BETASTAD 5 Tablet

In the management of hypertension and angina pectoris.

An adjunct to standard therapy in patients with stable chronic heart failure.

Dosage and Administration

Administration

For oral administration.

Dosage

- Hypertension or angina pectoris: The usual dose is 5-10mg orally as a single daily dose; the maximum recommended dose is 20mg daily.

- Congestive heart failure: The initial oral dose is 1.25mg once daily. If tolerated, the dose should be doubled after 1 week and then increased gradually at 1-4 week intervals to the maximum dose tolerated; this should not exceed 10mg once daily.

- Dosage in renal and hepatic impairment: The initial dose of bisoprolol fumarate for hypertension should be 2.5mg daily and that the dose should be increased cautiously in patients with severe hepatic impairment or renal impairment (creatinine clearance less than 40ml/minute). A maximum dose of 10mg daily for both angina pectoris and hypertension in patients with severe hepatic impairment or with a creatinine clearance of less than 20ml/minute.

- Acute heart failure or during episodes of heart failure decompensation requiring i.v. inotropic therapy.

- Cardiogenic shock.

- Atrioventricular (AV) block of second or third degree (without a pacemaker).

- Sick sinus syndrome.

- Sinoatrial block.

- Bradycardia with less than 60beats/min. before the start of therapy.

- Hypotension (systolic blood pressure less than 100mmHg).

- Severe bronchial asthma or severe chronic obstructive pulmonary disease.

- Late stages of peripheral arterial occlusive disease and Raynaud’s syndrome.

- Untreated phaeochromocytoma.

- Metabolic acidosis.

- Hypersensitivity to bisoprolol or to any of the excipients.

- Central nervous system: Dizziness, vertigo, headache, paresthesia, hypoaesthesia, somnolence, anxiety/restlessness and decreased concentration/memory.

- Automatic nervous system: Dry mouth.

- Cardiovascular: Bradycardia, palpitations, other rhythm disturbances, cold extremities, claudication, hypotension, chest pain, congestive heart failure and dyspnea on exertion.

- Psychiatric: Vivid dreams, insomnia and depression.

- Gastrointestinal: Gastric/epigastric/abdominal pain, gastritis, dyspepsia, nausea, vomiting, diarrhea and constipation.

- Musculoskeletal: Muscle/joint pain, back/neck pain, muscle cramps and twitching/tremor.

- Skin: rash, eczema, skin irritation, pruritus, flushing, sweating, alopecia, angioedema, exfoliative dermatitis and cutaneous vasculitis.

- Special senses: Visual disturbances, ocular pain/pressure, abnormal lacrimation, tinnitus, earache and taste abnormalities.

- Metabolic: Gout.

- Respiratory: Asthma/bronchospasm, bronchitis, coughing, dyspnea, pharyngitis, rhinitis and sinusitis.

- Genit0-urinary: Decreased libido/impotence, cystitis and renal colic.

- Hematologic: Purpura.

- General: Fatigue, asthenia, chest pain, malaise, edema and weight gain.

See the package insert about the details.

- Patient receiving catecholamine-depleting drugs, such as reserpine or guanethidine

- Myocardial depressants or inhibitors of AV conduction, such as certain calcium antagonists [particularly of phenylalkylamine (verapamil) and benzodiazepine (diltiazem) classes],or antiarrhythmic agents, such as disopyramide

- rifampicin

Pregnancy

There are no adequate and well-controlled studies in pregnant women. Bisoprolol should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Lactation

Small amounts of bisoprolol have been detected in the milk of lactating rats. 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 is administered to nursing women.

See the package insert about the details.

- Cardiac failure

- In patients without a history of cardiac failure

- Abrupt cessation of therapy

- Peripheral vascular disease

- Bronchospastic disease

- Diabetes and hypoglycemia

- Thyrotoxicosis

- Bisoprolol is a beta1-selective adrenergic receptor blocking agent without significant membrane stabilizing activity or intrinsic sympathomimetic activity in its therapeutic dosage range.

- At low dosages, bisoprolol selectively inhibits response to adrenergic stimuli by competitively blocking cardiac beta1-adrenergic receptors, while having little effect on the beta2-adrenergic receptors of bronchial and vascular smooth muscle. At high dosages, the selectivity of bisoprolol on beta2- adrenergic receptors usually diminishes and bisoprolol will competitively inhibit beta1 and beta2-adrenergic receptors.