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Side Effects & Drug Interactions
ADVERSE REACTIONS
In U. S. controlled studies the frequency of serious adverse experiences reported was very low and causal relationship has not been established. The 580 patients from 31 to 87 years of age who received GLUCOTROL XL Extended Release Tablets in doses from 5 mg to 60 mg in both controlled and open trials were included in the evaluation of adverse experiences. All adverse experiences report-ed were tabulated independently of their possible causal relation to medication. Hypoglycemia: Text Continues Below
See PRECAUTIONS and OVERDOSAGE sections. Only 3.4% of patients receiving GLUCOTROL XL Extended Release Tablets had hypoglycemia documented by a blood-glucose measurement <60 mg/ dL and/ or symptoms believed to be associated with hypoglycemia. In a comparative efficacy study of GLUCOTROL XL and Glucotrol, hypoglycemia occurred rarely with an incidence of less than 1% with both drugs. In double-blind, placebo-controlled studies the adverse experiences reported with an incidence of 3% or more in GLUCOTROL XL-treated patients include: GLUCOTROL XL (%) Placebo (%) (N= 278) (N= 69)
Adverse Effect Asthenia 10.1 13.0
Headache 8.6 8.7 Dizziness 6.8 5.8
Nervousness 3.6 2.9 Tremor 3.6 0.0
Diarrhea 5.4 0.0 Flatulence 3.2 1.4 The following adverse experiences occurred with an incidence of less than 3% in GLUCOTROL XL-treated patients: Body as a whole pain Nervous system insomnia, paresthesia, anxiety, depression and hypesthesia Gastrointestinal nausea, dyspepsia, constipation and vomiting Metabolic hypoglycemia Musculoskeletal arthralgia, leg cramps and myalgia Cardiovascular syncope Skin sweating and pruritus Respiratory rhinitis Special senses blurred vision Urogenital polyuria Other adverse experiences occurred with an incidence of less than 1% in GLUCOTROL XL-treated patients: Body as a whole chills Nervous system hypertonia, confusion, vertigo, somnolence, gait abnormality and decreased libido Gastrointestinal anorexia and trace blood in stool Metabolic thirst and edema Cardiovascular arrhythmia, migraine, flushing and hypertension Skin rash and urticaria Respiratory pharyngitis and dyspnea Special senses pain in the eye, conjunctivitis and retinal hemorrhage Urogenital dysuria
Although these adverse experiences occurred in patients treated with GLUCOTROL XL, a causal relationship to the medication has not been established in all cases.
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