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SANDOZ CANDESARTAN PLUS 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: Sandoz Candesartan Plus (candesartan cilexetil/hydrochlorothiazide) is indicated for: • the treatment of essential hypertension in patients for whom combination therapy is appropriate. Sandoz Candesartan Plus is not indicated for initial therapy (see 4 DOSAGE AND ADMINISTRATION). The dosage of Sandoz Candesartan Plus…
Verbatim from this product's HC label. Tap a section to expand.
). The dosage of Sandoz Candesartan Plus must be individualized. The dose of Sandoz Candesartan Plus should be determined by titration of the individual components. 3 Pediatrics). 4 Geriatrics). 2 CONTRAINDICATIONS Sandoz Candesartan Plus (candesartan cilexetil/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
).
Valvular Stenosis:
There is concern on theoretical grounds that patients with aortic stenosis might be at particular risk of decreased coronary perfusion when treated with vasodilators because they do not develop as much afterload reduction. Driving and Operating Machinery The effect of candesartan cilexetil/hydrochlorothiazide on the ability to drive and use machines has not been studied, but based on its pharmacodynamic properties candesartan cilexetil/hydrochlorothiazide is unlikely to affect this ability.
When driving vehicles or operating machines, it should be taken into account that occasionally dizziness or weariness may occur during treatment of hypertension. Exercise caution when driving or operating a vehicle or potentially dangerous machinery.
Sandoz Candesartan Plus Product Monograph Page 10 of 57 Endocrine and Metabolism Metabolism: Patients receiving thiazides, including hydrochlorothiazide (HCTZ), should be carefully observed for clinical signs of fluid and electrolyte imbalance (hyponatremia, hypochloremic alkalosis and hypokalemia).
Periodic determinations of serum electrolytes, to detect possible electrolyte disturbance, should be performed at appropriate intervals. Warning signs or symptoms of fluid and electrolyte imbalance include dryness of the mouth, thirst, weakness, lethargy, drowsiness, restlessness, muscle pain or cramps, muscle fatigue, hypotension, oliguria, tachycardia and gastrointestinal disturbances such as nausea and vomiting.
Hypokalemia may develop, especially with brisk diuresis, when severe cirrhosis is present, or after prolonged therapy. Interference with adequate oral electrolyte intake will also contribute to hypokalemia. g. increased ventricular irritability).
Any chloride deficit during thiazide therapy is generally mild and usually does not require specific treatment except under extraordinary circumstances (as in liver disease or renal disease). Dilutional hyponatremia may occur in edematous patients in hot weather.
5 Post-Market Adverse Reactions). 1 Pregnant Women). 2 Breast-feeding). • Children aged < 1 year. 4 Drug-Drug Interactions). • Patients with severe hepatic impairment and/or cholestasis. 73 m2 BSA). • Patients with gout. • Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.
Sandoz Candesartan Plus Product Monograph Page 5 of 57 3 SERIOUS WARNINGS AND PRECAUTIONS BOX Serious Warnings and Precautions • When used in pregnancy, angiotensin receptor (AT1) blockers (ARBs) can cause injury or even death of the developing fetus.
1 Pregnant Women). 1 Dosing Considerations • The dosage of Sandoz Candesartan Plus (candesartan cilexetil/hydrochlorothiazide) must be individualized. • The fixed combination is not for initial therapy. • The dose of Sandoz Candesartan Plus should be determined by titration of the individual components.
5 mg or 32 mg / 25 mg tablet once daily may be taken if the doses on which the patient was stabilized are the same as those in the fixed combination (see 1 INDICATIONS). Initiation of therapy requires consideration of recent antihypertensive treatment, the extent of blood pressure elevation, salt restriction, and other pertinent clinical factors.
Candesartan cilexetil Monotherapy The recommended initial dose of candesartan cilexetil is 16 mg, once daily. Total daily doses of candesartan cilexetil should range from 8 to 32 mg. Doses higher than 32 mg do not appear to have a greater effect on blood pressure reduction, and there is relatively little experience with such doses.
Most of the antihypertensive effect is present within 2 weeks and the maximal blood pressure reduction is generally obtained within 4 weeks. g. patients treated with diuretics, particularly those with impaired renal function) consideration should be given to administration of a lower dose.
Sandoz Candesartan Plus (candesartan cilexetil/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 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. 5 Post-Market Adverse Reactions). 1 Pregnant Women). 2 Breast-feeding). • Children aged < 1 year. 4 Drug-Drug Interactions). • Patients with severe hepatic impairment and/or cholestasis.
73 m2 BSA). • Patients with gout. • Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption. Sandoz Candesartan Plus Product Monograph Page 5 of 57
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Appropriate therapy is water restriction rather than administration of salt, except in rare instances, when the hyponatremia is life threatening. In actual salt depletion, appropriate replacement is the therapy of choice. Hyperuricemia may occur or acute gout may be precipitated in certain patients receiving thiazide therapy.
Thiazides may decrease serum PBI (protein bound iodine) levels without signs of thyroid disturbance. Thiazides have been shown to increase excretion of magnesium; this may result in hypomagnesemia. Thiazides may decrease urinary calcium excretion and may cause intermittent and slight elevation of serum calcium in the absence of known disorders of calcium metabolism.
Marked hypercalcemia may be evidence of hidden hyperparathyroidism. Thiazides should be discontinued before carrying out tests for parathyroid function. 4 Drug-Drug Interactions). Increases in cholesterol and triglyceride levels may be associated with thiazide Sandoz Candesartan Plus Product Monograph Page 11 of 57 diuretic therapy.
However, at the doses, contained in candesartan cilexetil/hydrochlorothiazide, minimal effects were observed.
Hepatic/Biliary/Pancreatic Hepatic Impairment:
Thiazides should be used with caution in patients with impaired hepatic function or progressive liver disease, since minor alterations of fluid or electrolyte balance may precipitate hepatic coma. 2 Recommended Dose and Dosage Adjustment, Hepatic Impairment).
Candesartan cilexetil/hydrochlorothiazide is contraindicated in patients with severe hepatic failure and/or cholestasis (see 2 CONTRAINDICATIONS). No studies were carried out with candesartan cilexetil/hydrochlorothiazide fixed combination in patients with impaired hepatic function.
Immune Hypersensitivity Reactions:
Sensitivity reactions to hydrochlorothiazide may occur in patients with or without a history of allergy or bronchial asthma.
Systemic Lupus Erythematosus:
The possibility of exacerbation or activation of systemic lupus erythematosus has been reported in patients treated with hydrochlorothiazide. Ophthalmologic Choroidal Effusion, Acute Myopia and Secondary Angle-Closure Glaucoma related to Hydrochlorothiazide: Hydrochlorothiazide, a sulfonamide, can cause an idiosyncratic reaction, resulting in choroidal effusion, acute transient myopia and/or acute angle-closure glaucoma.
Symptoms include acute onset of decreased visual acuity, blurred vision or ocular pain and typically occur within hours to weeks of drug initiation. Untreated acute angle-closure glaucoma can lead to permanent vision loss. The primary treatment is to discontinue candesartan cilexetil/hydrochlorothiazide as rapidly as possible.
Prompt medical or surgical treatments may need to be considered if the intraocular pressure remains uncontrolled. Risk factors for developing acute angle-closure glaucoma may include a history of sulfonamide or penicillin allergy. Peri-Operative Considerations Thiazides may increase the responsiveness to tubocurarine.
Sandoz Candesartan Plus Product Monograph Page 12 of 57 Renal Renal Impairment:
As a consequence of inhibiting the renin-angiotensin-aldosterone system (RAAS), changes in renal function have been seen in susceptible individuals. In patients whose renal function may depend on the activity of the RAAS, such as patients with bilateral renal artery stenosis, unilateral renal artery stenosis to a solitary kidney, or severe congestive heart failure, treatment with agents that inhibit this system has been associated with oliguria, progressive azotemia, and rarely, acute renal failure and/or death.
In susceptible patients, concomitant diuretic use may further increase risk. The use of ARBs, including the candesartan cilexetil […]
4 Drug-Drug Interactions). Concomitant Diuretic Therapy In patients receiving diuretics, candesartan cilexetil therapy should be initiated with caution, since these patients may be volume-depleted and thus more likely to experience hypotension following initiation of additional antihypertensive therapy.
Sandoz Candesartan Plus Product Monograph Page 6 of 57 Whenever possible, all diuretics should be discontinued two to three days prior to the administration of candesartan cilexetil, to reduce the likelihood of hypotension (see 7 WARNINGS AND PRECAUTIONS, Hypotension).
If this is not possible because of the patient’s condition, candesartan cilexetil should be administered with caution and the blood pressure monitored closely. Thereafter, the dosage should be adjusted according to the individual response of the patient.
As a rule, concomitant diuretic therapy is not necessary when Sandoz Candesartan Plus is used.
Dosage Adjustments in the Presence of Pathologies Hepatic Impairment:
Dose titration is recommended in patients with mild to moderate chronic liver disease. Sandoz Candesartan Plus is contraindicated in patients with severe hepatic impairment and/or cholestasis (see 2 CONTRAINDICATIONS). 73m2 BSA), a dose titration is recommended.
73 m2 BSA) (see 2 CONTRAINDICATIONS). 3 Pediatrics).
Geriatrics (>65 years of age):
No dose adjustment of Sandoz Candesartan Plus is necessary for elderly patients. 4 Geriatrics). 4 Administration Sandoz Candesartan Plus should be taken once daily, at approximately the same time each day, with or without food. 5 Missed Dose If a patient misses a dose of Sandoz Candesartan Plus and remembers within 12 hours, the patient should take the dose as soon as possible and then go back to the regular schedule.
If it is more than 12 hours after the patient remembers, they should not take the missed dose; the next dose should be taken on time. Sandoz Candesartan Plus Product Monograph Page 7 of 57 A double dose of Sandoz Candesartan Plus should never be taken to make up for a missed dose.
5 OVERDOSAGE No specific information is available on the treatment of overdosage with Sandoz Candesartan Plus (candesartan cilexetil/hydrochlorothiazide). Treatment is symptomatic and supportive. Candesartan cilexetil Limited data are available in regard to overdosage of candesartan cilexetil in humans.
The most likely manifestations of overdosage would be hypotension, dizziness and tachycardia; bradycardia could occur from reflex parasympathetic (vagal) stimulation. Thirst, ventricular arrhythmias, sedation/impairment of consciousness and muscle cramps can also be observed.
If symptomatic hypotension should […]
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