We performed a randomized, double-blind, three-period cross-over study of felbamate (FBM, 2-phenyl-1,3-propanediol dicarbamate: Carter-Wallace 554) in patients with complex partial seizures. Patients continued carbamazepine (CBZ) throughout the study and were observed in the hospital for the entire trial period. The entry criteria required at least six seizures in a 3-week baseline period (and no more than 1 week with a single seizure) with CBZ alone. Thirty subjects were randomized. Two left the study after randomization, 1 owing to seizure exacerbation, and 1 owing to hyponatremia, which may have been related to CBZ therapy. The daily dosage of 50 mg/kg (maximum 3,000 mg) FBM per day was well tolerated by all 28 patients who completed the study. Only mild adverse experience were observed during the trial. FBM reduced CBZ level (p less than 0.0001; 95% confidence interval -28%, -20%). There was no significant difference in seizure frequency between placebo and FBM periods (one-sided p = 0.172), but when a correction was made for the lower CBZ level noted during FBM periods, the data suggested a strong antiseizure effect of FBM.
Felbamate (FBM) is a novel antiepileptic drug (AED) currently undergoing clinical evaluation in the United States. During a controlled clinical trial conducted at the National Institutes of Health Clinical Center, FBM was added to constant carbamazepine (CBZ) monotherapy. CBZ total concentrations were reduced during active FBM treatment (mean reduction 25%, range 10-42%, p less than 0.001). The effect was evident after the first week of treatment and reached a plateau in 2-4 weeks. To clarify the interaction mechanism, free and total concentrations of CBZ and its plasma metabolites were determined by high-performance liquid chromatography (HPLC) and ultrafiltration in four patients. In these patients, FBM treatment reduced CBZ concentrations and increased CBZ-epoxide (CBZ-E) concentrations (p less than 0.01). Free fractions of all compounds were unmodified. FBM appears to be capable of inducing CBZ metabolism. CBZ-FBM interaction may be clinically relevant.
Historically, herbs and foods have been used as galactogogues by breastfeeding women to maintain and increase milk supply. Commonly used herbs and foods used as galactogogues are reviewed. Doses, other uses for taking herbals by breastfeeding mothers, and cautions to observe when using these galactogogues are discussed. This information can be used by health care professionals as general guidelines to counsel lactating mothers who wish to use or are already using herbals or consuming foods to stimulate milk supply. A brief mention of prescription galactogogue alternatives is provided. Sources of currently available nonprescription galactogogue information are listed. This information will be useful for community, clinic, hospital, and other health care settings where consultative services are provided to breastfeeding mothers. Utilization of the information provided will allow health care professionals to counsel mothers on the use of herbals and foods as galactogogues.
A breastfeeding mother is confronted with a wide variety of over-the-counter products, necessitating careful guidance from her health care professional. This article presents a discussion and comprehensive tables that cover, by category, over-the-counter medications that nursing mothers may need to take. These tables should greatly assist the health care professional in the important task of counseling the nursing mother about the proper use of over-the-counter medications. This information will enable health care professionals to interpret information on the topic of over-the-counter medications and breastfeeding; list medications, in specific over-the-counter categories, that are usually safe to take while breastfeeding; recommend over-the-counter medications of choice for a breastfeeding mother; and generally counsel a breastfeeding mother who is taking or expects to take over-the-counter medications.
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