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Terbinafine lamisil 250 mg oral tablet b) Placebo c) dosing intervals between 250 mg dose and each of the combination d) Interaction with other medications (e.g., CYP2D6 inhibitor) e) Contraindications 2.3 Therapeutic Index The therapeutic index of a compound is the proportion of patients who achieve at least 50% reduction in disease activity (DAD) as compared with pretreatment values (i.e., placebo). Therapeutic Index are defined as Terbinafine 240 Pills 350mg $319 - $1.33 Per pill follows: Treatment Patients with at least 50% reduction in disease activity (DAD) from pretreatment values (placebo) Placebo patients 100% with more than 50% reduction in disease activity (DAD) from pretreatment values (placebo) Placebo patients 0% 2.4 Dose-Composition-Induced Dose-Response A Dose-Response-Effect (DREC) study was performed comparing the efficacy of lamisil 250 mg with the potency of imatinib mesylate (500 mg) in patients with mild to moderate chronic obstructive pulmonary disease (COPD). DREC is the time to first treatment response (e.g., improvement in the patient's condition) a dose-dependent manner for the two drugs (1). A DREC value of 50% indicates that patients experience at least 50% reduction in disease activity (DAD) as compared with pretreatment values (placebo), and a DREC of 75% or more indicates that of patients will experience at least 75% reduction. For the DREC study, 200 patients were randomized to lamisil or imatinib mesylate (500 mg) on four separate occasions. Placebo and imatinib mesylate were prepared as described above and were administered orally at different times of day. After 1 week treatment, at each time point, lamisil and imatinib mesylate were administered the responses recorded. One week after the last dose of lamisil or imatinib mesylate was administered, the patients were randomized to a fourth group of patients receiving only placebo. Treatment was monitored by daily oral end-of-study surveys (EMAOS) to determine the response. At each time point, EMAOS was repeated at half-lives of 6, 12, 18, 24, and 36 months after the last dose. Results The mean DREC for lamisil compared with placebo was 42.2% (60/200) at day 6, 61.8% (125/200) 12, 75.4% (200/200) at day 18, and 73.9% (200/200) at day 24. The DREC for imatinib mesylate compared with lamisil was 54.8% (70/200). Treatment-emergent adverse effects included: eosinophilic chest pain or discomfort, asthenia, asthenia weakness at doses less than 250 mg/day, diplopia at doses less than 250 mg/day, and headache at doses less than 250 mg/day (P <.001). The frequency of treatment-emergent adverse effects was higher with lamisil than imatinib mesylate (P <.001). No significant treatment-emergent adverse effects were reported with lamisil at doses less than 250 mg/day compared with imatinib mesylate. Lamisil has been shown to be as efficacious imatinib mesylate in the treatment of mild to moderate COPD patients. The combination of lamisil and imatinib mesylate was more effective than lamisil alone in the treatment of moderate COPD patients. These data suggest a synergistic effect of lamisil and imatinib mesylate in the treatment of moderate to severe COPD. No patients had a serious adverse event. 2.5 Adverse Reactions Common Adverse Reactions (≥1%) in Patients Who Received Lamisil Common Adverse Reactions (≥1%) in Patients Who Received Imatinib Mesylate The following adverse reactions have been identified during postmarketing experience with lamisil: In the randomized DREC study, occurrence of treatment-emergent serious adverse events, mainly respiratory tract disorders, occurred during the interval from pretreatment to 28 days post-dose and included: bronchospasm (5.3%), asthenia bronchopneumonia (4.8%), hypercapnia (4.3%), hypotension (3.4%), transient respiratory acidosis (3.1%), tachycardia (2.6%), orthostatic hypotension (2.1%), bronchospasm ()