Bisoplus HCT 5/12.5

Rx

Indications

Treatment of hypertension is not controlled properly with bisoprolol fumarate and hydrochlorothiazide alone.

Dosage

• Adults: The usual initial daily dose is 1 tablet per day.
  If necessary, the dose can be increased 2 tablets per day.
• Patients with renal or hepatic impairment: The dosage should be reduced.
• Children: This product has not been studied in children, so its use not recommended in children

Usage

Bisoplus HCT 5/12.5 is orally administered with glass of water in the morning.

• Hypersensitivity to the active substances, other thiazides, sulphonamides or to any of the excipients.
• Acute heart failure or during episodes of heart failure decompensation requiring IV inotropic therapy.
• Cardiogenic shock.
• 2nd or 3rd degree AV block (without pacemaker).
• Sinus node syndrome (sick sinus syndrome).
• Sinoatrial block.
• Bradycardia with < 60 beats/min before starting treatment.
• Severe bronchial asthma.
• Late stages of peripheral arterial occlusive disease or Raynaud’s syndrome.
• Untreated phaeochromocytoma.
• Metabolic acidosis.
• Severe renal insufficiency with oliguria or anuria (creatinine clearance < 30 ml/min and/or serum creatinine > 1.8 mg/100 ml).
• Acute glomerulonephritis.
• Coma and pre-coma hepaticum.
• Therapy resistant hypokalaemia.
• Severe hyponatremia.
• Hypercalcemia.
• Gout.

Common

• Hyperglycaemia, hyperuricaemia, disorders in fluid and electrolyte balance (especially hypokalaemia and hyponatremia, also hypomagnesaemia and hypochloridaemia and hypercalcaemia).
• Dizziness, headache, fatigue. These symptoms occur especially at the beginning of treatment. They are generally mild and often disappear within 1 to 2 weeks.
• Feeling cold or numb in the extremities.
• Nausea, vomiting, diarrhea, constipation.
• Increase in triglycerides and cholesterol, glucosuria.

• Treatment with Bisoplus HCT 5/12.5 should not be stopped abruptly, especially in patients with coronary artery disease, as this can lead to a temporary deterioration in the patient’s condition.
• Particularly careful medical supervision is required in the case of:
  – Heart failure (in patients with simultaneous stable, chronic heart failure, therapy with the single active ingredient bisoprolol and the recommended titration phase must be started).
  – Bronchospasm (bronchial asthma, obstructive airways diseases).
  – Simultaneous treatment with inhalation anesthetics.
  – Diabetes mellitus with strongly fluctuating blood glucose values; symptoms of hypoglycemia can be masked.
  – Strict fasting.
  – Ongoing desensitization therapy.
  – 1st degree AV block.
  – Prinzmetal’s angina. Cases of coronary spasm have been observed. Despite its high beta 1 selectivity, episodes of angina cannot be completely ruled out when bisoprolol is administered to patients with Prinzmetal’s angina.
  – Peripheral arterial occlusive disease (aggravation of the symptoms is possible especially at the start of treatment).
  – Hypovolemia.
  – Liver dysfunction.
• Although cardioselective selectivity beta 1 beta-blockers can have a smaller effect on lung function than non-selective beta blockers, so beta blockers should in principle not be used in patients with obstructive airway diseases, unless there are compelling clinical reasons to do so. If such reasons exist, Bisoplus HCT 5/12.5 comp should be used with caution. In the case of bronchial asthma or other chronic obstructive pulmonary dysfunction that can cause symptoms, concomitant bronchodilator therapy should be given. Occasionally an increase in airway resistance can occur in patients with asthma and require an increase in the dose of beta 2-sympathomimetics.
• Metabolic alkalosis can be exacerbated by impaired fluid and electrolyte balance.
• As well as others beta-blocker, bisoprolol can increase both the sensitivity to allergens and the severity of anaphylactic reactions. This also applies to desensitization therapy. Adrenaline does not always show the desired therapeutic effect.
• In patients with existing or a history of psoriasis, the prescription of beta-blockers (e.g. bisoprolol) should only be given after careful risk-benefit assessment.
• Allowed in patients with a pheochromocytoma beta-blockers (e.g. bisoprolol) should only be administered after the alpha receptors have been blocked.
• Treatment with beta-blockers (e.g. bisoprolol) can mask the symptoms of thyrotoxicosis.
• Cases of acute cholecystitis have been reported in patients with cholelithiasis.
• Disturbance of the electrolyte and fluid balance: Due to the HCTZ component, the continuous long-term administration of Bisoplus HCT 5/12.5 can lead to a disturbance of the electrolyte and fluid balance, especially hypokalaemia and hyponatremia, but also hypomagnesaemia, hypochloridaemia and hypercalcaemia.
• Hypokalaemia tends to lead to the development of severe arrhythmias, sometimes to torsade de pointes with fatal outcome.
• The risk of a gout attack is increased in patients with hyperuricemia.
• During long-term treatment with Bisoplus HCT 5/12.5, the serum electrolytes (especially potassium, sodium, calcium), creatinine and urea, blood lipids (cholesterol and triglycerides), uric acid and blood sugar should be checked regularly.
• Choroidal effusion, acute myopia and secondary angle closure glaucoma: Sulfonamides and sulfonamide derivatives can trigger an idiosyncratic reaction that leads to a choroidal effusion with a visual field defect, transient myopia and an acute angle closure glaucoma. Symptoms include an acute onset of deterioration in vision or eye pain, which usually occurs a few hours to weeks after starting treatment with the drug. If left untreated, secondary angle closure glaucoma can lead to permanent vision loss. The primary treatment is to stop taking the medicine as soon as possible. Immediate medical or surgical treatment may need to be considered if intraocular pressure remains uncontrolled. Risk factors for developing acute angle closure glaucoma may include a history of sulfamide or penicillin allergies.

Notes

• During treatment with Bisoplus HCT 5/12.5, patients should ensure that they drink sufficient fluids and, due to increased potassium losses, consume foods rich in potassium (e.g. bananas, vegetables, nuts). Potassium losses can be reduced or prevented by simultaneous treatment with potassium-sparing diuretics.
• General anesthesia: In patients receiving general anesthesia, beta-blockers reduce the incidence of arrhythmias and myocardial ischemia during induction, intubation and postoperatively. It is currently recommended not to discontinue existing beta-blocker therapy during surgery. The anesthetist must be informed about therapy with beta-blockers, as this can result in potential interactions with other drugs, resulting bradyarrhythmias, attenuation of reflex tachycardias and the compensation of blood loss through reduced reflex reactions. If it is necessary to discontinue beta-blocker therapy before the operation, this should be done gradually and completed up to approx. 48 hours before the anesthesia.
• Photosensitivity reactions can occur in conjunction with thiazide diuretics. If photosensitivity reactions occur, it is recommended to protect exposed areas of the body from sun or UVA rays. In severe cases, it may be necessary to stop treatment with Bisoplus HCT 5/12.5.
• Non-melanoma skin cancer: In two epidemiological studies based on the Danish national cancer registry, an increased risk of non-melanoma skin cancer (NMSC) [basal cell carcinoma (BCC) and squamous cell carcinoma (SCC)] was observed with increasing cumulative dose of hydrochlorothiazide (HCTZ). Photosensitizing effects of HCTZ could contribute to the development of NMSC.
  Patients taking HCTZ should be made aware of the risk of NMSC and should be advised to regularly check their skin for new lesions and to report any suspicious skin changes immediately. Patients should be advised of possible preventive measures to minimize the risk of skin cancer; such as limitation of exposure to sunlight and UV radiation or, in the event of exposure, use of appropriate sun protection. Suspicious skin changes should be investigated immediately, including histological examinations of biopsies if necessary. The use of HCTZ should be reviewed in patients who have already developed NMSC.
• The use of Bisoplus HCT 5/12.5 can lead to positive results in doping tests.
• The use of Bisoplus HCT 5/12.5 during lactation and breastfeeding is not recommended.
• As bisoprolol can cause drowsiness, dizziness and fatigue as side effects, these may affect the patient’s ability to drive or operate machinery.