Bisoplus HCT 10/25

Rx

Indications: 

Hypertension is not controlled properly with bisoprolol fumarate and hydrochlorothiazide alone.

Dosage:

• Adults: The usual initial daily dose is ½ tablet per day.
  If necessary, the dose can be increased 1 tablet 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 10/25 is orally administered with glass of water in the morning.

• Known hypersensitivity to any of the active substances or excipients.
• Patients with untreated or decompensated cardiac failure, cardiogenic shock, sinoatrial block, second or third degree AV block, marked bradycardia (heart rate less than 60 beats/min), acute myocardial infarction, severe asthma, severe renal or hepatic failure, Addison’s disease.

• Dizziness, vertigo, headache, paresthesia, hypoaesthesia, somnolence, anxiety/restlessness, decreased concentration/memory.
• Dry mouth.
• Bradycardia, palpitations and other rhythm disturbances, cold extremities, claudication, hypotension, chest pain, congestive heart failure, dyspnea on exertion.
• Vivid dreams, insomnia, depression.
• Gastric/epigastric/abdominal pain, gastritis, dyspepsia, nausea, vomiting, diarrhea, constipation, pancreatitis, jaundice (intrahepatic cholestatic jaundice), sialadenitis, cramping, gastric irritation.
• Muscle/joint pain, back/neck pain, muscle cramps, twitching/tremor.
• Rash, eczema, skin irritation, pruritus, flushing, sweating, alopecia, angioedema, exfoliative dermatitis, cutaneous vasculitis, erythema multiforme including Stevens-Johnson syndrome, exfoliative dermatitis including toxic epidermal necrolysis.
• Visual disturbances, ocular pain/pressure, abnormal lacrimation, tinnitus, earache, taste abnormalities.
• Gout, hyperglycemia, glycosuria, hyperuricemia.
• Asthma/bronchospam, bronchitis, coughing, dyspnea, pharyngitis, rhinitis, sinusitis.
• Decreased libido/impotence, cystitis, renal colic, renal failure, interstitial nephritis.
• Purpura, aplastic anemia, agranulocytosis, leukopenia, hemolytic anemia, thrombocytopenia.
• Fatigue, asthenia, chest pain, malaise, edema, weight gain.
• Weakness.
• Purpura, photosensitivity, urticaria, necrotizing angiitis (vasculitis and cutaneous vasculitis), fever, respiratory distress including pneumonitis and pulmonary edema.
• Transient blurred vision, xanthopsia.

• Use with care in patients with a prolonged PR conduction interval, poor cardiac reserve and peripheral circulatory disease.
• Bisoprolol must be used with caution in bronchospasm (if airway resistance occur, therapy should be discontinued).
• Bisoprolol may mask the symptoms of hypoglycaemia in diabetic patients.
• Beta blockers may mask the symptoms of hyperthyroidism in patients with thyrotoxicosis.
• Thiazides may precipitate attacks of gout in susceptible patients.
• All diuretics should used with caution in patients with existing fluid and electrolyte disturbances or who are at risk from changes in fluid and electrolyte balance.
• Thiazides may cause hyperglycaemia and aggravate or unmask diabetes mellitus.
• Thiazides can reduce urinary excretion of calcium, sometimes resulting in mild hypercalcaemia; they should not be given to patients with pre-existing hypercalcaemia. There is a possibility that thiazides may exacerbate or activate systemic lupus erythematosus in susceptible patients.
• For a suggestion that thiazides may increase the risk of developing gallstones.
• Increases in cholesterol and triglyceride levels may be associated with thiazide diuretic therapy.
• Bisoprolol fumarate and hydrochlorothiazide should be used during pregnancy only if the potential benefit justifies the risk to the fetus. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
• Patients should be aware of how they react to drug before driving or operating machinery.