Ziac Special Precautions

Treatment with bisoprolol must not be withdrawn abruptly unless clearly indicated, since abrupt withdrawal of bisoprolol may lead to an acute deterioration of the patient's condition in particular in patients with ischemic heart disease (see Dosage & Administration).
Bisoprolol + hydrochlorothiazide (Ziac) must be used with caution in patients with: accompanying heart failure; diabetes mellitus showing large fluctuations in blood glucose values; symptoms of hypoglycemia (e.g. tachycardia, palpitations or sweating) can be masked; strict fasting; first degree AV block.
Prinzmetal's angina: Cases of coronary vasospasm have been observed. Despite its high beta₁-selectivity, angina attacks cannot be completely excluded when bisoprolol is administered to patients with Prinzmetal's angina. Utmost caution must be exercised.
Peripheral arterial occlusive disease. Aggravation of symptoms may occur especially when starting therapy; hypovolemia; impaired liver function.
As with other beta-blockers, bisoprolol may increase both the sensitivity towards allergens and the severity of anaphylactic reactions. This also applies to desensitization therapy. Epinephrine treatment may not always yield the expected therapeutic effect.
Patients with psoriasis or with a history of psoriasis should only be given beta-blockers (e.g. bisoprolol) after careful balancing of benefits against risks.
The symptoms of thyrotoxicosis may be masked under treatment with bisoprolol.
In patients with pheochromocytoma, bisoprolol must not be administered until after alpha-receptor blockade.
In patients undergoing general anesthesia, the anesthetist must be aware of beta-blockade. If it is thought necessary to withdraw beta-blocker therapy before surgery, this should be done gradually and completed about 48 hours before anesthesia.
Although cardioselective (beta₁) beta-blockers may have less effect on lung function than non-selective betablockers, as with all beta-blockers, these should be avoided in patients with obstructive airways diseases, unless there are compelling clinical reasons for their use. Where such reasons exist, bisoprolol + hydrochlorothiazide (Ziac) may be used with caution. In bronchial asthma or other chronic obstructive pulmonary diseases, which may cause symptoms, concomitant bronchodilating therapy is recommended. Occasionally an increase of the airway resistance may occur in patients with asthma, therefore the dose of beta₂-stimulants may have to be increased.
Photosensitivity reactions may occur with thiazide diuretics. If photosensitivity reactions occur, it is recommended to protect exposed areas to the sun or to artificial UVA light. In severe cases it may be necessary to stop the treatment.
An increased risk of non-melanoma skin cancer (NMSC) [basal cell carcinoma (BCC) and squamous cell carcinoma (SCC)] with increasing cumulative dose of hydrochlorothiazide exposure has been observed in two epidemiological studies based on the Danish National Cancer Registry. Photosensitizing actions of hydrochlorothiazide could act as a possible mechanism for NMSC.
Patients taking hydrochlorothiazide should be informed of the risk of NMSC and advised to regularly check their skin for any new lesions and promptly report any suspicious skin lesions. Possible preventive measures such as limited exposure to sunlight and UV rays and, in case of exposure, adequate protection should be advised to the patients in order to minimize the risk of skin cancer. Suspicious skin lesions should be promptly examined potentially including histological examinations of biopsies. The use of hydrochlorothiazide may also need to be reconsidered in patients who have experienced previous NMSC (see Adverse Reactions).
Long-term, continuous administration of hydrochlorothiazide may lead to fluid and electrolyte disturbances, in particular to hypokalemia, hyponatremia, hypomagnesemia, hypochloremia, and hypercalcemia. Hypokalemia facilitates the development of severe arrhythmias, particularly torsade de pointes, which may be fatal.
During long term-therapy with bisoprolol + hydrochlorothiazide (Ziac), monitoring of serum electrolytes (especially potassium, sodium, calcium), creatinine, urea, serum lipids (cholesterol and triglycerides), uric acid as well as blood glucose is recommended.
In patients with hyperuricemia, the risk for attacks of gout may be increased.
Metabolic alkalosis may worsen due to disturbance of fluid and electrolyte hemostasis.
In patients with cholelithiasis acute cholecystitis has been reported. Hydrochlorothiazide can cause an idiosyncratic reaction, resulting in choroidal effusion with visual field defect, acute transient myopia and acute angle-closure glaucoma. Symptoms include acute onset of decreased visual acuity 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 hydrochlorothiazide as rapidly as possible.
Acute Respiratory Toxicity: Very rare severe cases of acute respiratory toxicity, including acute respiratory distress syndrome (ARDS) have been reported after taking hydrochlorothiazide.
Pulmonary oedema typically develops within minutes to hours after hydrochlorothiazide intake. At the onset, symptoms include dyspnoea, fever, pulmonary deterioration and hypotension. If diagnosis of ARDS is suspected, Bisoprolol fumarate + Hydrocholorothiazide (Ziac) should be withdrawn and appropriate treatment given. Hydrochlorothiazide should not be administered to patients who previously experienced ARDS following hydrochlorothiazide intake.
Effects on the ability to drive and use machines: In general bisoprolol + hydrochlorothiazide (Ziac) has no or negligible influence on the ability to drive and use machines.
However, depending on the individual patient's response to treatment, the ability to drive a vehicle or to use machines may be impaired. This needs to be considered particularly at start of treatment, upon change of medication, or in conjunction with alcohol.