Bislol Plus 2.5 Tablet: Each film coated tablet contains Bisoprolol hemifumarate USP 2.5 mg and Hydrochlorothiazide BP 6.25 mg.
Bislol Plus 5 Tablet: Each film coated tablet contains Bisoprolol hemifumarate USP 5 mg and Hydrochlorothiazide BP 6.25 mg.
Bislol Plus 10 Tablet: Each film coated tablet contains Bisoprolol hemifumarate USP 10 mg and Hydrochlorothiazide BP 6.25 mg.
Bislol Plus is a fixed dose combination of Bisoprolol hemifumarate & Hydrochlorothiazide. Bisoprolol is a selective beta-1 blocker and Hydrochlorothiazide is a thiazide type of diuretic also used in hypertension.
Mode of action:
Bisoprolol is a highly Beta-1 selective beta blocker. The desirable therapeutic actions of beta blockers result from blocking the beta1-receptor of the heart and kidney. Hydrochlorothiazide is a novel diuretic which affects the distal renal tubular mechanism of electrolyte reabsorption and resulting reduce blood volume or Cardiac Output.
Pharmacokinetics:
Absorption: Bisoprolol hemifumarate and hydrochlorothiazide are well absorbed following oral administration. Mean peak plasma concentrations of about 9.0 ng/ml, 19 ng/ml and 36 ng/ml occur approximately 3 hours after the administration of the 2.5 mg/6.25 mg, 5 mg/6.25 mg and 10 mg/6.25 mg combination tablets, respectively. Distribution: Concentrations of hydrochlorothiazide are 1.6 to 1.8 times higher in whole blood than in plasma. Binding to serum proteins has been reported to be approximately 40% to 68%. Metabolism: The pharmacokinetic characteristics the two enantiomers are similar. Bisoprolol is not metabolized by cytochrome P450 Il D6 (debrisoquin hydroxylase). Excretion: The elimination T1/2 of bisoprolol ranges from 7 to 15 hours and that of hydrochlorothiazide ranges from 4 to 10 hours. The percent of dose excreted unchanged in urine is about 55% for and about 60% for hydrochlorothiazide.
The combination is indicated to the management of Hypertension & coronary artery disease (Angina pectoris).
The dose of Bislol Plus is once daily. Bisoprolol/hydrochlorothiazide combination therapy using bisoprolol doses of 2.5 to 20 mg and hydrochlorothiazide doses of 6.25 to 25 mg, the antihypertensive effects increased with increasing doses of either component.
Bisoprolol hemifumarate and hydrochlorothiazide tablets should not be combined with other beta-blocking agents. Bisoprolol hemifumarate and hydrochlorothiazide tablets should be used with caution when myocardial depressants or inhibitors of AV conduction, such as certain calcium antagonists (particularly of the phenylalkylamine [verapamil] and benzothiazepine [diltiazem] classes), or antiarrhythmic agents, such as disopyramide, are used concurrently. Both digitalis glycosides and beta-blockers slow atrioventricular conduction and decrease heart rate. Concomitant use can increase the risk of bradycardia. Over dosage: There are limited data on overdose with bisoprolol hemifumarate and hydrochlorothiazide tablets. However, several cases of overdose with bisoprolol hemifumarate have been reported (maximum: 2,000 mg). Bradycardia and/or hypotension were noted. Sympathomimetic agents were given in some cases and all patients recovered.
Bisoprolol is USFDA pregnancy category C & hydrochlorothiazide is USFDA pregnancy category B. There are no adequate and well-controlled studies with bisoprolol hemifumarate and hydrochlorothiazide tablets in pregnant women. Bisoprolol hemifumarate and hydrochlorothiazide should be used during pregnancy only if the potential benefit justifies the risk to the fetus. There are no data on the excretion of bisoprolol into human milk. Hydrochlorothiazide is secreted into human milk in low concentrations.
The probability of developing hypokalemia as well as hyperurecemia is reduced.
Keep out of reach of children. Store in a cool (Below 25 C temperature) and dry place protected from light.