April 2003

Jane S. Ricciuti, RPh, MS

April 22, 2003

Parasympathomimetic Agents

Mytelase

(ambenonium chloride) Capsules

Manufacturer: Sanofi-Synthelabo, Inc

Drug Approval Classification: Supplemental New Drug Application (Approval Date: 2/26/03)

Precautions: The labeling for Mytelase (ambenonium chloride) has been revised to include a Geriatric subsection to the "Precautions" section:

Geriatric Use: Clinical studies of MYTELASE did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.'

Mytelase (ambenonium chloride) Capsules Letter

Mytelase (ambenonium chloride) Capsules

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Cite this: April 2003 - Medscape - Apr 23, 2003.

Table 1. Moxifloxacin Efficacy in the Treatment of Penicillin-Resistant *Streptococcus pneumoniae* CAP
Pathogen	Moxifloxacin		Comparators
Pathogen	n/N	%	n/N	%
All S pneumoniae	230/244	94	138/162	85
S pneumoniae bacteremia	53/58	91	35/41	85
S pneumoniae with penicillin MIC penicillin ≥ 2 mcg/mL	21/21	100	5/5	100
S pneumoniae bacteremia with penicillin MIC penicillin ≥ 2 mcg/mL	7/7	100	2/2	100

Table 2. Adverse Events Reported in Pediatric Cooperative Group Trial
	*No. (%) of Temodar* Patients (N = 122)**
Body System/Organ Class Adverse Event (AE)	All Events	Grade 3/4
Subjects reporting an AE body as a whole	107 (88)	69 (57)
Central and Peripheral Nervous System
Central cerebral CNS cortex	22 (18)	13 (11)
Gastrointestinal System
Nausea	56 (46)	5 (4)
Vomiting	62 (51)	4 (3)
Platelet, Bleeding, and Clotting
Thrombocytopenia	71 (58)	31 (25)
Red Blood Cell Disorders
Decreased hemoglobin	62 (51)	7 (6)
White Cell and RES Disorders
Decreased WBC	71 (58)	21 (17)
Lymphopenia	73 (60)	48 (39)
Neutropenia	62 (51)	24 (20)

Table 3. Outcomes of Randomized Treatment at Week 24 (Pooled Studies T20-301 and T20-302)
Outcomes	Fuzeon + Background Regimen 90 mg Twice Daily	Background Regimen
	N = 661	N = 334
HIV-1 RNA log change from baseline (log₁₀ copies/mL)	-1.52	-0.73
CD4+ cell count change from baseline (cells/mm²)	+71	+35
HIV RNA ≥ 1 log below baseline	342 (52%)	86 (26%)
HIV RNA < 400 copies/mL	247 (37%)	54 (16%)
HIV RNA < 50 copies/mL	151 (23%)	30 (9%)
Discontinued due to adverse reactions/labs*	40 (6%)	12 (4%)
Discontinued due to injection site reactions*	20 (3%)	N/A
Discontinued due to other reactions*	36 (5%)	14 (4%)

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April 2003

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