic alkalosis.
03/2022 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 .................................................................................................
4 4 DOSAGE AND ADMINISTRATION................................................................................. 1 Dosing Considerations .............................................................................................. 2 Recommended Dose and Dosage Adjustment .........................................................
5 Missed Dose .............................................................................................................. 5 5 OVERDOSAGE.............................................................................................................
5 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................................. 6 7 WARNINGS AND PRECAUTIONS .................................................................................. 1 Special Populations .................................................................................................
03/2022 7 WARNINGS AND PRECAUTIONS 03/2022 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 .................................................................................................
4 4 DOSAGE AND ADMINISTRATION................................................................................. 1 Dosing Considerations .............................................................................................. 2 Recommended Dose and Dosage Adjustment .........................................................
5 Missed Dose .............................................................................................................. 5 5 OVERDOSAGE.............................................................................................................
5 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................................. 6 7 WARNINGS AND PRECAUTIONS .................................................................................. 1 Special Populations .................................................................................................
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Chlorthalidone 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.
Nervous system disorders:
Common: dizziness, slow mentation. Rare: paresthesia, headache.
Renal and urinary disorders:
Rare: glycosuria, allergic interstitial nephritis. Reproductive system and breast disorders Common: impotence.
Respiratory, thoracic and mediastinal disorders:
APO-CHLORTHALIDONE (Chlorthalidone) Page 13 of 30 Rare: idiosyncratic pulmonary edema (respiratory disorders).
Skin and subcutaneous tissue disorders:
Common: urticaria and other forms of skin rash. Rare: photosensitivity.
Vascular disorders:
Common: postural hypotension, which may be aggravated by alcohol, anesthetics or sedatives. Very rare: vasculitis. 5 Post-Market Adverse Reactions Information is not available.
1 Pregnant Women .............................................................................................. 2 Breast-feeding ................................................................................................... 3 Pediatrics...........................................................................................................
4 Geriatrics ........................................................................................................... 11 8 ADVERSE REACTIONS................................................................................................
1 Adverse Reaction Overview .................................................................................... 5 Post-Market Adverse Reactions.............................................................................. 13 9 DRUG INTERACTIONS ...............................................................................................
3 Drug-Behavioural Interactions ................................................................................ 4 Drug-Drug Interactions ........................................................................................... 5 Drug-Food Interactions ...........................................................................................
6 Drug-Herb Interactions ........................................................................................... 7 Drug-Laboratory Test Interactions.......................................................................... 17 10 CLINICAL PHARMACOLOGY .......................................................................................
1 Mechanism of Action ........................................................................................ 2 Pharmacodynamics ........................................................................................... 3 Pharmacokinetics ..............................................................................................
18 11 STORAGE, STABILITY AND DISPOSAL ......................................................................... 19 12 SPECIAL HANDLING INSTRUCTIONS........................................................................... 19 PART II: SCIENTIFIC INFORMATION ......................................................................................
21 13 PHARMACEUTICAL INFORMATION ........................................................................... 21 14 CLINICAL TRIALS .......................................................................................................
22 15 MICROBIOLOGY ....................................................................................................... 22 16 NON-CLINICAL TOXICOLOGY .....................................................................................
22 17 SUPPORTING PRODUCT MONOGRAPHS .................................................................... 22 PATIENT MEDICATION INFORMATION ................................................................................. 23 APO-CHLORTHALIDONE (Chlorthalidone) Page 4 of 30 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS APO-CHLORTHALIDONE (chlorthalidone) is indicated for: • Treatment of hypertension.
It may be used alone or in association with other antihypertensive agents. • Adjunctive therapy of edema associated with: renal disease, congestive heart failure of mild to moderate degree (functional class II, III), glomerular filtration rate greater than 30 mL/min; ascites due to cirrhosis of the liver in stable patients; estrogen therapy; corticosteroid therapy.
1 Pediatrics Pediatrics (<18 years of age): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use. 2 Geriatrics Geriatrics (>65 years of age): Evidence from clinical studies and experience suggests that use in the geriatric population is associated with differences in safety or effectiveness.
2 Recommended Dose and Dosage Adjustment […]
1 Pregnant Women .............................................................................................. 2 Breast-feeding ................................................................................................... 3 Pediatrics...........................................................................................................
4 Geriatrics ........................................................................................................... 11 8 ADVERSE REACTIONS................................................................................................
1 Adverse Reaction Overview .................................................................................... 5 Post-Market Adverse Reactions.............................................................................. 13 9 DRUG INTERACTIONS ...............................................................................................
3 Drug-Behavioural Interactions ................................................................................ 4 Drug-Drug Interactions ........................................................................................... 5 Drug-Food Interactions ...........................................................................................
6 Drug-Herb Interactions ........................................................................................... 7 Drug-Laboratory Test Interactions.......................................................................... 17 10 CLINICAL PHARMACOLOGY .......................................................................................
1 Mechanism of Action ........................................................................................ 2 Pharmacodynamics ........................................................................................... 3 Pharmacokinetics ..............................................................................................
18 11 STORAGE, STABILITY AND DISPOSAL ......................................................................... 19 12 SPECIAL HANDLING INSTRUCTIONS........................................................................... 19 PART II: SCIENTIFIC INFORMATION ......................................................................................
21 13 PHARMACEUTICAL INFORMATION ........................................................................... 21 14 CLINICAL TRIALS .......................................................................................................
22 15 MICROBIOLOGY ....................................................................................................... 22 16 NON-CLINICAL TOXICOLOGY .....................................................................................
22 17 SUPPORTING PRODUCT MONOGRAPHS .................................................................... 22 PATIENT MEDICATION INFORMATION ................................................................................. 23 APO-CHLORTHALIDONE (Chlorthalidone) Page 4 of 30 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS APO-CHLORTHALIDONE (chlorthalidone) is indicated for: • Treatment of hypertension.
It may be used alone or in association with other antihypertensive agents. • Adjunctive therapy of edema associated with: renal disease, congestive heart failure of mild to moderate degree (functional class II, III), glomerular filtration rate greater than 30 mL/min; ascites due to cirrhosis of the liver in stable patients; estrogen therapy; corticosteroid therapy.
1 Pediatrics Pediatrics (<18 years of age): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use. 2 Geriatrics Geriatrics (>65 years of age): Evidence from clinical studies and experience suggests that use in the geriatric population is associated with differences in safety or effectiveness.
2 […]