BISOPROLOL KANAWATI 5 mg
Tablets

Antihypertensive drugs

  • Chemical Composition

    Bisoprolol Fumarte 5 mg

  • Packing

    20Coated Tablets

  • Medical Id

    T101

  • License Number

    240/2014

  • License date

    2/10/2014

Excipients colloidal silicon dioxide ‚ corn starch ‚dibasic calcium phosphate anhydrous ‚hypromellose ‚ magnesium stearate ‚microcrystalline cellulose ‚polyethylene glycol ‚ polysorbate ‚titanium dioxide ‚red and yellow iron oxide E102 ‚ E127
Mechanism Of Action Bisoprolol is a beta1-selective (cardioselective) adrenoceptor blocking agent without significant membrane stabilizing activity or intrinsic sympathomimetic activity in its therapeutic dosage range. Cardioselectivity is not absolute, however, and at higher doses (≥ 20 mg) bisoprolol fumarate also inhibits beta2-adrenoceptors, chiefly located in the bronchial and vascular musculature; to retain selectivity, it is therefore important to use the lowest effective dose.
INDICATIONS BISOPROLOL KANAWATI is indicated in the management of hypertension. It may be used alone or in combination with other antihypertensive agents.
CONTRAINDICATIONS BISOPROLOL KANAWATI is contraindicated in patients with cardiogenic shock, overt cardiac failure, second or third degree AV block, and marked sinus bradycardia.
Side EFFECTS The most common side effects associated with bisoprolol fumarate include dizziness, headache, somnolence, sleep disturbances, dry mouth, bradycardia, palpitations and hypotension, dyspepsia, nausea, vomiting, diarrhea, constipation, peptic ulcer. rash, pruritus, visual disturbances, tinnitus, coughing, bronchospasm, dyspnea, pharyngitis, rhinitis, sinusitis, decreased libido/impotence.
WARNINGS In general, beta-blocking agents should be avoided in patients with overt congestive failure. Continued depression of the myocardium with beta-blockers can, in some patients, precipitate cardiac failure. At the first signs or symptoms of heart failure, discontinuation of bisoprolol should be considered. In some cases, beta-blocker therapy can be continued while heart failure is treated with other drugs. Exacerbation of angina pectoris, and, in some instances, myocardial infarction or ventricular arrhythmia, have been observed in patients with coronary artery disease following abrupt cessation of therapy with beta-blockers. Such patients should, therefore, be cautioned against interruption or discontinuation of therapy without the physician’s advice. Even in patients without overt coronary artery disease, it may be advisable to taper therapy with bisoprolol over approximately one week with the patient under careful observation. If withdrawal symptoms occur, bisoprolol therapy should be reinstituted, at least temporarily. Beta-blockers can precipitate or aggravate symptoms of arterial insufficiency in patients with peripheral vascular disease. Caution should be exercised in such individuals. PATIENTS WITH BRONCHOSPASTIC DISEASE SHOULD, IN GENERAL, NOT RECEIVE BETA-BLOCKERS. Because of its relative beta1-selectivity, however, bisoprolol may be used with caution in patients with bronchospastic disease who do not respond to, or who cannot tolerate other antihypertensive treatment. Since beta1-selectivity is not absolute, the lowest possible dose of bisoprolol fumarate should be used with therapy starting at 2.5 mg. A beta2 agonist (bronchodilator) should be made available. If bisoprolol treatment is to be continued perioperatively, particular care should be taken when anesthetic agents which depress myocardial function, such as ether, cyclopropane, and trichloroethylene, are used. Beta-blockers may mask some of the manifestations of hypoglycemia, particularly tachycardia. Patients subject to spontaneous hypoglycemia, or diabetic patients receiving insulin or oral hypoglycemic agents, should be cautioned about these possibilities and bisoprolol fumarate should be used with caution. Beta-adrenergic blockade may mask clinical signs of hyperthyroidism, such as tachycardia. Abrupt withdrawal of beta-blockade may be followed by an exacerbation of the symptoms of hyperthyroidism or may precipitate thyroid storm. Use caution in adjusting the dose of bisoprolol in patients with renal or hepatic impairment.
DRUG INTERACTIONS Bisoprolol should not be combined with other beta-blocking agents. Patients receiving catecholamine-depleting drugs, such as reserpine or guanethidine, should be closely monitored, because the added beta-adrenergic blocking action of bisoprolol may produce excessive reduction of sympathetic activity. In patients receiving concurrent therapy with clonidine, if therapy is to be discontinued, it is suggested that bisoprolol be discontinued for several days before the withdrawal of clonidine. Bisoprolol should be used with care when myocardial depressants or inhibitors of AV conduction, such as certain calcium antagonists [particularly (verapamil) and (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. Concurrent use of rifampin increases the metabolic clearance of bisoprolol, resulting in a shortened elimination half-life of bisoprolol. However, initial dose modification is generally not necessary.
Pregnancy And lactations Category C": There are no adequate and well-controlled studies in pregnant women. Bisoprolol fumarate should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk caution should be exercised when bisoprolol fumarate is administered to nursing women.
Dosage And Administration The dose of bisoprolol fumarate must be individualized to the needs of the patient. The usual starting dose is 5 mg once daily. In some patients, 2.5 mg may be an appropriate starting dose. If the antihypertensive effect of 5 mg is inadequate, the dose may be increased to 10 mg and then, if necessary, to 20 mg once daily. Patients with Renal or Hepatic Impairment: In patients with hepatic impairment (hepatitis or cirrhosis) or renal dysfunction (creatinine clearance less than 40 ml/min), the initial daily dose should be 2.5 mg and caution should be used in dose-titration. Since limited data suggest that bisoprolol fumarate is not dialyzable, drug replacement is not necessary in patients undergoing dialysis. Geriatric Patients: It is not necessary to adjust the dose in the elderly, unless there is also significant renal or hepatic dysfunction. Pediatric Patients: There is no pediatric experience with bisoprolol fumarate.
OVERDOSE The most common signs expected with overdosage of a beta-blocker are bradycardia, hypotension, congestive heart failure, bronchospasm, and hypoglycemia. In general, if overdose occurs, bisoprolol therapy should be stopped and supportive and symptomatic treatment should be provided.
Storage Conditions “ Store at room temperature, between 20°- 25° C” “Keep out of reach of children” “Prescription only medicine”