Cardicor Tablet 2.5mg

Product Information

CARDICOR

Cardicor®Bisoprolol

Presentation

Cardicor-2.5 Tablet: Yellow, shield-shaped, scored on one side and ª marked on another side of the tablet; each film coated tablet

contains Bisoprolol Fumarate USP 2.5mg.

Cardicor-5 Tablet: Orange, shield-shaped, scored on one side and ª marked on another side of the tablet; each film coated tablet

contains Bisoprolol Fumarate USP 5mg.

Indications

Bisoprolol is indicated in the management of hypertension and stable chronic angina. It can also be used in the treatment of

stable chronic heart failure in addition to ACE inhibitors, and diuretics, and optionally cardiac glycosides. It may be used alone

or in combination with other antihypertensive agents.

Dosage and administration

Bisoprolol tablet should be taken in morning and can be taken with food in morning. Hypertension & angina pectoris: The usual

starting dose is Bisoprolol 5mg (one Cardicor-5 tablet) once daily. In some patients, Bisoprolol 2.5mg (one Cardicor-2.5 tablet)

may be an appropriate starting dose. If the antihypertensive effect of Bisoprolol 5mg is inadequate, the dose may be increased to

Bisoprolol 10mg and then, if necessary, to 20mg once daily. Heart failure: Adjunct in heart failure, initially 1.25mg once daily

(in the morning) for 1 week, then if well tolerated, increased to 2.5mg once daily for 1 week, then 3.75mg once daily for 1 week,

then 5mg once daily for 4 weeks, then 7.5mg once daily for 4 weeks, then 10mg once daily; max. 10mg daily.

Patients with renal impairment: In patients with severe renal impairment (creatinine clearance < 20ml/min) the dose should not

exceed 10mg once daily, the initial daily dose should be 2.5mg and caution should be used in dose-titration. Patients with hepatic

impairment: No dosage adjustment is required, however careful monitoring is advised. Maximum 10mg daily in severe impairment.

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. Paediatric Patients: There is no paediatric experience with Bisoprolol.

Contra-indications, warnings, etc.

Contra-indications: Bisoprolol is contra-indicated in patients with cardiogenic shock, overt cardiac failure, second or third

degree AV block, and marked sinus bradycardia. Warnings: The treatment of stable chronic heart failure with Bisoprolol has to be

initiated with special titration phase. Especially in patients with ischemic heart disease the cessation of therapy with

Bisoprolol must not be done abruptly unless clearly indicated, because this may lead to transition worsening of heart condition.

Use in pregnancy and lactation: Bisoprolol should not be used during pregnancy unless clearly necessary. If treatment with

Bisoprolol is considered necessary, the uteroplacental blood flow and the foetal growth should be monitored. In case of harmful

effects on pregnancy or the foetus, alternative treatment should be considered. The newborn infant must be closely monitored.

Symptoms of hypoglycaemia and bradycardia are generally to be expected within the first 3 days. It is not known whether this drug

is excreted in human milk. Therefore, breastfeeding is not recommended during administration of Bisoprolol. Drug Interactions:

Bisoprolol should not be combined with other beta-blocking agents. Patients receiving catecholaminedepleting 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

(verapamil and diltiazem classes), or antiarrhythmic agents, such as disopyramide, are used concurrently. 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. There was no effect of Bisoprolol on prothrombin time in patients

on stable doses of warfarin. Risk of Anaphylactic Reaction: While taking ß-blockers, patients with a history of severe

anaphylactic reaction to a variety of allergens may be more reactive to repeated challenge, either accidental, diagnostic, or

therapeutic. Such patients may be unresponsive to the usual doses of epinephrine

used to treat allergic reactions.

Side-effects: Fatigue, dizziness, headache, disturbances of the gut such as nausea, vomiting, diarrhoea, constipation or abdominal

pain, cold or numb extremities, e.g. hands and feet, muscle weakness or cramps, slower than normal heart beat

(bradycardia), worsening of heart failure, sleep disturbance, depression, breathing difficulties due to a narrowing of the airways

(bronchospasm) in people with asthma or COPD. Overdose: The most common signs expected with overdose of a beta-blocker are

bradycardia, hypotension, congestive heart failure, bronchospasm, and hypoglycemia. Only a few cases of overdose with Bisoprolol

have been reported. Bradycardia and/or hypotension were noted. Sympathomimetic agents were given in some cases, and all patients

recovered. In general, if overdose occurs, Bisoprolol therapy should be stopped and supportive and symptomatic treatment should

be provided.

Pharmaceutical precautions

Store in a cool and dry place, protected from light.

Packaging quantities

Cardicor-2.5 Tablet: Cartons containing 30 tablets in blister pack.

Cardicor-5 Tablet:Cartons containing 30 tablets in blister pack.