MINT-CHLORTHALIDONE

, 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.

5 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%. MINT-CHLORTHALIDONE (Chlorthalidone) Page 11 of 29 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 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.

Nervous system disorders:

Common: dizziness, slow mentation. Rare: paresthesia, headache.

, Monitoring and Laboratory Test 2 CONTRAINDICATIONS MINT-CHLORTHALIDONE is contraindicated in: • Patients with hypersensitivity or suspected hypersensitivity to chlorthalidone and other sulfonamide derivatives 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 with anuria, severe renal failure (creatinine clearance lower than 30 mL/min), severe hepatic failure, refractory hypokalemia or conditions involving enhanced potassium loss, hyponatremia, hypercalcemia, hyperuricemia (history of gout or uric acid calculi), untreated Addison’s Disease and concomitant lithium therapy.

• Pregnancy. 1 Pregnant Women. • Breastfeeding. 2 Breastfeeding. , 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.

5 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.

MINT-CHLORTHALIDONE is contraindicated in: • Patients with hypersensitivity or suspected hypersensitivity to chlorthalidone and other sulfonamide derivatives 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 with anuria, severe renal failure (creatinine clearance lower than 30 mL/min), severe hepatic failure, refractory hypokalemia or conditions involving enhanced potassium loss, hyponatremia, hypercalcemia, hyperuricemia (history of gout or uric acid calculi), untreated Addison’s Disease and concomitant lithium therapy.

• Pregnancy. 1 Pregnant Women. • Breastfeeding. 2 Breastfeeding.