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Pivot Concepts:
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Target Concepts:
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Query: UMLS:C0027497 (
nausea
)
23,468
document(s) hit in 31,850,051 MEDLINE articles (0.00 seconds)
A double-blind, randomized phase I clinical trial was carried out to compare Fansimef (a fixed-dose combination of mefloquine, sulfadoxine, and pyrimethamine) with sulfadoxine and pyrimethamine (
Fansidar
) for safety and tolerance. Twenty adult male Brazilian subjects from malaria endemic areas were studied for a period of 66 days, which included 2 days before and 63 days after drug administration.Both drugs were well tolerated and safe, as seen from the absence of drug-induced changes in the various laboratory, haematological, and biochemical parameters measured. Fansimef produced a complete clearance of parasites on day 3, with an "S" type response in one subject who had blood smears which were positive for Plasmodium falciparum on day 0. Two subjects in the sufladoxine-pyrimethamine group also had P. falciparum infections on day 0; the parasitaemia was cleared on day 2 in one of these subjects and on day 3 in the other, but an early RI response (recrudescence) was observed in the former case. Relapses due to P. vivax occurred in both groups.Side-effects due to Fansimef included mild dizziness,
nausea
, and vomiting. The incidence of dizziness and
nausea
was similar in the sulfadoxine-pyrimethamine group. In both groups, these side-effects were mild, short-lived and did not require specific treatment. Thus, Fansimef in an oral dose of three tablets (total of 750 mg mefloquine (base) plus 1500 mg sulfadoxine plus 75 mg pyrimethamine) was found to be well tolerated and safe.
...
PMID:A phase I clinical trial of Fansimef (mefloquine plus sulfadoxine-pyrimethamine) in Brazilian male subjects. 389 98
One hundred and five healthy nonimmunes in Colombia took part in a randomize, double-blind comparison of 250 mg of Lariam (L) (active ingredient: mefloquine) on alternate weeks or one tablet of
Fansidar
(F) (active ingredients: sulfadoxine and pyrimethamine) weekly for malaria prophylaxis during at least six months. Volunteers also gave blood for determination of drug concentrations after six months and/or 24-27 months of prophylaxis. Twenty-five volunteers withdrew involuntarily when they lost their jobs in the company. Two who took L withdrew due to moderate diarrhea and mild
nausea
or headache, weakness, drowsiness and anxiety. One volunteer stopped taking F due to severe unilateral hypostatic eczema and slight S-T depressions on the ECG. The rest completed at least six (range 6-36) months of prophylaxis. The mean half-life for L was 26 days. The AUCs in the time interval 0-14 days for L varied between 19.3-31.5 mumol x days/l. For the main metabolite, the corresponding range was 28.8-81.3 mumol x days/l. The range of trough concentrations at day 0 and 14 were 0.95-2.01 mumol/l for L and 1.69-5.62 mumol/l for the metabolite. No differences in tolerability and efficacy were noted between L and F. Our kinetic results do not indicate that enzymatic induction or inhibition would be important during long-term prophylaxis with mefloquine. This favors a continued use of the drug for very long periods of time (= years).
...
PMID:Comparative tolerability and kinetics during long-term intake of Lariam and Fansidar for malaria prophylaxis in nonimmune volunteers. 825 6
The standard first-line treatment for malaria in adults in Papua New Guinea is chloroquine; for severe and treatment-failure malaria standard therapy is a combination of quinine and
Fansidar
(sulphadoxine-pyrimethamine). These standard treatments are currently under revision. The present study evaluated the effect of halofantrine in treatment-failure falciparum malaria in adults in Port Moresby compared to standard therapy. In the halofantrine group all parasites were cleared by day 5 after starting therapy, in the quinine-
Fansidar
group by day 7. There was no evidence of recurrence of parasitaemia during the 21-day follow-up in either group.
Nausea
was associated with halofantrine use in 68% of patients. In the quinine-
Fansidar
group 79% had muffled deafness, 32% tinnitus and 26% dizziness; 32% of patients withdrew from treatment on day 2 because of intolerance to quinine. Halofantrine in this study population provided an efficacy against treatment-failure falciparum malaria similar to that of quinine-
Fansidar
, with a more favourable profile of adverse effects.
...
PMID:Halofantrine versus quinine-Fansidar combination in the treatment of post-chloroquine falciparum parasitaemia. 1093 52