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Treatment-Emergent Adverse Event Incidence in 6- to 9 Week Placebo-Controlled Clinical Trials* Clonazepam Maximum Daily Dose Central klonopin & Peripheral Nervous Coordination Abnormal† Memory Disturbance Reference ID: 3398090 NDA 017533 Klonopin (clonazepam) tablets FDA Approved Labeling Text October 2013 Clonazepam Maximum Daily Dose Intellectual Ability Reduced Emotional Lability Libido Decreased Respiratory System Upper Respiratory Tract Gastrointestinal System Appetite Decreased Reference ID: 3398090 NDA 017533 Klonopin (clonazepam) tablets FDA Approved Labeling Text October 2013 Clonazepam Maximum Daily Dose Allergic Reaction Resistance Mechanism Micturition Frequency Urinary Tract Infection† Vision Disorders Reproductive Disorders‡ Ejaculation Delayed * Events reported by at least 1% of patients treated with Klonopin and for which the incidence was greater than that for placebo .
klonopin effects clonazepam metabolites rivotril galenika clonazepam zapiz 0.25 clonotril clonazepam † Indicates that the p-value for the dose-trend test (Cochran-Mantel-Haenszel) for adverse event incidence was ≤0 .
‡ Denominators for klonopin events in gender-specific systems are: n=240 (clonazepam), 102 (placebo) for male, and 334 (clonazepam), 192 (placebo) for female .
Reference ID: 3398090 NDA 017533 Klonopin (clonazepam) tablets FDA Approved Labeling Text October 2013 Commonly Observed Adverse Events: Incidence of Most Commonly Observed Adverse Events* in Acute Therapy in Pool of 6- to 9-Week Trials (Genentech Preferred Term) Coordination Abnormal * Treatment-emergent events for which the incidence in klonopin the clonazepam patients was ≥5% and at least twice that in the placebo patients .
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