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adverse reactions
ADVERSE REACTIONS Bisoprolol Fumarate and Hydrochlorothiazide Bisoprolol fumarate/H6.25 mg is well tolerated in most patients. Most adverse effects (AEs) have been mild and transient. In more than 65,000 patients treated worldwide with bisoprolol fumarate, occurrences of bronchospasm have been rare. Discontinuation rates for AEs were similar for bisoprolol fumarate/H6.25 mg and placebo-treated patients. In the United States, 252 patients received bisoprolol fumarate (2.5 mg, 5 mg, 10 mg or 40 mg)/H6.25 mg and 144 patients received placebo in two controlled trials. In Study 1, bisoprolol fumarate 5 mg/H6.25 mg was administered for 4 weeks. In Study 2, bisoprolol fumarate 2.5 mg, 10 mg or 40 mg/H6.25 mg was administered for 12 weeks. All adverse experiences, whether drug related or not, and drug related adverse experiences in patients treated with bisoprolol fumarate 2.5 mg to 10 mg/H6.25 mg, reported during comparable, 4 week treatment periods by at least 2% of bisoprolol fumarate/H6.25 mg-treated patients (plus additional selected adverse experiences) are presented in the following table: % of Patients with Adverse Experiences Averages adjusted to combine across studies. Body System/ Adverse Experience All Adverse Experiences Drug Related Adverse Experiences Placebo Combined across studies. (n=144) % B2.5- 40/H6.25 (n=252) % Placebo (n=144) % B2.5- 10/H6.25 (n=221) % Cardiovascular bradycardia arrhythmia peripheral ischemia chest pain 0.7 1.4 0.9 0.7 1.1 0.4 0.7 1.8 0.7 0.0 0.9 0.7 0.9 0.0 0.4 0.9 Respiratory bronchospasm cough rhinitis URI 0.0 1.0 2.0 2.3 0.0 2.2 0.7 2.1 0.0 0.7 0.7 0.0 0.0 1.5 0.9 0.0 Body as a Whole asthenia fatigue peripheral edema 0.0 2.7 0.7 0.0 4.6 1.1 0.0 1.7 0.7 0.0 3.0 0.9 Central Nervous System dizziness headache 1.8 4.7 5.1 4.5 1.8 2.7 3.2 0.4 Musculoskeletal muscle cramps myalgia 0.7 1.4 1.2 2.4 0.7 0.0 1.1 0.0 Psychiatric insomnia somnolence loss of libido impotence 2.4 0.7 1.2 0.7 1.1 1.1 0.4 1.1 2.0 0.7 1.2 0.7 1.2 0.9 0.4 1.1 Gastrointestinal diarrhea nausea dyspepsia 1.4 0.9 0.7 4.3 1.1 1.2 1.2 0.9 0.7 1.1 0.9 0.9 Other adverse experiences that have been reported with the individual components are listed below. Bisoprolol Fumarate USP In clinical trials worldwide, or in postmarketing experience, a variety of other AEs, in addition to those listed above, have been reported. While in many cases it is not known whether a causal relationship exists between bisoprolol and these AEs, they are listed to alert the physician to a possible relationship. Central Nervous System: Unsteadiness, dizziness, vertigo, headache, syncope, paresthesia, hypoesthesia, hyperesthesia, sleep disturbance/vivid dreams, insomnia, somnolence, depression, anxiety/restlessness, decreased concentration/memory. Cardiovascular: Bradycardia, palpitations and other rhythm disturbances, cold extremities, claudication, hypotension, orthostatic hypotension, chest pain, congestive heart failure, dyspnea on exertion. Gastrointestinal: Gastric/epigastric/abdominal pain, peptic ulcer, gastritis, dyspepsia, nausea, vomiting, diarrhea, constipation, dry mouth. Musculoskeletal: Arthralgia, muscle/joint pain, back/neck pain, muscle cramps, twitching/tremor. Skin: Rash, acne, eczema, psoriasis, skin irritation, pruritus, purpura, flushing, sweating, alopecia, dermatitis, exfoliative dermatitis (very rarely), cutaneous vaculitis. Special Senses: Visual disturbances, ocular pain/pressure, abnormal lacrimation, tinnitus, decreased hearing, earache, taste abnormalities. Metabolic: Gout. Respiratory : Asthma, bronchospasm, bronchitis, dyspnea, pharyngitis, rhinitis, sinusitis, URI (upper respiratory infection). Genito-urinary: Decreased libido/impotence, Peyronie’s disease (very rarely), cystitis, renal colic, polyuria. General: Fatigue, asthenia, chest pain, malaise, edema, weight gain, angioedema. In addition, a variety of adverse effects have been reported with other beta-adrenergic blocking agents and should be considered potential adverse effects: 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. Allergic: Fever, combined with aching and sore throat, laryngospasm, and respiratory distress. Hematologic: Agranulocytosis, thrombocytopenia. Gastrointestinal: Mesenteric arterial thrombosis and ischemic colitis. Miscellaneous: The oculomucocutaneous syndrome associated with the beta-blocker practolol has not been reported with bisoprolol fumarate during investigational use or extensive foreign marketing experience. Hydrochlorothiazide USP The following adverse experiences, in addition to those listed in the above table, have been reported with hydrochlorothiazide USP (generally with doses of 25 mg or greater). General: Weakness. Central Nervous System: Vertigo, paresthesia, restlessness. Cardiovascular: Orthostatic hypotension (may be potentiated by alcohol, barbiturates, or narcotics). Gastrointestinal: Anorexia, gastric irritation, cramping, constipation, jaundice (intrahepatic cholestatic jaundice), pancreatitis, cholecystitis, sialadenitis, dry mouth. Musculoskeletal: Muscle spasm. Hypersensitive Reactions: Purpura, photosensitivity, rash, urticaria, necrotizing angiitis (vasculitis and cutaneous vasculitis), fever, respiratory distress including pneumonitis and pulmonary edema, anaphylactic reactions. Special Senses: Transient blurred vision, xanthopsia. Metabolic: Gout. Genitourinary: Sexual dysfunction, renal failure, renal dysfunction, interstitial nephritis. Laboratory Abnormalities Bisoprolol Fumarate and Hydrochlorothiazide Tablets Because of the low dose of hydrochlorothiazide in bisoprolol fumarate and hydrochlorothiazide, adverse metabolic effects with bisoprolol fumarate/H6.25 mg are less frequent and of smaller magnitude than with HCTZ 25 mg. Laboratory data on serum potassium from the U.S. placebo-controlled trials are shown in the following table: Serum Potassium Data from U.S. Placebo Controlled Studies Placebo Combined across studies. (n=130 Patients with normal serum potassium at baseline. ) B2.5/ H6.25 mg (n=28 ) B5/ H6.25 mg (n=149 ) B10/ H6.25 mg (n=28 ) HCTZ mg (n=142 ) Potassium Mean Change Mean change from baseline at Week 4. (mEq/L) +0.04 +0.11 -0.08 0.00 -0.30 %Hypokalemia Percentage of patients with abnormality at Week 4. 0.0% 0.0% 0.7% 0.0% 5.5% Treatment with both beta blockers and thiazide diuretics is associated with increases in uric acid. However, the magnitude of the change in patients treated with B/H 6.25 mg was smaller than in patients treated with HCTZ 25 mg. Mean increases in serum triglycerides were observed in patients treated with bisoprolol fumarate and hydrochlorothiazide 6.25 mg. Total cholesterol was generally unaffected, but small decreases in HDL cholesterol were noted. Other laboratory abnormalities that have been reported with the individual components are listed below. Bisoprolol Fumarate USP In clinical trials, the most frequently reported laboratory change was an increase in serum triglycerides, but this was not a consistent finding. Sporadic liver test abnormalities have been reported. In the U.S. controlled trials experience with bisoprolol fumarate treatment for 4 to 12 weeks, the incidence of concomitant elevations in SGOT and SGPT from 1 to 2 times normal was 3.9%, compared to 2.5% for placebo. No patient had concomitant elevations greater than twice normal. In the long-term, uncontrolled experience with bisoprolol fumarate treatment for 6 to 18 months, the incidence of one or more concomitant elevations in SGOT and SGPT from 1 to 2 times normal was 6.2%. The incidence of multiple occurrences was 1.9%. For concomitant elevations in SGOT and SGPT of greater than twice normal, the incidence was 1.5%. The incidence of multiple occurrences was 0.3%. In many cases these elevations were attributed to underlying disorders, or resolved during continued treatment with bisoprolol fumarate. Other laboratory changes included small increases in uric acid, creatinine, BUN, serum potassium, glucose, and phosphorus and decreases in WBC and platelets. There have been occasional reports of eosinophilia. These were generally not of clinical importance and rarely resulted in discontinuation of bisoprolol fumarate. As with other beta-blockers, ANA conversions have also been reported on bisoprolol fumarate. About 15% of patients in long-term studies converted to a positive titer, although about one-third of these patients subsequently reconverted to a negative titer while on continued therapy. Hydrochlorothiazide USP Hyperglycemia, glycosuria, hyperuricemia, hypokalemia and other electrolyte imbalances (see PRECAUTIONS ), hyperlipidemia, hypercalcemia, leukopenia, agranulocytosis, thrombocytopenia, aplastic anemia and hemolytic anemia have been associated with HCTZ therapy.