Classes
DEA Class; Rx
Common Brand Names; Ziac
- Thiazide Combos
Description
Beta-blocker and thiazide diuretic; for mild to moderate HTN; bisoprolol is beta-1-receptor-selective, has low lipid solubility, is excreted by renal and non-renal pathways, and is devoid of partial agonist or membrane stabilizing activity.
Indications
Indicated for the treatment of hypertension in patients who do not respond to monotherapy.
Contraindications
Anuria
Cardiogenic shock
Heart block 2°/3°
Hypersensitivity to either component or sulfonamide derivatives
Overt cardiac failure
Marked sinus bradycardia
Adverse Effects
No adverse effects specific to the combination have been observed; adverse effects limited to those previously reported with bisoprolol fumarate and hydrochlorothiazide
Bisoprolol fumarate
- Arthralgia (2-3%)
- Chest pain (1-2%)
- Diarrhea (3%)
- Dyspnea (1-2%)
- Fatigue (6-8%)
- Hypoaesthesia (1-2%)
- Insomnia (2-3%)
- Nausea/vomiting (2%)
- Rhinitis (3-4%)
- Sinusitis (2%)
- Upper respiratory infection (5%)
- Weakness (≤2%)
Hydrochlorothiazide
- Anorexia
- Epigastric distress
- Hypotension
- Orthostatic hypotension
- Photosensitivity
- Anaphylaxis
- Anemia
- Confusion
- Erythema multiforme
- Stevens-Johnson syndrome
- Exfoliative dermatitis including toxic epidermal necrolysis
- Hypomagnesemia
- Dizziness
- Headache
- Hyperuricemia
Warnings
Although the probability of developing hypokalemia is reduced with therapy because of very low dose of HCTZ employed, periodic determination of serum electrolytes should be performed, and patients should be observed for signs of fluid or electrolyte disturbances, eg, hyponatremia, hypochloremic alkalosis, hypokalemia, and hypomagnesemia
Thiazides have been shown to increase urinary excretion of magnesium; this may result in hypomagnesemia; warning signs or symptoms of fluid and electrolyte imbalance include dryness of mouth, thirst, weakness, lethargy, drowsiness, restlessness, muscle pains or cramps, muscular fatigue, hypotension, oliguria, tachycardia, and gastrointestinal disturbances such as nausea and vomiting
Hypokalemia may develop, especially with brisk diuresis when severe cirrhosis is present, during concomitant use of corticosteroids or adrenocorticotropic hormone (ACTH) or after prolonged therapy; interference with adequate oral electrolyte intake will also contribute to hypokalemia; hypokalemia and hypomagnesemia can provoke ventricular arrhythmias or sensitize or exaggerate the response of the heart to the toxic effects of digitalis; hypokalemia may be avoided or treated by potassium supplementation or increased intake of potassium-rich foods
Dilutional hyponatremia may occur in edematous patients in hot weather; appropriate therapy is water restriction rather than salt administration, except in rare instances when hyponatremia is life-threatening; in actual salt depletion, appropriate replacement is therapy of choice
Calcium excretion is decreased by thiazides, and pathologic changes in parathyroid glands, with hypercalcemia and hypophosphatemia, have been observed in a few patients on prolonged thiazide therapy
Pregnancy and Lactation
There are no adequate and well-controlled studies on pregnant women; therapy should be used during pregnancy only if potential benefit justifies risk to fetus
Bisoprolol fumarate alone or in combination with HCTZ has not been studied in nursing mothers; thiazides are excreted in human breast milk; small amounts of bisoprolol fumarate(<2% of the dose) have been detected in milk of lactating rats; because of potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or discontinue drug, taking into account importance of drug to mother
Maximum Dosage
20 mg/day PO bisoprolol and 12.5 mg/day PO hydrochlorothiazide.
20 mg/day PO bisoprolol and 12.5 mg/day PO hydrochlorothiazide.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
How supplied
Bisoprolol fumarate/Hydrochlorothiazide
tablet
- 2.5mg/6.25mg
- 5mg/6.25mg
- 10mg/6.25mg