Bisoprolol Fumarate Tablets USP

SECTION 2: Hazards identification

Dose and Administration The dose of Bisoprolol fumarate tablets, USP 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. Adverse Effects Central Nervous System: Dizziness, unsteadiness, vertigo, syncope, headache, paresthesia, hypoesthesia, hyperesthesia, somnolence, sleep disturbances, anxiety/restlessness, and decreased concentration/ memory. Autonomic Nervous System: Dry mouth. Cardiovascular Bradycardia: Palpitations and other rhythm disturbances, cold extremities, claudication, hypotension, orthostatic hypotension, chest pain, congestive heart failure, dyspnea on exertion. Psychiatric: Vivid dreams, insomnia, depression. Gastrointestinal: Gastric/epigastric/abdominal pain, gastritis, dyspepsia, nausea, vomiting, diarrhoea, constipation, peptic ulcer. Musculoskeletal: Muscle/joint pain, arthralgia, back/neck pain, muscle cramps, twitching/tremor. Skin: Rash, acne, eczema, psoriasis, skin irritation, pruritus, flushing, sweating, alopecia, dermatitis, angioedema, exfoliative dermatitis, cutaneous vasculitis. Special Senses: Visual disturbances, ocular pain/pressure, abnormal lacrimation, tinnitus, decreased hearing, earache, taste abnormalities. Respiratory: Asthma/bronchospasm, bronchitis, coughing, dyspnea, pharyngitis, rhinitis, sinusitis, URI. Central Nervous System: Reversible mental depression progressing to catatonia, hallucinations, an acute reversible syndrome characterized by disorientation to time and place, emotional lability, slightly clouded sensorium. Overdosage If overdose occurs, bisoprolol fumarate therapy should be stopped and supportive and symptomatic treatment should be provided. Limited data suggest that bisoprolol fumarate is not dialyzable. Based on the expected pharmacologic actions and recommendations for other beta-blockers, the following general measures should be considered when clinically warranted: Bradycardia: Administer IV atropine. If the response is inadequate, isoproterenol or another agent with positive chronotropic properties may be given cautiously. Under some circumstances, transvenous pacemaker insertion may be necessary. Hypotension: IV fluids and vasopressors should be administered. Intravenous glucagon may be useful. Heart Block (second or third degree): Patients should be carefully monitored and treated with isoproterenol infusion or transvenous cardiac pacemaker insertion, as appropriate. Congestive Heart Failure: Initiate conventional therapy (i.e., digitalis, diuretics, inotropic agents, vasodilating agents). Bronchospasm: Administer bronchodilator therapy such as isoproterenol and/or aminophylline. Hypoglycemia: Administer IV glucose. Pregnancy Comments 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. Pregnancy Category Category C